🇺🇸 Puri-Nethol in United States

15 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. Abdominal Pain — 3 reports (20%)
  2. Intestinal Fistula — 2 reports (13.33%)
  3. Intestinal Stenosis — 2 reports (13.33%)
  4. Large Intestine Perforation — 2 reports (13.33%)
  5. Abdominal Hernia — 1 report (6.67%)
  6. Abscess Intestinal — 1 report (6.67%)
  7. Anaemia Macrocytic — 1 report (6.67%)
  8. Anal Abscess — 1 report (6.67%)
  9. Anal Fistula — 1 report (6.67%)
  10. Anal Injury — 1 report (6.67%)

Source database →

Puri-Nethol 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 Puri-Nethol approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Puri-Nethol in United States?

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