🇺🇸 sandimmun in United States

894 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. Pyrexia — 140 reports (15.66%)
  2. Drug Interaction — 108 reports (12.08%)
  3. Product Use In Unapproved Indication — 105 reports (11.74%)
  4. Acute Kidney Injury — 89 reports (9.96%)
  5. Diarrhoea — 82 reports (9.17%)
  6. Blood Creatinine Increased — 81 reports (9.06%)
  7. Drug Ineffective — 78 reports (8.72%)
  8. Vomiting — 72 reports (8.05%)
  9. Hypertension — 70 reports (7.83%)
  10. Renal Impairment — 69 reports (7.72%)

Source database →

Other Immunology approved in United States

Frequently asked questions

Is sandimmun approved in United States?

Yes. FDA has authorised it.

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

Sohag University is the originator. The local marketing authorisation holder may differ — check the official source linked above.