🇺🇸 Pegasys in United States

FDA authorised Pegasys on 16 October 2002 · 48,646 US adverse-event reports

Marketing authorisations

FDA — authorised 16 October 2002

  • Application: BLA103964
  • Marketing authorisation holder: Pharmaand GmbH
  • Local brand name: PEGASYS
  • Indication: VIAL — SUBCUTANEOUS
  • Status: approved

Read official source →

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. Fatigue — 8,986 reports (18.47%)
  2. Nausea — 6,926 reports (14.24%)
  3. Anaemia — 5,934 reports (12.2%)
  4. Rash — 4,616 reports (9.49%)
  5. Headache — 4,335 reports (8.91%)
  6. White Blood Cell Count Decreased — 4,052 reports (8.33%)
  7. Pruritus — 4,044 reports (8.31%)
  8. Diarrhoea — 3,279 reports (6.74%)
  9. Pyrexia — 3,273 reports (6.73%)
  10. Vomiting — 3,201 reports (6.58%)

Source database →

Pegasys in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Infectious Disease approved in United States

Frequently asked questions

Is Pegasys approved in United States?

Yes. FDA authorised it on 16 October 2002; FDA has authorised it.

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

Pharmaand GmbH holds the US marketing authorisation.