Drug

Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide

36 flagged reaction(s) · 798 total co-reports · max PRR 66.3

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	Haemorrhoids	76	66.3	70.6	signal
2	Hiatus Hernia	49	64.4	67.0	signal
3	Coeliac Disease	20	34.7	35.2	signal
4	Irritable Bowel Syndrome	41	32.6	33.7	signal
5	Gastrooesophageal Reflux Disease	141	29.9	33.6	signal
6	Diverticulitis	41	25.2	26.1	signal
7	Helicobacter Infection	12	20.0	20.2	signal
8	Cholecystitis	13	18.6	18.8	signal
9	Gastric Ulcer	18	16.1	16.3	signal
10	Chronic Kidney Disease	72	16.0	16.9	signal
11	Hepatic Steatosis	17	15.5	15.7	signal
12	Gastroenteritis Viral	15	14.1	14.2	signal
13	Acute Kidney Injury	105	11.7	12.7	signal
14	Hair Texture Abnormal	9	11.3	11.4	signal
15	Hair Colour Changes	8	10.8	10.9	signal
16	Impaired Gastric Emptying	8	10.7	10.7	signal
17	Gastroenteritis	9	10.5	10.6	signal
18	Product Administration Error	12	10.2	10.3	signal
19	Madarosis	7	10.2	10.2	signal
20	Rectal Haemorrhage	25	9.9	10.0	signal
21	Small Intestinal Obstruction	7	9.7	9.7	signal
22	Oesophagitis	6	9.3	9.4	signal
23	Pancreatitis Acute	12	9.1	9.2	signal
24	Cholelithiasis	17	8.8	8.9	signal
25	Inflammatory Bowel Disease	5	8.6	8.7	signal
26	Blood Count Abnormal	7	7.7	7.8	signal
27	Diarrhoea Haemorrhagic	4	7.3	7.3	signal
28	Knee Operation	4	7.0	7.0	signal
29	Rotator Cuff Syndrome	5	6.6	6.6	signal
30	Drug Administration Error	11	6.0	6.0	signal
31	Cholecystectomy	4	6.0	6.0	signal
32	Local Swelling	6	5.8	5.8	signal
33	Drug Dispensing Error	3	3.3	3.3	no signal
34	Product Adhesion Issue	3	1.4	1.4	no signal
35	Device Breakage	3	1.3	1.3	no signal
36	Renal Cancer	3	1.1	1.1	no signal