Skip to Content

Roflumilast Side Effects

In Summary

More frequently reported side effects include: diarrhea, headache, nausea, weight loss, and psychiatric signs and symptoms. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to roflumilast: oral tablet

Along with its needed effects, roflumilast may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking roflumilast:

More Common

Less Common

  • Chills
  • cough
  • diarrhea
  • discouragement
  • fear or nervousness
  • feeling sad or empty
  • fever
  • general feeling of discomfort or illness
  • headache
  • irritability
  • joint pain
  • loss of appetite
  • loss of interest or pleasure
  • muscle aches and pains
  • nausea
  • runny nose
  • shivering
  • sleeplessness
  • sore throat
  • sweating
  • thoughts of killing oneself or changes in behavior
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
  • unusual tiredness or weakness
  • vomiting

Some side effects of roflumilast may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less Common

  • Abdominal or stomach pain
  • back pain
  • bladder pain
  • bloody or cloudy urine
  • burning feeling in the chest or stomach
  • decreased appetite
  • difficult, burning, or painful urination
  • dizziness
  • frequent urge to urinate
  • indigestion
  • lower back or side pain
  • muscle spasm
  • pain or tenderness around the eyes and cheekbones
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath or troubled breathing
  • sneezing
  • stomach upset
  • stuffy or runny nose
  • sweating
  • tenderness in the stomach area
  • tightness of the chest or wheezing
  • trembling or shaking of the hands or feet

For Healthcare Professionals

Applies to roflumilast: oral tablet

Psychiatric

Common (1% to 10%): Anxiety, depression

Frequency not reported: Suicidal ideation and behavior (including completed suicide)

Postmarketing reports:[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, abdominal pain, dyspepsia, gastritis, vomiting[Ref]

Metabolic

Common (1% to 10%): Weight decreased, decreased appetite

Nervous system

Common (1% to 10%): Headache, dizziness, insomnia, tremor[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, muscle spasms[Ref]

Immunologic

Common (1% to 10%): Influenza, rhinitis, sinusitis, urinary tract infection

Genitourinary

Postmarketing reports: Gynecomastia[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (including angioedema, urticaria, and rash)

References

1. "Product Information. Daliresp (roflumilast)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Hide