Drug Safety Information for NIFEDIPINE (Nifedipine)

Adverse Drug Reactions for NIFEDIPINE* (Nifedipine)

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 NIFEDIPINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea1158
2Nausea1045
3Hypertension963
4Dizziness*943
5Drug ineffective*826
6Headache*799
7Diarrhoea796
8Vomiting791
9Fatigue*787
10Oedema peripheral778
11Asthenia771
12Pyrexia765
13Pain761
14Anaemia720
15Malaise716
16Pneumonia712
17Hypotension694
18Blood pressure increased649
19Fall622
20Chest pain608

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

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

Reason # of FDA Reports
1Hypertension*20889
2Product used for unknown indication8589
3Blood pressure*1286
4Cardiac disorder580
5Blood pressure increased580
6Tocolysis567
7Raynaud's phenomenon521
8Ill-defined disorder514
9Blood pressure abnormal425
10Essential hypertension361

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


Types of Adverse Events for NIFEDIPINE

Total Reports Filed with FDA: 110515


Number of FDA Adverse Event Reports by Patient Age for NIFEDIPINE

Total Reports Filed with FDA: 110515*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nifedipine (Cordipin, Corinfar, Adalat cc, Coracten, Adalate lp, Nifedicalxl, Angiopine, Nifediac, Fenigidin, Afeditab, Nifedical, Adalat, Afeditab cr, Coracten xl, Vascard, Nifediac cc, Procardia xl, Procardia, Nifedipine)

Charts are based on 110515 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 NIFEDIPINE 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.