OpenClaim

Itraconazole Side Effects

The most commonly reported side effects of itraconazole include drug interaction, off label use, and dyspnoea, based on 11,516 FDA adverse event reports from 2004 to 2025. 8.1% of reports found the drug to be ineffective.

Itraconazole side effects

Percentages show how often each reaction appears relative to total reports for itraconazole.

1
Drug Ineffective8.1%934
2
Drug Interaction7.9%905
3
Off Label Use5.2%603
4
Dyspnoea3.3%382
5
Pyrexia3.3%379
6
Nausea3.0%341
7
Pneumonia2.9%339
8
Condition Aggravated2.8%318
9
Diarrhoea2.5%286
10
Fatigue2.5%283
11
Cough2.2%258
12
Rash2.1%245
13
Febrile Neutropenia2.1%238
14
Product Use In Unapproved Indication2.0%232
15
Drug Interaction1.9%224

These are voluntary reports and do not establish that itraconazole caused these reactions.

Report severity

89.6%Serious10,322 reports
38.2%Hospitalizations4,395 reports
19.7%Fatal2,267 reports

Seriousness is determined by the reporter, not by OpenClaim.

Itraconazole drug interactions

Other drugs that appear in adverse event reports alongside itraconazole. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Tacrolimus6.3%725
2
Amphotericin-b6.1%708
3
Voriconazole5.6%641
4
Prednisone5.0%571
5
Mycophenolate4.9%559
6
Prednisolone4.1%469
7
Cyclosporine3.6%414
8
Fluconazole2.9%336
9
Cyclophosphamide2.8%322
10
Methylprednisolone2.6%300
11
Dexamethasone2.6%294
12
Fludarabine-phosphate2.5%288
13
Methotrexate2.3%269
14
Cytarabine2.3%261
15
Terbinafine2.0%235

Taken alongside

1
Sulfamethoxazole9.4%1,081
2
Acyclovir7.6%880
3
Trimethoprim7.6%875
4
Prednisone7.4%852
5
Omeprazole6.5%745
6
Acetaminophen6.2%710
7
Albuterol5.4%617
8
Furosemide5.3%610
9
Prednisolone5.3%605
10
Amphotericin-b4.9%569
11
Levofloxacin4.8%555
12
Ciprofloxacin4.5%523
13
Fluconazole4.4%506
14
Methylprednisolone4.4%501
15
Amoxicillin3.9%448

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports itraconazole side effects

40.4% of itraconazole adverse event reports involve female patients and 46.5% involve male patients. The largest age group is adult at 57%. These figures reflect who reports side effects, not underlying risk.

Sex

Female40.4%
Male46.5%
Unknown13.0%

Age group

< 21.5%
2–115.4%
12–175.1%
18–6457.5%
65+30.6%

What is itraconazole used for

Conditions and purposes for which patients were taking itraconazole when the adverse event was reported.

AbscessAbscess FungalAbscess LimbAcanthamoeba KeratitisAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAcute Promyelocytic LeukaemiaAcute Pulmonary HistoplasmosisAdverse EventAllergic Bronchopulmonary MycosisAllergic Granulomatous AngiitisAllergy TestAllogenic Stem Cell TransplantationAlternaria Infection

Showing 15 of 659 indications

Itraconazole brand names and reporting trend

Itraconazole is sold under the brand name Tolsura.

Brand names

Tolsura10,537

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking itraconazole with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.