Drug

Icosapent Ethyl Capsules

37 flagged reaction(s) · 342 total co-reports · max PRR 21.1

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Poor Quality Product Administered	12	21.1	21.3	signal
2	Hypomagnesaemia	15	19.5	19.7	signal
3	Product Odour Abnormal	10	17.3	17.5	signal
4	Blood Triglycerides Increased	17	17.3	17.5	signal
5	Myocarditis	9	14.3	14.4	signal
6	Gastric Ulcer	14	13.2	13.4	signal
7	Iron Deficiency Anaemia	6	11.8	11.8	signal
8	Pulmonary Arterial Hypertension	9	11.1	11.2	signal
9	Maternal Exposure During Pregnancy	52	10.6	11.1	signal
10	Neuroleptic Malignant Syndrome	7	10.6	10.6	signal
11	Adrenal Insufficiency	7	10.5	10.6	signal
12	Cerebral Infarction	14	10.3	10.4	signal
13	Joint Dislocation	6	10.3	10.3	signal
14	Hepatic Function Abnormal	19	9.2	9.4	signal
15	Prescribed Underdose	10	9.0	9.1	signal
16	Helicobacter Infection	5	8.8	8.9	signal
17	Folliculitis	5	8.7	8.7	signal
18	Interstitial Lung Disease	23	8.6	8.7	signal
19	Product Physical Issue	9	8.1	8.2	signal
20	Product Taste Abnormal	6	8.0	8.1	signal
21	Lower Limb Fracture	8	7.5	7.6	signal
22	Hip Arthroplasty	6	7.1	7.1	signal
23	Eructation	7	6.6	6.7	signal
24	Cytokine Release Syndrome	7	6.6	6.6	signal
25	Serotonin Syndrome	7	6.6	6.6	signal
26	Pemphigus	4	5.8	5.8	signal
27	Hand Deformity	4	5.5	5.5	signal
28	Pneumocystis Jirovecii Pneumonia	3	5.4	5.4	signal
29	Toxic Skin Eruption	3	5.3	5.4	signal
30	Glycosylated Haemoglobin Increased	7	5.0	5.0	signal
31	Synovitis	4	4.0	4.0	signal
32	Diabetic Ketoacidosis	5	3.8	3.8	signal
33	Osteonecrosis Of Jaw	5	3.6	3.6	signal
34	Pregnancy	4	3.6	3.6	signal
35	Premature Delivery	3	3.4	3.4	no signal
36	Psoriatic Arthropathy	7	3.1	3.1	signal
37	Device Difficult To Use	3	0.8	0.8	no signal