Isopropyl Alcohol Spray side effects: what 3,540 FDA adverse event reports show

Isopropyl Alcohol Spray · Isopropyl Alcohol · 199 reaction terms · 131,777 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Isopropyl Alcohol

openFDA label

Who reports

3,540 reports · 99% serious · 2,327 with death outcome · 98% female

openFDA FAERS counts, all years, deduplication not applied

Used for

(s) • First aid to help prevent infection in minor cuts, scrapes, and burns.

FDA label, Indications and Usage

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

Reporting / coding artifact 2Lab value / disease marker 3No label text to screen 35

What the badges mean

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.
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, 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). 159 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
Helicobacter infection	1,501	1,024.7 980.7–1,070.6ROR 1,778.3 · calibrated p 2e-20 ✓	862.3 EB05 826.3 · IC025 +9.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 534.6 · 96% clinician	no trial arm names this drug
Folliculitis	1,473	987.0 944.2–1,031.7ROR 1,689.7 · calibrated p 4e-20 ✓	835.3 EB05 800.1 · IC025 +9.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 575.9 · 96% clinician	no trial arm names this drug
Pemphigus	1,529	832.0 797.5–867.9ROR 1,463.8 · calibrated p 3e-19 ✓	721.8 EB05 691.9 · IC025 +9.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 423.8 · 97% clinician	no trial arm names this drug
Hand deformity	1,508	772.8 740.7–806.2ROR 1,345.5 · calibrated p 7e-19 ✓	676.7 EB05 648.5 · IC025 +9.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 430.7 · 96% clinician	no trial arm names this drug
Pericarditis	1,485	580.1 556.2–604.9ROR 998.5 · calibrated p 3e-17 ✓	524.2 EB05 502.2 · IC025 +8.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 308.7 · 96% clinician	no trial arm names this drug
Hypercholesterolaemia	772	520.3 487.2–555.7ROR 665.2 · calibrated p 3e-15 ✓	472.3 EB05 445.0 · IC025 +8.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 294.7 · 94% clinician	no trial arm names this drug
Synovitis	1,407	501.3 480.0–523.5ROR 831.2 · calibrated p 2e-16 ✓	458.8 EB05 439.1 · IC025 +8.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 280.6 · 97% clinician	no trial arm names this drug
Joint range of motion decreased	1,027	493.4 467.2–521.0ROR 694.6 · calibrated p 2e-15 ✓	451.2 EB05 428.5 · IC025 +8.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 336.6 · 94% clinician	no trial arm names this drug
Irritable bowel syndrome	1,489	444.0 426.2–462.7ROR 765.7 · calibrated p 6e-16 ✓	410.6 EB05 393.4 · IC025 +8.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 304.0 · 96% clinician	no trial arm names this drug
Glossodynia (burning tongue/mouth pain)	1,527	434.6 417.4–452.4ROR 763.4 · calibrated p 6e-16 ✓	402.5 EB05 385.8 · IC025 +8.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 339.8 · 96% clinician	no trial arm names this drug
Wound infection	727	424.9 397.1–454.6ROR 534.4 · calibrated p 3e-14 ✓	392.1 EB05 368.7 · IC025 +8.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 246.5 · 93% clinician	no trial arm names this drug
Autoimmune disorder	521	341.1 314.3–370.3ROR 399.8 · calibrated p 6e-13 ✓	318.6 EB05 296.3 · IC025 +7.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 200.0 · 97% clinician	no trial arm names this drug
Bursitis	655	340.2 316.7–365.4ROR 417.2 · calibrated p 4e-13 ✓	318.5 EB05 298.6 · IC025 +7.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 219.6 · 94% clinician	no trial arm names this drug
Wound	1,461	328.7 315.4–342.5ROR 559.0 · calibrated p 2e-14 ✓	310.0 EB05 296.9 · IC025 +8.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 215.1 · 96% clinician	no trial arm names this drug
Fibromyalgia	1,137	291.0 277.0–305.8ROR 428.3 · calibrated p 3e-13 ✓	276.0 EB05 262.8 · IC025 +7.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 211.6 · 95% clinician	no trial arm names this drug
Impaired healing	1,488	281.3 270.2–292.8ROR 484.5 · calibrated p 8e-14 ✓	267.5 EB05 256.3 · IC025 +7.9 3/3 methods agree	Reporting / coding artifact	serious PRR 188.3 · 96% clinician	no trial arm names this drug
Systemic lupus erythematosus	1,490	260.6 250.3–271.2ROR 449.2 · calibrated p 2e-13 ✓	248.7 EB05 238.3 · IC025 +7.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 148.5 · 96% clinician	no trial arm names this drug
Liver injury	1,017	260.1 246.6–274.4ROR 364.6 · calibrated p 1e-12 ✓	247.9 EB05 235.4 · IC025 +7.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 149.9 · 95% clinician	no trial arm names this drug
Type 2 diabetes mellitus	1,289	235.1 224.8–245.9ROR 369.2 · calibrated p 1e-12 ✓	225.3 EB05 215.2 · IC025 +7.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 138.2 · 96% clinician	no trial arm names this drug
Sciatica	554	214.4 198.3–231.9ROR 254.0 · calibrated p 5e-11 ✓	205.4 EB05 191.5 · IC025 +7.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 161.3 · 97% clinician	no trial arm names this drug
Pulmonary fibrosis	666	213.9 199.5–229.4ROR 263.3 · calibrated p 3e-11 ✓	205.2 EB05 192.4 · IC025 +7.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 121.0 · 97% clinician	no trial arm names this drug
Obesity	554	213.1 197.1–230.4ROR 252.5 · calibrated p 5e-11 ✓	204.2 EB05 190.3 · IC025 +7.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 138.5 · 94% clinician	no trial arm names this drug
Laryngitis	336	189.2 170.6–209.8ROR 208.9 · calibrated p 3e-10 ✓	181.4 EB05 165.7 · IC025 +7.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=336 · 98% clinician	no trial arm names this drug
Contraindicated product administered	926	187.6 177.3–198.6ROR 253.8 · calibrated p 5e-11 ✓	181.2 EB05 171.6 · IC025 +7.3 3/3 methods agree	Reporting / coding artifact	serious PRR 131.4 · 94% clinician	no trial arm names this drug
Psoriatic arthropathy	1,223	185.8 177.4–194.6ROR 283.4 · calibrated p 2e-11 ✓	179.6 EB05 171.3 · IC025 +7.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 131.6 · 96% clinician	no trial arm names this drug
Lower limb fracture	550	175.7 162.5–190.0ROR 207.8 · calibrated p 3e-10 ✓	169.6 EB05 158.0 · IC025 +7.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 108.7 · 96% clinician	no trial arm names this drug
Foot deformity	317	174.2 156.6–193.8ROR 191.2 · calibrated p 7e-10 ✓	167.5 EB05 152.6 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 114.1 · 97% clinician	no trial arm names this drug
Red blood cell sedimentation rate increased	315	173.2 155.6–192.7ROR 190.0 · calibrated p 7e-10 ✓	166.5 EB05 151.7 · IC025 +6.9 3/3 methods agree	Lab value / disease marker	serious PRR 110.7 · 97% clinician	no trial arm names this drug
Lower respiratory tract infection	1,253	168.5 161.0–176.3ROR 260.2 · calibrated p 4e-11 ✓	163.4 EB05 155.9 · IC025 +7.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 100.5 · 96% clinician	no trial arm names this drug
Hip arthroplasty	405	162.3 147.9–178.2ROR 183.2 · calibrated p 9e-10 ✓	156.8 EB05 144.4 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 94.5 · 98% clinician	no trial arm names this drug
Joint dislocation	280	161.8 144.4–181.4ROR 175.6 · calibrated p 1e-9 ✓	155.8 EB05 141.1 · IC025 +6.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 102.9 · 98% clinician	no trial arm names this drug
Prescribed overdose	510	160.3 147.8–174.0ROR 187.2 · calibrated p 7e-10 ✓	155.2 EB05 144.2 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 154.5 · 95% clinician	no trial arm names this drug
Gait inability	784	143.7 135.0–153.0ROR 184.3 · calibrated p 8e-10 ✓	139.8 EB05 131.8 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 101.3 · 94% clinician	no trial arm names this drug
Blister	1,302	140.9 134.9–147.3ROR 222.4 · calibrated p 2e-10 ✓	137.4 EB05 131.2 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 132.2 · 96% clinician	no trial arm names this drug
Arthropathy	1,278	138.9 132.8–145.2ROR 216.8 · calibrated p 2e-10 ✓	135.4 EB05 129.3 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 96.0 · 96% clinician	no trial arm names this drug
Infusion related reaction (reaction during infusion)	1,494	137.1 131.8–142.6ROR 236.5 · calibrated p 9e-11 ✓	133.7 EB05 128.1 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 98.1 · 96% clinician	no trial arm names this drug
Blood cholesterol increased	1,037	134.7 127.9–141.9ROR 190.1 · calibrated p 6e-10 ✓	131.4 EB05 124.8 · IC025 +6.9 3/3 methods agree	Lab value / disease marker	serious PRR 115.9 · 96% clinician	no trial arm names this drug
Hepatic enzyme increased	1,457	129.8 124.7–135.1ROR 219.9 · calibrated p 2e-10 ✓	126.8 EB05 121.4 · IC025 +6.8 3/3 methods agree	Lab value / disease marker	serious PRR 106.6 · 96% clinician	no trial arm names this drug
Ill-defined disorder	1,302	129.6 124.1–135.5ROR 204.5 · calibrated p 3e-10 ✓	126.6 EB05 121.0 · IC025 +6.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 111.0 · 96% clinician	no trial arm names this drug
Stomatitis (mouth sores)	1,285	128.2 122.6–134.0ROR 200.7 · calibrated p 4e-10 ✓	125.2 EB05 119.6 · IC025 +6.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 109.3 · 96% clinician	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Isopropyl Alcohol Spray (searched ISOPROPYL ALCOHOL SPRAY).

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
Pemphigus	1,529	832.0 797.5–867.9ROR 1,463.8 · calibrated p 3e-19 ✓	721.8 EB05 691.9 · IC025 +9.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 423.8 · 97% clinician	no trial arm names this drug
Glossodynia (burning tongue/mouth pain)	1,527	434.6 417.4–452.4ROR 763.4 · calibrated p 6e-16 ✓	402.5 EB05 385.8 · IC025 +8.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 339.8 · 96% clinician	no trial arm names this drug
Hand deformity	1,508	772.8 740.7–806.2ROR 1,345.5 · calibrated p 7e-19 ✓	676.7 EB05 648.5 · IC025 +9.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 430.7 · 96% clinician	no trial arm names this drug
Joint swelling	1,506	75.0 72.1–77.9ROR 129.8 · calibrated p 2e-8 ✓	74.0 EB05 70.9 · IC025 +6.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 74.1 · 97% clinician	no trial arm names this drug
Helicobacter infection	1,501	1,024.7 980.7–1,070.6ROR 1,778.3 · calibrated p 2e-20 ✓	862.3 EB05 826.3 · IC025 +9.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 534.6 · 96% clinician	no trial arm names this drug
Infusion related reaction (reaction during infusion)	1,494	137.1 131.8–142.6ROR 236.5 · calibrated p 9e-11 ✓	133.7 EB05 128.1 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 98.1 · 96% clinician	no trial arm names this drug
Systemic lupus erythematosus	1,490	260.6 250.3–271.2ROR 449.2 · calibrated p 2e-13 ✓	248.7 EB05 238.3 · IC025 +7.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 148.5 · 96% clinician	no trial arm names this drug
Irritable bowel syndrome	1,489	444.0 426.2–462.7ROR 765.7 · calibrated p 6e-16 ✓	410.6 EB05 393.4 · IC025 +8.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 304.0 · 96% clinician	no trial arm names this drug
Impaired healing	1,488	281.3 270.2–292.8ROR 484.5 · calibrated p 8e-14 ✓	267.5 EB05 256.3 · IC025 +7.9 3/3 methods agree	Reporting / coding artifact	serious PRR 188.3 · 96% clinician	no trial arm names this drug
Pericarditis	1,485	580.1 556.2–604.9ROR 998.5 · calibrated p 3e-17 ✓	524.2 EB05 502.2 · IC025 +8.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 308.7 · 96% clinician	no trial arm names this drug
Folliculitis	1,473	987.0 944.2–1,031.7ROR 1,689.7 · calibrated p 4e-20 ✓	835.3 EB05 800.1 · IC025 +9.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 575.9 · 96% clinician	no trial arm names this drug
Rash	1,467	20.1 19.3–20.9ROR 33.6 · calibrated p 1e-4 ✓	20.0 EB05 19.2 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.0 · 96% clinician	no trial arm names this drug
Wound	1,461	328.7 315.4–342.5ROR 559.0 · calibrated p 2e-14 ✓	310.0 EB05 296.9 · IC025 +8.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 215.1 · 96% clinician	no trial arm names this drug
Hypersensitivity (allergic reaction)	1,460	47.0 45.2–48.9ROR 79.3 · calibrated p 6e-7 ✓	46.6 EB05 44.7 · IC025 +5.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 51.1 · 96% clinician	no trial arm names this drug
Pain	1,459	14.1 13.5–14.6ROR 23.2 · calibrated p 1e-3 ✓	14.0 EB05 13.4 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.9 · 95% clinician	no trial arm names this drug

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.

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 Isopropyl Alcohol Spray?

In FDA FAERS, the most frequently co-reported reaction terms for Isopropyl Alcohol Spray are pemphigus, glossodynia, hand deformity, joint swelling, helicobacter infection, infusion related reaction. 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 Isopropyl Alcohol Spray have an FDA boxed warning?

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

Do FAERS signals prove that Isopropyl Alcohol Spray 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 116e0c9c-cbe0-bf67-e063-6394a90ae530, effective 20240215; matched on openfda.generic_name.exact:"ISOPROPYL ALCOHOL SPRAY")
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, 199 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 ISOPROPYL ALCOHOL SPRAY, 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.