Buspirone: Side Effects, Uses & Monitoring
Buspirone hydrochloride tablets are indicated for the management of anxiety disorder or the short-term relief of the symptoms of anxiety.
- Data source
- FDA labeling via NIH DailyMed (label 3c115eea…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Dizziness | 12% |
| Drowsiness | 10% |
| Nausea | 8% |
| Headache | 6% |
| Nervousness | 5% |
| Dry mouth | 4% |
| Fatigue | 4% |
| Insomnia | 3% |
| Lightheadedness | 3% |
| Decreased concentration | 2% |
| Excitement | 2% |
| Anger/hostility | 2% |
| Confusion | 2% |
| Depression | 2% |
| Blurred vision | 2% |
| Abdominal/gastric distress | 2% |
| Diarrhea | 2% |
| Constipation | 2% |
| Vomiting | 2% |
| Numbness | 2% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
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,…
Conditions associated with Buspirone in labeling
Anxiety Disorder
A group of mental health conditions characterized by excessive worry, fear, or nervousness that interferes wit...
Diarrhea
Loose, watery stools occurring more than three times a day, which can be acute or chronic....
Dizziness
A feeling of lightheadedness, unsteadiness, or spinning, which can have many causes....
Generalized Anxiety Disorder
Persistent, excessive worry about everyday situations that is difficult to control and interferes with daily l...
Insomnia
Difficulty falling asleep, staying asleep, or getting restful sleep despite adequate opportunity, affecting da...
Vertigo
The sensation of spinning or movement when still, often due to inner ear or neurological conditions....
Frequently Asked Questions
What is Buspirone used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Buspirone?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Buspirone. Individual risk varies.
Does Buspirone require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Buspirone.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.