Acetic Acid side effects: what 345 FDA adverse event reports show

Acetic Acid · 11 reaction terms · 120 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

345 reports · 79% serious · 28 with death outcome · 66% female

openFDA FAERS counts, all years, deduplication not applied

Used for

0.25% Acetic Acid Irrigation, USP, is indicated as a constant or intermittent bladder rinse to help prevent the growth and proliferation of susceptible urinary pathogens (especially ammonia forming bacteria) in the management of patients who require prolonged placement of an indwelling urethral catheter.

FDA label, Indications and Usage

What it is

DESCRIPTION 0.25% Acetic Acid Irrigation, USP, is a sterile, nonpyrogenic hypotonic solution for irrigation of the urinary bladder. Each 100 mL contains 250 mg Glacial Acetic Acid, USP, (CH 3 COOH) in Water for Injection, USP. pH 3.0 (2.8 to 3.4). Osmolarity: 42 mOsmol/L (calc.). No antimicrobial agent has been added.

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 11 strongest signals

No label text to screen 11

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 0 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
Obstructive airways disorder	16	87.2 54.0–140.8ROR 91.4 · χ² 1,278 / p 3e-280	79.2 EB05 51.7 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 66.1	no trial data cached
Secretion discharge	15	73.9 45.0–121.2ROR 77.2 · χ² 1,006 / p 5e-221	67.7 EB05 43.5 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 88.5	no trial data cached
Pneumothorax	13	49.9 29.3–85.0ROR 51.8 · χ² 575 / p 3e-127	46.7 EB05 29.0 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 36.6	no trial data cached
Eosinophilia	14	48.7 29.2–81.4ROR 50.8 · χ² 608 / p 2e-134	45.9 EB05 29.0 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 37.2	no trial data cached
Coronary artery disease	21	41.9 27.6–63.4ROR 44.5 · χ² 798 / p 8e-176	40.4 EB05 27.9 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 31.1 · ♀ 5% (drug 66%) · 70% consumer	no trial data cached
Ear discomfort	7	41.6 20.0–86.6ROR 42.4 · χ² 238 / p 5e-54	37.5 EB05 19.4 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2	no trial data cached
Vaginal discharge	6	36.3 16.4–80.3ROR 36.9 · χ² 172 / p 1e-39	32.4 EB05 15.4 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=6	no trial data cached
Bronchospasm (airway tightening)	8	34.0 17.1–67.4ROR 34.8 · χ² 224 / p 5e-51	31.5 EB05 16.9 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 27.4	no trial data cached
Macular degeneration	6	30.6 13.8–67.7ROR 31.1 · χ² 144 / p 2e-33	27.4 EB05 12.4 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 24.1	no trial data cached
Paraesthesia oral	7	29.6 14.2–61.7ROR 30.2 · χ² 166 / p 3e-38	27.2 EB05 13.4 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 38.6	no trial data cached
Upper gastrointestinal haemorrhage	7	25.2 12.1–52.5ROR 25.7 · χ² 140 / p 2e-32	23.0 EB05 10.7 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.5	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
Coronary artery disease	21	41.9 27.6–63.4ROR 44.5 · χ² 798 / p 8e-176	40.4 EB05 27.9 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 31.1 · ♀ 5% (drug 66%) · 70% consumer	no trial data cached
Obstructive airways disorder	16	87.2 54.0–140.8ROR 91.4 · χ² 1,278 / p 3e-280	79.2 EB05 51.7 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 66.1	no trial data cached
Secretion discharge	15	73.9 45.0–121.2ROR 77.2 · χ² 1,006 / p 5e-221	67.7 EB05 43.5 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 88.5	no trial data cached
Eosinophilia	14	48.7 29.2–81.4ROR 50.8 · χ² 608 / p 2e-134	45.9 EB05 29.0 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 37.2	no trial data cached
Pneumothorax	13	49.9 29.3–85.0ROR 51.8 · χ² 575 / p 3e-127	46.7 EB05 29.0 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 36.6	no trial data cached
Bronchospasm (airway tightening)	8	34.0 17.1–67.4ROR 34.8 · χ² 224 / p 5e-51	31.5 EB05 16.9 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 27.4	no trial data cached
Upper gastrointestinal haemorrhage	7	25.2 12.1–52.5ROR 25.7 · χ² 140 / p 2e-32	23.0 EB05 10.7 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.5	no trial data cached
Paraesthesia oral	7	29.6 14.2–61.7ROR 30.2 · χ² 166 / p 3e-38	27.2 EB05 13.4 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 38.6	no trial data cached
Ear discomfort	7	41.6 20.0–86.6ROR 42.4 · χ² 238 / p 5e-54	37.5 EB05 19.4 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2	no trial data cached
Macular degeneration	6	30.6 13.8–67.7ROR 31.1 · χ² 144 / p 2e-33	27.4 EB05 12.4 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 24.1	no trial data cached
Vaginal discharge	6	36.3 16.4–80.3ROR 36.9 · χ² 172 / p 1e-39	32.4 EB05 15.4 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=6	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Zoledronic acid (bisphosphonates) ↔ Osteonecrosis of the jaw.

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 Acetic Acid?

In FDA FAERS, the most frequently co-reported reaction terms for Acetic Acid are coronary artery disease, obstructive airways disorder, secretion discharge, eosinophilia, pneumothorax, bronchospasm. 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 Acetic Acid have an FDA boxed warning?

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

Do FAERS signals prove that Acetic Acid 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 41bc12af-fac5-4ac1-b907-dcb3e35a054c, effective 20180202; matched on openfda.generic_name.exact:"ACETIC ACID" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
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, 11 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.