FDA Adverse Events Reports (FAERS) Summary for SENSIPAR

These tables and charts are based on 44,256 total reports for SENSIPAR (CINACALCET HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 43,399 pharmaceutical company-submitted and non-U.S. FAERS reports and 857 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 857 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch SENSIPAR summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with SENSIPAR (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG DOSE OMISSION	8739
2	HOSPITALIZATION	6868
3	LABORATORY TEST ABNORMAL	4221
4	OFF LABEL USE	2271
5	NAUSEA	2194
6	INTENTIONAL PRODUCT MISUSE	2084
7	DEATH	1622
8	MALAISE	1552
9	VOMITING	1462
10	ADVERSE DRUG REACTION	1456
11	DIARRHEA	1067
12	DECREASED APPETITE	782
13	ABDOMINAL DISCOMFORT	765
14	MUSCLE SPASMS	586
15	LOW BLOOD PRESSURE	541
16	ABDOMINAL PAIN UPPER	529
17	DIZZINESS	513
18	UNEVALUABLE EVENT	498
19	BLOOD PARATHYROID HORMONE INCREASED	488
20	KIDNEY FAILURE	458
21	FATIGUE	458
22	ADVERSE EVENT	452
23	CHRONIC KIDNEY DISEASE	445
24	KIDNEY FAILURE	427
25	SHORTNESS OF BREATH	388
26	DRUG INEFFECTIVE	387
27	ITCHING	377
28	CONSTIPATION	369
29	HEADACHE	367
30	PAIN	350
31	BLOOD PARATHYROID HORMONE ABNORMAL	340
32	BLOOD CALCIUM DECREASED	339
33	APPETITE LOST	323
34	PNEUMONIA	317
35	LACK OF STRENGTH AND ENERGY (ASTHENIA)	311
36	PINS AND NEEDLES	302
37	ACUTE KIDNEY INJURY	278
38	HOSPICE CARE	266
39	BLOOD CALCIUM INCREASED	250
40	HIGH BLOOD PRESSURE	248
41	PAIN IN EXTREMITY	246
42	SURGERY	239
43	GASTROINTESTINAL DISORDER	230
44	RASH	228
45	NUMBNESS	225
46	LIVING IN RESIDENTIAL INSTITUTION	214
47	HYPOCALCAEMIA	208
48	DIFFICULTY SWALLOWING	207
49	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	205
50	REHABILITATION THERAPY	203
51	FALL	200
52	COMMON COLD	194
53	STROKE	189
54	ANXIETY	181
55	COUGH	181
56	NEPHROGENIC ANAEMIA	179
57	JOINT PAIN	178
58	WEIGHT DECREASED	176
59	BLOOD PARATHYROID HORMONE DECREASED	174
60	CHEST PAIN	170
61	FEELING ABNORMAL	165
62	HEART ATTACK (MYOCARDIAL INFARCTION)	165
63	DRUG INTOLERANCE	154
64	MUSCLE PAIN	153
65	SEIZURE	152
66	ABDOMINAL PAIN	148
67	DRUG HYPERSENSITIVITY	143
68	TRANSPLANT	143
69	DIALYSIS	139
70	NEPHROGENIC SYSTEMIC FIBROSIS	139
71	ANEMIA	135
72	TREATMENT NONCOMPLIANCE	135
73	SEPSIS	134
74	BLOOD PHOSPHORUS INCREASED	131
75	GASTRIC DISORDER	130
76	HYPERPARATHYROIDISM SECONDARY	130
77	SWELLING OF LIMBS	130
78	BLOOD CALCIUM ABNORMAL	128
79	DEPRESSION	128
80	HAEMOGLOBIN DECREASED	128
81	INFECTION	127
82	KIIDNEY INJURY	126
83	CARDIAC DISORDER	123
84	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	123
85	RENAL TRANSPLANT	123
86	HYPERSENSITIVITY	120
87	INSOMNIA	120
88	FEVER	119
89	ILL-DEFINED DISORDER	118
90	BACK PAIN	117
91	CARDIAC ARREST	112
92	GAIT DISTURBANCE	112
93	DROWSINESS	109
94	BLOOD PRESSURE DECREASED	108
95	TREMOR	106
96	MUSCULAR WEAKNESS	105
97	ARRHYTHMIA	104
98	BONE PAIN	103
99	CONVULSION	103
100	GASTROINTESTINAL BLEEDING	100

Latest Known Outcomes for Reactions Reported for SENSIPAR

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	36422
2	Patient has not recovered/symtoms have not resolved	2916
3	Patient recovered	1988
4	Patient died	1606
5	Patient is recovering/symptoms resolving	459
6	Patient has recovered but has consequent health issues	22

Search all MedWatch and FAERS by keyword:

SENSIPAR Total Reports

Male	Female	Unknown	Total
18251	21052	4953	44,256

Top Countries Reporting

	Country	Number of Reports
1	United States	41833
2	Canada	235
3	South Africa	64
4	Australia	56
5	United Kingdom	7
6	Switzerland	2
7	China	2
8	Croatia	2
9	Puerto Rico	2
10	Belgium	1

Outcomes for Reports

Serious: 15028
Not Serious: 29227
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Hyperparathyroidism
Product used for unknown indication
Hyperparathyroidism tertiary
Hyperparathyroidism primary
Hypercalcaemia

Top Companies Reporting

AMGEN

Safety-Related FDA Updates

FDA Approval Date: 2004-03-08

SENSIPAR (CINACALCET HYDROCHLORIDE) Rx Drug:
Cartilage calcification pseudo goutSafety label updated Safety-related Labeling Changes

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 the cases for SENSIPAR reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. 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. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA 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 or comments about this report.