Drug · FAERS side-effect profile with label screen

Azilsartan Kamedoxomil and Chlorthalidone side effects: what 1,253 FDA adverse event reports show

Azilsartan Kamedoxomil And Chlorthalidone · 26 reaction terms · 391 drug–reaction co-reports · data 2026-09-14

Drug class

Angiotensin ii receptor blocker

FDA label, Indications wording of the closest related product

Label matched

Azilsartan Kamedoxomil (Azilsartan Medoxomil)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,253 reports · 51% serious · 39 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Azilsartan medoxomil is indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs.

FDA label, Indications and Usage

What it is

Azilsartan medoxomil, a prodrug, is hydrolyzed to azilsartan in the gastrointestinal tract during absorption. Azilsartan is an angiotensin II receptor blocker. The drug substance used in the d.

FDA label, Description section

Boxed warning

FETAL TOXICITY When pregnancy is detected, discontinue azilsartan medoxomil as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] .

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 19 strongest signals

Labeled — boxed warning 1Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 6Lab value / disease marker 2Not in label — unassessed 7

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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 7 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Product odour abnormal	19	30.7 19.6–48.0ROR 31.1 · χ² 516 / p 2e-114	29.8 EB05 20.2 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Blood sodium decreased	34	30.3 21.7–42.2ROR 31.1 · χ² 934 / p 2e-205	29.8 EB05 22.3 · IC025 +3.8 3/3 methods agree	Likely indication confounding term in indications	serious PRR 35.1	no trial data cached
Poor venous access	16	26.0 16.0–42.3ROR 26.3 · χ² 359 / p 2e-80	25.2 EB05 16.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=16	no trial data cached
Body temperature decreased	12	20.2 11.5–35.6ROR 20.4 · χ² 201 / p 8e-46	19.3 EB05 11.2 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 25.2	no trial data cached
Hyponatraemia (low sodium)	47	14.0 10.6–18.5ROR 14.5 · χ² 556 / p 4e-123	13.8 EB05 10.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 14.4	no trial data cached
Glomerular filtration rate decreased	9	12.4 6.5–23.9ROR 12.5 · χ² 84 / p 3e-20	10.1 EB05 4.9 · IC025 +1.8 3/3 methods agree	Lab value / disease marker	serious PRR 13.4	no trial data cached
Gout	13	12.1 7.1–20.8ROR 12.2 · χ² 122 / p 1e-28	10.6 EB05 6.0 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.0	no trial data cached
Inflammatory bowel disease	7	11.9 5.7–24.9ROR 12.0 · χ² 59 / p 6e-15	8.9 EB05 3.9 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.6	no trial data cached
Poor quality product administered	7	11.5 5.5–24.0ROR 11.5 · χ² 57 / p 2e-14	8.4 EB05 3.8 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious n=1	no trial data cached
Hyperkalaemia (high potassium)	23	11.0 7.4–16.5ROR 11.2 · χ² 200 / p 1e-45	10.2 EB05 6.8 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 12.6	no trial data cached
Disease recurrence	27	9.5 6.5–13.8ROR 9.7 · χ² 197 / p 6e-45	8.7 EB05 6.1 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 19.4 · ♀ 93% (drug 56%)	no trial data cached
Blood pressure increased	72	7.9 6.3–9.8ROR 8.3 · χ² 428 / p 3e-95	7.6 EB05 6.2 · IC025 +2.5 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 9.1	no trial data cached
Product packaging quantity issue	5	7.7 3.2–18.4ROR 7.7 · χ² 23 / p 9e-7	5.0 EB05 2.3 · IC025 +0.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Hypertensive crisis	5	7.5 3.1–18.0ROR 7.5 · χ² 22 / p 1e-6	4.9 EB05 2.2 · IC025 +0.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 8.4	no trial data cached
Product dispensing error	9	6.9 3.6–13.3ROR 7.0 · χ² 40 / p 1e-10	5.3 EB05 3.0 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Erectile dysfunction	9	5.9 3.1–11.2ROR 5.9 · χ² 32 / p 1e-8	4.6 EB05 2.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Prescribed underdose	6	5.0 2.3–11.2ROR 5.1 · χ² 16 / p 4e-5	3.8 EB05 1.9 · IC025 +0.5	Not in label — unassessed	serious PRR 1.6	no trial data cached
Wrong technique in product usage process	35	2.9 2.1–4.0ROR 3.0 · χ² 42 / p 4e-11	2.8 EB05 2.1 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.2	no trial data cached
Product storage error	11	2.1 1.2–3.8ROR 2.1 · χ² 6 / p 0.009	2.0 EB05 1.2 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 2.3	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Blood pressure increased	72	7.9 6.3–9.8ROR 8.3 · χ² 428 / p 3e-95	7.6 EB05 6.2 · IC025 +2.5 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 9.1	no trial data cached
Hyponatraemia (low sodium)	47	14.0 10.6–18.5ROR 14.5 · χ² 556 / p 4e-123	13.8 EB05 10.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 14.4	no trial data cached
Wrong technique in product usage process	35	2.9 2.1–4.0ROR 3.0 · χ² 42 / p 4e-11	2.8 EB05 2.1 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.2	no trial data cached
Blood sodium decreased	34	30.3 21.7–42.2ROR 31.1 · χ² 934 / p 2e-205	29.8 EB05 22.3 · IC025 +3.8 3/3 methods agree	Likely indication confounding term in indications	serious PRR 35.1	no trial data cached
Disease recurrence	27	9.5 6.5–13.8ROR 9.7 · χ² 197 / p 6e-45	8.7 EB05 6.1 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 19.4 · ♀ 93% (drug 56%)	no trial data cached
Hyperkalaemia (high potassium)	23	11.0 7.4–16.5ROR 11.2 · χ² 200 / p 1e-45	10.2 EB05 6.8 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 12.6	no trial data cached
Product odour abnormal	19	30.7 19.6–48.0ROR 31.1 · χ² 516 / p 2e-114	29.8 EB05 20.2 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Poor venous access	16	26.0 16.0–42.3ROR 26.3 · χ² 359 / p 2e-80	25.2 EB05 16.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=16	no trial data cached
Gout	13	12.1 7.1–20.8ROR 12.2 · χ² 122 / p 1e-28	10.6 EB05 6.0 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.0	no trial data cached
Body temperature decreased	12	20.2 11.5–35.6ROR 20.4 · χ² 201 / p 8e-46	19.3 EB05 11.2 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 25.2	no trial data cached
Product storage error	11	2.1 1.2–3.8ROR 2.1 · χ² 6 / p 0.009	2.0 EB05 1.2 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 2.3	no trial data cached
Erectile dysfunction	9	5.9 3.1–11.2ROR 5.9 · χ² 32 / p 1e-8	4.6 EB05 2.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Product dispensing error	9	6.9 3.6–13.3ROR 7.0 · χ² 40 / p 1e-10	5.3 EB05 3.0 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Glomerular filtration rate decreased	9	12.4 6.5–23.9ROR 12.5 · χ² 84 / p 3e-20	10.1 EB05 4.9 · IC025 +1.8 3/3 methods agree	Lab value / disease marker	serious PRR 13.4	no trial data cached
Poor quality product administered	7	11.5 5.5–24.0ROR 11.5 · χ² 57 / p 2e-14	8.4 EB05 3.8 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious n=1	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.

Hyponatraemia — n=47, PRR 14.0
Hyperkalaemia — n=23, PRR 11.0

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 Azilsartan Kamedoxomil and Chlorthalidone?

In FDA FAERS, the most frequently co-reported reaction terms for Azilsartan Kamedoxomil and Chlorthalidone are blood pressure increased, hyponatraemia, blood sodium decreased, hyperkalaemia, poor venous access, gout. 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 Azilsartan Kamedoxomil and Chlorthalidone have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue azilsartan medoxomil as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] .

Do FAERS signals prove that Azilsartan Kamedoxomil and Chlorthalidone 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 c09103d8-c094-473d-a303-bbb4f334aa8c, effective 20260420; matched on openfda.generic_name.exact:"AZILSARTAN KAMEDOXOMIL")
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, field patient.drug.openfda.generic_name.exact, 26 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.