🇺🇸 Precedex in United States

FDA authorised Precedex on 17 December 1999 · 583 US adverse-event reports

Marketing authorisations

FDA — authorised 17 December 1999

  • Application: NDA021038
  • Marketing authorisation holder: HOSPIRA
  • Status: supplemented

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. Hypotension — 86 reports (14.75%)
  2. Off Label Use — 79 reports (13.55%)
  3. Bradycardia — 71 reports (12.18%)
  4. Pneumonia — 64 reports (10.98%)
  5. Cardiac Arrest — 62 reports (10.63%)
  6. Respiratory Failure — 49 reports (8.4%)
  7. Acute Kidney Injury — 46 reports (7.89%)
  8. Pyrexia — 44 reports (7.55%)
  9. Blood Pressure Decreased — 41 reports (7.03%)
  10. Drug Ineffective — 41 reports (7.03%)

Source database →

Precedex in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Precedex approved in United States?

Yes. FDA authorised it on 17 December 1999; FDA has authorised it.

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

HOSPIRA holds the US marketing authorisation.