Substance / Medication

Roflumilast

Overview

Active Ingredient
roflumilast
RxNorm CUI
1091836

Indications

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 tablets are not a bronchodilator and are not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.

Labeler: Jubilant Cadista Pharmaceuticals Inc.Updated: 2026-02-09T00:00:00.000ZFull label on DailyMed

Contraindications

When this intervention should not be used

The use of Roflumilast tablets is contraindicated in the following condition: Clinical Pharmacology (12.3) Use in Specific Populations (8.6) [seeand]. Moderate to severe liver impairment (Child-Pugh B or C)

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

Clinical Trials

14 trials linked to this intervention

14
Total Trials
3
Recruiting
5
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Efficacy and Safety of Roflumilast Cream in Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.
Kow Chia Siang, Ramachandram Dinesh Sanggaran, Hasan Syed Shahzad et al. · Australas J Dermatol · 2025
PMID: 40130783Meta-Analysis
Efficacy and Safety of Topical Roflumilast for the Treatment of Psoriasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
de Moraes-Souza Rafaela, Chahine Chater Regina, Pera Calvi Izabela et al. · Clin Drug Investig · 2024
PMID: 39172296Meta-AnalysisFull text (PMC)
A Review of Topical Roflumilast for the Treatment of Plaque Psoriasis.
Pixley Jessica N, Schaetzle Taylor, Feldman Steven R · Ann Pharmacother · 2023
PMID: 36420929Meta-Analysis
Roflumilast in patients with advanced chronic obstructive pulmonary disease: towards a better-targeted use.
Alexa Ioana, Alexa-Stratulat Teodora, Antoniu Sabina et al. · Expert Opin Pharmacother · 2019
PMID: 30462926Meta-Analysis
Pharmacological mechanism of roflumilast in the treatment of asthma-COPD overlap.
Zhang Xiaoli, Chen Yuqing, Fan Liyu et al. · Drug Des Devel Ther · 2018
PMID: 30122895Meta-AnalysisFull text (PMC)
Effect of roflumilast on chronic obstructive pulmonary disease: a systematic review and meta-analysis.
Shen Lu-Fei, Lv Xiao-Dong, Chen Wen-Yu et al. · Ir J Med Sci · 2018
PMID: 29397527Meta-Analysis
Drug safety evaluation of roflumilast for the treatment of COPD: a meta-analysis.
Rogliani Paola, Calzetta Luigino, Cazzola Mario et al. · Expert Opin Drug Saf · 2016
PMID: 27279341Meta-Analysis
Potential treatment benefits and safety of roflumilast in COPD: a systematic review and meta-analysis.
Yuan Lianfang, Dai Xuan, Yang Meng et al. · Int J Chron Obstruct Pulmon Dis · 2016
PMID: 27418821Meta-AnalysisFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Health Goals

Goals connected through associated conditions

Quick Facts

Type
Substance / Medication
Fully Specified Name
Roflumilast (substance)
SNOMED CT
448971002
UMLS CUI
C0965618
RxNorm CUI
1091836
Labeler
Jubilant Cadista Pharmaceuticals Inc.

Clinical Data

This intervention maps to 7 entities in the Healos knowledge graph.

1
Conditions
3
Biomarkers
2
Specialists
0
Symptoms
14
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.

Roflumilast — Conditions, Biomarkers & Specialists | Healos | Healos