FDA label 7b5fec19-e4e6-877f-e053-2a91aa0a7a11

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ]. Trazodone hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Antidepresants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients ( 5.1 ) • Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) • Trazodone hydrochloride tablets are not approved for use in pediatric patients ( 8.4 )

5.8 Discontinuation Syndrome Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see Dosage and Administration (2.6) ].

5.9 Potential for Cognitive and Motor Impairment Trazodone hydrochloride tablets may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous tasks. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.

5.10 Angle-Closure Glaucoma The pupillary dilation that occurs following use of many antidepressant drugs including trazodone hydrochloride tablets may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including trazodone hydrochloride tablets, in patients with untreated anatomically narrow angles.

5.11 Hyponatremia Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including trazodone hydrochloride tablets. Cases with serum sodium lower than 110 mmol/L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). In patients with symptomatic hyponatremia, discontinue trazodone hydrochloride tablets and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs [see Use in Specific Populations (8.5) ] .

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Suicidal Thoughts and Behavior in Children, Adolescents and Young Adults [see Boxed Warning and Warnings and Precautions (5.1)] • Serotonin Syndrome [see Warnings and Precautions (5.2) ] • Cardiac Arrythmias [see Warnings and Precautions (5.3) ] • Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.4) ] • Increased Risk of Bleeding [see Warnings and Precautions (5.5) ] • Priapism [see Warnings and Precautions (5.6) ] • Activation of Mania or Hypomania [see Warnings and Precautions (5.7) ] • Discontinuation Syndrome [see Warnings and Precautions (5.8) ] • Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.9) ] • Angle-Closure Glaucoma [see Warnings and Precautions (5.10)] • Hyponatremia [see Warnings and Precautions (5.11)] Most common adverse reactions (incidence ≥ 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 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. Table 2: Common Adverse Reactions Occurring in ≥ 2% of Trazodone Hydrochloride Tablets-treated Patients and Greater than the Rate of Placebo- Treated Patients as Observed in Controled Clinical Studies Inpatients Outpatients Trazodone Hydrochloride Tablets N=142 Placebo N=95 Trazodone Hydrochloride Tablets N=157 Placebo N=158 Allergic Skin Condition/Edema 3% 1% 7% 1% Autonomic Blurred Vision 6% 4% 15% 4% Constipation 7% 4% 8% 6% Dry Mouth 15% 8% 34% 20% Cardiovascular Hypertension 20% 1% 1% * Hypotension 7% 1% 4% 0 Syncope 3% 2% 5% 1% CNS Confusion 5% 0 6% 8% Decreased Concentration 3% 2% 1% 0 Disorientation 2% 0 * 0 Dizziness/Light-Headedness 20% 5% 28% 15% Drowsiness 24% 6% 41% 20% Fatigue 11% 4% 6% 3% Headache 10% 5% 20% 16% Nervousness 15% 11% 6% 8% Gastrointestinal Abdominal/Gastric Disorder 4% 4% 6% 4% Diarrhea 0 1% 5% 1% Nausea/Vomiting 10% 1% 13% 10% Musculoskeletal Aches/Pains 6% 3% 5% 3% Neurological Incoordination 5% 0 2% * Tremors 3% 1% 5% 4% Othe r Eyes Red/Tired/Itching 3% 0 0 0 Head Full-Heavy 3% 0 0 0 Malaise 3% 0 0 0 Nasal/Sinus Congestion 3% 0 6% 3% Weight Gain 1% 0 5% 2% Weight Loss * 3% 6% 3% *Incidence less than 1% Other adverse reactions occurring at an incidence of <2% with the use of trazodone hydrochloride in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired memory, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, paresthesia, retrograde ejaculation, shortness of breath, and tachycardia/palpitations. Occasional sinus bradycardia has occurred in long-term studies. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of trazodone hydrochloride tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure: Blood and lymphatic system disorders: hemolytic anemia, leukocytosis Cardiac disorders: cardiospasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation. Prolonged QT interval, torsade de pointes, and ventricular tachycardia have been reported at doses of 100 mg per day or less [see Warnings and Precautions (5.3) ]. Endocrine disorders: inappropriate ADH syndrome Eye disorders: diplopia Gastrointestinal disorders: increased salivation, nausea/vomiting General disorders and administration site conditions: chills, edema, unexplained death, weakness Hepatobiliary disorders: cholestasis, jaundice, hyperbilirubinemia, liver enzyme alterations Investigations: increased amylase Metabolism and nutrition disorders: methemoglobinemia Nervous system disorders: aphasia, ataxia, cerebrovascular accident, extrapyramidal symptoms, grand mal seizures, paresthesia, tardive dyskinesia, vertigo Psychiatric disorders: abnormal dreams, agitation, anxiety, hallucinations, insomnia, paranoid reaction, psychosis, stupor Renal and urinary disorders: urinary incontinence, urinary retention Reproductive system and breast disorders: breast enlargement or engorgement, clitorism, lactation, priapism [see Warnings and Precautions (5.6) ] Respiratory, thoracic and mediastinal disorders: apnea Skin and subcutaneous tissue disorders: alopecia, hirsutism, leukonychia, pruritus, psoriasis, rash, urticaria Vascular disorders: vasodilation

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. Table 2: Common Adverse Reactions Occurring in ≥ 2% of Trazodone Hydrochloride Tablets-treated Patients and Greater than the Rate of Placebo- Treated Patients as Observed in Controled Clinical Studies Inpatients Outpatients Trazodone Hydrochloride Tablets N=142 Placebo N=95 Trazodone Hydrochloride Tablets N=157 Placebo N=158 Allergic Skin Condition/Edema 3% 1% 7% 1% Autonomic Blurred Vision 6% 4% 15% 4% Constipation 7% 4% 8% 6% Dry Mouth 15% 8% 34% 20% Cardiovascular Hypertension 20% 1% 1% * Hypotension 7% 1% 4% 0 Syncope 3% 2% 5% 1% CNS Confusion 5% 0 6% 8% Decreased Concentration 3% 2% 1% 0 Disorientation 2% 0 * 0 Dizziness/Light-Headedness 20% 5% 28% 15% Drowsiness 24% 6% 41% 20% Fatigue 11% 4% 6% 3% Headache 10% 5% 20% 16% Nervousness 15% 11% 6% 8% Gastrointestinal Abdominal/Gastric Disorder 4% 4% 6% 4% Diarrhea 0 1% 5% 1% Nausea/Vomiting 10% 1% 13% 10% Musculoskeletal Aches/Pains 6% 3% 5% 3% Neurological Incoordination 5% 0 2% * Tremors 3% 1% 5% 4% Othe r Eyes Red/Tired/Itching 3% 0 0 0 Head Full-Heavy 3% 0 0 0 Malaise 3% 0 0 0 Nasal/Sinus Congestion 3% 0 6% 3% Weight Gain 1% 0 5% 2% Weight Loss * 3% 6% 3% *Incidence less than 1% Other adverse reactions occurring at an incidence of <2% with the use of trazodone hydrochloride in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired memory, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, paresthesia, retrograde ejaculation, shortness of breath, and tachycardia/palpitations. Occasional sinus bradycardia has occurred in long-term studies.

6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of trazodone hydrochloride tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure: Blood and lymphatic system disorders: hemolytic anemia, leukocytosis Cardiac disorders: cardiospasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation. Prolonged QT interval, torsade de pointes, and ventricular tachycardia have been reported at doses of 100 mg per day or less [see Warnings and Precautions (5.3) ]. Endocrine disorders: inappropriate ADH syndrome Eye disorders: diplopia Gastrointestinal disorders: increased salivation, nausea/vomiting General disorders and administration site conditions: chills, edema, unexplained death, weakness Hepatobiliary disorders: cholestasis, jaundice, hyperbilirubinemia, liver enzyme alterations Investigations: increased amylase Metabolism and nutrition disorders: methemoglobinemia Nervous system disorders: aphasia, ataxia, cerebrovascular accident, extrapyramidal symptoms, grand mal seizures, paresthesia, tardive dyskinesia, vertigo Psychiatric disorders: abnormal dreams, agitation, anxiety, hallucinations, insomnia, paranoid reaction, psychosis, stupor Renal and urinary disorders: urinary incontinence, urinary retention Reproductive system and breast disorders: breast enlargement or engorgement, clitorism, lactation, priapism [see Warnings and Precautions (5.6) ] Respiratory, thoracic and mediastinal disorders: apnea Skin and subcutaneous tissue disorders: alopecia, hirsutism, leukonychia, pruritus, psoriasis, rash, urticaria Vascular disorders: vasodilation

<table border="0" cellspacing="0" cellpadding="0"> <col width="125.05pt"/> <col width="68.2pt"/> <col width="49.5pt"/> <col width="58.5pt"/> <col width="45pt"/> <tbody> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td colspan="2" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Inpatients</paragraph> </td> <td colspan="2" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Outpatients</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Trazodone Hydrochloride Tablets</paragraph> <paragraph>N=142</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Placebo N=95</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Trazodone Hydrochloride Tablets</paragraph> <paragraph>N=157</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Placebo N=158</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph> <content styleCode="bold">Allergic</content> </paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Skin Condition/Edema</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>1%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>7%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>1%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph> <content styleCode="bold">Autonomic</content> </paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Blurred Vision</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>6%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>4%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>15%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>4%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Constipation</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>7%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>4%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>8%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>6%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Dry Mouth</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>15%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>8%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>34%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>20%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph> <content styleCode="bold">Cardiovascular</content> </paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Hypertension</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>20%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>1%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>1%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>*</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Hypotension</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>7%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>1%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>4%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Syncope</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>2%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>5%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>1%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph> <content styleCode="bold">CNS</content> </paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Confusion</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>5%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>6%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>8%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Decreased Concentration</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>2%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>1%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Disorientation</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>2%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>*</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Dizziness/Light-Headedness</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>20%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>5%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>28%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>15%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Drowsiness</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>24%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>6%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>41%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>20%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Fatigue</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>11%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>4%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>6%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Headache</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>10%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>5%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>20%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>16%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Nervousness</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>15%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>11%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>6%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>8%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph> <content styleCode="bold">Gastrointestinal</content> </paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Abdominal/Gastric Disorder</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>4%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>4%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>6%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>4%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Diarrhea</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>1%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>5%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>1%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Nausea/Vomiting</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>10%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>1%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>13%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>10%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph> <content styleCode="bold">Musculoskeletal</content> </paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Aches/Pains</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>6%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>5%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph> <content styleCode="bold">Neurological</content> </paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Incoordination</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>5%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>2%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>*</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Tremors</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>1%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>5%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>4%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph> <content styleCode="bold">Othe</content>r </paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Eyes Red/Tired/Itching</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Head Full-Heavy</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Malaise</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Nasal/Sinus Congestion</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>6%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Weight Gain</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>1%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>0</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>5%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>2%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Weight Loss</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>*</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>6%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>3%</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>*Incidence less than 1%</paragraph> </td> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> <td styleCode=" Botrule Toprule Lrule Rrule "/> </tr> </tbody> </table>