35/100 · Moderate
Manufactured by sanofi-aventis U.S. LLC
Dupilumab Adverse Reactions Mostly Non-Serious, Skin-Related Issues Predominate
782,562 FDA adverse event reports analyzed
Last updated: 2026-05-12
DUPILUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by sanofi-aventis U.S. LLC. Based on analysis of 782,562 FDA adverse event reports, DUPILUMAB has a safety score of 35 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. The most commonly reported adverse reactions for DUPILUMAB include PRURITUS, DERMATITIS ATOPIC, PRODUCT USE IN UNAPPROVED INDICATION, RASH, INJECTION SITE PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DUPILUMAB.
Dupilumab has a safety concern score of 35 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 782,562 adverse event reports for this medication, which is primarily manufactured by Sanofi-Aventis U.S. Llc.
The most commonly reported adverse events include Pruritus, Dermatitis Atopic, Product Use In Unapproved Indication. Of classified reports, 10.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most adverse reactions are non-serious, with skin-related issues being the most common.
Serious adverse events account for only 10.9% of total reports. The majority of reports involve skin conditions, such as pruritus and rash.
Patients taking Dupilumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions are not commonly reported, but patients should be cautious with concurrent use of other topical or systemic medications affecting the skin. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dupilumab received a safety concern score of 35/100 (moderate concern). This is based on a 10.9% serious event ratio across 411,661 classified reports. The score accounts for 782,562 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 236,958, Male: 151,443, Unknown: 46. The most frequently reported age groups are age 60 (5,728 reports), age 62 (5,624 reports), age 63 (5,529 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 411,661 classified reports for DUPILUMAB:
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.
Drug interactions are not commonly reported, but patients should be cautious with concurrent use of other topical or systemic medications affecting the skin.
If you are taking Dupilumab, here are important things to know. The most commonly reported side effects include pruritus, dermatitis atopic, product use in unapproved indication, rash, injection site pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any adverse reactions to their healthcare provider immediately. Follow prescribed dosing and administration instructions carefully to minimize the risk of adverse events. 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 the safety profile of dupilumab, with ongoing reviews to ensure patient safety.
The FDA has received approximately 782,562 adverse event reports associated with Dupilumab. 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 Dupilumab include Pruritus, Dermatitis Atopic, Product Use In Unapproved Indication, Rash, Injection Site Pain. By volume, the top reported reactions are: Pruritus (48,441 reports), Dermatitis Atopic (37,675 reports), Product Use In Unapproved Indication (36,010 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Dupilumab.
Out of 411,661 classified reports, 44,975 (10.9%) were classified as serious and 366,686 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 Dupilumab break down by patient sex as follows: Female: 236,958, Male: 151,443, Unknown: 46. 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 Dupilumab adverse events are: age 60: 5,728 reports, age 62: 5,624 reports, age 63: 5,529 reports, age 61: 5,501 reports, age 59: 5,318 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 Dupilumab adverse event reports is Sanofi-Aventis U.S. Llc. 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 Dupilumab include: Drug Ineffective, Eczema, Dry Skin, Product Dose Omission Issue, Condition Aggravated. 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 Dupilumab 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.
Dupilumab has a safety concern score of 35 out of 100 (moderate 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. Most adverse reactions are non-serious, with skin-related issues being the most common.
Key safety signals identified in Dupilumab's adverse event data include: Skin-related reactions, including pruritus and rash, are the most frequently reported adverse events.. There is a notable number of reports related to product use issues, such as dose omission and incorrect administration.. Serious adverse events, while less frequent, include pneumonia and hospitalization.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions are not commonly reported, but patients should be cautious with concurrent use of other topical or systemic medications affecting the skin. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dupilumab.
Patients should report any adverse reactions to their healthcare provider immediately. Follow prescribed dosing and administration instructions carefully to minimize the risk of adverse events.
Dupilumab has 782,562 adverse event reports on file with the FDA. Serious adverse events account for only 10.9% of total reports. The volume of reports for Dupilumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety profile of dupilumab, with ongoing reviews to ensure patient safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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