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

Get emergency medical help if you have any of these signs of an allergic reaction while taking roflumilast: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may have unusual thoughts or behavior, or thoughts about suicide, while taking this medicine. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, depression, trouble sleeping, or if you feel impulsive, or you have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

• rapid and unintended weight loss;

• tremors;

• pain or burning when you urinate;

Less serious side effects of roflumilast may include:

• nausea, diarrhea, stomach pain;

• loss of appetite, minor weight loss;

• dizziness;

• runny or stuffy nose;

• back pain; or

• flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

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