Bupropion: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Bupropion. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Headache34%
Dry mouth26%
Insomnia20%
Nausea13%
Nasopharyngitis13%
Constipation9%
Infection9%
Anxiety7%
Flatulence6%
Dizziness6%
Sinusitis5%
Cough4%
Decreased appetite4%
Tremor3%
Abnormal dreams3%
Myalgia3%
Pain in extremity3%
Feeling jittery3%
Rash3%
Tinnitus3%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

Major Depressive Disorder: Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL TRIALS ). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demons…

Source: FDA labeling via NIH DailyMed (set 0bff4522…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.