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Breo Ellipta Side Effects

Generic name: fluticasone / vilanterol

Medically reviewed by Drugs.com. Last updated on Dec 16, 2022.

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.

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

Less common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • 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
  • tightness of the chest
  • tingling of the hands or feet
  • trouble sleeping
  • troubled 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

Frequently asked questions

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Breo Ellipta (fluticasone-vilanterol)." GlaxoSmithKline (2013):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer