🇺🇸 Wheat in United States

656 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. Off Label Use — 167 reports (25.46%)
  2. Therapeutic Response Unexpected — 81 reports (12.35%)
  3. Diarrhoea — 72 reports (10.98%)
  4. Constipation — 60 reports (9.15%)
  5. Nausea — 59 reports (8.99%)
  6. Incorrect Dose Administered — 58 reports (8.84%)
  7. Overdose — 42 reports (6.4%)
  8. Abdominal Pain Upper — 41 reports (6.25%)
  9. Underdose — 39 reports (5.95%)
  10. Abdominal Distension — 37 reports (5.64%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Wheat approved in United States?

Yes. FDA has authorised it.

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

Shiraz University of Medical Sciences is the originator. The local marketing authorisation holder may differ — check the official source linked above.