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

Daliresp is used to prevent worsening of symptoms in people with severe chronic obstructive pulmonary disease (COPD).

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

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

Important information

You should not use Daliresp if you have moderate or severe liver disease.

You may have unusual thoughts or behavior, or thoughts about suicide, while taking Daliresp. 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.

Before taking this medicine

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

To make sure you can safely take Daliresp, tell your doctor if you have any of these other conditions:

  • liver disease;

  • 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.

FDA pregnancy category C. It is not known whether Daliresp will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

Roflumilast can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice. Do not share this medication with other people, even if they have the same symptoms you have.

How should I take Daliresp?

Take Daliresp exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Daliresp is usually taken once per day, with or without food. Follow your doctor"s instructions.

Weight loss is a common side effect of this medicine. While using Daliresp, weigh yourself regularly and tell your doctor if you have any unplanned or unexplained weight loss.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Follow your doctor"s instructions about any restrictions on food, beverages, or activity.

Daliresp side effects

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

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;

  • tremors;

  • pain or burning when you urinate;

Common Daliresp side effects may include:

  • nausea, diarrhea;

  • loss of appetite, minor weight loss;

  • headache, dizziness;

  • occasional sleep problems;

  • back pain; or

  • flu symptoms.

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.

See also: Side effects (in more detail)

What other drugs will affect Daliresp?

Many drugs can interact with Daliresp, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all medicines you use now and any medicine you start or stop using.


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