FDA label d04e55e2-651f-49fe-e053-2a95a90aee0c

WARNING: ABUSE AND DEPENDENCE CNS stimulants, including Amphetamine extended-release oral suspension, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy [see Warnings and Precautions (5.1) and Drug Abuse and Dependence (9.2 , 9.3) ] . WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning. CNS stimulants, including Amphetamine extended-release oral suspension, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. ( 5.1 , 9.3 ) Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy ( 9.2 , 9.3 )

5 WARNINGS AND PRECAUTIONS Serious Cardiovascular Reactions: Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, or coronary artery disease. ( 5.2 ) Blood Pressure and Heart Rate Increases: Monitor blood pressure and pulse. Consider benefits and risks before use in patients for whom blood pressure increases may be problematic. ( 5.3 ) Psychiatric Adverse Reactions: May cause 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. ( 5.4 ) Long-Term Suppression of Growth: Monitor height and weight in pediatric patients during treatment. ( 5.5 ) Peripheral Vasculopathy , including Raynaud's phenomenon : Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants. ( 5.6 ) Serotonin Syndrome: Increased risk when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during overdosage situations. If it occurs, discontinue Amphetamine extended-release oral suspension and initiate supportive treatment. ( 5.7 ) 5.1 Potential for Abuse or Dependence CNS stimulants, including Amphetamine extended-release oral suspension, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Boxed Warning , Drug Abuse and Dependence (9.2 , 9.3) ] . 5.2 Serious Cardiovascular Reactions Sudden death, stroke, and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in children and adolescents with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Amphetamine extended-release oral suspension treatment. 5.3 Blood Pressure and Heart Rate Increases CNS stimulants cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for potential tachycardia and hypertension. 5.4 Psychiatric Adverse Events Exacerbation of Pre-Existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Illness CNS stimulants may induce a mixed or manic episode in patients with bipolar disorder. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or has a history of depressive symptoms or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Amphetamine extended-release oral suspension. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in 0.1% of CNS stimulant-treated patients compared to 0% in placebo-treated patients. 5.5 Long-Term Suppression of Growth CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including Amphetamine extended-release oral suspension. Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted [ Use in Specific Populations (8.4) ] . 5.6 Peripheral Vasculopathy, including Raynaud's Phenomenon Stimulants, including Amphetamine extended-release oral suspension, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients. 5.7 Serotonin Syndrome Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort [see Drug Interactions (7.1) ] . The co-administration with cytochrome P450 2D6 (CYP2D6) inhibitors may also increase the risk with increased exposure to Amphetamine extended-release oral suspension. In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see Drug Interactions (7.1) ] . Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Concomitant use of Amphetamine extended-release oral suspension with MAOI drugs is contraindicated [see Contraindications (4) ] . Discontinue treatment with Amphetamine extended-release oral suspension and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of Amphetamine extended-release oral suspension with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Amphetamine extended-release oral suspension with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome. 5.8 Potential for Overdose Due to Medication Errors Medication errors, including substitution and dispensing errors, between Amphetamine extended-release oral suspension and other amphetamine products could occur, leading to possible overdosage. To avoid substitution errors and overdosage, do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine salt compositions and differing pharmacokinetic profiles [see Dosage and Administration (2.5) ] . 5.9 Potential for Intestinal Necrosis Cases of intestinal necrosis, including some deaths, have been reported with the concomitant use of sodium polystyrene sulfonate and sorbitol, two of the inactive ingredients in Amphetamine extended-release oral suspension. In these cases, patients were administered sodium polystyrene sulfonate to treat hyperkalemia at doses greater than 200 times the amount present in Amphetamine extended-release oral suspension. However, no absolute safe levels for the interaction of sodium polystyrene sulfonate and sorbitol have been established.

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Drug Dependence [see Boxed Warning , Warnings and Precautions (5.1) , and Drug Abuse and Dependence (9.2 , 9.3) ] Hypersensitivity to amphetamine, or other components of Amphetamine extended-release oral suspension [see Contraindications (4) ] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4) and Drug Interactions (7.1) ] Serious Cardiovascular Reactions [see Warnings and Precautions (5.2) ] Blood Pressure and Heart Rate Increases [see Warnings and Precautions (5.3) ] Psychiatric Adverse Reactions [see Warnings and Precautions (5.4) ] Long-Term Suppression of Growth [see Warnings and Precautions (5.5) ] Peripheral Vasculopathy, including Raynaud's phenomenon [see Warnings and Precautions (5.6) ] Serotonin Syndrome [see Warnings and Precautions (5.7) ] Potential for Intestinal Necrosis [see Warnings and Precautions (5.9) ] Pediatric patients ages 6 to 12 years: 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 ) Pediatric patients ages 13 to 17 years: 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 Neos Therapeutics, Inc. at 1-888-319-1789 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 clinical practice. The safety of Amphetamine extended-release oral suspension has been established from adequate and well-controlled studies of single-entity amphetamine product extended-release (MAS ER) capsules [see Clinical Studies (14) ] . The adverse reactions of MAS ER capsules in these adequate and well-controlled studies are described below. The premarketing development program for MAS ER 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). Adverse Reactions Leading to Discontinuation of Treatment The most frequent adverse reactions leading to discontinuation of MAS ER in controlled and uncontrolled, multiple-dose clinical trials of pediatric patients ages 6 to 12 years (N=595) were anorexia (loss of appetite) (2.9%), insomnia (1.5%), weight loss (1.2%), emotional lability (1%), and depression (0.7%). In a separate placebo-controlled 4-week study in pediatric patients 13 to 17 years with ADHD, five patients (2.1%) discontinued treatment due to adverse events among MAS ER-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 MAS ER-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 MAS ER-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 MAS ER-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 pediatric patients 6 to 12 years and a 4-week clinical trial in pediatric patients 13 to 17 years of age and adults, respectively, treated with MAS ER or placebo are presented in the tables below. Table 2: Adverse Reactions Reported by 2% or More of Children (6-12 years old) Receiving MAS ER with Higher Incidence than on Placebo in a 584-Patient Clinical Study Body System Preferred Term MAS ER (n=374) Placebo (n=210) General Abdominal Pain (stomachache) 14% 10% Fever 5% 2% Infection 4% 2% Accidental Injury 3% 2% Asthenia (fatigue) 2% 0% Digestive System Loss of Appetite 22% 2% Vomiting 7% 4% Nausea 5% 3% Dyspepsia 2% 1% Nervous System Insomnia 17% 2% Emotional Lability 9% 2% Nervousness 6% 2% Dizziness 2% 0% Metabolic/Nutritional Weight Loss 4% 0% Table 3: Adverse Reactions Reported by 5% or More of Adolescents (13-17 Years Old) Weighing ≤ 75kg Receiving MAS ER with Higher Incidence than Placebo in a 287 Patient Clinical Forced Weekly-Dose Titration Study* Body System Preferred Term MAS ER (n=233) Placebo (n=54) General Abdominal Pain (stomachache) 11% 2% Digestive System Loss of Appetite b 36% 2% Nervous System Insomnia b 12% 4% Metabolic/Nutritional Weight Loss b 9% 0% * Included doses up to 40 mg b Dose-related adverse reactions Note: The following reactions did not meet the criterion for inclusion in Table 3 but were reported by 2% to 4% of adolescent patients receiving MAS ER with a higher incidence than patients receiving placebo in this study: accidental injury, asthenia (fatigue), dry mouth, dyspepsia, emotional lability, nausea, somnolence, and vomiting. Table 4: Adverse Reactions Reported by 5% or More of Adults Receiving MAS ER with Higher Incidence Than Placebo in a 255 Patient Clinical Forced Weekly-Dose Titration Study* Body System Preferred Term MAS ER (n=191) Placebo (n=64) General Headache 26% 13% Asthenia 6% 5% Digestive System Dry Mouth 35% 5% Loss of Appetite 33% 3% Nausea 8% 3% Diarrhea 6% 0% Nervous System Insomnia 27% 13% Agitation 8% 5% Anxiety 8% 5% Dizziness 7% 0% Cardiovascular System Tachycardia 6% 3% Metabolic/Nutritional Weight Loss 10% 0% Urogenital System Urinary Tract Infection 5% 0% *Included doses up to 60 mg. Note: The following reactions did not meet the criterion for inclusion in Table 4 but were reported by 2% to 4% of adult patients receiving MAS ER 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. 6.2 Adverse Reactions from Clinical Trials and Spontaneous Postmarketing Reports of Other Amphetamine Products The following adverse reactions are from clinical trials and spontaneous postmarketing reports of other amphetamine products in pediatric patients and adults with ADHD. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiovascular: Palpitations, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System: Restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, aggression, anger, logorrhea, and paresthesia (including formication). 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, change in libido, frequent or prolonged erections. Skin: Alopecia. Musculoskeletal, Connective Tissue, and Bone Disorders: Rhabdomyolysis. Psychiatric Disorders: Dermatillomania, bruxism. Vascular Disorders: Raynaud's phenomenon

<table width="455px"><caption>Table 2: Adverse Reactions Reported by 2% or More of Children (6-12 years old) Receiving MAS ER with Higher Incidence than on Placebo in a 584-Patient Clinical Study</caption><col/><col/><col/><col/><tbody><tr><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold">Body System</content></td><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold"> Preferred Term</content></td><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold">MAS ER (n=374) </content></td><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold">Placebo (n=210) </content></td></tr><tr><td rowspan="5" styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold"> General </content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Abdominal Pain (stomachache)</td><td styleCode=" Botrule Toprule Lrule Rrule "> 14%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 10%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Fever</td><td styleCode=" Botrule Toprule Lrule Rrule "> 5%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 2%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Infection</td><td styleCode=" Botrule Toprule Lrule Rrule "> 4%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 2%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Accidental Injury</td><td styleCode=" Botrule Toprule Lrule Rrule "> 3%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 2%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Asthenia (fatigue)</td><td styleCode=" Botrule Toprule Lrule Rrule "> 2%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 0%</td></tr><tr><td rowspan="4" styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold"> Digestive System </content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Loss of Appetite</td><td styleCode=" Botrule Toprule Lrule Rrule "> 22%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 2%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Vomiting</td><td styleCode=" Botrule Toprule Lrule Rrule "> 7%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 4%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Nausea</td><td styleCode=" Botrule Toprule Lrule Rrule "> 5%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 3%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Dyspepsia</td><td styleCode=" Botrule Toprule Lrule Rrule "> 2%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 1%</td></tr><tr><td rowspan="4" styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold"> Nervous System </content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Insomnia</td><td styleCode=" Botrule Toprule Lrule Rrule "> 17%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 2%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Emotional Lability</td><td styleCode=" Botrule Toprule Lrule Rrule "> 9%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 2%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Nervousness</td><td styleCode=" Botrule Toprule Lrule Rrule "> 6%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 2%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Dizziness</td><td styleCode=" Botrule Toprule Lrule Rrule "> 2%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 0%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold">Metabolic/Nutritional </content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Weight Loss</td><td styleCode=" Botrule Toprule Lrule Rrule "> 4%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 0%</td></tr></tbody></table>

<table width="458px"><caption>Table 3: Adverse Reactions Reported by 5% or More of Adolescents (13-17 Years Old) Weighing &#x2264; 75kg Receiving MAS ER with Higher Incidence than Placebo in a 287 Patient Clinical Forced Weekly-Dose Titration Study*</caption><col/><col/><col/><col/><tbody><tr><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold">Body System</content></td><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold"> Preferred Term</content></td><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold"> MAS ER (n=233) </content></td><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold">Placebo (n=54) </content></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold"> General</content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Abdominal Pain (stomachache)</td><td styleCode=" Botrule Toprule Lrule Rrule "> 11%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 2%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold"> Digestive System</content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Loss of Appetite ^b</td><td styleCode=" Botrule Toprule Lrule Rrule "> 36%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 2%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold"> Nervous System</content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Insomnia ^b</td><td styleCode=" Botrule Toprule Lrule Rrule "> 12%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 4%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold">Metabolic/Nutritional</content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Weight Loss ^b</td><td styleCode=" Botrule Toprule Lrule Rrule "> 9%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 0%</td></tr></tbody></table>

<table width="451px"><caption>Table 4: Adverse Reactions Reported by 5% or More of Adults Receiving MAS ER with Higher Incidence Than Placebo in a 255 Patient Clinical Forced Weekly-Dose Titration Study*</caption><col/><col/><col/><col/><tbody><tr><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold">Body System </content></td><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold">Preferred Term </content></td><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold">MAS ER (n=191) </content></td><td styleCode=" Botrule Toprule Lrule Rrule "><content styleCode="bold"> Placebo (n=64) </content></td></tr><tr><td rowspan="2" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold">General</content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Headache</td><td styleCode=" Botrule Toprule Lrule Rrule "> 26%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 13%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Asthenia</td><td styleCode=" Botrule Toprule Lrule Rrule "> 6%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 5%</td></tr><tr><td rowspan="4" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold">Digestive System</content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Dry Mouth</td><td styleCode=" Botrule Toprule Lrule Rrule "> 35%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 5%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Loss of Appetite</td><td styleCode=" Botrule Toprule Lrule Rrule "> 33%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 3%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Nausea</td><td styleCode=" Botrule Toprule Lrule Rrule "> 8%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 3%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Diarrhea</td><td styleCode=" Botrule Toprule Lrule Rrule "> 6%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 0%</td></tr><tr><td rowspan="4" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold">Nervous System</content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Insomnia</td><td styleCode=" Botrule Toprule Lrule Rrule "> 27%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 13%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Agitation</td><td styleCode=" Botrule Toprule Lrule Rrule "> 8%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 5%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Anxiety</td><td styleCode=" Botrule Toprule Lrule Rrule "> 8%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 5%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> Dizziness</td><td styleCode=" Botrule Toprule Lrule Rrule "> 7%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 0%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold">Cardiovascular System</content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Tachycardia</td><td styleCode=" Botrule Toprule Lrule Rrule "> 6%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 3%</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold">Metabolic/Nutritional</content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Weight Loss</td><td styleCode=" Botrule Toprule Lrule Rrule "> 10%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 0% </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold">Urogenital System</content></td><td styleCode=" Botrule Toprule Lrule Rrule "> Urinary Tract Infection</td><td styleCode=" Botrule Toprule Lrule Rrule "> 5%</td><td styleCode=" Botrule Toprule Lrule Rrule "> 0%</td></tr></tbody></table>