Zyban Advantage Pack Side Effects
Generic Name: bupropion, bupropion hydrochloride
Please note - some side effects for Zyban Advantage Pack may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects by Body System - for Healthcare Professionals
Applies to: oral tablet; oral tablet, extended release
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 opioids, 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 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.
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 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, restlessness, and completed suicide 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 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, bradycardia, 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.
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 side effects have infrequently included syndrome of inappropriate antidiuretic hormone and hormone level changes.
Hematologic side effects have rarely included ecchymosis, anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, thrombocytopenia, and eosinophilia.
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 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.
False-positive urine immunoassay screening tests for amphetamines have been reported in patients taking bupropion. This can happen even following discontinuation of therapy. This is due to lack of specificity of some screening tests. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish bupropion from amphetamines.
Metabolic side effects have frequently included weight loss and weight gain. Hyponatremia, hyperglycemia, hypoglycemia have also been reported in patients receiving bupropion.
Musculoskeletal side effects have frequently included arthritis. Leg cramps, musculoskeletal chest pain, muscle rigidity, rhabdomyolysis, and muscle weakness have been reported rarely.
Hepatic side effects have rarely included jaundice, abnormal liver function tests, hepatic damage, and hepatitis.
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 side effects have rarely included accommodation abnormality, dry eye, diplopia, mydriasis, blurred vision, and increased intraocular pressure.
Immunologic side effects have included isolated cases of Stevens-Johnson syndrome and serum sickness-like reactions.Top
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