Bupropion Side Effects

Brand Names: Zyban, Wellbutrin, Wellbutrin SR, Wellbutrin XL

Please note - some side effects for Bupropion 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 Bupropion - for the consumer

Bupropion

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 Bupropion:

Constipation; dizziness; drowsiness; dry mouth; headache; increased sweating; loss of appetite; nausea; nervousness; restlessness; taste changes; trouble sleeping; vomiting; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; delusions; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; hearing problems; menstrual changes; new or worsening mental or mood changes (eg, concentration problems, panic attacks, aggressiveness, agitation, anxiety, impulsiveness, irritability, hostility, exaggerated feeling of well-being or inability to sit still); red, swollen, blistered, or peeling skin; seizures; severe headache or dizziness; severe or persistent joint or muscle pain; severe or persistent nervousness, restlessness, or trouble sleeping; shortness of breath; suicidal thoughts or attempts; tremor; unusual swelling; vision changes; worsening depression.

Bupropion Extended-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 Bupropion Extended-Release Tablets:

Constipation; dizziness; drowsiness; dry mouth; flushing; gas; headache; increased sweating; increased urination; loss of appetite; nausea; nervousness; restlessness; ringing in the ears; stomach pain; taste changes; trouble sleeping; vomiting; weakness; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; delusions; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; hearing problems; menstrual changes; new or worsening mental or mood changes (eg, concentration problems, panic attacks, aggressiveness, agitation, anxiety, impulsiveness, irritability, hostility, exaggerated feeling of well-being or inability to sit still); red, swollen, blistered, or peeling skin; seizures; severe headache or dizziness; severe or persistent joint or muscle pain; severe or persistent nervousness, restlessness, or trouble sleeping; shortness of breath; suicidal thoughts or attempts; tremor; unusual swelling; vision changes; worsening depression.

Bupropion 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 Bupropion 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; 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; shortness of breath; suicidal thoughts or attempts; tremor.

For the professional

Bupropion

The information included under ADVERSE REACTIONS is based primarily on data from the dose-response trial and the comparative trial that evaluated Bupropion Hydrochloride Extended-Release Tablets, USP (SR) 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 Bupropion Hydrochloride Extended-Release Tablets, USP (SR) and 5% of the 313 patients treated with placebo. The more common events leading to discontinuation of treatment with Bupropion Hydrochloride Extended-Release Tablets, USP (SR) 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 Bupropion Hydrochloride Extended-Release Tablets, USP (SR) 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 Bupropion Hydrochloride Extended-Release Tablets, USP (SR). The occurrence of these adverse events may be minimized by reducing the dose of Bupropion Hydrochloride Extended-Release Tablets, USP (SR). In addition, insomnia may be minimized by avoiding bedtime doses.

Adverse Events Occurring at an Incidence of 1% or More Among Patients Treated With Bupropion Hydrochloride Extended-Release Tablets, USP (SR):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 Bupropion Hydrochloride Extended-Release Tablets, USP (SR) 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 Bupropion Hydrochloride Extended-Release Tablets, USP (SR), NTS, or the combination of Bupropion Hydrochloride Extended-Release Tablets, USP (SR) and NTS compared to those treated with placebo. Reported adverse events were classified using a COSTART-based dictionary.

Bupropion Hydrochloride Extended-Release Tablets, USP (SR) was well-tolerated in the long-term maintenance trial that evaluated chronic administration of Bupropion Hydrochloride Extended-Release Tablets, USP (SR) 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 Bupropion sustained-release. 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 Bupropion Hydrochloride Extended-Release Tablets, USP (SR) is unknown.

Body (General): 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.

Cardiovascular: 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.

Digestive: 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.

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 co-administered with warfarin.

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

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

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

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

Urogenital: 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.

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