Drug Safety Information for NIASPAN (Niacin)

Safety-related Labeling Changes for NIASPAN (NIACIN) Rx Drug: FDA Link

Safety-related Labeling Changes for NIASPAN TITRATION STARTER PACK (NIACIN) Rx Drug: FDA Link

Adverse Drug Reactions for NIASPAN* (Niacin)

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 NIASPAN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Flushing*17372
2Pruritus*6491
3Feeling hot4091
4Paraesthesia*3635
5Erythema3158
6Skin burning sensation2121
7Blood glucose increased1849
8Dizziness*1746
9Nausea1713
10Headache1493
11Diarrhoea1355
12Burning sensation*1268
13Rash*1156
14Myalgia1093
15Fatigue1068
16Hot flush*1031
17Dyspnoea974
18Pain*964
19Hyperhidrosis859
20Insomnia*844

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

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

Reason # of FDA Reports
1Product used for unknown indication23850
2Blood cholesterol increased*21138
3High density lipoprotein decreased*10298
4Low density lipoprotein increased7692
5Blood triglycerides increased5262
6Hyperlipidaemia*3805
7Blood cholesterol*2898
8Blood cholesterol abnormal1999
9Dyslipidaemia1686
10Hypercholesterolaemia1211

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


Types of Adverse Events for NIASPAN

Total Reports Filed with FDA: 124587


Number of FDA Adverse Event Reports by Patient Age for NIASPAN

Total Reports Filed with FDA: 124587*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Niacin (Wampocap, Advicor 1000/20, Nicolar, Nicobid, Enduracin, Niaspan, Niacor, Niacin)

Charts are based on 124587 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 NIASPAN 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.