🇺🇸 Midazolam injection in United States

55 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. Nausea — 10 reports (18.18%)
  2. Pyrexia — 8 reports (14.55%)
  3. Vomiting — 8 reports (14.55%)
  4. Staphylococcal Infection — 7 reports (12.73%)
  5. Endocarditis — 6 reports (10.91%)
  6. Depressed Level Of Consciousness — 4 reports (7.27%)
  7. Acute Respiratory Distress Syndrome — 3 reports (5.45%)
  8. Condition Aggravated — 3 reports (5.45%)
  9. Hypotension — 3 reports (5.45%)
  10. Unresponsive To Stimuli — 3 reports (5.45%)

Source database →

Midazolam injection 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 Midazolam injection approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Midazolam injection in United States?

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