ICOSAPENT ETHYL

N/A

Manufactured by Amarin Pharma Inc.

18,725 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ICOSAPENT ETHYL

ICOSAPENT ETHYL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amarin Pharma Inc.. The most commonly reported adverse reactions for ICOSAPENT ETHYL include PRODUCT ODOUR ABNORMAL, PRODUCT PHYSICAL ISSUE, OFF LABEL USE, DIARRHOEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ICOSAPENT ETHYL.

Top Adverse Reactions

PRODUCT ODOUR ABNORMAL963 reports
PRODUCT PHYSICAL ISSUE733 reports
OFF LABEL USE728 reports
DIARRHOEA546 reports
DRUG INEFFECTIVE535 reports
POOR QUALITY PRODUCT ADMINISTERED501 reports
NAUSEA488 reports
ARTHRALGIA468 reports
PRODUCT TASTE ABNORMAL430 reports
FATIGUE389 reports
PRESCRIBED UNDERDOSE301 reports
BLOOD TRIGLYCERIDES INCREASED283 reports
HEADACHE274 reports
DIZZINESS271 reports
ERUCTATION265 reports
ABDOMINAL DISCOMFORT250 reports
CONDITION AGGRAVATED249 reports
PAIN IN EXTREMITY249 reports
PAIN238 reports
VOMITING237 reports
DEATH226 reports
RASH225 reports
DYSPNOEA223 reports
WEIGHT INCREASED219 reports
PRODUCT COLOUR ISSUE197 reports
BLOOD GLUCOSE INCREASED195 reports
PRODUCT DOSE OMISSION ISSUE189 reports
INSOMNIA186 reports
PERIPHERAL SWELLING185 reports
PRURITUS183 reports
ABDOMINAL PAIN UPPER177 reports
THERAPY INTERRUPTED177 reports
MYALGIA171 reports
NASOPHARYNGITIS169 reports
ASTHENIA168 reports
CONSTIPATION162 reports
SINUSITIS157 reports
URTICARIA155 reports
HYPOAESTHESIA154 reports
INTENTIONAL UNDERDOSE149 reports
MOBILITY DECREASED149 reports
DECREASED APPETITE147 reports
HYPERTENSION147 reports
MUSCLE SPASMS146 reports
BLOOD PRESSURE INCREASED145 reports
MALAISE145 reports
PRODUCT ADHESION ISSUE144 reports
PYREXIA143 reports
WEIGHT DECREASED140 reports
PNEUMONIA137 reports
BACK PAIN136 reports
JOINT SWELLING135 reports
ALOPECIA133 reports
DYSPEPSIA131 reports
PSORIATIC ARTHROPATHY128 reports
FALL127 reports
COVID 19125 reports
DYSGEUSIA125 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS124 reports
ATRIAL FIBRILLATION122 reports
UNDERDOSE122 reports
MATERNAL EXPOSURE DURING PREGNANCY119 reports
RHEUMATOID ARTHRITIS115 reports
TYPE 2 DIABETES MELLITUS115 reports
PRODUCT USE ISSUE114 reports
DRUG HYPERSENSITIVITY113 reports
SWELLING113 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION111 reports
MUSCULOSKELETAL PAIN111 reports
BLOOD CHOLESTEROL INCREASED107 reports
COUGH107 reports
DRUG INTOLERANCE107 reports
MYOCARDIAL INFARCTION106 reports
STOMATITIS104 reports
ACUTE KIDNEY INJURY101 reports
CHEST PAIN101 reports
DRUG INDUCED LIVER INJURY100 reports
ARTHROPATHY99 reports
CHRONIC KIDNEY DISEASE99 reports
DRUG INTERACTION97 reports
FEELING ABNORMAL97 reports
HEPATIC ENZYME INCREASED95 reports
FIBROMYALGIA94 reports
GASTROOESOPHAGEAL REFLUX DISEASE93 reports
PRODUCT SIZE ISSUE93 reports
GAIT DISTURBANCE92 reports
SCIATICA90 reports
ANXIETY89 reports
CEREBROVASCULAR ACCIDENT89 reports
PRODUCT USE IN UNAPPROVED INDICATION89 reports
ABDOMINAL PAIN88 reports
PRODUCT STORAGE ERROR88 reports
CONTUSION87 reports
OSTEOARTHRITIS87 reports
RETCHING87 reports
PRODUCT LEAKAGE86 reports
C REACTIVE PROTEIN INCREASED82 reports
CONTRAINDICATED PRODUCT ADMINISTERED82 reports
BRONCHITIS81 reports
MEMORY IMPAIRMENT81 reports

Report Outcomes

Out of 7,788 classified reports for ICOSAPENT ETHYL:

Serious 38.9%Non-Serious 61.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male3,684 (52.4%)
Female3,300 (47.0%)
Unknown44 (0.6%)

Reports by Age

Age 70195 reports
Age 69172 reports
Age 65169 reports
Age 43165 reports
Age 72164 reports
Age 73161 reports
Age 71157 reports
Age 66154 reports
Age 76153 reports
Age 64152 reports
Age 74143 reports
Age 67142 reports
Age 61139 reports
Age 68137 reports
Age 60118 reports
Age 62118 reports
Age 63111 reports
Age 75108 reports
Age 59107 reports
Age 53106 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ICOSAPENT ETHYL?

This profile reflects 18,725 FDA FAERS reports that mention ICOSAPENT ETHYL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ICOSAPENT ETHYL?

Frequently reported terms in FAERS include PRODUCT ODOUR ABNORMAL, PRODUCT PHYSICAL ISSUE, OFF LABEL USE, DIARRHOEA, DRUG INEFFECTIVE, POOR QUALITY PRODUCT ADMINISTERED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ICOSAPENT ETHYL?

Labeling and FAERS entries often list Amarin Pharma Inc. in connection with ICOSAPENT ETHYL. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.