PDE4 Inhibitor Pregnancy: Avoid — animal data shows developmental toxicity

Roflumilast

Brand names: Daxas

Adult dose

Dose: 500 mcg once daily

Route: Oral

Frequency: Once daily (with or without food)

Max: 500 mcg OD

For severe COPD (FEV1 <50% predicted) with chronic bronchitis and frequent exacerbations, as add-on to bronchodilator therapy. NOT a bronchodilator — no acute relief.

Paediatric dose

Route: N/A

Frequency: N/A

Max: Not licensed in children

Not established in paediatric patients

Dose adjustments

Renal

No dose adjustment required

Hepatic

Contraindicated in moderate-severe hepatic impairment (Child-Pugh B/C)

Clinical pearls

Anti-inflammatory, not bronchodilatory — add on to LAMA/LABA in GOLD 3/4 COPD with chronic bronchitis and ≥2 exacerbations/year
Weight loss common and sustained — monitor weight monthly, stop if >5% loss
Monitor for psychiatric symptoms — advise patient to report mood changes
NICE TA244: recommended as add-on for severe COPD with chronic bronchitis and ≥2 exacerbations/year despite triple therapy

Contraindications

Moderate-severe hepatic impairment
Inflammatory bowel disease
Suicide risk or psychiatric history (relative)
Concurrent theophylline (pharmacokinetic interaction)

Side effects

Diarrhoea (9%)
Nausea
Headache
Weight loss (mean 2 kg)
Abdominal pain
Insomnia
Depression/suicidal ideation (rare but black box warning in US)

Interactions

Theophylline — do not combine (pharmacokinetic interaction)
Strong CYP3A4 inducers (rifampicin) — reduced roflumilast levels
Oral contraceptives — may reduce efficacy

Monitoring

Weight (monthly)
Mood and psychiatric symptoms
LFTs (at baseline)
Exacerbation frequency

Reference: BNFc; BNF; NICE TA244; GOLD COPD Guidelines 2024. Verify against your local formulary and the latest BNF before prescribing.

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways