Drug Safety Information for ADVICOR (Lovastatin; niacin)

Adverse Drug Reactions for ADVICOR* (Lovastatin; 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 ADVICOR
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Flushing*	216
2	Pruritus	57
3	Dizziness	51
4	Nausea	44
5	Myalgia	43
6	Paraesthesia	41
7	Oedema peripheral	35
8	Fatigue*	35
9	Myocardial infarction	34
10	Asthenia	33
11	Blood glucose increased	31
12	Pain	30
13	Fall	29
14	Arthralgia	29
15	Diarrhoea	29
16	Drug ineffective	29
17	Dyspnoea	27
18	Feeling hot	27
19	Pain in extremity	26
20	Vomiting	25

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

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

	Reason	# of FDA Reports
1	Blood cholesterol increased*	735
2	Product used for unknown indication	435
3	Blood cholesterol	144
4	High density lipoprotein decreased	80
5	Low density lipoprotein increased	80
6	Blood triglycerides increased	63
7	Hypercholesterolaemia	52
8	Dyslipidaemia	45
9	Hyperlipidaemia	30
10	Lipids increased	17

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

Types of Adverse Events for ADVICOR

Total Reports Filed with FDA: 3701

Number of FDA Adverse Event Reports by Patient Age for ADVICOR

Total Reports Filed with FDA: 3701*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Lovastatin; niacin (Advicor)

Charts are based on 3701 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.