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Overview: Roflumilast is used to reduce the risk of chronic bronchitis flare ups. Common side effects include nausea, diarrhea, and reduced appetite. You should check your weight regularly while taking this medicine. Tell your healthcare provider if you have significant or unexpected weight loss.

Uses

What is roflumilast used for?

Roflumilast is commonly used to reduce the risk of flare ups in people with a certain type of chronic obstructive pulmonary disease (COPD), called chronic bronchitis.

Roflumilast may also be used for other conditions as determined by your healthcare provider.

Roflumilast is also available in forms that are applied to the skin. See Zoryve for more information. 

How does roflumilast work (mechanism of action)?

People with chronic obstructive pulmonary disease (COPD) have ongoing problems with airflow in the lungs. Roflumilast increases the levels of a substance in the lungs called cyclic AMP. This substance relaxes the muscles in the airways and reduces the amount of swelling (inflammation) in the lungs, which can help make it easier to breathe.

How is roflumilast supplied (dosage forms)?

Brands and other names

  • Daliresp

Dosage forms and strengths

  • 250 mcg, 500 mcg oral tablets 

How should I store roflumilast?

Roflumilast should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. 

Side Effects

What are the most common side effects of roflumilast?

The most common side effects of roflumilast are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Diarrhea
  • Weight loss (see below)
  • Nausea
  • Headache
  • Back pain
  • Flu-like symptoms
  • Trouble sleeping
  • Dizziness
  • Reduced appetite

There may be other side effects of roflumilast that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of roflumilast?

While less common, the most serious side effects of roflumilast are described below, along with what to do if they happen.

Severe Allergic Reactions. Roflumilast may cause allergic reactions, which can be serious. Stop taking roflumilast and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Suicidal Thoughts and Actions. Roflumilast may cause suicidal thoughts or actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Weight Loss. Some people may lose weight while taking roflumilast. You should check your weight regularly while taking this medicine. Tell your healthcare provider if you have significant or unexpected weight loss. 

Warnings & Precautions

Who should not use roflumilast?

Allergies to Ingredients. People who are allergic to any of the following should not take roflumilast.

  • Daliresp
  • Roflumilast
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific roflumilast products they stock.

Liver Problems. Roflumilast should not be used if your liver is not working as well as it should be. If there is a concern about the health of your liver, your healthcare provider may do tests to determine if it is working well enough to take this medicine.

What should I know about roflumilast before using it?

Do not take roflumilast unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share roflumilast with other people, even if they have the same condition as you. It may harm them.

Keep roflumilast out of the reach of children.

Roflumilast is a medicine used daily to prevent symptoms. Do not use it when a quick response to breathing problems is needed. Certain inhaled medicines, sometimes called rescue inhalers, should be used to treat sudden symptoms. Get medical help right away if your breathing does not get better after using a rescue inhaler.

What should I tell my healthcare provider before using roflumilast?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if roflumilast is right for you.

In particular, make sure that you discuss any of the following.

Mental Health Problems. Tell your healthcare provider if you have mental health problems, including depression or suicidal thoughts.

Other Medicines and Supplements. Roflumilast may interact with other medicines and supplements. Before taking roflumilast, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how roflumilast could affect pregnancy or harm an unborn baby. Taking roflumilast around the time that you give birth may not be safe. Tell your healthcare provider if you are or plan to become pregnant.

Breastfeeding. It is not known if roflumilast passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should stop breastfeeding or stop roflumilast.

Interactions

Does roflumilast interact with foods or drinks?

There are no known interactions between roflumilast and foods or drinks.

It is unknown if drinking alcohol will affect roflumilast. The risk of dizziness may be increased if you drink alcohol while taking roflumilast.

Does roflumilast interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking roflumilast.

  • A birth control pill that contains the hormone ethinyl estradiol
  • A macrolide antibiotic, such as clarithromycin or erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections
  • Any medicine for seizures, such as carbamazepine, phenytoin, or phenobarbital
  • Cimetidine (Tagamet HB), which is a medicine used for heartburn
  • Fluvoxamine (Luvox), which is a medicine commonly used for obsessive-compulsive disorder (OCD)
  • Ketoconazole, which is a medicine used for fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Phenytoin (Dilantin, Phenytek, and others), which is a medicine to control seizures
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Phenobarbital, which is a medicine that may be used to treat insomnia or seizures

Many other medicines may alter the blood levels of roflumilast. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with roflumilast. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much roflumilast?

If you or someone else has used too much roflumilast, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of roflumilast?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.