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Why is it prescribed?

Roflumilast is indicated as add-on therapy to bronchodilator treatment for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis (i.e. patients with a history of chronic cough and sputum) in patients 18 years and older with a history of frequent flare-ups.

Products that have this ingredient include •Daxas® •

See other drugs used in the treatment of •COPD •

The most common side effects are:

  • diarrhea
  • weight loss
  • nausea
  • dizziness
  • headache
  • abdominal or back pain
  • tremor
  • irregular heart beat

Patients who take roflumilast may be at increased risk of mental or mood changes, including suicidal thoughts or actions. The risk may be greater in patients who have had these problems in the past. Watch patients who take roflumilast closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood, anxious behavior, trouble sleeping, or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.



Roflumilast is a selective Phosphodiesterase 4 (PDE4) Inhibitor. It is an anti-inflammatory medication which helps reduce the risk of flare-ups and worsened breathing problems in people with severe chronic obstructive pulmonary disease (COPD).

Roflumilast should not be used for the relief of a sudden attack of shortness of breath.  A rescue inhaler should be available for those situations.  

 It should not be used on its own but rather, as add-on therapy to bronchodilator treatment.  Do not use more frequently than once daily.

Use is not recommended in the following situations:

  • allergy to roflumilast or to any ingredient in the formulation
  • moderate to severe liver disease

Caution is recommended in the following situations:

  • mild to moderate liver disease
  • history of mental illness, including depression
  • fast or irregular heart beat
  • severe immunological diseases eg HIV

The following drugs and drug classes have been known to interact with rofumilast:

  • Cimetidine, enoxacin, erythromycin, fluvoxamine, itraconazole, or ketoconazole - they may increase the risk of roflumilast's side effects
  • Carbamazepine, phenytoin, phenobarbital, primidone, rifampin, or St. John's wort - they may decrease roflumilast's effectiveness

Use in pregnancy and breastfeeding:  Insufficient evidence exists to establish safety in pregnancy and breastfeeding.  Consult doctor or pharmacist before use.