What is the dose of Daliresp (Roflumilast)?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: April 6, 2025View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

From the Guidelines

Daliresp (roflumilast) should be prescribed at a standard dose of 500 micrograms (0.5 mg) taken once daily for severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations. This oral medication works by inhibiting the enzyme phosphodiesterase-4 (PDE4), which reduces inflammation in the lungs and helps prevent COPD exacerbations 1. The medication should be taken consistently at the same time each day, with or without food. Patients should be aware that common side effects include diarrhea, weight loss, nausea, headache, and back pain, which often improve with continued use. It is not a rescue medication for acute bronchospasm and should be used as part of a comprehensive COPD management plan. Liver function should be monitored, and the medication should be used cautiously in patients with depression or suicidal thoughts as it may worsen these conditions. Roflumilast has been shown to decrease the number of moderate or severe exacerbations per patient-year, as well as the proportion of patients who have an exacerbation, and increase time to next exacerbation 1. However, it also increases adverse events, and its use should be carefully considered in individual patients. The most recent and highest quality study supports the use of roflumilast in patients with severe COPD and a history of exacerbations, particularly those with chronic bronchitis 1. Key points to consider when prescribing Daliresp include:

  • Patient selection: severe COPD with chronic bronchitis and a history of exacerbations
  • Dosing: 500 micrograms (0.5 mg) once daily
  • Monitoring: liver function, depression, and suicidal thoughts
  • Side effects: diarrhea, weight loss, nausea, headache, and back pain
  • Benefits: reduced exacerbations, improved lung function, and increased time to next exacerbation.

From the FDA Drug Label

The maintenance dose of roflumilast is one 500 micrograms (mcg) tablet per day, with or without food. Starting treatment with a dose of roflumilast 250 mcg once daily for 4 weeks and increasing to roflumilast 500 mcg once daily thereafter may reduce the rate of treatment discontinuation in some patients

The recommended dose of Daliresp (roflumilast) is 500 mcg once daily, with or without food, after an initial 4-week period of 250 mcg once daily. 2 2

From the Research

Daliresp Dose Information

  • The studies provided do not explicitly mention the dose of Daliresp (roflumilast) 3, 4, 5, 6, 7.
  • However, one study mentions that roflumilast is administered at a dose of 500 μg once daily 6.
  • It is essential to consult the prescribing information or a healthcare professional for the recommended dose of Daliresp.

Roflumilast Efficacy and Safety

  • Roflumilast has been shown to improve lung function and reduce the frequency of exacerbations in patients with COPD 3, 4, 5, 7.
  • The most common adverse effects of roflumilast include diarrhea, nausea, weight loss, and headaches 3, 5.
  • Roflumilast has been found to be generally well tolerated, with side effects typically being mild to moderate 5.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Roflumilast, a Novel Phosphodiesterase 4 Inhibitor, for COPD Patients with a History of Exacerbations.

Clinical medicine insights. Circulatory, respiratory and pulmonary medicine, 2011

Research

Roflumilast: a review of its use in the treatment of COPD.

International journal of chronic obstructive pulmonary disease, 2016

Research

Roflumilast for COPD.

Drugs of today (Barcelona, Spain : 1998), 2010

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.