SENSIPAR FDA MedWatch Voluntary U.S. Reports Summary
These tables and charts are created from 859 U.S. reports for SENSIPAR (CINACALCET HYDROCHLORIDE) voluntarily reported by individuals directly to the FDA via the MedWatch Reporting System from 2004 through July 30, 2026. Events listed on this page represent serious and often rare adverse events
reported to the FDA, and often do not represent typical side effects for the medication. Find common side effects on the most recent
official drug label.
For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS SENSIPAR Report.
Top Adverse Events Reported with SENSIPAR (from U.S. FDA Medwatch Reports)
Side Effect # of FDA Reports 1 DEATH 209 2 HOSPITALIZATION 78 3 NAUSEA 47 4 VOMITING 41 5 THERAPY CESSATION 38 6 DIARRHEA 28 7 SHORTNESS OF BREATH 24 8 DIALYSIS 22 9 FATIGUE 22 10 LACK OF STRENGTH AND ENERGY (ASTHENIA) 18 11 PNEUMONIA 17 12 DECREASED APPETITE 16 13 DIZZINESS 15 14 DRUG DOSE OMISSION 15 15 MALAISE 15 16 CONFUSIONAL STATE 13 17 HEADACHE 13 18 HEART ATTACK (MYOCARDIAL INFARCTION) 13 19 LOWER LIMBS SWELLING 13 20 RENAL TRANSPLANT 13 21 FALL 12 22 CHEST PAIN 11 23 STROKE 10 24 INFECTION 10 25 LOSS OF CONSCIOUSNESS 10
SENSIPAR Total Medwatch Safety Reports by Patient Sex
| Male | Female | Unknown | Total |
|---|---|---|---|
| 409 | 437 | 13 | 859 |
| Medwatch Reporter Type | Count |
| Consumer | 126 |
| Physician | 11 |
| Pharmacist | 435 |
| Other Health Professional | 216 |
| Top Indications | |
| Hyperparathyroidism | |
| Product used for unknown indication | |
| Hyperparathyroidism tertiary | |
| Hyperparathyroidism primary | |
| Hypercalcaemia | |
Type of Outcome Reported
Serious: 655
Not Serious: 204
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.
Suspected Role
Primary Suspect: 859
Concomitant Drugs: 346
Note: A single MedWatch report can list more than one drug. This summary includes SENSIPAR identified as the suspect drug or as a concomitantly taken drug.
FDA Safety-Related Labeling Changes
SENSIPAR (CINACALCET HYDROCHLORIDE) Rx Drug:
FDA Safety-related Labeling Changes
Cartilage calcification pseudo gout Safety label updated
Have experience (good or bad) with SENSIPAR? Rate SENSIPAR at Ask a Patient.
For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.
NOTES
This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.
After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"
The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.
Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."
FDA uses the "MedDRA" classification system to describe reported adverse
reactions. MedDRA is a standardized medical terminology that facilitates
sharing of regulatory information internationally. In some cases, "patient
friendly" terms for the layman designated by MedDRA have been substituted
for medical jargon. Please
contact us
with questions about this report.
