Drug · FAERS side-effect profile with label screen
Miconazole side effects: what 2,412 FDA adverse event reports show
Brand names
Oravig
openFDA label
Who reports
2,412 reports · 84% serious · 287 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ORAVIG is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults. ORAVIG is an azole antifungal indicated for the local treatment of oropharyngeal candidiasis in adults.
FDA label, Indications and Usage
What it is
ORAVIG (miconazole) buccal tablets are applied topically to the gum once daily and release miconazole as the buccal tablet gradually dissolves [see Clinical Pharmacology (12.3)] . Miconazole i.
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 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 4Likely indication confounding 1Reporting / coding artifact 5Lab value / disease marker 2Not in label — unassessed 26
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 65 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 |
|---|---|---|---|---|---|---|
| International normalised ratio increased | 127 | 38.5 32.5–45.6ROR 40.6 · χ² 4,584 / p <1e-300 | 38.1 EB05 32.9 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious PRR 29.0 · 97% clinician | no trial data cached |
| Oral candidiasis (oral thrush) | 38 | 25.4 18.5–34.9ROR 25.8 · χ² 866 / p 1e-190 | 25.1 EB05 19.1 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.7 | no trial data cached |
| Drug interaction | 238 | 13.0 11.6–14.7ROR 14.4 · χ² 2,652 / p <1e-300 | 13.0 EB05 11.7 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 9.9 · 95% clinician | no trial data cached |
| Haematuria (blood in urine) | 48 | 12.2 9.2–16.1ROR 12.4 · χ² 481 / p 6e-107 | 11.9 EB05 9.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · ♀ 32% (drug 63%) · 96% clinician | no trial data cached |
| Candida infection (yeast infection) | 21 | 10.9 7.1–16.8ROR 11.0 · χ² 180 / p 3e-41 | 10.0 EB05 6.6 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.7 | no trial data cached |
| Full blood count abnormal | 13 | 10.7 6.2–18.4ROR 10.8 · χ² 105 / p 6e-25 | 9.1 EB05 5.2 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 9.7 | no trial data cached |
| Haematoma | 30 | 10.0 7.0–14.3ROR 10.1 · χ² 235 / p 3e-53 | 9.3 EB05 6.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 93% clinician | no trial data cached |
| Vaginal discharge | 11 | 9.5 5.3–17.2ROR 9.6 · χ² 76 / p 2e-18 | 7.7 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Eosinophilia | 19 | 9.5 6.0–14.8ROR 9.5 · χ² 135 / p 1e-31 | 8.3 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Cytomegalovirus infection | 17 | 8.9 5.5–14.3ROR 8.9 · χ² 111 / p 3e-26 | 7.7 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 21 | 8.2 5.4–12.5ROR 8.3 · χ² 126 / p 2e-29 | 7.2 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Pericardial effusion | 21 | 7.9 5.2–12.1ROR 8.0 · χ² 120 / p 3e-28 | 7.0 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 90% (drug 63%) · 95% clinician | no trial data cached |
| Application site pain | 19 | 7.5 4.8–11.7ROR 7.6 · χ² 101 / p 5e-24 | 6.5 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=6 | no trial data cached |
| Premature baby | 26 | 7.5 5.1–11.0ROR 7.6 · χ² 140 / p 2e-32 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Upper gastrointestinal haemorrhage | 14 | 7.2 4.3–12.2ROR 7.2 · χ² 69 / p 5e-17 | 6.0 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| End stage renal disease | 15 | 7.1 4.3–11.7ROR 7.1 · χ² 72 / p 9e-18 | 6.0 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Hyponatraemia (low sodium) | 45 | 7.0 5.2–9.3ROR 7.1 · χ² 224 / p 6e-51 | 6.6 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 12 | 6.9 3.9–12.2ROR 6.9 · χ² 55 / p 6e-14 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Hypokalaemia (low potassium) | 36 | 6.8 4.9–9.4ROR 6.9 · χ² 173 / p 7e-40 | 6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 97% clinician | no trial data cached |
| Acute respiratory failure | 15 | 6.8 4.1–11.3ROR 6.8 · χ² 69 / p 6e-17 | 5.8 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Economic problem | 12 | 6.8 3.8–11.9ROR 6.8 · χ² 53 / p 1e-13 | 5.5 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | no trial data cached |
| Fungal infection | 25 | 6.5 4.4–9.6ROR 6.6 · χ² 112 / p 2e-26 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 | no trial data cached |
| Haematemesis (vomiting blood) | 19 | 6.5 4.1–10.2ROR 6.5 · χ² 83 / p 4e-20 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Conjunctivitis | 13 | 6.1 3.6–10.6ROR 6.2 · χ² 51 / p 5e-13 | 5.1 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Drug level increased | 11 | 5.8 3.2–10.4ROR 5.8 · χ² 39 / p 2e-10 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 | no trial data cached |
| Pericarditis | 11 | 5.7 3.2–10.3ROR 5.8 · χ² 38 / p 3e-10 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Lip swelling | 21 | 5.5 3.6–8.4ROR 5.5 · χ² 73 / p 7e-18 | 4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 · 100% clinician | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 11 | 5.5 3.0–9.9ROR 5.5 · χ² 36 / p 1e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Multi-organ failure | 11 | 5.4 3.0–9.8ROR 5.5 · χ² 36 / p 1e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Acute respiratory distress syndrome | 11 | 5.4 3.0–9.7ROR 5.4 · χ² 35 / p 1e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Mouth ulceration | 13 | 5.4 3.1–9.2ROR 5.4 · χ² 42 / p 5e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Cellulitis (skin infection) | 31 | 5.3 3.8–7.6ROR 5.4 · χ² 105 / p 5e-25 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Drug exposure during pregnancy | 21 | 5.3 3.5–8.1ROR 5.3 · χ² 69 / p 5e-17 | 4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Chronic kidney disease | 46 | 5.2 3.9–6.9ROR 5.3 · χ² 153 / p 2e-35 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 11 | 5.2 2.9–9.3ROR 5.2 · χ² 33 / p 5e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 | no trial data cached |
| Dermatitis | 12 | 5.0 2.9–8.9ROR 5.1 · χ² 35 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Pancytopenia (all blood cells low) | 31 | 4.8 3.4–6.9ROR 4.9 · χ² 91 / p 9e-22 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · ♀ 42% (drug 63%) · 93% clinician | no trial data cached |
| Melaena (black stool) | 12 | 4.7 2.7–8.3ROR 4.7 · χ² 32 / p 9e-9 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Liver function test abnormal | 15 | 4.5 2.7–7.4ROR 4.5 · χ² 37 / p 6e-10 | 4.0 EB05 2.6 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 | no trial data cached |
| Anhedonia | 13 | 4.3 2.5–7.3ROR 4.3 · χ² 29 / p 3e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | 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 |
|---|---|---|---|---|---|---|
| Drug interaction | 238 | 13.0 11.6–14.7ROR 14.4 · χ² 2,652 / p <1e-300 | 13.0 EB05 11.7 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 9.9 · 95% clinician | no trial data cached |
| International normalised ratio increased | 127 | 38.5 32.5–45.6ROR 40.6 · χ² 4,584 / p <1e-300 | 38.1 EB05 32.9 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious PRR 29.0 · 97% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 50 | 3.9 3.0–5.1ROR 4.0 · χ² 105 / p 5e-25 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Haematuria (blood in urine) | 48 | 12.2 9.2–16.1ROR 12.4 · χ² 481 / p 6e-107 | 11.9 EB05 9.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · ♀ 32% (drug 63%) · 96% clinician | no trial data cached |
| Chronic kidney disease | 46 | 5.2 3.9–6.9ROR 5.3 · χ² 153 / p 2e-35 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Hyponatraemia (low sodium) | 45 | 7.0 5.2–9.3ROR 7.1 · χ² 224 / p 6e-51 | 6.6 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Gastrointestinal haemorrhage | 39 | 4.0 3.0–5.5ROR 4.1 · χ² 86 / p 8e-21 | 3.9 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Oral candidiasis (oral thrush) | 38 | 25.4 18.5–34.9ROR 25.8 · χ² 866 / p 1e-190 | 25.1 EB05 19.1 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.7 | no trial data cached |
| Hypokalaemia (low potassium) | 36 | 6.8 4.9–9.4ROR 6.9 · χ² 173 / p 7e-40 | 6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 97% clinician | no trial data cached |
| Swelling face | 31 | 4.1 2.9–5.9ROR 4.2 · χ² 71 / p 2e-17 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 83% (drug 63%) · 90% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 31 | 4.8 3.4–6.9ROR 4.9 · χ² 91 / p 9e-22 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · ♀ 42% (drug 63%) · 93% clinician | no trial data cached |
| Cellulitis (skin infection) | 31 | 5.3 3.8–7.6ROR 5.4 · χ² 105 / p 5e-25 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Haematoma | 30 | 10.0 7.0–14.3ROR 10.1 · χ² 235 / p 3e-53 | 9.3 EB05 6.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 93% clinician | no trial data cached |
| Burning sensation | 28 | 3.5 2.4–5.0ROR 3.5 · χ² 47 / p 4e-12 | 3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.3 · ♀ 83% (drug 63%) · 85% consumer | no trial data cached |
| Foetal exposure during pregnancy | 26 | 2.8 1.9–4.1ROR 2.8 · χ² 28 / p 6e-8 | 2.7 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Haematuria — n=48, PRR 12.2
- Haematoma — n=30, PRR 10.0
- Stevens-johnson syndrome — n=21, PRR 8.2
- Pericardial effusion — n=21, PRR 7.9
- Premature baby — n=26, PRR 7.5
- Hyponatraemia — n=45, PRR 7.0
- Hypokalaemia — n=36, PRR 6.8
- Cellulitis — n=31, PRR 5.3
- Chronic kidney disease — n=46, PRR 5.2
- Pancytopenia — n=31, PRR 4.8
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 Miconazole?
In FDA FAERS, the most frequently co-reported reaction terms for Miconazole are international normalised ratio increased, thrombocytopenia, haematuria, chronic kidney disease, hyponatraemia, gastrointestinal haemorrhage. 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 Miconazole have an FDA boxed warning?
No. The FDA label retrieved for Miconazole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Miconazole 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 dc2427ff-e566-4b48-b289-9e51c011250a, effective 20260108; matched on
openfda.generic_name.exact:"MICONAZOLE" 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, fieldpatient.drug.openfda.generic_name.exact, 105 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.