Oxcarbazepine

5 WARNINGS AND PRECAUTIONS Hyponatremia: Monitor serum sodium levels ( 5.1 ) Cross Hypersensitivity Reaction to Carbamazepine: Discontinue immediately if hypersensitivity occurs ( 5.3 ) Serious Dermatological Reactions: If occurs, consider discontinuation ( 5.4 ) Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior ( 5.5 ) Withdrawal of AEDs: Withdraw Oxcarbazepine Oral Suspension gradually ( 5.6 ) Cognitive/Neuropsychiatric Adverse Reactions: May cause cognitive dysfunction, somnolence, and coordination abnormalities. Use caution when operating machinery ( 5.7 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Monitor and discontinue if another cause cannot be established ( 5.8 ) Hematologic Events: Consider discontinuing ( 5.9 ) Seizure Control During Pregnancy: Active metabolite may decrease ( 5.10 ) Risk of Seizure Aggravation: Discontinue if occurs ( 5.11 ) 5.1 Hyponatremia Clinically significant hyponatremia (sodium <125 mmol/L) can develop during Oxcarbazepine Oral Suspension use. In the 14 controlled epilepsy studies 2.5% of Oxcarbazepine Oral Suspension-treated patients (38/1,524) had a sodium of less than 125 mmol/L at some point during treatment, compared to no such patients assigned placebo or active control (carbamazepine and phenobarbital for adjunctive and monotherapy substitution studies, and phenytoin and valproate for the monotherapy initiation studies). Clinically significant hyponatremia generally occurred during the first 3 months of treatment with Oxcarbazepine Oral Suspension, although there were patients who first developed a serum sodium <125 mmol/L more than 1 year after initiation of therapy. Most patients who developed hyponatremia were asymptomatic but patients in the clinical trials were frequently monitored and some had their Oxcarbazepine Oral Suspension dose reduced, discontinued, or had their fluid intake restricted for hyponatremia. Whether or not these maneuvers prevented the occurrence of more severe events is unknown. Cases of symptomatic hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH) have been reported during postmarketing use. In clinical trials, patients whose treatment with Oxcarbazepine Oral Suspension was discontinued due to hyponatremia generally experienced normalization of serum sodium within a few days without additional treatment. Measurement of serum sodium levels should be considered for patients during maintenance treatment with Oxcarbazepine Oral Suspension, particularly if the patient is receiving other medications known to decrease serum sodium levels (e.g., drugs associated with inappropriate ADH secretion) or if symptoms possibly indicating hyponatremia develop (e.g., nausea, malaise, headache, lethargy, confusion, obtundation, or increase in seizure frequency or severity). 5.2 Anaphylactic Reactions and Angioedema Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of Oxcarbazepine Oral Suspension. Angioedema associated with laryngeal edema can be fatal. If a patient develops any of these reactions after treatment with Oxcarbazepine Oral Suspension, the drug should be discontinued and an alternative treatment started. These patients should not be rechallenged with the drug [ see Warnings and Precautions (5.3) ]. 5.3 Cross Hypersensitivity Reaction to Carbamazepine Approximately 25% to 30% of patients who have had hypersensitivity reactions to carbamazepine will experience hypersensitivity reactions with Oxcarbazepine Oral Suspension. For this reason patients should be specifically questioned about any prior experience with carbamazepine, and patients with a history of hypersensitivity reactions to carbamazepine should ordinarily be treated with Oxcarbazepine Oral Suspension only if the potential benefit justifies the potential risk. If signs or symptoms of hypersensitivity develop, Oxcarbazepine Oral Suspension should be discontinued immediately [ see Warnings and Precautions (5.2 , 5.8) ]. 5.4 Serious Dermatological Reactions Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults in association with Oxcarbazepine Oral Suspension use. Such serious skin reactions may be life threatening, and some patients have required hospitalization with very rare reports of fatal outcome. The median time of onset for reported cases was 19 days after treatment initiation. Recurrence of the serious skin reactions following rechallenge with Oxcarbazepine Oral Suspension has also been reported. The reporting rate of TEN and SJS associated with Oxcarbazepine Oral Suspension use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate estimates by a factor of 3- to 10-fold. Estimates of the background incidence rate for these serious skin reactions in the general population range between 0.5 to 6 cases per million-person years. Therefore, if a patient develops a skin reaction while taking Oxcarbazepine Oral Suspension, consideration should be given to discontinuing Oxcarbazepine Oral Suspension use and prescribing another antiepileptic medication. Association with HLA-B*1502 Patients carrying the HLA-B*1502 allele may be at increased risk for SJS/TEN with Oxcarbazepine Oral Suspension treatment. Human Leukocyte Antigen (HLA) allele B*1502 increases the risk for developing SJS/TEN in patients treated with carbamazepine. The chemical structure of Oxcarbazepine Oral Suspension is similar to that of carbamazepine. Available clinical evidence, and data from nonclinical studies showing a direct interaction between Oxcarbazepine Oral Suspension and HLA-B*1502 protein, suggest that the HLA-B*1502 allele may also increase the risk for SJS/TEN with Oxcarbazepine Oral Suspension. The frequency of HLA-B*1502 allele ranges from 2 to 12% in Han Chinese populations, is about 8% in Thai populations, and above 15% in the Philippines and in some Malaysian populations. Allele frequencies up to about 2% and 6% have been reported in Korea and India, respectively. The frequency of the HLA-B*1502 allele is negligible in people from European descent, several African populations, indigenous peoples of the Americas, Hispanic populations, and in Japanese (<1%). Testing for the presence of the HLA-B*1502 allele should be considered in patients with ancestry in genetically at-risk populations, prior to initiating treatment with Oxcarbazepine Oral Suspension. The use of Oxcarbazepine Oral Suspension should be avoided in patients positive for HLA-B*1502 unless the benefits clearly outweigh the risks. Consideration should also be given to avoid the use of other drugs associated with SJS/TEN in HLA-B*1502 positive patients, when alternative therapies are otherwise equally acceptable. Screening is not generally recommended in patients from populations in which the prevalence of HLAB* 1502 is low, or in current Oxcarbazepine Oral Suspension users, as the risk of SJS/TEN is largely confined to the first few months of therapy, regardless of HLA B*1502 status. The use of HLA-B*1502 genotyping has important limitations and must never substitute for appropriate clinical vigilance and patient management. The role of other possible factors in the development of, and morbidity from, SJS/TEN, such as antiepileptic drug (AED) dose, compliance, concomitant medications, comorbidities, and the level of dermatologic monitoring have not been well characterized. 5.5 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including oxcarbazepine oral suspension, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were 4 suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Table 2 shows absolute and relative risk by indication for all evaluated AEDs. Table 2: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events Per 1,000 Patients Drug Patients with Events Per 1,000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1,000 Patients Epilepsy 1.0 3.4 3.5 2.4 Psychiatric 5.7 8.5 1.5 2.9 Other 1.0 1.8 1.9 0.9 Total 2.4 4.3 1.8 1.9 The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing oxcarbazepine oral suspension or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers. 5.6 Withdrawal of AEDs As with most antiepileptic drugs, oxcarbazepine oral suspension should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus [ see Dosage and Administration (2.4) and Clinical Studies (14) ]. But if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered. 5.7 Cognitive/Neuropsychiatric Adverse Reactions Use of oxcarbazepine oral suspension has been associated with central nervous system-related adverse reactions. The most significant of these can be classified into 3 general categories: 1) cognitive symptoms including psychomotor slowing, difficulty with concentration, and speech or language problems, 2) somnolence or fatigue, and 3) coordination abnormalities, including ataxia and gait disturbances. Patients should be monitored for these signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on oxcarbazepine oral suspension to gauge whether it adversely affects their ability to drive or operate machinery. Adult Patients In one large, fixed-dose study, Oxcarbazepine Oral Suspension was added to existing AED therapy (up to three concomitant AEDs). By protocol, the dosage of the concomitant AEDs could not be reduced as Oxcarbazepine Oral Suspension was added, reduction in Oxcarbazepine Oral Suspension dosage was not allowed if intolerance developed, and patients were discontinued if unable to tolerate their highest target maintenance doses. In this trial, 65% of patients were discontinued because they could not tolerate the 2400 mg/day dose of Oxcarbazepine Oral Suspension on top of existing AEDs. The adverse events seen in this study were primarily CNS related and the risk for discontinuation was dose related. In this trial, 7.1% of oxcarbazepine-treated patients and 4% of placebo-treated patients experienced a cognitive adverse reaction. The risk of discontinuation for these events was about 6.5 times greater on oxcarbazepine than on placebo. In addition, 26% of oxcarbazepine-treated patients and 12% of placebo-treated patients experienced somnolence. The risk of discontinuation for somnolence was about 10 times greater on oxcarbazepine than on placebo. Finally, 28.7% of oxcarbazepine-treated patients and 6.4% of placebo-treated patients experienced ataxia or gait disturbances. The risk for discontinuation for these events was about 7 times greater on oxcarbazepine than on placebo. In a single placebo-controlled monotherapy trial evaluating 2400 mg/day of Oxcarbazepine Oral Suspension, no patients in either treatment group discontinued double-blind treatment because of cognitive adverse events, somnolence, ataxia, or gait disturbance. In the 2 dose-controlled conversion to monotherapy trials comparing 2400 mg/day and 300 mg/day Oxcarbazepine Oral Suspension, 1.1% of patients in the 2400 mg/day group discontinued double-blind treatment because of somnolence or cognitive adverse reactions compared to 0% in the 300 mg/day group. In these trials, no patients discontinued because of ataxia or gait disturbances in either treatment group. Pediatric Patients A study was conducted in pediatric patients (3 to 17 years old) with inadequately controlled partial-onset seizures in which oxcarbazepine was added to existing AED therapy (up to 2 concomitant AEDs). By protocol, the dosage of concomitant AEDs could not be reduced as Oxcarbazepine Oral Suspension was added. Oxcarbazepine Oral Suspension was titrated to reach a target dose ranging from 30 mg/kg to 46 mg/kg (based on a patient’s body weight with fixed doses for predefined weight ranges). Cognitive adverse events occurred in 5.8% of oxcarbazepine-treated patients (the single most common event being concentration impairment, 4 of 138 patients) and in 3.1% of patients treated with placebo. In addition, 34.8% of oxcarbazepine-treated patients and 14.0% of placebo-treated patients experienced somnolence. (No patient discontinued due to a cognitive adverse reaction or somnolence.). Finally, 23.2% of oxcarbazepine-treated patients and 7.0% of placebo-treated patients experienced ataxia or gait disturbances. Two (1.4%) oxcarbazepine-treated patients and 1 (0.8%) placebo-treated patient discontinued due to ataxia or gait disturbances. 5.8 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, has occurred with Oxcarbazepine Oral Suspension. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Oxcarbazepine Oral Suspension should be discontinued if an alternative etiology for the signs or symptoms cannot be established. 5.9 Hematologic Events Rare reports of pancytopenia, agranulocytosis, and leukopenia have been seen in patients treated with Oxcarbazepine Oral Suspension during postmarketing experience. Discontinuation of the drug should be considered if any evidence of these hematologic events develops. 5.10 Seizure Control During Pregnancy Due to physiological changes during pregnancy, plasma levels of the active metabolite of oxcarbazepine, the 10- monohydroxy derivative (MHD), may gradually decrease throughout pregnancy. It is recommended that patients be monitored carefully during pregnancy. Close monitoring should continue through the postpartum period because MHD levels may return after delivery. 5.11 Risk of Seizure Aggravation Exacerbation of or new onset primary generalized seizures has been reported with Oxcarbazepine Oral Suspension. The risk of aggravation of primary generalized seizures is seen especially in children but may also occur in adults. In case of seizure aggravation, Oxcarbazepine Oral Suspension should be discontinued.

<table><caption>Table 2: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis</caption><colgroup><col width="147"/><col width="147"/><col width="147"/><col width="147"/><col width="147"/></colgroup><tbody><tr><td valign="top"><content styleCode="bold">Indication</content></td><td valign="top"><content styleCode="bold">Placebo Patients with Events Per 1,000 Patients</content></td><td valign="top"><content styleCode="bold">Drug Patients with Events Per 1,000 Patients</content></td><td valign="top"><content styleCode="bold">Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients</content></td><td valign="top"><content styleCode="bold">Risk Difference: Additional Drug Patients with Events Per 1,000 Patients</content></td></tr><tr><td styleCode="Toprule">Epilepsy</td><td styleCode="Toprule">1.0</td><td styleCode="Toprule">3.4</td><td styleCode="Toprule">3.5</td><td styleCode="Toprule">2.4</td></tr><tr><td>Psychiatric</td><td>5.7</td><td>8.5</td><td>1.5</td><td>2.9</td></tr><tr><td>Other</td><td>1.0</td><td>1.8</td><td>1.9</td><td>0.9</td></tr><tr><td styleCode="Toprule">Total</td><td styleCode="Toprule">2.4</td><td styleCode="Toprule">4.3</td><td styleCode="Toprule">1.8</td><td styleCode="Toprule">1.9</td></tr></tbody></table>

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Hyponatremia [see Warnings and Precautions (5.1) ] Anaphylactic Reactions and Angioedema [see Warnings and Precautions (5.2) ] Cross Hypersensitivity Reaction to Carbamazepine [see Warnings and Precautions (5.3) ] Serious Dermatological Reactions [see Warnings and Precautions (5.4) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.5) ] Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.7) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see Warnings and Precautions (5.8) ] Hematologic Events [see Warnings and Precautions (5.9) ] The most common (≥ 10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions in adults and pediatrics were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, and abnormal gait ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Epic Pharma, LLC at 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most Common Adverse Reactions in All Clinical Studies Adjunctive Therapy/Monotherapy in Adults Previously Treated with Other AEDs The most common (≥10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions with Oxcarbazepine Oral Suspension: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus tremor, and abnormal gait. Approximately 23% of these 1,537 adult patients discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were: dizziness (6.4%), diplopia (5.9%), ataxia (5.2%), vomiting (5.1%), nausea (4.9%), somnolence (3.8%), headache (2.9%), fatigue (2.1%), abnormal vision (2.1%), tremor (1.8%), abnormal gait (1.7%), rash (1.4%), hyponatremia (1.0%). Monotherapy in Adults Not Previously Treated with Other AEDs The most common (≥5%) adverse reactions with Oxcarbazepine Oral Suspension in these patients were similar to those in previously treated patients. Approximately 9% of these 295 adult patients discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were: dizziness (1.7%), nausea (1.7%), rash (1.7%), headache (1.4%). Adjunctive Therapy/Monotherapy in Pediatric Patients 4 Years Old and Above Previously Treated with Other AEDs The most common (≥5%) adverse reactions with Oxcarbazepine Oral Suspension in these patients were similar to those seen in adults. Approximately 11% of these 456 pediatric patients discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were: somnolence (2.4%), vomiting (2.0%), ataxia (1.8%), diplopia (1.3%), dizziness (1.3%), fatigue (1.1%), nystagmus (1.1%). Monotherapy in Pediatric Patients 4 Years Old and Above Not Previously Treated with Other AEDs The most common (≥5%) adverse reactions with Oxcarbazepine Oral Suspension in these patients were similar to those in adults. Approximately 9.2% of 152 pediatric patients discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated (≥1%) with discontinuation were rash (5.3%) and maculopapular rash (1.3%). Adjunctive Therapy/Monotherapy in Pediatric Patients 1 Month to <4 Years Old Previously Treated or Not Previously Treated with Other AEDs: The most common (≥5%) adverse reactions with Oxcarbazepine Oral Suspension in these patients were similar to those seen in older children and adults except for infections and infestations which were more frequently seen in these younger children. Approximately 11% of these 241 pediatric patients discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were: convulsions (3.7%), status epilepticus (1.2%), and ataxia (1.2%). Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Adults Previously Treated with Other AEDs Table 3 lists adverse reactions that occurred in at least 2% of adult patients with epilepsy, treated with Oxcarbazepine Oral Suspension or placebo as adjunctive treatment and were numerically more common in the patients treated with any dose of Oxcarbazepine Oral Suspension. Table 4 lists adverse reactions in patients converted from other AEDs to either high-dose Oxcarbazepine Oral Suspension (2400 mg/day) or low-dose (300 mg/day) Oxcarbazepine Oral Suspension. Note that in some of these monotherapy studies patients who dropped out during a preliminary tolerability phase are not included in the tables. Table 3: Adverse Reactions in a Controlled Clinical Study of Adjunctive Therapy with Oxcarbazepine Oral Suspension in Adults Oxcarbazepine Oral Suspension Dosage (mg/day) Body System/ Adverse Reaction Oxcarbazepine Oral Suspension 600 N=163% Oxcarbazepine Oral Suspension 1200 N=171% Oxcarbazepine Oral Suspension 2400 N=126% Placebo N=166% Body as a Whole Fatigue 15 12 15 7 Asthenia 6 3 6 5 Leg Edema 2 1 2 1 Increased Weight 1 2 2 1 Feeling Abnormal 0 1 2 0 Cardiovascular System Hypotension 0 1 2 0 Digestive System Nausea 15 25 29 10 Vomiting 13 25 36 5 Abdominal Pain 10 13 11 5 Diarrhea 5 6 7 6 Dyspepsia 5 5 6 2 Constipation 2 2 6 4 Gastritis 2 1 2 1 Metabolic and Nutritional Disorders Hyponatremia 3 1 2 1 Musculoskeletal System Muscle Weakness 1 2 2 0 Sprains and Strains 0 2 2 1 Nervous System Headache 32 28 26 23 Dizziness 26 32 49 13 Somnolence 20 28 36 12 Ataxia 9 17 31 5 Nystagmus 7 20 26 5 Abnormal Gait 5 10 17 1 Insomnia 4 2 3 1 Tremor 3 8 16 5 Nervousness 2 4 2 1 Agitation 1 1 2 1 Abnormal Coordination 1 3 2 1 Abnormal EEG 0 0 2 0 Speech Disorder 1 1 3 0 Confusion 1 1 2 1 Cranial Injury NOS 1 0 2 1 Dysmetria 1 2 3 0 Abnormal Thinking 0 2 4 0 Respiratory System Rhinitis 2 4 5 4 Skin and Appendages Acne 1 2 2 0 Special Senses Diplopia 14 30 40 5 Vertigo 6 12 15 2 Abnormal Vision 6 14 13 4 Abnormal Accommodation 0 0 2 0 Table 4: Adverse Reactions in Controlled Clinical Studies of Monotherapy with Oxcarbazepine Oral Suspension in Adults Previously Treated with Other AEDs Body System/Adverse Reaction Oxcarbazepine Oral Suspension 2,400 mg/day N=86% Oxcarbazepine Oral Suspension 300 mg/day N=86% Body as a Whole Fatigue 21 5 Fever 3 0 Allergy 2 0 Generalized Edema 2 1 Chest Pain 2 0 Digestive System Nausea 22 7 Vomiting 15 5 Diarrhea 7 5 Dyspepsia 6 1 Anorexia 5 3 Abdominal Pain 5 3 Dry Mouth 3 0 Hemorrhage Rectum 2 0 Toothache 2 1 Hemic and Lymphatic System Lymphadenopathy 2 0 Infections and Infestations Viral Infection 7 5 Infection 2 0 Metabolic and Nutritional Disorders Hyponatremia 5 0 Thirst 2 0 Nervous System Headache 31 15 Dizziness 28 8 Somnolence 19 5 Anxiety 7 5 Ataxia 7 1 Confusion 7 0 Nervousness 7 0 Insomnia 6 3 Tremor 6 3 Amnesia 5 1 Aggravated Convulsions 5 2 Emotional Lability 3 2 Hypoesthesia 3 1 Abnormal Coordination 2 1 Nystagmus 2 0 Speech Disorder 2 0 Respiratory System Upper Respiratory Tract Infection 10 5 Coughing 5 0 Bronchitis 3 0 Pharyngitis 3 0 Skin and Appendages Hot Flushes 2 1 Purpura 2 0 Special Senses Abnormal Vision 14 2 Diplopia 12 1 Taste Perversion 5 0 Vertigo 3 0 Earache 2 1 Ear Infection NOS 2 0 Urogenital and Reproductive System Urinary Tract Infection 5 1 Micturition Frequency 2 1 Vaginitis 2 0 Controlled Clinical Study of Monotherapy in Adults Not Previously Treated with Other AEDs Table 5 lists adverse reactions in a controlled clinical study of monotherapy in adults not previously treated with other AEDs that occurred in at least 2% of adult patients with epilepsy treated with Oxcarbazepine Oral Suspension or placebo and were numerically more common in the patients treated with Oxcarbazepine Oral Suspension. Table 5: Adverse Reactions in a Controlled Clinical Study of Monotherapy with Oxcarbazepine Oral Suspension in Adults Not Previously Treated with Other AEDs Body System / Adverse Reaction Oxcarbazepine Oral Suspension N=55% Placebo N=49% Body as a Whole Falling Down NOS 4 0 Digestive System Nausea 16 12 Diarrhea 7 2 Vomiting 7 6 Constipation 5 0 Dyspepsia 5 4 Musculoskeletal System Back Pain 4 2 Nervous System Dizziness 22 6 Headache 13 10 Ataxia 5 0 Nervousness 5 2 Amnesia 4 2 Abnormal Coordination 4 2 Tremor 4 0 Respiratory System Upper Respiratory Tract Infection 7 0 Epistaxis 4 0 Infection Chest 4 0 Sinusitis 4 2 Skin and Appendages Rash 4 2 Special Senses Vision Abnormal 4 0 Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Pediatric Patients Previously Treated with Other AEDs Table 6 lists adverse reactions that occurred in at least 2% of pediatric patients with epilepsy treated with oxcarbazepine or placebo as adjunctive treatment and were numerically more common in the patients treated with oxcarbazepine. Table 6: Adverse Reactions in Controlled Clinical Studies of Adjunctive Therapy/Monotherapy with Oxcarbazepine Oral Suspension in Pediatric Patients Previously Treated with Other AEDs Body System/ Adverse Reaction Oxcarbazepine Oral Suspension N=171% Placebo N=139% Body as a Whole Fatigue 13 9 Allergy 2 0 Asthenia 2 1 Digestive System Vomiting 33 14 Nausea 19 5 Constipation 4 1 Dyspepsia 2 0 Nervous System Headache 31 19 Somnolence 31 13 Dizziness 28 8 Ataxia 13 4 Nystagmus 9 1 Emotional Lability 8 4 Abnormal Gait 8 3 Tremor 6 4 Speech Disorder 3 1 Impaired Concentration 2 1 Convulsions 2 1 Involuntary Muscle Contractions 2 1 Respiratory System Rhinitis 10 9 Pneumonia 2 1 Skin and Appendages Bruising 4 2 Increased Sweating 3 0 Special Senses Diplopia 17 1 Abnormal Vision 13 1 Vertigo 2 0 Other Events Observed in Association with the Administration of Oxcarbazepine Oral Suspension. In the paragraphs that follow, the adverse reactions, other than those in the preceding tables or text, that occurred in a total of 565 children and 1,574 adults exposed to Oxcarbazepine Oral Suspension and that are reasonably likely to be related to drug use are presented. Events common in the population, events reflecting chronic illness and events likely to reflect concomitant illness are omitted particularly if minor. They are listed in order of decreasing frequency. Because the reports cite events observed in open label and uncontrolled trials, the role of Oxcarbazepine Oral Suspension in their causation cannot be reliably determined. Body as a Whole: fever, malaise, pain chest precordial, rigors, weight decrease. Cardiovascular System: bradycardia, cardiac failure, cerebral hemorrhage, hypertension, hypotension postural, palpitation, syncope, tachycardia. Digestive System: appetite increased, blood in stool, cholelithiasis, colitis, duodenal ulcer, dysphagia, enteritis, eructation, esophagitis, flatulence, gastric ulcer, gingival bleeding, gum hyperplasia, hematemesis, hemorrhage rectum, hemorrhoids, hiccup, mouth dry, pain biliary, pain right hypochondrium, retching, sialoadenitis, stomatitis, stomatitis ulcerative. Hematologic and Lymphatic System: thrombocytopenia. Laboratory Abnormality: gamma-GT increased, hyperglycemia, hypocalcemia, hypoglycemia, hypokalemia, liver enzymes elevated, serum transaminase increased. Musculoskeletal System: hypertonia muscle. Nervous System: aggressive reaction, amnesia, anguish, anxiety, apathy, aphasia, aura, convulsions aggravated, delirium, delusion, depressed level of consciousness, dysphonia, dystonia, emotional lability, euphoria, extrapyramidal disorder, feeling drunk, hemiplegia, hyperkinesia, hyperreflexia, hypoesthesia, hypokinesia, hyporeflexia, hypotonia, hysteria, libido decreased, libido increased, manic reaction, migraine, muscle contractions involuntary, nervousness, neuralgia, oculogyric crisis, panic disorder, paralysis, paroniria, personality disorder, psychosis, ptosis, stupor, tetany. Respiratory System: asthma, dyspnea, epistaxis, laryngismus, pleurisy. Skin and Appendages: acne, alopecia, angioedema, bruising, dermatitis contact, eczema, facial rash, flushing, folliculitis, heat rash, hot flushes, photosensitivity reaction, pruritus genital, psoriasis, purpura, rash erythematous, rash maculopapular, vitiligo, urticaria. Special Senses: accommodation abnormal, cataract, conjunctival hemorrhage, edema eye, hemianopia, mydriasis, otitis externa, photophobia, scotoma, taste perversion, tinnitus, xerophthalmia. Surgical and Medical Procedures: procedure dental oral, procedure female reproductive, procedure musculoskeletal, procedure skin. Urogenital and Reproductive System: dysuria, hematuria, intermenstrual bleeding, leukorrhea, menorrhagia, micturition frequency, pain renal, pain urinary tract, polyuria, priapism, renal calculus. Other: Systemic lupus erythematosus. Laboratory Tests Serum sodium levels below 125 mmol/L have been observed in patients treated with Oxcarbazepine Oral Suspension [ see Warnings and Precautions (5.1) ]. Experience from clinical trials indicates that serum sodium levels return toward normal when the Oxcarbazepine Oral Suspension dosage is reduced or discontinued, or when the patient was treated conservatively (e.g., fluid restriction). Laboratory data from clinical trials suggest that Oxcarbazepine Oral Suspension use was associated with decreases in T 4 , without changes in T 3 or TSH. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of Oxcarbazepine Oral Suspension. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole: multi-organ hypersensitivity disorders characterized by features such as rash, fever, lymphadenopathy, abnormal liver function tests, eosinophilia and arthralgia [ see Warnings and Precautions (5.8) ] Cardiovascular System: atrioventricular block Immune System Disorders: anaphylaxis [ see Warnings and Precautions (5.2) ] Digestive System: pancreatitis and/or lipase and/or amylase increase Hematologic and Lymphatic Systems: aplastic anemia [ see Warnings and Precautions (5.9) ] Metabolism and Nutrition Disorders: hypothyroidism and syndrome of inappropriate antidiuretic hormone secretion (SIADH) Skin and Subcutaneous Tissue Disorders: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis [ see Warnings and Precautions (5.4) ], Acute Generalized Exanthematous Pustulosis (AGEP) Musculoskeletal, connective tissue and bone disorders: There have been reports of decreased bone mineral density, osteoporosis and fractures in patients on long-term therapy with Oxcarbazepine Oral Suspension. Injury, Poisoning, and Procedural Complications: fall Nervous System Disorders: dysarthria

<table><caption>Table 3: Adverse Reactions in a Controlled Clinical Study of Adjunctive Therapy with Oxcarbazepine Oral Suspension in Adults</caption><colgroup><col width="246"/><col width="99"/><col width="104"/><col width="99"/><col width="83"/></colgroup><tbody><tr><td styleCode="Botrule Lrule" valign="top"/><td styleCode="Botrule Lrule Rrule" colspan="4" align="center" valign="bottom">Oxcarbazepine Oral Suspension Dosage (mg/day)</td></tr><tr><td styleCode="Botrule Lrule" valign="top"><content styleCode="bold">Body System/</content><content styleCode="bold"> Adverse </content><content styleCode="bold">Reaction</content></td><td styleCode="Botrule Lrule Rrule" align="left" valign="top"><paragraph><content styleCode="bold">Oxcarbazepine Oral Suspension</content></paragraph><paragraph><content styleCode="bold">600 </content><content styleCode="bold"> N=163%</content></paragraph></td><td styleCode="Botrule Lrule Rrule" align="left" valign="top"><paragraph><content styleCode="bold">Oxcarbazepine Oral Suspension</content></paragraph><paragraph><content styleCode="bold">1200 </content><content styleCode="bold"> N=171%</content></paragraph></td><td styleCode="Botrule Lrule Rrule" align="left" valign="top"><paragraph><content styleCode="bold">Oxcarbazepine</content> <content styleCode="bold">Oral Suspension</content></paragraph><paragraph><content styleCode="bold">2400 </content><content styleCode="bold"> N=126%</content></paragraph></td><td styleCode="Botrule Lrule Rrule" align="left" valign="top"><content styleCode="bold">Placebo </content><content styleCode="bold"> N=166%</content></td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Body as a Whole</content></td><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Fatigue</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">15</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">12</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">15</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">7</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Asthenia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">6</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">6</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Leg Edema</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Increased Weight</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Feeling Abnormal</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Cardiovascular System</content></td><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Hypotension</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Digestive System</content></td><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Nausea</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">15</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">25</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">29</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">10</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Vomiting</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">13</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">25</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">36</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Abdominal Pain</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">10</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">13</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">11</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Diarrhea</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">6</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">7</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">6</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Dyspepsia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">6</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Constipation</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">6</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">4</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Gastritis</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Metabolic and Nutritional Disorders</content></td><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Hyponatremia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Musculoskeletal System</content></td><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Muscle Weakness</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Sprains and Strains</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Nervous System</content></td><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Headache</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">32</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">28</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">26</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">23</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Dizziness</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">26</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">32</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">49</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">13</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Somnolence</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">20</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">28</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">36</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">12</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Ataxia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">9</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">17</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">31</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Nystagmus</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">7</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">20</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">26</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Abnormal Gait</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">10</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">17</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Insomnia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Tremor</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">8</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">16</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Nervousness</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Agitation</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Abnormal Coordination</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Abnormal EEG</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Speech Disorder</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Confusion</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Cranial Injury NOS</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Dysmetria</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Abnormal Thinking</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Respiratory System</content></td><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Rhinitis</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">4</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Skin and Appendages</content></td><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Acne</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Special Senses</content></td><td styleCode="Botrule" align="center" valign="bottom"/><td styleCode="Botrule" align="center" valign="bottom"/><td styleCode="Botrule" align="center" valign="bottom"/><td styleCode="Botrule Rrule" align="center" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Diplopia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">14</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">30</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">40</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Vertigo</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">6</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">12</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">15</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Abnormal Vision</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">6</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">14</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">13</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">4</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Abnormal Accommodation</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr></tbody></table>

<table><caption>Table 4: Adverse Reactions in Controlled Clinical Studies of Monotherapy with Oxcarbazepine Oral Suspension in Adults Previously Treated with Other AEDs</caption><colgroup><col width="325"/><col width="126"/><col width="176"/></colgroup><tbody><tr><td styleCode="Lrule Toprule" valign="bottom"/><td styleCode="Toprule" colspan="2" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule" valign="top"><content styleCode="bold">Body System/Adverse</content> <content styleCode="bold">Reaction</content></td><td styleCode="Botrule Lrule Rrule" align="left" valign="top"><paragraph><content styleCode="bold">Oxcarbazepine </content></paragraph><paragraph><content styleCode="bold">Oral Suspension</content> <content styleCode="bold">2,400</content><content styleCode="bold"> mg/day</content><content styleCode="bold"> N=86%</content></paragraph></td><td styleCode="Botrule Lrule Rrule" align="left" valign="top"><paragraph><content styleCode="bold">Oxcarbazepine</content></paragraph><paragraph><content styleCode="bold">Oral Suspension</content> <content styleCode="bold">300</content><content styleCode="bold"> mg/day</content><content styleCode="bold"> N=86%</content></paragraph></td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Body as a Whole</content></td><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Fatigue</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">21</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Fever</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Allergy</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Generalized Edema</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Chest Pain</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Digestive System</content></td><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Nausea</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">22</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">7</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Vomiting</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">15</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Diarrhea</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">7</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Dyspepsia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">6</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Anorexia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Abdominal Pain</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Dry Mouth</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Hemorrhage Rectum</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Toothache</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Hemic and Lymphatic System</content></td><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Lymphadenopathy</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Infections and Infestations</content></td><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Viral Infection</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">7</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Infection</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Rrule Toprule" valign="bottom"><content styleCode="bold">Metabolic and Nutritional Disorders</content></td><td styleCode="Botrule Rrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Hyponatremia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Thirst</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Nervous System</content></td><td styleCode="Botrule" align="center" valign="bottom"/><td styleCode="Botrule Rrule" align="center" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Headache</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">31</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">15</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Dizziness</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">28</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">8</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Somnolence</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">19</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Anxiety</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">7</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Ataxia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">7</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Confusion</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">7</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Nervousness</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">7</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Insomnia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">6</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Tremor</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">6</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Amnesia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Aggravated Convulsions</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Emotional Lability</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Hypoesthesia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Abnormal Coordination</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Nystagmus</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Speech Disorder</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Respiratory System</content></td><td styleCode="Botrule" align="center" valign="bottom"/><td styleCode="Botrule Rrule" align="center" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Upper Respiratory Tract Infection</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">10</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Coughing</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Bronchitis</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Pharyngitis</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Skin and Appendages</content></td><td styleCode="Botrule" align="center" valign="bottom"/><td styleCode="Botrule Rrule" align="center" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Hot Flushes</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Purpura</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Rrule Toprule" valign="bottom"><content styleCode="bold">Special Senses</content></td><td styleCode="Botrule Rrule" align="center" valign="bottom"/><td styleCode="Botrule Rrule" align="center" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Abnormal Vision</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">14</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Diplopia</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">12</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Taste Perversion</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Vertigo</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">3</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Earache</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Ear Infection NOS</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom"><content styleCode="bold">Urogenital and Reproductive System</content></td><td styleCode="Botrule" align="left" valign="bottom"/><td styleCode="Botrule Rrule" align="left" valign="bottom"/></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Urinary Tract Infection</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Micturition Frequency</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">1</td></tr><tr><td styleCode="Lrule Toprule" valign="bottom">Vaginitis</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr></tbody></table>

<table><caption>Table 5: Adverse Reactions in a Controlled Clinical Study of Monotherapy with Oxcarbazepine Oral Suspension in Adults Not Previously Treated with Other AEDs</caption><colgroup><col width="307"/><col width="152"/><col width="120"/></colgroup><tbody><tr><td styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold"> Body System / Adverse Reaction</content></td><td styleCode="Botrule Lrule Rrule Toprule" align="left" valign="bottom"><paragraph><content styleCode="bold">Oxcarbazepine</content></paragraph><paragraph><content styleCode="bold">Oral Suspension</content></paragraph><paragraph><content styleCode="bold"> N=55%</content></paragraph></td><td styleCode="Botrule Lrule Rrule Toprule" align="left" valign="bottom"><content styleCode="bold"> Placebo </content><content styleCode="bold"> N=49%</content></td></tr><tr><td styleCode="Botrule Lrule Toprule" valign="bottom"><content styleCode="bold">Body as a Whole</content></td><td styleCode="Botrule" align="center" valign="bottom"/><td styleCode="Botrule Rrule" align="center" valign="bottom"/></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Falling Down NOS</td><td styleCode="Botrule Lrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom"><content styleCode="bold">Digestive System</content></td><td styleCode="Botrule" align="center" valign="bottom"/><td styleCode="Botrule Rrule" align="center" valign="bottom"/></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Nausea</td><td styleCode="Botrule Lrule" align="left" valign="bottom">16</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">12</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Diarrhea</td><td styleCode="Botrule Lrule" align="left" valign="bottom">7</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Vomiting</td><td styleCode="Botrule Lrule" align="left" valign="bottom">7</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">6</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Constipation</td><td styleCode="Botrule Lrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Dyspepsia</td><td styleCode="Botrule Lrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">4</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom"><content styleCode="bold">Musculoskeletal System</content></td><td styleCode="Botrule" align="center" valign="bottom"/><td styleCode="Botrule Rrule" align="center" valign="bottom"/></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Back Pain</td><td styleCode="Botrule Lrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom"><content styleCode="bold">Nervous System</content></td><td styleCode="Botrule" align="center" valign="bottom"/><td styleCode="Botrule Rrule" align="center" valign="bottom"/></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Dizziness</td><td styleCode="Botrule Lrule" align="left" valign="bottom">22</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">6</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Headache</td><td styleCode="Botrule Lrule" align="left" valign="bottom">13</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">10</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Ataxia</td><td styleCode="Botrule Lrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Nervousness</td><td styleCode="Botrule Lrule" align="left" valign="bottom">5</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Amnesia</td><td styleCode="Botrule Lrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Abnormal Coordination</td><td styleCode="Botrule Lrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Tremor</td><td styleCode="Botrule Lrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom"><content styleCode="bold">Respiratory System</content></td><td styleCode="Botrule" align="center" valign="bottom"/><td styleCode="Botrule Rrule" align="center" valign="bottom"/></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Upper Respiratory Tract Infection</td><td styleCode="Botrule Lrule" align="left" valign="bottom">7</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Epistaxis</td><td styleCode="Botrule Lrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Infection Chest</td><td styleCode="Botrule Lrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Sinusitis</td><td styleCode="Botrule Lrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom"><content styleCode="bold">Skin and Appendages</content></td><td styleCode="Botrule" align="center" valign="bottom"/><td styleCode="Botrule Rrule" align="center" valign="bottom"/></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Rash</td><td styleCode="Botrule Lrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">2</td></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom"><content styleCode="bold">Special Senses</content></td><td styleCode="Botrule" align="center" valign="bottom"/><td styleCode="Botrule Rrule" align="center" valign="bottom"/></tr><tr><td styleCode="Botrule Lrule" align="left" valign="bottom">Vision Abnormal</td><td styleCode="Botrule Lrule" align="left" valign="bottom">4</td><td styleCode="Botrule Lrule Rrule" align="left" valign="bottom">0</td></tr></tbody></table>