🇺🇸 Ora-Plus in United States

10 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. Acute Respiratory Failure — 1 report (10%)
  2. Dehydration — 1 report (10%)
  3. Discomfort — 1 report (10%)
  4. Drug Dispensing Error — 1 report (10%)
  5. Epileptic Encephalopathy — 1 report (10%)
  6. Expired Product Administered — 1 report (10%)
  7. Hypoxia — 1 report (10%)
  8. Incorrect Dose Administered — 1 report (10%)
  9. Medication Error — 1 report (10%)
  10. Musculoskeletal Stiffness — 1 report (10%)

Source database →

Ora-Plus 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 Ora-Plus approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Ora-Plus in United States?

Universitaire Ziekenhuizen KU Leuven is the originator. The local marketing authorisation holder may differ — check the official source linked above.