Drug · FAERS side-effect profile with label screen
Antifungal Miconazole Powder Spray side effects: what 1,337 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Miconazole Nitrate
openFDA label
Who reports
1,337 reports · 47% serious · 85 with death outcome · 76% female
openFDA FAERS counts, all years, deduplication not applied
Used for
cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris) relieves symtoms of athlete's foot, including itching, burning and cracking
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 28 strongest signals
Reporting / coding artifact 8Lab value / disease marker 2No label text to screen 18
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. 11 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Vaginal discharge | 22 | 34.4 22.7–52.1ROR 35.0 · χ² 679 / p 5e-150 | 33.4 EB05 23.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 100% consumer | no trial data cached |
| International normalised ratio increased | 41 | 22.3 16.5–30.2ROR 23.0 · χ² 815 / p 2e-179 | 22.1 EB05 17.0 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 29.5 · 98% clinician | no trial data cached |
| Cytomegalovirus infection | 22 | 20.8 13.7–31.4ROR 21.1 · χ² 394 / p 6e-88 | 20.4 EB05 14.1 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.5 · 100% clinician | no trial data cached |
| Vaginal haemorrhage | 42 | 15.5 11.5–20.8ROR 15.9 · χ² 555 / p 6e-123 | 15.3 EB05 11.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 · ♀ 100% (drug 76%) · 98% consumer | no trial data cached |
| Application site pain | 19 | 13.5 8.7–21.2ROR 13.7 · χ² 208 / p 2e-47 | 12.8 EB05 8.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=5 | no trial data cached |
| Salivary hypersecretion | 7 | 11.0 5.2–23.0ROR 11.0 · χ² 54 / p 1e-13 | 8.0 EB05 3.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.1 | no trial data cached |
| Tooth abscess | 7 | 10.7 5.1–22.5ROR 10.8 · χ² 52 / p 2e-13 | 7.8 EB05 3.6 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.1 | no trial data cached |
| Blood calcium decreased | 7 | 9.7 4.6–20.4ROR 9.8 · χ² 46 / p 5e-12 | 7.0 EB05 3.3 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 14.8 | no trial data cached |
| Tooth infection | 8 | 9.5 4.8–19.0ROR 9.6 · χ² 53 / p 2e-13 | 7.1 EB05 3.6 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 | no trial data cached |
| Oral discomfort | 8 | 9.0 4.5–18.0ROR 9.1 · χ² 49 / p 1e-12 | 6.7 EB05 3.4 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 | no trial data cached |
| Product packaging issue | 5 | 8.4 3.5–20.3ROR 8.5 · χ² 26 / p 2e-7 | 5.4 EB05 2.4 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Skin fissures | 10 | 8.3 4.5–15.4ROR 8.4 · χ² 57 / p 2e-14 | 6.5 EB05 3.6 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Incorrect product administration duration | 10 | 7.7 4.2–14.3ROR 7.8 · χ² 52 / p 3e-13 | 6.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Skin haemorrhage | 7 | 7.6 3.6–15.9ROR 7.6 · χ² 34 / p 3e-9 | 5.5 EB05 2.8 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 | no trial data cached |
| Application site pruritus | 11 | 7.6 4.2–13.7ROR 7.7 · χ² 57 / p 3e-14 | 6.1 EB05 3.5 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Tooth loss | 10 | 7.5 4.0–13.9ROR 7.6 · χ² 50 / p 7e-13 | 5.9 EB05 3.3 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 | no trial data cached |
| Incorrect route of product administration | 8 | 7.5 3.7–14.9ROR 7.5 · χ² 39 / p 3e-10 | 5.6 EB05 3.0 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Basal cell carcinoma | 7 | 7.0 3.4–14.7ROR 7.1 · χ² 30 / p 2e-8 | 5.1 EB05 2.6 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| Mouth ulceration | 9 | 6.7 3.5–12.9ROR 6.7 · χ² 38 / p 3e-10 | 5.2 EB05 2.9 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 | no trial data cached |
| Drug effect less than expected | 6 | 6.7 3.0–14.8ROR 6.7 · χ² 24 / p 6e-7 | 4.7 EB05 2.3 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Pharyngeal oedema | 6 | 6.0 2.7–13.4ROR 6.1 · χ² 20 / p 3e-6 | 4.3 EB05 2.2 · IC025 +0.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 7 | 5.9 2.8–12.4ROR 6.0 · χ² 24 / p 5e-7 | 4.4 EB05 2.3 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 | no trial data cached |
| Incorrect drug administration duration | 9 | 4.9 2.6–9.5ROR 5.0 · χ² 25 / p 4e-7 | 4.0 EB05 2.3 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 13.2 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 7 | 4.9 2.3–10.3ROR 4.9 · χ² 18 / p 1e-5 | 3.8 EB05 2.0 · IC025 +0.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 | no trial data cached |
| Underdose | 21 | 4.5 2.9–6.9ROR 4.6 · χ² 54 / p 1e-13 | 4.1 EB05 2.9 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · 100% consumer | no trial data cached |
| Product administered at inappropriate site | 5 | 4.3 1.8–10.4ROR 4.3 · χ² 10 / p 1e-3 | 3.3 EB05 1.6 · IC025 +0.2 | Reporting / coding artifact | – | no trial data cached |
| Drug effective for unapproved indication | 8 | 4.3 2.2–8.6ROR 4.3 · χ² 17 / p 2e-5 | 3.5 EB05 2.0 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious n=1 | no trial data cached |
| Expired product administered | 6 | 2.8 1.3–6.3ROR 2.8 · χ² 5 / p 0.010 | 2.5 EB05 1.3 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | – | 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 |
|---|---|---|---|---|---|---|
| Vaginal haemorrhage | 42 | 15.5 11.5–20.8ROR 15.9 · χ² 555 / p 6e-123 | 15.3 EB05 11.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 · ♀ 100% (drug 76%) · 98% consumer | no trial data cached |
| International normalised ratio increased | 41 | 22.3 16.5–30.2ROR 23.0 · χ² 815 / p 2e-179 | 22.1 EB05 17.0 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 29.5 · 98% clinician | no trial data cached |
| Cytomegalovirus infection | 22 | 20.8 13.7–31.4ROR 21.1 · χ² 394 / p 6e-88 | 20.4 EB05 14.1 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.5 · 100% clinician | no trial data cached |
| Vaginal discharge | 22 | 34.4 22.7–52.1ROR 35.0 · χ² 679 / p 5e-150 | 33.4 EB05 23.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 100% consumer | no trial data cached |
| Underdose | 21 | 4.5 2.9–6.9ROR 4.6 · χ² 54 / p 1e-13 | 4.1 EB05 2.9 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · 100% consumer | no trial data cached |
| Application site pain | 19 | 13.5 8.7–21.2ROR 13.7 · χ² 208 / p 2e-47 | 12.8 EB05 8.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=5 | no trial data cached |
| Application site pruritus | 11 | 7.6 4.2–13.7ROR 7.7 · χ² 57 / p 3e-14 | 6.1 EB05 3.5 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Tooth loss | 10 | 7.5 4.0–13.9ROR 7.6 · χ² 50 / p 7e-13 | 5.9 EB05 3.3 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 | no trial data cached |
| Incorrect product administration duration | 10 | 7.7 4.2–14.3ROR 7.8 · χ² 52 / p 3e-13 | 6.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Skin fissures | 10 | 8.3 4.5–15.4ROR 8.4 · χ² 57 / p 2e-14 | 6.5 EB05 3.6 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Incorrect drug administration duration | 9 | 4.9 2.6–9.5ROR 5.0 · χ² 25 / p 4e-7 | 4.0 EB05 2.3 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 13.2 | no trial data cached |
| Mouth ulceration | 9 | 6.7 3.5–12.9ROR 6.7 · χ² 38 / p 3e-10 | 5.2 EB05 2.9 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 | no trial data cached |
| Drug effective for unapproved indication | 8 | 4.3 2.2–8.6ROR 4.3 · χ² 17 / p 2e-5 | 3.5 EB05 2.0 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious n=1 | no trial data cached |
| Incorrect route of product administration | 8 | 7.5 3.7–14.9ROR 7.5 · χ² 39 / p 3e-10 | 5.6 EB05 3.0 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Oral discomfort | 8 | 9.0 4.5–18.0ROR 9.1 · χ² 49 / p 1e-12 | 6.7 EB05 3.4 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 | 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 Antifungal Miconazole Powder Spray?
In FDA FAERS, the most frequently co-reported reaction terms for Antifungal Miconazole Powder Spray are vaginal haemorrhage, international normalised ratio increased, cytomegalovirus infection, vaginal discharge, application site pain, application site pruritus. 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 Antifungal Miconazole Powder Spray have an FDA boxed warning?
No. The FDA label retrieved for Antifungal Miconazole Powder Spray has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Antifungal Miconazole Powder 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 cc24f4ca-a403-0dc4-e053-2a95a90a5dad, effective 20251029; matched on
openfda.generic_name.exact:"ANTIFUNGAL MICONAZOLE POWDER 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, fieldpatient.drug.openfda.generic_name.exact, 39 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.