Amlodipine and Olmesartan Medoxomil side effects: what 2,504 FDA adverse event reports show
Drug class
Calcium channel blocker and may be
Label matched
Amlodipine (Katerzia)
Who reports
2,504 reports · 58% serious · 90 with death outcome · 54% female
Used for
KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: Hypertension ( 1.1 ) KATERZIA is indicated for the treatment of hypertension in adults and children 6 years and older, to lower blood pressure.
What it is
KATERZIA oral suspension contains 1.30 mg/mL amlodipine benzoate, equivalent to 1 mg/mL amlodipine, a long-acting calcium channel blocker. Amlodipine benzoate is chemically described as 3-Ethy.
Boxed warning
None in the current label
Causality screen of the 35 strongest signals
What the badges mean
- 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.
- 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.
- 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. 65 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 | 93 | 60.5 49.5–73.9ROR 62.7 · χ² 5,343 / p <1e-300 | 59.3 EB05 49.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 60.9 | no trial data cached |
| Haemorrhoids | 133 | 57.4 48.6–67.7ROR 60.5 · χ² 7,267 / p <1e-300 | 56.5 EB05 48.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 62.1 | no trial data cached |
| Coeliac disease | 32 | 27.4 19.4–38.7ROR 27.7 · χ² 785 / p 5e-173 | 26.9 EB05 20.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 30.5 | no trial data cached |
| Irritable bowel syndrome | 67 | 26.3 20.8–33.4ROR 27.0 · χ² 1,604 / p <1e-300 | 26.1 EB05 21.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 26.1 | no trial data cached |
| Diverticulitis | 75 | 22.8 18.2–28.5ROR 23.5 · χ² 1,538 / p <1e-300 | 22.6 EB05 18.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 210 | 22.0 19.3–25.0ROR 23.9 · χ² 4,191 / p <1e-300 | 21.9 EB05 19.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 28.5 | no trial data cached |
| Gastric ulcer | 40 | 17.6 13.0–24.0ROR 17.9 · χ² 610 / p 5e-135 | 17.4 EB05 13.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 | no trial data cached |
| Helicobacter infection | 17 | 14.0 8.7–22.5ROR 14.1 · χ² 192 / p 6e-44 | 13.1 EB05 8.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Chronic kidney disease | 126 | 13.8 11.6–16.3ROR 14.5 · χ² 1,484 / p <1e-300 | 13.7 EB05 11.8 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 13.8 | no trial data cached |
| End stage renal disease | 30 | 13.7 9.6–19.5ROR 13.8 · χ² 339 / p 5e-76 | 13.3 EB05 9.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Product administration error | 31 | 13.0 9.2–18.5ROR 13.2 · χ² 332 / p 2e-74 | 12.6 EB05 9.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 26.4 | no trial data cached |
| Cholecystitis | 16 | 11.3 6.9–18.4ROR 11.4 · χ² 140 / p 1e-32 | 10.0 EB05 6.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Cholelithiasis | 43 | 11.0 8.2–14.8ROR 11.2 · χ² 381 / p 4e-85 | 10.6 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Gastroenteritis | 18 | 10.4 6.5–16.4ROR 10.4 · χ² 143 / p 3e-33 | 9.2 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Clostridium difficile colitis | 13 | 10.3 6.0–17.7ROR 10.3 · χ² 100 / p 1e-23 | 8.6 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Small intestinal obstruction | 15 | 10.2 6.2–17.0ROR 10.3 · χ² 116 / p 2e-27 | 8.8 EB05 5.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Impaired gastric emptying | 15 | 9.9 6.0–16.3ROR 9.9 · χ² 111 / p 4e-26 | 8.5 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 169 | 9.3 8.0–10.8ROR 9.9 · χ² 1,252 / p 2e-274 | 9.2 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Drug administration error | 31 | 8.3 5.9–11.8ROR 8.4 · χ² 193 / p 3e-44 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 17.2 | no trial data cached |
| Gastroenteritis viral | 17 | 7.9 4.9–12.6ROR 7.9 · χ² 95 / p 9e-23 | 6.8 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Flushing | 93 | 7.6 6.3–9.3ROR 7.9 · χ² 531 / p 7e-118 | 7.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 · 87% consumer | no trial data cached |
| Gastritis | 23 | 7.3 4.9–11.0ROR 7.4 · χ² 120 / p 4e-28 | 6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Tubulointerstitial nephritis | 14 | 6.3 3.7–10.6ROR 6.3 · χ² 57 / p 2e-14 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Rectal haemorrhage | 31 | 6.0 4.2–8.5ROR 6.1 · χ² 125 / p 2e-29 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Pancreatitis acute | 15 | 5.6 3.4–9.3ROR 5.7 · χ² 53 / p 2e-13 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Renal injury | 20 | 5.6 3.6–8.6ROR 5.6 · χ² 71 / p 2e-17 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 80 | 5.5 4.4–6.8ROR 5.6 · χ² 290 / p 2e-65 | 5.3 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Hepatic steatosis | 12 | 5.4 3.1–9.5ROR 5.4 · χ² 39 / p 2e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Renal failure (kidney failure) | 83 | 5.2 4.2–6.4ROR 5.3 · χ² 279 / p 7e-63 | 5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Syncope (fainting) | 61 | 5.1 4.0–6.5ROR 5.2 · χ² 198 / p 3e-45 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Weight decreased (weight loss) | 167 | 5.0 4.3–5.8ROR 5.3 · χ² 540 / p 1e-119 | 4.9 EB05 4.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Gastrointestinal haemorrhage | 49 | 4.9 3.7–6.4ROR 5.0 · χ² 148 / p 2e-34 | 4.7 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Haematochezia (blood in stool) | 27 | 4.1 2.8–6.0ROR 4.1 · χ² 60 / p 4e-15 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Feeling hot | 28 | 3.8 2.6–5.5ROR 3.9 · χ² 56 / p 4e-14 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 0.9 · 75% consumer | no trial data cached |
| Coronary artery disease | 12 | 3.3 1.9–5.8ROR 3.3 · χ² 17 / p 2e-5 | 3.0 EB05 1.9 · IC025 +0.6 | Likely indication confounding term in indications; also in warnings | serious PRR 3.3 | 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) | 210 | 22.0 19.3–25.0ROR 23.9 · χ² 4,191 / p <1e-300 | 21.9 EB05 19.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 28.5 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 169 | 9.3 8.0–10.8ROR 9.9 · χ² 1,252 / p 2e-274 | 9.2 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Weight decreased (weight loss) | 167 | 5.0 4.3–5.8ROR 5.3 · χ² 540 / p 1e-119 | 4.9 EB05 4.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Haemorrhoids | 133 | 57.4 48.6–67.7ROR 60.5 · χ² 7,267 / p <1e-300 | 56.5 EB05 48.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 62.1 | no trial data cached |
| Chronic kidney disease | 126 | 13.8 11.6–16.3ROR 14.5 · χ² 1,484 / p <1e-300 | 13.7 EB05 11.8 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 13.8 | no trial data cached |
| Flushing | 93 | 7.6 6.3–9.3ROR 7.9 · χ² 531 / p 7e-118 | 7.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 · 87% consumer | no trial data cached |
| Hiatus hernia | 93 | 60.5 49.5–73.9ROR 62.7 · χ² 5,343 / p <1e-300 | 59.3 EB05 49.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 60.9 | no trial data cached |
| Renal failure (kidney failure) | 83 | 5.2 4.2–6.4ROR 5.3 · χ² 279 / p 7e-63 | 5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 80 | 5.5 4.4–6.8ROR 5.6 · χ² 290 / p 2e-65 | 5.3 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Diverticulitis | 75 | 22.8 18.2–28.5ROR 23.5 · χ² 1,538 / p <1e-300 | 22.6 EB05 18.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 | no trial data cached |
| Irritable bowel syndrome | 67 | 26.3 20.8–33.4ROR 27.0 · χ² 1,604 / p <1e-300 | 26.1 EB05 21.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 26.1 | no trial data cached |
| Syncope (fainting) | 61 | 5.1 4.0–6.5ROR 5.2 · χ² 198 / p 3e-45 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Gastrointestinal haemorrhage | 49 | 4.9 3.7–6.4ROR 5.0 · χ² 148 / p 2e-34 | 4.7 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Cholelithiasis | 43 | 11.0 8.2–14.8ROR 11.2 · χ² 381 / p 4e-85 | 10.6 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Gastric ulcer | 40 | 17.6 13.0–24.0ROR 17.9 · χ² 610 / p 5e-135 | 17.4 EB05 13.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 | 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=93, PRR 60.5
- Haemorrhoids — n=133, PRR 57.4
- Coeliac disease — n=32, PRR 27.4
- Irritable bowel syndrome — n=67, PRR 26.3
- Diverticulitis — n=75, PRR 22.8
- Gastrooesophageal reflux disease — n=210, PRR 22.0
- Gastric ulcer — n=40, PRR 17.6
- End stage renal disease — n=30, PRR 13.7
- Cholelithiasis — n=43, PRR 11.0
- Acute kidney injury — n=169, PRR 9.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Amlodipine (dihydropyridine CCBs) ↔ Peripheral oedema.
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 Amlodipine and Olmesartan Medoxomil?
In FDA FAERS, the most frequently co-reported reaction terms for Amlodipine and Olmesartan Medoxomil are gastrooesophageal reflux disease, acute kidney injury, weight decreased, haemorrhoids, chronic kidney disease, flushing. 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 Amlodipine and Olmesartan Medoxomil have an FDA boxed warning?
No. The FDA label retrieved for Amlodipine and Olmesartan Medoxomil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Amlodipine and 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 df673a4d-acb8-444c-a472-c87ab8cbd366, effective 20251216; matched on
openfda.generic_name.exact:"AMLODIPINE") - 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, 100 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.