Breo Ellipta Side Effects

Generic name: fluticasone / vilanterol

Medically reviewed by Drugs.com. Last updated on Apr 22, 2024.

Note: This document provides detailed information about Breo Ellipta.

Applies to fluticasone / vilanterol: inhalation powder Side Effects associated with fluticasone / vilanterol. Some dosage forms listed on this page may not apply specifically to the brand name Breo Ellipta.

Applies to fluticasone / vilanterol: inhalation powder.

Precautions

If you will be using this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for any unwanted effects. You may need to have your eyes checked at regular visits. Be sure to keep all appointments.

Tell your doctor what other medicines you are using for your asthma or COPD. Follow your doctor's instructions on how you should take these medicine.

This medicine should not be used if you are having an asthma or COPD attack, or if symptoms of an asthma or COPD attack has already started. Your doctor will prescribe another medicine for you to use in case of an acute attack. If the other medicine does not work as well, tell your doctor right away.

This medicine may increase the chance of asthma-related problems. Be sure to read about these risks in the patient information leaflet and talk to your doctor or pharmacist about any questions or concerns that you have.

This medicine may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma. Talk to your doctor if you have concerns about this.

Talk with your doctor or get medical care right away if:

• Your symptoms do not improve after using this medicine for 1 week or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (eg, you use 1 whole canister of the short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of the short-acting inhaler for 2 or more days in a row).
• You have a significant decrease in your peak flow when measured as directed by your doctor.

This medicine should not be used together with similar inhaled medicines such as arformoterol (Brovana®), budesonide/formoterol (Symbicort®), formoterol (Foradil®, Perforomist®), indacaterol (Onbrez®), or salmeterol (Serevent®).

This medicine may weaken your immune system and increase your risk for infection. Tell your doctor about any immune system problems or infections, including herpes in your eye or tuberculosis. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat, or pain when eating or swallowing.

This medicine may increase your risk of having pneumonia. Check with your doctor right away if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or increased breathing problems.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, lightheadedness, dizziness, or fainting, loss of appetite, mental depression, muscle pain or weakness, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Your doctor may want you to carry a medical identification (ID) card stating that you are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.

This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, or shortness of breath after using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine

This medicine may increase your risk for heart and blood vessel problems, including changes in heart rhythm. Check with your doctor right away if you have dizziness, fainting spells, severe tiredness, chest pain, trouble with breathing, sudden or severe headache, or fast or irregular heartbeat.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may affect blood sugar and potassium levels. If you have heart disease or are diabetic and notice a change in the results of your blood or urine sugar or potassium tests, check with your doctor.

This medicine may cause a slowed growth in children. Talk with your doctor if you have any concerns about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

For healthcare professionals

Applies to fluticasone / vilanterol: inhalation powder.

General adverse events

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

See also:

Frequently asked questions

• Can asthma inhalers cause a sore throat?
• Trelegy vs. Breo: How does their use and cost compare?

Further information

Breo Ellipta side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer