Roflumilast

Generic name: roflumilast [ roe-FLOO-mi-last ]
Brand name: Daliresp
Dosage form: oral tablet (250 mcg; 500 mcg)
Drug class: Selective phosphodiesterase-4 inhibitors

Medically reviewed by Drugs.com on Apr 1, 2024. Written by Cerner Multum.

What is roflumilast?

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

Roflumilast is used to prevent worsening of symptoms in people with severe COPD.

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

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

Roflumilast side effects

Get emergency medical help if you have signs of an allergic reaction: 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.

• rapid and unintended weight loss;

• tremors;

• pain or burning when you urinate;

Common side effects of roflumilast 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.

Related/similar drugs

Breztri Aerosphere, prednisone, Symbicort, Ventolin HFA, Ventolin, Breo Ellipta, Spiriva

Warnings

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

Some people have thoughts about suicide while taking roflumilast. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

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

Before taking this medicine

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

Tell your doctor if you have ever had:

• liver disease; or

• depression, mental illness, or suicidal thoughts or actions.

Some people have thoughts about while taking roflumilast. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

It is not known whether roflumilast will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breast-feed while using roflumilast.

Do not give this medicine to a child without medical advice.

How should I take roflumilast?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take roflumilast with or without food.

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

Do not share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture and heat.

Roflumilast dosing information

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

Initial dose: 250 mcg orally once a day for 4 weeks
Maintenance dose: 500 mcg orally once a day

Comments:
-Starting the dose at 250 mcg daily may reduce the rate of treatment discontinuation, but it is not the effective/therapeutic dose.
-This drug is not a bronchodilator and is not indicated for acute exacerbation treatment.

Use(s): To reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

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

What should I avoid while taking roflumilast?

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

What other drugs will affect roflumilast?

Many drugs can affect roflumilast. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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