🇺🇸 Actinomycin in United States

949 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. Off Label Use — 191 reports (20.13%)
  2. Neutropenia — 108 reports (11.38%)
  3. Drug Ineffective — 98 reports (10.33%)
  4. Product Use In Unapproved Indication — 91 reports (9.59%)
  5. Febrile Neutropenia — 89 reports (9.38%)
  6. Disease Progression — 88 reports (9.27%)
  7. Maternal Exposure Before Pregnancy — 85 reports (8.96%)
  8. Malignant Neoplasm Progression — 73 reports (7.69%)
  9. Disease Recurrence — 64 reports (6.74%)
  10. Alopecia — 62 reports (6.53%)

Source database →

Actinomycin 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 Actinomycin approved in United States?

Yes. FDA has authorised it.

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

H. Lee Moffitt Cancer Center and Research Institute is the originator. The local marketing authorisation holder may differ — check the official source linked above.