85/100 · Critical
Manufactured by Roerig
Flucanazole Adverse Events: High Seriousness and Diverse Reactions
136,411 FDA adverse event reports analyzed
Last updated: 2026-05-12
FLUCONAZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Roerig. Based on analysis of 136,411 FDA adverse event reports, FLUCONAZOLE 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 FLUCONAZOLE include DRUG INEFFECTIVE, OFF LABEL USE, PYREXIA, NAUSEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUCONAZOLE.
Fluconazole 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 136,411 adverse event reports for this medication, which is primarily manufactured by Roerig.
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Pyrexia. Of classified reports, 84.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Flucanazole reports show a high percentage of serious adverse events, particularly respiratory and renal issues.
The most common reactions include nausea, diarrhea, and fatigue, indicating gastrointestinal and general discomfort. Drug interactions and pneumonia are significant safety concerns, especially in older adults.
Patients taking Fluconazole should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Flucanazole can interact with other medications, and reports of pneumonia are common, especially in older adults. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Fluconazole received a safety concern score of 85/100 (high concern). This is based on a 84.9% serious event ratio across 67,685 classified reports. The score accounts for 136,411 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: Female: 35,495, Male: 26,016, Unknown: 318. The most frequently reported age groups are age 65 (1,113 reports), age 63 (1,089 reports), age 66 (1,086 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 67,685 classified reports for FLUCONAZOLE:
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.
Flucanazole can interact with other medications, and reports of pneumonia are common, especially in older adults.
If you are taking Fluconazole, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, pyrexia, nausea, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before starting Flucanazole, especially if you are taking other medications. Monitor for signs of serious adverse events such as respiratory issues and renal failure. 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.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and drug interactions.
The FDA has received approximately 136,411 adverse event reports associated with Fluconazole. 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 Fluconazole include Drug Ineffective, Off Label Use, Pyrexia, Nausea, Diarrhoea. By volume, the top reported reactions are: Drug Ineffective (4,933 reports), Off Label Use (4,328 reports), Pyrexia (4,122 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Fluconazole.
Out of 67,685 classified reports, 57,435 (84.9%) were classified as serious and 10,250 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 Fluconazole break down by patient sex as follows: Female: 35,495, Male: 26,016, Unknown: 318. 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 Fluconazole adverse events are: age 65: 1,113 reports, age 63: 1,089 reports, age 66: 1,086 reports, age 62: 1,072 reports, age 60: 1,063 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 Fluconazole 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 Fluconazole include: Fatigue, Pain, Drug Interaction, Pneumonia, Headache. 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 Fluconazole 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.
Fluconazole 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. Flucanazole reports show a high percentage of serious adverse events, particularly respiratory and renal issues.
Key safety signals identified in Fluconazole's adverse event data include: High percentage of serious adverse events (84.9%). Common reactions include gastrointestinal issues (nausea, diarrhea) and general discomfort (fatigue, pain). Significant drug interactions and pneumonia reports. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Flucanazole can interact with other medications, and reports of pneumonia are common, especially in older adults. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Fluconazole.
Consult a healthcare provider before starting Flucanazole, especially if you are taking other medications. Monitor for signs of serious adverse events such as respiratory issues and renal failure.
Fluconazole has 136,411 adverse event reports on file with the FDA. The most common reactions include nausea, diarrhea, and fatigue, indicating gastrointestinal and general discomfort. The volume of reports for Fluconazole reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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