🇺🇸 tacrolimus capsules in United States

150 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. Death — 49 reports (32.67%)
  2. Drug Ineffective — 15 reports (10%)
  3. Off Label Use — 15 reports (10%)
  4. Condition Aggravated — 13 reports (8.67%)
  5. Product Quality Issue — 13 reports (8.67%)
  6. Pneumonia — 10 reports (6.67%)
  7. Renal Impairment — 10 reports (6.67%)
  8. Vomiting — 9 reports (6%)
  9. Immunosuppressant Drug Level Decreased — 8 reports (5.33%)
  10. Pyrexia — 8 reports (5.33%)

Source database →

tacrolimus capsules 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 capsules approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for tacrolimus capsules in United States?

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