🇺🇸 CEFOPERAZONE SODIUM in United States

FDA authorised CEFOPERAZONE SODIUM on 23 July 1986 · 979 US adverse-event reports

Marketing authorisations

FDA — authorised 23 July 1986

  • Application: NDA050613
  • Marketing authorisation holder: PFIZER
  • Local brand name: CEFOBID IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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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 — 193 reports (19.71%)
  2. Platelet Count Decreased — 115 reports (11.75%)
  3. Pyrexia — 108 reports (11.03%)
  4. Pneumonia — 106 reports (10.83%)
  5. Drug Ineffective — 104 reports (10.62%)
  6. Hepatic Function Abnormal — 83 reports (8.48%)
  7. Coagulopathy — 72 reports (7.35%)
  8. Anaemia — 66 reports (6.74%)
  9. Diarrhoea — 66 reports (6.74%)
  10. White Blood Cell Count Decreased — 66 reports (6.74%)

Source database →

CEFOPERAZONE SODIUM 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 CEFOPERAZONE SODIUM approved in United States?

Yes. FDA authorised it on 23 July 1986; FDA has authorised it.

Who is the marketing authorisation holder for CEFOPERAZONE SODIUM in United States?

PFIZER holds the US marketing authorisation.