🇺🇸 Cipro HC in United States

FDA authorised Cipro HC on 10 February 1998 · 108 US adverse-event reports

Marketing authorisations

FDA — authorised 10 February 1998

  • Application: NDA020805
  • Marketing authorisation holder: SANDOZ
  • 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. Pain — 19 reports (17.59%)
  2. Drug Ineffective — 15 reports (13.89%)
  3. Anxiety — 12 reports (11.11%)
  4. Headache — 11 reports (10.19%)
  5. Drug Hypersensitivity — 10 reports (9.26%)
  6. Chronic Kidney Disease — 9 reports (8.33%)
  7. Asthenia — 8 reports (7.41%)
  8. Hypertension — 8 reports (7.41%)
  9. Nausea — 8 reports (7.41%)
  10. Vomiting — 8 reports (7.41%)

Source database →

Cipro HC 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 Cipro HC approved in United States?

Yes. FDA authorised it on 10 February 1998; FDA has authorised it.

Who is the marketing authorisation holder for Cipro HC in United States?

SANDOZ holds the US marketing authorisation.