Daliresp (Roflumilast) - Oral

What Is Daliresp?

Daliresp (roflumilast) is a prescription medication option used to reduce the number of episodes and the symptoms associated with chronic obstructive pulmonary disease (COPD). Daliresp blocks phosphodiesterase 4 (PDE4), which is a type of protein.

However, it's important to remember that Daliresp is not a bronchodilator (a type of medication that makes breathing easier by relaxing the muscles in the lungs and widening the airways [bronchi]) and therefore is not used to treat severe bronchospasms.

This PDE4 inhibitor is thought to work by lessening lung swelling.

While this article will feature Daliresp (available as an orally administered tablet), roflumilast is also available in a topical (cream) form under the brand name Zoryve.

Drug Facts

Generic Name: Roflumilast

Brand Name(s): Daliresp

Drug Availability: Prescription

Administration Route: Oral

Therapeutic Classification: Respiratory agent

Available Generically: Yes

Controlled Substance: N/A

Active Ingredient: Roflumilast

Dosage Form(s): Tablet

What Is Daliresp Used For?

The Food and Drug Administration (FDA) has approved Daliresp to treat people with severe or very severe COPD with a history of flare-ups. These individuals may also have chronic bronchitis, a type of COPD.

Chronic bronchitis is swelling and irritation of the airways in the lungs. Some COPD symptoms may also include mucus in your lungs, breathing difficulties, and cough.

COPD usually affects smokers and people older than 40. As people age, the risk of COPD also rises.

In the United States (U.S.), over 15 million people have COPD. However, more than half of adults with low-functioning lungs don’t know they have COPD. In 2018, COPD was the fourth leading cause of death in the U.S.

Although effective, Daliresp is actually not the go-to option for COPD. Various inhalers are usually tried first. However, if COPD symptoms are still uncontrolled with these inhalers, then experts recommend Daliresp as a potential option.

How to Take Daliresp

Take Daliresp once daily with or without food. It's also important to establish a routine. Therefore, take Daliresp at around the same time every day.

Follow the directions on your prescription label carefully, and ask your healthcare provider to explain anything you do not understand. Then, take Daliresp exactly as directed. Do not take more or less of it or more often than your healthcare provider prescribes it.

Storage

Daliresp is a non-controlled prescription medication. As a result, your healthcare provider can give you refills for up to one year from the originally written date on the prescription.

If you’re just starting to take Daliresp, your healthcare provider might give you fewer refills to monitor COPD symptoms and medication side effects before raising the dose.

Once you bring Daliresp home from the pharmacy, store the medication at room temperature. Moreover, keep it out of reach of children and pets, and avoid storing it in a bathroom.

If necessary, however, Daliresp has a safe storage range between 59-86 degrees Fahrenheit for a short time.

If you’re going to travel with Daliresp, know the regulations of your final destination. In general, you may need a copy of your Daliresp prescription. Also, keep the medication in the original container—with your name on it—from the pharmacy.

How Long Does Daliresp Take to Work?

After four weeks of treatment with daily 500 micrograms of Daliresp, you might notice less mucus from your lungs.

What Are the Side Effects of Daliesp?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

As with all medications, Daliresp can cause side effects. Tell your healthcare provider about any side effects you experience while taking this medication.

Common Side Effects

Common side effects with Daliresp may include:

Severe Side Effects

Although weight loss and insomnia are common side effects of Daliresp, these can sometimes be excessive. Immediately let your healthcare provider know if you notice a significant amount of weight loss or severe insomnia.

Daliresp may also lead to new or worsening mental health conditions. Get help right away if you experience the following.

Long-Term Side Effects

After long-term Daliresp treatment for six or 12 months, many of the possible side effects are similar to the medication’s common side effects.

Long-term treatment with Daliresp is also potentially linked to the severe symptoms of suicidal thoughts and weight loss. After stopping Daliresp, however, many people did regain some of their weight.

Report Side Effects

Daliresp may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Daliresp Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For prevention of COPD:
      • Adults—One 500 microgram (mcg) tablet per day.
      • Children—Use and dose must be determined by your doctor.

Modifications

Users should be aware of the following before beginning Daliresp:

Pregnancy: ​​There is limited safety and effectiveness data on Daliresp use in pregnant parents. However, in animal studies, Daliresp is linked to negative effects in unborn pups.

Breastfeeding: There is little safety and effectiveness data for Daliresp in nursing babies. Although the amount of medication in human breast milk is likely very low, the manufacturer—AstraZeneca—recommends against taking Daliresp when nursing.

If you have any questions or concerns, talk with your healthcare provider to help you weigh the benefits and risks of taking Daliresp while pregnant and nursing.

Adults over 65: Studies showed no overall differences in the safety and efficacy of Daliresp when compared to people over the age of 65 versus younger individuals in dosing trials.

Therefore, while the potential for greater sensitivity of some older people cannot be ruled out when considering prescribing or determining how to dose for Daliresp, no preemptive dosage adjustments in older people should be made unless needed on a case-by-case basis.

Pediatric use: There are limited studies on the effectiveness of Daliresp in infants and young children as COPD does not generally occur in that population. Therefore, speak to your healthcare provider about the potential risks associated with your child taking Daliresp.

People who smoke: Smoking can lower Daliresp's effectiveness. Try to stop smoking before starting Diuril, and avoid smoking while taking Daliresp. Your healthcare provider can help you with this goal.

People with liver impairment: The manufacturer doesn’t recommend Daliresp in people with moderate to severe liver impairment.

Missed Dose

If you missed a dose of Daliresp, take it as soon as you remember. If it’s close to your next dose, wait to take the following dose at your upcoming dosing schedule. Don’t try to take more than one dose at a time to make up for the missed dose.

Overdose: What Happens If I Take Too Much Daliresp?

There are no reports of overdose with Daliresp. However, a single high dose of 2500 micrograms and 5000 micrograms was linked to the following side effects.

If you accidentally took too many Daliresp tablets, seek immediate medical attention.

What Happens If I Overdose on Daliresp?

If you think you or someone else may have overdosed on Daliresp, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Daliresp, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine is used to prevent acute flare-ups of COPD. It is not used to stop a flare-up that has already started. You should use an inhaled medicine for the acute flare-ups that will work quickly to help you breathe better. If you do not have an inhaled medicine for acute COPD flare-ups, or if you have any questions about this, check with your doctor.

This medicine may cause some people to be agitated or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, having trouble sleeping, or feeling nervous or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause you to lose weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn't Take Daliresp?

Daliresp is not appropriate for everyone. You should not take this medication if you are allergic to roflumilast or any of the inactive ingredients in Daliresp.

Daliresp may be used with caution in some people only if the healthcare provider determines it is safe. This includes:

  • Liver impairment: If you have moderate to severe liver impairment, AstraZeneca recommends avoiding Daliresp.
  • Pregnancy: During pregnancy, animal studies show potential negative effects in unborn pups. Speak with your healthcare provider about the benefits and risks of taking Daliresp during pregnancy. 
  • Nursing: The manufacturer recommends against Daliresp use while nursing. Discuss with your healthcare provider to weigh the benefits and risks.

What Other Medications May Interact With Daliresp?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter (OTC) medicines, and vitamins or supplements. 

Take the following medications with caution:

  • Birth-control medications: Some oral birth control medications may raise the amount of Daliresp in the body, which raises the likelihood of side effects.
  • CYP450-inducing medications: Cytochrome P450 (CYP450) is a family of proteins in the liver that help break down medications—like Daliresp. However, other medications—like phenytoin for seizure treatment—encourage these proteins to break down Daliresp quickly. With lower amounts of Daliresp in the body, the medication is less effective in treating COPD.
  • CYP3A4-inhibiting medications: CYP3A4 is a member of the CYP450 family of proteins. CYP3A4 is one of the proteins that help break down Daliresp. If you take a medication or drink grapefruit juice that blocks CYP3A4, there will be higher amounts of Daliresp in the body and a higher likelihood of side effects.
  • Dual-inhibiting CYP3A4 and CYP1A2 medications: In addition to CYP3A4, CYP1A2 is another member of the CYP450 family that helps break down Daliresp. If you take medication—like an erythromycin antibiotic—that prevents CYP3A4 and CYP1A2 from working as well, then the higher amounts of Daliresp in the body can raise the risk of serious side effects.

If you have any questions or concerns about these drug interactions, speak with your healthcare provider or pharmacist.

What Medications Are Similar?

Daliresp is currently the only PDE4 inhibitor used to treat COPD.

Frequently Asked Questions

  • Where is Daliresp available?

    Daliresp is available as a prescription from your healthcare provider. Many local retail community pharmacies carry Daliresp. If they don’t, they can probably order the medication for you.

  • How much does Dalirep cost?

    Since Daliresp is not available as a generic, this medication can be expensive. Although there is a savings program, it isn’t useful for people with Medicare, Medicaid, Veteran Affairs (VA), or similar benefits. If necessary, consider calling AstraZeneca for additional assistance at 1-800-236-9933.

  • Is Daliresp effective for other lung conditions, such as asthma?

    Currently, the FDA has only approved Daliresp for COPD treatment.

How Can I Stay Healthy While Taking Daliresp?

After receiving a diagnosis of COPD from your healthcare provider, you might experience various emotions. Therefore, a strong social support network—with family, friends, and support groups—may help. If you’re experiencing depression or severe anxiety, a mental healthcare professional may also help.

Remember to learn and share about your medical condition. As you become more aware, you can find ways to feel in more control of your health. As your loved ones know more about COPD, they can give you the support and encouragement you need. Depending on the severity of your symptoms, you might need to find ways to make your daily activities easier. You might also want to ask family and friends for help with specific tasks.

In addition to monitoring your mental health, learn about your COPD triggers and avoid them. Examples of triggers include air pollution, dust, and cigarette smoke. If you smoke, try to find ways to quit smoking.

Continuing to work with your healthcare team is also important. Consider an action plan to help you determine the next steps if you’re experiencing symptoms or flare-ups. Also, stay up-to-date on your vaccines.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

13 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. Daliresp (roflumilast) prescribing information.

  2. Li H, Zuo J, Tang W. Phosphodiesterase-4 inhibitors for the treatment of inflammatory diseases. Front Pharmacol. 2018;9:1048. doi:10.3389/fphar.2018.01048

  3. MedlinePlus. Roflumilast.

  4. Global Initiative for Chronic Obstructive Lung Disease. Pocket guide to COPD diagnosis, management, and prevention.

  5. MedlinePlus. Chronic bronchitis.

  6. Devine JF. Chronic obstructive pulmonary disease: an overview. Am Health Drug Benefits. 2008;1(7):34-42.

  7. Centers for Disease Control and Prevention. Basics about COPD.

  8. Drugs and Lactation Database: National Library of Medicine. Roflumilast.

  9. MedlinePlus. Skin -  clammy.

  10. Prescribers’ Digital Reference. Roflumilast - drug summary.

  11. Lynch T, Price A. The effect of cytochrome P450 metabolism on drug response, interactions, and adverse effects. Am Fam Physician. 2007;76(3):391-396.

  12. National Heart, Lung, and Blood Institute. What is COPD?

  13. American Lung Association. My COPD action plan.

By Ross Phan, PharmD, BCACP, BCGP, BCPS
Ross is a writer for Verywell with years of experience practicing pharmacy in various settings. She is also a board-certified clinical pharmacist and the founder of Off Script Consults.