Dupixent

N/A

Manufactured by Sanofi-Aventis U.S. LLC

838,442 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Dupixent

Dupixent is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sanofi-Aventis U.S. LLC. The most commonly reported adverse reactions for Dupixent 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 Dupixent.

Top Adverse Reactions

PRURITUS52,379 reports
DERMATITIS ATOPIC41,045 reports
PRODUCT USE IN UNAPPROVED INDICATION38,078 reports
RASH35,570 reports
INJECTION SITE PAIN32,857 reports
DRUG INEFFECTIVE27,750 reports
ECZEMA24,172 reports
PRODUCT DOSE OMISSION ISSUE23,332 reports
DRY SKIN23,316 reports
CONDITION AGGRAVATED19,621 reports
ARTHRALGIA17,651 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION17,346 reports
ASTHMA14,715 reports
ACCIDENTAL EXPOSURE TO PRODUCT13,305 reports
SKIN EXFOLIATION13,299 reports
DYSPNOEA12,782 reports
OFF LABEL USE12,593 reports
ERYTHEMA12,524 reports
DRY EYE12,355 reports
INCORRECT DOSE ADMINISTERED11,572 reports
EXPOSURE VIA SKIN CONTACT11,430 reports
INJECTION SITE SWELLING10,951 reports
PRODUCT USE ISSUE10,648 reports
COUGH10,199 reports
INJECTION SITE ERYTHEMA10,065 reports
EYE PRURITUS9,347 reports
PRODUCT DOSE OMISSION IN ERROR9,015 reports
THERAPEUTIC RESPONSE DECREASED8,708 reports
PAIN8,699 reports
HEADACHE8,540 reports
THERAPEUTIC RESPONSE SHORTENED8,204 reports
FATIGUE7,621 reports
OCULAR HYPERAEMIA7,576 reports
COVID 197,442 reports
RASH ERYTHEMATOUS6,582 reports
SKIN FISSURES6,460 reports
NASOPHARYNGITIS6,310 reports
SLEEP DISORDER6,277 reports
VISION BLURRED6,261 reports
EYE IRRITATION6,249 reports
URTICARIA6,025 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION5,921 reports
CONJUNCTIVITIS5,630 reports
INJECTION SITE PRURITUS5,621 reports
ILLNESS5,264 reports
SKIN BURNING SENSATION5,084 reports
HYPERSENSITIVITY5,042 reports
INJECTION SITE BRUISING5,028 reports
NAUSEA4,782 reports
DIZZINESS4,730 reports
INJECTION SITE REACTION4,620 reports
PYREXIA4,538 reports
DISCOMFORT4,505 reports
PAIN IN EXTREMITY4,421 reports
DERMATITIS4,417 reports
RASH MACULAR4,292 reports
NASAL CONGESTION4,116 reports
INJECTION SITE RASH4,067 reports
DIARRHOEA4,057 reports
SKIN HAEMORRHAGE3,843 reports
IMPAIRED QUALITY OF LIFE3,841 reports
WEIGHT INCREASED3,824 reports
INSOMNIA3,798 reports
PNEUMONIA3,793 reports
RASH PRURITIC3,787 reports
SINUSITIS3,709 reports
MYALGIA3,611 reports
MALAISE3,604 reports
INFLUENZA3,584 reports
INJECTION SITE URTICARIA3,532 reports
ALOPECIA3,470 reports
VISUAL IMPAIRMENT3,441 reports
RHINORRHOEA3,404 reports
LACRIMATION INCREASED3,347 reports
ORAL HERPES3,244 reports
PRODUCT PREPARATION ERROR3,140 reports
PERIPHERAL SWELLING3,117 reports
OROPHARYNGEAL PAIN3,095 reports
PRODUCT STORAGE ERROR2,930 reports
EYE PAIN2,889 reports
HOSPITALISATION2,872 reports
INTENTIONAL DOSE OMISSION2,789 reports
WHEEZING2,787 reports
PRODUCT DOSE OMISSION2,735 reports
BACK PAIN2,718 reports
DRUG HYPERSENSITIVITY2,718 reports
VOMITING2,654 reports
EYE SWELLING2,553 reports
REBOUND EFFECT2,508 reports
INFECTION2,499 reports
INJECTION SITE MASS2,488 reports
FALL2,474 reports
SKIN DISCOLOURATION2,434 reports
SKIN IRRITATION2,433 reports
STRESS2,341 reports
PSORIASIS2,335 reports
PARAESTHESIA2,328 reports
SKIN SWELLING2,297 reports
EYE DISORDER2,254 reports
ABDOMINAL PAIN UPPER2,216 reports

Report Outcomes

Out of 438,464 classified reports for Dupixent:

  • Serious: 48,573 reports (11.1%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 389,891 reports (88.9%)
Serious 11.1%Non-Serious 88.9%

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 Breakdown

Reports by Sex

Female252,872 (61.0%)
Male161,818 (39.0%)
Unknown46 (0.0%)

Reports by Age

Age 606,024 reports
Age 625,965 reports
Age 635,911 reports
Age 615,868 reports
Age 645,680 reports
Age 595,641 reports
Age 585,458 reports
Age 575,226 reports
Age 555,107 reports
Age 655,097 reports
Age 565,003 reports
Age 544,941 reports
Age 534,801 reports
Age 524,630 reports
Age 664,557 reports
Age 514,470 reports
Age 674,309 reports
Age 504,294 reports
Age 494,135 reports
Age 684,112 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with Dupixent?

This profile reflects 838,442 FDA FAERS reports that mention Dupixent. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Dupixent?

Frequently reported terms in FAERS include PRURITUS, DERMATITIS ATOPIC, PRODUCT USE IN UNAPPROVED INDICATION, RASH, INJECTION SITE PAIN, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Dupixent?

Labeling and FAERS entries often list Sanofi-Aventis U.S. LLC in connection with Dupixent. Always verify the specific product and NDC with your pharmacist.

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Drugs Also Linked to PRURITUS

The following drugs share commonly reported adverse reactions with Dupixent:

ACETAMINOPHEN (35/100)ACETAMINOPHEN 325 MG (65/100)ACETAMINOPHEN 325MG (65/100)ACETAMINOPHEN 500 MG (65/100)ACETAMINOPHEN 500MG (85/100)ACETAMINOPHEN, ASPIRIN, CAFFEINE (45/100)ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL (74/100)ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE (65/100)ACETAMINOPHEN TABLET EXTENDED RELEASE (85/100)ADAPALENE (55/100)ADAPALENE AND BENZOYL PEROXIDE (72/100)ALCOHOL ANTISEPTIC (25/100)

View all drugs reporting PRURITUS →

Explore More

Safety RankingsSearch All DrugsCompare DrugsSanofi-Aventis U.S. LLC PortfolioPRURITUS in Other DrugsDERMATITIS ATOPIC in Other DrugsPRODUCT USE IN UNAPPROVED INDICATION in Other Drugs
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.