Salicylic Acid side effects: what 52,579 FDA adverse event reports show

Salicylic Acid · 903 reaction terms · 143,516 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

52,579 reports · 4% serious · 632 with death outcome · 73% female

openFDA FAERS counts, all years, deduplication not applied

Used for

This product is indicated for the topical treatment and removal of common warts and plantar warts.

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 1Lab value / disease marker 2No label text to screen 37

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). 863 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
Broncholithiasis	15	368.0 182.0–744.3ROR 368.1 · calibrated p 2e-10 ✓	153.6 EB05 98.8 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=15	no trial arm names this drug
Lichen nitidus	10	157.0 75.4–326.9ROR 157.0 · calibrated p 1e-7 ✓	93.0 EB05 54.0 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=10	no trial arm names this drug
Chemical burn of skin	533	105.1 95.5–115.6ROR 106.2 · calibrated p 8e-8 ✓	82.9 EB05 77.1 · IC025 +6.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=8 · 98% consumer	no trial arm names this drug
Skin irritation	7,729	80.8 78.9–82.6ROR 94.5 · calibrated p 2e-7 ✓	67.2 EB05 65.9 · IC025 +6.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=13 · 99% consumer	no trial arm names this drug
Skin burning sensation	11,556	77.4 76.0–78.8ROR 98.9 · calibrated p 1e-7 ✓	64.8 EB05 63.8 · IC025 +6.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.5 · 99% consumer	no trial arm names this drug
Acne	11,763	72.8 71.5–74.1ROR 93.5 · calibrated p 2e-7 ✓	61.6 EB05 60.6 · IC025 +5.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.0 · 99% consumer	no trial arm names this drug
Skin fragility	332	62.7 55.8–70.3ROR 63.0 · calibrated p 3e-6 ✓	54.0 EB05 49.3 · IC025 +5.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	100% consumer	no trial arm names this drug
Pain of skin	3,499	59.3 57.3–61.4ROR 63.5 · calibrated p 3e-6 ✓	51.7 EB05 50.2 · IC025 +5.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.1 · 99% consumer	no trial arm names this drug
Acne cystic	378	56.9 51.1–63.4ROR 57.3 · calibrated p 6e-6 ✓	49.7 EB05 45.7 · IC025 +5.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	99% consumer	no trial arm names this drug
Sensitive skin	884	55.4 51.7–59.4ROR 56.3 · calibrated p 6e-6 ✓	48.6 EB05 46.0 · IC025 +5.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=3 · 99% consumer	no trial arm names this drug
Seborrhoea	434	53.2 48.1–58.8ROR 53.6 · calibrated p 9e-6 ✓	46.9 EB05 43.3 · IC025 +5.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=4 · 100% consumer	no trial arm names this drug
Acne pustular	95	52.2 42.2–64.7ROR 52.3 · calibrated p 1e-5 ✓	45.8 EB05 38.6 · IC025 +4.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	100% consumer	no trial arm names this drug
Skin hypopigmentation	175	44.1 37.8–51.6ROR 44.3 · calibrated p 3e-5 ✓	39.6 EB05 34.9 · IC025 +4.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	100% consumer	no trial arm names this drug
Dry skin	12,766	42.8 42.1–43.5ROR 56.2 · calibrated p 6e-6 ✓	38.7 EB05 38.1 · IC025 +5.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 6.6 · 99% consumer	no trial arm names this drug
Skin discomfort	236	38.8 33.9–44.3ROR 39.0 · calibrated p 6e-5 ✓	35.3 EB05 31.7 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	99% consumer	no trial arm names this drug
Anti-cyclic citrullinated peptide antibody	59	38.6 29.5–50.4ROR 38.6 · calibrated p 8e-5 ✓	34.9 EB05 28.0 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious n=59 · ♀ 100% (drug 73%) · 98% clinician	no trial arm names this drug
Skin swelling	730	37.4 34.7–40.3ROR 37.9 · calibrated p 7e-5 ✓	34.2 EB05 32.2 · IC025 +4.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5 · 99% consumer	no trial arm names this drug
Seronegative arthritis	95	36.8 29.8–45.4ROR 36.9 · calibrated p 1e-4 ✓	33.5 EB05 28.2 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=95 · ♀ 100% (drug 73%) · 100% clinician	no trial arm names this drug
Lupus vulgaris	96	34.9 28.4–43.0ROR 35.0 · calibrated p 1e-4 ✓	32.0 EB05 27.0 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=96 · ♀ 100% (drug 73%) · 100% clinician	no trial arm names this drug
Skin hyperpigmentation	679	34.3 31.7–37.0ROR 34.7 · calibrated p 1e-4 ✓	31.6 EB05 29.6 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=6 · 99% consumer	no trial arm names this drug
Lymph node calcification	15	33.1 19.5–56.0ROR 33.1 · calibrated p 4e-4 ✓	29.6 EB05 19.0 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=15	no trial arm names this drug
Skin exfoliation	5,759	29.6 28.9–30.4ROR 33.2 · calibrated p 2e-4 ✓	27.6 EB05 27.0 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 6.5 · 99% consumer	no trial arm names this drug
Choroiditis	24	27.2 18.0–41.1ROR 27.2 · calibrated p 7e-4 ✓	25.0 EB05 17.7 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=24 · ♀ 0% (drug 73%)	no trial arm names this drug
Erythema (skin redness)	12,317	25.4 25.0–25.8ROR 32.9 · calibrated p 2e-4 ✓	23.9 EB05 23.6 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 5.5 · 99% consumer	no trial arm names this drug
Retinitis	93	23.5 19.0–28.9ROR 23.5 · calibrated p 0.001 ✓	22.1 EB05 18.6 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=93 · ♀ 100% (drug 73%) · 97% clinician	no trial arm names this drug
Rash papular	1,168	21.8 20.6–23.1ROR 22.3 · calibrated p 0.001 ✓	20.7 EB05 19.8 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.6 · 99% consumer	no trial arm names this drug
Skin tightness	239	21.4 18.8–24.3ROR 21.5 · calibrated p 0.001 ✓	20.3 EB05 18.2 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=6 · 99% consumer	no trial arm names this drug
Chemical burn	51	18.7 14.1–24.8ROR 18.7 · calibrated p 0.003 ✓	17.8 EB05 14.0 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=11 · 94% consumer	no trial arm names this drug
Deep vein thrombosis postoperative	75	15.8 12.6–19.9ROR 15.8 · calibrated p 0.006 ✓	15.2 EB05 12.5 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=75 · ♀ 100% (drug 73%) · 96% clinician	no trial arm names this drug
Adjustment disorder with depressed mood	77	15.8 12.6–19.8ROR 15.8 · calibrated p 0.006 ✓	15.1 EB05 12.5 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=77 · ♀ 100% (drug 73%) · 99% clinician	no trial arm names this drug
Rash macular	1,261	15.0 14.1–15.8ROR 15.3 · calibrated p 0.006 ✓	14.4 EB05 13.8 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.4 · 99% consumer	no trial arm names this drug
Dislocation of vertebra	71	13.1 10.4–16.6ROR 13.1 · calibrated p 0.013 ✓	12.6 EB05 10.2 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=71 · ♀ 100% (drug 73%) · 96% clinician	no trial arm names this drug
Skin fissures	598	13.0 12.0–14.1ROR 13.2 · calibrated p 0.012 ✓	12.6 EB05 11.8 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=17 · 98% consumer	no trial arm names this drug
Dermatitis	650	12.9 11.9–13.9ROR 13.0 · calibrated p 0.012 ✓	12.5 EB05 11.7 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 4.1 · 99% consumer	no trial arm names this drug
Swollen joint count increased	96	12.6 10.3–15.5ROR 12.7 · calibrated p 0.015 ✓	12.1 EB05 10.2 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious n=96 · ♀ 100% (drug 73%) · 100% clinician	no trial arm names this drug
Scar	479	11.4 10.4–12.5ROR 11.5 · calibrated p 0.020 ✓	11.1 EB05 10.3 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 4.2 · 99% consumer	no trial arm names this drug
Inappropriate schedule of product administration	4,809	11.1 10.8–11.4ROR 12.1 · calibrated p 0.016 ✓	10.8 EB05 10.6 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 2.5 · 99% consumer	no trial arm names this drug
Scab	292	10.5 9.4–11.8ROR 10.6 · calibrated p 0.027 ✓	10.2 EB05 9.3 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=9 · 98% consumer	no trial arm names this drug
Skin warm	141	9.9 8.4–11.7ROR 9.9 · calibrated p 0.035 ✓	9.5 EB05 8.2 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=3 · 100% consumer	no trial arm names this drug
Eyelid exfoliation	18	9.3 5.8–14.9ROR 9.3 · calibrated p 0.052	8.0 EB05 5.1 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=3	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Salicylic Acid only as a background or rescue medication (NCT01225562, NCT01082874); 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
Drug ineffective (drug did not work)	13,789	4.2 4.2–4.3ROR 5.4 · calibrated p 0.200	4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.7 · 99% consumer	no trial arm names this drug
Dry skin	12,766	42.8 42.1–43.5ROR 56.2 · calibrated p 6e-6 ✓	38.7 EB05 38.1 · IC025 +5.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 6.6 · 99% consumer	no trial arm names this drug
Erythema (skin redness)	12,317	25.4 25.0–25.8ROR 32.9 · calibrated p 2e-4 ✓	23.9 EB05 23.6 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 5.5 · 99% consumer	no trial arm names this drug
Acne	11,763	72.8 71.5–74.1ROR 93.5 · calibrated p 2e-7 ✓	61.6 EB05 60.6 · IC025 +5.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.0 · 99% consumer	no trial arm names this drug
Skin burning sensation	11,556	77.4 76.0–78.8ROR 98.9 · calibrated p 1e-7 ✓	64.8 EB05 63.8 · IC025 +6.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.5 · 99% consumer	no trial arm names this drug
Skin irritation	7,729	80.8 78.9–82.6ROR 94.5 · calibrated p 2e-7 ✓	67.2 EB05 65.9 · IC025 +6.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=13 · 99% consumer	no trial arm names this drug
Skin exfoliation	5,759	29.6 28.9–30.4ROR 33.2 · calibrated p 2e-4 ✓	27.6 EB05 27.0 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 6.5 · 99% consumer	no trial arm names this drug
Inappropriate schedule of product administration	4,809	11.1 10.8–11.4ROR 12.1 · calibrated p 0.016 ✓	10.8 EB05 10.6 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 2.5 · 99% consumer	no trial arm names this drug
Rash	4,766	4.4 4.3–4.5ROR 4.8 · calibrated p 0.262	4.4 EB05 4.3 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 5.2 · 97% consumer	no trial arm names this drug
Overdose	3,778	7.1 6.8–7.3ROR 7.5 · calibrated p 0.080	7.0 EB05 6.8 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 1.3 · 99% consumer	no trial arm names this drug
Pain of skin	3,499	59.3 57.3–61.4ROR 63.5 · calibrated p 3e-6 ✓	51.7 EB05 50.2 · IC025 +5.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.1 · 99% consumer	no trial arm names this drug
Pruritus (itching)	3,474	3.7 3.6–3.8ROR 3.9 · calibrated p 0.400	3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.7 · 95% consumer	no trial arm names this drug
Hypersensitivity (allergic reaction)	2,988	6.5 6.3–6.8ROR 6.9 · calibrated p 0.105	6.4 EB05 6.2 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.1 · 94% consumer	no trial arm names this drug
Condition aggravated	1,660	2.2 2.1–2.3ROR 2.2 · calibrated p 0.933	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 5.1 · 89% consumer	no trial arm names this drug
Underdose	1,482	8.2 7.8–8.7ROR 8.4 · calibrated p 0.056	8.1 EB05 7.7 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.8 · 98% consumer	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.

✓ 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 Salicylic Acid?

In FDA FAERS, the most frequently co-reported reaction terms for Salicylic Acid are dry skin, erythema, acne, skin burning sensation, skin irritation, skin exfoliation. 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 Salicylic Acid have an FDA boxed warning?

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

Do FAERS signals prove that Salicylic 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 17b570e7-3cf8-2f20-e054-00144ff8d46c, effective 20171218; matched on openfda.generic_name.exact:"SALICYLIC 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, 903 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 SALICYLIC ACID, 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.