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adverse reactions
6 ADVERSE REACTIONS The following risks are discussed in greater detail in other sections of the labeling: Clinical worsening and suicide risk [see WARNINGS AND PRECAUTIONS: Clinical Worsening and Suicide Risk (5.1) ] Activation of Psychosis and/or Mania [see WARNINGS AND PRECAUTIONS: Activation of Psychosis and/or Mania (5.2) and WARNINGS AND PRECAUTIONS: Screening Patients for Bipolar Disorder (5.3) ] Hepatotoxicity [see WARNINGS AND PRECAUTIONS: Potential for Hepatotoxicity (5.6) ] Agitation and Insomnia [see WARNINGS AND PRECAUTIONS: Agitation and Insomnia (5.7) ] Psychosis, confusion and other neuropsychiatric phenomena [see WARNINGS AND PRECAUTIONS: Psychosis, Confusion, and Other Neuropsychiatric Phenomena (5.8) ] Altered appetite [see WARNINGS AND PRECAUTIONS: Altered Appetite and Weight (5.9) ] Allergic reactions, including anaphylactoid/anaphylactic reactions, erythema multiforme, Stevens-Johnson syndrome and other symptoms suggestive of delayed hypersensitivity [see WARNINGS AND PRECAUTIONS: Allergic Reactions (5.10) ] Hypertension [see WARNINGS AND PRECAUTIONS: Cardiovascular Effects (5.11) ] Most common adverse reactions are (incidence ≥ 5%; ≥ 2× placebo rate): Dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency, rash ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biovail Pharmaceuticals at (866-246-8245 (opt.3) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Commonly Observed Adverse Reactions in Controlled Clinical Trials Adverse reactions from Table 4 occurring in at least 5% of patients treated with the sustained-release formulation of bupropion hydrochloride and at a rate at least twice the placebo rate are listed below for the 300- and 400-mg/day dose groups. 300 mg/day of WELLBUTRIN SR ( equivalent to 348 mg/day bupropion HBr) : Anorexia, dry mouth, rash, sweating, tinnitus, and tremor. 400 mg/day of WELLBUTRIN SR ( equivalent to 464 mg/day bupropion HBr) : Abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency. Aplenzin is bioequivalent to WELLBUTRIN XL ® , which has been demonstrated to have similar bioavailability both to the immediate-release formulation of bupropion and to the sustained-release formulation of bupropion. The information included under this subsection and under subsections 6.2 and 6.3 is based primarily on data from controlled clinical trials with WELLBUTRIN SR ® Tablets, the sustained-release formulation of bupropion hydrochloride. 6.2 Adverse Reactions Leading to Discontinuation of Treatment With WELLBUTRIN or WELLBUTRIN SR In placebo-controlled clinical trials, 9% and 11% of patients treated with 300 and 400 mg/day, respectively, of the sustained-release formulation of bupropion hydrochloride and 4% of patients treated with placebo discontinued treatment due to adverse reactions. The specific adverse reactions in these trials that led to discontinuation in at least 1% of patients treated with either 300 mg/day or 400 mg/day of WELLBUTRIN SR ® , the sustained-release formulation of bupropion hydrochloride, and at a rate at least twice the placebo rate are listed in Table 4. Table 4. Treatment Discontinuations Due to Adverse Reactions in Placebo-Controlled Trials for Major Depressive Disorder Adverse Reaction Term WELLBUTRIN SR ® (Bupropion HCl) 300 mg/day Equivalent to 348 mg/day bupropion HBr (n = 376) WELLBUTRIN SR ® (Bupropion HCl) 400 mg/day Equivalent to 464 mg/day bupropion HBr (n = 114) Placebo (n = 385) Rash 2.4% 0.9% 0.0% Nausea 0.8% 1.8% 0.3% Agitation 0.3% 1.8% 0.3% Migraine 0.0% 1.8% 0.3% In clinical trials with the immediate-release formulation of bupropion, 10% of patients and volunteers discontinued due to an adverse reaction. Reactions resulting in discontinuation, in addition to those listed above for the sustained-release formulation of bupropion hydrochloride, include vomiting, seizures, and sleep disturbances. 6.3 Adverse Reactions Occurring at an Incidence of 1% or More Among Patients Treated With WELLBUTRIN or WELLBUTRIN SR Table 5 enumerates treatment-emergent adverse reactions that occurred among patients treated with 300 and 400 mg/day of the sustained-release formulation of bupropion hydrochloride and with placebo in controlled trials. Reactions that occurred in either the 300- or 400-mg/day group at an incidence of 1% or more and were more frequent than in the placebo group are included. Reported adverse reactions were classified using a COSTART-based Dictionary. Accurate estimates of the incidence of adverse reactions associated with the use of any drug are difficult to obtain. Estimates are influenced by drug dose, detection technique, setting, physician judgments, etc. The figures cited cannot be used to predict precisely the incidence of untoward reactions in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. These incidence figures also cannot be compared with those obtained from other clinical studies involving related drug products as each group of drug trials is conducted under a different set of conditions. Finally, it is important to emphasize that the tabulation does not reflect the relative severity and/or clinical importance of the reactions. A better perspective on the serious adverse reactions associated with the use of bupropion is provided in the WARNINGS AND PRECAUTIONS section (5) . Table 5. Treatment-Emergent Adverse Reactions in Placebo-Controlled Trials Adverse reactions that occurred in at least 1% of patients treated with either 300 or 400 mg/day of the sustained-release formulation of bupropion hydrochloride, but equally or more frequently in the placebo group, were: abnormal dreams, accidental injury, acne, appetite increased, back pain, bronchitis, dysmenorrhea, dyspepsia, flatulence, flu syndrome, hypertension, neck pain, respiratory disorder, rhinitis, and tooth disorder. for Major Depressive Disorder Body System/Adverse Reaction WELLBUTRIN SR ® (Bupropion HCl) 300 mg/day Equivalent to 348 mg/day bupropion HBr (n = 376) WELLBUTRIN SR ® (Bupropion HCl) 400 mg/day Equivalent to 464 mg/day bupropion HBr (n = 114) Placebo (n = 385) — Hyphen denotes adverse reactions occurring in greater than 0 but less than 0.5% of patients. Body (General) Headache 26% 25% 23% Infection 8% 9% 6% Abdominal pain 3% 9% 2% Asthenia 2% 4% 2% Chest pain 3% 4% 1% Pain 2% 3% 2% Fever 1% 2% — Cardiovascular Palpitation 2% 6% 2% Flushing 1% 4% — Migraine 1% 4% 1% Hot flashes 1% 3% 1% Digestive Dry mouth 17% 24% 7% Nausea 13% 18% 8% Constipation 10% 5% 7% Diarrhea 5% 7% 6% Anorexia 5% 3% 2% Vomiting 4% 2% 2% Dysphagia 0% 2% 0% Musculoskeletal Myalgia 2% 6% 3% Arthralgia 1% 4% 1% Arthritis 0% 2% 0% Twitch 1% 2% — Nervous system Insomnia 11% 16% 6% Dizziness 7% 11% 5% Agitation 3% 9% 2% Anxiety 5% 6% 3% Tremor 6% 3% 1% Nervousness 5% 3% 3% Somnolence 2% 3% 2% Irritability 3% 2% 2% Memory decreased — 3% 1% Paresthesia 1% 2% 1% Central nervous system stimulation 2% 1% 1% Respiratory Pharyngitis 3% 11% 2% Sinusitis 3% 1% 2% Increased cough 1% 2% 1% Skin Sweating 6% 5% 2% Rash 5% 4% 1% Pruritus 2% 4% 2% Urticaria 2% 1% 0% Special senses Tinnitus 6% 6% 2% Taste perversion 2% 4% — Blurred vision or diplopia 3% 2% 2% Urogenital Urinary frequency 2% 5% 2% Urinary urgency — 2% 0% Vaginal hemorrhage Incidence based on the number of female patients. 0% 2% — Urinary tract infection 1% 0% — Additional reactions to those listed in Table 5 that occurred at an incidence of at least 1% in controlled clinical trials of the immediate-release formulation of bupropion hydrochloride (300 to 600 mg/day) and that were numerically more frequent than placebo were: cardiac arrhythmias (5% vs 4%), hypertension (4% vs 2%), hypotension (3% vs 2%), tachycardia (11% vs 9%), appetite increase (4% vs 2%), dyspepsia (3% vs 2%), menstrual complaints (5% vs 1%), akathisia (2% vs 1%), impaired sleep quality (4% vs 2%), sensory disturbance (4% vs 3%), confusion (8% vs 5%), decreased libido (3% vs 2%), hostility (6% vs 4%), auditory disturbance (5% vs 3%), and gustatory disturbance (3% vs 1%). 6.4 Other Events Observed During the Clinical Development and Postmarketing Experience of Bupropion In addition to the adverse events noted above, the following events have been reported in clinical trials and postmarketing experience with the sustained-release formulation of bupropion hydrochloride in depressed patients and in nondepressed smokers, as well as in clinical trials and postmarketing clinical experience with the immediate-release formulation of bupropion hydrochloride. Adverse events for which frequencies are provided below occurred in clinical trials with the sustained-release formulation of bupropion hydrochloride. The frequencies represent the proportion of patients who experienced a treatment-emergent adverse event on at least one occasion in placebo-controlled studies for depression (n = 987) or smoking cessation (n = 1,013), or patients who experienced an adverse event requiring discontinuation of treatment in an open-label surveillance study with the sustained-release formulation of bupropion hydrochloride (n = 3,100). All treatment-emergent adverse events are included except those listed in Tables 2 through 5, those events listed in other safety-related sections, those adverse events subsumed under COSTART terms that are either overly general or excessively specific so as to be uninformative, those events not reasonably associated with the use of the drug, and those events that were not serious and occurred in fewer than 2 patients. Events of major clinical importance are described in the WARNINGS AND PRECAUTIONS section (5) . Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions of frequency: Frequent adverse events are defined as those occurring in at least 1/100 patients. Infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, while rare events are those occurring in less than 1/1,000 patients. Adverse events for which frequencies are not provided occurred in clinical trials or postmarketing experience with bupropion. Only those adverse events not previously listed for sustained-release bupropion are included. The extent to which these events may be associated with Aplenzin is unknown. Body (General) Infrequent were chills, facial edema, musculoskeletal chest pain, and photosensitivity. Rare was malaise. Also observed were arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity. These symptoms may resemble serum sickness [see WARNINGS AND PRECAUTIONS: Allergic Reactions (5.10) ] . Cardiovascular Infrequent were postural hypotension, stroke, tachycardia, and vasodilation. Rare was syncope. Also observed were complete atrioventricular block, extrasystoles, hypotension, hypertension (in some cases severe; [see WARNINGS AND PRECAUTIONS: Cardiovascular Effects (5.11) ] , myocardial infarction, phlebitis, and pulmonary embolism. Digestive Infrequent were abnormal liver function, bruxism, gastric reflux, gingivitis, glossitis, increased salivation, jaundice, mouth ulcers, stomatitis, and thirst. Rare was edema of tongue. Also observed were colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, intestinal perforation, liver damage, pancreatitis, and stomach ulcer. Endocrine Also observed were hyperglycemia, hypoglycemia, and syndrome of inappropriate antidiuretic hormone. Hemic and Lymphatic Infrequent was ecchymosis. Also observed were anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, and thrombocytopenia. Altered PT and/or INR, infrequently associated with hemorrhagic or thrombotic complications, were observed when bupropion was coadministered with warfarin. Metabolic and Nutritional Infrequent were edema and peripheral edema. Also observed was glycosuria. Musculoskeletal Infrequent were leg cramps. Also observed were muscle rigidity/fever/rhabdomyolysis and muscle weakness. Nervous System Infrequent were abnormal coordination, decreased libido, depersonalization, dysphoria, emotional lability, hostility, hyperkinesia, hypertonia, hypesthesia, suicidal ideation, and vertigo. Rare were amnesia, ataxia, derealization, and hypomania. Also observed were abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, coma, delirium, delusions, dysarthria, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, hallucinations, hypokinesia, increased libido, manic reaction, neuralgia, neuropathy, paranoid ideation, restlessness, and unmasking tardive dyskinesia. Respiratory Rare was bronchospasm. Also observed was pneumonia. Skin Rare was maculopapular rash. Also observed were alopecia, angioedema, exfoliative dermatitis, and hirsutism. Special Senses Infrequent were accommodation abnormality and dry eye. Also observed were deafness, diplopia, increased intraocular pressure, and mydriasis. Urogenital Infrequent were impotence, polyuria, and prostate disorder. Also observed were abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, salpingitis, urinary incontinence, urinary retention, and vaginitis.