🇺🇸 Epivir in United States

FDA authorised Epivir on 17 November 1995 · 5,102 US adverse-event reports

Marketing authorisations

FDA — authorised 17 November 1995

  • Application: NDA020596
  • Marketing authorisation holder: VIIV HLTHCARE
  • Status: supplemented

FDA — authorised 17 November 1995

  • Application: NDA020564
  • Marketing authorisation holder: VIIV HLTHCARE
  • Status: supplemented

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.

Most-reported reactions

  1. Pain — 776 reports (15.21%)
  2. Emotional Distress — 722 reports (14.15%)
  3. Anxiety — 713 reports (13.97%)
  4. Anhedonia — 647 reports (12.68%)
  5. Chronic Kidney Disease — 469 reports (9.19%)
  6. Renal Failure — 445 reports (8.72%)
  7. Anaemia — 359 reports (7.04%)
  8. Pyrexia — 341 reports (6.68%)
  9. Renal Impairment — 319 reports (6.25%)
  10. Depression — 311 reports (6.1%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Epivir approved in United States?

Yes. FDA authorised it on 17 November 1995; FDA authorised it on 17 November 1995; FDA has authorised it.

Who is the marketing authorisation holder for Epivir in United States?

VIIV HLTHCARE holds the US marketing authorisation.