FDA — authorised 28 September 1989
- Application: NDA019910
- Marketing authorisation holder: VIIV HLTHCARE
- Local brand name: RETROVIR
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Combivir in United States
FDA authorised Combivir on 28 September 1989 · 5,324 US adverse-event reports
Marketing authorisations
FDA — authorised 2 February 1990
- Application: NDA019951
- Marketing authorisation holder: VIIV HLTHCARE
- Local brand name: RETROVIR
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 November 1995
- Application: NDA020596
- Marketing authorisation holder: VIIV HLTHCARE
- Local brand name: EPIVIR
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 November 1995
- Application: NDA020564
- Marketing authorisation holder: VIIV HLTHCARE
- Local brand name: EPIVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 1997
- Application: NDA020857
- Marketing authorisation holder: VIIV HLTHCARE
- Local brand name: COMBIVIR
- 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: 5,324
Most-reported reactions
- Drug Exposure During Pregnancy — 1,130 reports (21.22%)
- Pain — 595 reports (11.18%)
- Emotional Distress — 552 reports (10.37%)
- Anxiety — 551 reports (10.35%)
- Foetal Exposure During Pregnancy — 551 reports (10.35%)
- Anhedonia — 500 reports (9.39%)
- Anaemia — 425 reports (7.98%)
- Abortion Spontaneous — 383 reports (7.19%)
- Premature Baby — 322 reports (6.05%)
- Chronic Kidney Disease — 315 reports (5.92%)
Combivir in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Combivir approved in United States?
Yes. FDA authorised it on 28 September 1989; FDA authorised it on 2 February 1990; FDA authorised it on 17 November 1995.
Who is the marketing authorisation holder for Combivir in United States?
VIIV HLTHCARE holds the US marketing authorisation.