FDA — authorised 29 September 1986
- Application: NDA018731
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: BUSPAR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Buspar in United States
FDA authorised Buspar on 29 September 1986 · 7,392 US adverse-event reports
Marketing authorisations
FDA — authorised 20 December 2000
- Application: NDA021190
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: BUSPAR
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 7,392
Most-reported reactions
- Anxiety — 966 reports (13.07%)
- Nausea — 930 reports (12.58%)
- Drug Ineffective — 862 reports (11.66%)
- Fatigue — 785 reports (10.62%)
- Depression — 708 reports (9.58%)
- Headache — 708 reports (9.58%)
- Dizziness — 670 reports (9.06%)
- Pain — 648 reports (8.77%)
- Insomnia — 564 reports (7.63%)
- Dyspnoea — 551 reports (7.45%)
Buspar in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Buspar approved in United States?
Yes. FDA authorised it on 29 September 1986; FDA authorised it on 20 December 2000; FDA has authorised it.
Who is the marketing authorisation holder for Buspar in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.