Roflumilast: what it treats, how to take it, side effects
Last updated September 3, 2026.
Roflumilast (brand name Daliresp) is a once-daily tablet that reduces COPD flare-ups. It is a PDE4 inhibitor that calms airway inflammation, and it is not a bronchodilator, so it does nothing for sudden shortness of breath.
What does it treat?
It reduces the risk of exacerbations in people with severe COPD tied to chronic bronchitis who have a history of flare-ups. It is added on top of inhalers when flares keep breaking through. It treats no other lung condition, and it is not for asthma.
How do you take it?
The target dose is 500 mcg by mouth once daily, with or without food, at about the same time each day. Many people start at 250 mcg once daily for the first 4 weeks, then step up to 500 mcg; this lower start reduces the stomach and other side effects that make people quit, though 250 mcg alone is not the effective dose. If you miss a dose, take it when remembered unless the next dose is close, and never double up.
Side effects to know
- Common: diarrhea, nausea, reduced appetite, weight loss, headache, back pain, dizziness, and insomnia, mostly in the first weeks.
- Serious: psychiatric events including anxiety, depression, insomnia, and suicidal thinking, which the label warns about directly, and clinically significant weight loss that should be tracked on a scale.
Who should not take it?
Do not take roflumilast with moderate or severe liver impairment (Child-Pugh B or C). Weigh it carefully if you have a history of depression or suicidal thinking; the label tells patients and families to watch for mood changes and report them. Strong enzyme inducers like rifampin, phenobarbital, carbamazepine, and phenytoin make it ineffective and should not be combined. It is not for acute breathing attacks, and use in pregnancy needs a doctor's judgment.
When is it an emergency?
If thoughts of harming or killing yourself appear while taking roflumilast, call or text 988 (the Suicide and Crisis Lifeline in the US) immediately, or your local crisis line elsewhere, and contact your prescriber. For a breathing emergency, use your rescue inhaler and call 911 if it does not work; roflumilast will not help an attack. Pymander's escalation routing is built and tested specifically for this class of decision; see the safety architecture working paper.
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Common questions
Why was I prescribed 250 mcg first instead of 500 mcg?
The label supports starting at 250 mcg once daily for the first 4 weeks, then increasing to 500 mcg, because the lower start reduces the nausea, diarrhea, and other side effects that lead people to stop. The 250 mcg dose itself is not the therapeutic dose, so do not stay on it unless your prescriber says so.
Is roflumilast a steroid or an inhaler?
Neither. It is an oral PDE4 inhibitor, a pill that reduces airway inflammation by a different mechanism than steroids. It works alongside your inhalers, not instead of them, and it will not relieve a sudden breathing attack.
What is the warning about depression?
The label warns about psychiatric events including insomnia, anxiety, depression, and suicidal thoughts, and tells patients and families to watch for mood changes. Tell your prescriber about any history of depression before starting, and report new or worsening symptoms right away. Thoughts of self-harm mean call or text 988 in the US immediately.
Will roflumilast make me lose weight?
It often does. Weight loss is a common, labeled effect, which is why regular weigh-ins are recommended. If the loss is unexplained, rapid, or significant, your prescriber should evaluate it and may stop the drug.
How long until roflumilast starts preventing flares?
It works over weeks to months by reducing inflammation, not overnight. Judge it by what does not happen: fewer flare-ups across a season compared with your usual pattern. Keep taking it daily even when you feel well.
Can I drink alcohol while taking roflumilast?
There is no direct labeled interaction, but alcohol worsens sleep and mood, both of which this drug can already disturb, and it adds nausea. Modest intake with your prescriber's awareness is the sensible frame; heavy drinking with COPD is its own problem worth raising.