Understanding Breo Ellipta Side Effects

Every medication comes with potential side effects, and Breo Ellipta (fluticasone furoate/vilanterol) is no exception. The good news is that most people tolerate it well, and the most common side effects are mild. But there are some serious reactions you should know about before starting treatment.

This guide covers exactly what to expect, how to manage common issues, and when you need to call your doctor right away.

What Is Breo Ellipta?

Breo Ellipta is a once-daily inhaler that combines two medications: fluticasone furoate (an inhaled corticosteroid that reduces airway inflammation) and vilanterol (a long-acting beta-agonist that relaxes airway muscles). It's FDA-approved for maintenance treatment of asthma in adults and COPD (chronic obstructive pulmonary disease).

For a deeper look at what this medication is and how it works, see our guides on what Breo is and how Breo works.

Common Side Effects

These side effects are the most frequently reported in clinical trials. They're usually mild and often improve as your body adjusts to the medication:

• Nasopharyngitis (common cold symptoms) — Runny nose, sore throat, and congestion are among the most commonly reported effects.
• Headache — Typically mild and resolves on its own. Over-the-counter pain relievers can help.
• Oral candidiasis (thrush) — A fungal infection in the mouth caused by the corticosteroid component. White patches on the tongue or inside the cheeks are the telltale sign. Rinsing your mouth with water after each use is the single best way to prevent this.
• Upper respiratory tract infection — Symptoms similar to a cold or mild flu.
• Back pain — Reported in clinical trials, usually mild.
• Dysphonia (hoarseness) — The corticosteroid can irritate your vocal cords, making your voice hoarse or raspy. Mouth rinsing helps with this too.
• Sinusitis — Sinus pressure, congestion, or infection.
• Cough — Some people experience a cough right after inhaling the dose. This is usually brief.
• Oropharyngeal pain — Soreness in the throat or mouth area.

Most of these side effects affect fewer than 10% of users and typically don't require stopping the medication.

Serious Side Effects

These are less common but require immediate medical attention:

Boxed Warning: Asthma-Related Death Risk

Breo Ellipta carries an FDA boxed warning — the most serious type of safety warning. Long-acting beta-agonists (LABAs) like vilanterol have been associated with an increased risk of asthma-related death. This risk is considered a class effect of all LABAs. However, when used in combination with an inhaled corticosteroid (as in Breo), the risk appears to be significantly reduced. Breo should only be used for asthma when a patient isn't adequately controlled on an ICS alone.

Pneumonia

Patients with COPD who use inhaled corticosteroids have a higher risk of developing pneumonia. Elderly patients are at even greater risk. Watch for fever, chills, increased mucus production, or worsening breathing — and contact your doctor immediately if these occur.

Other Serious Side Effects

• Paradoxical bronchospasm — Sudden worsening of breathing immediately after using the inhaler. Stop using Breo and seek emergency care if this happens.
• Cardiovascular effects — Increased heart rate, elevated blood pressure, or irregular heartbeat (arrhythmias) from the vilanterol component.
• Adrenal insufficiency — Long-term use of corticosteroids can suppress your adrenal glands. Symptoms include extreme fatigue, weakness, nausea, and low blood pressure.
• Bone density loss — Prolonged inhaled corticosteroid use may reduce bone mineral density, increasing fracture risk.
• Eye problems — Glaucoma (increased eye pressure) and cataracts have been reported with long-term corticosteroid use.
• Immunosuppression — Corticosteroids can lower your immune response, making you more susceptible to infections. Avoid exposure to chickenpox and measles if you haven't had them.
• Hypokalemia and hyperglycemia — The LABA component may lower potassium levels and raise blood sugar, especially at higher doses.

Specific Populations

Certain groups may face additional risks:

• Elderly patients — COPD patients over 65 have a higher risk of pneumonia with inhaled corticosteroids. Bone density monitoring may also be recommended.
• Pregnant or nursing women — Breo is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the risk. Discuss options with your doctor.
• People with cardiovascular disease — Vilanterol can increase heart rate and blood pressure. Use with caution if you have heart disease, arrhythmias, or high blood pressure.
• Patients with diabetes — Monitor blood sugar more closely, as the LABA component can raise glucose levels.
• People with liver problems — Severe hepatic impairment increases systemic exposure to fluticasone. Your doctor may need to monitor you more closely.

How to Manage Common Side Effects

Most side effects from Breo can be minimized with a few simple steps:

1. Rinse your mouth after every use. Swish water around your mouth and spit it out after each inhalation. This significantly reduces your risk of thrush and hoarseness.
2. Use the inhaler at the same time each day. Consistent timing helps your body adjust and ensures steady medication levels.
3. Stay hydrated. Drinking water throughout the day can help with throat irritation and cough.
4. Report persistent symptoms. If a side effect lasts more than a week or two, tell your doctor. They may adjust your dose or switch you to a different medication.
5. Don't stop suddenly. If you need to stop Breo, your doctor will taper you appropriately, especially if you've been using it long-term.

If you experience any serious side effects — difficulty breathing after using the inhaler, chest pain, rapid heartbeat, signs of pneumonia, or severe allergic reaction (rash, swelling, trouble breathing) — seek medical attention immediately.

Final Thoughts

Breo Ellipta is generally well-tolerated, and most side effects are manageable with simple precautions like mouth rinsing. The once-daily dosing is a major convenience advantage over twice-daily alternatives like Advair or Symbicort.

That said, the boxed warning about asthma-related death and the pneumonia risk in COPD patients are important to take seriously. Stay in regular contact with your doctor, report any new or worsening symptoms, and don't skip follow-up appointments.

If cost is affecting whether you can stay on Breo, check out our guide on how to save money on Breo. And if you're having trouble finding it at your pharmacy, search Medfinder to check local availability.