Drug · FAERS side-effect profile with label screen
Efinaconazole side effects: what 1,933 FDA adverse event reports show
Brand names
Jublia
openFDA label
Who reports
1,933 reports · 37% serious · 102 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes . JUBLIA is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes . (1)
FDA label, Indications and Usage
What it is
JUBLIA (efinaconazole) topical solution, 10% is a clear, colorless to pale yellow solution for topical use. Each gram of JUBLIA contains 100 mg of efinaconazole. Efinaconazole is an azole anti.
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 2Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 33
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.
- 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. 96 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 |
|---|---|---|---|---|---|---|
| Aspiration | 150 | 152.3 130.5–177.8ROR 165.0 · χ² 22,093 / p <1e-300 | 147.4 EB05 128.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 241.1 | no trial data cached |
| Sputum discoloured | 121 | 140.7 118.2–167.3ROR 150.0 · χ² 16,431 / p <1e-300 | 135.9 EB05 116.8 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 284.1 · ♀ 88% (drug 60%) | no trial data cached |
| Obstructive airways disorder | 121 | 118.9 99.9–141.4ROR 126.7 · χ² 13,879 / p <1e-300 | 115.5 EB05 99.2 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 191.1 · ♀ 88% (drug 60%) | no trial data cached |
| Blood test abnormal | 140 | 109.3 93.1–128.3ROR 117.7 · χ² 14,768 / p <1e-300 | 106.6 EB05 92.6 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 258.8 | no trial data cached |
| Pulmonary fibrosis | 125 | 71.4 60.2–84.7ROR 76.3 · χ² 8,558 / p <1e-300 | 70.2 EB05 60.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 112.1 · ♀ 88% (drug 60%) | no trial data cached |
| Pulmonary mass | 94 | 69.0 56.6–84.1ROR 72.5 · χ² 6,196 / p <1e-300 | 67.7 EB05 56.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 116.8 · ♀ 85% (drug 60%) | no trial data cached |
| Transaminases increased | 139 | 68.3 58.2–80.2ROR 73.5 · χ² 9,102 / p <1e-300 | 67.3 EB05 58.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 113.2 | no trial data cached |
| Liver function test increased | 120 | 61.4 51.6–73.0ROR 65.4 · χ² 7,034 / p <1e-300 | 60.5 EB05 51.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 149.0 · ♀ 88% (drug 60%) | no trial data cached |
| Haemoptysis | 122 | 47.5 40.0–56.5ROR 50.7 · χ² 5,495 / p <1e-300 | 47.0 EB05 40.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 83.3 · ♀ 87% (drug 60%) | no trial data cached |
| Full blood count abnormal | 40 | 41.3 30.4–56.2ROR 42.2 · χ² 1,528 / p <1e-300 | 40.4 EB05 31.0 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 85.4 · ♀ 6% (drug 60%) · 95% clinician | no trial data cached |
| Hypercholesterolaemia | 36 | 41.0 29.6–56.7ROR 41.7 · χ² 1,359 / p 7e-298 | 40.0 EB05 30.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 67.8 · ♀ 7% (drug 60%) · 97% clinician | no trial data cached |
| Hyperlipidaemia | 44 | 40.0 29.8–53.6ROR 40.9 · χ² 1,628 / p <1e-300 | 39.2 EB05 30.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 68.5 · ♀ 8% (drug 60%) · 98% clinician | no trial data cached |
| Hypoxia (low oxygen) | 120 | 37.2 31.3–44.3ROR 39.6 · χ² 4,189 / p <1e-300 | 36.9 EB05 31.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 59.0 · ♀ 88% (drug 60%) | no trial data cached |
| Lower respiratory tract infection | 152 | 36.5 31.3–42.5ROR 39.5 · χ² 5,207 / p <1e-300 | 36.2 EB05 31.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 60.2 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 152 | 35.8 30.8–41.8ROR 38.8 · χ² 5,108 / p <1e-300 | 35.6 EB05 31.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 95.1 | no trial data cached |
| Micturition urgency | 37 | 35.5 25.8–48.9ROR 36.2 · χ² 1,203 / p 5e-264 | 34.8 EB05 26.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 91.6 · ♀ 3% (drug 60%) · 97% clinician | no trial data cached |
| Incorrect route of product administration | 52 | 33.7 25.7–44.0ROR 34.6 · χ² 1,612 / p <1e-300 | 33.2 EB05 26.3 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 94.7 · ♀ 7% (drug 60%) | no trial data cached |
| Bacterial infection | 53 | 31.0 23.8–40.5ROR 31.9 · χ² 1,508 / p <1e-300 | 30.7 EB05 24.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 53.8 · ♀ 11% (drug 60%) · 92% clinician | no trial data cached |
| Ulcer | 45 | 30.7 23.0–41.0ROR 31.4 · χ² 1,262 / p 1e-276 | 30.3 EB05 23.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 57.7 · ♀ 13% (drug 60%) · 91% clinician | no trial data cached |
| Application site pain | 60 | 29.6 23.1–38.0ROR 30.6 · χ² 1,629 / p <1e-300 | 29.3 EB05 23.6 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=9 · 81% consumer | no trial data cached |
| Gout | 44 | 26.6 19.9–35.7ROR 27.2 · χ² 1,058 / p 2e-232 | 26.3 EB05 20.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 61.3 · ♀ 8% (drug 60%) · 95% clinician | no trial data cached |
| End stage renal disease | 44 | 26.0 19.4–34.8ROR 26.6 · χ² 1,030 / p 3e-226 | 25.7 EB05 19.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 40.5 · ♀ 5% (drug 60%) · 98% clinician | no trial data cached |
| Appendicitis | 22 | 25.7 17.0–39.0ROR 26.0 · χ² 498 / p 2e-110 | 25.2 EB05 17.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 40.7 · 100% clinician | no trial data cached |
| Blood creatinine increased | 148 | 24.6 21.1–28.7ROR 26.6 · χ² 3,329 / p <1e-300 | 24.5 EB05 21.3 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious PRR 44.1 | no trial data cached |
| Neuralgia | 52 | 23.3 17.8–30.5ROR 23.9 · χ² 1,087 / p 1e-238 | 23.1 EB05 18.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 52.9 · ♀ 17% (drug 60%) · 96% clinician | no trial data cached |
| Ventricular fibrillation | 23 | 22.4 14.9–33.7ROR 22.7 · χ² 449 / p 5e-100 | 22.0 EB05 15.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 35.1 · 100% clinician | no trial data cached |
| Pleural effusion | 122 | 21.8 18.3–25.9ROR 23.2 · χ² 2,399 / p <1e-300 | 21.7 EB05 18.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 35.1 · ♀ 83% (drug 60%) | no trial data cached |
| Joint injury | 41 | 20.8 15.4–28.2ROR 21.3 · χ² 754 / p 3e-166 | 20.6 EB05 15.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 41.1 · ♀ 6% (drug 60%) · 93% clinician | no trial data cached |
| Wheezing | 113 | 20.8 17.4–24.8ROR 22.0 · χ² 2,107 / p <1e-300 | 20.7 EB05 17.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 44.3 · ♀ 85% (drug 60%) | no trial data cached |
| Application site erythema | 50 | 20.6 15.7–27.2ROR 21.2 · χ² 915 / p 3e-201 | 20.5 EB05 16.1 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=4 · 80% consumer | no trial data cached |
| Multiple organ dysfunction syndrome | 49 | 19.1 14.5–25.2ROR 19.5 · χ² 821 / p 7e-181 | 18.9 EB05 14.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 29.7 · ♀ 7% (drug 60%) · 98% clinician | no trial data cached |
| Musculoskeletal stiffness | 152 | 18.8 16.2–21.9ROR 20.4 · χ² 2,556 / p <1e-300 | 18.8 EB05 16.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 47.7 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 133 | 18.0 15.3–21.2ROR 19.3 · χ² 2,126 / p <1e-300 | 17.9 EB05 15.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 43.9 · ♀ 89% (drug 60%) | no trial data cached |
| Product packaging quantity issue | 18 | 17.9 11.3–28.4ROR 18.1 · χ² 271 / p 4e-61 | 17.4 EB05 11.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Intervertebral disc degeneration | 15 | 17.5 10.6–29.0ROR 17.6 · χ² 217 / p 2e-49 | 16.8 EB05 10.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 31.3 | no trial data cached |
| Blister | 89 | 17.3 14.1–21.1ROR 18.0 · χ² 1,348 / p 2e-295 | 17.2 EB05 14.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Cardiogenic shock | 22 | 16.7 11.1–25.4ROR 16.9 · χ² 310 / p 1e-69 | 16.3 EB05 11.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 26.1 · 100% clinician | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 170 | 15.1 13.1–17.4ROR 16.5 · χ² 2,233 / p <1e-300 | 15.0 EB05 13.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 30.5 | no trial data cached |
| Asthma | 154 | 14.9 12.8–17.4ROR 16.1 · χ² 1,994 / p <1e-300 | 14.9 EB05 13.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 32.8 | no trial data cached |
| Coronary artery disease | 40 | 14.2 10.5–19.4ROR 14.5 · χ² 479 / p 2e-106 | 14.0 EB05 10.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 · ♀ 3% (drug 60%) · 98% clinician | 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 |
|---|---|---|---|---|---|---|
| Asthenia (weakness) | 201 | 5.8 5.1–6.6ROR 6.4 · χ² 808 / p 5e-178 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Drug hypersensitivity | 173 | 9.7 8.4–11.1ROR 10.5 · χ² 1,348 / p 3e-295 | 9.6 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 40.9 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 170 | 15.1 13.1–17.4ROR 16.5 · χ² 2,233 / p <1e-300 | 15.0 EB05 13.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 30.5 | no trial data cached |
| Anaemia (low red blood cells) | 162 | 9.2 8.0–10.7ROR 10.0 · χ² 1,188 / p 1e-260 | 9.1 EB05 7.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 | no trial data cached |
| Cough | 158 | 6.1 5.3–7.1ROR 6.6 · χ² 682 / p 1e-150 | 6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 · ♀ 86% (drug 60%) | no trial data cached |
| Product dose omission issue | 157 | 6.0 5.2–7.0ROR 6.4 · χ² 655 / p 8e-145 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 33.3 | no trial data cached |
| Tremor (shaking) | 154 | 10.1 8.6–11.7ROR 10.8 · χ² 1,256 / p 2e-275 | 9.9 EB05 8.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 | no trial data cached |
| Asthma | 154 | 14.9 12.8–17.4ROR 16.1 · χ² 1,994 / p <1e-300 | 14.9 EB05 13.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 32.8 | no trial data cached |
| Musculoskeletal stiffness | 152 | 18.8 16.2–21.9ROR 20.4 · χ² 2,556 / p <1e-300 | 18.8 EB05 16.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 47.7 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 152 | 35.8 30.8–41.8ROR 38.8 · χ² 5,108 / p <1e-300 | 35.6 EB05 31.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 95.1 | no trial data cached |
| Lower respiratory tract infection | 152 | 36.5 31.3–42.5ROR 39.5 · χ² 5,207 / p <1e-300 | 36.2 EB05 31.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 60.2 | no trial data cached |
| Aspiration | 150 | 152.3 130.5–177.8ROR 165.0 · χ² 22,093 / p <1e-300 | 147.4 EB05 128.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 241.1 | no trial data cached |
| Blood creatinine increased | 148 | 24.6 21.1–28.7ROR 26.6 · χ² 3,329 / p <1e-300 | 24.5 EB05 21.3 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious PRR 44.1 | no trial data cached |
| Constipation | 142 | 7.1 6.1–8.3ROR 7.6 · χ² 748 / p 4e-165 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.2 · ♀ 82% (drug 60%) | no trial data cached |
| Blood test abnormal | 140 | 109.3 93.1–128.3ROR 117.7 · χ² 14,768 / p <1e-300 | 106.6 EB05 92.6 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 258.8 | 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.
- Aspiration — n=150, PRR 152.3
- Sputum discoloured — n=121, PRR 140.7
- Obstructive airways disorder — n=121, PRR 118.9
- Pulmonary fibrosis — n=125, PRR 71.4
- Pulmonary mass — n=94, PRR 69.0
- Transaminases increased — n=139, PRR 68.3
- Liver function test increased — n=120, PRR 61.4
- Haemoptysis — n=122, PRR 47.5
- Hypercholesterolaemia — n=36, PRR 41.0
- Hyperlipidaemia — n=44, PRR 40.0
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 Efinaconazole?
In FDA FAERS, the most frequently co-reported reaction terms for Efinaconazole are asthenia, drug hypersensitivity, oedema peripheral, anaemia, cough, tremor. 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 Efinaconazole have an FDA boxed warning?
No. The FDA label retrieved for Efinaconazole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Efinaconazole 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 922d4d25-c530-11e1-9b21-0800200c9a66, effective 20250701; matched on
openfda.generic_name.exact:"EFINACONAZOLE") - 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, 136 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.