Overview of clinically significant adverse reactions to bupropion

J Clin Psychiatry. 1983 May;44(5 Pt 2):191-6.


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.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Akathisia, Drug-Induced
  • Ambulatory Care
  • Antidepressive Agents / adverse effects*
  • Antidepressive Agents / poisoning
  • Antidepressive Agents, Tricyclic / adverse effects
  • Bupropion
  • Clinical Trials as Topic
  • Depressive Disorder / drug therapy
  • Depressive Disorder / psychology
  • Dose-Response Relationship, Drug
  • Electroencephalography
  • Female
  • Hospitalization
  • Humans
  • Male
  • Middle Aged
  • Propiophenones / adverse effects*
  • Propiophenones / poisoning
  • Seizures / chemically induced
  • Suicide, Attempted


  • Antidepressive Agents
  • Antidepressive Agents, Tricyclic
  • Propiophenones
  • Bupropion