Posaconazole side effects: what 16,150 FDA adverse event reports show
Who reports
16,150 reports · 86% serious · 3,855 with death outcome · 41% female
Used for
Posaconazole is an azole antifungal indicated as follows: • Posaconazole is indicated for the treatment of invasive aspergillosis as follows: ( 1.1 ) o Posaconazole injection : adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.
What it is
Posaconazole injection contains posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3 R ,5 R )-5-(2,4-difluorophenyl)tetrahydro-5-(1 H -1,2,4-triaz.
Boxed warning
None in the current label
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.
- 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. 1,021 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 |
|---|---|---|---|---|---|---|
| Npm1 gene mutation | 11 | 7,039.8 1,560.5–31,758.6ROR 7,044.6 · χ² 10,851 / p <1e-300 | 375.1 EB05 223.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Pseudoaldosteronism | 96 | 1,266.8 955.7–1,679.0ROR 1,274.3 · χ² 60,389 / p <1e-300 | 565.0 EB05 476.3 · IC025 +6.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=68 · 97% clinician | not reported in cached trials |
| Protothecosis | 34 | 737.6 483.8–1,124.6ROR 739.2 · χ² 15,403 / p <1e-300 | 370.5 EB05 277.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 100% (drug 41%) | not reported in cached trials |
| Acquired apparent mineralocorticoid excess | 17 | 518.1 295.0–909.9ROR 518.6 · χ² 5,883 / p <1e-300 | 260.9 EB05 172.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Antibiotic level below therapeutic | 29 | 508.5 330.8–781.6ROR 509.4 · χ² 10,152 / p <1e-300 | 293.7 EB05 214.4 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | 100% clinician | not reported in cached trials |
| Left atrial hypertrophy | 11 | 361.0 184.9–704.8ROR 361.3 · χ² 2,806 / p <1e-300 | 189.6 EB05 113.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Demodicidosis | 19 | 337.8 203.8–559.8ROR 338.2 · χ² 4,785 / p <1e-300 | 211.0 EB05 142.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Fusarium infection | 115 | 262.8 215.2–321.1ROR 264.7 · χ² 24,671 / p <1e-300 | 210.6 EB05 180.3 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=113 | not reported in cached trials |
| Microsporidia infection | 50 | 212.6 157.7–286.7ROR 213.3 · χ² 8,850 / p <1e-300 | 170.7 EB05 134.5 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 0% (drug 41%) · 100% clinician | not reported in cached trials |
| Adenovirus reactivation | 19 | 206.1 127.0–334.5ROR 206.3 · χ² 3,166 / p <1e-300 | 151.0 EB05 102.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Geotrichum infection | 29 | 205.1 138.6–303.4ROR 205.4 · χ² 4,902 / p <1e-300 | 158.6 EB05 115.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | not reported in cached trials |
| Chimerism | 11 | 182.9 97.2–343.9ROR 183.0 · χ² 1,585 / p <1e-300 | 125.8 EB05 74.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Acanthamoeba infection | 23 | 178.4 115.4–275.9ROR 178.7 · χ² 3,407 / p <1e-300 | 138.9 EB05 97.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 41%) · 100% clinician | not reported in cached trials |
| Corynebacterium bacteraemia | 10 | 177.8 91.8–344.4ROR 177.9 · χ² 1,392 / p <1e-300 | 120.8 EB05 70.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Scedosporium infection | 83 | 176.8 140.6–222.3ROR 177.7 · χ² 12,592 / p <1e-300 | 150.1 EB05 124.9 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=83 | not reported in cached trials |
| Encephalitis fungal | 10 | 164.1 85.0–316.9ROR 164.2 · χ² 1,296 / p 5e-284 | 114.4 EB05 66.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Allogenic stem cell transplantation | 17 | 158.8 96.0–262.9ROR 159.0 · χ² 2,233 / p <1e-300 | 122.3 EB05 80.9 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | not reported in cached trials |
| Bronchiolitis obliterans syndrome | 18 | 154.6 94.8–252.1ROR 154.8 · χ² 2,316 / p <1e-300 | 120.7 EB05 80.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Disseminated toxoplasmosis | 11 | 136.7 73.4–254.5ROR 136.8 · χ² 1,219 / p 2e-267 | 102.2 EB05 60.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Chronic graft versus host disease in lung | 16 | 135.6 81.0–227.0ROR 135.8 · χ² 1,813 / p <1e-300 | 107.3 EB05 70.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | NCT01075984: 1/237 (0.4%) on Posaconazole (serious AE) |
| Central nervous system fungal infection | 19 | 126.0 78.7–201.8ROR 126.2 · χ² 2,033 / p <1e-300 | 103.2 EB05 69.8 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | not reported in cached trials |
| Hepatosplenic candidiasis | 13 | 125.1 70.8–221.1ROR 125.2 · χ² 1,347 / p 3e-295 | 98.1 EB05 61.0 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | NCT01782131: 1/287 (0.3%) on Posaconazole (serious AE) |
| Differentiation syndrome | 61 | 121.1 93.1–157.3ROR 121.5 · χ² 6,526 / p <1e-300 | 107.0 EB05 86.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=61 | not reported in cached trials |
| Pulmonary mucormycosis | 42 | 115.1 84.0–157.8ROR 115.4 · χ² 4,255 / p <1e-300 | 101.0 EB05 77.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=42 · 95% clinician | not reported in cached trials |
| Enterobacter bacteraemia | 24 | 112.1 73.9–170.1ROR 112.3 · χ² 2,329 / p <1e-300 | 95.5 EB05 67.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Acute myeloid leukaemia refractory | 13 | 108.8 61.7–191.5ROR 108.8 · χ² 1,182 / p 3e-259 | 87.8 EB05 54.6 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | not reported in cached trials |
| Primary adrenal insufficiency | 23 | 108.6 71.0–166.2ROR 108.8 · χ² 2,163 / p <1e-300 | 92.7 EB05 65.1 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=23 · 100% clinician | not reported in cached trials |
| Disseminated coccidioidomycosis | 11 | 108.3 58.5–200.4ROR 108.4 · χ² 981 / p 9e-216 | 85.6 EB05 51.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Adenoviral hepatitis | 17 | 102.6 62.6–168.2ROR 102.7 · χ² 1,491 / p <1e-300 | 86.2 EB05 57.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Acute myeloid leukaemia recurrent | 155 | 101.8 86.5–119.9ROR 102.8 · χ² 14,245 / p <1e-300 | 93.4 EB05 81.7 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious n=155 | NCT01782131: 2/288 (0.7%) on Posaconazole (serious AE) |
| Mucormycosis | 185 | 100.5 86.6–116.6ROR 101.7 · χ² 16,808 / p <1e-300 | 92.4 EB05 81.7 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=185 · 91% clinician | NCT01782131: 1/287 (0.3%) on Posaconazole (serious AE) |
| Eye infection fungal | 26 | 95.6 64.2–142.4ROR 95.8 · χ² 2,178 / p <1e-300 | 83.7 EB05 60.1 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=26 · ♀ 0% (drug 41%) | NCT01782131: 1/288 (0.3%) on Posaconazole (serious AE) |
| Rhinocerebral mucormycosis | 23 | 93.5 61.2–142.7ROR 93.6 · χ² 1,875 / p <1e-300 | 81.5 EB05 57.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | not reported in cached trials |
| Lip squamous cell carcinoma | 11 | 90.8 49.3–167.4ROR 90.9 · χ² 831 / p 6e-183 | 74.4 EB05 44.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Mycotic endophthalmitis | 12 | 88.3 49.2–158.4ROR 88.3 · χ² 889 / p 1e-195 | 73.4 EB05 44.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Cerebral aspergillosis | 39 | 88.0 63.7–121.7ROR 88.3 · χ² 3,059 / p <1e-300 | 79.3 EB05 60.6 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=39 · ♀ 0% (drug 41%) · 92% clinician | NCT01782131: 1/287 (0.3%) on Posaconazole (serious AE) |
| Systemic mycosis | 74 | 87.9 69.5–111.1ROR 88.3 · χ² 5,866 / p <1e-300 | 80.6 EB05 66.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=74 · 96% clinician | not reported in cached trials |
| Phaeohyphomycosis | 29 | 87.5 60.1–127.5ROR 87.7 · χ² 2,242 / p <1e-300 | 77.9 EB05 56.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | not reported in cached trials |
| Labelled drug-drug interaction issue | 87 | 85.7 69.0–106.4ROR 86.2 · χ² 6,749 / p <1e-300 | 79.1 EB05 66.1 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=38 · 100% clinician | not reported in cached trials |
| Cutaneous mucormycosis | 11 | 85.3 46.4–157.1ROR 85.4 · χ² 782 / p 2e-172 | 70.7 EB05 42.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | 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 Posaconazole 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 (6 of 40 signal terms matched).
- NCT01782131 — A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergill (N=585, PHASE3; 309 AE terms posted; arms: Posaconazole; Voriconazole)
- NCT01075984 — Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole (N=279, PHASE1; 199 AE terms posted; arms: POS 200 mg IV Single Dose (Cohort 0); Placebo IV Single Dose (Cohort 0); POS 200 mg IV BID (Cohort 1); POS 300 mg IV BID (Cohort 2 and 3))
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 1,658 | 2.5 2.4–2.6ROR 2.7 · χ² 1,527 / p <1e-300 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,480 | 1.5 1.4–1.5ROR 1.5 · χ² 228 / p 9e-52 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 2.6 | not reported in cached trials |
| Febrile neutropenia | 1,072 | 21.3 20.1–22.6ROR 22.8 · χ² 20,493 / p <1e-300 | 21.0 EB05 20.0 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.1 · 94% clinician | NCT01782131: 24/288 (8.3%) on Posaconazole (serious AE) |
| Drug interaction | 1,021 | 8.4 7.9–8.9ROR 8.9 · χ² 6,657 / p <1e-300 | 8.3 EB05 7.9 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · 93% clinician | not reported in cached trials |
| Product use in unapproved indication | 1,008 | 5.4 5.1–5.7ROR 5.7 · χ² 3,612 / p <1e-300 | 5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 · 93% clinician | not reported in cached trials |
| Death | 976 | 1.5 1.4–1.6ROR 1.5 · χ² 153 / p 2e-35 | 1.5 EB05 1.4 · IC025 +0.5 | Outcome field, not a reaction | serious PRR 1.0 | NCT01782131: 2/288 (0.7%) on Posaconazole (serious AE) |
| Pyrexia (fever) | 890 | 3.3 3.1–3.6ROR 3.5 · χ² 1,480 / p <1e-300 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | NCT01782131: 7/288 (2.4%) on Posaconazole (serious AE) |
| Neutropenia (low neutrophils (infection-fighting cells)) | 747 | 7.2 6.7–7.7ROR 7.5 · χ² 3,979 / p <1e-300 | 7.1 EB05 6.7 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.9 · 91% clinician | NCT01782131: 24/288 (8.3%) on Posaconazole (serious AE) |
| Pneumonia (lung infection) | 680 | 2.7 2.5–2.9ROR 2.8 · χ² 756 / p 8e-167 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | NCT01782131: 1/288 (0.3%) on Posaconazole (serious AE) |
| Thrombocytopenia (low platelets) | 537 | 6.3 5.8–6.8ROR 6.5 · χ² 2,378 / p <1e-300 | 6.2 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 93% clinician | NCT01782131: 1/288 (0.3%) on Posaconazole (serious AE) |
| Diarrhoea (diarrhea) | 533 | 1.1 1.0–1.2ROR 1.1 · χ² 3 / p 0.046 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | NCT01782131: 1/288 (0.3%) on Posaconazole (serious AE) |
| Nausea | 513 | 0.8 0.8–0.9ROR 0.8 · χ² 15 / p 5e-5 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.9 | NCT01782131: 2/287 (0.7%) on Posaconazole (serious AE) |
| Septic shock | 457 | 13.9 12.7–15.2ROR 14.2 · χ² 5,394 / p <1e-300 | 13.7 EB05 12.7 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 · 91% clinician | NCT01782131: 16/288 (5.6%) on Posaconazole (serious AE) |
| Condition aggravated | 438 | 1.9 1.7–2.1ROR 1.9 · χ² 183 / p 5e-42 | 1.9 EB05 1.7 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.9 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 437 | 3.7 3.4–4.1ROR 3.8 · χ² 875 / p 1e-192 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.5 · 92% clinician | NCT01782131: 9/288 (3.1%) on Posaconazole (serious AE) |
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.
- Protothecosis — n=34, PRR 737.6
- Fusarium infection — n=115, PRR 262.8
- Microsporidia infection — n=50, PRR 212.6
- Geotrichum infection — n=29, PRR 205.1
- Acanthamoeba infection — n=23, PRR 178.4
- Scedosporium infection — n=83, PRR 176.8
- Differentiation syndrome — n=61, PRR 121.1
- Pulmonary mucormycosis — n=42, PRR 115.1
- Enterobacter bacteraemia — n=24, PRR 112.1
- Mucormycosis — n=185, PRR 100.5 (also seen in trial arm)
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 Posaconazole?
In FDA FAERS, the most frequently co-reported reaction terms for Posaconazole are febrile neutropenia, pyrexia, neutropenia, pneumonia, thrombocytopenia, diarrhoea. 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 Posaconazole have an FDA boxed warning?
No. The FDA label retrieved for Posaconazole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Posaconazole 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 1ebbd88b-547b-4b49-ab73-98094a2d5a79, effective 20260715; matched on
openfda.generic_name.exact:"POSACONAZOLE") - 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, 1,061 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
POSACONAZOLE, 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.