Breo Ellipta Side Effects

Generic Name: fluticasone / vilanterol

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

Some side effects of Breo Ellipta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fluticasone / vilanterol: inhalation powder

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, 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

Get emergency help immediately if any of the following symptoms of overdose occur while taking fluticasone / vilanterol:

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 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.

Cardiovascular

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

Gastrointestinal

Common (1% to 10%): Diarrhea

Musculoskeletal

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

Nervous system

Common (1% to 10%): Headache

Other

Common (1% to 10%): Influenza, pyrexia

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, oropharyngeal candidiasis, chronic obstructive pulmonary disease (COPD), pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, pharyngitis

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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