Roflumilast Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 6, 2025.

Applies to roflumilast: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine is used to prevent acute flare-ups of COPD. It is not used to stop a flare-up that has already started. You should use an inhaled medicine for the acute flare-ups that will work quickly to help you breathe better. If you do not have an inhaled medicine for acute COPD flare-ups, or if you have any questions about this, check with your doctor.

This medicine may cause some people to be agitated or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, having trouble sleeping, or feeling nervous or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause you to lose weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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)

See also:

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