🇺🇸 Phesgo in United States

FDA authorised Phesgo on 29 June 2020 · 3,158 US adverse-event reports

Marketing authorisations

FDA — authorised 29 June 2020

  • Application: BLA761170
  • Marketing authorisation holder: GENENTECH INC
  • Status: supplemented

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. No Adverse Event — 890 reports (28.18%)
  2. Off Label Use — 860 reports (27.23%)
  3. Diarrhoea — 357 reports (11.3%)
  4. Injection Site Pain — 202 reports (6.4%)
  5. Pain — 189 reports (5.98%)
  6. Injection Site Reaction — 160 reports (5.07%)
  7. Pyrexia — 131 reports (4.15%)
  8. Death — 127 reports (4.02%)
  9. Fatigue — 123 reports (3.89%)
  10. Rash — 119 reports (3.77%)

Source database →

Phesgo in other countries

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

Other Other approved in United States

Frequently asked questions

Is Phesgo approved in United States?

Yes. FDA authorised it on 29 June 2020; FDA has authorised it.

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

GENENTECH INC holds the US marketing authorisation.