FDA — authorised 14 May 2002
- Application: ANDA076110
- Marketing authorisation holder: TEVA
- Local brand name: TORSEMIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 TORSEMIDE in United States
FDA authorised TORSEMIDE on 14 May 2002 · 19,182 US adverse-event reports
Marketing authorisations
FDA — authorised 27 May 2003
- Application: ANDA076226
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: TORSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2003
- Application: ANDA076346
- Marketing authorisation holder: PLIVA PHARM IND
- Local brand name: TORSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 March 2005
- Application: ANDA076943
- Marketing authorisation holder: HIKMA
- Local brand name: TORSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2005
- Application: ANDA076894
- Marketing authorisation holder: COREPHARMA
- Local brand name: TORSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 October 2007
- Application: ANDA078249
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: TORSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 June 2008
- Application: ANDA078007
- Marketing authorisation holder: HIKMA
- Local brand name: TORSEMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 27 January 2009
- Application: ANDA079234
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: TORSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 2010
- Application: ANDA090656
- Marketing authorisation holder: AM REGENT
- Local brand name: TORSEMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 22 March 2011
- Application: ANDA090613
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: TORSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 June 2021
- Application: NDA213218
- Marketing authorisation holder: SARFE PHARMS
- Local brand name: SOAANZ
- Indication: TABLET — 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: 19,182
Most-reported reactions
- Dyspnoea — 3,328 reports (17.35%)
- Fatigue — 2,091 reports (10.9%)
- Diarrhoea — 1,936 reports (10.09%)
- Nausea — 1,935 reports (10.09%)
- Dizziness — 1,847 reports (9.63%)
- Acute Kidney Injury — 1,742 reports (9.08%)
- Death — 1,662 reports (8.66%)
- General Physical Health Deterioration — 1,583 reports (8.25%)
- Oedema Peripheral — 1,532 reports (7.99%)
- Fall — 1,526 reports (7.96%)
TORSEMIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is TORSEMIDE approved in United States?
Yes. FDA authorised it on 14 May 2002; FDA authorised it on 27 May 2003; FDA authorised it on 30 May 2003.
Who is the marketing authorisation holder for TORSEMIDE in United States?
TEVA holds the US marketing authorisation.