Roflumilast is used in people with severe chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways) to reduce the number of episodes or worsening of COPD symptoms. Roflumilast is in a class of medications called phosphodiesterase inhibitors. It works by decreasing swelling in the lungs.

Side Effects Of Roflumilast

Roflumilast may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • diarrhea
  • nausea
  • dizziness
  • headache
  • back pain
  • muscle spasm
  • decrease in appetite
  • uncontrollable shaking of a part of your body

Some side effects can be serious. If you experience any of the symptoms listed in the SPECIAL PRECAUTIONS section, call your doctor immediately.

Roflumilast may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Warnings & Precautions

Before taking roflumilast:

  • tell your doctor and pharmacist if you are allergic to roflumilast, any other medications, or any of the ingredients in roflumilast tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: carbamazepine (Tegretol), cimetidine (Tagamet), enoxacin (not available in the U.S.), erythromycin (E.E.S., E-Mycin, Erythrocin), fluvoxamine, ketoconazole (Nizoral), phenobarbital, phenytoin (Dilantin), rifampicin and certain oral contraceptives (‘birth control pills’). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have liver disease. Your doctor may tell you not to take roflumilast.
  • tell your doctor if you have or have ever had a history of mental health conditions, including depression; thoughts about harming or killing yourself, or planning or trying to do so; extreme worry; or other unusual changes in your behavior or mood. Talk to your doctor about the risks of taking roflumilast.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Roflumilast, call your doctor.
  • you should know that your mental health may change in unexpected ways during treatment with roflumilast. You, your family, or your caregiver should call your doctor right away if you experience any of the following new symptoms or a worsening of these symptoms: difficulty falling asleep or staying asleep; depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; or changes in mood. Be sure that your family or caregiver knows these symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
  • you should know that roflumilast can cause weight loss. Your weight should be checked regularly by your doctor and you should also check your weight on a regular basis during treatment with roflumilast. If you notice you are losing weight, call your doctor.

Dosage Of Roflumilast

Roflumilast comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take roflumilast at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take roflumilast exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not use roflumilast to treat sudden attacks of breathing problems. Talk to your doctor about the use of other medications to treat symptoms of a sudden breathing problem.

Roflumilast may control COPD but does not cure it. Continue to take roflumilast even if you feel well. Do not stop taking roflumilast without talking to your doctor.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with roflumilast and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the manufacturer’s website to obtain the Medication Guide.


Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.


All information has been provided courtesy of MedLinePlus from the National Library of Medicine and from the FDA.