FDA
- Status: approved
🇺🇸 Frusemide in United States
1,573 US adverse-event reports
Marketing authorisations
FDA
- Application: ANDA076748
- Marketing authorisation holder: DR REDDYS LABS INC
- Local brand name: ROSIGLITAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078023
- Marketing authorisation holder: WATSON LABS
- Local brand name: ROSIGLITAZONE
- Indication: TABLET — ORAL
- 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: 1,573
Most-reported reactions
- Dyspnoea — 295 reports (18.75%)
- Hypotension — 176 reports (11.19%)
- Renal Failure Acute — 152 reports (9.66%)
- Cardiac Failure — 144 reports (9.15%)
- Diarrhoea — 143 reports (9.09%)
- Fall — 136 reports (8.65%)
- Vomiting — 134 reports (8.52%)
- Malaise — 131 reports (8.33%)
- Nausea — 131 reports (8.33%)
- Pneumonia — 131 reports (8.33%)
Frusemide in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Frusemide approved in United States?
Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Frusemide in United States?
Melbourne Health is the originator. The local marketing authorisation holder may differ — check the official source linked above.