85/100 · Critical
Manufactured by Roerig
Voriconazole Adverse Events: High Seriousness and Diverse Reactions
52,026 FDA adverse event reports analyzed
Last updated: 2026-05-12
VORICONAZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Roerig. Based on analysis of 52,026 FDA adverse event reports, VORICONAZOLE 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 VORICONAZOLE include DRUG INEFFECTIVE, OFF LABEL USE, DRUG INTERACTION, DEATH, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VORICONAZOLE.
Voriconazole 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 52,026 adverse event reports for this medication, which is primarily manufactured by Roerig.
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Drug Interaction. Of classified reports, 92.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Voriconazole reports show a high percentage of serious adverse events, particularly respiratory and infectious complications.
The drug is associated with a wide range of reactions, indicating potential for diverse side effects. Neutropenia and sepsis are among the most frequently reported serious conditions.
Patients taking Voriconazole should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Voriconazole can cause drug interactions and increased drug levels, leading to potential toxicity. It is important to monitor drug levels and avoid concomitant use with other immunosuppressants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Voriconazole received a safety concern score of 85/100 (high concern). This is based on a 92.1% serious event ratio across 29,377 classified reports. The score accounts for 52,026 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: 15,916, Female: 10,218, Unknown: 144. The most frequently reported age groups are age 68 (594 reports), age 65 (590 reports), age 66 (575 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 29,377 classified reports for VORICONAZOLE:
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.
Voriconazole can cause drug interactions and increased drug levels, leading to potential toxicity. It is important to monitor drug levels and avoid concomitant use with other immunosuppressants.
If you are taking Voriconazole, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, drug interaction, death, pyrexia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of severe infections, respiratory failure, and organ dysfunction. Regularly check blood counts and liver function tests. 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 continues to monitor voriconazole for safety, particularly for serious infections and organ dysfunction. Healthcare providers should be vigilant and report any adverse events.
The FDA has received approximately 52,026 adverse event reports associated with Voriconazole. 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 Voriconazole include Drug Ineffective, Off Label Use, Drug Interaction, Death, Pyrexia. By volume, the top reported reactions are: Drug Ineffective (4,098 reports), Off Label Use (2,341 reports), Drug Interaction (2,315 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Voriconazole.
Out of 29,377 classified reports, 27,068 (92.1%) were classified as serious and 2,309 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 Voriconazole break down by patient sex as follows: Male: 15,916, Female: 10,218, Unknown: 144. 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 Voriconazole adverse events are: age 68: 594 reports, age 65: 590 reports, age 66: 575 reports, age 69: 571 reports, age 67: 561 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 Voriconazole adverse event reports is Roerig. 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 Voriconazole include: Pneumonia, Condition Aggravated, Bronchopulmonary Aspergillosis, Febrile Neutropenia, Aspergillus Infection. 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 Voriconazole 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.
Voriconazole 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. Voriconazole reports show a high percentage of serious adverse events, particularly respiratory and infectious complications.
Key safety signals identified in Voriconazole's adverse event data include: High number of reports of death and severe infections like pneumonia and sepsis.. Multiple organ dysfunction syndrome and acute kidney injury are key safety signals.. Drug interactions and increased drug levels are also significant safety concerns.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Voriconazole can cause drug interactions and increased drug levels, leading to potential toxicity. It is important to monitor drug levels and avoid concomitant use with other immunosuppressants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Voriconazole.
Monitor patients for signs of severe infections, respiratory failure, and organ dysfunction. Regularly check blood counts and liver function tests.
Voriconazole has 52,026 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, indicating potential for diverse side effects. The volume of reports for Voriconazole reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor voriconazole for safety, particularly for serious infections and organ dysfunction. Healthcare providers should be vigilant and report any adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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