Drug Safety Information for CARDENE SR (Nicardipine hydrochloride)

FDA Safety-related Labeling Changes for CARDENE (NICARDIPINE HYDROCHLORIDE) Discontinued Drug: Safety Information Link

FDA Safety-related Labeling Changes for CARDENE (NICARDIPINE HYDROCHLORIDE) Discontinued Drug: Safety Information Link

FDA Safety-related Labeling Changes for CARDENE SR (NICARDIPINE HYDROCHLORIDE) Brand name discontinued; available as generic: Safety Information Link

Adverse Drug Reactions for CARDENE SR* (Nicardipine 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 CARDENE SR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Renal failure201
2Renal failure acute166
3Pyrexia164
4Fall164
5Hypertension150
6Drug interaction146
7Anaemia137
8Hypotension128
9Thrombocytopenia126
10Dyspnoea115
11Vomiting110
12Confusional state105
13Acute pulmonary oedema99
14Malaise98
15Hyponatraemia97
16Diarrhoea93
17Caesarean section89
18Aspartate aminotransferase increased87
19Asthenia86
20Alanine aminotransferase increased85

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

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

Reason # of FDA Reports
1Hypertension3493
2Product used for unknown indication2046
3Tocolysis282
4Essential hypertension282
5Pre-eclampsia176
6Premature labour131
7Blood pressure increased123
8Threatened labour96
9Blood pressure management64
10Prophylaxis64

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


Types of Adverse Events for CARDENE SR

Total Reports Filed with FDA: 17394


Number of FDA Adverse Event Reports by Patient Age for CARDENE SR

Total Reports Filed with FDA: 17394*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nicardipine hydrochloride (Perdipine, Nicardipine hcl, Cardene i.v., Loxen, Cardene iv, Vasonase, Cardene sr, Flusemide, Nicardipine, Cardene)

Charts are based on 17394 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 CARDENE SR 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.