Note: This document contains side effect information about fluticasone / vilanterol. Some dosage forms listed on this page may not apply to the brand name Breo Ellipta.
Applies to fluticasone / vilanterol: inhalation powder.
Warning
Inhalation route (Powder)
Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US trial that compared the safety of another LABA (salmeterol) with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including vilanterol, an active ingredient in fluticasone furoate/vilanterol trifenatate The safety and efficacy of fluticasone furoate/vilanterol trifenatate in patients with asthma have not been established. Fluticasone furoate/vilanterol trifenatate is not indicated for the treatment of asthma.
Serious side effects of Breo Ellipta
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 of Breo Ellipta
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