🇺🇸 Elbasvir/Grazoprevir in United States

FDA authorised Elbasvir/Grazoprevir on 28 January 2016 · 120 US adverse-event reports

Marketing authorisation

FDA — authorised 28 January 2016

  • Application: NDA208261
  • Marketing authorisation holder: MSD SUB MERCK
  • Local brand name: ZEPATIER
  • 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. Treatment Failure — 18 reports (15%)
  2. Hepatitis C — 16 reports (13.33%)
  3. Osteoporosis — 14 reports (11.67%)
  4. Foot Fracture — 12 reports (10%)
  5. Drug Resistance — 11 reports (9.17%)
  6. Nausea — 11 reports (9.17%)
  7. Fibrosis — 10 reports (8.33%)
  8. Headache — 10 reports (8.33%)
  9. Insomnia — 9 reports (7.5%)
  10. Pruritus — 9 reports (7.5%)

Source database →

Frequently asked questions

Is Elbasvir/Grazoprevir approved in United States?

Yes. FDA authorised it on 28 January 2016.

Who is the marketing authorisation holder for Elbasvir/Grazoprevir in United States?

MSD SUB MERCK holds the US marketing authorisation.