Applies to fluticasone / vilanterol: inhalation powder.
Serious side effects
Along with its needed effects, fluticasone/vilanterol 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 fluticasone / vilanterol:
More common
- Body aches or pain
- chills
- cough
- difficulty with breathing
- ear congestion
- fever
- headache
- loss of voice
- muscle aches
- sneezing
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Less common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chest pain or tightness
- diarrhea
- dizziness
- general feeling of discomfort or illness
- joint or muscle pain
- loss of appetite
- nausea
- nervousness
- pain or tenderness around the eyes and cheekbones
- pounding in the ears
- slow or fast heartbeat
- sweating
- tingling of the hands or feet
- trouble sleeping
- trouble breathing
- unusual weight gain or loss
- vomiting
Incidence not known
- Fast, irregular, pounding, or racing heartbeat or pulse
- muscle spasms
- noisy breathing
- tremor
Get emergency help immediately if any of the following symptoms of overdose occur while taking fluticasone / vilanterol:
Symptoms of overdose
- Arm, back, or jaw pain
- chest discomfort
- chest heaviness
- confusion
- decreased urine
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- fruit-like breath odor
- increased hunger or thirst
- increased urination
- loss of appetite
- muscle cramps
- numbness or tingling in the hands, feet, or lips
- rapid, deep breathing
- restlessness
- seizures
- shakiness in the legs, arms, hands, or feet
- stomach cramp or pain
- unexplained weight loss
Other side effects
Some side effects of fluticasone / vilanterol 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
- Creamy white, curd-like patches in the mouth or throat
- difficulty with moving
- muscle stiffness
- pain when eating or swallowing
For Healthcare Professionals
Applies to fluticasone / vilanterol: inhalation powder.
General
The most common adverse reactions are nasopharyngitis, upper respiratory tract infection, headache, and oral candidiasis.[Ref]
Cardiovascular
Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Extrasystoles[Ref]
Gastrointestinal
Common (1% to 10%): Diarrhea, oral candidiasis, abdominal pain[Ref]
Musculoskeletal
Common (1% to 10%): Back pain, arthralgia, fractures
Postmarketing reports: Muscle spasm[Ref]
Nervous system
Common (1% to 10%): Headache, tremor[Ref]
Other
Common (1% to 10%): Influenza, pyrexia, peripheral edema[Ref]
Respiratory
Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, oropharyngeal candidiasis, chronic obstructive pulmonary disease (COPD), pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, pharyngitis, oropharyngitis fungal
Frequency not reported: Paradoxical bronchospasm[Ref]
Hypersensitivity
Postmarketing reports: Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria[Ref]
Metabolic
Postmarketing reports: Hyperglycemia
