Precautions and Warnings With Roflumilast

Before starting treatment with roflumilast, there are many precautions to be aware of, including warnings relating to who should not use the drug and possible complications that may occur. This prescription medication could cause potentially serious side effects, such as depression and suicidal thoughts, and should not be used by people who have moderate-to-severe liver problems.

What Should I Tell My Healthcare Provider Before Taking Roflumilast?

You should talk with your healthcare provider prior to taking roflumilast (Daliresp™) if you have:
  • Depression
  • Anxiety
  • A history of suicidal thoughts or actions
  • Liver disease, such as liver failure, cirrhosis, or hepatitis
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Roflumilast Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medicine include the following:
  • Roflumilast is not a bronchodilator and should not be used as a "rescue" medication. You should still keep a rescue inhaler, such as albuterol, available if necessary.
  • In studies, roflumilast increased the risk for psychiatric side effects, including depression, anxiety, and suicidal thoughts and actions. It is important for you and your loved ones to be aware of this possibility. If you or someone around you thinks you might be in psychiatric trouble, please seek immediate medical attention.
  • In studies, weight loss was a common roflumilast side effect. In some cases, this may be a desirable thing; however, too much weight loss can be serious. Your healthcare provider should monitor your weight; you may have to stop taking roflumilast if you lose too much weight (see Daliresp and Weight Loss for more information).
  • Roflumilast is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Daliresp and Pregnancy).
  • It is not known whether roflumilast passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking this medication (see Daliresp and Breastfeeding).

Roflumilast Drug Information

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