Drug Safety Information for SIMCOR (Niacin; simvastatin)

Adverse Drug Reactions for SIMCOR* (Niacin; simvastatin)

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 SIMCOR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Flushing*5235
2Pruritus2007
3Feeling hot1385
4Paraesthesia*1180
5Erythema975
6Skin burning sensation734
7Blood glucose increased596
8Headache575
9Dizziness514
10Nausea425
11Burning sensation383
12Diarrhoea379
13Myalgia377
14Hot flush288
15Rash285
16Back pain271
17Muscle spasms259
18Pain in extremity251
19Hyperhidrosis244
20Fatigue235

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

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

Reason # of FDA Reports
1Blood cholesterol increased7585
2Product used for unknown indication6873
3Low density lipoprotein increased2951
4High density lipoprotein decreased1870
5Blood triglycerides increased1379
6Hyperlipidaemia1050
7Hypercholesterolaemia649
8Blood cholesterol577
9Dyslipidaemia552
10Blood cholesterol abnormal436

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


Types of Adverse Events for SIMCOR

Total Reports Filed with FDA: 25234


Number of FDA Adverse Event Reports by Patient Age for SIMCOR

Total Reports Filed with FDA: 25234*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Niacin; simvastatin (Simcor)

Charts are based on 25234 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 SIMCOR 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 SIMCOR's side effects.