Drug Safety Information for VASCEPA (Icosapent ethyl)

FDA Safety-related Labeling Changes for VASCEPA (ICOSAPENT ETHYL) Rx Drug: Safety Information Link

Adverse Drug Reactions for VASCEPA* (Icosapent ethyl)

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 VASCEPA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Arthralgia	30
2	Diarrhoea	25
3	Blood triglycerides increased	22
4	Product odour abnormal	16
5	Nausea	14
6	Dizziness	13
7	Fatigue	10
8	Eructation	10
9	Pain	10
10	Product physical issue	10
11	Headache	10
12	Blood glucose increased	10
13	Back pain	9
14	Product taste abnormal	9
15	Dyspepsia	9
16	Myalgia	9
17	Drug ineffective	9
18	Constipation	8
19	Abdominal discomfort	8
20	Abdominal distension	7

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	169
2	Blood triglycerides increased	125
3	Blood triglycerides	71
4	Blood cholesterol increased	45
5	Blood cholesterol	39
6	Blood cholesterol abnormal	18
7	Hypertriglyceridaemia	16
8	Supplementation therapy	15
9	Low density lipoprotein increased	11
10	Prophylaxis	11

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

Types of Adverse Events for VASCEPA

Total Reports Filed with FDA: 630

Number of FDA Adverse Event Reports by Patient Age for VASCEPA

Total Reports Filed with FDA: 630*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Icosapent ethyl (Vascepa)

Charts are based on 630 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.