Drug · FAERS side-effect profile with label screen

Atenolol and Chlorthalidone side effects: what 753 FDA adverse event reports show

Atenolol And Chlorthalidone · 23 reaction terms · 570 drug–reaction co-reports · data 2026-09-14

Drug class

beta-Adrenergic Blocker

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Atenolol (Atenolol)

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

Who reports

753 reports · 70% serious · 61 with death outcome · 66% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Hypertension Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol.

FDA label, Indications and Usage

What it is

DESCRIPTION Atenolol, USP, a synthetic, beta 1 -selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are: Atenolol (free base) has a molecular weight of 266.34.

FDA label, Description section

Boxed warning

None in the current 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 16 strongest signals

Labeled adverse reaction 1Labeled (related wording) 4Reporting / coding artifact 3Outcome field, not a reaction 1Not in label — unassessed 7

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.
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.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
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
Hepatic steatosis	49	73.5 56.1–96.4ROR 78.6 · χ² 3,427 / p <1e-300	71.4 EB05 56.1 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 68.6 · ♀ 100% (drug 66%)	no trial data cached
Contraindicated product administered	47	43.5 32.9–57.3ROR 46.3 · χ² 1,907 / p <1e-300	42.7 EB05 33.4 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious PRR 44.4 · ♀ 100% (drug 66%)	no trial data cached
Liver disorder	54	34.0 26.3–44.0ROR 36.5 · χ² 1,697 / p <1e-300	33.6 EB05 26.7 · IC025 +4.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 32.9 · ♀ 100% (drug 66%)	no trial data cached
Therapeutic product effect decreased	47	29.5 22.4–38.9ROR 31.4 · χ² 1,268 / p 5e-278	29.2 EB05 22.8 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 47.8 · ♀ 100% (drug 66%)	no trial data cached
Drug intolerance	74	21.4 17.3–26.6ROR 23.7 · χ² 1,426 / p <1e-300	21.3 EB05 17.5 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 27.1 · ♀ 94% (drug 66%)	no trial data cached
Hepatic enzyme increased	50	20.5 15.7–26.8ROR 21.9 · χ² 910 / p 3e-200	20.3 EB05 16.0 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 24.3 · ♀ 98% (drug 66%)	no trial data cached
Cardiac failure (heart failure)	50	17.3 13.3–22.7ROR 18.5 · χ² 756 / p 1e-166	17.2 EB05 13.5 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.3 · ♀ 98% (drug 66%)	no trial data cached
Cardiac failure congestive	50	17.2 13.1–22.5ROR 18.3 · χ² 748 / p 5e-165	17.0 EB05 13.4 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.2 · ♀ 95% (drug 66%)	no trial data cached
Multiple fractures	9	15.1 7.9–29.0ROR 15.3 · χ² 105 / p 6e-25	13.1 EB05 6.2 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.2	no trial data cached
Sedation	14	15.0 8.9–25.1ROR 15.2 · χ² 169 / p 7e-39	14.0 EB05 8.1 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 16.9	no trial data cached
Gastrointestinal disorder	47	14.8 11.2–19.5ROR 15.7 · χ² 594 / p 2e-131	14.6 EB05 11.4 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 18.5 · ♀ 100% (drug 66%)	no trial data cached
Synovitis	8	12.3 6.2–24.6ROR 12.5 · χ² 72 / p 8e-18	9.7 EB05 4.5 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Nightmare	13	10.4 6.1–17.9ROR 10.6 · χ² 102 / p 3e-24	8.8 EB05 5.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Femur fracture	11	9.9 5.5–17.7ROR 10.0 · χ² 79 / p 3e-19	8.0 EB05 4.4 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Disability	7	9.9 4.7–20.6ROR 9.9 · χ² 47 / p 3e-12	7.1 EB05 3.4 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Completed suicide (death by suicide)	17	5.6 3.5–9.0ROR 5.7 · χ² 60 / p 4e-15	4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree	Outcome field, not a reaction	serious PRR 4.6	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
Drug intolerance	74	21.4 17.3–26.6ROR 23.7 · χ² 1,426 / p <1e-300	21.3 EB05 17.5 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 27.1 · ♀ 94% (drug 66%)	no trial data cached
Liver disorder	54	34.0 26.3–44.0ROR 36.5 · χ² 1,697 / p <1e-300	33.6 EB05 26.7 · IC025 +4.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 32.9 · ♀ 100% (drug 66%)	no trial data cached
Cardiac failure congestive	50	17.2 13.1–22.5ROR 18.3 · χ² 748 / p 5e-165	17.0 EB05 13.4 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.2 · ♀ 95% (drug 66%)	no trial data cached
Cardiac failure (heart failure)	50	17.3 13.3–22.7ROR 18.5 · χ² 756 / p 1e-166	17.2 EB05 13.5 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.3 · ♀ 98% (drug 66%)	no trial data cached
Hepatic enzyme increased	50	20.5 15.7–26.8ROR 21.9 · χ² 910 / p 3e-200	20.3 EB05 16.0 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 24.3 · ♀ 98% (drug 66%)	no trial data cached
Hepatic steatosis	49	73.5 56.1–96.4ROR 78.6 · χ² 3,427 / p <1e-300	71.4 EB05 56.1 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 68.6 · ♀ 100% (drug 66%)	no trial data cached
Gastrointestinal disorder	47	14.8 11.2–19.5ROR 15.7 · χ² 594 / p 2e-131	14.6 EB05 11.4 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 18.5 · ♀ 100% (drug 66%)	no trial data cached
Therapeutic product effect decreased	47	29.5 22.4–38.9ROR 31.4 · χ² 1,268 / p 5e-278	29.2 EB05 22.8 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 47.8 · ♀ 100% (drug 66%)	no trial data cached
Contraindicated product administered	47	43.5 32.9–57.3ROR 46.3 · χ² 1,907 / p <1e-300	42.7 EB05 33.4 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious PRR 44.4 · ♀ 100% (drug 66%)	no trial data cached
Completed suicide (death by suicide)	17	5.6 3.5–9.0ROR 5.7 · χ² 60 / p 4e-15	4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree	Outcome field, not a reaction	serious PRR 4.6	no trial data cached
Sedation	14	15.0 8.9–25.1ROR 15.2 · χ² 169 / p 7e-39	14.0 EB05 8.1 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 16.9	no trial data cached
Nightmare	13	10.4 6.1–17.9ROR 10.6 · χ² 102 / p 3e-24	8.8 EB05 5.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Femur fracture	11	9.9 5.5–17.7ROR 10.0 · χ² 79 / p 3e-19	8.0 EB05 4.4 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Multiple fractures	9	15.1 7.9–29.0ROR 15.3 · χ² 105 / p 6e-25	13.1 EB05 6.2 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.2	no trial data cached
Synovitis	8	12.3 6.2–24.6ROR 12.5 · χ² 72 / p 8e-18	9.7 EB05 4.5 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	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.

Hepatic steatosis — n=49, PRR 73.5

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 Atenolol and Chlorthalidone?

In FDA FAERS, the most frequently co-reported reaction terms for Atenolol and Chlorthalidone are liver disorder, cardiac failure congestive, cardiac failure, hepatic enzyme increased, hepatic steatosis, gastrointestinal disorder. 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 Atenolol and Chlorthalidone have an FDA boxed warning?

No. The FDA label retrieved for Atenolol and Chlorthalidone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Atenolol 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 0fadc652-b075-46ec-ae05-beaf7d91ae13, effective 20260720; matched on openfda.generic_name.exact:"ATENOLOL")
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, 23 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.