Roflumilast
Brand names: Daxas
Roflumilast is an oral selective phosphodiesterase-4 inhibitor used as add-on maintenance therapy in severe chronic obstructive pulmonary disease associated with chronic bronchitis and frequent exacerbations.
ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.
Clinical monograph
How it works
It inhibits phosphodiesterase-4, raising intracellular cyclic AMP in inflammatory cells and thereby reducing the airway inflammation characteristic of COPD.
Prescribing in practice
- Psychiatric effects including mood changes, anxiety, depression and suicidal ideation have been reported and warrant careful assessment of mental health before and during treatment.
- Weight loss, diarrhoea and nausea are common, particularly early in treatment, and weight should be monitored.
- It is not a bronchodilator and is contraindicated in moderate to severe hepatic impairment.
Monitoring
Monitor body weight, mental health and gastrointestinal tolerability during treatment.
Counselling the patient
- Report any low mood, anxiety or thoughts of self-harm to your healthcare team without delay.
- Some weight loss, nausea and diarrhoea are common at first and often settle.
- This tablet adds to your inhalers and is not a reliever for breathlessness.
Evidence & guidelines
The MHRA has highlighted the risk of psychiatric reactions with roflumilast, and NICE guidance positions it as add-on therapy in selected severe COPD.
Reference: NICE TA244; GOLD COPD Guidelines 2024; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).
Related
Curated clinical cross-links plus same-class fallbacks.
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- Acute Asthma in Adults · BTS/SIGN British Guideline on Asthma 2019; NICE NG80
- Pulmonary Embolism Assessment · NICE NG158; ESC 2019 PE Guidelines
- Acute Exacerbation of COPD (AECOPD) · NICE NG115; GOLD 2024
- Spontaneous Pneumothorax (Adult) · BTS Pleural Disease 2023
- Atypical Pneumonia (Legionella / Mycoplasma / Chlamydophila) · BTS 2023; IDSA
- COPD Exacerbation Management · NICE NG115 / GOLD 2024