Zyban Side Effects

Generic Name: bupropion

Please note - some side effects for Zyban may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Zyban - for the Consumer

Zyban Sustained-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zyban Sustained-Release Tablets:

Anxiety; constipation; diarrhea; dizziness; drowsiness; dry mouth; loss of appetite; nausea; nervousness; stomach pain; stuffy nose; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; concentration problems, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated sense of well-being, inability to sit still, or other unusual or severe mental or mood changes; confusion; changes in sexual desire or ability; dark urine; delusions; fainting; fast or irregular heartbeat; fever or chills; hallucinations; hearing problems or ringing in the ears; joint or muscle pain; menstrual changes; red, swollen, blistered, or peeling skin; seizures; severe headache or dizziness; severe or persistent anxiety, agitation, restlessness, or trouble sleeping; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; suicidal thoughts or attempts; tremor; yellowing of the skin or eyes.

Zyban Side Effects - for the Professional

Zyban

The information included under ADVERSE REACTIONS is based primarily on data from the dose-response trial and the comparative trial that evaluated Zyban for smoking cessation. Information on additional adverse events associated with the sustained-release formulation of bupropion in depression trials, as well as the immediate-release formulation of bupropion, is included in a separate section.

Adverse Events Associated With the Discontinuation of Treatment

Adverse events were sufficiently troublesome to cause discontinuation of treatment in 8% of the 706 patients treated with Zyban and 5% of the 313 patients treated with placebo. The more common events leading to discontinuation of treatment with Zyban included nervous system disturbances (3.4%), primarily tremors, and skin disorders (2.4%), primarily rashes.

Incidence of Commonly Observed Adverse Events

The most commonly observed adverse events consistently associated with the use of Zyban were dry mouth and insomnia. The most commonly observed adverse events were defined as those that consistently occurred at a rate of 5 percentage points greater than that for placebo across clinical studies.

Dose Dependency of Adverse Events

The incidence of dry mouth and insomnia may be related to the dose of Zyban. The occurrence of these adverse events may be minimized by reducing the dose of Zyban. In addition, insomnia may be minimized by avoiding bedtime doses.

Adverse Events Occurring at an Incidence of 1% or More Among Patients Treated With Zyban

 Table 5 enumerates selected treatment-emergent adverse events from the dose-response trial that occurred at an incidence of 1% or more and were more common in patients treated with Zyban compared to those treated with placebo. Table 6 enumerates selected treatment-emergent adverse events from the comparative trial that occurred at an incidence of 1% or more and were more common in patients treated with Zyban, NTS, or the combination of Zyban and NTS compared to those treated with placebo. Reported adverse events were classified using a COSTART-based dictionary.

Zyban was well tolerated in the long-term maintenance trial that evaluated chronic administration of Zyban for up to 1 year and in the COPD trial that evaluated patients with mild-to-moderate COPD for a 12-week period. Adverse events in both studies were quantitatively and qualitatively similar to those observed in the dose-response and comparative trials.

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 in depressed patients and in nondepressed smokers, as well as in clinical trials and postmarketing clinical experience with the immediate-release formulation of bupropion.

Adverse events for which frequencies are provided below occurred in clinical trials with the sustained-release formulation of bupropion . 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 bupropion sustained-release tablets (n = 3,100). All treatment-emergent adverse events are included except those listed in Tables 5 and 6, those events listed in other safety-related sections of the insert, those adverse events subsumed under COSTART terms that are either overly general or excessively specified 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 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 Zyban is unknown.

Frequent were asthenia, fever, and headache. Infrequent were back pain, chills, inguinal hernia, musculoskeletal chest pain, 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.

Infrequent were flushing, migraine, postural hypotension, stroke, tachycardia, and vasodilation. Rare was syncope. Also observed were cardiovascular disorder, complete AV block, extrasystoles, hypotension, hypertension (in some cases severe, see PRECAUTIONS), myocardial infarction, phlebitis, and pulmonary embolism.

Frequent were dyspepsia, flatulence, and vomiting. Infrequent were abnormal liver function, bruxism, dysphagia, gastric reflux, gingivitis, glossitis, jaundice, and stomatitis. Rare was edema of tongue. Also observed were colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, increased salivation, intestinal perforation, liver damage, pancreatitis, stomach ulcer, and stool abnormality.

 Also observed were hyperglycemia, hypoglycemia, and syndrome of inappropriate antidiuretic hormone.

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.

 Infrequent were edema, increased weight, and peripheral edema. Also observed was glycosuria.

 Infrequent were leg cramps and twitching. Also observed were arthritis and muscle rigidity/fever/rhabdomyolysis, and muscle weakness.

 Frequent were agitation, depression, and irritability. Infrequent were abnormal coordination, CNS stimulation, confusion, decreased libido, decreased memory, depersonalization, emotional lability, hostility, hyperkinesia, hypertonia, hypesthesia, paresthesia, suicidal ideation, and vertigo. Rare were amnesia, ataxia, derealization, and hypomania. Also observed were abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, coma, completed suicide, delirium, delusions, dysarthria, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, hallucinations, hypokinesia, increased libido, manic reaction, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt, and unmasking tardive dyskinesia.

Rare was bronchospasm. Also observed was pneumonia.

Frequent was sweating. Infrequent was acne and dry skin. Rare was maculopapular rash. Also observed were alopecia, angioedema, exfoliative dermatitis, and hirsutism.

Frequent was blurred vision or diplopia. Infrequent were accommodation abnormality and dry eye. Also observed were deafness, increased intraocular pressure, and mydriasis.

Frequent was urinary frequency. Infrequent were impotence, polyuria, and urinary urgency. Also observed were abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, prostate disorder, salpingitis, urinary incontinence, urinary retention, urinary tract disorder, and vaginitis.

Side Effects by Body System

Nervous system

Nervous system side effects have frequently included headache (27%), insomnia (16% to 33%), dizziness (12%), tremor, somnolence, thinking abnormality, abnormal dreams (6%), sleep abnormalities, disturbed concentration, dysphoria, decreased memory, paresthesia, central nervous system (CNS) stimulation, akathisia, migraine, impaired sleep quality, pseudoparkinsonism, sedation, sensory disturbance, seizure, myoclonus, and dysarthria. Abnormal coordination, confusion, decreased libido, hyperkinesia, hypertonia, hypesthesia, vertigo, amnesia, ataxia, abnormal electroencephalogram (EEG), akinesia, aphasia, coma, dyskinesia, dystonia, extrapyramidal syndrome, hypokinesia, increased libido, neuralgia, neuropathy, unmasking tardive dyskinesia, abnormal neurological exam, impaired attention, sciatica, and aphasia have been reported rarely.

Grand mal seizures have been reported in 0.4% of patients undergoing bupropion therapy at dosages up to 450 mg daily. The incidence of seizures increases dramatically at higher dosages. The seizure rate in patients taking sustained-release bupropion up to a dosage of 300 mg/day (e.g. for smoking cessation) has been approximated at 0.1%.

The seizure risk associated with bupropion is dose-related but may also be dependent on concomitant predisposing factors, such as: a history of seizure disorder or head trauma; concomitant treatment with agents that lower seizure threshold (antipsychotics, antidepressants, theophylline, systemic steroids, etc.); or circumstances associated with increased risk of seizures (abrupt withdrawal of a benzodiazepine or alcohol, excessive alcohol intake, addiction to opiates, etc). One retrospective analysis has suggested that advancing age may be protective against bupropion- induced seizures.

Insomnia may also be dose-dependent. In a dose- response clinical study for smoking cessation, 29% of patients receiving bupropion 150 mg/day versus 35% of those receiving 300 mg/day reported insomnia. Insomnia may be minimized by reducing the dosage or avoiding administration at bedtime.

The Australian Adverse Drug Reaction Advisory Committee reported that 268 of the 780 reports it received in association with bupropion through mid- May 2001 involved nervous system disorders.

Two cases of elderly patients falling backwards have been attributed to the effects of bupropion on the basal ganglia.

Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.

Gastrointestinal

Gastrointestinal side effects have frequently included dry mouth (12% to 28%), nausea (9% to 15%), constipation (7%), diarrhea (9%), bloating (7%), cramps (7%), anorexia, vomiting, dysphagia, increase in appetite, taste perversion, abdominal pain, and dyspepsia. Bruxism, gastric reflux, gingivitis, glossitis, increased salivation, mouth ulcers, stomatitis, thirst disturbance, increased salivary flow, and flatulence have been reported infrequently. Edema of the tongue, gustatory disturbance, colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, intestinal perforation, pancreatitis, stomach ulcer, and stool abnormality have been reported rarely.

Genitourinary

One study in which 150 patients received the sustained released form of bupropion reported the incidence of orgasm dysfunction at 8% in patients receiving a 300 mg daily dose and 10% in patients receiving a 400 mg daily dose.

Among antidepressants, bupropion may be associated with the lowest incidence of sexual dysfunction (i.e., impotence, abnormal ejaculation, changes in libido).

Genitourinary side effects have included urinary frequency, urinary urgency, vaginal hemorrhage, urinary tract infection, impotence, menstrual complaints/irregularities, nocturia, and polyuria. Abnormal ejaculation, dyspareunia, dysuria, gynecomastia, menopause, painful erection, prostate disorder, salpingitis, urinary incontinence, urinary retention, urinary tract disorder, vaginitis, cystitis, vaginal irritation, testicular swelling, enuresis, glycosuria, ovarian disorder, pelvic infection, and painful ejaculation have been reported rarely.

Psychiatric

Psychiatric side effects have frequently included anxiety (6%), nervousness, agitation, depression, irritability, derealization, and hypomania. Depersonalization, emotional lability, hostility, suicidal ideation, aggression, delusions, euphoria, hallucinations, manic reaction, nightmares, paranoid ideation, delirium, psychosis, organic mental disorders, catatonia, and restlessness have been reported rarely.

The Australian Adverse Drug Reaction Advisory Committee reported that 285 of the 780 reports it received in association with bupropion through mid- May 2001 involved psychological disturbances.

Two cases of tactile hallucinations ("bugs crawling over skin") have been reported in association with bupropion extended-release (200 mg twice daily) therapy. In both cases the symptoms abated following a reduction in the total daily dose of bupropion (300 mg daily).

Cardiovascular

Cardiovascular side effects have frequently included palpitation, cardiac arrhythmias, hypertension (in some cases severe), hypotension, syncope, tachycardia, and edema. Postural hypotension, chest pain, electrocardiogram (ECG) abnormalities (premature beats and nonspecific ST- T changes), stroke, and vasodilation have been reported infrequently. Phlebitis and myocardial infarction have been reported rarely. There are also reports of complete atrioventricular (AV) block, extrasystoles, and myocardial infarction. Some investigators have suggested that bupropion therapy may be 10 to 100 times less likely to induce conduction problems than tricyclic antidepressants.

Hypertension has been reported regarding both patients with and without evidence of preexisting hypertension.

Dermatologic

The Australian Adverse Drug Reaction Advisory Committee reported that 307 of the 780 reports it received in association with bupropion through mid- May 2001 involved skin reactions. Urticaria was the most commonly reported event (167 cases). Other rashes (86 cases) were also reported.

Dermatologic side effects have frequently included sweating, hives(6%), rash (6%), pruritus (6%), urticaria, flushing, pallor, and dry skin. Alopecia and acne have been reported infrequently. Angioedema, exfoliative dermatitis, maculopapular rash, change in hair color, and hirsutism have been reported rarely. Two cases of erythema multiforme have also been reported.

Endocrine

Endocrine side effects have infrequently included syndrome of inappropriate antidiuretic hormone and hormone level changes.

Hematologic

Hematologic side effects have rarely included ecchymosis, anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, thrombocytopenia, and eosinophilia.

Hypersensitivity

Hypersensitivity side effects have rarely included reports of anaphylactoid reactions during clinical trials. In addition, there have been isolated cases of anaphylactic shock associated with bupropion.

Other

Other side effects have frequently included flu-like symptoms (3%), asthenia, pain, fatigue, fever/chills, and auditory disturbance. Facial edema, photosensitivity, peripheral edema, deafness, body odor, tinnitus, and malaise have been reported rarely.

Metabolic

Metabolic side effects have frequently included weight loss and weight gain. Hyponatremia, hyperglycemia, hypoglycemia have also been reported in patients receiving bupropion.

Musculoskeletal

Musculoskeletal side effects have frequently included arthritis. Leg cramps, musculoskeletal chest pain, muscle rigidity, rhabdomyolysis, and muscle weakness have been reported rarely.

Hepatic

Hepatic side effects have rarely included jaundice, abnormal liver function tests, hepatic damage, and hepatitis.

Respiratory

Respiratory side effects have frequently included upper respiratory complaints and cough. Bronchospasm, bronchitis, dyspnea, epistaxis, rate or rhythm disorder, pulmonary embolism, and pneumonia have been reported rarely.

Ocular

Ocular side effects have rarely included accommodation abnormality, dry eye, diplopia, mydriasis, blurred vision, and increased intraocular pressure.

Immunologic

Immunologic side effects have included isolated cases of Stevens-Johnson syndrome and serum sickness-like reactions.

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