Icosapent Ethyl

Common brands: Vascepa, Icosapent, Vitamin D, Aspirin 325, Aspirin 81

Top reporter: Amarin Pharma Inc.

Nonsteroidal Anti-inflammatory Drug [EPC]Provitamin D2 Compound [EPC]Platelet Aggregation Inhibitor [EPC]HMG-CoA Reductase Inhibitor [EPC]Corticosteroid [EPC]
8,170
Total Reports
4,275
Serious Reports
518
Death Reports
30
Reported Reactions
Death Report Ratio: High (6.34%)

Patient Demographics

Male
3,842
Female
3,431

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Icosapent Ethyl.

# Reaction Reports % of Total
1 PRODUCT ODOUR ABNORMAL 1,005
9.1%
2 PRODUCT PHYSICAL ISSUE 823
7.5%
3 OFF LABEL USE 761
6.9%
4 POOR QUALITY PRODUCT ADMINISTERED 586
5.3%
5 DIARRHOEA 573
5.2%
6 DRUG INEFFECTIVE 550
5.0%
7 NAUSEA 512
4.7%
8 ARTHRALGIA 484
4.4%
9 PRODUCT TASTE ABNORMAL 434
3.9%
10 FATIGUE 410
3.7%
11 PRESCRIBED UNDERDOSE 306
2.8%
12 BLOOD TRIGLYCERIDES INCREASED 291
2.6%
13 HEADACHE 288
2.6%
14 DIZZINESS 283
2.6%
15 ERUCTATION 272
2.5%
16 CONDITION AGGRAVATED 263
2.4%
17 ABDOMINAL DISCOMFORT 262
2.4%
18 PAIN IN EXTREMITY 257
2.3%
19 VOMITING 255
2.3%
20 PAIN 251
2.3%
21 DYSPNOEA 236
2.1%
22 DEATH 230
2.1%
23 RASH 230
2.1%
24 WEIGHT INCREASED 221
2.0%
25 PRODUCT COLOUR ISSUE 211
1.9%
26 PRODUCT DOSE OMISSION ISSUE 211
1.9%
27 BLOOD GLUCOSE INCREASED 203
1.8%
28 THERAPY INTERRUPTED 197
1.8%
29 PERIPHERAL SWELLING 195
1.8%
30 INSOMNIA 190
1.7%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.