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 | |
---|---|---|
1 | Nausea* | 770 |
2 | Off label use | 645 |
3 | Vomiting | 490 |
4 | Death | 420 |
5 | Diarrhoea | 359 |
6 | Hospitalisation | 300 |
7 | Hypotension | 220 |
8 | Dyspnoea | 211 |
9 | Dizziness | 209 |
10 | Blood parathyroid hormone increased | 202 |
11 | Muscle spasms | 189 |
12 | Pain | 178 |
13 | Abdominal discomfort | 176 |
14 | Asthenia | 174 |
15 | Nephrogenic systemic fibrosis | 153 |
16 | Hypocalcaemia | 152 |
17 | Pruritus | 145 |
18 | Abdominal pain upper | 144 |
19 | Convulsion | 143 |
20 | Paraesthesia | 139 |
* 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 | |
---|---|---|
1 | Hyperparathyroidism secondary | 5748 |
2 | Product used for unknown indication | 5658 |
3 | Hyperparathyroidism | 476 |
4 | Hyperparathyroidism primary | 374 |
5 | Renal failure chronic | 206 |
6 | Hypercalcaemia | 160 |
7 | Dialysis | 147 |
8 | Parathyroid disorder | 133 |
9 | Blood calcium increased | 79 |
10 | Blood parathyroid hormone increased | 70 |
*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.