🇺🇸 Diosmectite in United States

170 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. Diarrhoea — 27 reports (15.88%)
  2. Acute Kidney Injury — 22 reports (12.94%)
  3. Pancytopenia — 21 reports (12.35%)
  4. Pyrexia — 20 reports (11.76%)
  5. Urinary Tract Infection — 16 reports (9.41%)
  6. Anaemia — 15 reports (8.82%)
  7. Confusional State — 14 reports (8.24%)
  8. Fall — 12 reports (7.06%)
  9. Thrombocytopenia — 12 reports (7.06%)
  10. General Physical Health Deterioration — 11 reports (6.47%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Diosmectite approved in United States?

Yes. FDA has authorised it.

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

Ain Shams Maternity Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.