Roflumilast, Oral


What are other names for this medicine?

Type of medicine: PDE-4 inhibitor

Generic and brand names: roflumilast, oral; Daliresp

What is this medicine used for?

This medicine is taken by mouth to treat severe chronic obstructive pulmonary disease. This medicine should not be used to treat sudden breathing problems.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

  • An allergic reaction to any medicine
  • Depression or suicidal thoughts
  • Liver problems

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Take this medicine regularly, even if you feel well.

You may take this medicine with or without food.

This medicine is not intended to treat sudden breathing problems. Your healthcare provider will prescribe a medicine that you inhale through your mouth for fast relief of breathing problems.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222

Symptoms of an acute overdose may include: headache, stomach upset, dizziness, pounding heartbeat, lightheadedness, fainting, clammy skin.

What should I watch out for?

Contact your healthcare provider if you need to use your fast relief medicine (for example, albuterol) more often than usual or if you need to use more than recommended during a 24-hour period. Do not stop taking other medicines for sudden breathing problems or change your dosage unless your healthcare provider tells you to.

This medicine may cause unintended weight loss. You should check your weight regularly. Your provider will also examine you and check your weight regularly. Contact your healthcare provider if you are losing weight.

Behavior changes have been reported in some people taking this medicine. Contact your provider right away if you or your family notice any disturbing changes in your thoughts or behavior, such as:

  • More outgoing or aggressive behavior than normal
  • Confusion
  • Hallucinations
  • New or worsening trouble sleeping
  • New or worsening of depression or anxiety
  • Suicidal thoughts

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Increased trouble breathing, fast or irregular heartbeat, severe abdominal pain, trouble urinating, thoughts of suicide, new or worse anxiety or depression, confusion, hallucinations, unintended weight loss, worsening sleep problems, unusual thoughts, behavior, or mood changes.

Other: Headache, muscle aches and pains, muscle spasms, tremors, back pain, tiredness, nausea, vomiting, gas, stomach pain, diarrhea, problems sleeping, dizziness, decreased appetite.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

  • Antibiotics such as clarithromycin (Biaxin), enoxacin (Penetrex), erythromycin (Ery-Tabs, E.E.S.), isoniazid, metronidazole (Flagyl), norfloxacin (Noroxin), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane), and telithromycin (Ketek)
  • Antidepressants such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox CR), nefazodone, and sertraline (Zoloft)
  • Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole, posaconazole (Noxafil), and voriconazole (VFEND)
  • Anti-HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
  • Antiseizure medicines such as carbamazepine (Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin), and primidone (Mysoline)
  • Birth control pills
  • Bosentan (Tracleer)
  • Cimetidine (Tagamet)
  • Conivaptan (Vaprisol)
  • Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene, Cardene SR), quinidine, and verapamil (Calan, Covera, Isoptin)
  • Imatinib (Gleevec)
  • St. John's wort

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.


This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.

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