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Medications and Drugs

Brand Names: Daliresp

Generic Name: roflumilast (Pronunciation: roe FLOO mi last)

What is roflumilast (Daliresp)?

Roflumilast reduces inflammation in the lungs that leads to COPD (chronic obstructive pulmonary disease).

Roflumilast is used to prevent worsening of chronic obstructive pulmonary disease (COPD) in people with severe COPD and chronic bronchitis.

Roflumilast is not a bronchodilator. It will not treat a bronchospasm attack that has already begun.

Roflumilast may also be used for purposes not listed in this medication guide.

What are the possible side effects of roflumilast (Daliresp)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may have unusual thoughts or behavior, or thoughts about suicide, while taking this medicine. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, depression, trouble sleeping, or if you feel impulsive, or you have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

Less serious side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about roflumilast (Daliresp)?

You should not use roflumilast if you are allergic to it, or if you have moderate or severe liver disease.

There are many other drugs that can make roflumilast less effective and should not be used at the same time. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Before you take roflumilast, tell your doctor if you have liver disease or a history of depression, mental illness, or suicidal thoughts or actions.

You may have unusual thoughts or behavior, or thoughts about suicide, while taking this medicine. Tell your doctor if you have new or worsening depression, or suicidal thoughts. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, depression, trouble sleeping, or if you feel impulsive, or you have thoughts about suicide or hurting yourself.

Call your doctor at once if you have rapid and unintended weight loss.



Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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