Olmesartan Medoxomil side effects: what 35,736 FDA adverse event reports show
Drug class
Angiotensin ii receptor blocker (arb)
Who reports
35,736 reports · 65% serious · 1,618 with death outcome · 60% female
Used for
Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
What it is
Olmesartan medoxomil,USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olm.
Boxed warning
FETAL TOXICITY When pregnancy is detected, discontinue olmesartan medoxomil tablets as soon as possible ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
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 (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,143 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 |
|---|---|---|---|---|---|---|
| Sprue-like enteropathy | 3,478 | 1,419.6 1,335.7–1,508.7ROR 1,572.5 · calibrated p 1e-19 ✓ | 410.5 EB05 399.2 · IC025 +8.5 3/3 methods agree | Labeled — boxed warning exact term | serious n=3,155 | not reported in cached trials |
| Fractional exhaled nitric oxide increased | 78 | 484.7 358.8–654.8ROR 485.8 · calibrated p 3e-13 ✓ | 248.1 EB05 205.2 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=78 · ♀ 0% (drug 60%) | not reported in cached trials |
| Right atrial hypertrophy | 48 | 447.4 307.0–652.1ROR 448.0 · calibrated p 1e-12 ✓ | 229.6 EB05 180.1 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=48 · ♀ 0% (drug 60%) | not reported in cached trials |
| Reactive gastropathy | 75 | 143.1 111.1–184.2ROR 143.4 · calibrated p 1e-8 ✓ | 111.7 EB05 92.0 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=69 | not reported in cached trials |
| Intestinal villi atrophy | 83 | 141.9 111.7–180.4ROR 142.2 · calibrated p 1e-8 ✓ | 111.3 EB05 92.6 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious n=80 · 100% clinician | not reported in cached trials |
| Personality change due to a general medical condition | 24 | 138.7 88.9–216.5ROR 138.8 · calibrated p 4e-8 ✓ | 103.1 EB05 72.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% consumer | not reported in cached trials |
| Diverticulum intestinal | 656 | 104.0 95.8–113.0ROR 106.0 · calibrated p 8e-8 ✓ | 88.1 EB05 82.6 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=614 | not reported in cached trials |
| Malabsorption | 690 | 89.9 83.1–97.4ROR 91.7 · calibrated p 2e-7 ✓ | 77.8 EB05 73.0 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=447 | not reported in cached trials |
| Rectal polyp | 130 | 87.8 73.0–105.5ROR 88.1 · calibrated p 4e-7 ✓ | 75.5 EB05 65.2 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=116 | not reported in cached trials |
| Large intestine polyp | 857 | 82.8 77.1–88.9ROR 84.8 · calibrated p 4e-7 ✓ | 72.4 EB05 68.4 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=787 | not reported in cached trials |
| Acquired oesophageal web | 41 | 79.8 57.6–110.6ROR 79.9 · calibrated p 1e-6 ✓ | 68.1 EB05 52.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=40 | not reported in cached trials |
| Diverticulum | 796 | 72.9 67.7–78.4ROR 74.5 · calibrated p 1e-6 ✓ | 64.7 EB05 61.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=737 | not reported in cached trials |
| Helicobacter test positive | 54 | 62.8 47.4–83.1ROR 62.9 · calibrated p 5e-6 ✓ | 55.7 EB05 44.3 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=52 | not reported in cached trials |
| Hiatus hernia | 977 | 47.7 44.8–50.9ROR 49.1 · calibrated p 2e-5 ✓ | 44.1 EB05 41.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 41.1 | not reported in cached trials |
| Erosive duodenitis | 57 | 45.1 34.4–59.0ROR 45.1 · calibrated p 3e-5 ✓ | 41.3 EB05 33.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=52 | not reported in cached trials |
| Haemorrhoids | 1,369 | 44.2 41.8–46.6ROR 45.9 · calibrated p 2e-5 ✓ | 41.1 EB05 39.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 40.9 | not reported in cached trials |
| Bronchial wall thickening | 48 | 41.5 31.0–55.7ROR 41.6 · calibrated p 6e-5 ✓ | 38.3 EB05 30.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 0% (drug 60%) | not reported in cached trials |
| Helicobacter gastritis | 82 | 41.2 32.9–51.5ROR 41.3 · calibrated p 5e-5 ✓ | 38.2 EB05 31.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=74 | not reported in cached trials |
| Gastric polyps | 142 | 39.2 33.1–46.5ROR 39.4 · calibrated p 6e-5 ✓ | 36.6 EB05 31.8 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=129 | NCT00923091: 1/332 (0.3%) on Olmesartan Medoxomil (serious AE) |
| Colon adenoma | 58 | 36.2 27.7–47.1ROR 36.2 · calibrated p 1e-4 ✓ | 33.7 EB05 27.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=56 | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 79 | 35.1 28.0–44.1ROR 35.2 · calibrated p 1e-4 ✓ | 33.0 EB05 27.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=79 · ♀ 0% (drug 60%) | not reported in cached trials |
| Peptic ulcer | 187 | 35.0 30.2–40.5ROR 35.1 · calibrated p 1e-4 ✓ | 32.9 EB05 29.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=186 | not reported in cached trials |
| Myoglobin blood increased | 86 | 34.8 28.0–43.3ROR 34.9 · calibrated p 1e-4 ✓ | 32.7 EB05 27.3 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=86 · ♀ 0% (drug 60%) | not reported in cached trials |
| Blood immunoglobulin m increased | 33 | 33.4 23.5–47.4ROR 33.4 · calibrated p 2e-4 ✓ | 31.1 EB05 23.2 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=33 · ♀ 100% (drug 60%) | not reported in cached trials |
| Infectious colitis | 28 | 32.7 22.3–47.8ROR 32.7 · calibrated p 3e-4 ✓ | 30.4 EB05 22.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=28 | not reported in cached trials |
| Right ventricular hypertrophy | 48 | 32.6 24.4–43.6ROR 32.6 · calibrated p 2e-4 ✓ | 30.6 EB05 24.0 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=48 · ♀ 0% (drug 60%) | not reported in cached trials |
| Gallbladder polyp | 41 | 32.5 23.7–44.5ROR 32.5 · calibrated p 2e-4 ✓ | 30.4 EB05 23.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=36 | not reported in cached trials |
| Blood immunoglobulin a decreased | 33 | 31.3 22.0–44.4ROR 31.3 · calibrated p 3e-4 ✓ | 29.3 EB05 21.8 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=32 · ♀ 100% (drug 60%) | not reported in cached trials |
| Coeliac disease | 493 | 31.0 28.3–33.9ROR 31.4 · calibrated p 2e-4 ✓ | 29.4 EB05 27.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 29.8 | not reported in cached trials |
| Gastrointestinal bacterial overgrowth | 28 | 28.2 19.3–41.3ROR 28.3 · calibrated p 6e-4 ✓ | 26.5 EB05 19.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=28 | not reported in cached trials |
| Gastritis erosive | 198 | 25.9 22.5–29.9ROR 26.1 · calibrated p 6e-4 ✓ | 24.8 EB05 22.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=182 | not reported in cached trials |
| Bronchial secretion retention | 49 | 23.6 17.8–31.4ROR 23.7 · calibrated p 0.001 ✓ | 22.6 EB05 17.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 0% (drug 60%) | not reported in cached trials |
| Polyp | 245 | 22.8 20.0–25.8ROR 22.9 · calibrated p 0.001 ✓ | 21.9 EB05 19.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=226 | NCT00923091: 1/329 (0.3%) on Olmesartan Medoxomil (serious AE) |
| Aortic valve stenosis | 63 | 21.4 16.6–27.5ROR 21.4 · calibrated p 0.002 ✓ | 20.5 EB05 16.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=63 · ♀ 22% (drug 60%) | not reported in cached trials |
| Pulmonary hypoplasia | 28 | 21.4 14.7–31.2ROR 21.4 · calibrated p 0.002 ✓ | 20.4 EB05 14.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | not reported in cached trials |
| Colitis microscopic | 162 | 20.9 17.9–24.5ROR 21.0 · calibrated p 0.002 ✓ | 20.2 EB05 17.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=159 · 91% clinician | not reported in cached trials |
| Blood immunoglobulin g increased | 41 | 20.4 14.9–27.8ROR 20.4 · calibrated p 0.002 ✓ | 19.5 EB05 15.0 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=40 · ♀ 100% (drug 60%) | not reported in cached trials |
| Chronic gastritis | 73 | 19.8 15.7–25.0ROR 19.8 · calibrated p 0.002 ✓ | 19.1 EB05 15.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=54 | NCT00923091: 1/329 (0.3%) on Olmesartan Medoxomil (serious AE) |
| Pulmonary function test abnormal | 50 | 19.4 14.6–25.7ROR 19.4 · calibrated p 0.003 ✓ | 18.6 EB05 14.7 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=50 · ♀ 0% (drug 60%) | not reported in cached trials |
| Foetal disorder | 27 | 19.3 13.2–28.4ROR 19.4 · calibrated p 0.003 ✓ | 18.5 EB05 13.2 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=27 · 100% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Olmesartan Medoxomil as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (3 of 40 signal terms matched).
- NCT00923091 — Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension (N=2689, PHASE3; 79 AE terms posted; arms: Olmesartan/Amlodipine/Hydrochlorothiazid; Olmesartan/Amlodipine/Hydrochlorothiazid; Olmesartan/Amlodipine/Hydrochlorothiazid; Olmesartan/Amlodipine/Hydrochlorothiazid)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Sprue-like enteropathy | 3,478 | 1,419.6 1,335.7–1,508.7ROR 1,572.5 · calibrated p 1e-19 ✓ | 410.5 EB05 399.2 · IC025 +8.5 3/3 methods agree | Labeled — boxed warning exact term | serious n=3,155 | not reported in cached trials |
| Diarrhoea (diarrhea) | 2,478 | 2.3 2.2–2.4ROR 2.4 · calibrated p 0.875 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | not reported in cached trials |
| Weight decreased (weight loss) | 2,218 | 4.7 4.5–4.9ROR 4.9 · calibrated p 0.241 | 4.7 EB05 4.5 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 | not reported in cached trials |
| Dizziness | 2,101 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.782 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | NCT00923091: 1/329 (0.3%) on Olmesartan Medoxomil (serious AE) |
| Gastrooesophageal reflux disease (acid reflux) | 2,077 | 15.6 14.9–16.3ROR 16.5 · calibrated p 0.005 ✓ | 15.2 EB05 14.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.6 | not reported in cached trials |
| Nausea | 2,037 | 1.5 1.5–1.6ROR 1.5 · calibrated p 0.673 | 1.5 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.6 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 2,018 | 7.9 7.5–8.2ROR 8.3 · calibrated p 0.060 | 7.8 EB05 7.5 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.8 | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,972 | 0.9 0.8–0.9ROR 0.9 · calibrated p 0.226 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | not reported in cached trials |
| Fatigue (tiredness) | 1,687 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.500 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled (related wording) related wording | serious PRR 1.3 | not reported in cached trials |
| Headache | 1,410 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.532 | 1.3 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.3 | NCT00923091: 15/333 (4.5%) on Olmesartan Medoxomil |
| Haemorrhoids | 1,369 | 44.2 41.8–46.6ROR 45.9 · calibrated p 2e-5 ✓ | 41.1 EB05 39.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 40.9 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,340 | 1.4 1.3–1.5ROR 1.4 · calibrated p 0.580 | 1.4 EB05 1.3 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.2 | not reported in cached trials |
| Hypotension (low blood pressure) | 1,315 | 3.9 3.7–4.1ROR 4.0 · calibrated p 0.381 | 3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.6 | not reported in cached trials |
| Constipation | 1,306 | 3.6 3.4–3.8ROR 3.7 · calibrated p 0.449 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | not reported in cached trials |
| Vomiting | 1,203 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.658 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | not reported in cached trials |
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.
- Fractional exhaled nitric oxide increased — n=78, PRR 484.7
- Reactive gastropathy — n=75, PRR 143.1
- Personality change due to a general medical condition — n=24, PRR 138.7
- Diverticulum intestinal — n=656, PRR 104.0
- Malabsorption — n=690, PRR 89.9
- Rectal polyp — n=130, PRR 87.8
- Large intestine polyp — n=857, PRR 82.8
- Acquired oesophageal web — n=41, PRR 79.8
- Diverticulum — n=796, PRR 72.9
- Hiatus hernia — n=977, PRR 47.7
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?
In FDA FAERS, the most frequently co-reported reaction terms for Olmesartan Medoxomil are sprue-like enteropathy, diarrhoea, weight decreased, dizziness, gastrooesophageal reflux disease, nausea. 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 have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue olmesartan medoxomil tablets as soon as possible ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
Do FAERS signals prove that Olmesartan Medoxomil 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 04f0107b-4194-4412-9ebb-3219da5a9ac9, effective 20260120; matched on
openfda.generic_name.exact:"OLMESARTAN MEDOXOMIL") - 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, 1,183 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 - ClinicalTrials.gov API v2 (query
OLMESARTAN MEDOXOMIL, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.