Zoryve (roflumilast) is a phosphodiesterase 4 inhibitor used as a cream for plaque psoriasis and atopic dermatitis, and used as a foam for plaque psoriasis and seborrheic dermatitis. Zoryve was first approved as a cream for adults with plaque psoriasis in July 2022. Since then, Zoryve received multiple additional indications and expanded pediatric labeling.
Read on to learn more about the cream and foam forms of Zoryve, including dosage and administration information, drug interactions, and more.
Medication Overview:
- Brand Name: Zoryve
- Generic Name: roflumilast
- Treatment for: Plaque psoriasis, seborrheic dermatitis and atopic dermatitis
- Manufacturer(s): Arcutis Biotherapeutics
- Initial FDA Approval: July 2022
| Indicated Condition | Indication | Age | Date Approved |
|---|---|---|---|
| Plaque Psoriasis | Zoryve cream, 0.3%, is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. Zoryve topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. | Cream: Adults and pediatric patients 6 and older. Foam: Adults and pediatric patients 12 and older. | Cream: July 2022 Foam: May 2025 |
| Seborrheic Dermatitis | Zoryve topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. | Adults and pediatric patients 9 and older. | December 2023 |
| Atopic Dermatitis | Zoryve cream, 0.15%, is indicated for the topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. Zoryve cream, 0.05%, is indicated for the topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age. | 0.15% cream: Adults and pediatric patients 6 and older. 0.05% cream: Pediatric patients 2 to 5 years old. | 0.15% cream: July 2024 0.05% cream: October 2025 |
Warnings and Precautions:
Cream: None listed.
Foam: Flammability: The propellants in Zoryve foam, 0.3%, are flammable. Avoid fire, flame, and smoking during and immediately following application.
Dosage and Administration:
Cream:
- For topical use only. Not for ophthalmic, oral, or intravaginal use.
- Plaque Psoriasis: Apply Zoryve cream, 0.3%, once daily to affected areas.
- Atopic Dermatitis: Adults and pediatric patients 6 and older: Apply Zoryve cream, 0.15%, once daily to affected areas.
- Atopic Dermatitis: Pediatric patients 2 to 5 years old: Apply Zoryve cream, 0.05%, once daily to affected areas.
Foam:
- Apply once daily to affected areas.
- For topical use only. Not for ophthalmic, oral, or intravaginal use.
Contraindications:
Cream: Moderate to severe liver impairment (Child-Pugh B or C).
Foam: Moderate to severe liver impairment (Child-Pugh B or C).
Drug Interactions:
Cream:
- Co-administration of roflumilast with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously may increase roflumilast systemic exposure and may result in increased adverse reactions. If these products are co-administered with Zoryve cream, weigh the potential for increased adverse reactions against benefit.
- Co-administration of roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased adverse reactions. If these products are co-administered with Zoryve cream, weigh the potential for increased adverse reactions against benefit.
Foam:
- Co-administration of roflumilast with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously may increase roflumilast systemic exposure and may result in increased adverse reactions. If these products are co-administered with Zoryve foam, 0.3%, weigh the potential for increased adverse reactions against benefit.
- Co-administration of roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased adverse reactions. If these products are co-administered with Zoryve foam, 0.3%, weigh the potential for increased adverse reactions against benefit.
Adverse Reactions:
Cream:
The most common adverse reactions (reported in ≥1% of subjects) are:
- Plaque Psoriasis: diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection.
- Atopic Dermatitis: headache, nausea, application site pain, diarrhea, vomiting, upper respiratory tract infection, rhinitis, and conjunctivitis.
Foam:
The most common adverse reactions (reported in ≥ 1% of patients) are:
- Seborrheic dermatitis: nasopharyngitis, nausea, and headache.
- Plaque psoriasis of the scalp and body: headache, diarrhea, nausea, and nasopharyngitis.
Examples of Roflumilast in Guidelines
Management of Atopic Dermatitis in Pediatric Patients
- American Academy of Dermatology
- April 2026
- “For pediatric patients aged 2 y and older with mild-to-moderate AD, we recommend the use of roflumilast cream.”
Management of Atopic Dermatitis in Adults with Phototherapy and Systemic Therapies
- American Academy of Dermatology
- June 2025
- “For adults with mild to moderate AD, we recommend the use of roflumilast 0.15% cream.”
Please note: This article is current as of May 27, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.
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