Roflumilast Side Effects

Some side effects of roflumilast may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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
  • Unexplained weight loss
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

General

During clinical trials, treatment was discontinued due to side effects in 14.8% of patients treated with roflumilast and 9.9% of patients treated with placebo. The most common side effects leading to roflumilast discontinuation were diarrhea and nausea. Serious side effects, whether considered drug-related or not by investigators, which occurred more often in patients treated with roflumilast included diarrhea, atrial fibrillation, lung cancer, prostate cancer, acute pancreatitis, and acute renal failure.

Psychiatric

Psychiatric side effects have included increased psychiatric adverse reactions (5.9%) including insomnia (2.4%), anxiety (1.4%), and depression (1.2%). Instances of suicidal ideation and behavior (including suicide attempt and completed suicide) have been reported.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (9.5%), nausea (4.7%), and acute pancreatitis. Abdominal pain, dyspepsia, gastritis, and vomiting have been reported in 1% to 2% of patients.

Metabolic

Metabolic side effects have included weight loss (7.5%).

In 2 clinical trials, moderate weight loss (5% to 10% of body weight) was reported in 20% of patients receiving roflumilast compared to 7% of patients who received placebo. Severe weight loss (greater than 10% body weight) was reported in 7% of patients who received roflumilast compared to 2% of patients receiving placebo.

Nervous system

Nervous system side effects have included headache (4.4%), dizziness (2.1%), and tremor (1% to 2%).

Other

Other side effects have included decreased appetite (2.1%).

Musculoskeletal

Musculoskeletal side effects have included back pain (3.2%) and muscle spasms (1% to 2%).

Respiratory

Respiratory side effects have included influenza (2.8%), rhinitis (1% to 2%), and sinusitis (1% to 2%).

Genitourinary

Genitourinary side effects have included urinary tract infection (1% to 2%).

Cardiovascular

Cardiovascular side effects have included atrial fibrillation.

Oncologic

Oncologic side effects have included lung cancer and prostate cancer.

Renal

Renal side effects have included acute renal failure.

Hypersensitivity

Hypersensitivity side effects postmarketing have included angioedema, urticaria and rash.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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