Overview of clinically significant adverse reactions to bupropion.
During the clinical development of bupropion (Wellbutrin) 1,153 depressed patients and 157 normal volunteers received bupropion (doses, 15-1200 mg/day); 177 placebo-treated and 196 tricyclic-treated patients (doses, 25-300 mg/day) also participated in these trials to provide a control comparison. Safety measures during the clinical trial program included adverse event symptomatology, vital signs, clinical laboratory examinations, and EEGs. There were no bupropion-related changes in vital signs, clinical laboratory, or EEG results severe enough to warrant treatment discontinuation. The most common cause for discontinuation in the bupropion (9.1%), placebo (6.8%), and tricyclic groups (9.2%) was agitation/excitement. The only adverse experience considered of medical significance in bupropion patients was major motor seizure. The incidence of a seizure was less than 1 per 1,000 at usual outpatient doses and less than 1 per 100 at usual inpatient doses. These incidences appear to be comparable to those seen with equally therapeutic doses of tricyclic antidepressants.
D000328:Adult; D000368:Aged; D017109:Akathisia, Drug-Induced; D000553:Ambulatory Care; D000928:Antidepressive Agents / Q000009:adverse effects* / Q000506:poisoning; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects; D016642:Bupropion; D002986:Clinical Trials as Topic; D003866:Depressive Disorder / Q000188:drug therapy / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004569:Electroencephalography; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D011427:Propiophenones / Q000009:adverse effects* / Q000506:poisoning; D012640:Seizures / Q000139:chemically induced; D013406:Suicide, Attempted
D000928:Antidepressive Agents; D000929:Antidepressive Agents, Tricyclic; D011427:Propiophenones; D016642:Bupropion