Breztri Aerosphere (budesonide/glycopyrrolate/formoterol) is a brand-name oral inhaler that’s prescribed for COPD. As with other drugs, Breztri Aerosphere can cause side effects, such as upper respiratory infection and back pain.

Breztri Aerosphere is specifically approved by the Food and Drug Administration (FDA) to treat chronic obstructive pulmonary disease (COPD).

This drug is not approved to treat asthma and cannot be used as a rescue inhaler.

Breztri Aerosphere can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Breztri Aerosphere in clinical trials:

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Breztri Aerosphere use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Breztri Aerosphere’s prescribing information.

Mild side effects that have been reported with Breztri Aerosphere include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while using Breztri Aerosphere and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.

Breztri Aerosphere may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Breztri Aerosphere’s prescribing information.

If you develop serious side effects while using Breztri Aerosphere, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

* For more information about this side effect, see “Side effect specifics” below.

Breztri Aerosphere may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Does Breztri Aerosphere inhaler cause weight gain?

No, weight gain was not a side effect reported in Breztri Aerosphere’s clinical trials. However, budesonide, which is a corticosteroid drug in Breztri Aerosphere, can reduce your adrenal function. This may cause weight loss.

Chronic obstructive pulmonary disease (COPD), which Breztri Aerosphere is prescribed to treat, may make it difficult to exercise. In turn, this could lead to weight gain. Additionally, corticosteroid medications, such as budesonide, may sometimes affect your appetite.

If you have questions about weight changes while using Breztri Aerosphere, talk with your doctor or pharmacist.

If I stop using Breztri Aerosphere, will I experience certain side effects?

Breztri Aerosphere is a treatment for COPD. If you stop treating your COPD, your symptoms will likely return. These may include:

If you want to stop using Breztri Aerosphere, talk with your doctor. They can recommend other treatments for your COPD, which can reduce the risk of symptoms returning.

Can Breztri Aerosphere cause shortness of breath?

It’s not likely. In clinical trials, shortness of breath was not a reported side effect of Breztri Aerosphere.

COPD, which this drug is prescribed to treat, causes shortness of breath. Breztri Aerosphere helps make it easier to breathe.

Sometimes, inhaled medications can cause a condition known as paradoxical bronchospasm. This is when the muscles in your airway contract and make it harder to breathe after using your inhaler. See the “Serious side effects” section above for more details.

If you have persistent shortness of breath or bronchospasms after using Breztri Aerosphere, let your doctor know. They may suggest other treatments for your COPD.

Learn more about some of the side effects that Breztri Aerosphere may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Breztri Aerosphere.

High blood sugar

In clinical trials, Breztri Aerosphere caused high blood sugar. This side effect was not common. Symptoms can include:

What you can do

If you notice any of the symptoms listed above while using Breztri Aerosphere, talk with your doctor. They’ll likely order a lab test to check your blood sugar. They’ll let you know whether you should continue using Breztri Aerosphere or switch to a different medication.

Upper respiratory infection

Upper respiratory infections, such as the common cold, were a commonly reported side effect in Breztri Aerosphere’s clinical trials. Symptoms can include:

  • stuffy or runny nose
  • pain in the forehead or cheeks
  • sneezing
  • sore throat
  • cough
  • headache

What you can do

Chronic obstructive pulmonary disease (COPD) can increase the risk of catching a cold. Let your doctor know if you seem to be getting more frequent colds while using Breztri Aerosphere.

To help prevent colds, make sure to wash your hands often. This is especially important after interacting with someone who is sick. If you do develop a cold, rest may help you feel better.

If your symptoms worsen or you aren’t feeling better after 2 weeks, contact your doctor. You may have a bacterial infection, which may need treatment with antibiotics.

Oral thrush

Oral thrush is a fungal infection caused by an overgrowth of yeast in the mouth. Budesonide, one of the active drugs in Breztri Aerosphere, can reduce the activity of your immune system (sometimes referred to as “weakening” the immune system). This effect can increase the risk of oral thrush.

In Breztri Aerosphere’s clinical trials, oral thrush was a commonly reported side effect. Symptoms can include:

  • painful swallowing
  • white patches inside your cheeks or the back of your throat
  • redness, burning, or soreness in your mouth

What you can do

After each use of your Breztri Aerosphere inhaler, rinse your mouth with water and spit it out. Let your doctor know if you have any of the symptoms listed above. They’ll likely prescribe an antifungal medication to treat the oral thrush.

Urinary retention

Urinary retention (inability to fully empty the bladder) was a rare side effect in clinical trials of Breztri Aerosphere. Symptoms can include:

  • pain when urinating
  • difficulty when beginning to urinate
  • more frequent urination without fully emptying the bladder

What you can do

Talk with your doctor if you’re having problems with urination while using Breztri Aerosphere. Over time, this problem may get worse. In some cases, it can lead to a urinary tract infection (UTI).

Changes in heart rate, rhythm, or blood pressure

In clinical trials of Breztri Aerosphere, changes in heart rate and rhythm were reported. However, these side effects were rare. Symptoms can include:

What you can do

Let your doctor know if you have any changes in your heart rate, rhythm, or blood pressure while using Breztri Aerosphere.

Be sure to tell your doctor if you’re taking any medications to manage your heart rate, such as Lopressor (metoprolol) or Coreg CR (carvedilol). Also, let them know if you’ve been diagnosed with any heart rhythm conditions, such as atrial fibrillation.

Allergic reaction

As with most drugs, Breztri Aerosphere can cause an allergic reaction in some people. In clinical trials, this side effect was rare.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep using Breztri Aerosphere. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Be sure to talk with your doctor about your health history before you use Breztri Aerosphere. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Allergic reaction. If you’ve had an allergic reaction to Breztri Aerosphere or any of its ingredients, your doctor will likely not prescribe Breztri Aerosphere. Ask your doctor what other medications may be better options for you.

Asthma. Breztri Aerosphere is not approved to treat asthma and cannot be used as a rescue inhaler. Using Breztri Aerosphere as a rescue inhaler could be dangerous. If you have untreated asthma, talk with your doctor about the best treatment options for this condition. If you also have chronic obstructive pulmonary disease (COPD), your doctor may still prescribe Breztri Aerosphere to treat your condition.

Infection. Budesonide, one of the active drugs in Breztri Aerosphere, can reduce your immune system’s response to infection. While using Breztri Aerosphere, tell your doctor if you develop an infection, such as the common cold, pneumonia, or oral thrush. They will likely recommend that you stop using Breztri Aerosphere until your infection is treated.

Tuberculosis. If you have tuberculosis (TB) or if you’ve had it in the past, let your doctor know. TB is a serious condition that can be life threatening. The infection that causes it can be inactive in your body for years after you’ve had it. Breztri Aerosphere may reduce your immune system activity, which could cause TB to become active again.

Tell your doctor right away if you develop symptoms of TB during treatment with this drug. These symptoms can include a cough that lasts at least 3 weeks or swollen glands. Your doctor will likely recommend that you stop using Breztri Aerosphere until your TB is treated. After treating your TB, they may prescribe this inhaler again. If so, they’ll likely monitor you closely for signs of TB returning.

Herpes in the eye. If you have or have previously had a herpes infection in your eye, tell your doctor. Breztri Aerosphere may reduce the activity of your immune system and reactivate the virus. Tell your doctor right away if you develop an active herpes infection during treatment. They will likely recommend that you stop using Breztri Aerosphere until your infection is treated. They can also recommend certain medications to help prevent herpes virus reactivation.

Eye problems. Breztri Aerosphere can increase your risk of long-term eye problems, such as glaucoma and cataracts. If you already have these conditions, this drug could make these conditions worse. Let your doctor know if you have changes in your vision while using Breztri Aerosphere. They can decide whether this drug is still safe for you.

Decreased bone mineral density. Over time, Breztri Aerosphere may cause osteoporosis (weakening of the bones), which may increase your risk of fractures. If you already have this condition, using this inhaler may further increase the risk of fractures. Other factors that may increase your risk of fractures include:

  • smoking
  • not exercising regularly
  • not eating a balanced diet
  • experiencing postmenopause
  • being age 65 or older
  • taking other medications that can weaken your bones, such as Rayos (prednisone) or Medrol (methylprednisolone)
  • having a family history of osteoporosis

Increased blood pressure and heart rate. Breztri Aerosphere may cause high blood pressure and a rapid heart rate. If you have either of these conditions, using Breztri Aerosphere may make them worse. Talk with your doctor if you have high blood pressure or heart rate problems or if you take medication to treat these conditions. They can advise whether Breztri Aerosphere is safe for you to use.

Overactive thyroid. Hyperthyroidism (an overactive thyroid) can cause your heart rate to increase. If you have an overactive thyroid, Breztri Aerosphere may make this symptom worse. Before you start using Breztri Aerosphere, tell your doctor if you have this thyroid condition. They will monitor your symptoms during treatment. If this side effect becomes serious, they may have you stop using Breztri Aerosphere.

Diabetes. Before you start using Breztri Aerosphere, tell your doctor if you have diabetes. This drug can increase your blood sugar. If you already have diabetes, Breztri Aerosphere could make your condition worse. Due to this risk, your doctor may recommend checking your blood sugar more often during treatment.

Urinary retention. Breztri Aerosphere can make it difficult to empty your bladder. If you have a condition that makes it difficult to urinate, tell your doctor. Breztri Aerosphere may make this condition worse. If you have one of these conditions, your doctor will monitor your symptoms during treatment. If necessary, they may recommend other treatment options for your condition.

Serious liver problems. Budesonide and formoterol, two of the active drugs in Breztri Aerosphere, are broken down by the liver. If you have liver problems, these drugs may build up in your body and increase your risk of side effects, such as nausea or high blood sugar. Your doctor may monitor you more closely for side effects while you use Breztri Aerosphere.

Seizure. If you have a seizure disorder, such as epilepsy, or have previously had a seizure, tell your doctor. Breztri Aerosphere may make this condition more severe. For this reason, your doctor may not prescribe this drug if you have a higher risk of seizures. If they do prescribe Breztri, they’ll likely monitor you closely for signs of worsening seizures.

Decreased adrenal function. Oral corticosteroids, such as Rayos (prednisone), are common long-term treatments for COPD. Over time, taking high doses of corticosteroids can cause an underactive adrenal gland. With this condition, your body doesn’t produce enough cortisol.

If you take corticosteroids for COPD, your doctor will likely stop this treatment when you start using Breztri Aerosphere. However, they may still prescribe corticosteroids with this drug during periods of stress or severe COPD flare-ups. This can reduce the risk of symptoms from decreased adrenal function, such as fatigue or nausea and vomiting.

Serious kidney problems. There are no studies of Breztri Aerosphere’s effects in people with severe kidney problems. However, many medications are filtered by the kidneys. As such, having kidney problems may affect how your body processes this medication. If you have kidney problems or are treating a condition with dialysis, talk with your doctor. They’ll determine if Breztri Aerosphere is safe for your condition.

Alcohol with Breztri Aerosphere

There’s no known interaction between alcohol and Breztri Aerosphere. However, alcohol is broken down by the liver. Budesonide and formoterol, two of the active drugs in Breztri Aerosphere, are also broken down by the liver. Heavy alcohol consumption during treatment with this drug may affect how well the liver can process the alcohol and the drug.

Alcohol and Breztri Aerosphere can also cause similar side effects, such as nausea or dizziness. For this reason, drinking alcohol during your treatment may worsen these side effects.

If you drink alcohol, ask your doctor how much, if any, is safe to drink during treatment with this drug.

Pregnancy and breastfeeding while using Breztri Aerosphere

Breztri Aerosphere contains three active drugs that you inhale: budesonide, formoterol, and glycopyrrolate. In clinical trials, inhaled budesonide during pregnancy was not known to cause fetal harm.

There are no clinical trials of formoterol or glycopyrrolate in human pregnancy. However, inhaled formoterol and glycopyrrolate did not cause fetal harm in animal studies.

Formoterol can relax the uterus. This may lead to complications during labor, such as preventing contractions.

If you’re pregnant or can become pregnant, tell your doctor before starting treatment with Breztri Aerosphere. They can discuss the risks and benefits of using this medication during pregnancy.

Budesonide passes into human breast milk, but it’s unknown if formoterol and glycopyrrolate also do. However, in animal studies, formoterol and glycopyrrolate passed into the milk of lactating animals. It’s not known whether any of these drugs may affect a child who is breastfed.

If you’re breastfeeding or planning to breastfeed, talk with your doctor. They can recommend ways to safely feed your child while using Breztri Aerosphere.

Breztri Aerosphere, like other medications, can cause side effects. Most are mild and will go away over time. However, some are serious and require medical attention. If you’d like to learn more about Breztri Aerosphere, talk with your doctor or pharmacist. They can help answer any questions you have about side effects during treatment.

Besides talking with your doctor, you can do some research on your own. These articles might help:

  • More information about Breztri Aerosphere. For details about other aspects of Breztri Aerosphere, refer to this article.
  • Cost. If you’d like to learn about Breztri Aerosphere and cost, see this article.
  • Drug comparisons. Learn how Breztri Aerosphere compares with Symbicort and Trelegy Ellipta.
  • Dosage. For information about the dosage of Breztri Aerosphere, view this article.
  • A look at chronic obstructive pulmonary disease (COPD). For details about COPD, see our COPD hub.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.