Drug side effects
dupilumab Side Effects
The reactions most often reported to the FDA for dupilumab (also sold as Dupixent), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 411,692
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2013 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of dupilumab come from 411,692 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 411,692 reports to the FDA Adverse Event Reporting System (FAERS) for dupilumab (Dupixent): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
411,692
Reports Mentioning Death
1,769
0.4% of reports — not proof the medicine caused the death
Hospitalizations
19,011
4.6% of reports
Top Indication
Dermatitis Atopic
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 1,769 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 1,049 |
| PNEUMONIA | 97 |
| DYSPNOEA | 72 |
| COVID-19 | 71 |
| PRURITUS | 61 |
| FALL | 59 |
| HOSPITALISATION | 59 |
| MYOCARDIAL INFARCTION | 51 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 45 |
| CONDITION AGGRAVATED | 43 |
| CEREBROVASCULAR ACCIDENT | 41 |
| INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION | 40 |
| RASH | 40 |
| NEOPLASM MALIGNANT | 37 |
| RESPIRATORY FAILURE | 35 |
| SEPSIS | 35 |
Reactions in Hospitalization Reports
Top reactions in 19,011 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| HOSPITALISATION | 2,699 |
| ASTHMA | 1,919 |
| DYSPNOEA | 1,803 |
| PNEUMONIA | 1,630 |
| PRURITUS | 1,245 |
| RASH | 977 |
| COVID-19 | 944 |
| COUGH | 870 |
| FALL | 845 |
| CONDITION AGGRAVATED | 751 |
| ARTHRALGIA | 655 |
| PYREXIA | 653 |
| DERMATITIS ATOPIC | 638 |
| PAIN | 612 |
| INJECTION SITE PAIN | 603 |
| INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION | 593 |
Nearby, Related Medications
What the FAERS Data Reveals About dupilumab Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 411,692 voluntary reports linked to dupilumab and its brand equivalents (Dupixent), spanning 2013 through 2025. Of those, 1,769 (0.4%) listed death as an outcome and 19,011 (4.6%) involved hospitalization. The most common indication reported alongside adverse events was Dermatitis Atopic.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 61% were female and 39% male; age distribution skews toward 45-64, with 92,830 reports in that bracket. The single most reported reaction is pruritus with 48,441 submissions, followed by dermatitis atopic and rash.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to dupilumab's 411,692.
Read our methodology - how this data is sourced, computed, and verified.