FDA label
What is Otezla used for?
Otezla contains apremilast. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Otezla lists 3 uses: Psoriatic Arthritis; Plaque Psoriasis; Oral Ulcers Associated with Behçet's Disease.
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Otezla, tablet, film coated
Indications and Usage, quoted from the label by Amgen, Inc (NDA205437). Cross-references to other label sections are left out.
Psoriatic Arthritis
OTEZLA is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis.
OTEZLA XR is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 50 kg with active psoriatic arthritis.
Plaque Psoriasis
OTEZLA/OTEZLA XR is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
OTEZLA is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
OTEZLA XR is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 50 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Oral Ulcers Associated with Behçet's Disease
OTEZLA/OTEZLA XR is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.
Source: DailyMed label, set id f6b1f516-4972-4d82-bced-113e47b41cc5, version 38, effective September 2, 2026. NDC 55513-137, one of 3 listings for this product.
Questions
What is Otezla used for?
The FDA label for Otezla lists 3 uses: Psoriatic Arthritis; Plaque Psoriasis; Oral Ulcers Associated with Behçet's Disease.
What drug class is Otezla?
FDA lists apremilast in the Phosphodiesterase 4 Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Otezla
- Is Otezla a controlled substance?Federal schedule
- Generic for OtezlaFDA Orange Book
- Generic for Otezla XRFDA Orange Book
- Phosphodiesterase 4 Inhibitors listFDA drug class
- Otezla Medicare Part D coverageBy plan and state
- NDC 55513-137Otezla NDC record
- NDC 55513-497Otezla NDC record
- NDC 55513-519Otezla NDC record