Drug · FAERS side-effect profile with label screen
Miconazole Nitrate side effects: what 8,674 FDA adverse event reports show
Brand names
Oravig
openFDA label
Who reports
8,674 reports · 39% serious · 432 with death outcome · 82% 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 1Labeled (related wording) 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 36
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.
- 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. 971 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 |
|---|---|---|---|---|---|---|
| Chemical burn of genitalia | 75 | 4,157.7 2,859.5–6,045.4ROR 4,194.0 · χ² 112,069 / p <1e-300 | 1,090.3 EB05 898.4 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=14 · 100% consumer | no trial data cached |
| Vulvovaginal burning sensation | 1,864 | 1,070.2 1,017.5–1,125.5ROR 1,362.7 · χ² 1,373,821 / p <1e-300 | 733.3 EB05 705.8 · IC025 +9.2 3/3 methods agree | Not in label — unassessed | serious n=109 · 99% consumer | no trial data cached |
| Vulvovaginal exfoliation | 12 | 733.5 384.2–1,400.3ROR 734.5 · χ² 6,164 / p <1e-300 | 296.2 EB05 180.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Vaginal erosion | 35 | 689.5 473.6–1,003.8ROR 692.3 · χ² 18,134 / p <1e-300 | 413.6 EB05 310.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=4 · 89% consumer | no trial data cached |
| Vulvovaginal pain | 1,001 | 641.8 600.5–685.9ROR 725.3 · χ² 504,189 / p <1e-300 | 501.0 EB05 475.5 · IC025 +8.6 3/3 methods agree | Not in label — unassessed | serious n=39 · 99% consumer | no trial data cached |
| Vulvovaginal swelling | 317 | 511.3 453.7–576.2ROR 530.6 · χ² 132,520 / p <1e-300 | 410.7 EB05 374.1 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious n=31 · 99% consumer | no trial data cached |
| Vaginal mucosal blistering | 36 | 461.4 323.1–658.8ROR 463.3 · χ² 13,473 / p <1e-300 | 320.7 EB05 242.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=4 · 91% consumer | no trial data cached |
| Vulvovaginal erythema | 110 | 369.3 302.5–451.0ROR 374.0 · χ² 34,668 / p <1e-300 | 303.0 EB05 258.4 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=9 · 100% consumer | no trial data cached |
| Vulvovaginal injury | 72 | 361.3 282.3–462.6ROR 364.3 · χ² 22,155 / p <1e-300 | 289.7 EB05 237.8 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | 100% consumer | no trial data cached |
| Vulvovaginal pruritus | 616 | 336.3 309.9–364.9ROR 361.9 · χ² 180,196 / p <1e-300 | 292.1 EB05 273.3 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious n=56 · 98% consumer | no trial data cached |
| Vulvovaginal discomfort | 460 | 282.0 256.6–309.9ROR 297.8 · χ² 114,961 / p <1e-300 | 249.7 EB05 231.1 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious n=28 · 98% consumer | no trial data cached |
| Vulvovaginal inflammation | 42 | 255.4 185.9–350.9ROR 256.6 · χ² 9,385 / p <1e-300 | 208.9 EB05 161.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=4 · 92% consumer | no trial data cached |
| Vulvovaginal rash | 31 | 186.6 129.6–268.8ROR 187.3 · χ² 5,137 / p <1e-300 | 156.6 EB05 115.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | 100% consumer | no trial data cached |
| Vaginal laceration | 13 | 150.4 85.9–263.4ROR 150.7 · χ² 1,677 / p <1e-300 | 117.6 EB05 73.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Cholestasis of pregnancy | 26 | 145.8 98.2–216.6ROR 146.3 · χ² 3,389 / p <1e-300 | 125.1 EB05 89.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Product used for unknown indication | 66 | 135.0 105.5–172.9ROR 136.1 · χ² 8,185 / p <1e-300 | 123.4 EB05 100.3 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Vaginal swelling | 17 | 119.5 73.5–194.5ROR 119.8 · χ² 1,792 / p <1e-300 | 101.2 EB05 66.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Chemical burn | 46 | 102.0 76.0–136.9ROR 102.5 · χ² 4,316 / p <1e-300 | 94.1 EB05 73.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=19 · 100% consumer | no trial data cached |
| Genital blister | 11 | 100.5 55.0–183.6ROR 100.6 · χ² 946 / p 5e-208 | 83.0 EB05 49.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Genital paraesthesia | 10 | 89.6 47.7–168.4ROR 89.7 · χ² 761 / p 7e-168 | 74.6 EB05 43.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Genital burning sensation | 18 | 51.3 32.2–81.8ROR 51.4 · χ² 821 / p 8e-181 | 47.9 EB05 32.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Oedema genital | 13 | 50.0 28.9–86.5ROR 50.1 · χ² 564 / p 5e-125 | 45.9 EB05 28.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Chemical injury | 16 | 47.6 29.0–78.1ROR 47.7 · χ² 671 / p 3e-148 | 44.4 EB05 29.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Vulval disorder | 12 | 44.5 25.1–78.7ROR 44.5 · χ² 459 / p 4e-102 | 41.1 EB05 25.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Genital swelling | 11 | 39.4 21.7–71.4ROR 39.4 · χ² 368 / p 3e-82 | 36.5 EB05 21.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Vaginal discharge | 139 | 33.9 28.7–40.0ROR 34.4 · χ² 4,345 / p <1e-300 | 33.3 EB05 28.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=7 · 97% consumer | no trial data cached |
| Vaginal haemorrhage | 482 | 27.7 25.3–30.2ROR 29.2 · χ² 12,243 / p <1e-300 | 27.3 EB05 25.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 99% consumer | no trial data cached |
| Vaginal disorder | 10 | 25.4 13.6–47.4ROR 25.4 · χ² 209 / p 1e-47 | 23.9 EB05 13.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Genital rash | 14 | 24.0 14.2–40.7ROR 24.1 · χ² 284 / p 6e-64 | 23.1 EB05 14.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Chemical burn of skin | 25 | 23.8 16.1–35.3ROR 23.9 · χ² 519 / p 3e-115 | 23.2 EB05 16.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Vaginal odour | 11 | 21.3 11.8–38.5ROR 21.3 · χ² 191 / p 9e-44 | 20.1 EB05 11.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Vulvovaginal mycotic infection | 25 | 15.5 10.5–22.9ROR 15.5 · χ² 322 / p 2e-72 | 15.0 EB05 10.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 · 75% consumer | no trial data cached |
| Vulvovaginal dryness | 20 | 15.1 9.7–23.5ROR 15.1 · χ² 248 / p 3e-56 | 14.5 EB05 9.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| International normalised ratio increased | 178 | 15.0 13.0–17.4ROR 15.3 · χ² 2,305 / p <1e-300 | 14.9 EB05 13.1 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 23.9 · ♀ 61% (drug 82%) · 96% clinician | no trial data cached |
| Application site pain | 136 | 15.0 12.7–17.7ROR 15.2 · χ² 1,756 / p <1e-300 | 14.9 EB05 12.9 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=48 · 97% consumer | no trial data cached |
| Haemorrhage subcutaneous | 20 | 13.6 8.8–21.2ROR 13.7 · χ² 221 / p 3e-50 | 12.9 EB05 8.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Anaphylactoid reaction | 21 | 12.4 8.1–19.1ROR 12.5 · χ² 209 / p 1e-47 | 11.6 EB05 7.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 43% (drug 82%) | no trial data cached |
| Hydronephrosis | 38 | 12.4 9.0–17.0ROR 12.4 · χ² 384 / p 1e-85 | 11.9 EB05 8.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.1 · 100% clinician | no trial data cached |
| Application site burn | 24 | 11.8 7.9–17.6ROR 11.8 · χ² 225 / p 4e-51 | 11.0 EB05 7.4 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=10 · 87% consumer | no trial data cached |
| Premature labour | 27 | 11.5 7.9–16.8ROR 11.5 · χ² 247 / p 6e-56 | 10.8 EB05 7.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=27 | 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 |
|---|---|---|---|---|---|---|
| Vulvovaginal burning sensation | 1,864 | 1,070.2 1,017.5–1,125.5ROR 1,362.7 · χ² 1,373,821 / p <1e-300 | 733.3 EB05 705.8 · IC025 +9.2 3/3 methods agree | Not in label — unassessed | serious n=109 · 99% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 1,199 | 2.2 2.1–2.3ROR 2.4 · χ² 837 / p 2e-184 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 0.8 · 93% consumer | no trial data cached |
| Vulvovaginal pain | 1,001 | 641.8 600.5–685.9ROR 725.3 · χ² 504,189 / p <1e-300 | 501.0 EB05 475.5 · IC025 +8.6 3/3 methods agree | Not in label — unassessed | serious n=39 · 99% consumer | no trial data cached |
| Vulvovaginal pruritus | 616 | 336.3 309.9–364.9ROR 361.9 · χ² 180,196 / p <1e-300 | 292.1 EB05 273.3 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious n=56 · 98% consumer | no trial data cached |
| Condition aggravated | 566 | 4.5 4.2–4.9ROR 4.8 · χ² 1,577 / p <1e-300 | 4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.0 · 94% consumer | no trial data cached |
| Vaginal haemorrhage | 482 | 27.7 25.3–30.2ROR 29.2 · χ² 12,243 / p <1e-300 | 27.3 EB05 25.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 99% consumer | no trial data cached |
| Vulvovaginal discomfort | 460 | 282.0 256.6–309.9ROR 297.8 · χ² 114,961 / p <1e-300 | 249.7 EB05 231.1 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious n=28 · 98% consumer | no trial data cached |
| Vulvovaginal swelling | 317 | 511.3 453.7–576.2ROR 530.6 · χ² 132,520 / p <1e-300 | 410.7 EB05 374.1 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious n=31 · 99% consumer | no trial data cached |
| Drug interaction | 302 | 4.6 4.1–5.1ROR 4.7 · χ² 854 / p 5e-188 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.4 · ♀ 57% (drug 82%) · 94% clinician | no trial data cached |
| Pain | 270 | 1.1 0.9–1.2ROR 1.1 · χ² 1 / p 0.172 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.5 · 77% consumer | no trial data cached |
| Off label use (used outside approved label) | 248 | 0.7 0.6–0.8ROR 0.7 · χ² 36 / p 1e-9 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Nausea | 232 | 0.7 0.6–0.8ROR 0.7 · χ² 28 / p 6e-8 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Diarrhoea (diarrhea) | 227 | 0.9 0.8–1.0ROR 0.8 · χ² 6 / p 0.008 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Pruritus (itching) | 200 | 1.3 1.1–1.5ROR 1.3 · χ² 12 / p 3e-4 | 1.3 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 2.2 · 73% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 184 | 0.8 0.7–0.9ROR 0.8 · χ² 11 / p 5e-4 | 0.8 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.4 | 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.
- Chemical burn of genitalia — n=75, PRR 4,157.7
- Vulvovaginal burning sensation — n=1,864, PRR 1,070.2
- Vaginal erosion — n=35, PRR 689.5
- Vulvovaginal pain — n=1,001, PRR 641.8
- Vulvovaginal swelling — n=317, PRR 511.3
- Vaginal mucosal blistering — n=36, PRR 461.4
- Vulvovaginal erythema — n=110, PRR 369.3
- Vulvovaginal injury — n=72, PRR 361.3
- Vulvovaginal pruritus — n=616, PRR 336.3
- Vulvovaginal discomfort — n=460, PRR 282.0
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 vulvovaginal burning sensation, vulvovaginal pain, vulvovaginal pruritus, vaginal haemorrhage, vulvovaginal discomfort, vulvovaginal swelling. 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, 1,011 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.