Breo Ellipta Side Effects

Generic Name: fluticasone / vilanterol

Note: This page contains information about the side effects of fluticasone / vilanterol. Some of the dosage forms included on this document may not apply to the brand name Breo Ellipta.

Not all side effects for Breo Ellipta may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to fluticasone / vilanterol: inhalation powder

In addition to its needed effects, some unwanted effects may be caused by fluticasone / vilanterol. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking fluticasone / vilanterol:

More common
  • Body aches or pain
  • chills, fever
  • cough
  • difficulty with breathing
  • ear congestion
  • 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
  • diarrhea
  • dizziness
  • general feeling of discomfort or illness
  • joint or muscle pain
  • loss of appetite
  • nausea or vomiting
  • 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

If any of the following symptoms of overdose occur while taking fluticasone / vilanterol, get emergency help immediately:

Symptoms of overdose
  • Abdominal or stomach pain
  • arm, back, or jaw pain
  • chest discomfort
  • chest tightness or heaviness
  • confusion
  • convulsions
  • decreased urine
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fruit-like breath odor
  • general feeling of discomfort or illness
  • increased hunger or thirst
  • increased urination
  • loss of appetite
  • muscle cramps
  • numbness or tingling in the hands, feet, or lips
  • rapid, deep breathing
  • restlessness
  • shakiness in the legs, arms, hands, or feet
  • stomach cramps
  • unexplained weight loss

Some of the side effects that can occur with fluticasone / vilanterol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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.

Cardiovascular

Common (1% to 10%): Hypertension, peripheral edema[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Other

Common (1% to 10%): Influenza, pyrexia[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[Ref]

References

1. "Product Information. Breo Ellipta (fluticasone-vilanterol)." GlaxoSmithKline, Research Triangle Park, NC.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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