Olmesartan Medoxomil-Hydrochlorothiazide side effects: what 7,404 FDA adverse event reports show
Who reports
7,404 reports · 69% serious · 178 with death outcome · 64% female
Used for
Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions.
What it is
Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, USP, and a thiazide diuretic, hydrochlorothiazide (HCTZ).
Boxed warning
FETAL TOXICITY When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide as soon as possible [see Warnings and Precautions (5.1 ), Use in Specific Populations (8.1) ]. Drugs that act direct.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 301 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hiatus hernia | 668 | 153.8 142.7–165.7ROR 168.9 · χ² 96,017 / p <1e-300 | 145.2 EB05 136.2 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 129.7 | no trial data cached |
| Haemorrhoids | 974 | 148.6 139.9–157.8ROR 170.9 · χ² 135,555 / p <1e-300 | 140.7 EB05 133.5 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 134.3 | no trial data cached |
| Coeliac disease | 318 | 94.8 85.0–105.8ROR 99.0 · χ² 28,473 / p <1e-300 | 91.2 EB05 83.1 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 89.4 | no trial data cached |
| Irritable bowel syndrome | 469 | 63.6 58.2–69.4ROR 67.8 · χ² 28,200 / p <1e-300 | 62.0 EB05 57.4 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 58.3 | no trial data cached |
| Diverticulitis | 593 | 62.1 57.4–67.1ROR 67.4 · χ² 34,860 / p <1e-300 | 60.7 EB05 56.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 53.4 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 1,357 | 48.7 46.4–51.2ROR 59.5 · χ² 62,564 / p <1e-300 | 47.9 EB05 45.8 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 56.3 | no trial data cached |
| Product administration error | 221 | 31.7 27.8–36.1ROR 32.6 · χ² 6,473 / p <1e-300 | 31.3 EB05 28.0 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 56.4 | no trial data cached |
| Gastric ulcer | 190 | 28.5 24.8–32.9ROR 29.3 · χ² 4,976 / p <1e-300 | 28.2 EB05 25.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 24.8 | no trial data cached |
| Inflammatory bowel disease | 77 | 22.3 17.9–27.9ROR 22.6 · χ² 1,536 / p <1e-300 | 22.1 EB05 18.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.8 | no trial data cached |
| Impaired gastric emptying | 99 | 22.2 18.2–27.0ROR 22.4 · χ² 1,964 / p <1e-300 | 21.9 EB05 18.5 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.3 | no trial data cached |
| Gastroenteritis | 112 | 21.9 18.2–26.4ROR 22.2 · χ² 2,200 / p <1e-300 | 21.7 EB05 18.5 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.4 | no trial data cached |
| Cholecystitis | 91 | 21.8 17.8–26.8ROR 22.1 · χ² 1,777 / p <1e-300 | 21.6 EB05 18.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.2 | no trial data cached |
| Helicobacter infection | 74 | 20.7 16.5–26.0ROR 20.9 · χ² 1,358 / p 1e-297 | 20.5 EB05 16.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 | no trial data cached |
| Small intestinal obstruction | 81 | 18.8 15.1–23.4ROR 19.0 · χ² 1,340 / p 1e-293 | 18.6 EB05 15.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.6 | no trial data cached |
| Clostridium difficile colitis | 69 | 18.5 14.6–23.4ROR 18.7 · χ² 1,119 / p 1e-245 | 18.3 EB05 14.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 985 | 18.4 17.4–19.5ROR 21.1 · χ² 16,231 / p <1e-300 | 18.3 EB05 17.4 · IC025 +4.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 15.2 | no trial data cached |
| Cholelithiasis | 204 | 17.7 15.5–20.3ROR 18.2 · χ² 3,186 / p <1e-300 | 17.6 EB05 15.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 | no trial data cached |
| Oesophagitis | 67 | 17.4 13.7–22.2ROR 17.6 · χ² 1,017 / p 2e-223 | 17.3 EB05 14.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 | no trial data cached |
| Hepatic steatosis | 103 | 15.8 13.0–19.1ROR 16.0 · χ² 1,402 / p <1e-300 | 15.6 EB05 13.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Gastritis | 140 | 15.2 12.9–17.9ROR 15.4 · χ² 1,829 / p <1e-300 | 15.0 EB05 13.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · ♀ 86% (drug 64%) | no trial data cached |
| Gastroenteritis viral | 93 | 14.6 11.9–17.9ROR 14.8 · χ² 1,161 / p 9e-255 | 14.5 EB05 12.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.4 | no trial data cached |
| Rectal haemorrhage | 189 | 12.5 10.8–14.4ROR 12.8 · χ² 1,977 / p <1e-300 | 12.4 EB05 10.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Ileus | 53 | 12.2 9.4–16.0ROR 12.3 · χ² 534 / p 2e-118 | 11.9 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Chronic kidney disease | 318 | 11.8 10.6–13.1ROR 12.3 · χ² 3,129 / p <1e-300 | 11.7 EB05 10.7 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 | no trial data cached |
| Drug administration error | 116 | 10.6 8.8–12.7ROR 10.7 · χ² 996 / p 8e-219 | 10.4 EB05 8.9 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 19.3 | no trial data cached |
| Pancreatitis acute | 80 | 10.2 8.2–12.7ROR 10.3 · χ² 652 / p 4e-144 | 9.9 EB05 8.2 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.5 | no trial data cached |
| Cholecystectomy | 36 | 9.0 6.5–12.5ROR 9.0 · χ² 247 / p 5e-56 | 8.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Iron deficiency anaemia | 28 | 8.7 6.0–12.5ROR 8.7 · χ² 181 / p 1e-41 | 7.9 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Syncope (fainting) | 299 | 8.5 7.6–9.5ROR 8.8 · χ² 1,969 / p <1e-300 | 8.4 EB05 7.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Constipation | 640 | 8.4 7.8–9.0ROR 9.1 · χ² 4,194 / p <1e-300 | 8.3 EB05 7.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Gallbladder disorder | 49 | 7.8 5.9–10.3ROR 7.8 · χ² 282 / p 2e-63 | 7.3 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Vitamin d deficiency | 26 | 7.6 5.2–11.1ROR 7.6 · χ² 141 / p 6e-33 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Malnutrition | 29 | 7.4 5.1–10.7ROR 7.4 · χ² 154 / p 1e-35 | 6.7 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Gastrointestinal haemorrhage | 217 | 7.3 6.4–8.4ROR 7.5 · χ² 1,180 / p 5e-259 | 7.2 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 33% (drug 64%) | no trial data cached |
| Weight decreased (weight loss) | 703 | 7.2 6.7–7.7ROR 7.8 · χ² 3,754 / p <1e-300 | 7.1 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.0 | no trial data cached |
| Colitis ulcerative | 107 | 6.8 5.6–8.2ROR 6.9 · χ² 524 / p 3e-116 | 6.6 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Appendicitis | 22 | 6.7 4.4–10.2ROR 6.7 · χ² 101 / p 4e-24 | 6.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Haematemesis (vomiting blood) | 60 | 6.7 5.2–8.6ROR 6.7 · χ² 285 / p 3e-64 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Presyncope (near-fainting) | 56 | 6.6 5.1–8.5ROR 6.6 · χ² 258 / p 2e-58 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Haematochezia (blood in stool) | 118 | 6.1 5.1–7.3ROR 6.2 · χ² 495 / p 5e-110 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Gastrooesophageal reflux disease (acid reflux) | 1,357 | 48.7 46.4–51.2ROR 59.5 · χ² 62,564 / p <1e-300 | 47.9 EB05 45.8 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 56.3 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 985 | 18.4 17.4–19.5ROR 21.1 · χ² 16,231 / p <1e-300 | 18.3 EB05 17.4 · IC025 +4.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 15.2 | no trial data cached |
| Haemorrhoids | 974 | 148.6 139.9–157.8ROR 170.9 · χ² 135,555 / p <1e-300 | 140.7 EB05 133.5 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 134.3 | no trial data cached |
| Weight decreased (weight loss) | 703 | 7.2 6.7–7.7ROR 7.8 · χ² 3,754 / p <1e-300 | 7.1 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.0 | no trial data cached |
| Hiatus hernia | 668 | 153.8 142.7–165.7ROR 168.9 · χ² 96,017 / p <1e-300 | 145.2 EB05 136.2 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 129.7 | no trial data cached |
| Constipation | 640 | 8.4 7.8–9.0ROR 9.1 · χ² 4,194 / p <1e-300 | 8.3 EB05 7.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Dizziness | 594 | 3.4 3.1–3.7ROR 3.6 · χ² 1,017 / p 2e-223 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Diverticulitis | 593 | 62.1 57.4–67.1ROR 67.4 · χ² 34,860 / p <1e-300 | 60.7 EB05 56.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 53.4 | no trial data cached |
| Diarrhoea (diarrhea) | 583 | 2.6 2.4–2.8ROR 2.7 · χ² 574 / p 4e-127 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Irritable bowel syndrome | 469 | 63.6 58.2–69.4ROR 67.8 · χ² 28,200 / p <1e-300 | 62.0 EB05 57.4 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 58.3 | no trial data cached |
| Hypotension (low blood pressure) | 422 | 6.0 5.4–6.6ROR 6.3 · χ² 1,757 / p <1e-300 | 5.9 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.2 | no trial data cached |
| Nausea | 404 | 1.5 1.3–1.6ROR 1.5 · χ² 58 / p 1e-14 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Chronic kidney disease | 318 | 11.8 10.6–13.1ROR 12.3 · χ² 3,129 / p <1e-300 | 11.7 EB05 10.7 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 | no trial data cached |
| Coeliac disease | 318 | 94.8 85.0–105.8ROR 99.0 · χ² 28,473 / p <1e-300 | 91.2 EB05 83.1 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 89.4 | no trial data cached |
| Syncope (fainting) | 299 | 8.5 7.6–9.5ROR 8.8 · χ² 1,969 / p <1e-300 | 8.4 EB05 7.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Hiatus hernia — n=668, PRR 153.8
- Haemorrhoids — n=974, PRR 148.6
- Coeliac disease — n=318, PRR 94.8
- Irritable bowel syndrome — n=469, PRR 63.6
- Diverticulitis — n=593, PRR 62.1
- Gastrooesophageal reflux disease — n=1,357, PRR 48.7
- Gastric ulcer — n=190, PRR 28.5
- Inflammatory bowel disease — n=77, PRR 22.3
- Cholecystitis — n=91, PRR 21.8
- Helicobacter infection — n=74, PRR 20.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Hydrochlorothiazide (thiazides) ↔ Hyponatraemia.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Olmesartan Medoxomil-Hydrochlorothiazide?
In FDA FAERS, the most frequently co-reported reaction terms for Olmesartan Medoxomil-Hydrochlorothiazide are gastrooesophageal reflux disease, acute kidney injury, haemorrhoids, weight decreased, hiatus hernia, constipation. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Olmesartan Medoxomil-Hydrochlorothiazide have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide as soon as possible [see Warnings and Precautions (5.1 ), Use in Specific Populations (8.1) ]. Drugs that act direct.
Do FAERS signals prove that Olmesartan Medoxomil-Hydrochlorothiazide causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID c8197eea-e990-4c0e-bc2d-f080bac8de17, effective 20250926; matched on
openfda.generic_name.exact:"OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 341 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.