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Side Effects of Roflumilast
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Roflumilast has been studied extensively in clinical trials. In these studies, one group of people received roflumilast, while another group was given a placebo (a "sugar pill" that does not contain any active ingredients). As a result, it was possible to see what side effects occurred, how often they appeared, and how they compared to the placebo.
In clinical trials, the most common roflumilast side effects included:
- Weight loss -- in up to 20 percent of people (see Daliresp and Weight Loss)
- Diarrhea -- up to 9.5 percent
- Nausea -- up to 4.7 percent
- Headaches -- up to 4.4 percent
- Back pain -- up to 3.2 percent
- Influenza (the flu) -- up to 2.8 percent
- Insomnia -- up to 2.4 percent
- Dizziness -- up to 2.1 percent
- Decreased appetite -- up to 2.1 percent.
Other common side effects, occurring in 1 to 2 percent of people, included but were not limited to:
- Abdominal (stomach) pain
- Indigestion or heartburn
- Vomiting
- Runny or stuffy nose
- Sinus infection
- Urinary tract infection (UTI), such as a bladder infection
- Muscle spasms
- Shakiness (tremors)
- Anxiety
- Depression.
You may experience some or none of the side effects listed in this article. Unfortunately, there is no way for your healthcare provider to know beforehand if you will have problems with a medicine that you have never tried.
Therefore, make sure to let your healthcare provider know if you develop any side effects while taking roflumilast or if something "just does not seem right." While it may not be related to the medication, your healthcare provider will be able to diagnose and treat the problem.
Written by/reviewed by: Kristi Monson, PharmD
Last reviewed by: Kristi Monson, PharmD