70%Isopropyl Alcohol side effects: what 3,572 FDA adverse event reports show

70%Isopropyl Alcohol · Alcohol Prep Pads · 199 reaction terms · 131,858 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Alcohol Prep Pads

openFDA label

Who reports

3,572 reports · 99% serious · 2,331 with death outcome · 98% female

openFDA FAERS counts, all years, deduplication not applied

Used for

For the preparation of the skin prior to an injection Wipe injection site vigorously and discard Alcohol Swab

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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 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	1,015.5 971.8–1,061.2ROR 1,750.8 · χ² 1,294,116 / p <1e-300	854.7 EB05 819.0 · IC025 +9.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 531.6 · 96% clinician	no trial arm names this drug
Folliculitis	1,473	978.2 935.7–1,022.6ROR 1,663.9 · χ² 1,229,926 / p <1e-300	827.9 EB05 793.0 · IC025 +9.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 572.6 · 96% clinician	no trial arm names this drug
Pemphigus	1,529	824.5 790.3–860.2ROR 1,440.8 · χ² 1,100,829 / p <1e-300	715.4 EB05 685.8 · IC025 +9.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 421.4 · 97% clinician	no trial arm names this drug
Hand deformity	1,508	765.8 734.0–799.1ROR 1,324.6 · χ² 1,017,311 / p <1e-300	670.7 EB05 642.8 · IC025 +9.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 428.2 · 96% clinician	no trial arm names this drug
Pericarditis	1,485	574.9 551.2–599.6ROR 983.2 · χ² 773,992 / p <1e-300	519.5 EB05 497.7 · IC025 +8.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 306.9 · 96% clinician	no trial arm names this drug
Hypercholesterolaemia	772	515.7 482.8–550.8ROR 657.6 · χ² 363,834 / p <1e-300	468.1 EB05 441.0 · IC025 +8.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 293.0 · 94% clinician	no trial arm names this drug
Synovitis	1,407	496.8 475.6–518.8ROR 819.0 · χ² 641,240 / p <1e-300	454.8 EB05 435.2 · IC025 +8.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 279.0 · 97% clinician	no trial arm names this drug
Joint range of motion decreased	1,027	489.0 463.0–516.4ROR 685.9 · χ² 461,037 / p <1e-300	447.2 EB05 424.7 · IC025 +8.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 334.6 · 94% clinician	no trial arm names this drug
Irritable bowel syndrome	1,489	440.1 422.3–458.6ROR 753.9 · χ² 606,428 / p <1e-300	406.9 EB05 389.9 · IC025 +8.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 302.3 · 96% clinician	no trial arm names this drug
Glossodynia (burning tongue/mouth pain)	1,527	430.7 413.6–448.4ROR 751.5 · χ² 609,513 / p <1e-300	398.9 EB05 382.4 · IC025 +8.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 337.9 · 96% clinician	no trial arm names this drug
Wound infection	727	421.1 393.5–450.6ROR 528.4 · χ² 283,780 / p <1e-300	388.6 EB05 365.4 · IC025 +8.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 245.1 · 93% clinician	no trial arm names this drug
Autoimmune disorder	521	338.1 311.4–367.0ROR 395.6 · χ² 165,196 / p <1e-300	315.8 EB05 293.7 · IC025 +7.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 198.9 · 97% clinician	no trial arm names this drug
Bursitis	655	337.1 313.8–362.2ROR 412.6 · χ² 207,242 / p <1e-300	315.7 EB05 295.9 · IC025 +7.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 218.3 · 94% clinician	no trial arm names this drug
Wound	1,461	325.7 312.6–339.5ROR 550.5 · χ² 448,095 / p <1e-300	307.2 EB05 294.2 · IC025 +8.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 213.8 · 96% clinician	no trial arm names this drug
Fibromyalgia	1,137	288.4 274.4–303.1ROR 422.6 · χ² 310,316 / p <1e-300	273.5 EB05 260.4 · IC025 +7.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 210.4 · 95% clinician	no trial arm names this drug
Impaired healing	1,488	278.7 267.7–290.2ROR 477.1 · χ² 393,245 / p <1e-300	265.1 EB05 254.0 · IC025 +7.8 3/3 methods agree	Reporting / coding artifact	serious PRR 187.3 · 96% clinician	no trial arm names this drug
Systemic lupus erythematosus	1,490	258.2 248.0–268.8ROR 442.3 · χ² 365,846 / p <1e-300	246.5 EB05 236.1 · IC025 +7.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 147.7 · 96% clinician	no trial arm names this drug
Liver injury	1,017	257.8 244.4–272.0ROR 360.0 · χ² 249,119 / p <1e-300	245.7 EB05 233.3 · IC025 +7.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 149.0 · 95% clinician	no trial arm names this drug
Type 2 diabetes mellitus	1,289	233.0 222.8–243.7ROR 364.0 · χ² 286,493 / p <1e-300	223.3 EB05 213.2 · IC025 +7.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 137.4 · 96% clinician	no trial arm names this drug
Sciatica	554	212.5 196.5–229.8ROR 251.3 · χ² 112,382 / p <1e-300	203.6 EB05 189.8 · IC025 +7.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 160.4 · 97% clinician	no trial arm names this drug
Pulmonary fibrosis	666	212.0 197.7–227.4ROR 260.4 · χ² 134,842 / p <1e-300	203.4 EB05 190.7 · IC025 +7.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 120.4 · 97% clinician	no trial arm names this drug
Obesity	555	211.6 195.7–228.8ROR 250.3 · χ² 112,111 / p <1e-300	202.8 EB05 189.0 · IC025 +7.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 137.7 · 94% clinician	no trial arm names this drug
Laryngitis	336	187.5 169.1–208.0ROR 206.9 · χ² 60,228 / p <1e-300	179.8 EB05 164.2 · 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	186.0 175.7–196.8ROR 250.7 · χ² 165,110 / p <1e-300	179.5 EB05 170.0 · IC025 +7.3 3/3 methods agree	Reporting / coding artifact	serious PRR 130.7 · 94% clinician	no trial arm names this drug
Psoriatic arthropathy	1,223	184.1 175.8–192.9ROR 279.5 · χ² 216,147 / p <1e-300	178.0 EB05 169.8 · IC025 +7.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 130.9 · 96% clinician	no trial arm names this drug
Lower limb fracture	550	174.1 161.0–188.3ROR 205.6 · χ² 91,819 / p <1e-300	168.1 EB05 156.6 · IC025 +7.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 108.1 · 96% clinician	no trial arm names this drug
Foot deformity	317	172.6 155.1–192.1ROR 189.3 · χ² 52,387 / p <1e-300	166.0 EB05 151.2 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 113.5 · 97% clinician	no trial arm names this drug
Red blood cell sedimentation rate increased	315	171.6 154.2–191.0ROR 188.1 · χ² 51,756 / p <1e-300	165.1 EB05 150.3 · IC025 +6.9 3/3 methods agree	Lab value / disease marker	serious PRR 110.1 · 97% clinician	no trial arm names this drug
Lower respiratory tract infection	1,253	167.0 159.5–174.7ROR 256.6 · χ² 201,180 / p <1e-300	161.9 EB05 154.5 · IC025 +7.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 100.0 · 96% clinician	no trial arm names this drug
Hip arthroplasty	405	160.9 146.6–176.6ROR 181.3 · χ² 62,495 / p <1e-300	155.4 EB05 143.1 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 94.0 · 98% clinician	no trial arm names this drug
Joint dislocation	280	160.4 143.1–179.8ROR 173.9 · χ² 43,020 / p <1e-300	154.5 EB05 139.9 · IC025 +6.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 102.3 · 98% clinician	no trial arm names this drug
Prescribed overdose	510	158.9 146.5–172.4ROR 185.2 · χ² 77,807 / p <1e-300	153.8 EB05 142.9 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 153.6 · 95% clinician	no trial arm names this drug
Gait inability	784	142.4 133.8–151.7ROR 182.2 · χ² 107,488 / p <1e-300	138.6 EB05 130.6 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 100.7 · 94% clinician	no trial arm names this drug
Blister	1,302	139.7 133.7–146.0ROR 219.2 · χ² 175,378 / p <1e-300	136.1 EB05 130.0 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 131.4 · 96% clinician	no trial arm names this drug
Arthropathy	1,279	137.8 131.7–144.1ROR 214.1 · χ² 169,939 / p <1e-300	134.3 EB05 128.3 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 95.5 · 96% clinician	no trial arm names this drug
Infusion related reaction (reaction during infusion)	1,494	135.9 130.6–141.3ROR 232.8 · χ² 195,902 / p <1e-300	132.5 EB05 127.0 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 97.5 · 96% clinician	no trial arm names this drug
Blood cholesterol increased	1,039	133.8 127.0–140.9ROR 188.2 · χ² 133,994 / p <1e-300	130.5 EB05 123.9 · IC025 +6.8 3/3 methods agree	Lab value / disease marker	serious PRR 115.5 · 96% clinician	no trial arm names this drug
Hepatic enzyme increased	1,457	128.6 123.6–133.9ROR 216.5 · χ² 180,958 / p <1e-300	125.6 EB05 120.3 · IC025 +6.8 3/3 methods agree	Lab value / disease marker	serious PRR 106.0 · 96% clinician	no trial arm names this drug
Ill-defined disorder	1,302	128.5 122.9–134.3ROR 201.6 · χ² 161,464 / p <1e-300	125.5 EB05 119.9 · IC025 +6.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 110.3 · 96% clinician	no trial arm names this drug
Stomatitis (mouth sores)	1,285	127.0 121.5–132.8ROR 197.9 · χ² 157,573 / p <1e-300	124.1 EB05 118.5 · IC025 +6.8 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

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning 70%Isopropyl Alcohol only as a background or rescue medication (NCT03523962, NCT02203591); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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	824.5 790.3–860.2ROR 1,440.8 · χ² 1,100,829 / p <1e-300	715.4 EB05 685.8 · IC025 +9.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 421.4 · 97% clinician	no trial arm names this drug
Glossodynia (burning tongue/mouth pain)	1,527	430.7 413.6–448.4ROR 751.5 · χ² 609,513 / p <1e-300	398.9 EB05 382.4 · IC025 +8.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 337.9 · 96% clinician	no trial arm names this drug
Hand deformity	1,508	765.8 734.0–799.1ROR 1,324.6 · χ² 1,017,311 / p <1e-300	670.7 EB05 642.8 · IC025 +9.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 428.2 · 96% clinician	no trial arm names this drug
Joint swelling	1,506	74.3 71.5–77.3ROR 127.8 · χ² 108,093 / p <1e-300	73.3 EB05 70.3 · IC025 +6.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 73.7 · 97% clinician	no trial arm names this drug
Helicobacter infection	1,501	1,015.5 971.8–1,061.2ROR 1,750.8 · χ² 1,294,116 / p <1e-300	854.7 EB05 819.0 · IC025 +9.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 531.6 · 96% clinician	no trial arm names this drug
Infusion related reaction (reaction during infusion)	1,494	135.9 130.6–141.3ROR 232.8 · χ² 195,902 / p <1e-300	132.5 EB05 127.0 · IC025 +6.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 97.5 · 96% clinician	no trial arm names this drug
Systemic lupus erythematosus	1,490	258.2 248.0–268.8ROR 442.3 · χ² 365,846 / p <1e-300	246.5 EB05 236.1 · IC025 +7.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 147.7 · 96% clinician	no trial arm names this drug
Irritable bowel syndrome	1,489	440.1 422.3–458.6ROR 753.9 · χ² 606,428 / p <1e-300	406.9 EB05 389.9 · IC025 +8.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 302.3 · 96% clinician	no trial arm names this drug
Impaired healing	1,488	278.7 267.7–290.2ROR 477.1 · χ² 393,245 / p <1e-300	265.1 EB05 254.0 · IC025 +7.8 3/3 methods agree	Reporting / coding artifact	serious PRR 187.3 · 96% clinician	no trial arm names this drug
Pericarditis	1,485	574.9 551.2–599.6ROR 983.2 · χ² 773,992 / p <1e-300	519.5 EB05 497.7 · IC025 +8.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 306.9 · 96% clinician	no trial arm names this drug
Folliculitis	1,473	978.2 935.7–1,022.6ROR 1,663.9 · χ² 1,229,926 / p <1e-300	827.9 EB05 793.0 · IC025 +9.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 572.6 · 96% clinician	no trial arm names this drug
Rash	1,469	20.0 19.2–20.8ROR 33.2 · χ² 26,894 / p <1e-300	19.9 EB05 19.0 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 25.9 · 96% clinician	no trial arm names this drug
Pain	1,461	14.0 13.4–14.5ROR 22.9 · χ² 18,069 / p <1e-300	13.9 EB05 13.3 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.8 · 95% clinician	no trial arm names this drug
Wound	1,461	325.7 312.6–339.5ROR 550.5 · χ² 448,095 / p <1e-300	307.2 EB05 294.2 · IC025 +8.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 213.8 · 96% clinician	no trial arm names this drug
Hypersensitivity (allergic reaction)	1,460	46.6 44.8–48.5ROR 78.1 · χ² 65,164 / p <1e-300	46.2 EB05 44.3 · IC025 +5.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 50.8 · 96% 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 70%Isopropyl Alcohol?

In FDA FAERS, the most frequently co-reported reaction terms for 70%Isopropyl Alcohol 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 70%Isopropyl Alcohol have an FDA boxed warning?

No. The FDA label retrieved for 70%Isopropyl Alcohol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that 70%Isopropyl Alcohol 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 da108e12-4327-db1c-e053-2a95a90a211b, effective 20231027; matched on openfda.generic_name.exact:"70%ISOPROPYL ALCOHOL")
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 70%ISOPROPYL ALCOHOL, results-bearing studies sorted by enrollment)

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.