Symbicort (budesonide and formoterol)
Symbicort (budesonide and formoterol) is a combination inhaler that has an inhaled corticosteroid and a long-acting beta agonist. Long-acting beta agonist is abbreviated LABA. Symbicort is approved for the treatment of asthma for people ages 12 years and older, as well as COPD (chronic obstructive pulmonary disease).1 It is made by AstraZeneca. Symbicort is taken via metered dose inhaler.
Do not take Symbicort if you are having an asthma attack. It does not work quickly enough. Use a rescue inhaler (short-acting beta agonist) instead.
How does Symbicort work?
Symbicort contains two medications. Budesonide is an inhaled corticosteroid.1 This medication reduces inflammation in the airways. Corticosteroids affect many different types of inflammatory cells, including eosinophils and mast cells. They also affect signaling chemicals that have a role in inflammation such as histamine, leukotrienes, and cytokines.
Formoterol is a LABA.1 This medication relaxes the muscles that surround the airways. This helps the airways to open up. Formoterol also prevents mast cells from sending out chemical signals that increase inflammation. This makes the airways less sensitive (“hyperresponsive”).
How is Symbicort taken?
Ask your health care provider or respiratory therapist to show you how to use your inhaler properly.
Symbicort is a red metered dose inhaler.2 It comes in two strengths: 80 mcg and 160 mcg budesonide, combined with 4.5 mcg formoterol. Take two puffs twice per day: once in the morning and once in the evening (Table).2
Before using the inhaler for the first time, you have to prime it.2 To prime the inhaler, shake it for five seconds. Turn the inhaler away from you and press the canister down, releasing one puff into the air. Shake and spray your inhaler one more time. You have to prime it again if you have not used the inhaler for seven days or if you drop it.
Table. Using your Symbicort metered dose inhaler
- Shake the inhaler for 5 seconds.
- Breathe out until your lungs are empty.
- Put the mouthpiece in your mouth and close your lips around it.
- Begin to breathe in deeply and slowly through your mouth. Push the counter down to release a “puff” as you breathe in. (Continue to press down on the counter.)
- After you have inhaled fully, hold your breath for 10 seconds.
- Release your finger from the counter. Breathe out slowly.
- Remove the inhaler from your mouth.
- Shake the inhaler again and repeat steps 2 through 7.
- Rinse your mouth with water and spit out the water. This step will help to prevent thrush, a fungal infection of the mouth.
- Read the Patient Information that comes with your inhaler for complete instructions.
- The inhaler is best used at room temperature.
- You can use a spacer or valved holding chamber with a metered dose inhaler. These devices help the medications to get into your lungs.
Symbicort [patient information]. Wilmington, DE: AstraZeneca; 2013.
What should I do if I miss a dose of Symbicort?
If you miss a dose of Symbicort, just skip that dose.2 Take the next dose at the regular time. Do not take two doses at once.
What are the recommendations for storing, cleaning, and discarding Symbicort?
Symbicort comes in a red plastic inhaler with a separate metal canister containing the medication.1 Do not use the Symbicort inhaler with other medications. Do not use other inhalers with the Symbicort canister.
Once a week, wipe the mouthpiece and outside with a clean dry cloth.2 Do not try to take apart your inhaler or put it in water.
Throw away the canister and inhaler when the counter reads 0. You have used all the medication. Store your Symbicort at room temperature (68˚F and 77˚F).1 Avoid high heat or flames.
What are the risks of taking Symbicort?
One of the medications in the Symbicort inhaler is formoterol, a LABA. In large studies, people who took a different LABA called salmeterol had an increased risk of asthma-related death.1 In these studies, there were 13 deaths out of 13,176 people who took salmeterol, compared with three deaths out of 13,179 people who took a fake medication (placebo). Children and adolescents who take LABAs have a higher risk of hospitalization.
The US Food and Drug Administration says that LABAs should only be used with second medication, such as an inhaled corticosteroid.3 Symbicort contains both a LABA and an inhaled corticosteroid. Trials are underway to study LABAs as part of a combination treatment.4 Currently, it is not known whether taking a LABA with an inhaled corticosteroid decreases the risk of asthma-related death.
What are the possible side effects of taking Symbicort?
Taking Symbicort could cause your airways to tighten suddenly (“bronchospasm”).1 This side effect can happen right after using the inhaler. Take your rescue inhaler and call your health care provider.
Common side effects of Symbicort in people with asthma are colds and flu, sore throat, headache, stuffy nose, sinus inflammation, stomach pain, vomiting, and back pain.2 Using too much formoterol, one of the medications in Symbicort, can cause increased heart rate, high blood pressure, chest pain, headache, tremor, or nervousness.
Inhaled corticosteroids such as budesonide can cause thrush, a fungal infection in your mouth. You can help to prevent this by rinsing your mouth with water after using the inhaler and spitting out the water.
Corticosteroids can lower your immune system, so you are more likely to get an infection. Symptoms of an infection are fever, pain, aches, chills, fatigue, nausea, or vomiting. Avoid contact with people who have chicken pox, measles, or other contagious diseases.
Children who use corticosteroids may grow more slowly.2 Your child’s growth should be checked regularly.
Are there people who should not take Symbicort?
Do not take Symbicort if you are having an asthma attack.2 Symbicort does not work quickly enough. Use a rescue inhaler instead.
People taking another LABA should not take Symbicort.2 If your asthma can be controlled with a low- or medium-dose inhaled corticosteroid alone, you also should not take Symbicort.1
Tell your health care provider if you have had problems with your heart, eyes, immune system, thyroid, or liver.2 You should also tell your provider if you have high blood pressure, seizures, diabetes, or osteoporosis. Let your provider know if you have any infections, including tuberculosis or herpes simplex of the eye. Taking corticosteroids or LABAs may worsen these conditions. Extra monitoring or an alternative treatment may be needed.
Tell your health care provider about any prescription medications you take, particularly LABAs, oral corticosteroids, antifungals, or anti-HIV medications.2 Let your provider know about over-the-counter medications or supplements that you take.
There are no high-quality studies of Symbicort in pregnant or breastfeeding women.2 The National Heart, Lung, and Blood Institute states that budesonide (one ingredient in Symbicort) is the preferred inhaled corticosteroid during pregnancy.5 They cite available studies with reassuring safety data. These guidelines also state that women can breastfeed while taking an inhaled corticosteroid or beta agonist.5 A small percentage of budesonide (0.3% to 1%) does pass into the breastmilk.1 There is very little information about using formoterol during pregnancy.5 The prescribing information for Symbicort suggests talking to your doctor about whether to use this medication during pregnancy or breastfeeding.2
If you are allergic to any ingredient in Symbicort, you should not take this medication.2
What evidence do we have that Symbicort works?
Symbicort has been studied in two high-quality studies.1 These studies included 1,076 adolescents and adults with mild, moderate, and severe asthma. These studies compared Symbicort with budesonide and formoterol alone and with a fake treatment (placebo). The people treated with Symbicort had better lung function, needed less rescue medication, had fewer asthma symptoms and better quality of life, compared with either drug alone or placebo.
Two other studies showed that lung function began to improve within 15 minutes of taking Symbicort. Lung function was at its peak three hours after taking the medication. Improvements lasted for 12 hours.
Is there a generic alternative to Symbicort?
There is no generic alternative to Symbicort. The two medications in Symbicort are available separately.
Budesonide is marketed as Pulmicort. Formoterol is marketed as Foradil. Neither is available in generic inhaler form to treat asthma.
- Symbicort [prescribing information]. Wilmington, DE: AstraZeneca; 2013.
- Symbicort [patient information]. Wilmington, DE: AstraZeneca; 2013.
- US Food and Drug Administration. Drug labels now contain updated recommendations on the appropriate use of long-acting inhaled asthma medications called long-acting beta-agonists. Accessed 2/15/15 at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213836.htm
- US Food and Drug Administration. FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs). Accessed 2/15/15 at: http://www.fda.gov/Drugs/DrugSafety/ucm251512.htm.
- National Heart Lung and Blood Institute. Working group report on managing asthma during pregnancy: Recommendations for pharmacologic treatment. Update 2004. Accessed 1/20/15 at: http://www.nhlbi.nih.gov/files/docs/resources/lung/astpreg_full.pdf