Amiloride side effects: what 849 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Amiloride Hydrochloride (Amiloride Hydrochloride)
Who reports
849 reports · 85% serious · 63 with death outcome · 56% female
Used for
Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to: a. help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic b.
What it is
DESCRIPTION Amiloride HCl, an antikaliuretic-diuretic agent, is a pyrazine-carbonyl-guanidine that is unrelated chemically to other known antikaliuretic or diuretic agents. It is the salt of a moderately strong base (pKa 8.7).
Boxed warning
Like other potassium-conserving agents, amiloride may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) which, if uncorrected, is potentially fatal. Hyperkalemia occurs commonly (about 10%) when amiloride is used without a kaliuretic diuretic.
Causality screen of the 19 strongest signals
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 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.
- 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. 10 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 |
|---|---|---|---|---|---|---|
| Hyperkalaemia (high potassium) | 34 | 24.1 17.3–33.5ROR 25.0 · χ² 730 / p 5e-161 | 23.8 EB05 17.8 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 16.2 · 97% clinician | no trial data cached |
| Renal failure acute | 29 | 16.7 11.6–23.8ROR 17.2 · χ² 412 / p 8e-92 | 16.4 EB05 11.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Polyneuropathy | 8 | 16.6 8.3–33.1ROR 16.8 · χ² 102 / p 2e-24 | 14.4 EB05 6.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Quality of life decreased | 9 | 16.6 8.6–31.7ROR 16.7 · χ² 116 / p 2e-27 | 14.8 EB05 7.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 | no trial data cached |
| Generalised oedema | 8 | 16.1 8.1–32.0ROR 16.2 · χ² 98 / p 2e-23 | 13.8 EB05 6.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Myocardial ischaemia | 7 | 15.1 7.2–31.5ROR 15.2 · χ² 78 / p 4e-19 | 12.2 EB05 5.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Peritonitis bacterial | 6 | 14.7 6.6–32.7ROR 14.8 · χ² 64 / p 7e-16 | 11.1 EB05 4.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| International normalised ratio increased | 17 | 14.6 9.1–23.4ROR 14.9 · χ² 202 / p 4e-46 | 13.8 EB05 8.6 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 11.0 | no trial data cached |
| Hypomagnesaemia | 8 | 14.2 7.1–28.4ROR 14.4 · χ² 86 / p 1e-20 | 11.8 EB05 5.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Nephropathy | 5 | 13.2 5.5–31.6ROR 13.2 · χ² 45 / p 1e-11 | 8.8 EB05 3.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 9 | 12.0 6.3–23.0ROR 12.1 · χ² 80 / p 2e-19 | 9.7 EB05 4.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.2 | no trial data cached |
| Drug level increased | 8 | 11.9 6.0–23.8ROR 12.0 · χ² 70 / p 4e-17 | 9.3 EB05 4.4 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 | no trial data cached |
| Tachypnoea | 6 | 10.9 4.9–24.3ROR 11.0 · χ² 45 / p 1e-11 | 7.5 EB05 3.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Rash maculo-papular | 9 | 10.0 5.2–19.2ROR 10.1 · χ² 64 / p 5e-16 | 7.7 EB05 4.0 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Drug dispensing error | 5 | 8.0 3.3–19.1ROR 8.0 · χ² 24 / p 5e-7 | 5.1 EB05 2.3 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Serotonin syndrome | 5 | 6.5 2.7–15.5ROR 6.5 · χ² 18 / p 1e-5 | 4.4 EB05 2.0 · IC025 +0.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Glycosylated haemoglobin increased | 6 | 5.9 2.7–13.1ROR 5.9 · χ² 20 / p 5e-6 | 4.3 EB05 2.1 · IC025 +0.7 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 | no trial data cached |
| Anger | 8 | 5.8 2.9–11.6ROR 5.9 · χ² 27 / p 9e-8 | 4.5 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Plasma cell myeloma | 6 | 3.8 1.7–8.4ROR 3.8 · χ² 10 / p 9e-4 | 3.1 EB05 1.6 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.8 | 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 |
|---|---|---|---|---|---|---|
| Hyperkalaemia (high potassium) | 34 | 24.1 17.3–33.5ROR 25.0 · χ² 730 / p 5e-161 | 23.8 EB05 17.8 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 16.2 · 97% clinician | no trial data cached |
| Renal failure acute | 29 | 16.7 11.6–23.8ROR 17.2 · χ² 412 / p 8e-92 | 16.4 EB05 11.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| International normalised ratio increased | 17 | 14.6 9.1–23.4ROR 14.9 · χ² 202 / p 4e-46 | 13.8 EB05 8.6 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 11.0 | no trial data cached |
| Rash maculo-papular | 9 | 10.0 5.2–19.2ROR 10.1 · χ² 64 / p 5e-16 | 7.7 EB05 4.0 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 9 | 12.0 6.3–23.0ROR 12.1 · χ² 80 / p 2e-19 | 9.7 EB05 4.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.2 | no trial data cached |
| Quality of life decreased | 9 | 16.6 8.6–31.7ROR 16.7 · χ² 116 / p 2e-27 | 14.8 EB05 7.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 | no trial data cached |
| Anger | 8 | 5.8 2.9–11.6ROR 5.9 · χ² 27 / p 9e-8 | 4.5 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Drug level increased | 8 | 11.9 6.0–23.8ROR 12.0 · χ² 70 / p 4e-17 | 9.3 EB05 4.4 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 | no trial data cached |
| Hypomagnesaemia | 8 | 14.2 7.1–28.4ROR 14.4 · χ² 86 / p 1e-20 | 11.8 EB05 5.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Generalised oedema | 8 | 16.1 8.1–32.0ROR 16.2 · χ² 98 / p 2e-23 | 13.8 EB05 6.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Polyneuropathy | 8 | 16.6 8.3–33.1ROR 16.8 · χ² 102 / p 2e-24 | 14.4 EB05 6.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Myocardial ischaemia | 7 | 15.1 7.2–31.5ROR 15.2 · χ² 78 / p 4e-19 | 12.2 EB05 5.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Plasma cell myeloma | 6 | 3.8 1.7–8.4ROR 3.8 · χ² 10 / p 9e-4 | 3.1 EB05 1.6 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Glycosylated haemoglobin increased | 6 | 5.9 2.7–13.1ROR 5.9 · χ² 20 / p 5e-6 | 4.3 EB05 2.1 · IC025 +0.7 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 | no trial data cached |
| Tachypnoea | 6 | 10.9 4.9–24.3ROR 11.0 · χ² 45 / p 1e-11 | 7.5 EB05 3.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | 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.
- Renal failure acute — n=29, PRR 16.7
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 Amiloride?
In FDA FAERS, the most frequently co-reported reaction terms for Amiloride are hyperkalaemia, renal failure acute, international normalised ratio increased, rash maculo-papular, agranulocytosis, quality of life decreased. 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 Amiloride have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Like other potassium-conserving agents, amiloride may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) which, if uncorrected, is potentially fatal. Hyperkalemia occurs commonly (about 10%) when amiloride is used without a kaliuretic diuretic.
Do FAERS signals prove that Amiloride 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 2b70cf0c-45be-428f-b396-5001ed4e30fc, effective 20230505; matched on
openfda.generic_name.exact:"AMILORIDE HYDROCHLORIDE") - 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, 29 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.