Drug · FAERS side-effect profile with label screen

Spironolactone and Hydrochlorothiazide side effects: what 746 FDA adverse event reports show

Spironolactone And Hydrochlorothiazide · 23 reaction terms · 287 drug–reaction co-reports · data 2026-09-14

Drug class

Aldosterone Antagonist

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

Label matched

Spironolactone (Spironolactone)

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

Who reports

746 reports · 55% serious · 45 with death outcome · 72% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Spironolactone tablets are an aldosterone antagonist indicated for: • The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1 ). • Use as an add-on therapy for the treatment of hypertension, to lower blood pressure.

FDA label, Indications and Usage

What it is

Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17‑ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, wh.

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 17 strongest signals

Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 7Not in label — unassessed 7

What the badges mean

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. 6 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
Infusion site pain	41	89.9 66.7–121.2ROR 95.1 · χ² 3,508 / p <1e-300	86.1 EB05 66.2 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious n=17 · 90% consumer	no trial data cached
Dermatitis contact	20	49.3 32.0–75.9ROR 50.6 · χ² 897 / p 2e-197	47.1 EB05 32.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=10 · 80% consumer	no trial data cached
Ejection fraction decreased	20	35.9 23.3–55.3ROR 36.9 · χ² 644 / p 2e-142	34.8 EB05 23.8 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 39.4 · ♀ 5% (drug 72%)	no trial data cached
Seasonal allergy	14	27.7 16.5–46.6ROR 28.2 · χ² 334 / p 6e-75	26.8 EB05 16.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Pulmonary arterial hypertension	10	19.2 10.4–35.5ROR 19.4 · χ² 155 / p 8e-36	17.9 EB05 9.4 · IC025 +2.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 20.7	no trial data cached
Device occlusion	9	18.1 9.4–34.6ROR 18.3 · χ² 129 / p 4e-30	16.4 EB05 7.9 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Dyspnoea exertional	24	17.9 12.0–26.5ROR 18.4 · χ² 366 / p 8e-82	17.5 EB05 12.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.8 · 83% consumer	no trial data cached
Obesity	10	17.5 9.5–32.4ROR 17.7 · χ² 140 / p 2e-32	16.1 EB05 8.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 21.3	no trial data cached
Device failure	8	14.7 7.4–29.4ROR 14.9 · χ² 89 / p 2e-21	12.3 EB05 5.5 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device leakage	18	11.9 7.5–18.7ROR 12.1 · χ² 169 / p 7e-39	10.9 EB05 6.8 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious n=7	no trial data cached
Cardiac failure congestive	28	9.6 6.7–13.9ROR 10.0 · χ² 209 / p 1e-47	8.9 EB05 6.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.2 · ♀ 25% (drug 72%)	no trial data cached
Device use error	10	8.2 4.4–15.2ROR 8.3 · χ² 56 / p 3e-14	6.4 EB05 3.6 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Device malfunction	16	6.6 4.1–10.8ROR 6.8 · χ² 71 / p 1e-17	5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 15.4	no trial data cached
Device dislocation	9	5.8 3.0–11.1ROR 5.8 · χ² 31 / p 1e-8	4.6 EB05 2.6 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.7	no trial data cached
Device issue	11	3.5 2.0–6.3ROR 3.6 · χ² 17 / p 1e-5	3.1 EB05 1.9 · IC025 +0.6	Reporting / coding artifact	serious PRR 6.4	no trial data cached
Injection site pruritus	8	3.4 1.7–6.7ROR 3.4 · χ² 11 / p 5e-4	2.9 EB05 1.6 · IC025 +0.3	Not in label — unassessed	serious PRR 9.3	no trial data cached
Injection site haemorrhage	9	3.2 1.7–6.1ROR 3.2 · χ² 11 / p 4e-4	2.8 EB05 1.6 · IC025 +0.4	Not in label — unassessed	serious PRR 16.5	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
Infusion site pain	41	89.9 66.7–121.2ROR 95.1 · χ² 3,508 / p <1e-300	86.1 EB05 66.2 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious n=17 · 90% consumer	no trial data cached
Cardiac failure congestive	28	9.6 6.7–13.9ROR 10.0 · χ² 209 / p 1e-47	8.9 EB05 6.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.2 · ♀ 25% (drug 72%)	no trial data cached
Dyspnoea exertional	24	17.9 12.0–26.5ROR 18.4 · χ² 366 / p 8e-82	17.5 EB05 12.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.8 · 83% consumer	no trial data cached
Ejection fraction decreased	20	35.9 23.3–55.3ROR 36.9 · χ² 644 / p 2e-142	34.8 EB05 23.8 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 39.4 · ♀ 5% (drug 72%)	no trial data cached
Dermatitis contact	20	49.3 32.0–75.9ROR 50.6 · χ² 897 / p 2e-197	47.1 EB05 32.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=10 · 80% consumer	no trial data cached
Device leakage	18	11.9 7.5–18.7ROR 12.1 · χ² 169 / p 7e-39	10.9 EB05 6.8 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious n=7	no trial data cached
Device malfunction	16	6.6 4.1–10.8ROR 6.8 · χ² 71 / p 1e-17	5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 15.4	no trial data cached
Seasonal allergy	14	27.7 16.5–46.6ROR 28.2 · χ² 334 / p 6e-75	26.8 EB05 16.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Device issue	11	3.5 2.0–6.3ROR 3.6 · χ² 17 / p 1e-5	3.1 EB05 1.9 · IC025 +0.6	Reporting / coding artifact	serious PRR 6.4	no trial data cached
Device use error	10	8.2 4.4–15.2ROR 8.3 · χ² 56 / p 3e-14	6.4 EB05 3.6 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Obesity	10	17.5 9.5–32.4ROR 17.7 · χ² 140 / p 2e-32	16.1 EB05 8.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 21.3	no trial data cached
Pulmonary arterial hypertension	10	19.2 10.4–35.5ROR 19.4 · χ² 155 / p 8e-36	17.9 EB05 9.4 · IC025 +2.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 20.7	no trial data cached
Injection site haemorrhage	9	3.2 1.7–6.1ROR 3.2 · χ² 11 / p 4e-4	2.8 EB05 1.6 · IC025 +0.4	Not in label — unassessed	serious PRR 16.5	no trial data cached
Device dislocation	9	5.8 3.0–11.1ROR 5.8 · χ² 31 / p 1e-8	4.6 EB05 2.6 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.7	no trial data cached
Device occlusion	9	18.1 9.4–34.6ROR 18.3 · χ² 129 / p 4e-30	16.4 EB05 7.9 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious n=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.

Dermatitis contact — n=20, PRR 49.3
Dyspnoea exertional — n=24, PRR 17.9
Cardiac failure congestive — n=28, PRR 9.6

✓ A hand-written Bradford Hill causality assessment exists for this drug: Spironolactone ↔ Hyperkalaemia.

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 Spironolactone and Hydrochlorothiazide?

In FDA FAERS, the most frequently co-reported reaction terms for Spironolactone and Hydrochlorothiazide are infusion site pain, cardiac failure congestive, dyspnoea exertional, ejection fraction decreased, dermatitis contact, seasonal allergy. 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 Spironolactone and Hydrochlorothiazide have an FDA boxed warning?

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

Do FAERS signals prove that Spironolactone and 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 10a5c989-66e3-494d-bfd8-b2d6df3be411, effective 20260515; matched on openfda.generic_name.exact:"SPIRONOLACTONE")
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.