🇺🇸 Pancrelipase Capsules in United States

FDA authorised Pancrelipase Capsules on 30 April 2009 · 11 US adverse-event reports

Marketing authorisation

FDA — authorised 30 April 2009

  • Application: BLA020725
  • Marketing authorisation holder: ABBVIE
  • Local brand name: CREON
  • Indication: CAPSULE, DELAYED RELEASE — ORAL
  • Status: approved

Read official source →

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. Atrial Fibrillation — 2 reports (18.18%)
  2. Arteriosclerosis — 1 report (9.09%)
  3. Cellulitis — 1 report (9.09%)
  4. Chronic Obstructive Pulmonary Disease — 1 report (9.09%)
  5. Colitis Ischaemic — 1 report (9.09%)
  6. Diabetes Mellitus — 1 report (9.09%)
  7. Duodenitis — 1 report (9.09%)
  8. Exposure During Pregnancy — 1 report (9.09%)
  9. Hyperglycaemia — 1 report (9.09%)
  10. Hyponatraemia — 1 report (9.09%)

Source database →

Other Gastroenterology approved in United States

Frequently asked questions

Is Pancrelipase Capsules approved in United States?

Yes. FDA authorised it on 30 April 2009.

Who is the marketing authorisation holder for Pancrelipase Capsules in United States?

ABBVIE holds the US marketing authorisation.