FDA — authorised 15 August 1996
- Application: NDA020503
- Marketing authorisation holder: KINDEVA
- Local brand name: PROVENTIL-HFA
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
🇺🇸 Albuterol/salbutamol in United States
FDA authorised Albuterol/salbutamol on 15 August 1996 · 3,075 US adverse-event reports
Marketing authorisations
FDA — authorised 29 October 2004
- Application: NDA021457
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: PROAIR HFA
- Indication: AEROSOL, METERED — INHALATION
- 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: 22 April 2025 – 22 April 2026
- Total reports: 3,075
Most-reported reactions
- Dyspnoea — 423 reports (13.76%)
- Pneumonia — 400 reports (13.01%)
- Fatigue — 362 reports (11.77%)
- Headache — 323 reports (10.5%)
- Nausea — 284 reports (9.24%)
- Cough — 271 reports (8.81%)
- Pain — 267 reports (8.68%)
- Death — 260 reports (8.46%)
- Off Label Use — 251 reports (8.16%)
- Diarrhoea — 234 reports (7.61%)
Other Respiratory approved in United States
Frequently asked questions
Is Albuterol/salbutamol approved in United States?
Yes. FDA authorised it on 15 August 1996; FDA authorised it on 29 October 2004.
Who is the marketing authorisation holder for Albuterol/salbutamol in United States?
KINDEVA holds the US marketing authorisation.