🇺🇸 Rapamune in United States

5,045 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 — 985 reports (19.52%)
  2. Transplant Rejection — 567 reports (11.24%)
  3. Alopecia — 484 reports (9.59%)
  4. Transplant Dysfunction — 457 reports (9.06%)
  5. Pneumonia — 449 reports (8.9%)
  6. Acne — 444 reports (8.8%)
  7. Death — 426 reports (8.44%)
  8. Ovarian Cyst — 425 reports (8.42%)
  9. Product Use In Unapproved Indication — 415 reports (8.23%)
  10. Drug Ineffective — 393 reports (7.79%)

Source database →

Rapamune in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Rapamune approved in United States?

Yes. FDA has authorised it.

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

Wyeth is now a wholly owned subsidiary of Pfizer is the originator. The local marketing authorisation holder may differ — check the official source linked above.