Drug · FAERS side-effect profile with label screen

Econazole side effects: what 920 FDA adverse event reports show

Econazole Nitrate · 34 reaction terms · 269 drug–reaction co-reports · data 2026-09-14

Drug class

Azole antifungal

FDA label, Indications wording of the closest related product

Label matched

Econazole Nitrate (Econazole Nitrate)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

920 reports · 65% serious · 53 with death outcome · 53% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Econazole nitrate topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. Econazole nitrate is an azole.

FDA label, Indications and Usage

What it is

Econazole nitrate topical foam, 1% contains the azole antifungal agent, econazole nitrate in an oil-in-water emulsion base consisting of the following inactive ingredients: dimethicone, glycerin, polysorbate 20, povidone, propylene glycol, stearic acid, trolamine, purified water and butane as a propellant.

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 23 strongest signals

Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 19

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.

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. 11 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
Vasculitis	14	27.4 16.3–46.1ROR 27.8 · χ² 330 / p 5e-74	26.5 EB05 16.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 22.2	no trial data cached
International normalised ratio increased	30	23.8 16.7–33.8ROR 24.5 · χ² 632 / p 9e-140	23.4 EB05 17.2 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	serious PRR 23.3 · 93% clinician	no trial data cached
Glaucoma	15	17.8 10.7–29.3ROR 18.0 · χ² 221 / p 3e-50	17.1 EB05 10.5 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.8	no trial data cached
Caesarean section	9	17.5 9.1–33.4ROR 17.6 · χ² 124 / p 5e-29	15.8 EB05 7.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Weight fluctuation	7	15.3 7.3–32.1ROR 15.4 · χ² 80 / p 2e-19	12.5 EB05 5.1 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Eosinophilia	11	14.4 8.0–25.8ROR 14.5 · χ² 124 / p 5e-29	12.8 EB05 6.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.2	no trial data cached
Blood sodium decreased	11	13.3 7.4–24.0ROR 13.5 · χ² 114 / p 8e-27	11.7 EB05 6.1 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	serious PRR 13.3	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	13	11.6 6.8–19.9ROR 11.8 · χ² 116 / p 3e-27	10.1 EB05 5.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.2	no trial data cached
Fungal infection	16	11.0 6.7–17.8ROR 11.1 · χ² 135 / p 2e-31	9.7 EB05 5.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.0	no trial data cached
Meningioma	7	10.8 5.2–22.7ROR 10.9 · χ² 53 / p 2e-13	7.9 EB05 3.6 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Hypoaesthesia oral	7	10.6 5.1–22.2ROR 10.7 · χ² 52 / p 3e-13	7.7 EB05 3.6 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 14.6	no trial data cached
Economic problem	7	10.4 4.9–21.7ROR 10.4 · χ² 50 / p 7e-13	7.5 EB05 3.5 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 10.0	no trial data cached
Anhedonia	12	10.3 5.9–18.1ROR 10.5 · χ² 92 / p 4e-22	8.6 EB05 4.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Hepatic cytolysis	5	9.3 3.9–22.4ROR 9.4 · χ² 29 / p 3e-8	5.9 EB05 2.6 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Anosmia (loss of smell)	5	7.9 3.3–18.8ROR 7.9 · χ² 23 / p 6e-7	5.1 EB05 2.3 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Procedural pain	9	7.4 3.9–14.2ROR 7.5 · χ² 44 / p 2e-11	5.7 EB05 3.1 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Dementia	9	7.4 3.8–14.1ROR 7.4 · χ² 43 / p 2e-11	5.6 EB05 3.1 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Drug exposure during pregnancy	11	7.3 4.0–13.1ROR 7.3 · χ² 53 / p 1e-13	5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 7.1	no trial data cached
Psychomotor hyperactivity	5	6.8 2.9–16.4ROR 6.9 · χ² 19 / p 5e-6	4.5 EB05 2.1 · IC025 +0.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.0	no trial data cached
Pain of skin	6	5.1 2.3–11.2ROR 5.1 · χ² 16 / p 4e-5	3.8 EB05 1.9 · IC025 +0.5	Not in label — unassessed	serious PRR 14.2	no trial data cached
Skin irritation	7	3.5 1.7–7.3ROR 3.5 · χ² 10 / p 8e-4	3.0 EB05 1.6 · IC025 +0.3	Not in label — unassessed	serious n=3	no trial data cached
Dermatitis atopic	7	3.2 1.5–6.7ROR 3.2 · χ² 8 / p 0.002	2.8 EB05 1.5 · IC025 +0.2	Not in label — unassessed	serious n=2	no trial data cached
Injection site pruritus	8	2.7 1.4–5.5ROR 2.8 · χ² 7 / p 0.004	2.5 EB05 1.4 · IC025 +0.1	Not in label — unassessed	serious PRR 4.2	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
International normalised ratio increased	30	23.8 16.7–33.8ROR 24.5 · χ² 632 / p 9e-140	23.4 EB05 17.2 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	serious PRR 23.3 · 93% clinician	no trial data cached
Fungal infection	16	11.0 6.7–17.8ROR 11.1 · χ² 135 / p 2e-31	9.7 EB05 5.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.0	no trial data cached
Glaucoma	15	17.8 10.7–29.3ROR 18.0 · χ² 221 / p 3e-50	17.1 EB05 10.5 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.8	no trial data cached
Vasculitis	14	27.4 16.3–46.1ROR 27.8 · χ² 330 / p 5e-74	26.5 EB05 16.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 22.2	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	13	11.6 6.8–19.9ROR 11.8 · χ² 116 / p 3e-27	10.1 EB05 5.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.2	no trial data cached
Anhedonia	12	10.3 5.9–18.1ROR 10.5 · χ² 92 / p 4e-22	8.6 EB05 4.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Drug exposure during pregnancy	11	7.3 4.0–13.1ROR 7.3 · χ² 53 / p 1e-13	5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 7.1	no trial data cached
Blood sodium decreased	11	13.3 7.4–24.0ROR 13.5 · χ² 114 / p 8e-27	11.7 EB05 6.1 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	serious PRR 13.3	no trial data cached
Eosinophilia	11	14.4 8.0–25.8ROR 14.5 · χ² 124 / p 5e-29	12.8 EB05 6.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.2	no trial data cached
Dementia	9	7.4 3.8–14.1ROR 7.4 · χ² 43 / p 2e-11	5.6 EB05 3.1 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Procedural pain	9	7.4 3.9–14.2ROR 7.5 · χ² 44 / p 2e-11	5.7 EB05 3.1 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Caesarean section	9	17.5 9.1–33.4ROR 17.6 · χ² 124 / p 5e-29	15.8 EB05 7.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Injection site pruritus	8	2.7 1.4–5.5ROR 2.8 · χ² 7 / p 0.004	2.5 EB05 1.4 · IC025 +0.1	Not in label — unassessed	serious PRR 4.2	no trial data cached
Dermatitis atopic	7	3.2 1.5–6.7ROR 3.2 · χ² 8 / p 0.002	2.8 EB05 1.5 · IC025 +0.2	Not in label — unassessed	serious n=2	no trial data cached
Skin irritation	7	3.5 1.7–7.3ROR 3.5 · χ² 10 / p 8e-4	3.0 EB05 1.6 · IC025 +0.3	Not in label — unassessed	serious n=3	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.

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 Econazole?

In FDA FAERS, the most frequently co-reported reaction terms for Econazole are international normalised ratio increased, fungal infection, glaucoma, vasculitis, drug reaction with eosinophilia and systemic symptoms, anhedonia. 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 Econazole have an FDA boxed warning?

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

Do FAERS signals prove that Econazole 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 3eb40c94-f369-ce4b-e063-6294a90abed4, effective 20251031; matched on openfda.generic_name.exact:"ECONAZOLE NITRATE")
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, 34 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.