Spironolactone side effects: what 139,599 FDA adverse event reports show

Spironolactone · 1,201 reaction terms · 578,989 drug–reaction co-reports · data 2026-09-14

Drug class

Aldosterone Antagonist

FDA label (Established Pharmacologic Class)

Who reports

139,599 reports · 78% serious · 18,066 with death outcome · 59% 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 is a steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7.

PubChem CID 5833 (ChEBI)

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 40 strongest signals

Labeled adverse reaction 1Likely indication confounding 7Reporting / coding artifact 2Lab value / disease marker 6Not in label — unassessed 24

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.
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). 1,161 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
Ejection fraction	225	94.0 79.6–111.2ROR 94.2 · calibrated p 2e-7 ✓	57.5 EB05 51.5 · IC025 +5.5 3/3 methods agree	Likely indication confounding term in indications	serious n=221 · ♀ 100% (drug 59%)	not reported in cached trials
Sensitisation	257	75.8 65.2–88.1ROR 75.9 · calibrated p 1e-6 ✓	50.2 EB05 45.2 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=257 · ♀ 100% (drug 59%)	not reported in cached trials
Polycystic ovaries	284	33.0 29.0–37.5ROR 33.0 · calibrated p 2e-4 ✓	27.1 EB05 24.5 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=280 · ♀ 100% (drug 59%)	not reported in cached trials
N-terminal prohormone brain natriuretic peptide increased	247	32.0 27.9–36.7ROR 32.0 · calibrated p 2e-4 ✓	26.4 EB05 23.7 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious n=238	not reported in cached trials
Device maintenance issue	97	31.0 24.9–38.6ROR 31.0 · calibrated p 3e-4 ✓	25.7 EB05 21.7 · IC025 +4.2 3/3 methods agree	Reporting / coding artifact	♀ 100% (drug 59%) · 100% consumer	not reported in cached trials
Hyperkalaemia (high potassium)	5,027	25.1 24.4–25.9ROR 26.0 · calibrated p 5e-4 ✓	21.6 EB05 21.1 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 18.0 · serious PRR 16.0 · 94% clinician	NCT00094302: 1/1,722 (0.1%) on Spironolactone (serious AE)
Cardioactive drug level increased	190	24.9 21.4–29.1ROR 25.0 · calibrated p 7e-4 ✓	21.4 EB05 19.0 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious n=189 · 100% clinician	not reported in cached trials
Brash syndrome	188	24.0 20.6–28.0ROR 24.1 · calibrated p 9e-4 ✓	20.8 EB05 18.4 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=188 · 100% clinician	not reported in cached trials
Sputum culture positive	114	24.0 19.7–29.2ROR 24.0 · calibrated p 9e-4 ✓	20.7 EB05 17.7 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	serious n=112 · ♀ 100% (drug 59%) · 100% clinician	not reported in cached trials
Cardiac failure chronic	585	23.8 21.8–26.0ROR 23.9 · calibrated p 9e-4 ✓	20.6 EB05 19.3 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=584 · ♀ 36% (drug 59%)	not reported in cached trials
Ejection fraction abnormal	156	21.7 18.4–25.7ROR 21.7 · calibrated p 0.001 ✓	19.0 EB05 16.6 · IC025 +3.9 3/3 methods agree	Likely indication confounding term in indications	serious n=148	not reported in cached trials
Orthopnoea	384	20.4 18.4–22.7ROR 20.5 · calibrated p 0.002 ✓	18.0 EB05 16.6 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=374	not reported in cached trials
Right ventricular failure	789	18.8 17.4–20.2ROR 18.9 · calibrated p 0.003 ✓	16.8 EB05 15.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 12.2	not reported in cached trials
Brain natriuretic peptide increased	344	18.8 16.8–21.0ROR 18.8 · calibrated p 0.003 ✓	16.7 EB05 15.3 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	serious n=323	not reported in cached trials
Hepatic encephalopathy	1,031	18.5 17.4–19.8ROR 18.7 · calibrated p 0.003 ✓	16.6 EB05 15.7 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	age-adj. PRR 16.3 · serious PRR 12.2	NCT00094302: 1/1,723 (0.1%) control (serious AE)
Hepatorenal syndrome	175	17.2 14.7–20.1ROR 17.2 · calibrated p 0.004 ✓	15.5 EB05 13.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=174 · ♀ 0% (drug 59%) · 100% clinician	not reported in cached trials
Ischaemic cardiomyopathy	294	15.7 13.9–17.7ROR 15.7 · calibrated p 0.006 ✓	14.2 EB05 12.9 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=293 · ♀ 23% (drug 59%)	not reported in cached trials
Oesophageal varices haemorrhage	194	14.6 12.6–16.9ROR 14.6 · calibrated p 0.008 ✓	13.3 EB05 11.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=192 · ♀ 0% (drug 59%)	not reported in cached trials
Acute prerenal failure	103	14.4 11.8–17.6ROR 14.4 · calibrated p 0.009 ✓	13.1 EB05 11.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=103 · ♀ 0% (drug 59%) · 100% clinician	not reported in cached trials
Product monitoring error	122	13.9 11.5–16.7ROR 13.9 · calibrated p 0.010 ✓	12.7 EB05 10.9 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious n=122 · 100% clinician	not reported in cached trials
Left atrial dilatation	107	13.6 11.1–16.5ROR 13.6 · calibrated p 0.011 ✓	12.4 EB05 10.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=108 · ♀ 0% (drug 59%) · 100% clinician	not reported in cached trials
Varices oesophageal	251	13.5 11.9–15.4ROR 13.6 · calibrated p 0.011 ✓	12.4 EB05 11.2 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=247	not reported in cached trials
Pulmonary arterial pressure increased	134	13.3 11.2–15.9ROR 13.3 · calibrated p 0.012 ✓	12.2 EB05 10.5 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	serious n=123	not reported in cached trials
Obstructive sleep apnoea syndrome	114	13.3 11.0–16.1ROR 13.3 · calibrated p 0.012 ✓	12.2 EB05 10.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=113 · ♀ 100% (drug 59%)	not reported in cached trials
Bronchial secretion retention	102	13.1 10.7–16.0ROR 13.1 · calibrated p 0.013 ✓	12.0 EB05 10.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=101 · ♀ 100% (drug 59%)	not reported in cached trials
Congestive cardiomyopathy	341	13.1 11.7–14.6ROR 13.1 · calibrated p 0.012 ✓	12.1 EB05 11.0 · IC025 +3.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=339	not reported in cached trials
Infusion site discharge	137	13.0 10.9–15.5ROR 13.0 · calibrated p 0.013 ✓	11.9 EB05 10.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	♀ 100% (drug 59%) · 100% consumer	not reported in cached trials
Nephrogenic anaemia	357	12.3 11.1–13.7ROR 12.4 · calibrated p 0.015 ✓	11.4 EB05 10.5 · IC025 +3.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=356 · 100% clinician	not reported in cached trials
Atrial tachycardia	161	12.3 10.5–14.5ROR 12.3 · calibrated p 0.016 ✓	11.4 EB05 9.9 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=158 · 100% clinician	not reported in cached trials
Rhinitis allergic	329	11.9 10.7–13.4ROR 12.0 · calibrated p 0.017 ✓	11.1 EB05 10.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=322 · ♀ 100% (drug 59%)	not reported in cached trials
Hepatic neoplasm malignant	158	11.9 10.1–14.0ROR 11.9 · calibrated p 0.018 ✓	11.0 EB05 9.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=158 · ♀ 0% (drug 59%) · 100% clinician	not reported in cached trials
Bundle branch block left	305	11.5 10.2–12.9ROR 11.5 · calibrated p 0.020 ✓	10.7 EB05 9.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=304	NCT00094302: 2/1,722 (0.1%) on Spironolactone
Ammonia increased	362	11.4 10.2–12.7ROR 11.4 · calibrated p 0.020 ✓	10.6 EB05 9.7 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious n=341	not reported in cached trials
Pulmonary arterial hypertension	1,021	11.2 10.6–12.0ROR 11.3 · calibrated p 0.021 ✓	10.5 EB05 10.0 · IC025 +3.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	age-adj. PRR 9.7 · serious PRR 7.9	not reported in cached trials
Hyperparathyroidism secondary	177	11.2 9.6–13.1ROR 11.2 · calibrated p 0.022 ✓	10.4 EB05 9.1 · IC025 +3.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=177	not reported in cached trials
Infusion site haemorrhage	221	10.9 9.5–12.5ROR 10.9 · calibrated p 0.024 ✓	10.2 EB05 9.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=88 · 100% consumer	NCT00094302: 1/1,723 (0.1%) control (serious AE)
Infusion site infection	154	10.9 9.2–12.8ROR 10.9 · calibrated p 0.025 ✓	10.1 EB05 8.8 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=86 · ♀ 100% (drug 59%) · 100% consumer	NCT00094302: 2/1,722 (0.1%) on Spironolactone (serious AE)
Hypervolaemia	325	10.8 9.7–12.1ROR 10.9 · calibrated p 0.025 ✓	10.1 EB05 9.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=315	not reported in cached trials
Cardiac failure acute	445	10.7 9.7–11.8ROR 10.7 · calibrated p 0.025 ✓	10.0 EB05 9.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=444	not reported in cached trials
Left ventricular failure	226	10.6 9.2–12.1ROR 10.6 · calibrated p 0.027 ✓	9.9 EB05 8.8 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=224	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Heart failure	8,457	7.47.2–7.6	signal
Hyponatraemia	3,605	7.06.8–7.2	signal
Kidney injury	15,667	5.35.2–5.4	signal
Arrhythmia / qt	4,944	3.93.8–4.0	signal
Gi bleeding	4,058	3.43.3–3.5	signal
Anaemia	5,573	2.82.8–2.9	signal
Fall / fracture	5,502	2.22.1–2.2	signal
Rhabdomyolysis / myopathy	1,126	2.12.0–2.2	raised
Hypoglycaemia	1,285	2.01.9–2.1	raised
Serious infection	10,214	2.02.0–2.0	raised
Severe cutaneous reaction	959	1.91.8–2.1	raised
Thrombocytopenia	2,763	1.91.8–2.0	raised
Liver injury	3,702	1.91.8–1.9	raised
Myocardial infarction	2,432	1.81.7–1.9	raised
Interstitial lung disease	984	1.51.5–1.6	raised
Pancreatitis	810	1.51.4–1.6	raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Spironolactone 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 (5 of 40 signal terms matched).

NCT00094302 — Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function (N=3445, PHASE3; 1020 AE terms posted; arms: Placebo; Spironolactone)
NCT00141778 — Renin-angiotensin-aldosterone System (RAAS), Inflammation, and Post-Operative Atrial Fibrillation (AF) (N=455, PHASE2, PHASE3; 7 AE terms posted; arms: Placebo; Ramipril; Spironolactone)

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
Dyspnoea (shortness of breath)	10,837	2.9 2.9–3.0ROR 3.1 · calibrated p 0.603	2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	age-adj. PRR 2.4 · serious PRR 2.5	NCT00094302: 11/1,722 (0.6%) on Spironolactone; 11/1,723 (0.6%) control (serious AE)
Fatigue (tiredness)	8,570	1.7 1.6–1.7ROR 1.7 · calibrated p 0.773	1.7 EB05 1.6 · IC025 +0.7	Not in label — unassessed	age-adj. PRR 1.4 · serious PRR 1.7	NCT00094302: 2/1,722 (0.1%) on Spironolactone; 1/1,723 (0.1%) control (serious AE)
Nausea	8,153	1.6 1.5–1.6ROR 1.6 · calibrated p 0.701	1.6 EB05 1.5 · IC025 +0.6	Labeled adverse reaction exact term	age-adj. PRR 1.4 · serious PRR 1.6	NCT00094302: 1/1,722 (0.1%) on Spironolactone; 5/1,723 (0.3%) control (serious AE)
Diarrhoea (diarrhea)	7,804	1.8 1.8–1.9ROR 1.9 · calibrated p 0.877	1.8 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	age-adj. PRR 1.5 · serious PRR 1.8	NCT00094302: 1/1,723 (0.1%) control (serious AE)
Acute kidney injury (sudden kidney damage)	7,007	7.2 7.0–7.4ROR 7.5 · calibrated p 0.080	6.9 EB05 6.8 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 5.5 · serious PRR 5.1	not reported in cached trials
Dizziness	6,529	2.0 1.9–2.0ROR 2.0 · calibrated p 0.960	2.0 EB05 1.9 · IC025 +0.9	Labeled adverse reaction exact term	age-adj. PRR 1.6 · serious PRR 1.9	NCT00094302: 5/1,722 (0.3%) on Spironolactone; 3/1,723 (0.2%) control (serious AE)
Headache	6,229	1.5 1.5–1.5ROR 1.5 · calibrated p 0.656	1.5 EB05 1.5 · IC025 +0.5	Labeled adverse reaction exact term	age-adj. PRR 1.4 · serious PRR 1.5 · ♀ 80% (drug 59%)	NCT00094302: 5/1,722 (0.3%) on Spironolactone; 1/1,723 (0.1%) control (serious AE)
Hypotension (low blood pressure)	6,024	4.6 4.5–4.7ROR 4.8 · calibrated p 0.259	4.5 EB05 4.4 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.6 · serious PRR 3.5	NCT00094302: 17/1,722 (1.0%) on Spironolactone; 18/1,723 (1.0%) control (serious AE)
Off label use (used outside approved label)	5,931	1.0 1.0–1.1ROR 1.0 · calibrated p 0.324	1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 0.9 · serious PRR 1.1	not reported in cached trials
Drug ineffective (drug did not work)	5,418	0.6 0.6–0.6ROR 0.6 · calibrated p 0.085	0.6 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 0.7 · serious PRR 0.8	not reported in cached trials
Fall	5,245	2.4 2.3–2.5ROR 2.4 · calibrated p 0.837	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	age-adj. PRR 1.8 · serious PRR 2.0	NCT00094302: 1/1,723 (0.1%) control (serious AE)
Asthenia (weakness)	5,181	2.1 2.0–2.1ROR 2.1 · calibrated p 0.990	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	age-adj. PRR 1.6 · serious PRR 1.8	NCT00094302: 1/1,722 (0.1%) on Spironolactone (serious AE)
Death	5,082	0.9 0.9–0.9ROR 0.9 · calibrated p 0.231	0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Outcome field, not a reaction	age-adj. PRR 0.8 · serious PRR 0.7	NCT00094302: 4/1,722 (0.2%) on Spironolactone; 3/1,723 (0.2%) control (serious AE)
Vomiting	5,053	1.6 1.6–1.7ROR 1.6 · calibrated p 0.737	1.6 EB05 1.6 · IC025 +0.6	Labeled adverse reaction exact term	age-adj. PRR 1.5 · serious PRR 1.5	NCT00094302: 2/1,722 (0.1%) on Spironolactone; 2/1,723 (0.1%) control (serious AE)
Hyperkalaemia (high potassium)	5,027	25.1 24.4–25.9ROR 26.0 · calibrated p 5e-4 ✓	21.6 EB05 21.1 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 18.0 · serious PRR 16.0 · 94% clinician	NCT00094302: 1/1,722 (0.1%) on Spironolactone (serious AE)

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.

Sensitisation — n=257, PRR 75.8
Polycystic ovaries — n=284, PRR 33.0
Brash syndrome — n=188, PRR 24.0
Cardiac failure chronic — n=585, PRR 23.8
Orthopnoea — n=384, PRR 20.4
Right ventricular failure — n=789, PRR 18.8
Hepatic encephalopathy — n=1,031, PRR 18.5 (also seen in trial arm)
Hepatorenal syndrome — n=175, PRR 17.2
Oesophageal varices haemorrhage — n=194, PRR 14.6
Acute prerenal failure — n=103, PRR 14.4

✓ 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?

In FDA FAERS, the most frequently co-reported reaction terms for Spironolactone are dyspnoea, fatigue, nausea, diarrhoea, acute kidney injury, dizziness. 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 have an FDA boxed warning?

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

Do FAERS signals prove that Spironolactone 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" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
PubChem CID 5833 description (ChEBI)
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, 1,201 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 SPIRONOLACTONE, 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.