Drug Safety Information for SULAR (Nisoldipine)

Safety-related Labeling Changes for SULAR (NISOLDIPINE) Rx Drug: FDA Link

Adverse Drug Reactions for SULAR* (Nisoldipine)

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 SULAR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea75
2Dizziness68
3Drug ineffective68
4Headache*63
5Fatigue59
6Asthenia58
7Oedema peripheral57
8Myocardial infarction54
9Dyspnoea54
10Pain53
11Pruritus46
12Diarrhoea45
13Pain in extremity44
14Hypertension44
15Blood pressure increased42
16Anxiety*42
17Back pain39
18Cerebrovascular accident38
19Cardiac failure congestive36
20Injury34

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

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

Reason # of FDA Reports
1Hypertension*781
2Product used for unknown indication341
3Blood pressure101
4Cardiomyopathy34
5Ill-defined disorder19
6Blood pressure abnormal17
7Raynaud's phenomenon15
8Coronary artery disease14
9Prinzmetal angina13
10Chest pain6

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


Types of Adverse Events for SULAR

Total Reports Filed with FDA: 5626


Number of FDA Adverse Event Reports by Patient Age for SULAR

Total Reports Filed with FDA: 5626*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nisoldipine (Sular, Nisoldipine)

Charts are based on 5626 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 SULAR Reviews and Review Summary .

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.

Visit   DrugInformer.com more on SULAR's side effects.