Buspirone
Azaspirodecanedione Derivatives
- Drug class
- Azaspirodecanedione Derivatives
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 46
- FDA reports (12 mo)
- 1,032
Overview
Plain-language summary, compiled from the cited regulatory records
Buspirone is a medication classified as an azaspirodecanedione derivative [1]. It is approved for the management of anxiety disorders and for the short-term relief of anxiety symptoms [1]. Clinical trials have shown its effectiveness in outpatients diagnosed with Generalized Anxiety Disorder (GAD) [1].
This medication is available under various brand names [1]. In the past 12 months, there have been 1,032 adverse event reports associated with buspirone [2]. Among the frequently reported adverse events are product dose omission issues, dyspnoea, fatigue, headache, and nausea [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 22 | May 1, 2026 |
| US United States | FDA | 20 | April 24, 2026 |
| CA Canada | Health Canada | 4 | May 11, 2026 |
GBUnited Kingdom· MHRA
22 products
Uses
Buspirone is indicated for the treatment of short-term management of anxiety disorders and the relief of symptoms of anxiety with or without accompanying symptoms of depression.
How to take
USUnited States· FDA
20 products
Uses
INDICATIONS AND USAGE
Buspirone hydrochloride tablets are indicated for the management of anxiety disorders 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. 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.
CACanada· Health Canada
4 products
Uses
e. more than 4 weeks) has not been evaluated in controlled clinical trials. 1 Pediatrics Pediatrics (˂ 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics: Buspirone has not been systematically evaluated in geriatric patients. 4 Geriatrics). Long-term use of BUSPIRONE should be avoided in geriatric patients. DOSAGE AND ADMINISTRATION, Dosing Considerations).
How to take
Drug interactions
Known interactions involving Buspirone. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 570. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL422890020 · revised March 13, 2026
- [2]FDA DailyMed · 02628a0c-bfdb-4a… · revised May 3, 2019 [PDF]
- [3]Health Canada (DPD) · 02207664 · revised March 22, 2025
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.