SENSIPAR FDA MedWatch Direct Reports Summary

These tables and charts are created from 857 voluntary U.S. reports for SENSIPAR (CINACALCET HYDROCHLORIDE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

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 Effects Associated 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	23
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	STROKE	10
23	CHEST PAIN	10
24	INFECTION	10
25	LOSS OF CONSCIOUSNESS	10

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SENSIPAR Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
408	436	13	857

Medwatch Reporter Type	Count
Consumer	124
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: 653
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: 857
Concomitant Drugs: 344
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.