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Posaconazole side effects: what 16,150 FDA adverse event reports show

Posaconazole · 1,061 reaction terms · 54,712 drug–reaction co-reports · data 2026-09-14
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Drug class

Azole Antifungal

FDA label (Established Pharmacologic Class) · compare the class

Who reports

16,150 reports · 86% serious · 3,855 with death outcome · 41% female

openFDA FAERS counts, all years, deduplication not applied

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.

FDA label, Indications and Usage

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.

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) 4Likely indication confounding 4Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 29
What the badges mean

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.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Npm1 gene mutation117,039.8
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 — unassessedserious n=11not reported in cached trials
Pseudoaldosteronism961,266.8
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% cliniciannot reported in cached trials
Protothecosis34737.6
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 — unassessedserious n=34 · ♀ 100% (drug 41%)not reported in cached trials
Acquired apparent mineralocorticoid excess17518.1
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 — unassessedserious n=14not reported in cached trials
Antibiotic level below therapeutic29508.5
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 marker100% cliniciannot reported in cached trials
Left atrial hypertrophy11361.0
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 — unassessedserious n=11not reported in cached trials
Demodicidosis19337.8
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 — unassessedserious n=15not reported in cached trials
Fusarium infection115262.8
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 — unassessedserious n=113not reported in cached trials
Microsporidia infection50212.6
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 — unassessedserious n=50 · ♀ 0% (drug 41%) · 100% cliniciannot reported in cached trials
Adenovirus reactivation19206.1
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 — unassessedserious n=19not reported in cached trials
Geotrichum infection29205.1
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 — unassessedserious n=29 · 100% cliniciannot reported in cached trials
Chimerism11182.9
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 — unassessedserious n=11not reported in cached trials
Acanthamoeba infection23178.4
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 — unassessedserious n=23 · ♀ 0% (drug 41%) · 100% cliniciannot reported in cached trials
Corynebacterium bacteraemia10177.8
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 — unassessedserious n=10not reported in cached trials
Scedosporium infection83176.8
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 — unassessedserious n=83not reported in cached trials
Encephalitis fungal10164.1
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 — unassessedserious n=10not reported in cached trials
Allogenic stem cell transplantation17158.8
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=17not reported in cached trials
Bronchiolitis obliterans syndrome18154.6
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 — unassessedserious n=18not reported in cached trials
Disseminated toxoplasmosis11136.7
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 — unassessedserious n=11not reported in cached trials
Chronic graft versus host disease in lung16135.6
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 — unassessedserious n=16NCT01075984: 1/237 (0.4%) on Posaconazole (serious AE)
Hepatosplenic candidiasis13125.1
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=13NCT01782131: 1/287 (0.3%) on Posaconazole (serious AE)
Differentiation syndrome61121.1
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 — unassessedserious n=61not reported in cached trials
Pulmonary mucormycosis42115.1
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 — unassessedserious n=42 · 95% cliniciannot reported in cached trials
Enterobacter bacteraemia24112.1
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 — unassessedserious n=24not reported in cached trials
Disseminated coccidioidomycosis11108.3
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 — unassessedserious n=11not reported in cached trials
Adenoviral hepatitis17102.6
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 — unassessedserious n=17not reported in cached trials
Mucormycosis185100.5
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 — unassessedserious n=185 · 91% clinicianNCT01782131: 1/287 (0.3%) on Posaconazole (serious AE)
Eye infection fungal2695.6
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 mucormycosis2393.5
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 — unassessedserious n=23 · 100% cliniciannot reported in cached trials
Lip squamous cell carcinoma1190.8
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 — unassessedserious n=11not reported in cached trials
Mycotic endophthalmitis1288.3
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 — unassessedserious n=12not reported in cached trials
Cerebral aspergillosis3988.0
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% clinicianNCT01782131: 1/287 (0.3%) on Posaconazole (serious AE)
Systemic mycosis7487.9
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 — unassessedserious n=74 · 96% cliniciannot reported in cached trials
Phaeohyphomycosis2987.5
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 — unassessedserious n=29 · 100% cliniciannot reported in cached trials
Labelled drug-drug interaction issue8785.7
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 artifactserious n=38 · 100% cliniciannot reported in cached trials
Cutaneous mucormycosis1185.3
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 — unassessedserious n=11not 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).

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.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Off label use (used outside approved label)1,6582.5
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 artifactserious PRR 2.4not reported in cached trials
Drug ineffective (drug did not work)1,4801.5
1.4–1.5ROR 1.5 · χ² 228 / p 9e-52
1.5 EB05 1.4 · IC025 +0.5Reporting / coding artifactserious PRR 2.6not reported in cached trials
Febrile neutropenia1,07221.3
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% clinicianNCT01782131: 24/288 (8.3%) on Posaconazole (serious AE)
Drug interaction1,0218.4
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 artifactserious PRR 5.6 · 93% cliniciannot reported in cached trials
Product use in unapproved indication1,0085.4
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 artifactserious PRR 4.0 · 93% cliniciannot reported in cached trials
Death9761.5
1.4–1.6ROR 1.5 · χ² 153 / p 2e-35
1.5 EB05 1.4 · IC025 +0.5Outcome field, not a reactionserious PRR 1.0NCT01782131: 2/288 (0.7%) on Posaconazole (serious AE)
Pyrexia (fever)8903.3
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 2.7NCT01782131: 7/288 (2.4%) on Posaconazole (serious AE)
Neutropenia (low neutrophils (infection-fighting cells))7477.2
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% clinicianNCT01782131: 24/288 (8.3%) on Posaconazole (serious AE)
Pneumonia (lung infection)6802.7
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 1.9NCT01782131: 1/288 (0.3%) on Posaconazole (serious AE)
Thrombocytopenia (low platelets)5376.3
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% clinicianNCT01782131: 1/288 (0.3%) on Posaconazole (serious AE)
Diarrhoea (diarrhea)5331.1
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 1.1NCT01782131: 1/288 (0.3%) on Posaconazole (serious AE)
Nausea5130.8
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 0.9NCT01782131: 2/287 (0.7%) on Posaconazole (serious AE)
Septic shock45713.9
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% clinicianNCT01782131: 16/288 (5.6%) on Posaconazole (serious AE)
Condition aggravated4381.9
1.7–2.1ROR 1.9 · χ² 183 / p 5e-42
1.9 EB05 1.7 · IC025 +0.8Reporting / coding artifactserious PRR 1.9not 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.

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

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.