FDA — authorised 21 July 2006
- Application: NDA021929
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: SYMBICORT
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
🇺🇸 budesonide and formoterol in United States
FDA authorised budesonide and formoterol on 21 July 2006 · 313 US adverse-event reports
Marketing authorisations
FDA — authorised 15 March 2022
- Application: ANDA211699
- Marketing authorisation holder: MYLAN
- 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: 313
Most-reported reactions
- Dyspnoea — 78 reports (24.92%)
- Asthma — 41 reports (13.1%)
- Device Malfunction — 30 reports (9.58%)
- Cough — 28 reports (8.95%)
- Intentional Device Misuse — 25 reports (7.99%)
- Product Dose Omission Issue — 24 reports (7.67%)
- Allergic Granulomatous Angiitis — 23 reports (7.35%)
- Fatigue — 22 reports (7.03%)
- Wheezing — 22 reports (7.03%)
- Malaise — 20 reports (6.39%)
budesonide and formoterol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is budesonide and formoterol approved in United States?
Yes. FDA authorised it on 21 July 2006; FDA authorised it on 15 March 2022.
Who is the marketing authorisation holder for budesonide and formoterol in United States?
ASTRAZENECA holds the US marketing authorisation.