Roflumilast 500microgram tablets
Requires a prescription from a doctor or prescriber
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Yellow Card
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Drug safety updates
MHRA alerts for Roflumilast
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Roflumilast
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Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Roflumilast
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Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
5 branded products available
MHRA licensed products
View all licensed products for Roflumilast on the MHRA register
Daxas 500microgram tablets
Roflumilast 500microgram tablets
Roflumilast 500microgram tablets
Roflumilast 500microgram tablets
This is the NHS Drug Tariff indicative price used for reimbursement purposes. It may not reflect the price paid by patients or pharmacies.
View full Drug TariffSource: NHS Drug Tariff via NHSBSA. Derived from dm+d VMPP (Virtual Medicinal Product Pack) pricing data. Contains public sector information licensed under the Open Government Licence v3.0.
WHO defined daily dose (DDD)
500 microgram
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via the NHS dm+d supplementary mapping files (NHSBSA). Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(2)
Roflumilast for treating chronic obstructive pulmonary disease (TA461)
Dupilumab for maintenance treatment of uncontrolled chronic obstructive pulmonary disease with raised blood eosinophils (TA1142)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 26 · Randomised trials: 19 · 2013–2026
Showing the 50 most relevant studies, sorted by most relevant.
R. de Moraes-Souza, Regina Chahine Chater, Izabela Pera Calvi, et al.
Clinical Drug Investigation, 2024
Jonghoo Lee, J. Song
International Journal of Chronic Obstructive Pulmonary Disease, 2024
Musaad Alruwaili, Rakan Fahad Alamer, R. Ahmed, et al.
ENT Updates, 2025
C. S. Kow, D. Ramachandram, S. S. Hasan, et al.
Australasian Journal of Dermatology, 2025
- Dermatitis, Atopic
- Benzamides
- Aminopyridines
Ramsamooj A, Joy BM, Manguerra DD Jr, et al.
2026
Aleid AM, Mohammed Alshreef S, Tariq Alrubaiaan M, et al.
2026
M. Lebwohl, L. Kircik, A. Moore, et al.
JAMA, 2022
E. Simpson, L. Eichenfield, J. Alonso‐Llamazares, et al.
JAMA Dermatology, 2024
Gupta AK, Bamimore MA, Wang T, et al.
2026
- Scalp Dermatoses
- Psoriasis
- Immunomodulating Agents
BackgroundRecently, the literature has expanded with peer-reviewed studies on immunomodulatory agents' efficacy on scalp psoriasis-which, in turn, widened knowledge gaps regarding these agents' relative effectiveness. We determined the relative efficacy of immunomodulatory monotherapies for scalp psoriasis.MethodsWe ran Bayesian network meta-analyses (NMAs) using outcomes related to Psoriasis Scalp Severity Index (PSSI) and scalp-specific Physician's Global Assessment of clear (0) or almost clear (1) (Sc-PGA 0/1).ResultsWe estimated the relative efficacy of 22 interventions (including placebo), and analyzed 9 outcomes, namely: proportion of participants who attained Sc-PGA 0/1, proportion of participants who achieved 100% improvement in PSSI (PSSI-100), and proportion of participants who achieved 90% improvement in PSSI (PSSI-90) at 8, 12, and 16 weeks.ConclusionsWe are the first to provide comparative evidence on the efficacy of newly investigated agents such as deucravacitinib, tildrakizumab, roflumilast and icotrokinra. In general, the IL-17 inhibitors (bimekizumab, ixekizumab, secukinumab, brodalumab) and IL-23 inhibitors (icotrokinra, guselkumab, tildrakizumab) were effective depending upon the outcome and time-point being considered. At 16 weeks, for PSSI-100, ixekizumab 150 mg at weeks 0, 2, 4, 8, and 12 ranked highest; at 16 weeks, for Sc-PGA 0/1 bimekizumab 320 mg every 4 weeks ranked highest; at 8 weeks, for PSSI-100 ixekizumab 80 mg every 2 weeks ranked highest; at 8 weeks, for Sc-PGA 0/1 secukinumab 300 mg at weeks 1, 2, 3 and then every 4 weeks ranked highest. Small-molecule therapies (apremilast, deucravacitinib, roflumilast) improved scalp psoriasis modestly. Our work would guide the design of future studies and clinical decision-making.
Abstract licence: CC BY
CDA-AMC
Canadian Journal of Health Technologies, 2026
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
17 hours
Mechanism
Roflumilast and its active metabolite (roflumilast N-oxide) are inhibitors of PDE4.
Food interactions
1 warning
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
80%
[L37564]
…
Half-life
17 hours
[L37564]
Protein binding
99%
[L37564]
Volume of distribution
2.9 L/kg
[L37564]
Metabolism
[L37564]
…
Elimination
70%
[A38469]
Clearance
9.6 L/h
[L37564]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
The oral formulation of roflumilast is indicated to manage chronic obstructive pulmonary disease.[L46546] It was first approved by the EMA in July 2010, and by the FDA in January 2018.[L37564] Roflumilast topical cream is indicated to treat plaque psoriasis. The cream formulation was first approved by the FDA in July 2022 [L42580] and by Health Canada in April 2023.[L46541] On December 15, 2023, the FDA approved a new topical foam formulation of roflumilast for the treatment of seborrheic dermatitis in patients aged 9 years and older.[L49281]
[L37564][L46541][L46546]
The topical cream of roflumilast is indicated for the treatment of plaque psoriasis, including intertriginous areas, and for mild to moderate atopic dermatitis in adults and pediatric patients six years of age and older with the cream 0.15%.
[L51219][L54136]
, and in pediatric patients two to five years of age with the cream 0.05%.
[L54136]
In Canada, it is approved for the same indication in patients 12 years of age and older.
[L52650]
The topical foam is approved for use in patients nine years of age and older to treat seborrheic dermatitis.
[L49276]
Known interactions with other medicines. Always consult a healthcare professional.
Showing 50 of 1460 interactions
[L37564]
In the event of an overdose, administer support medical care as soon as possible. Hemodialysis is unlikely to be of benefit given the extensive protein binding of roflumilast.
[L37564]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L37564]
In the fasted state, maximum plasma concentrations are reached in 0.5 to 2 hours, while in the fed state, Cmax is reduced by 40%, Tmax is increased by one hour, and total absorption is unchanged.
[L37564]
Applied topically, the mean systemic exposure for roflumilast and its N-oxide metabolite in adults was 72.7 ± 53.1 and 628 ± 648 h∙ng/mL, respectively.
[L42580]
The mean systemic exposure for roflumilast and its N-oxide metabolite in adolescents was 25.1 ± 24.0 and 140 ± 179 h∙ng/mL, respectively.
[L42580]
[L37564]
[L37564]
[L37564]
[L37564]
The N-oxide metabolite is less potent than its parent drug in regards to PDE4 inhibition, but its plasma AUC is approximately 10-fold greater.
[L37564]
[A38469]
[L37564]
Proteins and enzymes this drug interacts with in the body
Enzymes involved in drug metabolism — important for understanding drug interactions
ATC D05AX06
ATC R03DX07
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Show
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Roflumilast
Additional database identifiers
Drugs Product Database (DPD)
20639
ChemSpider
395793
BindingDB
14774
PDB
ROF
ZINC
ZINC000000592419
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8780
GenAtlas
PDE4A
GeneCards
PDE4A
GenBank Gene Database
L20965
GenBank Protein Database
347120
Guide to Pharmacology
1300
UniProt Accession
PDE4A_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8781
GenAtlas
PDE4B
GeneCards
PDE4B
GenBank Gene Database
L20966
GenBank Protein Database
347122
Guide to Pharmacology
1301
UniProt Accession
PDE4B_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8782
GenAtlas
PDE4C
GeneCards
PDE4C
GenBank Gene Database
Z46632
GenBank Protein Database
727223
Guide to Pharmacology
1302
UniProt Accession
PDE4C_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8783
GenAtlas
PDE4D
GeneCards
PDE4D
GenBank Gene Database
L20970
GenBank Protein Database
347130
Guide to Pharmacology
1303
UniProt Accession
PDE4D_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2637
GenAtlas
CYP3A4
GeneCards
CYP3A4
GenBank Gene Database
M18907
Guide to Pharmacology
1337
UniProt Accession
CP3A4_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2596
GenAtlas
CYP1A2
GeneCards
CYP1A2
GenBank Gene Database
Z00036
Guide to Pharmacology
1319
UniProt Accession
CP1A2_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72