Safety profile
For full safety information, please click here for the Summary of Product Characteristics.
| BOREAS safety profilea,b,1 |
DUPIXENT |
Placebo |
| Any Adverse Events (AE) |
77% |
76% |
| Any serious AE (SAE) |
14% |
16% |
| Any AE leading to death |
2% |
2% |
| Any AE leading to permanent study intervention discontinuation |
3% |
3% |
| Major adverse cardiovascular eventc |
1% |
2% |
| AEs OCCURRING IN ≥5% OF PATIENTS IN EITHER GROUP | ||
| Nasopharyngitis |
9% |
10% |
| Upper respiratory tract infection |
8% |
10% |
| Headache |
8% |
7% |
| COPD |
6% |
6% |
| COVID-19 |
4% |
6% |
| Hypertension |
4% |
6% |
| Diarrhoea |
5% |
4% |
| Back pain |
5% |
3% |
aThe safety population consisted of all patients who received at least 1 full or partial dose of DUPIXENT or placebo; the analysis was performed according to the treatment each patient received.1,2
bIn Boreas, one patient assigned to the placebo group inadvertently received DUPIXENT, so the safety population includes 470 patients in the placebo group and 469 patients in the DUPIXENT group.1
cMajor adverse cardiovascular events (adjudicated) included cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.1,2
| NOTUS safety profilea,2 |
DUPIXENT |
Placebo |
| Any AE |
67% |
66% |
| Any SAE |
13% |
16% |
| Any AE leading to death |
3% |
2% |
| Any AE leading to permanent study intervention discontinuation |
4% |
3% |
| Major adverse cardiovascular eventc |
1% |
2% |
| AEs OCCURRING IN ≥5% OF PATIENTS IN EITHER GROUP | ||
| COVID-19 |
9% |
8% |
| Headache |
8% |
7% |
| COPD |
5% |
8% |
| Nasopharyngitis |
6% |
5% |
aThe safety population consisted of all patients who received at least 1 full or partial dose of DUPIXENT or placebo; the analysis was performed according to the treatment each patient received.1,2
bIn Boreas, one patient assigned to the placebo group inadvertently received DUPIXENT, so the safety population includes 470 patients in the placebo group and 469 patients in the DUPIXENT group.1
cMajor adverse cardiovascular events (adjudicated) included cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.1,2
DUPIXENT HAS A GENERALLY WELL-TOLERATED SAFETY PROFILE ACROSS 6 INDICATIONS3
| System class | Adverse reaction | Frequencyd |
| Blood and lymphatic system disorders | Eosinophilia | Common |
| Immune system disorders |
Angioedemae
|
Uncommon
|
|
Anaphylactic reaction Serum sickness reaction Serum sickness-like reaction | Rare | |
| Skin and subcutaneous tissue disorders | Facial rashe | Uncommon |
| Musculoskeletal and connective tissue disorders | Arthralgiae | Common |
| General disorders and administration site conditions | Injection site reactions (includes erythema, oedema, pruritus, pain, swelling, and bruising) | Common |
| Common adverse events occurring predominantly in atopic dermatitis clinical trials | ||
| Infections and infestations | Conjunctivitis, oral herpes | Common |
| Eye disorders | Conjunctivitis allergic | Common |
|
Keratitise Blepharitisf Eye pruritusf Dry eyef | Uncommon | |
| Ulcerative keratitisf | Rare | |
dCommon (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000).3
eFrom postmarketing reporting.3
fThe frequencies for eye pruritus, blepharitis, and dry eye were common, and ulcerative keratitis was uncommon in atopic dermatitis studies.3
| BOREAS safety profilea,b,1 |
DUPIXENT |
Placebo |
| Any Adverse Events (AE) |
77% |
76% |
| Any serious AE (SAE) |
14% |
16% |
| Any AE leading to death |
2% |
2% |
| Any AE leading to permanent study intervention discontinuation |
3% |
3% |
| Major adverse cardiovascular eventc |
1% |
2% |
| AEs OCCURRING IN ≥5% OF PATIENTS IN EITHER GROUP | ||
| Nasopharyngitis |
9% |
10% |
| Upper respiratory tract infection |
8% |
10% |
| Headache |
8% |
7% |
| COPD |
6% |
6% |
| COVID-19 |
4% |
6% |
| Hypertension |
4% |
6% |
| Diarrhoea |
5% |
4% |
| Back pain |
5% |
3% |
aThe safety population consisted of all patients who received at least 1 full or partial dose of DUPIXENT or placebo; the analysis was performed according to the treatment each patient received.1,2
bIn Boreas, one patient assigned to the placebo group inadvertently received DUPIXENT, so the safety population includes 470 patients in the placebo group and 469 patients in the DUPIXENT group.1
cMajor adverse cardiovascular events (adjudicated) included cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.1,2
| NOTUS safety profilea,2 |
DUPIXENT |
Placebo |
| Any AE |
67% |
66% |
| Any SAE |
13% |
16% |
| Any AE leading to death |
3% |
2% |
| Any AE leading to permanent study intervention discontinuation |
4% |
3% |
| Major adverse cardiovascular eventc |
1% |
2% |
| AEs OCCURRING IN ≥5% OF PATIENTS IN EITHER GROUP | ||
| COVID-19 |
9% |
8% |
| Headache |
8% |
7% |
| COPD |
5% |
8% |
| Nasopharyngitis |
6% |
5% |
aThe safety population consisted of all patients who received at least 1 full or partial dose of DUPIXENT or placebo; the analysis was performed according to the treatment each patient received.1,2
bIn Boreas, one patient assigned to the placebo group inadvertently received DUPIXENT, so the safety population includes 470 patients in the placebo group and 469 patients in the DUPIXENT group.1
cMajor adverse cardiovascular events (adjudicated) included cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.1,2
DUPIXENT HAS A GENERALLY WELL-TOLERATED SAFETY PROFILE ACROSS 6 INDICATIONS3
| System class | Adverse reaction | Frequencyd |
| Blood and lymphatic system disorders | Eosinophilia | Common |
| Immune system disorders |
Angioedemae
|
Uncommon
|
|
Anaphylactic reaction Serum sickness reaction Serum sickness-like reaction | Rare | |
| Skin and subcutaneous tissue disorders | Facial rashe | Uncommon |
| Musculoskeletal and connective tissue disorders | Arthralgiae | Common |
| General disorders and administration site conditions | Injection site reactions (includes erythema, oedema, pruritus, pain, swelling, and bruising) | Common |
| Common adverse events occurring predominantly in atopic dermatitis clinical trials | ||
| Infections and infestations | Conjunctivitis, oral herpes | Common |
| Eye disorders | Conjunctivitis allergic | Common |
|
Keratitise Blepharitisf Eye pruritusf Dry eyef | Uncommon | |
| Ulcerative keratitisf | Rare | |
dCommon (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000).3
eFrom postmarketing reporting.3
fThe frequencies for eye pruritus, blepharitis, and dry eye were common, and ulcerative keratitis was uncommon in atopic dermatitis studies.3
DUPIXENT IS NOT AN IMMUNOSUPPRESSANT AND NOT A STEROID3
For more information, click here to view the DUPIXENT MoA.
Special warnings and precautions for use
Acute exacerbations of Asthma or COPD
DUPIXENT should not be used to treat acute symptoms or acute exacerbations of asthma or COPD. DUPIXENT should not be used to treat acute bronchospasm or status asthmaticus.
Corticosteroids
Systemic, topical, or inhaled corticosteroids should not be discontinued abruptly upon initiation of therapy with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Biomarkers of type 2 inflammation may be suppressed by systemic corticosteroid use. This should be taken into consideration to determine type 2 status in patients taking oral corticosteroids.
Hypersensitivity
If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of DUPIXENT should be discontinued immediately and appropriate therapy initiated. Cases of anaphylactic reaction, angioedema, and serum sickness/serum sickness-like reaction have been reported. Anaphylactic reactions and angioedema have occurred from minutes to up to seven days after the DUPIXENT injection.
Eosinophilic conditions
Cases of eosinophilic pneumonia and cases of vasculitis consistent with EGPA have been reported with DUPIXENT in adult patients who participated in the asthma development program. Cases of vasculitis consistent with EGPA have been reported with DUPIXENT and placebo in adult patients with co-morbid asthma in the CRSwNP development program. Physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis, conditions which are often treated with systemic corticosteroid therapy. These events usually, but not always, may be associated with the reduction of oral corticosteroid therapy.
Helminth infection
Patients with known helminth infections were excluded from participation in clinical studies. DUPIXENT may influence the immune response against helminth infections by inhibiting IL-4/IL-13 signalling. Patients with pre-existing helminth infections should be treated before initiating DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, treatment with DUPIXENT should be discontinued until infection resolves. Cases of enterobiasis were reported in children 6 to 11 years old who participated in the paediatric asthma development program.
Conjunctivitis, dry eye and keratitis related events
Conjunctivitis, dry eye and keratitis related events have been reported with DUPIXENT, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis.
Patients should be advised to promptly report new onset or worsening eye symptoms to their healthcare provider. Sudden changes in vision or significant eye pain that does not settle warrant urgent review. Patients treated with DUPIXENT who develop conjunctivitis or dry eye that does not resolve following standard treatment or signs and symptoms suggestive of keratitis should undergo ophthalmological examination, as appropriate.
Patients with comorbid asthma
Patients on DUPIXENT who also have co-morbid asthma should not adjust or stop their asthma treatments without consultation with their physicians. Patients with comorbid asthma should be monitored carefully following discontinuation of DUPIXENT.
Vaccinations
Concurrent use of live and live attenuated vaccines with DUPIXENT should be avoided as clinical safety and efficacy have not been established. It is recommended that patients should be brought up to date with live and live attenuated immunisations in agreement with current immunisation guidelines prior to treatment with DUPIXENT. Clinical data are not available to support more specific guidance for live or live attenuated vaccines administration in patients treated with DUPIXENT. Immune responses to TdaP vaccine and meningococcal polysaccharide vaccine were assessed.
ABBREVIATIONS
AE, adverse event; COPD, chronic obstructive pulmonary disease; COVID‑19, coronavirus disease 2019; CRSwNP, chronic rhinosinusitis with nasal polyposis; EGPA, eosinophilic granulomatosis with polyangiitis; SAE, serious adverse event; TdaP, tetanus, diphtheria, and acellular pertussis vaccine
REFERENCES
- Bhatt SP, et al. N Engl J Med. 2023;389(3):205‑214.
- Bhatt SP, et al. N Engl J Med. 2024;390(24):2274‑2283.
- DUPIXENT (dupilumab). Summary of Product Characteristics. 2025. Date last accessed: December 2025.