Prescription medication · Anti-IL-4/IL-13 Monoclonal Antibody
dupilumab
Also sold as Dupixent. Dupixent can treat moderate-to-severe atopic dermatitis (eczema) in adults and children 6 months and older.
Data updated 2026-05-15
- 411,692
- FDA reportsHeavily reported
- $1608.24
- Brand price (NADAC)
dupilumab (Dupixent) is a prescription Anti-IL-4/IL-13 Monoclonal Antibody. Dupixent can treat moderate-to-severe atopic dermatitis (eczema) in adults and children 6 months and older.
Dupixent is a medicine that can help treat several conditions. It works by blocking certain proteins in your body that cause inflammation.
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Drug Pricing (NADAC)
Brand Price
$1608.24/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Dupixent can treat moderate-to-severe atopic dermatitis (eczema) in adults and children 6 months and older.
Common side effects
Injection site reactions (like redness, swelling, or pain), Conjunctivitis (pink eye), Blepharitis (eyelid inflammation)
Key warnings
Dupixent can cause serious allergic reactions, including anaphylaxis.
The sections below are summarized in plain English from dupilumab's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Dupixent is a type of medicine called a monoclonal antibody. It blocks two proteins called interleukin-4 (IL-4) and interleukin-13 (IL-13). By blocking these proteins, Dupixent helps to reduce inflammation and improve your symptoms.
How to Take It
Dupixent is given as a shot under the skin (subcutaneous injection). The dose and how often you get the shot depends on your condition and weight. Your doctor will tell you exactly how much Dupixent to take and when. You can inject Dupixent yourself, or have someone else do it for you. Dupixent can be used with or without topical corticosteroids.
This is a plain-language summary of dupilumab's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. There is a pregnancy registry to track outcomes in women who use Dupixent during pregnancy; you can enroll by calling 1-877-311-8972. It is not known if Dupixent passes into breast milk or if it could harm a nursing baby, so talk to your doctor about the best way to feed your baby if you are using Dupixent.
This is a plain-language summary of dupilumab's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose of Dupixent, talk to your doctor about when to take your next dose. Try to take Dupixent as prescribed to get the most benefit.
This is a plain-language summary of dupilumab's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Dupixent in the refrigerator between 36°F and 46°F (2°C to 8°C) in its original carton to protect it from light. Dupixent may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days, but do not store it above this temperature, and use it within those 14 days or throw it away. Do not freeze or shake Dupixent.
Side Effects (from patient reports)
Based on 411,692 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for dupilumab, by number of reports
- Itching
Itching
48,441 reports
- Eczema
Eczema
37,675 reports
- Skin rash
Skin rash
33,431 reports
- Pain at the injection site
Pain at the injection site
30,477 reports
- Eczema
Eczema
22,304 reports
- Dry skin
Dry skin
21,662 reports
- Condition getting worse 18,451
Condition getting worse
18,451 reports
- Joint pain 16,570
Joint pain
16,570 reports
- Taking the medicine at the wrong time 16,307
Taking the medicine at the wrong time
16,307 reports
- Asthma 13,665
Asthma
13,665 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for dupilumab each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where dupilumab sits
dupilumab has more FDA adverse-event reports than 99% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is dupilumab; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 411,692 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2013–2025.
Total Reports
411,692
Reports Mentioning Death
1,769
0.4% of reports — not proof of cause
Hospitalization Reports
19,011
Top Indication
Dermatitis Atopic
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | PRURITUS | 48,441 |
| 2 | DERMATITIS ATOPIC | 37,675 |
| 4 | RASH | 33,431 |
| 5 | INJECTION SITE PAIN | 30,477 |
| 7 | ECZEMA | 22,304 |
| 8 | DRY SKIN | 21,662 |
| 10 | CONDITION AGGRAVATED | 18,451 |
| 11 | ARTHRALGIA | 16,570 |
| 12 | INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION | 16,307 |
| 13 | ASTHMA | 13,665 |
| 14 | SKIN EXFOLIATION | 12,486 |
| 15 | ACCIDENTAL EXPOSURE TO PRODUCT | 12,191 |
| 16 | ERYTHEMA | 11,817 |
| 18 | DRY EYE | 11,640 |
| 19 | DYSPNOEA | 11,604 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Dupixent can cause serious allergic reactions, including anaphylaxis. Stop using Dupixent and get medical help right away if you have any signs of an allergic reaction. Tell your doctor if you get new or worsening eye problems, such as conjunctivitis or keratitis. Dupixent can sometimes cause eosinophilic conditions, so watch for symptoms like a vasculitic rash, worsening lung symptoms, heart problems, kidney problems, or nerve damage. Do not stop taking steroid medicines suddenly when you start Dupixent. Talk to your doctor about how to slowly lower your steroid dose if needed. Tell your doctor if you develop new psoriasis symptoms or joint symptoms.
Common Questions
What should I tell my doctor before starting Dupixent?
Can I get vaccines while using Dupixent?
What are the most common side effects of Dupixent?
How is Dupixent given?
How often will I need to take Dupixent?
What if I have an allergic reaction to Dupixent?
Can Dupixent be used with other medicines?
What should I do if my symptoms get worse while taking Dupixent?
How long does it take for Dupixent to start working?
Is there a generic version of Dupixent available?
What are the common side effects of dupilumab?
What drug class is dupilumab?
Is dupilumab safe during pregnancy?
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What the FDA Data Shows for dupilumab
The FDA label for dupilumab (sold under brand names such as Dupixent) classifies it as a prescription-only medication in the Anti-IL-4/IL-13 Monoclonal Antibody class. Dupixent can treat moderate-to-severe atopic dermatitis (eczema) in adults and children 6 months and older. Official labeling lists 27 commonly reported side effects, including Injection site reactions (like redness, swelling, or pain), Conjunctivitis (pink eye), Blepharitis (eyelid inflammation).
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 411,692 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: September 30, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages