Wellbutrin SR Side Effects
Generic Name: Bupropion
Please note - some side effects for Wellbutrin SR 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).
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For the consumer For the professional
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Side Effects of Wellbutrin SR - for the consumer
Wellbutrin SR 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 Wellbutrin SR Sustained-Release Tablets:
Seek medical attention right away if any of these SEVERE side effects occur when using Wellbutrin SR Sustained-Release Tablets:Constipation; dizziness; drowsiness; dry mouth; flushing; 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.
TopSevere 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.
For the professional
Wellbutrin SR
The information included under the Incidence in Controlled Trials subsection of ADVERSE REACTIONS is based primarily on data from controlled clinical trials with WELLBUTRIN SR Tablets. Information on additional adverse events associated with the sustained-release formulation of bupropion in smoking cessation trials, as well as the immediate-release formulation of bupropion, is included in a separate section.
Incidence in Controlled Trials With WELLBUTRIN SR
Adverse Events Associated With Discontinuation of Treatment Among Patients Treated With WELLBUTRIN SR TabletsIn placebo-controlled clinical trials, 9% and 11% of patients treated with 300 and 400 mg/day, respectively, of WELLBUTRIN SR Tablets and 4% of patients treated with placebo discontinued treatment due to adverse events. The specific adverse events in these trials that led to discontinuation in at least 1% of patients treated with either 300 or 400 mg/day of WELLBUTRIN SR Tablets and at a rate at least twice the placebo rate are listed in Table 4.
Adverse Event Term |
WELLBUTRIN SR 300 mg/day (n = 376) |
WELLBUTRIN SR 400 mg/day (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% |
Table 5 enumerates treatment-emergent adverse events that occurred among patients treated with 300 and 400 mg/day of WELLBUTRIN SR Tablets and with placebo in placebo-controlled trials. Events 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 events were classified using a COSTART-based Dictionary.
Accurate estimates of the incidence of adverse events 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 events 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 events. A better perspective on the serious adverse events associated with the use of WELLBUTRIN SR Tablets is provided in the WARNINGS and PRECAUTIONS sections.
|
Body System/ Adverse Event |
WELLBUTRIN SR 300 mg/day (n = 376) |
WELLBUTRIN SR 400 mg/day (n = 114) |
Placebo (n = 385) |
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† |
0% |
2% |
— |
Urinary tract infection |
1% |
0% |
— |
*Adverse events that occurred in at least 1% of patients treated with either 300 or 400 mg/day of WELLBUTRIN SR Tablets, 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.
†Incidence based on the number of female patients.
— Hyphen denotes adverse events occurring in greater than 0 but less than 0.5% of patients.
Incidence of Commonly Observed Adverse Events in Controlled Clinical TrialsAdverse events from Table 5 occurring in at least 5% of patients treated with WELLBUTRIN SR Tablets and at a rate at least twice the placebo rate are listed below for the 300- and 400-mg/day dose groups.
WELLBUTRIN SR 300 mg/day
Anorexia, dry mouth, rash, sweating, tinnitus, and tremor.
WELLBUTRIN SR 400 mg/day
Abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency.
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 WELLBUTRIN SR Tablets (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 sections of the labeling.
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 WELLBUTRIN SR 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 .
CardiovascularInfrequent were postural hypotension, stroke, tachycardia, and vasodilation. Rare was syncope. Also observed were complete atrioventricular block, extrasystoles, hypotension, hypertension (in some cases severe, see PRECAUTIONS), myocardial infarction, phlebitis, and pulmonary embolism.
DigestiveInfrequent 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.
EndocrineAlso observed were hyperglycemia, hypoglycemia, and syndrome of inappropriate antidiuretic hormone.
Hemic and LymphaticInfrequent 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 NutritionalInfrequent were edema and peripheral edema. Also observed was glycosuria.
MusculoskeletalInfrequent were leg cramps. Also observed were muscle rigidity/fever/rhabdomyolysis and muscle weakness.
Nervous SystemInfrequent 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), akinesia, aggression, 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.
RespiratoryRare was bronchospasm. Also observed was pneumonia.
SkinRare was maculopapular rash. Also observed were alopecia, angioedema, exfoliative dermatitis, and hirsutism.
Special SensesInfrequent were accommodation abnormality and dry eye. Also observed were deafness, diplopia, increased intraocular pressure, and mydriasis.
UrogenitalInfrequent 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.
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