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Overview: Budesonide/formoterol is a spray 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 budesonide/formoterol.

Uses

What is budesonide/formoterol used for?

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

Budesonide/formoterol may also be used for other conditions as determined by your healthcare provider.

How does budesonide/formoterol work (mechanism of action)?

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

How is budesonide/formoterol supplied (dosage forms)?

Brand and other names

  • Breyna
  • Symbicort

Dosage forms and strengths

  • 80 mcg/4.5 mcg inhalation aerosol
  • 160 mcg/4.5 mcg inhalation aerosol

How should I store budesonide/formoterol?

Budesonide/formoterol 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 it with the mouthpiece down. Keep it in a dry place away from sunlight and heat. It may burst if exposed to temperatures over 120 F (49 C).

Side Effects

What are the most common side effects of budesonide/formoterol?

The most common side effects of budesonide/formoterol 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
  • Back pain
  • Infection or swelling in the lungs or sinuses
  • Stomach pain
  • Vomiting
  • Oral thrush (see below)

There may be other side effects of budesonide/formoterol 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 budesonide/formoterol?

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

Severe Allergic Reactions. Budesonide/formoterol may cause allergic reactions, which can be serious. Stop using budesonide/formoterol 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 budesonide/formoterol 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 budesonide/formoterol. 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. Budesonide/formoterol 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 budesonide/formoterol and contact your healthcare provider right away if your breathing gets worse instead of better right after using budesonide/formoterol.

Glaucoma. Budesonide/formoterol 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. Budesonide/formoterol 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. Budesonide/formoterol may increase your blood sugar levels. Talk to your healthcare provider about how to maintain healthy blood sugar levels.

Infection. Budesonide/formoterol 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 budesonide/formoterol 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). Budesonide/formoterol 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. Budesonide/formoterol may cause nervous system effects, including tremor or nervousness. Contact your healthcare provider right away if you develop these symptoms.

Oral Thrush. Budesonide/formoterol 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 budesonide/formoterol. 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, budesonide/formoterol may slow down growth. Keep all appointments for your healthcare provider to monitor growth rate.

Weak Bones. Using budesonide/formoterol 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 budesonide/formoterol.

Warnings & Precautions

Who should not use budesonide/formoterol?

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

  • Symbicort
  • Breyna
  • Budesonide
  • Formoterol
  • Any of the ingredients in the specific product dispensed

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

Sudden COPD or Asthma Symptoms. Unless your healthcare provider tells you to, do not use budesonide/formoterol to treat a sudden worsening of symptoms, such as from an asthma attack or a COPD flare-up. Ask your healthcare provider if you are not sure which medicine to use for quick relief of symptoms. 

What should I know about budesonide/formoterol before using it?

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

Ask your pharmacist or other healthcare provider to show you how to correctly prime, use, and clean budesonide/formoterol. Follow the “Instructions for Use” that comes with your budesonide/formoterol before using it for the first time and whenever you are not sure how to use it. The medicine needs to be primed so you get the correct dose. You also need to shake budesonide/formoterol well before each spray.

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

Keep budesonide/formoterol out of the reach of children.

After using budesonide/formoterol, 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 budesonide/formoterol dose without talking to your healthcare provider first.

What should I tell my healthcare provider before using budesonide/formoterol?

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 budesonide/formoterol 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. Budesonide/formoterol may interact with other medicines and supplements. Before using budesonide/formoterol, 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 budesonide/formoterol 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 budesonide/formoterol while you are pregnant or trying to get pregnant.

Breastfeeding. Budesonide 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 budesonide/formoterol while breastfeeding.

Interactions

Does budesonide/formoterol interact with foods or drinks?

There are no known interactions between budesonide/formoterol and foods or drinks.

It is unknown if drinking alcohol will affect budesonide/formoterol.

Does budesonide/formoterol 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 budesonide/formoterol.

  • 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 beta-blocker eye drop, such as timolol (Timoptic), carteolol (Ocupress), or betaxolol (Betegan), which is a medicine that may be used to lower eye 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
  • 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 budesonide/formoterol. 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 budesonide/formoterol. 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 budesonide/formoterol?

If you or someone else has used too much budesonide/formoterol, 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 budesonide/formoterol?

If you miss a dose, skip the missed dose. Use your next dose when you normally would. Do not use double or extra doses.