85/100 · Critical
Manufactured by Janssen Pharmaceuticals, Inc.
High Safety Concerns with Itraconazole, Particularly for Serious Reactions and Drug Interactions
20,198 FDA adverse event reports analyzed
Last updated: 2026-05-12
ITRACONAZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Pharmaceuticals, Inc.. Based on analysis of 20,198 FDA adverse event reports, ITRACONAZOLE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for ITRACONAZOLE include DRUG INTERACTION, DRUG INEFFECTIVE, OFF LABEL USE, PYREXIA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ITRACONAZOLE.
Itraconazole has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 20,198 adverse event reports for this medication, which is primarily manufactured by Janssen Pharmaceuticals, Inc..
The most commonly reported adverse events include Drug Interaction, Drug Ineffective, Off Label Use. Of classified reports, 89.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events, including pneumonia, sepsis, and respiratory failure, account for a significant portion of reports.
Drug interactions are a major concern, with over 1,100 reports of drug interactions. The majority of reactions are non-serious, but the high number of serious events is a cause for concern.
Patients taking Itraconazole should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Itraconazole can interact with many other drugs, potentially leading to adverse effects. Healthcare providers should be cautious when prescribing it with other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Itraconazole received a safety concern score of 85/100 (high concern). This is based on a 89.6% serious event ratio across 11,315 classified reports. The score accounts for 20,198 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 5,273, Female: 4,544, Unknown: 104. The most frequently reported age groups are age 65 (211 reports), age 60 (185 reports), age 67 (184 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 11,315 classified reports for ITRACONAZOLE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Itraconazole can interact with many other drugs, potentially leading to adverse effects. Healthcare providers should be cautious when prescribing it with other medications.
If you are taking Itraconazole, here are important things to know. The most commonly reported side effects include drug interaction, drug ineffective, off label use, pyrexia, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Inform your healthcare provider about all medications you are taking to avoid potential drug interactions. Be aware of the signs of serious adverse events such as pneumonia, sepsis, and respiratory failure, and seek medical attention if they occur. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors Itraconazole due to its high number of adverse event reports, particularly for serious conditions. Regular monitoring and follow-up are recommended.
The FDA has received approximately 20,198 adverse event reports associated with Itraconazole. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Itraconazole include Drug Interaction, Drug Ineffective, Off Label Use, Pyrexia, Dyspnoea. By volume, the top reported reactions are: Drug Interaction (1,118 reports), Drug Ineffective (1,100 reports), Off Label Use (606 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Itraconazole.
Out of 11,315 classified reports, 10,140 (89.6%) were classified as serious and 1,175 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Itraconazole break down by patient sex as follows: Male: 5,273, Female: 4,544, Unknown: 104. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Itraconazole adverse events are: age 65: 211 reports, age 60: 185 reports, age 67: 184 reports, age 64: 177 reports, age 58: 171 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Itraconazole adverse event reports is Janssen Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Itraconazole include: Pneumonia, Nausea, Diarrhoea, Condition Aggravated, Febrile Neutropenia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Itraconazole to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Itraconazole has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Serious adverse events, including pneumonia, sepsis, and respiratory failure, account for a significant portion of reports.
Key safety signals identified in Itraconazole's adverse event data include: Drug interactions are frequent, with over 1,100 reports.. Pneumonia and sepsis are among the most common serious adverse events.. Pyrexia and dyspnoea are also frequently reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Itraconazole can interact with many other drugs, potentially leading to adverse effects. Healthcare providers should be cautious when prescribing it with other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Itraconazole.
Inform your healthcare provider about all medications you are taking to avoid potential drug interactions. Be aware of the signs of serious adverse events such as pneumonia, sepsis, and respiratory failure, and seek medical attention if they occur.
Itraconazole has 20,198 adverse event reports on file with the FDA. Drug interactions are a major concern, with over 1,100 reports of drug interactions. The volume of reports for Itraconazole reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Itraconazole due to its high number of adverse event reports, particularly for serious conditions. Regular monitoring and follow-up are recommended. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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