Roflumilast Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 25, 2025.

Applies to roflumilast: oral tablet.

Serious side effects of roflumilast

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 side effects

• unexplained weight loss

Less common side effects

• 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

Other side effects of roflumilast

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 side effects

• 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 adverse events

• 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)

Further information

Roflumilast side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer