Drug · FAERS side-effect profile with label screen
Voriconazole Injection side effects: what 21,588 FDA adverse event reports show
Who reports
21,588 reports · 94% serious · 6,336 with death outcome · 39% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: Invasive aspergillosis ( 1.1 ) Candidemia in non-neutropenics and other deep tissue Candida infections ( 1.2 ) Esop.
FDA label, Indications and Usage
What it is
Voriconazole USP, an azole antifungal agent is available as film-coated tablets for oral administration.
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) 9Likely indication confounding 7Lab value / disease marker 1Not in label — unassessed 21
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.
- 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. 1,065 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 |
|---|---|---|---|---|---|---|
| Fluoride increased | 36 | 2,027.7 1,139.1–3,609.4ROR 2,031.1 · χ² 22,745 / p <1e-300 | 483.1 EB05 364.6 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=32 · 94% clinician | not reported in cached trials |
| Periostitis | 226 | 1,050.5 870.2–1,268.2ROR 1,061.6 · χ² 112,496 / p <1e-300 | 480.9 EB05 430.6 · IC025 +7.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=197 · 90% clinician | not reported in cached trials |
| Fluorosis | 40 | 832.6 545.2–1,271.7ROR 834.2 · χ² 17,329 / p <1e-300 | 367.3 EB05 281.3 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=38 · ♀ 59% (drug 39%) · 100% clinician | not reported in cached trials |
| Cerebral aspergillosis | 191 | 440.7 371.5–522.8ROR 444.6 · χ² 57,082 / p <1e-300 | 293.2 EB05 260.0 · IC025 +7.2 3/3 methods agree | Labeled (related wording) related wording | serious n=191 · 91% clinician | not reported in cached trials |
| Hypertrophic osteoarthropathy | 21 | 427.8 255.8–715.5ROR 428.2 · χ² 5,889 / p <1e-300 | 233.3 EB05 161.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=19 · ♀ 60% (drug 39%) · 100% clinician | not reported in cached trials |
| Geotrichum infection | 61 | 392.0 291.1–527.9ROR 393.1 · χ² 16,604 / p <1e-300 | 256.1 EB05 206.6 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=61 · 95% clinician | not reported in cached trials |
| Scopulariopsis infection | 13 | 389.0 204.2–741.0ROR 389.2 · χ² 3,307 / p <1e-300 | 197.1 EB05 122.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Scedosporium infection | 165 | 304.4 255.6–362.5ROR 306.8 · χ² 37,633 / p <1e-300 | 225.2 EB05 197.8 · IC025 +6.8 3/3 methods agree | Likely indication confounding term in indications | serious n=165 · 91% clinician | not reported in cached trials |
| Mycotic endophthalmitis | 43 | 287.9 204.8–404.8ROR 288.5 · χ² 9,233 / p <1e-300 | 201.8 EB05 156.1 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=43 | not reported in cached trials |
| Fusarium infection | 142 | 255.1 212.1–306.8ROR 256.8 · χ² 28,180 / p <1e-300 | 196.3 EB05 170.7 · IC025 +6.6 3/3 methods agree | Likely indication confounding term in indications | serious n=140 · 91% clinician | not reported in cached trials |
| Disseminated trichosporonosis | 13 | 234.9 128.1–430.7ROR 235.0 · χ² 2,247 / p <1e-300 | 148.2 EB05 92.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Pericarditis fungal | 13 | 234.9 128.1–430.7ROR 235.0 · χ² 2,247 / p <1e-300 | 148.2 EB05 92.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Photodermatosis | 82 | 231.6 182.0–294.7ROR 232.5 · χ² 14,976 / p <1e-300 | 179.0 EB05 148.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=77 · 94% clinician | not reported in cached trials |
| Choroiditis | 72 | 230.6 178.3–298.1ROR 231.3 · χ² 13,079 / p <1e-300 | 177.3 EB05 145.5 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=72 · ♀ 0% (drug 39%) | not reported in cached trials |
| Central nervous system fungal infection | 41 | 229.6 163.3–322.7ROR 230.0 · χ² 7,343 / p <1e-300 | 170.7 EB05 131.2 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=41 · 95% clinician | not reported in cached trials |
| Disseminated aspergillosis | 85 | 215.3 170.2–272.3ROR 216.2 · χ² 14,629 / p <1e-300 | 169.3 EB05 141.2 · IC025 +6.1 3/3 methods agree | Likely indication confounding term in indications | serious n=85 · 98% clinician | not reported in cached trials |
| Disseminated mucormycosis | 69 | 210.4 162.2–273.0ROR 211.1 · χ² 11,619 / p <1e-300 | 164.9 EB05 134.7 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=69 · 100% clinician | not reported in cached trials |
| Fungal endocarditis | 52 | 209.2 155.0–282.3ROR 209.7 · χ² 8,673 / p <1e-300 | 161.8 EB05 128.1 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious n=52 · 92% clinician | not reported in cached trials |
| Pulmonary mucormycosis | 84 | 189.3 149.8–239.1ROR 190.0 · χ² 12,977 / p <1e-300 | 152.7 EB05 127.2 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=84 · 100% clinician | not reported in cached trials |
| Osteomyelitis fungal | 25 | 184.1 120.0–282.5ROR 184.4 · χ² 3,667 / p <1e-300 | 138.5 EB05 98.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=25 | not reported in cached trials |
| Keratitis fungal | 32 | 181.3 124.3–264.5ROR 181.6 · χ² 4,674 / p <1e-300 | 140.0 EB05 103.8 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=32 · ♀ 73% (drug 39%) | not reported in cached trials |
| Encephalitis fungal | 13 | 166.0 92.1–299.0ROR 166.1 · χ² 1,679 / p <1e-300 | 117.6 EB05 73.1 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | not reported in cached trials |
| Dilatation intrahepatic duct acquired | 42 | 164.8 118.8–228.6ROR 165.1 · χ² 5,695 / p <1e-300 | 132.4 EB05 102.1 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=42 · ♀ 100% (drug 39%) | not reported in cached trials |
| Aspergilloma | 45 | 157.3 114.8–215.5ROR 157.6 · χ² 5,868 / p <1e-300 | 128.0 EB05 99.6 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=45 · 100% clinician | not reported in cached trials |
| Systemic mycosis | 161 | 155.6 131.8–183.7ROR 156.7 · χ² 21,137 / p <1e-300 | 131.9 EB05 115.7 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=160 · 96% clinician | not reported in cached trials |
| Abscess fungal | 22 | 150.5 96.0–235.8ROR 150.6 · χ² 2,695 / p <1e-300 | 117.2 EB05 81.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=22 · 91% clinician | not reported in cached trials |
| Toxic optic neuropathy | 57 | 148.3 112.2–196.0ROR 148.7 · χ² 7,095 / p <1e-300 | 123.3 EB05 98.7 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious n=57 · ♀ 0% (drug 39%) · 100% clinician | not reported in cached trials |
| Mucormycosis | 331 | 143.4 127.9–160.8ROR 145.6 · χ² 40,593 / p <1e-300 | 124.0 EB05 113.2 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=331 · 93% clinician | not reported in cached trials |
| Aspergillus infection | 831 | 142.9 133.0–153.5ROR 148.6 · χ² 101,784 / p <1e-300 | 124.1 EB05 117.2 · IC025 +6.7 3/3 methods agree | Likely indication confounding term in indications | serious n=830 · 91% clinician | not reported in cached trials |
| Aspergillus test positive | 39 | 140.9 100.7–197.2ROR 141.2 · χ² 4,602 / p <1e-300 | 116.1 EB05 88.6 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=38 · 92% clinician | not reported in cached trials |
| Bronchopulmonary aspergillosis | 882 | 125.3 116.9–134.2ROR 130.6 · χ² 96,087 / p <1e-300 | 110.6 EB05 104.6 · IC025 +6.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 67.8 · 95% clinician | not reported in cached trials |
| Intracranial infection | 14 | 125.3 71.8–218.6ROR 125.4 · χ² 1,418 / p <1e-300 | 96.7 EB05 61.2 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | not reported in cached trials |
| Trichosporon infection | 44 | 121.4 88.8–166.1ROR 121.7 · χ² 4,557 / p <1e-300 | 103.1 EB05 80.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=43 · 100% clinician | not reported in cached trials |
| Chloropsia | 14 | 118.6 68.1–206.7ROR 118.7 · χ² 1,350 / p 7e-296 | 92.7 EB05 58.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Zygomycosis | 51 | 117.1 87.6–156.6ROR 117.4 · χ² 5,128 / p <1e-300 | 100.6 EB05 79.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=51 · 100% clinician | not reported in cached trials |
| Hepatic infection fungal | 12 | 107.4 59.1–195.0ROR 107.4 · χ² 1,043 / p 3e-229 | 84.1 EB05 51.3 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | not reported in cached trials |
| Actinic keratosis | 259 | 107.0 94.2–121.6ROR 108.3 · χ² 24,369 / p <1e-300 | 95.7 EB05 86.3 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=257 | not reported in cached trials |
| Transmission of an infectious agent via product | 18 | 105.7 65.0–172.0ROR 105.8 · χ² 1,589 / p <1e-300 | 86.8 EB05 58.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Phaehyphomycosis | 13 | 102.9 58.1–182.3ROR 102.9 · χ² 1,094 / p 3e-240 | 82.1 EB05 51.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Eye infection fungal | 36 | 102.0 72.3–143.8ROR 102.2 · χ² 3,163 / p <1e-300 | 88.1 EB05 66.5 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=36 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Voriconazole as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT01151085 — Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan) (N=1002, phase n/a; 91 AE terms posted; arms: Voriconazole)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 ineffective (drug did not work) | 3,939 | 2.9 2.8–3.0ROR 3.3 · χ² 5,257 / p <1e-300 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | not reported in cached trials |
| Off label use (used outside approved label) | 2,077 | 2.3 2.2–2.4ROR 2.5 · χ² 1,636 / p <1e-300 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | not reported in cached trials |
| Drug interaction | 2,013 | 12.5 12.0–13.0ROR 13.6 · χ² 21,114 / p <1e-300 | 12.3 EB05 11.9 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.0 · 94% clinician | NCT01151085: 1/946 (0.1%) on Voriconazole (serious AE) |
| Pyrexia (fever) | 1,060 | 3.0 2.8–3.2ROR 3.1 · χ² 1,412 / p <1e-300 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | NCT01151085: 1/946 (0.1%) on Voriconazole |
| Pneumonia (lung infection) | 902 | 2.7 2.5–2.9ROR 2.8 · χ² 988 / p 3e-217 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 | not reported in cached trials |
| Bronchopulmonary aspergillosis | 882 | 125.3 116.9–134.2ROR 130.6 · χ² 96,087 / p <1e-300 | 110.6 EB05 104.6 · IC025 +6.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 67.8 · 95% clinician | not reported in cached trials |
| Condition aggravated | 855 | 2.8 2.6–2.9ROR 2.8 · χ² 966 / p 3e-212 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 · 91% clinician | not reported in cached trials |
| Aspergillus infection | 831 | 142.9 133.0–153.5ROR 148.6 · χ² 101,784 / p <1e-300 | 124.1 EB05 117.2 · IC025 +6.7 3/3 methods agree | Likely indication confounding term in indications | serious n=830 · 91% clinician | not reported in cached trials |
| Febrile neutropenia | 737 | 10.9 10.2–11.7ROR 11.3 · χ² 6,579 / p <1e-300 | 10.8 EB05 10.1 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 · 93% clinician | not reported in cached trials |
| Death | 722 | 0.8 0.8–0.9ROR 0.8 · χ² 32 / p 9e-9 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.5 | not reported in cached trials |
| Respiratory failure | 680 | 9.1 8.5–9.8ROR 9.4 · χ² 4,883 / p <1e-300 | 9.0 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · 93% clinician | not reported in cached trials |
| Product use in unapproved indication | 652 | 2.6 2.4–2.8ROR 2.6 · χ² 644 / p 2e-142 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · 90% clinician | not reported in cached trials |
| Multiple organ dysfunction syndrome | 636 | 22.6 20.9–24.5ROR 23.3 · χ² 12,845 / p <1e-300 | 22.1 EB05 20.7 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.6 · 94% clinician | not reported in cached trials |
| Neutropenia (low neutrophils (infection-fighting cells)) | 604 | 4.3 4.0–4.7ROR 4.4 · χ² 1,555 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | NCT01151085: 1/946 (0.1%) on Voriconazole |
| Drug resistance | 590 | 22.8 21.1–24.7ROR 23.4 · χ² 12,016 / p <1e-300 | 22.3 EB05 20.8 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 15.2 · 94% clinician | not reported in cached trials |
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.
- Fluoride increased — n=36, PRR 2,027.7
- Hypertrophic osteoarthropathy — n=21, PRR 427.8
- Geotrichum infection — n=61, PRR 392.0
- Mycotic endophthalmitis — n=43, PRR 287.9
- Photodermatosis — n=82, PRR 231.6
- Choroiditis — n=72, PRR 230.6
- Disseminated mucormycosis — n=69, PRR 210.4
- Pulmonary mucormycosis — n=84, PRR 189.3
- Osteomyelitis fungal — n=25, PRR 184.1
- Systemic mycosis — n=161, PRR 155.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Voriconazole ↔ Hallucination.
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 Voriconazole?
In FDA FAERS, the most frequently co-reported reaction terms for Voriconazole are pyrexia, pneumonia, bronchopulmonary aspergillosis, aspergillus infection, febrile neutropenia, respiratory failure. 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 Voriconazole have an FDA boxed warning?
No. The FDA label retrieved for Voriconazole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Voriconazole 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 16a80777-f1f3-45bb-a312-998b07767fe3, effective 20260424; matched on
openfda.generic_name.exact:"VORICONAZOLE") - 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, 1,105 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 - ClinicalTrials.gov API v2 (query
VORICONAZOLE, results-bearing studies sorted by enrollment)
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.