Roflumilast is a prescription medication used to decrease the number of flare-ups or the worsening of COPD (Chronic Obstructive Pulmonary Disease). Roflumilast belongs to a group of medications called phosphodiesterase inhibitors. It is thought to work by decreasing inflammation in the lungs.

This medication comes in tablet form and is usually taken once a day, with or without food.

Common side effects include diarrhea, weight loss, nausea, and headache.

Roflumilast is a prescription medicine used in adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

 

Roflumilast can cause serious side effects. See "Roflumilast Precautions" section.

The most common side effects of roflumilast include:

  • diarrhea
  • weight loss
  • nausea
  • headache
  • back pain
  • flu like symptoms
  • problems sleeping (insomnia)
  • dizziness
  • decreased appetite

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of roflumilast. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • rifampicin;
  • phenobarbital; 
  • carbamazepine;
  • phenytoin;
  • erythromycin;
  • ketoconazole;
  • fluvoxamine; 
  • enoxacin; 
  • cimetidine;
  • certain birth control pills.

This is not a complete list of roflumilast drug interactions. Ask your doctor or pharmacist for more information.

Roflumilast can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking roflumilast.

  1. Roflumilast may cause mental health problems including suicidal thoughts and behavior. Some people taking roflumilast may develop mood or behavior problems including:
    • thoughts of suicide or dying
    • attempt to commit suicide
    • trouble sleeping (insomnia)
    • new or worse anxiety
    • new or worse depression
    • acting on dangerous impulses
    • other unusual changes in your behavior or mood
  2. Weight loss. Roflumilast can cause weight loss. You should check your weight on a regular basis. You will also need to see your healthcare provider regularly to have your weight checked. If you notice that you are losing weight, call your healthcare provider. Your healthcare provider may ask you to stop taking roflumilast if you lose too much weight.

Do not take roflumilast if you have certain liver problems. Talk with your healthcare provider before you take roflumilast if you have liver problems.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of roflumilast there are no specific foods that you must exclude from your diet when receiving roflumilast.

Before you take roflumilast, tell your healthcare provider if you:

  • have or have had a history of mental health problems including depression and suicidal behavior
  • have liver problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

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

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if roflumilast passes into your breast milk. You and your healthcare provider should decide if you will take roflumilast or breastfeed. You should not do both.

  • Take roflumilast exactly as your healthcare provider tells you to take it.
  • Roflumilast can be taken with or without food.
  • If you take more than your prescribed dose of roflumilast, call your healthcare provider or go to the nearest hospital emergency room right away.

Take roflumilast exactly as prescribed. Follow the directions on your prescription label carefully.

The recommended dose of roflumilast is one 500 microgram (mcg) tablet per day with or without food.

If you take too much roflumilast, call your local Poison Control Center or seek emergency medical attention right away.

 

 

 
  • Store roflumilast at 68°F to 77°F (20°C to 25°C); excursions permitted to 15° - 30°C (59° - 86°F). 
  • Keep roflumilast and all medicines out of the reach of children.
Reviewed By: 
Review Date: 
June 19, 2012
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<p>Roflumilast falls into category C:</p><p>In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.</p><p>OR</p><p>There are no well-controlled studies that have been done in pregnant women. Roflumilast should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.</p><p>OR</p><p>No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Roflumilast should be given to a pregnant woman only if clearly needed.</p>
<ul><li>Roflumilast 500 Mcg Oral Tablet</ul>
<ul><li>Oral Tablet</ul>
Quick Facts: 

Roflumilast can cause weight loss. You should check your weight on a regular basis. You will also need to see your healthcare provider regularly to have your weight checked. If you notice that you are losing weight, call your healthcare provider.

Roflumilast may cause mental health problems including suicidal thoughts and behavior. Tell your doctor if you notice any changes in behaviors.

Roflumilast can be taken with or without food.

Long Title: 
Roflumilast treats severe chronic obstructive pulmonary disease (COPD). Take Daliresp at the same time each day to maintain even blood levels.