85/100 · Critical
Manufactured by Dr. Reddy's Laboratories Inc.
Fluorouracil Cream, 0.5% Adverse Reactions: High Serious Event Rate
122,970 FDA adverse event reports analyzed
Last updated: 2026-05-12
FLUOROURACIL CREAM, 0.5% is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Dr. Reddy's Laboratories Inc.. Based on analysis of 122,970 FDA adverse event reports, FLUOROURACIL CREAM, 0.5% 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 FLUOROURACIL CREAM, 0.5% include DIARRHOEA, NEUTROPENIA, NAUSEA, VOMITING, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUOROURACIL CREAM, 0.5%.
Fluorouracil Cream, 0.5% 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 122,970 adverse event reports for this medication, which is primarily manufactured by Dr. Reddy'S Laboratories Inc..
The most commonly reported adverse events include Diarrhoea, Neutropenia, Nausea. Of classified reports, 94.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High incidence of serious adverse events such as death, sepsis, and pulmonary embolism.
Neutropenia and thrombocytopenia are common, indicating potential hematological toxicity. Significant gastrointestinal issues like diarrhea and nausea are frequently reported.
Patients taking Fluorouracil Cream, 0.5% should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Fluorouracil cream, 0.5% can cause severe hematological and gastrointestinal side effects. It is contraindicated in patients with severe liver or kidney dysfunction. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Fluorouracil Cream, 0.5% received a safety concern score of 85/100 (high concern). This is based on a 94.9% serious event ratio across 72,439 classified reports. The score accounts for 122,970 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: 33,943, Female: 27,968, Unknown: 816. The most frequently reported age groups are age 65 (1,833 reports), age 67 (1,832 reports), age 68 (1,783 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 72,439 classified reports for FLUOROURACIL CREAM, 0.5%:
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.
Fluorouracil cream, 0.5% can cause severe hematological and gastrointestinal side effects. It is contraindicated in patients with severe liver or kidney dysfunction.
If you are taking Fluorouracil Cream, 0.5%, here are important things to know. The most commonly reported side effects include diarrhoea, neutropenia, nausea, vomiting, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed usage strictly and report any unusual symptoms to a healthcare provider immediately. Avoid use in patients with pre-existing liver or kidney conditions. 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 adverse events for Fluorouracil cream, 0.5%, and regulatory actions may be taken based on ongoing safety assessments.
The FDA has received approximately 122,970 adverse event reports associated with Fluorouracil Cream, 0.5%. 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 Fluorouracil Cream, 0.5% include Diarrhoea, Neutropenia, Nausea, Vomiting, Off Label Use. By volume, the top reported reactions are: Diarrhoea (6,625 reports), Neutropenia (4,984 reports), Nausea (4,689 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Fluorouracil Cream, 0.5%.
Out of 72,439 classified reports, 68,777 (94.9%) were classified as serious and 3,662 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 Fluorouracil Cream, 0.5% break down by patient sex as follows: Male: 33,943, Female: 27,968, Unknown: 816. 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 Fluorouracil Cream, 0.5% adverse events are: age 65: 1,833 reports, age 67: 1,832 reports, age 68: 1,783 reports, age 70: 1,774 reports, age 62: 1,743 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 Fluorouracil Cream, 0.5% adverse event reports is Dr. Reddy'S Laboratories 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 Fluorouracil Cream, 0.5% include: Disease Progression, Neuropathy Peripheral, Pyrexia, Fatigue, Thrombocytopenia. 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 Fluorouracil Cream, 0.5% 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.
Fluorouracil Cream, 0.5% 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. High incidence of serious adverse events such as death, sepsis, and pulmonary embolism.
Key safety signals identified in Fluorouracil Cream, 0.5%'s adverse event data include: High rate of serious adverse events (94.9%). Multiple hematological and gastrointestinal reactions. Significant number of reports involving death and sepsis. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Fluorouracil cream, 0.5% can cause severe hematological and gastrointestinal side effects. It is contraindicated in patients with severe liver or kidney dysfunction. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Fluorouracil Cream, 0.5%.
Follow prescribed usage strictly and report any unusual symptoms to a healthcare provider immediately. Avoid use in patients with pre-existing liver or kidney conditions.
Fluorouracil Cream, 0.5% has 122,970 adverse event reports on file with the FDA. Neutropenia and thrombocytopenia are common, indicating potential hematological toxicity. The volume of reports for Fluorouracil Cream, 0.5% reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors adverse events for Fluorouracil cream, 0.5%, and regulatory actions may be taken based on ongoing safety assessments. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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