🇺🇸 Ontruzant in United States

685 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. Diarrhoea — 153 reports (22.34%)
  2. Product Use In Unapproved Indication — 89 reports (12.99%)
  3. Off Label Use — 67 reports (9.78%)
  4. Pyrexia — 67 reports (9.78%)
  5. Nausea — 66 reports (9.64%)
  6. Anaemia — 61 reports (8.91%)
  7. Vomiting — 50 reports (7.3%)
  8. Chills — 47 reports (6.86%)
  9. Hypokalaemia — 44 reports (6.42%)
  10. Dyspnoea — 41 reports (5.99%)

Source database →

Ontruzant 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 Ontruzant approved in United States?

Yes. FDA has authorised it.

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

Institut fuer Frauengesundheit is the originator. The local marketing authorisation holder may differ — check the official source linked above.