roflumilast at a glance
Medicine class
Phosphodiesterase-4 inhibitor
Usual role
Maintenance add-on treatment for selected adults with severe COPD, chronic bronchitis and frequent exacerbations
Form
Oral film-coated tablet that may be taken with or without food
Not a reliever
It does not treat a sudden attack of breathlessness
Important monitoring
Body weight, treatment tolerability and changes in mood or behaviour
What is roflumilast used for?
Its licensed use is:
Maintenance treatment of severe COPD associated with chronic bronchitis in adults who have frequent exacerbations, as an addition to bronchodilator treatment.
How does roflumilast work?
Roflumilast blocks phosphodiesterase-4, an enzyme that breaks down cyclic AMP in inflammatory and structural cells. This raises intracellular cyclic AMP and reduces inflammatory activity relevant to COPD. Its active metabolite, roflumilast N-oxide, also contributes.
roflumilast preparations and strengths
Tablet
Route: Oral
Strengths: 250 micrograms, 500 micrograms
How to take roflumilast
Take roflumilast exactly as prescribed and check the dispensing label if unsure.
Swallow the tablet with water.
It may be taken with or without food.
Do not stop or reduce prescribed COPD inhalers unless advised by your treating clinician.
roflumilast side effects
Common or expected effects
- Diarrhoea
- Nausea or abdominal pain
- Reduced appetite or weight loss
- Headache
- Insomnia
Get urgent medical advice
- Facial, lip or tongue swelling, breathing difficulty, or another severe allergic reaction
- New or worsening depression, suicidal thoughts or suicidal behaviour
- Unexplained, clinically concerning weight loss
- Persistent intolerable diarrhoea, nausea, abdominal pain or headache
roflumilast in pregnancy
Human pregnancy data are limited, and animal studies found reproductive toxicity. Roflumilast is not recommended during pregnancy; effective contraception is advised during treatment. Discuss pregnancy or plans to conceive promptly with the prescriber.
roflumilast while breastfeeding
Roflumilast should not be used while breastfeeding because animal data show passage into milk and a risk to the infant cannot be excluded. A prescriber or specialist should review treatment and feeding options.
roflumilast interactions
Check all prescribed, over-the-counter and herbal products with a pharmacist or prescriber. Important examples include:
Rifampicin, phenobarbital, carbamazepine or phenytoin
These strong enzyme inducers can substantially reduce roflumilast exposure and effectiveness, so combined treatment is not recommended.
Fluvoxamine, cimetidine or enoxacin
These medicines can increase roflumilast exposure and make persistent adverse effects more likely, requiring treatment reassessment.
Theophylline
Combined use for maintenance treatment is not recommended because supporting clinical evidence is lacking.
Common questions about roflumilast
Answers are fully visible for fast scanning and source review.
Is roflumilast an inhaler?
No. Roflumilast is an oral tablet used alongside appropriate inhaled COPD treatments.
Is roflumilast a steroid?
No. It is a non-steroid anti-inflammatory treatment that inhibits phosphodiesterase-4.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.