FDA label bdecce86-e035-472d-8131-180414c321fe

WARNING: POTENTIAL FOR ABUSE Amphetamines have a high potential for abuse . Administration of amphetamines for prolonged periods of time may lead to drug dependence. Pay particular attention to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others and the drugs should be prescribed or dispensed sparingly [ see DRUG ABUSE AND DEPENDENCE (9) ]. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse reactions. WARNING: POTENTIAL FOR ABUSE See full prescribing information for complete boxed warning Amphetamines have a high potential for abuse; prolonged administration may lead to dependence. ( 9 ) Misuse of amphetamines may cause sudden death and serious cardiovascular adverse reactions.

5 WARNINGS and PRECAUTIONS Serious Cardiovascular Events: Sudden death has been reported with usual doses of CNS stimulants in children and adolescents with structural cardiac abnormalities or other serious heart problems; sudden death, stroke, and myocardial infarction have been reported in adults taking CNS stimulants at usual doses. Stimulant drugs should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems. ( 5.1 ) Increase in Blood Pressure: Monitor blood pressure and pulse at appropriate intervals. Use with caution in patients for whom blood pressure increases may be problematic. ( 5.1 ) Psychiatric Adverse Events: Stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis. Evaluate for bipolar disorder prior to stimulant use. Monitor for aggressive behavior. ( 5.2 ) Long-term Suppression of Growth: Monitor height and weight at appropriate intervals. ( 5.3 ) Seizures: May lower the convulsive threshold. Discontinue in the presence of seizures. ( 5.4 ) Visual Disturbance: Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. ( 5.5 ) Tics: May exacerbate tics. Evaluate for tics and Tourette's syndrome prior to stimulant administration. ( 5.6 ) 5.1 Serious Cardiovascular Events Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems Children and Adolescents Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug [ see CONTRAINDICATIONS (4) ]. Adults Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs [ see CONTRAINDICATIONS (4) ]. Hypertension and Other Cardiovascular Conditions Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia [ see CONTRAINDICATIONS (4) and ADVERSE REACTIONS (6) ]. Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g. electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation. 5.2 Psychiatric Adverse Events Pre-Existing Psychosis Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorder. Bipolar Illness Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. Emergence of New Psychotic or Manic Symptoms Treatment-emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients. Aggression Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility. 5.3 Long-Term Suppression of Growth Monitor growth in children during treatment with stimulants. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted. Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. In a controlled trial of ADDERALL XR in adolescents, mean weight change from baseline within the initial 4 weeks of therapy was -1.1 lbs. and -2.8 lbs., respectively, for patients receiving 10 mg and 20 mg ADDERALL XR. Higher doses were associated with greater weight loss within the initial 4 weeks of treatment. Chronic use of amphetamines can be expected to cause a similar suppression of growth. 5.4 Seizures There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in the absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, ADDERALL XR should be discontinued. 5.5 Visual Disturbance Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. 5.6 Tics Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in patients and their families should precede use of stimulant medications. 5.7 Prescribing and Dispensing The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. ADDERALL XR should be used with caution in patients who use other sympathomimetic drugs.

6 ADVERSE REACTIONS 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 clinical practice. Children (ages 6 to 12): Most common adverse reactions (≥5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea and fever. ( 6.1 ) Adolescents (ages 13 to 17): Most common adverse reactions (≥5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, weight loss, and nervousness. ( 6.1 ) Adults: Most common adverse reactions ≥5% and with a higher incidence than on placebo were dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, and urinary tract infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience The premarketing development program for ADDERALL XR included exposures in a total of 1315 participants in clinical trials (635 pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy adult subjects). Of these, 635 patients (ages 6 to 12) were evaluated in two controlled clinical studies, one open-label clinical study, and two single-dose clinical pharmacology studies (N= 40). Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse reactions, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs. Adverse reactions during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized event categories. In the tables and listings that follow, COSTART terminology has been used to classify reported adverse reactions. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. Adverse Reactions Leading to Discontinuation of Treatment In two placebo-controlled studies of up to 5 weeks duration among children with ADHD, 2.4% (10/425) of ADDERALL XR-treated patients discontinued due to adverse reactions (including 3 patients with loss of appetite, one of whom also reported insomnia) compared to 2.7% (7/259) receiving placebo. The most frequent adverse reactions leading to discontinuation of ADDERALL XR in controlled and uncontrolled, multiple-dose clinical trials of children (N=595) were anorexia (loss of appetite) (2.9%), insomnia (1.5%), weight loss (1.2%), emotional lability (1%), and depression (0.7%). Over half of these patients were exposed to ADDERALL XR for 12 months or more. In a separate placebo-controlled 4-week study in adolescents with ADHD, five patients (2.1%) discontinued treatment due to adverse events among ADDERALL XR-treated patients (N=233) compared to none who received placebo (N=54). The most frequent adverse event leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of ADDERALL XR-treated patients and at a rate at least twice that of placebo) was insomnia (1.3%, n=3). In one placebo-controlled 4-week study among adults with ADHD with doses 20 mg to 60 mg, 23 patients (12.0%) discontinued treatment due to adverse events among ADDERALL XR-treated patients (N=191) compared to one patient (1.6%) who received placebo (N=64). The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of ADDERALL XR-treated patients and at a rate at least twice that of placebo) were insomnia (5.2%, n=10), anxiety (2.1%, n=4), nervousness (1.6%, n=3), dry mouth (1.6%, n=3), anorexia (1.6%, n=3), tachycardia (1.6%, n=3), headache (1.6%, n=3), and asthenia (1.0%, n=2). Adverse Reactions Occurring in Controlled Trials Adverse reactions reported in a 3-week clinical trial of children and a 4-week clinical trial in adolescents and adults, respectively, treated with ADDERALL XR or placebo are presented in the tables below. Table 1 Adverse Reactions Reported by 2% or More of Children (6-12 Years Old) Receiving ADDERALL XR with Higher Incidence Than on Placebo in a 584-Patient Clinical Study Body System Preferred Term ADDERALL XR (n=374) Placebo (n=210) General Abdominal Pain (stomachache) Fever Infection Accidental Injury Asthenia (fatigue) 14% 5% 4% 3% 2% 10% 2% 2% 2% 0% Digestive System Loss of Appetite Vomiting Nausea Dyspepsia 22% 7% 5% 2% 2% 4% 3% 1% Nervous System Insomnia Emotional Lability Nervousness Dizziness 17% 9% 6% 2% 2% 2% 2% 0% Metabolic/Nutritional Weight Loss 4% 0% Table 2 Adverse Reactions Reported by 5% or More of Adolescents (13-17 Years Old) Weighing ≤ 75 kg/165 lbs Receiving ADDERALL XR with Higher Incidence Than Placebo in a 287 Patient Clinical Forced Weekly-Dose Titration Study* Body System Preferred Term ADDERALL XR (n=233) Placebo (n=54) *Included doses up to 40 mg a Appears the same due to rounding b Dose-related adverse reactions Note: The following reactions did not meet the criterion for inclusion in Table 2 but were reported by 2% to 4% of adolescent patients receiving ADDERALL XR with a higher incidence than patients receiving placebo in this study: accidental injury, asthenia (fatigue), dry mouth, dyspepsia, emotional lability, nausea, somnolence, and vomiting. General Abdominal Pain (stomachache) 11% 2% Digestive System Loss of Appetite b 36% 2% Nervous System Insomnia b Nervousness 12% 6% 4% 6% a Metabolic/Nutritional Weight Loss b 9% 0% Table 3 Adverse Reactions Reported by 5% or More of Adults Receiving ADDERALL XR with Higher Incidence Than on Placebo in a 255 Patient Clinical Forced Weekly-Dose Titration Study* Body System Preferred Term ADDERALL XR (n=191) Placebo (n=64) *Included doses up to 60 mg. Note: The following reactions did not meet the criterion for inclusion in Table 3 but were reported by 2% to 4% of adult patients receiving ADDERALL XR with a higher incidence than patients receiving placebo in this study: infection, photosensitivity reaction, constipation, tooth disorder (e.g., teeth clenching, tooth infection), emotional lability, libido decreased, somnolence, speech disorder (e.g., stuttering, excessive speech), palpitation, twitching, dyspnea, sweating, dysmenorrhea, and impotence. General Headache Asthenia 26% 6% 13% 5% Digestive System Dry Mouth Loss of Appetite Nausea Diarrhea 35% 33% 8% 6% 5% 3% 3% 0% Nervous System Insomnia Agitation Anxiety Dizziness 27% 8% 8% 7% 13% 5% 5% 0% Cardiovascular System Tachycardia 6% 3% Metabolic/Nutritional Weight Loss 11% 0% Urogenital System Urinary Tract Infection 5% 0% Hypertension [ see WARNINGS AND PRECAUTIONS (5.1) ] In a controlled 4-week outpatient clinical study of adolescents with ADHD, isolated systolic blood pressure elevations ≥15 mmHg were observed in 7/64 (11%) placebo-treated patients and 7/100 (7%) patients receiving ADDERALL XR 10 or 20 mg. Isolated elevations in diastolic blood pressure ≥ 8 mmHg were observed in 16/64 (25%) placebo-treated patients and 22/100 (22%) ADDERALL XR-treated patients. Similar results were observed at higher doses. In a single-dose pharmacokinetic study in 23 adolescents with ADHD, isolated increases in systolic blood pressure (above the upper 95% CI for age, gender, and stature) were observed in 2/17 (12%) and 8/23 (35%), subjects administered 10 mg and 20 mg ADDERALL XR, respectively. Higher single doses were associated with a greater increase in systolic blood pressure. All increases were transient, appeared maximal at 2 to 4 hours post dose and not associated with symptoms. 6.2 Adverse Reactions Associated with the Use of Amphetamine, ADDERALL XR, or ADDERALL The following adverse reactions have been associated with the use of amphetamine, ADDERALL XR, or ADDERALL: Cardiovascular Palpitations. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea, dermatillomania. Eye Disorders Vision blurred, mydriasis. Gastrointestinal Unpleasant taste, constipation, other gastrointestinal disturbances. Allergic Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported. Endocrine Impotence, changes in libido. Skin Alopecia.

<table width="80%" ID="i9d36e81f-1855-4d6c-8f01-3ad7d4a34c79"> <caption> Table 1 Adverse Reactions Reported by 2% or More of Children (6-12 Years Old) Receiving ADDERALL XR with Higher Incidence Than on Placebo in a 584-Patient Clinical Study </caption> <col width="25%" align="left"/> <col width="25%" align="left"/> <col width="25%" align="left"/> <col width="25%" align="left"/> <thead> <tr> <th styleCode="Botrule Lrule Rrule" align="left"> <content styleCode="bold">Body System</content> </th> <th styleCode="Botrule Lrule Rrule" align="left"> <content styleCode="bold">Preferred Term</content> </th> <th styleCode="Botrule Lrule Rrule" align="left"> <content styleCode="bold">ADDERALL XR</content> <content styleCode="bold">(n=374)</content> </th> <th styleCode="Botrule Lrule Rrule" align="left"> <content styleCode="bold">Placebo</content> <content styleCode="bold">(n=210)</content> </th> </tr> </thead> <tbody> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">General</content> </td> <td styleCode="Botrule Lrule Rrule"> Abdominal Pain (stomachache) Fever Infection Accidental Injury Asthenia (fatigue) </td> <td styleCode="Botrule Lrule Rrule"> 14% 5% 4% 3% 2% </td> <td styleCode="Botrule Lrule Rrule"> 10% 2% 2% 2% 0% </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Digestive System</content> </td> <td styleCode="Botrule Lrule Rrule"> Loss of Appetite Vomiting Nausea Dyspepsia </td> <td styleCode="Botrule Lrule Rrule"> 22% 7% 5% 2% </td> <td styleCode="Botrule Lrule Rrule"> 2% 4% 3% 1% </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Nervous System</content> </td> <td styleCode="Botrule Lrule Rrule"> Insomnia Emotional Lability Nervousness Dizziness </td> <td styleCode="Botrule Lrule Rrule"> 17% 9% 6% 2% </td> <td styleCode="Botrule Lrule Rrule"> 2% 2% 2% 0% </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Metabolic/Nutritional</content> </td> <td styleCode="Botrule Lrule Rrule"> Weight Loss </td> <td styleCode="Botrule Lrule Rrule"> 4% </td> <td styleCode="Botrule Lrule Rrule"> 0% </td> </tr> </tbody> </table>

<table width="80%" ID="i2075a9f8-9fef-43b5-8786-0c93cfffcd2d"> <caption> Table 2 Adverse Reactions Reported by 5% or More of Adolescents (13-17 Years Old) Weighing &#x2264; 75 kg/165 lbs Receiving ADDERALL XR with Higher Incidence Than Placebo in a 287 Patient Clinical Forced Weekly-Dose Titration Study* </caption> <col width="25%" align="left"/> <col width="25%" align="left"/> <col width="25%" align="left"/> <col width="25%" align="left"/> <thead> <tr> <th styleCode="Botrule Lrule Rrule" align="left"> <content styleCode="bold">Body System</content> </th> <th styleCode="Botrule Lrule Rrule" align="left"> <content styleCode="bold">Preferred Term</content> </th> <th styleCode="Botrule Lrule Rrule" align="left"> <content styleCode="bold">ADDERALL XR</content> <content styleCode="bold">(n=233)</content> </th> <th styleCode="Botrule Lrule Rrule" align="left"> <content styleCode="bold">Placebo</content> <content styleCode="bold">(n=54)</content> </th> </tr> </thead> <tfoot> <tr> <td colspan="4" align="left"> *Included doses up to 40 mg ^a Appears the same due to rounding ^b Dose-related adverse reactions Note: The following reactions did not meet the criterion for inclusion in Table 2 but were reported by 2% to 4% of adolescent patients receiving ADDERALL XR with a higher incidence than patients receiving placebo in this study: accidental injury, asthenia (fatigue), dry mouth, dyspepsia, emotional lability, nausea, somnolence, and vomiting. </td> </tr> </tfoot> <tbody> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">General</content> </td> <td styleCode="Botrule Lrule Rrule"> Abdominal Pain (stomachache) </td> <td styleCode="Botrule Lrule Rrule"> 11% </td> <td styleCode="Botrule Lrule Rrule"> 2% </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Digestive System</content> </td> <td styleCode="Botrule Lrule Rrule"> Loss of Appetite ^b </td> <td styleCode="Botrule Lrule Rrule"> 36% </td> <td styleCode="Botrule Lrule Rrule"> 2% </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Nervous System</content> </td> <td styleCode="Botrule Lrule Rrule"> Insomnia ^b Nervousness </td> <td styleCode="Botrule Lrule Rrule"> 12% 6% </td> <td styleCode="Botrule Lrule Rrule"> 4% 6%^a </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Metabolic/Nutritional</content> </td> <td styleCode="Botrule Lrule Rrule"> Weight Loss ^b </td> <td styleCode="Botrule Lrule Rrule"> 9% </td> <td styleCode="Botrule Lrule Rrule"> 0% </td> </tr> </tbody> </table>

<table width="80%" ID="iac4fe191-1fd9-4c22-8c9b-22249890cfcd"> <caption> Table 3 Adverse Reactions Reported by 5% or More of Adults Receiving ADDERALL XR with Higher Incidence Than on Placebo in a 255 Patient Clinical Forced Weekly-Dose Titration Study* </caption> <col width="25%" align="left"/> <col width="25%" align="left"/> <col width="25%" align="left"/> <col width="25%" align="left"/> <thead> <tr> <th styleCode="Botrule Lrule Rrule" align="left"> <content styleCode="bold">Body System</content> </th> <th styleCode="Botrule Lrule Rrule" align="left"> <content styleCode="bold">Preferred Term</content> </th> <th styleCode="Botrule Lrule Rrule" align="left"> <content styleCode="bold">ADDERALL XR</content> <content styleCode="bold">(n=191)</content> </th> <th styleCode="Botrule Lrule Rrule" align="left"> <content styleCode="bold">Placebo</content> <content styleCode="bold">(n=64)</content> </th> </tr> </thead> <tfoot> <tr> <td colspan="4" align="left"> *Included doses up to 60 mg. Note: The following reactions did not meet the criterion for inclusion in Table 3 but were reported by 2% to 4% of adult patients receiving ADDERALL XR with a higher incidence than patients receiving placebo in this study: infection, photosensitivity reaction, constipation, tooth disorder (e.g., teeth clenching, tooth infection), emotional lability, libido decreased, somnolence, speech disorder (e.g., stuttering, excessive speech), palpitation, twitching, dyspnea, sweating, dysmenorrhea, and impotence. </td> </tr> </tfoot> <tbody> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">General</content> </td> <td styleCode="Botrule Lrule Rrule"> Headache Asthenia </td> <td styleCode="Botrule Lrule Rrule"> 26% 6% </td> <td styleCode="Botrule Lrule Rrule"> 13% 5% </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Digestive System</content> </td> <td styleCode="Botrule Lrule Rrule"> Dry Mouth Loss of Appetite Nausea Diarrhea </td> <td styleCode="Botrule Lrule Rrule"> 35% 33% 8% 6% </td> <td styleCode="Botrule Lrule Rrule"> 5% 3% 3% 0% </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Nervous System</content> </td> <td styleCode="Botrule Lrule Rrule"> Insomnia Agitation Anxiety Dizziness </td> <td styleCode="Botrule Lrule Rrule"> 27% 8% 8% 7% </td> <td styleCode="Botrule Lrule Rrule"> 13% 5% 5% 0% </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Cardiovascular System</content> </td> <td styleCode="Botrule Lrule Rrule"> Tachycardia </td> <td styleCode="Botrule Lrule Rrule"> 6% </td> <td styleCode="Botrule Lrule Rrule"> 3% </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Metabolic/Nutritional</content> </td> <td styleCode="Botrule Lrule Rrule"> Weight Loss </td> <td styleCode="Botrule Lrule Rrule"> 11% </td> <td styleCode="Botrule Lrule Rrule"> 0% </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Urogenital System</content> </td> <td styleCode="Botrule Lrule Rrule"> Urinary Tract Infection </td> <td styleCode="Botrule Lrule Rrule"> 5% </td> <td styleCode="Botrule Lrule Rrule"> 0% </td> </tr> </tbody> </table>