The incidence of seizures increases dramatically at higher dosages. Grand mal seizures have been reported in 0.4% of patients undergoing bupropion therapy at dosages up to 450 mg daily. The Australian Adverse Drug Reaction Advisory Committee reported that 268 of the 780 reports it received in association with bupropion (the active ingredient contained in Wellbutrin) through mid-May 2001 involved nervous system disorders. Insomnia may be minimized by reducing the dosage or avoiding administration at bedtime. 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. In both cases the symptoms abated following a reduction in the total daily dose of bupropion (300 mg daily). Two cases of tactile hallucinations ("bugs crawling over skin") have been reported in association with bupropion extended-release (200 mg twice daily) therapy. 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. Postmarketing reports: Completed suicide, delirium, manic reaction, restlessness, suicidal behavior, suicide attempt Rare (0.01% to 0.1%): Derealization, impaired attentionįrequency not reported: Abnormalities in mental status, post-ictal confusion, sleep disturbances Uncommon (0.1% to 1%): Aggression, bruxism, depersonalization, emotional lability, formal thought disorder, frigidity, mood instability, nightmares, paranoia, paranoid ideation, psychosis, suicidal ideation Very common (10% or more): Insomnia (up to 45%), agitation (up to 31.9%), abnormal dreams (up to 13%)Ĭommon (1% to 10%): Anxiety, confusion, decreased/increased libido, decreased memory/memory impairment, delusions, depression, disturbed concentration, dysphoria, euphoria, hallucinations, hostility, impaired sleep quality, irritability, mania/ hypomania, nervousness, thinking abnormality Smoking cessation is often associated with nicotine withdrawal symptoms, some of which are also recognized as adverse events associated with bupropion (the active ingredient contained in Wellbutrin) Psychiatric The most commonly observed adverse reactions were dry mouth and insomnia. Additional events leading to discontinuation in the immediate-release formulation included mental state abnormalities, vomiting, seizures, headaches, and sleep disturbances, many of which occurred at doses greater than the recommended daily dose.Īdverse events leading to treatment discontinuation with Zyban (R) included tremors, and rashes. In placebo-controlled clinical studies, the specific adverse events that led to discontinuation in at least 1% of patients treated with either 300 mg or 400 mg per day of Wellbutrin SR (R)included rash, nausea, agitation, and migraine. For Healthcare ProfessionalsĪpplies to bupropion: oral tablet, oral tablet extended release. 1 142 143 162 161 167 168 (See Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders under Cautions.)Īgitation, dry mouth, insomnia, headache/ migraine, nausea/vomiting, constipation, tremor. 161 162 167Īppropriately monitor and closely observe all patients who are started on bupropion therapy for clinical worsening, suicidality, or unusual changes in behavior involve family members and/or caregivers in this process. Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo. 1 142 143 168 (See Pediatric Use under Cautions.) 1 142 143 161 162 168 Bupropion is not approved for use in pediatric patients. Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders balance this risk with clinical need.Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders
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