🇺🇸 Emtricitabine/rilpivirine/tenofovir disoproxil fumarate in United States

FDA authorised Emtricitabine/rilpivirine/tenofovir disoproxil fumarate on 10 August 2011 · 132 US adverse-event reports

Marketing authorisations

FDA — authorised 10 August 2011

  • Application: NDA202123
  • Marketing authorisation holder: GILEAD SCIENCES INC
  • Local brand name: COMPLERA
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 May 2025

  • Application: ANDA208452
  • Marketing authorisation holder: MYLAN
  • 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. Foetal Exposure During Pregnancy — 25 reports (18.94%)
  2. Death — 14 reports (10.61%)
  3. Abdominal Pain — 13 reports (9.85%)
  4. Maternal Exposure During Pregnancy — 13 reports (9.85%)
  5. Headache — 12 reports (9.09%)
  6. Nausea — 12 reports (9.09%)
  7. Exposure During Pregnancy — 11 reports (8.33%)
  8. Premature Baby — 11 reports (8.33%)
  9. Treatment Noncompliance — 11 reports (8.33%)
  10. Abortion Induced — 10 reports (7.58%)

Source database →

Other Infectious Disease / Virology approved in United States

Frequently asked questions

Is Emtricitabine/rilpivirine/tenofovir disoproxil fumarate approved in United States?

Yes. FDA authorised it on 10 August 2011; FDA authorised it on 20 May 2025.

Who is the marketing authorisation holder for Emtricitabine/rilpivirine/tenofovir disoproxil fumarate in United States?

GILEAD SCIENCES INC holds the US marketing authorisation.