🇺🇸 Cinacalcet HCl in United States

FDA authorised Cinacalcet HCl on 8 March 2004 · 521 US adverse-event reports

Marketing authorisations

FDA — authorised 8 March 2004

  • Application: NDA021688
  • Marketing authorisation holder: AMGEN
  • Local brand name: SENSIPAR
  • Indication: TABLET — ORAL
  • 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 — 107 reports (20.54%)
  2. Hospitalisation — 73 reports (14.01%)
  3. Death — 66 reports (12.67%)
  4. Hypocalcaemia — 58 reports (11.13%)
  5. Nausea — 43 reports (8.25%)
  6. Drug Ineffective — 39 reports (7.49%)
  7. Hypercalcaemia — 35 reports (6.72%)
  8. Pneumonia — 34 reports (6.53%)
  9. Arteriovenous Fistula Site Complication — 33 reports (6.33%)
  10. Vomiting — 33 reports (6.33%)

Source database →

Cinacalcet HCl 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 Cinacalcet HCl approved in United States?

Yes. FDA authorised it on 8 March 2004; FDA has authorised it.

Who is the marketing authorisation holder for Cinacalcet HCl in United States?

AMGEN holds the US marketing authorisation.