FDA label
What is roflumilast used for?
The FDA-approved uses of roflumilast, 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 says: “Roflumilast tablets are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.”
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Roflumilast, tablet
Indications and Usage, quoted from the label by Micro Labs Limited (ANDA208180). Cross-references to other label sections are left out.
Roflumilast tablets are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Limitations of Use
Roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
Roflumilast tablet 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.
Source: DailyMed label, set id dc2a689f-cfa4-4863-9623-a9813dcf86a9, version 6, effective July 24, 2025. NDC 42571-259, one of 27 listings for this product.
Questions
What is roflumilast used for?
The FDA label says: “Roflumilast tablets are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.”
What drug class is roflumilast?
FDA lists roflumilast 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.
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