From the Guidelines
Daliresp (roflumilast) can cause several side effects, with the most common being diarrhea, nausea, reduced appetite, weight loss, abdominal pain, sleep disturbance, and headache, as reported in the 2017 global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease report 1. The most serious potential side effects include:
- Mental health changes: Depression, anxiety, suicidal thoughts
- Severe weight loss
- Persistent diarrhea
- Sleep disturbance Patients should be aware that weight loss is common, affecting patients taking Daliresp, due to the medication's effect on fat metabolism. It's essential to monitor for mood changes and report any mental health concerns to your doctor immediately, as the risk of psychiatric events is higher in patients with a history of depression or anxiety 1. Diarrhea typically occurs within the first few weeks of treatment and may resolve on its own, but if it persists or becomes severe, contact your healthcare provider. To minimize side effects, Daliresp is usually started at a lower dose and increased gradually, and it is crucial to take Daliresp as prescribed and not stop taking it without consulting your doctor, as sudden discontinuation may worsen COPD symptoms. If you experience any severe or persistent side effects, contact your healthcare provider promptly, and regular check-ups are important to monitor for potential side effects and adjust treatment if necessary 1. Some key points to consider when taking Daliresp include:
- Avoiding the medication in underweight patients
- Using it with caution in patients with depression
- Monitoring for signs of liver problems
- Being aware of the potential for increased risk of bacterial resistance and impaired hearing tests when used with certain antibiotics 1.
From the FDA Drug Label
Roflumilast tablets can cause serious side effects, including:
- Roflumilast tablets may cause mental health problems including suicidal thoughts and behavior.
- Weight loss. The most common side effects of roflumilast tablets include:
- diarrhea
- weight loss
- nausea
- headache
- back pain
- flu like symptoms
- problems sleeping (insomnia)
- dizziness
- decreased appetite
The side effects of Daliresp (roflumilast) include mental health problems, such as suicidal thoughts and behavior, and weight loss. The most common side effects are:
- Diarrhea
- Weight loss
- Nausea
- Headache
- Back pain
- Flu-like symptoms
- Insomnia
- Dizziness
- Decreased appetite [2] [3]
From the Research
Side Effects of Daliresp (Roflumilast)
The side effects of Daliresp (roflumilast) include:
- Gastrointestinal symptoms such as diarrhoea, nausea, vomiting, or dyspepsia 4, 5, 6, 7, 8
- Weight loss 4, 5, 6, 7, 8
- Psychiatric adverse events, including insomnia and depressive mood symptoms 4, 5, 7
- Headache 5, 6
- Increased risk of psychiatric symptoms, particularly with roflumilast 500 µg 4
Common Adverse Events
The most common adverse events associated with roflumilast are:
- Diarrhoea, which was more commonly reported with PDE₄ inhibitor treatment 4
- Nausea 5, 6
- Weight loss, which was associated with roflumilast use 4, 5, 6, 7, 8
Serious Adverse Events
There is no evidence to suggest that roflumilast is associated with an increased risk of mortality 4 or respiratory disease and infection 8. However, it may be associated with an increased risk of psychiatric adverse events 4, 5, 7.