What is the most important information I should know 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.
- 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, or other unusual changes in behavior or mood
- 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.
Who should not take DALIRESP?
Do not take DALIRESP if you have certain liver problems. Talk with your healthcare provider before taking 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
- Are breastfeeding or plan to breastfeed. It is not known if DALIRESP passes into your breast milk
What are the most common side effects of DALIRESP?
The most common side effects of DALIRESP include diarrhea, weight loss, nausea, headache, back pain, flu-like symptoms, problems sleeping (insomnia), dizziness, and decreased appetite. These are not all the possible side effects of DALIRESP. Always tell your healthcare provider about any side effects that bother you or don't go away.
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.
Please see full Prescribing Information, including Medication Guide.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.1-800-FDA-1088.