9 mins read

Overview: Fluticasone/vilanterol is a powder that you inhale to help manage breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD). It reduces inflammation and relaxes the muscles around your airways to make it easier to breathe. Common side effects include sore throat or common cold symptoms. Notify your healthcare provider right away if your breathing gets worse instead of better after using fluticasone/vilanterol.

Uses

What is fluticasone/vilanterol used for?

Fluticasone/vilanterol is commonly used as a controller (maintenance) inhaler for the following conditions. 

Fluticasone/vilanterol may also be used for other conditions as determined by your healthcare provider.

How does fluticasone/vilanterol work (mechanism of action)?

People with asthma or COPD have chronic and ongoing airflow problems in the lungs. Fluticasone/vilanterol contains two medicines. Fluticasone reduces swelling or inflammation in the lungs. Vilanterol relaxes the muscles around the airways. This can help to make it easier to breathe.

How is fluticasone/vilanterol supplied (dosage forms)?

Brand and other names

  • Breo

Dosage forms and strengths

  • 50 mcg/25 mcg inhalation powder (Ellipta inhaler)
  • 100 mcg/25 mcg inhalation powder (Ellipta inhaler)
  • 200 mcg/25 mcg inhalation powder (Ellipta inhaler)

How should I store fluticasone/vilanterol?

Fluticasone/vilanterol should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Keep fluticasone/vilanterol in its unopened foil tray until you are ready to use it. Once the foil tray has been opened, fluticasone/vilanterol is only good for six weeks. If the inhaler is not empty after six weeks, it should be thrown out and replaced.

 

Side Effects

What are the most common side effects of fluticasone/vilanterol?

The most common side effects of fluticasone/vilanterol are listed below. These side effects may vary depending on the condition that is being treated. Tell your healthcare provider if you have any of these side effects that bother you.

  • Infection in the nose or throat, flu, or common cold symptoms
  • Sore throat or mouth pain 
  • Headache
  • Oral thrush (see below)
  • Back pain
  • Infection or swelling in the lungs or sinuses
  • Cough
  • Joint pain
  • High blood pressure
  • Fever
  • Hoarseness

There may be other side effects of fluticasone/vilanterol that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of fluticasone/vilanterol?

While less common, the most serious side effects of fluticasone/vilanterol are described below, along with what to do if they happen.

Severe Allergic Reactions. Fluticasone/vilanterol may cause allergic reactions, which can be serious. Stop using fluticasone/vilanterol and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Reduced Adrenal Function. Long-term use of fluticasone/vilanterol can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone). This is known as adrenal insufficiency. This is especially a concern if you have been taking a corticosteroid by mouth, such as prednisone, and you stop it and switch to fluticasone/vilanterol. Adrenal insufficiency can get worse if your body is under stress because of fever, surgery, or trauma. Tell your healthcare provider if you have any of the following symptoms of adrenal insufficiency.

  • Nausea and vomiting
  • Weakness, tiredness, or lack of energy
  • Low blood pressure

Sudden Breathing Problems. Fluticasone/vilanterol may cause the muscles around your airways to tighten (bronchospasm) right after you use it, instead of relaxing these muscles. In some cases, this can be serious. Stop using fluticasone/vilanterol and contact your healthcare provider right away if your breathing gets worse instead of better right after using fluticasone/vilanterol.

Glaucoma. Fluticasone/vilanterol may increase pressure inside the eye and cause or worsen narrow-angle glaucoma, which can lead to blindness. Tell your healthcare provider right away if you have any of the following symptoms of glaucoma.

  • Loss of vision
  • Eye pain or redness
  • Severe headache or vomiting
  • Seeing bright, colorful circles around lights (vision halos)

Heart Effects. Fluticasone/vilanterol may increase your risk of certain effects on the heart, such as raising your heart rate, blood pressure, or causing an abnormal heart rhythm (arrhythmia). If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Also call your healthcare provider or get medical attention right away if you have chest pain, a fast or irregular heartbeat, or if you feel your heartbeat more than usual.

Increased Blood Sugar. Fluticasone/vilanterol may increase your blood sugar levels. Talk to your healthcare provider about how to maintain healthy blood sugar levels.

Infection. Fluticasone/vilanterol can increase the risk of infections, including serious infections. Call your healthcare provider right away if you have an infection or any of the following symptoms.

  • Cough or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss

Pneumonia. Pneumonia is an infection of the lungs that can make it hard to breathe. Some people with COPD who use fluticasone/vilanterol have developed pneumonia. Contact your healthcare provider right away if you have any of the following symptoms of pneumonia. 

  • Trouble breathing
  • Increased mucus or change in mucus color
  • Worsening cough
  • Fever or chills

Low Potassium Level (Hypokalemia). Fluticasone/vilanterol can cause a low potassium level, which can be serious and may lead to death. Your healthcare provider may check your potassium levels, especially if you take certain other medicines. Keep all appointments to have your blood checked. Call your healthcare provider if you have any of the following symptoms of a low potassium level.

  • Weakness
  • Unusual tiredness
  • Muscle cramps or twitching
  • Constipation

Nervous System Effects. Fluticasone/vilanterol may cause nervous system effects, including tremor or nervousness. Contact your healthcare provider right away if you develop these symptoms.

Oral Thrush. Fluticasone/vilanterol can cause a fungal infection in your mouth and throat, a condition known as oral thrush or oral candidiasis. To help prevent thrush, rinse your mouth with water and spit out the water (do not swallow it) after each dose of fluticasone/vilanterol. Contact your healthcare provider if you notice any of the following symptoms of oral thrush. 

  • Cracking in the corners of the mouth
  • Loss of taste
  • Red or white patches in the mouth or throat
  • Raised white spots in the mouth or throat

Slow Growth. In people who are still growing, such as children and adolescents, fluticasone/vilanterol may slow down growth. Keep all appointments with your healthcare provider to monitor growth rate.

Weak Bones. Using fluticasone/vilanterol for a long time may cause the bones to become weaker, leading to reduced bone density (osteopenia). It may also cause a more serious condition called osteoporosis, which can cause bones to break (or fracture) more easily. Your healthcare provider may monitor your bone density while you are using fluticasone/vilanterol. 

Warnings & Precautions

Who should not use fluticasone/vilanterol?

Allergies to Ingredients. People who are allergic to any of the following should not use fluticasone/vilanterol.

  • Breo Ellipta
  • Fluticasone
  • Vilanterol
  • Milk proteins
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific fluticasone/vilanterol products they stock.

Sudden COPD or Asthma Symptoms. If you are currently having a sudden worsening of symptoms, such as from an asthma attack or a COPD flare-up, you should not use fluticasone/vilanterol to treat these symptoms. Fluticasone/vilanterol should be used daily to prevent and manage symptoms. Do not use it as a quick-relief (rescue) inhaler.

What should I know about fluticasone/vilanterol before using it?

Do not use fluticasone/vilanterol unless it has been prescribed to you by a healthcare provider. Use it as prescribed. Using fluticasone/vilanterol more often than prescribed may increase the risk of serious side effects.

Ask your pharmacist or other healthcare provider to show you how to correctly use and clean fluticasone/vilanterol. Follow the “Instructions for Use” that comes with your fluticasone/vilanterol before using it for the first time or whenever you are not sure how to use it.

Do not share fluticasone/vilanterol with other people, even if they have the same condition as you. It may harm them.

Keep fluticasone/vilanterol out of the reach of children.

Fluticasone/vilanterol is a medicine used daily to prevent symptoms. Do not use it when a quick response to breathing problems is needed. Other inhaled medicines, sometimes called quick-relief (or rescue) inhalers, should be used to treat sudden symptoms. Get medical help right away if your breathing does not get better after using a rescue inhaler.

After using fluticasone/vilanterol, rinse your mouth out with water and spit the water out. This helps lower your chance of getting a fungal infection in your mouth or throat, called oral thrush.

Do not stop using or change your fluticasone/vilanterol dose without talking to your healthcare provider first.

Try to use your fluticasone/vilanterol around the same time each day. 

What should I tell my healthcare provider before using fluticasone/vilanterol?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if fluticasone/vilanterol is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Any allergies, including to medicines or foods
  • An infection, a history of immune system problems or severe infections, or if you have been exposed to chickenpox or measles
  • Diabetes or high blood sugar
  • Eye problems, such as glaucoma or cataracts
  • Heart problems, including arrhythmias
  • High blood pressure
  • History of bone conditions, such as osteomalacia, osteopenia, or osteoporosis, or if you are at risk for weak bones, such as if you use tobacco or are inactive for a long period of time
  • Liver problems
  • Seizures
  • Thyroid problems

Other Medicines and Supplements. Fluticasone/vilanterol may interact with other medicines and supplements. Before using fluticasone/vilanterol, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how fluticasone/vilanterol could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should use fluticasone/vilanterol while you are pregnant or trying to get pregnant.

Breastfeeding. It is not known if fluticasone/vilanterol passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use fluticasone/vilanterol while breastfeeding.

Interactions

Does fluticasone/vilanterol interact with foods or drinks?

There are no known interactions between fluticasone/vilanterol and foods or drinks.

It is unknown if drinking alcohol will affect fluticasone/vilanterol.

Does fluticasone/vilanterol interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using fluticasone/vilanterol.

  • A beta-blocker, such as metoprolol (Lopressor), atenolol (Tenormin), or propranolol (Inderal LA), which is a medicine that may be used for certain heart conditions or to reduce blood pressure
  • A diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure
  • A long-acting beta-2 agonist (LABA), such as salmeterol (Serevent), formoterol (Perforomist), arformoterol (Brovana), or olodaterol (Striverdi), which is an inhaled medicine used for asthma or COPD
  • A medicine for HIV or AIDS
  • A monoamine oxidase inhibitor (MAOI) within the past two weeks, which is a medicine usually used for depression or Parkinson’s disease
  • A tricyclic antidepressant within the past two weeks, such as amitriptyline, nortriptyline, or protriptyline, even if it is not used for depression
  • Medicines within the past two weeks that can cause QT prolongation, which is a dangerous heart rhythm problem
  • Ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections

Some other medicines may alter the blood levels of fluticasone/vilanterol. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with fluticasone/vilanterol. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much fluticasone/vilanterol?

If you or someone else has used too much fluticasone/vilanterol, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of fluticasone/vilanterol?

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only use it when your next dose is due. Do not use double or extra doses.