🇺🇸 Tacrolimus cap. in United States

1,307 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 — 489 reports (37.41%)
  2. Tremor — 203 reports (15.53%)
  3. Diarrhoea — 95 reports (7.27%)
  4. Product Dispensing Error — 90 reports (6.89%)
  5. Lung Transplant — 86 reports (6.58%)
  6. Death — 81 reports (6.2%)
  7. Headache — 78 reports (5.97%)
  8. Nausea — 71 reports (5.43%)
  9. Hospitalisation — 57 reports (4.36%)
  10. Product Substitution Issue — 57 reports (4.36%)

Source database →

Tacrolimus cap. in other countries

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

Frequently asked questions

Is Tacrolimus cap. approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Tacrolimus cap. in United States?

Chong Kun Dang Pharmaceutical is the originator. The local marketing authorisation holder may differ — check the official source linked above.