What is Daliresp (roflumilast) and how is it used?
Daliresp is a prescription medicine used in adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations).
Daliresp is not a bronchodilator and should not be used for treating sudden breathing problems. Your healthcare provider may give you other medicine to use for sudden breathing problems.
What are the most important side effects and other facts about Daliresp (roflumilast)?
Daliresp can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking Daliresp.
1. Daliresp may cause mental health problems including suicidal thoughts and behavior. Some people taking Daliresp may develop mood or behavior problems including:
- thoughts of suicide or dying
- attempt to commit suicide
- trouble sleeping (insomnia)
- new or worse anxiety
- new or worse depression
- acting on dangerous impulses
- other unusual changes in your behavior or mood
2. Weight loss. Daliresp can cause weight loss. You should check your weight on a regular basis. You will also need to see your healthcare provider regularly to have your weight checked. If you notice that you are losing weight, call your healthcare provider. Your healthcare provider may ask you to stop taking Daliresp if you lose too much weight.
Daliresp may affect the way other medicines work, and other medicines may affect how Daliresp works. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Other side effects of Daliresp (roflumilast)
The most common side effects of Daliresp include:
- diarrhea
- weight loss
- nausea
- headache
- back pain
- flu like symptoms
- problems sleeping (insomnia)
- dizziness
- decreased appetite
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Daliresp.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Daliresp (roflumilast)?
- Take Daliresp exactly as your healthcare provider tells you to take it.
- Daliresp can be taken with or without food.
- If you take more than your prescribed dose of Daliresp, call your healthcare provider or go to the nearest hospital emergency room right away.
Daliresp (roflumilast) contraindications, pregnancy safety and drug interactions
It is not known if Daliresp is safe and effective in children.
Who should not take Daliresp?
Do not take Daliresp if you:
- have certain liver problems. Talk with your healthcare provider before you take Daliresp if you have liver problems.
What should I tell my healthcare provider before taking Daliresp?
Before you take Daliresp, tell your healthcare provider if you:
- have or have had a history of mental health problems including depression and suicidal behavior.
- have liver problems
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if Daliresp will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if Daliresp passes into your breast milk. You and your healthcare provider should decide if you will take Daliresp or breastfeed. You should not do both.