Key facts about Roflumilast
What dosages is Roflumilast available in?
Roflumilast is available as a 250 mcg and 500 mcg oral tablet.
What is Roflumilast used for?
Roflumilast is a PDE-4 inhibitor used for COPD (chronic obstructive pulmonary disease).
How does Roflumilast work?
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor. PDE-4 is a protein in your body that is involved in making inflammatory chemicals in the lungs. Because it blocks PDE-4, Roflumilast prevents inflammation, which helps you breathe better and prevent COPD flare-ups.
How do I take Roflumilast?
Roflumilast is typically taken by mouth once daily with or without food. The typical maintenance dose is 500 mcg per day.
Is it safe for me to take Roflumilast?
Roflumilast is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if you have moderate to severe liver impairment.
Roflumilast Common Side Effects
Common side effects of Roflumilast include:
- Diarrhea (10%)
- Weight loss (8%)
- Nausea (5%)
- Headache (4%)
Other Side Effects:
- Back pain
- Flu
- Difficulty sleeping
- Dizziness
- Loss of appetite
- Upset stomach
- Runny nose
- Sinus inflammation
- Urinary tract infection
- Muscle spasm
- Tremor
- Anxiety
- Depression
Roflumilast Serious Side Effects
Serious side effects are rare with Roflumilast. Contact your healthcare provider immediately if you experience any of the following.
- Depression or suicidal thoughts
Effects of other drugs, drug classes and over-the-counter products on Roflumilast
The following medications may interact with Roflumilast:
- Inhibitors of CYP3A4 or dual inhibitors of CYP3A4 and CYP1A2 (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) – Will increase Roflumilast levels and may result in increased adverse reactions
Who makes Roflumilast?
Various FDA-approved generic manufacturers
Is Roflumilast safe in pregnancy?
It is not known if Roflumilast will harm your unborn baby. If you become pregnant while receiving Roflumilast, talk to your healthcare provider.













