FDA — authorised 8 March 2018
- Application: ANDA208915
- Marketing authorisation holder: CIPLA
- Local brand name: CINACALCET HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 CINACALCET HYDROCHLORIDE in United States
FDA authorised CINACALCET HYDROCHLORIDE on 8 March 2018 · 1,324 US adverse-event reports
Marketing authorisations
FDA — authorised 27 December 2018
- Application: ANDA204377
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: CINACALCET HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 September 2020
- Application: ANDA208368
- Marketing authorisation holder: DR REDDYS
- Local brand name: CINACALCET HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 October 2020
- Application: ANDA209403
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: CINACALCET HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 December 2021
- Application: ANDA204364
- Marketing authorisation holder: STEVENS J
- Local brand name: CINACALCET HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA208971
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: CINACALCET HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA090539
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: CINACALCET HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,324
Most-reported reactions
- Off Label Use — 242 reports (18.28%)
- Death — 211 reports (15.94%)
- Hypocalcaemia — 154 reports (11.63%)
- Drug Ineffective — 145 reports (10.95%)
- Hypercalcaemia — 136 reports (10.27%)
- Nausea — 118 reports (8.91%)
- Vomiting — 106 reports (8.01%)
- Parathyroid Tumour Benign — 75 reports (5.66%)
- Diarrhoea — 73 reports (5.51%)
- Blood Parathyroid Hormone Increased — 64 reports (4.83%)
CINACALCET HYDROCHLORIDE 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 HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 8 March 2018; FDA authorised it on 27 December 2018; FDA authorised it on 18 September 2020.
Who is the marketing authorisation holder for CINACALCET HYDROCHLORIDE in United States?
CIPLA holds the US marketing authorisation.