Roflumilast (Daliresp) is an oral medication that's used as maintenance treatment in people with severe chronic obstructive pulmonary disease (COPD). It helps lower the risk for COPD flare-ups. This medication belongs to the drug class called phosphodiesterase-4 (PDE-4) inhibitors. Roflumilast (Daliresp) is a tablet that's taken by mouth once per day. Side effects include diarrhea, nausea, and weight loss. This medication has a brand-name and generic version available.
Maintenance treatment for severe chronic obstructive pulmonary disease (COPD)
Roflumilast (Daliresp) is a phosphodiesterase-4 (PDE-4) inhibitor. It blocks PDE-4, a protein in your body that's involved in causing inflammation in the lungs and making it difficult for you to breathe. By blocking PDE-4, roflumilast (Daliresp) lessens inflammation and opens up your airways to help you breathe better.
Source: DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Unexplained weight loss
Less common
Chills
discouragement
fear or nervousness
feeling sad or empty
general feeling of discomfort or illness
headache
irritability
joint pain
loss of appetite
loss of interest or pleasure
muscle aches and pains
shivering
sweating
thoughts of killing oneself or changes in behavior
tiredness
trouble concentrating
trouble sleeping
unable to sleep
unusual tiredness or weakness
vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Abdominal or stomach pain
back pain
bladder pain
bloody or cloudy urine
burning feeling in the chest or stomach
decreased appetite
difficult, burning, or painful urination
dizziness
frequent urge to urinate
indigestion
lower back or side pain
pain or tenderness around the eyes and cheekbones
shakiness in the legs, arms, hands, or feet
shortness of breath or troubled breathing
stomach upset
stuffy or runny nose
sweating
tenderness in the stomach area
tightness of the chest or wheezing
trembling or shaking of the hands or feet
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Lowers your risk of future COPD flare-ups, so you're less likely to have to go to the hospital
Possible option for people who are already using triple inhaler therapy and are still having COPD flare-ups
Taken by mouth once a day
Only available as a tablet that can't be split or crushed
Might cause trouble sleeping and mood or behavior changes (e.g., anxiety, depression)
Not recommended for people for moderate or severe liver problems
Take roflumilast (Daliresp) as prescribed once per day, regardless of what other COPD inhalers you're using. Roflumilast (Daliresp) helps lower the risk of having more COPD flare-ups in the long run.
Take roflumilast (Daliresp) at any time of day with or without food. It might be helpful to take it with food to help prevent or ease possible diarrhea or nausea from the medication.
Use your rescue inhaler to relieve any sudden trouble breathing. Roflumilast (Daliresp) isn't meant to be used to quickly relieve symptoms of a COPD flare-up.
Call your prescriber or pulmonologist if your breathing or peak flow rate worsens. Also contact your prescriber if you're using your rescue inhaler more often than usual. These could be signs that you need more help to manage your COPD.
It's possible for roflumilast (Daliresp) to cause insomnia (trouble sleeping). If you have trouble sleeping while you're taking the medication, some things you can try to help include taking it earlier during the day and avoiding screen time late at night. You can also talk to your prescriber for other ways to manage this side effect.
Make sure to eat regularly and follow a nutritious diet while you're taking roflumilast (Daliresp). This medication might lower your appetite and cause weight loss. Check your weight every so often and contact your prescriber if you're noticing concerning weight loss.
Although rare, some people might have depression or anxiety after they start taking roflumilast (Daliresp). Let your prescriber know if you start feeling depressed or anxious or have concerning changes in mood or behavior while you're taking this medication. All call 911 or get medical help right away if you're having thoughts of harming yourself.
Roflumilast (Daliresp) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Roflumilast (Daliresp) isn't a rescue medication and won't help to treat a COPD exacerbation (when COPD symptoms suddenly get worse, also called a flare-up). It's recommended that you use your rescue inhaler to quickly help you breathe in these situations.
Talk with your prescriber if roflumilast (Daliresp) isn't working well to control your COPD and you're experiencing worsening symptoms, such as coughing and trouble breathing. They can discuss with you about your options to manage your COPD better.
Risk factors: History of mental health problems
Roflumilast (Daliresp) can raise the risk for changes in mood or behavior, including trouble sleeping, anxiety, and depression. Although rare, some people also had suicidal thoughts or behaviors while they were taking this medication.
Talk to your prescriber before you start roflumilast (Daliresp) if you have a history of having depression, suicidal thoughts, or mental health problems. Your prescriber will discuss with you about the risks and benefits of taking the medication.
It's a good idea to remind your friends and family to look out for you in case you have changes in mood or thoughts while you're taking roflumilast (Daliresp). Contact your prescriber if you start to have unusual changes in mood, thoughts, or behaviors. And call 911 or seek medical attention right away if you're having thoughts of hurting yourself.
Weight loss is a common side effect of roflumilast (Daliresp). In clinical studies, some people lost between 5% to 10% (or even more) of their body weight after they took the medication for a year. Most people gained back this weight after they stopped taking roflumilast (Daliresp).
Make sure to follow a balanced and nutritious diet while you're taking roflumilast (Daliresp). It's recommended that you periodically monitor your weight. Let your prescriber know if you experience significant weight loss that's not due to changes in your diet or exercise routine. You might need to stop taking roflumilast (Daliresp).
Roflumilast (Daliresp) can interact with many other medications. In particular, some medications can lower the amount of roflumilast (Daliresp) in the body so that it doesn't work as well to help manage COPD. Examples of such medications include rifampin, carbamazepine (Tegretol), and phenytoin (Dilantin).
Make sure to tell your care team about all of the over-the-counter and prescription medications you're currently taking. Before you start any new medications, check with a member of your care team to make sure that they're safe to take with roflumilast (Daliresp).
The typical starting dose is 250 mcg by mouth once per day for 4 weeks. Then, the dose is raised to 500 mcg by mouth once per day.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Moderate or severe liver problems
Maintenance treatment for severe chronic obstructive pulmonary disease (COPD)
Asthma
Chronic obstructive pulmonary disease (COPD)
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American Lung Association. (2024). Measuring your peak flow rate.
Aurobindo Pharma Limited. (2024). Roflumilast tablet [package insert]. DailyMed.
Calverley, P. M., et al. (2012). Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? The REACT study protocol. International Journal of Chronic Obstructive Pulmonary Disease.
Global Initiative for Chronic Obstructive Lung Disease. (2024). Pocket guide to COPD diagnosis, management, and prevention.
Janjua, S., et al. (2020). Phosphodiesterase-4 inhibitors for chronic obstructive pulmonary disease. The Cochrane Database of Systematic Reviews.
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