Summary
More frequently reported side effects include: diarrhea, headache, nausea, weight loss, and psychiatric signs and symptoms. Continue reading for a comprehensive list of adverse effects.
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
- 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
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
- 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)
