🇺🇸 DARUNAVIR ETHANOLATE in United States

462 US adverse-event reports

Marketing authorisations

FDA

  • Status: approved

FDA

  • Application: ANDA210187
  • Marketing authorisation holder: MICRO LABS USA
  • Local brand name: DARUNAVIR ETHANOLATE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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. Drug Interaction — 95 reports (20.56%)
  2. Off Label Use — 65 reports (14.07%)
  3. Virologic Failure — 60 reports (12.99%)
  4. Death — 40 reports (8.66%)
  5. Renal Impairment — 39 reports (8.44%)
  6. Drug Ineffective — 36 reports (7.79%)
  7. Treatment Noncompliance — 34 reports (7.36%)
  8. Nausea — 32 reports (6.93%)
  9. Foetal Exposure During Pregnancy — 31 reports (6.71%)
  10. Pathogen Resistance — 30 reports (6.49%)

Source database →

DARUNAVIR ETHANOLATE 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 DARUNAVIR ETHANOLATE approved in United States?

Yes. FDA has authorised it; FDA has authorised it.

Who is the marketing authorisation holder for DARUNAVIR ETHANOLATE in United States?

Marketing authorisation holder not available in our data.