Drug Safety Information for SENSIPAR (Cinacalcet hydrochloride)

FDA Safety-related Labeling Changes for SENSIPAR (CINACALCET HYDROCHLORIDE) Rx Drug: Safety Information Link

Cartilage calcification pseudo gout Safety label updated

Adverse Drug Reactions for SENSIPAR* (Cinacalcet hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with SENSIPAR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*770
2Off label use645
3Vomiting490
4Death420
5Diarrhoea359
6Hospitalisation300
7Hypotension220
8Dyspnoea211
9Dizziness209
10Blood parathyroid hormone increased202
11Muscle spasms189
12Pain178
13Abdominal discomfort176
14Asthenia174
15Nephrogenic systemic fibrosis153
16Hypocalcaemia152
17Pruritus145
18Abdominal pain upper144
19Convulsion143
20Paraesthesia139

* This side effect also appears in "Top 10 Side Effects of SENSIPAR " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking SENSIPAR
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hyperparathyroidism secondary5748
2Product used for unknown indication5658
3Hyperparathyroidism476
4Hyperparathyroidism primary374
5Renal failure chronic206
6Hypercalcaemia160
7Dialysis147
8Parathyroid disorder133
9Blood calcium increased79
10Blood parathyroid hormone increased70

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for SENSIPAR

Total Reports Filed with FDA: 21531


Number of FDA Adverse Event Reports by Patient Age for SENSIPAR

Total Reports Filed with FDA: 21531*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cinacalcet hydrochloride (Cinacalcet, Sensipar)

Charts are based on 21531 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and SENSIPAR Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.