HIGH-VOLUME · SEX-BALANCED
dupilumab Side Effects
dupilumab (also sold as Dupixent) is HIGH-VOLUME in this FAERS book #6 of 524 by FAERS report count. Signature opener: SEX-BALANCED - 61% of sex-coded reports are female (236,958 F / 151,443 M).
Data updated 2026-05-15
- 411,692
- FAERS reports
FAERS voluntary reports, 2013 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
dupilumab reporting skew - 61% of sex-coded reports are female (236,958 F / 151,443 M). Volume band HIGH-VOLUME #6 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for dupilumab (Dupixent): 411,692 FAERS rows (2013-2025). Top named reactions: PRURITUS, DERMATITIS ATOPIC, RASH. Outcome stamps DEATH-RARE · HOSP-LIGHT · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2013–2025). Stamps MEGA-CASE · DEATH-RARE · HOSP-LIGHT · SEX-BALANCED.
PRURITUS leads 48,441 of 411,692 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (92,830 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death is rare in this extract (1,769 / 411,692). Co-reported reactions in that thin subset:
| 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
Hospitalization is lighter here (19,011). Reactions in that subset:
| 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 |
How to read dupilumab FAERS figures (MEGA-CASE · DEATH-RARE · HOSP-LIGHT)
FAERS holds 411,692 voluntary reports linked to dupilumab (Dupixent), 2013-2025. Death is listed on 1,769 (0.4%). Hospitalization appears on 19,011 (4.6%). Top co-reported indication: Dermatitis Atopic.
MEGA-CASE books overweight common drugs and loud reporting cultures; SEX-BALANCED is the page opener, not a per-patient risk.
Read with dupilumab
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-RARE · HOSP-LIGHT stamps.
ABS(total_reports) peer at 410,053 FAERS cases (Δ 1,639 lighter vs dupilumab); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's MEGA-CASE · DEATH-RARE · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 417,458 FAERS cases (Δ 5,766 heavier vs dupilumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-RARE · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 387,984 FAERS cases (Δ 23,708 lighter vs dupilumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-RARE · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 366,491 FAERS cases (Δ 45,201 lighter vs dupilumab); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's MEGA-CASE · DEATH-RARE · HOSP-LIGHT · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 61.7 pp vs dupilumab's DEATH-RARE): CASELOAD · HOSP-MID.
dupilumab sits in MEGA-CASE; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.