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Dupilumab Side Effects

The most commonly reported side effects of dupilumab include pruritus, dermatitis atopic, and product use in unapproved indication, based on 411,742 FDA adverse event reports from 2016 to 2025. 6.3% of reports found the drug to be ineffective.

Dupilumab side effects

Percentages show how often each reaction appears relative to total reports for dupilumab.

1
Pruritus11.8%48,444
2
Dermatitis Atopic9.2%37,675
3
Product Use In Unapproved Indication8.7%36,011
4
Rash8.1%33,435
5
Injection Site Pain7.4%30,478
6
Drug Ineffective6.3%26,037
7
Eczema5.4%22,305
8
Dry Skin5.3%21,662
9
Product Dose Omission Issue5.0%20,792
10
Condition Aggravated4.5%18,453
11
Arthralgia4.0%16,572
12
Inappropriate Schedule Of Product Administration4.0%16,307
13
Asthma3.3%13,672
14
Skin Exfoliation3.0%12,486
15
Accidental Exposure To Product3.0%12,192

These are voluntary reports and do not establish that dupilumab caused these reactions.

Report severity

10.9%Serious45,005 reports
4.6%Hospitalizations19,031 reports
0.4%Fatal1,770 reports

Seriousness is determined by the reporter, not by OpenClaim.

Dupilumab drug interactions

Other drugs that appear in adverse event reports alongside dupilumab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Prednisone0.2%711
2
Omalizumab0.1%598
3
Upadacitinib0.1%435
4
Mepolizumab<0.1%345
5
Fluticasone<0.1%323
6
Methotrexate<0.1%309
7
Cyclosporine<0.1%296
8
Adalimumab<0.1%281
9
Budesonide<0.1%270
10
Benralizumab<0.1%235
11
Montelukast-sodium<0.1%232
12
Semaglutide<0.1%224
13
Apremilast<0.1%216
14
Tacrolimus<0.1%203
15
Tirzepatide<0.1%189

Taken alongside

1
Albuterol4.0%16,560
2
Fluticasone3.5%14,479
3
Montelukast-sodium3.0%12,415
4
Ergocalciferol2.4%9,870
5
Cetirizine-hydrochloride2.1%8,623
6
Triamcinolone2.0%8,211
7
Prednisone1.9%7,944
8
Budesonide1.7%7,126
9
Omeprazole1.7%6,941
10
Atorvastatin-calcium1.7%6,883
11
Levothyroxine-sodium1.6%6,651
12
Formoterol1.5%6,039
13
Acetaminophen1.3%5,210
14
Hydroxyzine1.3%5,154
15
Amlodipine1.3%5,151

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports dupilumab side effects

57.6% of dupilumab adverse event reports involve female patients and 36.8% involve male patients. The largest age group is adult at 65%. These figures reflect who reports side effects, not underlying risk.

Sex

Female57.6%
Male36.8%
Unknown5.7%

Age group

< 20.7%
2–117.9%
12–177.1%
18–6464.6%
65+19.8%

What is dupilumab used for

Conditions and purposes for which patients were taking dupilumab when the adverse event was reported.

11-beta-hydroxylase DeficiencyAbdominal PainAcarodermatitisAccidental Exposure To ProductAcneActinic KeratosisAcute SinusitisAdenocarcinomaAdenoiditisAdenomatous Polyposis ColiAdverse Food ReactionAgeusiaAlcoholismAllergic Fungal RhinosinusitisAllergic Sinusitis

Showing 15 of 1,854 indications

Dupilumab brand names and reporting trend

Dupilumab is sold under the brand name Dupixent.

Brand names

Dupixent20,489

Quarterly reports (20162025)

2016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking dupilumab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.