FDA Expands Pediatric Roflumilast Use
The expanded indication is supported by pharmacokinetic, safety, tolerability, exploratory efficacy, and long-term safety data from studies in children aged 2 to 5 years.
By
Kathryn Wighton
June 30, 2026
Clinical Scorecard: FDA Expands Pediatric Roflumilast Use
At a Glance
Category Detail
Condition Plaque Psoriasis Key Mechanisms Topical phosphodiesterase type 4 inhibitor Target Population Pediatric patients aged 2 years and older Care Setting Dermatology
Key Highlights
Roflumilast cream 0.3% approved for pediatric use in plaque psoriasis. Previously approved for adults and children aged 6 years and older at a 0.15% dose. Approval based on pharmacokinetics, safety, and efficacy data from pediatric studies. Topical steroids not recommended for sensitive areas or long-term use in children. Guideline-Based Recommendations
Diagnosis
Diagnosis of plaque psoriasis in pediatric patients aged 2 years and older. Management
Use roflumilast cream 0.3% as a topical treatment for plaque psoriasis. Monitoring & Follow-up
Monitor for common adverse reactions including diarrhea, headache, and application-site pain. Risks
Contraindicated in patients with moderate to severe liver impairment. Patient & Prescribing Data
Pediatric patients aged 2 years and older with plaque psoriasis.
Roflumilast cream 0.3% is safe and well tolerated in children.
Clinical Best Practices
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