OMEGA 3 ACID ETHYL ESTERS

N/A

Manufactured by Waylis Therapeutics LLC

27,867 FDA adverse event reports analyzed

Last updated: 2026-04-14

About OMEGA 3 ACID ETHYL ESTERS

OMEGA 3 ACID ETHYL ESTERS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Waylis Therapeutics LLC. The most commonly reported adverse reactions for OMEGA 3 ACID ETHYL ESTERS include FLUSHING, NAUSEA, FATIGUE, DRUG INEFFECTIVE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OMEGA 3 ACID ETHYL ESTERS.

Top Adverse Reactions

FLUSHING1,030 reports
NAUSEA853 reports
FATIGUE783 reports
DRUG INEFFECTIVE781 reports
DIARRHOEA743 reports
HEADACHE656 reports
PRURITUS649 reports
PAIN632 reports
DIZZINESS623 reports
DYSPNOEA555 reports
ARTHRALGIA458 reports
PAIN IN EXTREMITY446 reports
MALAISE443 reports
PRODUCT QUALITY ISSUE435 reports
ASTHENIA430 reports
OFF LABEL USE405 reports
BACK PAIN392 reports
VOMITING371 reports
BLOOD GLUCOSE INCREASED370 reports
RASH369 reports
FALL366 reports
ABDOMINAL DISCOMFORT346 reports
CHEST PAIN345 reports
FEELING HOT341 reports
CHRONIC KIDNEY DISEASE337 reports
INSOMNIA336 reports
WEIGHT DECREASED333 reports
ANXIETY330 reports
PARAESTHESIA329 reports
MYALGIA323 reports
DEPRESSION298 reports
ERYTHEMA298 reports
CONSTIPATION291 reports
RENAL FAILURE290 reports
ABDOMINAL PAIN UPPER286 reports
BLOOD TRIGLYCERIDES INCREASED272 reports
WEIGHT INCREASED270 reports
COUGH268 reports
ERUCTATION265 reports
DYSGEUSIA260 reports
FEELING ABNORMAL253 reports
HYPERTENSION251 reports
ACUTE KIDNEY INJURY250 reports
DYSPEPSIA244 reports
PNEUMONIA241 reports
MUSCLE SPASMS240 reports
GAIT DISTURBANCE234 reports
PYREXIA232 reports
DECREASED APPETITE228 reports
ABDOMINAL PAIN217 reports
DEATH214 reports
GASTROOESOPHAGEAL REFLUX DISEASE214 reports
OEDEMA PERIPHERAL214 reports
BLOOD CHOLESTEROL INCREASED211 reports
MYOCARDIAL INFARCTION204 reports
INJECTION SITE PAIN203 reports
THERAPEUTIC RESPONSE UNEXPECTED196 reports
BLOOD PRESSURE INCREASED195 reports
DRUG DOSE OMISSION193 reports
ANAEMIA180 reports
SOMNOLENCE179 reports
ATRIAL FIBRILLATION178 reports
HYPERHIDROSIS176 reports
HYPOTENSION176 reports
ABDOMINAL DISTENSION175 reports
URINARY TRACT INFECTION175 reports
HYPOAESTHESIA173 reports
PALPITATIONS170 reports
FLATULENCE169 reports
CONDITION AGGRAVATED161 reports
DRUG HYPERSENSITIVITY161 reports
ALOPECIA158 reports
URTICARIA155 reports
CEREBROVASCULAR ACCIDENT152 reports
CONTUSION152 reports
MUSCULAR WEAKNESS152 reports
CHEST DISCOMFORT150 reports
CHILLS150 reports
DEHYDRATION150 reports
PRODUCT ODOUR ABNORMAL149 reports
DIABETES MELLITUS148 reports
TREMOR148 reports
GASTROINTESTINAL HAEMORRHAGE141 reports
HEPATIC ENZYME INCREASED140 reports
ARTHRITIS135 reports
BURNING SENSATION135 reports
VISION BLURRED135 reports
HYPERSENSITIVITY134 reports
NASOPHARYNGITIS133 reports
SINUSITIS130 reports
HOT FLUSH126 reports
DRY MOUTH124 reports
HEART RATE INCREASED123 reports
SKIN BURNING SENSATION123 reports
MEMORY IMPAIRMENT122 reports
INFLUENZA LIKE ILLNESS121 reports
SYNCOPE121 reports
BRONCHITIS116 reports
DRUG INTERACTION116 reports
LOSS OF CONSCIOUSNESS113 reports

Report Outcomes

Out of 15,230 classified reports for OMEGA 3 ACID ETHYL ESTERS:

Serious 47.9%Non-Serious 52.1%

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

Female7,376 (51.8%)
Male6,803 (47.8%)
Unknown60 (0.4%)

Reports by Age

Age 64270 reports
Age 60239 reports
Age 63238 reports
Age 62235 reports
Age 59234 reports
Age 67230 reports
Age 70230 reports
Age 61225 reports
Age 65219 reports
Age 57214 reports
Age 56213 reports
Age 69209 reports
Age 68204 reports
Age 55201 reports
Age 66195 reports
Age 52187 reports
Age 74184 reports
Age 71183 reports
Age 58182 reports
Age 54179 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 OMEGA 3 ACID ETHYL ESTERS?

This profile reflects 27,867 FDA FAERS reports that mention OMEGA 3 ACID ETHYL ESTERS. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for OMEGA 3 ACID ETHYL ESTERS?

Frequently reported terms in FAERS include FLUSHING, NAUSEA, FATIGUE, DRUG INEFFECTIVE, DIARRHOEA, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures OMEGA 3 ACID ETHYL ESTERS?

Labeling and FAERS entries often list Waylis Therapeutics LLC in connection with OMEGA 3 ACID ETHYL ESTERS. 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.