Roflumilast
Prescription ·Exploratory record · not publication-reviewed ·Updated July 13, 2026
Roflumilast is an oral selective phosphodiesterase-4 inhibitor used to reduce COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. It is not a bronchodilator and is not for acute bronchospasm; key risks are diarrhea, nausea, weight loss, insomnia, anxiety, depression, and suicidal ideation.
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What the research says.
A quick, data-only summary. The full evidence, dosing, and sources are below.
Roflumilast is an oral selective phosphodiesterase-4 inhibitor used to reduce COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. NutriStack rates the supporting evidence as strong. Common adult dosing is Adults: 500 mcg orally once daily. Some patients start with 250 mcg once daily for 4 weeks to improve tolerability, then increase to 500 mcg once daily., though a prescriber sets the actual dose. This profile indexes 3 sources.
The bottom line
Evidence rating strong. Most-documented uses: reduced risk of copd exacerbations in severe copd with chronic bronchitis, adjunctive anti-inflammatory therapy for patients with frequent exacerbations, potential reduction in steroid- or hospitalization-requiring exacerbations. 3 sources indexed (2009–2026), with 0 interaction records on file.
How it works, mechanistically.
Core mechanism
Roflumilast and its active N-oxide metabolite inhibit phosphodiesterase-4 in inflammatory and structural cells relevant to COPD. This increases intracellular cyclic AMP and reduces release of pro-inflammatory mediators, leading to decreased airway inflammation and exacerbation frequency. The drug is metabolized mainly through CYP3A4 and CYP1A2 pathways, so strong enzyme inducers can reduce exposure.1,2
Dosing & protocol.
May be taken with or without food. Monitor weight and mood after initiation and dose escalation.
Full safety detail.
Side effects
- Diarrhea
- Nausea
- Reduced appetite
- Weight loss
- Abdominal pain
- Headache
- Insomnia
- Anxiety
- Depression
- Suicidal thoughts or behavior
- Back pain
- Dizziness
Sources, by evidence tier.
Numbered references. Citations throughout the page link here.
Randomized controlled trials
1- 1Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trialsCalverley PM et al. · Lancet · 2009
Trials showed reduced moderate or severe COPD exacerbations in selected patients with chronic bronchitis phenotype.
Reviews & position papers
1- 2Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary DiseaseGlobal Initiative for Chronic Obstructive Lung Disease · GOLD Report · 2025
Guidelines position roflumilast as add-on therapy for severe COPD with chronic bronchitis and exacerbations despite inhaled therapy.
Reference material
1- 3Roflumilast Tablets US Prescribing InformationURLU.S. National Library of Medicine · DailyMed · 2026
Labeling describes indication, 500 mcg daily dosing, optional 250 mcg starter period, contraindication in moderate or severe liver impairment, psychiatric warnings, and weight monitoring.
Common questions.
Quick answers about Roflumilast, drawn from the data on this page.
What is Roflumilast?
Roflumilast is an oral selective phosphodiesterase-4 inhibitor used to reduce COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. It is not a bronchodilator and is not for acute bronchospasm; key risks are diarrhea, nausea, weight loss, insomnia, anxiety, depression, and suicidal ideation.
What is Roflumilast used for?
Commonly cited benefits of Roflumilast include: Reduced risk of COPD exacerbations in severe COPD with chronic bronchitis; Adjunctive anti-inflammatory therapy for patients with frequent exacerbations; Potential reduction in steroid- or hospitalization-requiring exacerbations. NutriStack rates the overall evidence as strong.
What is a typical dose of Roflumilast?
A typical adult dose of Roflumilast is Adults: 500 mcg orally once daily. Some patients start with 250 mcg once daily for 4 weeks to improve tolerability, then increase to 500 mcg once daily.. The commonly recommended form is Oral tablet taken once daily with or without food. These are general ranges, not personalized advice; confirm the right dose with a clinician.
What are the side effects of Roflumilast?
Reported side effects include diarrhea, nausea, reduced appetite, weight loss, abdominal pain, headache. This is educational information; check with a healthcare professional before use.
How strong is the evidence for Roflumilast?
NutriStack rates this as Strong, meaning multiple high-quality meta-analyses or systematic reviews converge on the same finding. Full tier criteria are at https://nutristackapp.com/methodology/evidence-tiers.
Use this with your stack
Roflumilast in NutriStack.
Add it to your stack, see how it interacts with everything else you take, and get a Stack Score that updates the moment it does.