FDA — authorised 10 August 1964
- Application: NDA013174
- Marketing authorisation holder: ADVANZ PHARMA
- Local brand name: DYRENIUM
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 TRIAMTERENE in United States
FDA authorised TRIAMTERENE on 10 August 1964 · 10,939 US adverse-event reports
Marketing authorisations
FDA — authorised 19 August 2019
- Application: ANDA211581
- Marketing authorisation holder: AGNITIO
- Local brand name: TRIAMTERENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 July 2022
- Application: ANDA214768
- Marketing authorisation holder: BIOCON GENERICS
- Local brand name: TRIAMTERENE
- 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: 10,939
Most-reported reactions
- Fatigue — 1,411 reports (12.9%)
- Drug Ineffective — 1,315 reports (12.02%)
- Nausea — 1,303 reports (11.91%)
- Pain — 1,160 reports (10.6%)
- Diarrhoea — 1,116 reports (10.2%)
- Dizziness — 1,032 reports (9.43%)
- Dyspnoea — 1,027 reports (9.39%)
- Headache — 978 reports (8.94%)
- Arthralgia — 808 reports (7.39%)
- Asthenia — 789 reports (7.21%)
TRIAMTERENE 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 TRIAMTERENE approved in United States?
Yes. FDA authorised it on 10 August 1964; FDA authorised it on 19 August 2019; FDA authorised it on 6 July 2022.
Who is the marketing authorisation holder for TRIAMTERENE in United States?
ADVANZ PHARMA holds the US marketing authorisation.