🇺🇸 efavirenz, emtricitabine, and tenofovir in United States

38 US adverse-event reports

Marketing authorisation

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. Anaemia — 7 reports (18.42%)
  2. Maternal Exposure During Pregnancy — 6 reports (15.79%)
  3. Neutropenia — 6 reports (15.79%)
  4. Kaposi^S Sarcoma — 4 reports (10.53%)
  5. Renal Failure — 3 reports (7.89%)
  6. Thrombocytopenia — 3 reports (7.89%)
  7. Vomiting — 3 reports (7.89%)
  8. Abnormal Dreams — 2 reports (5.26%)
  9. Abortion Spontaneous — 2 reports (5.26%)
  10. Acute Kidney Injury — 2 reports (5.26%)

Source database →

efavirenz, emtricitabine, and tenofovir 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 efavirenz, emtricitabine, and tenofovir approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for efavirenz, emtricitabine, and tenofovir in United States?

University of North Carolina, Chapel Hill is the originator. The local marketing authorisation holder may differ — check the official source linked above.