Itraconazole side effects: what 11,610 FDA adverse event reports show
Who reports
11,610 reports · 89% serious · 2,259 with death outcome · 46% female
Used for
Itraconazole oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. (see CLINICAL PHARMACOLOGY: Special Populations , WARNINGS , and ADVERSE REACTIONS: Postmarketing Experience for more information).
What it is
DESCRIPTION Itraconazole, USP is an azole antifungal agent. Itraconazole, USP is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers..
Boxed warning
Congestive Heart Failure, Cardiac Effects and Drug Interactions Congestive Heart Failure and Cardiac Effects: If signs or symptoms of congestive heart failure occur during administration of itraconazole oral solution, continued itraconazole use should be reassessed .
Causality screen of the 40 strongest signals
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. 1,058 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Forced expiratory volume | 16 | 1,499.9 771.5–2,916.0ROR 1,502.0 · χ² 12,209 / p <1e-300 | 412.0 EB05 268.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Apparent mineralocorticoid excess | 17 | 776.4 439.4–1,372.0ROR 777.5 · χ² 8,636 / p <1e-300 | 336.1 EB05 222.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Granulomatous rosacea | 14 | 712.5 383.4–1,323.8ROR 713.3 · χ² 6,605 / p <1e-300 | 300.3 EB05 190.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Cutaneous sporotrichosis | 11 | 559.8 284.4–1,101.9ROR 560.3 · χ² 4,253 / p <1e-300 | 245.1 EB05 146.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Pseudoaldosteronism | 33 | 367.4 252.7–534.1ROR 368.4 · χ² 9,694 / p <1e-300 | 259.1 EB05 193.0 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=30 · 100% clinician | no trial data cached |
| Polyglandular disorder | 11 | 349.9 183.4–667.6ROR 350.2 · χ² 2,913 / p <1e-300 | 194.4 EB05 115.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Parathyroid gland enlargement | 23 | 341.4 218.6–533.1ROR 342.1 · χ² 6,268 / p <1e-300 | 231.6 EB05 162.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 46%) | no trial data cached |
| Pseudohyponatraemia | 19 | 310.5 190.8–505.2ROR 311.0 · χ² 4,731 / p <1e-300 | 209.2 EB05 141.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Chromoblastomycosis | 11 | 272.1 144.3–513.1ROR 272.4 · χ² 2,348 / p <1e-300 | 168.0 EB05 100.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Fluorosis | 11 | 261.2 138.8–491.8ROR 261.5 · χ² 2,265 / p <1e-300 | 163.8 EB05 97.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Phaehyphomycosis | 17 | 258.8 155.7–430.3ROR 259.2 · χ² 3,590 / p <1e-300 | 180.6 EB05 119.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Pulmonary histoplasmosis | 12 | 254.5 139.0–465.8ROR 254.7 · χ² 2,434 / p <1e-300 | 164.9 EB05 100.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Sporotrichosis | 12 | 245.7 134.4–449.1ROR 245.9 · χ² 2,359 / p <1e-300 | 161.2 EB05 98.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Upper respiratory fungal infection | 23 | 245.3 158.7–379.2ROR 245.8 · χ² 4,706 / p <1e-300 | 183.1 EB05 128.5 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=23 · ♀ 0% (drug 46%) | no trial data cached |
| Phaeohyphomycosis | 37 | 158.4 113.2–221.6ROR 158.9 · χ² 5,172 / p <1e-300 | 135.5 EB05 102.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 11% (drug 46%) · 100% clinician | no trial data cached |
| Fungal endocarditis | 23 | 153.4 100.3–234.8ROR 153.7 · χ² 3,068 / p <1e-300 | 126.7 EB05 88.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 74% (drug 46%) | no trial data cached |
| Lip squamous cell carcinoma | 13 | 151.3 85.9–266.5ROR 151.5 · χ² 1,654 / p <1e-300 | 116.2 EB05 72.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Mycotic endophthalmitis | 13 | 133.8 76.2–235.1ROR 134.0 · χ² 1,473 / p <1e-300 | 105.7 EB05 65.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Disseminated blastomycosis | 11 | 126.4 68.6–232.9ROR 126.5 · χ² 1,163 / p 3e-255 | 98.4 EB05 58.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Alternaria infection | 24 | 126.1 83.4–190.7ROR 126.4 · χ² 2,666 / p <1e-300 | 107.9 EB05 76.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 17% (drug 46%) · 100% clinician | no trial data cached |
| Histoplasmosis | 111 | 120.6 99.6–146.0ROR 121.7 · χ² 12,215 / p <1e-300 | 110.9 EB05 94.6 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious n=109 | no trial data cached |
| Symmetrical drug-related intertriginous and flexural exanthema | 49 | 118.9 89.1–158.7ROR 119.4 · χ² 5,260 / p <1e-300 | 107.0 EB05 84.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=47 · 100% clinician | no trial data cached |
| Bronchopulmonary aspergillosis allergic | 56 | 117.5 89.7–153.9ROR 118.0 · χ² 5,959 / p <1e-300 | 106.4 EB05 85.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=53 | no trial data cached |
| Keratitis fungal | 12 | 113.1 63.1–202.6ROR 113.2 · χ² 1,150 / p 2e-252 | 91.4 EB05 55.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Anaemia folate deficiency | 11 | 112.6 61.2–207.0ROR 112.7 · χ² 1,042 / p 7e-229 | 89.9 EB05 53.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Aspergilloma | 18 | 106.5 66.2–171.3ROR 106.7 · χ² 1,677 / p <1e-300 | 91.1 EB05 61.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Penicillium infection | 10 | 106.0 56.0–200.6ROR 106.1 · χ² 885 / p 8e-195 | 84.5 EB05 49.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Histoplasmosis disseminated | 84 | 102.9 82.6–128.1ROR 103.6 · χ² 7,918 / p <1e-300 | 95.3 EB05 79.4 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=84 · 94% clinician | no trial data cached |
| Idiopathic pneumonia syndrome | 16 | 102.5 62.0–169.6ROR 102.7 · χ² 1,426 / p <1e-300 | 87.2 EB05 56.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Aspergillosis | 70 | 100.7 79.2–128.0ROR 101.3 · χ² 6,447 / p <1e-300 | 93.0 EB05 76.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=70 · 97% clinician | no trial data cached |
| Trichosporon infection | 20 | 96.0 61.3–150.5ROR 96.2 · χ² 1,695 / p <1e-300 | 84.1 EB05 57.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=19 · 100% clinician | no trial data cached |
| Systemic mycosis | 57 | 92.7 71.1–120.9ROR 93.2 · χ² 4,829 / p <1e-300 | 85.7 EB05 68.6 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=56 · 92% clinician | no trial data cached |
| Lung transplant rejection | 30 | 85.2 59.1–122.9ROR 85.4 · χ² 2,303 / p <1e-300 | 77.5 EB05 56.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=29 | no trial data cached |
| Immune reconstitution inflammatory syndrome associated tuberculosis | 14 | 79.2 46.4–135.2ROR 79.3 · χ² 961 / p 3e-211 | 69.0 EB05 43.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Skin candida | 21 | 76.5 49.4–118.3ROR 76.6 · χ² 1,429 / p <1e-300 | 69.0 EB05 47.6 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 · 90% clinician | no trial data cached |
| Candida pneumonia | 13 | 75.4 43.3–131.3ROR 75.5 · χ² 846 / p 3e-186 | 65.7 EB05 40.9 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
| Scedosporium infection | 27 | 73.2 49.8–107.5ROR 73.4 · χ² 1,778 / p <1e-300 | 67.2 EB05 48.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 70% (drug 46%) | no trial data cached |
| Aspergillus test positive | 12 | 73.2 41.1–130.3ROR 73.3 · χ² 753 / p 5e-166 | 63.6 EB05 38.8 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Engraft failure | 11 | 72.3 39.6–132.1ROR 72.4 · χ² 676 / p 2e-149 | 62.4 EB05 37.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Lower respiratory tract infection fungal | 15 | 71.6 42.8–120.0ROR 71.7 · χ² 937 / p 3e-206 | 63.6 EB05 40.9 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 1,160 | 13.3 12.6–14.0ROR 14.7 · χ² 13,178 / p <1e-300 | 13.2 EB05 12.6 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.6 · 93% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 1,128 | 1.5 1.5–1.6ROR 1.6 · χ² 232 / p 9e-53 | 1.5 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 2.5 | no trial data cached |
| Off label use (used outside approved label) | 629 | 1.3 1.2–1.4ROR 1.3 · χ² 48 / p 3e-12 | 1.3 EB05 1.2 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.4 | no trial data cached |
| Pyrexia (fever) | 588 | 3.1 2.8–3.3ROR 3.2 · χ² 831 / p 4e-183 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.3 | no trial data cached |
| Dyspnoea (shortness of breath) | 488 | 1.6 1.4–1.7ROR 1.6 · χ² 100 / p 9e-24 | 1.6 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Pneumonia (lung infection) | 483 | 2.7 2.5–2.9ROR 2.8 · χ² 523 / p 5e-116 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Nausea | 459 | 1.1 1.0–1.1ROR 1.1 · χ² 1 / p 0.145 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | no trial data cached |
| Condition aggravated | 400 | 2.4 2.2–2.6ROR 2.4 · χ² 328 / p 2e-73 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 | no trial data cached |
| Diarrhoea (diarrhea) | 398 | 1.1 1.0–1.2ROR 1.1 · χ² 5 / p 0.013 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Febrile neutropenia | 371 | 10.2 9.2–11.2ROR 10.5 · χ² 3,050 / p <1e-300 | 10.1 EB05 9.2 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.5 · 97% clinician | no trial data cached |
| Fatigue (tiredness) | 343 | 0.8 0.7–0.9ROR 0.8 · χ² 18 / p 1e-5 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.8 | no trial data cached |
| Rash | 307 | 1.3 1.1–1.4ROR 1.3 · χ² 19 / p 7e-6 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Anaemia (low red blood cells) | 303 | 2.9 2.6–3.2ROR 2.9 · χ² 370 / p 9e-83 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 300 | 4.0 3.6–4.5ROR 4.1 · χ² 676 / p 2e-149 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 · 91% clinician | no trial data cached |
| Vomiting | 295 | 1.1 1.0–1.3ROR 1.1 · χ² 5 / p 0.014 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | 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.
- Parathyroid gland enlargement — n=23, PRR 341.4
- Phaeohyphomycosis — n=37, PRR 158.4
- Fungal endocarditis — n=23, PRR 153.4
- Alternaria infection — n=24, PRR 126.1
- Symmetrical drug-related intertriginous and flexural exanthema — n=49, PRR 118.9
- Bronchopulmonary aspergillosis allergic — n=56, PRR 117.5
- Histoplasmosis disseminated — n=84, PRR 102.9
- Aspergillosis — n=70, PRR 100.7
- Trichosporon infection — n=20, PRR 96.0
- Lung transplant rejection — n=30, PRR 85.2
✓ A hand-written Bradford Hill causality assessment exists for this drug: Itraconazole ↔ Heart failure.
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 Itraconazole?
In FDA FAERS, the most frequently co-reported reaction terms for Itraconazole are pyrexia, dyspnoea, pneumonia, nausea, diarrhoea, febrile neutropenia. 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 Itraconazole have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Congestive Heart Failure, Cardiac Effects and Drug Interactions Congestive Heart Failure and Cardiac Effects: If signs or symptoms of congestive heart failure occur during administration of itraconazole oral solution, continued itraconazole use should be reassessed .
Do FAERS signals prove that Itraconazole 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 43ded1aa-f825-40fe-aa9a-addd36a07f06, effective 20260803; matched on
openfda.generic_name.exact:"ITRACONAZOLE") - 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, 1,098 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.