Buspirone: Side Effects, Uses & Monitoring

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

Reported adverse reactions

ReactionHighest frequency reported*
Dizziness12%
Drowsiness10%
Nausea8%
Headache6%
Nervousness5%
Dry mouth4%
Fatigue4%
Insomnia3%
Lightheadedness3%
Decreased concentration2%
Excitement2%
Anger/hostility2%
Confusion2%
Depression2%
Blurred vision2%
Abdominal/gastric distress2%
Diarrhea2%
Constipation2%
Vomiting2%
Numbness2%

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

Labeled uses

Buspirone hydrochloride tablets are indicated for the management of anxiety disorder or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1 as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability,…

Source: FDA labeling via NIH DailyMed (set 3c115eea…). Not affiliated with FDA or NIH.

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