Learn about the common and serious side effects of Fluticasone/Vilanterol (Breo Ellipta), how to manage them, and when to contact your doctor right away.
Every medication has side effects, and Fluticasone/Vilanterol (brand name Breo Ellipta) is no exception. The good news? Most people tolerate this inhaler well, and serious side effects are uncommon. Still, it helps to know what's normal and what's not.
This guide covers the most common side effects, the serious ones to watch for, and practical tips for managing them.
Fluticasone/Vilanterol is a combination inhaler used once daily to treat asthma and COPD (chronic obstructive pulmonary disease). It contains two active ingredients:
If you want a deeper dive, check out our guide on what Fluticasone/Vilanterol is and how it's used.
These side effects happen relatively often and are usually mild. They tend to improve as your body adjusts to the medication.
The most frequently reported side effects include nasopharyngitis (cold-like symptoms), upper respiratory tract infections, and sinusitis. You might notice a runny nose, sore throat, or congestion. These are usually mild and manageable with over-the-counter remedies.
Headaches are common, especially in the first few weeks. They typically go away on their own. Over-the-counter pain relievers like acetaminophen or ibuprofen can help.
The corticosteroid component can promote yeast growth in your mouth, leading to white patches on the tongue or inside the cheeks. This is one of the most preventable side effects — rinse your mouth with water and spit it out after every use. Don't swallow the rinse water.
Some people notice their voice becomes raspy or hoarse. This happens because the corticosteroid can irritate the vocal cords. Rinsing your mouth after use helps with this, too.
Ironically, an inhaler meant to help your breathing can sometimes cause a brief cough right after you use it. This is usually harmless and goes away quickly.
Back pain has been reported in clinical trials. It's not entirely clear why, but it's generally mild.
These are less common but require medical attention. Contact your doctor promptly if you experience any of the following.
This is particularly important for COPD patients. Inhaled corticosteroids can increase the risk of pneumonia. Watch for symptoms like fever, chills, increased mucus production, change in mucus color, increased cough, or worsening breathing. If you develop these symptoms, see your doctor right away.
In rare cases, your airways may tighten immediately after using the inhaler instead of opening up. If you suddenly have trouble breathing right after a dose, stop using the inhaler and use your rescue inhaler. Call your doctor as soon as possible.
Vilanterol, the bronchodilator in Breo Ellipta, can affect your heart. Possible effects include increased heart rate, palpitations, or changes in blood pressure. People with existing heart conditions should be monitored closely. Tell your doctor if you feel your heart racing or pounding.
Long-term use of inhaled corticosteroids can affect your adrenal glands, which produce important hormones. Symptoms of adrenal suppression include extreme tiredness, weakness, nausea, and dizziness. This is more of a concern with high doses or prolonged use.
Inhaled corticosteroids may reduce bone mineral density over time, potentially increasing the risk of fractures. This is a long-term concern, not something you'd notice day to day. Your doctor may recommend calcium and vitamin D supplements or periodic bone density scans.
Long-term corticosteroid use can increase the risk of glaucoma and cataracts. Report any changes in vision, eye pain, or blurred vision to your doctor.
Because corticosteroids reduce inflammation by dampening the immune response, you may be more susceptible to infections. Avoid close contact with people who have chicken pox or measles if you haven't had them or been vaccinated.
Some patients experience hyperglycemia (high blood sugar) or hypokalemia (low potassium). If you have diabetes, monitor your blood sugar closely when starting this medication.
Fluticasone/Vilanterol carries an FDA black box warning — the most serious type of warning. Long-acting beta2-agonists (LABAs) like vilanterol may increase the risk of asthma-related death. This is why Breo Ellipta should only be used for asthma in patients who aren't adequately controlled on an inhaled corticosteroid alone. This warning does not apply to COPD patients.
This doesn't mean the medication is dangerous for most people — it means it should be prescribed carefully and used as directed.
Older adults may be more susceptible to bone density loss, cataracts, and glaucoma from the corticosteroid component. COPD patients over 65 should be particularly aware of the increased pneumonia risk.
Fluticasone/Vilanterol is Pregnancy Category C, meaning it should only be used if the potential benefit justifies the potential risk. Talk to your doctor about the safest options if you're pregnant, planning to become pregnant, or breastfeeding.
Breo Ellipta contains lactose, which includes trace amounts of milk proteins. If you have a severe allergy to milk proteins, you should not use this inhaler. A mild lactose intolerance (digestive) is generally not a problem.
Here are practical steps to minimize problems:
You should also be aware of drug interactions that could increase side effects, especially if you take strong CYP3A4 inhibitors or other beta-agonists.
Most people do well on Fluticasone/Vilanterol. The common side effects — cold symptoms, headaches, mild throat irritation — are manageable and often temporary. The serious side effects are uncommon but important to know about.
The key is to use the inhaler as prescribed, rinse your mouth after every dose, and stay in touch with your doctor. If you're concerned about cost affecting your ability to stay on the medication, check out ways to save on Fluticasone/Vilanterol. And if you need help finding it at a pharmacy near you, Medfinder can help.
You focus on staying healthy. We'll handle the rest.
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