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
1	Nausea	75
2	Dizziness	68
3	Drug ineffective	68
4	Headache*	63
5	Fatigue	59
6	Asthenia	58
7	Oedema peripheral	57
8	Myocardial infarction	54
9	Dyspnoea	54
10	Pain	53
11	Pruritus	46
12	Diarrhoea	45
13	Pain in extremity	44
14	Hypertension	44
15	Blood pressure increased	42
16	Anxiety*	42
17	Back pain	39
18	Cerebrovascular accident	38
19	Cardiac failure congestive	36
20	Injury	34

* 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
1	Hypertension*	781
2	Product used for unknown indication	341
3	Blood pressure	101
4	Cardiomyopathy	34
5	Ill-defined disorder	19
6	Blood pressure abnormal	17
7	Raynaud's phenomenon	15
8	Coronary artery disease	14
9	Prinzmetal angina	13
10	Chest pain	6

*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.

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.