What to Know About Symbicort (Budesonide and Formoterol)

Combination Inhaler Used to Treat Asthma and Improve COPD

Symbicort is a combination inhaler used for the treatment of asthma and to maintain airflow in people with chronic obstructive pulmonary disease (COPD). It contains an inhaled corticosteroid called budesonide that helps alleviate airway inflammation and a long-acting bronchodilator called formoterol fumarate dihydrate that helps keep airways open.

Woman taking asthma inhaler while standing outside
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Symbicort is not used as a rescue inhaler but instead provides long-term control of obstructive airway diseases like asthma and COPD. While safe, convenient, and effective, Symbicort is not appropriate for everyone.

The first Symbicort generic, simply referred to as budesonide/formoterol inhaler, was approved by the U.S. Food and Drug Administration (FDA) in February 2020 and is sold roughly half the price of Symbicort.

Uses

Symbicort is approved for use in adults and children 6 years of age and over.

Symbicort was first approved by the FDA for the treatment of asthma in 2006; it was licensed for the treatment of COPD in 2009. The combination medication is used to provide long-term control of persistent asthma symptoms and to maintain airflow in people in people with COPD, including those with chronic bronchitis or emphysema.

Each of the drugs contained in Symbicort has a distinct effect on the airways:

  • Budesonide, also found in the single-ingredient inhaler Pulmicort, is a corticosteroid (steroid) drug that tempers the overactive immune response that drives inflammation. Corticosteroids are synthetic drugs that mimic the natural hormone cortisol produced by the adrenal glands.
  • Formoterol is a long-acting beta-agonist (LABA) that relaxes the smooth muscles of the airways so that they dilate and remain open.

These effects are beneficial to people with reversible obstructive airways diseases, reducing the hyperresponsiveness that triggers airway spasms and alleviating bronchoconstriction that impedes airflow out of the lungs.

Asthma is considered a reversible obstructive disorder because symptoms can be alleviated and breathing normalized with little long-term harm to the airways.

COPD is only partially reversible in that airway damage tends to progress even with treatment. Even so, combination inhalers like Symbicort can slow the disease progression even in those with advanced disease.

Off-Label Uses

On rare occasions, doctors have been known to prescribe combination inhalers like Symbicort to treat severe or recurrent bronchitis unrelated to COPD.

This practice is not only unadvised but is extremely harmful. Because inhaled corticosteroids suppress the immune system, they can prolong respiratory infections or allow secondary infections to develop, increasing the risk of pneumonia.

Before Use

Symbicort is typically prescribed when more conservative therapies fail to provide relief of asthma or COPD. The indications for each disease are different.

With asthma, the inadequate control of asthma symptoms is the main factor doctors will consider. Generally speaking, if you use a rescue inhaler more than twice weekly, your asthma is poorly controlled. In such instances, a daily inhaled corticosteroid may be prescribed on its own, after which a LABA may be added if needed. LABAs are never used on their own with asthma.

Many health authorities, including the Global Initiative for Asthma (GINA), are now recommending the combined use of inhaled corticosteroids and LABAs from the start rather than taking a stepped approach to asthma treatment.

With COPD, the indications are slightly different. According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD), the combined use of an inhaled corticosteroid and LABA are reserved for people with severe COPD (defined as two or more exacerbations or one or more hospitalizations per year). Inhaled corticosteroids are rarely if ever used on their own with COPD.

While pulmonary function tests may be ordered to evaluate lung function, it is the frequency of exacerbations (a.k.a. "attacks") that will ultimately determine if Symbicort is the appropriate choice for you.

Precautions and Considerations

Symbicort should never be used in anyone with a known or suspected allergy to budesonide or formoterol.

Because cross-allergy between corticosteroids is common, Symbicort should be prescribed with caution if you've ever had an allergic reaction to other inhaled steroids like:

Caution should also be used in people with certain pre-existing health conditions. The long-term use of corticosteroids can affect the eyes, reduce bone mineral, and impair the function of the adrenal gland. The benefits and risks of treatment should be weighed before Symbicort is used in people with:

Symbicort is not contraindicated for use with these conditions, but it can make them worse. See your doctor regularly to monitor for progression of these pre-existing diseases if you use Symbicort.

Any child who has not been vaccinated for or previously exposed to measles or chickenpox should be vaccinated prior to the start of treatment. Because of its immunosuppressive effects, Symbicort can make these childhood infections worse and, in some cases, fatal. If a non-immunized child is exposed to measles or chickenpox while on Symbicort, let your doctor know.

Symbicort may also not be appropriate if you have a severe pre-existing infection that has not been resolved, including tuberculosis, shingles, and other serious bacterial, fungal, viral, or parasitic infections. Because of Symbicort's immunosuppressive effect, its use may need to be delayed until the infection is fully treated.

Symbicort is a Pregnancy Category C drug, meaning that the benefits of treatment may outweigh the risks in some cases. Category C drugs are those in which animal studies suggest a potential risk of fetal harm but no well-controlled human studies are available.

If you a pregnant, planning to get pregnant, or breastfeeding, speak with your doctor before using Symbicort to fully understand the benefits and risks of treatment for you.

Dosage

Symbicort is available as a metered-dose inhaler (MDI), a type of inhaler that uses an aerosolized propellent to deliver the medication deep into your lungs.

It comes in two different strengths:

  • 80 micrograms (mcg) budesonide and 4.5 mcg formoterol, offering 60 inhalations per canister
  • 160 mcg budesonide and 4.5 mcg formoterol, offering 120 inhalations per canister

The recommended dosage varies by age, disease type, and disease severity. In some cases, a lower starting dose may be recommended and only increased if control is not achieved. The maximum daily dose should never be exceeded.

Recommended Dosage Symbicort
Use For Age Dose
Asthma 6 to 11 years 2 inhalations of 80/4.5 mcg every 12 hours
Asthma 12 years and over 2 inhalations of either 80/4.5 mcg or 160/4.5 mcg every 12 hours
COPD Adults 2 inhalations of 160/4.5 mcg every 12 hours

Symbicort can provide relief within 15 minutes, but the full benefits of the drug may not be felt until after two weeks or more of uninterrupted use.

Call your doctor if you have no improvement in your condition after one week of use, have worsening symptoms, need to use a rescue inhaler two or more days in a row, or your peak flow meter results worsen.

Symbicort is not intended for permanent use in all people. Once symptom control is achieved, treatment may be stepped down to a low- or medium-dose inhaled corticosteroid, if appropriate.

How to Take and Store

People who have had asthma for some time are generally familiar with MDIs like Symbicort. The devices are relatively easy to use but do require hand/breath coordination to ensure the right amount of medication gets into the lungs.

Symbicort MDI inhaler is used as follows:

  1. If using the inhaler for the first time (or you have not used it for more than seven days), you will need to prime the device by shaking it for five seconds and releasing a test spray. Do this twice. If the inhaler has been used in the past seven days, shake for five seconds and skip the test sprays.
  2. Remove the mouthpiece cover. Attach a spacer if desired.
  3. Exhale fully to empty the lungs.
  4. Holding the canister upright, place the mouthpiece (or spacer) into your mouth, and close your lips to create a tight seal.
  5. As you compress the trigger, inhale forcefully and deeply through the mouth only. (Some people pinch their nostrils or use a nose clip to avoid nose breathing.)
  6. Hold your breath for 10 seconds.
  7. Exhale slowly.
  8. Shake the canister again for five seconds, and repeat steps 3 to 7.
  9. When finished, replace the mouthpiece cover.
  10. Rinse your mouth thoroughly with water and spit. Do not swallow the water.

With every compression of the inhaler, the built-in counter will tell you how many doses are left. Be sure to refill your prescription when the counter approaches 20.

You will need to clean your inhaler every seven days by wiping the inside and outside of the mouthpiece with a tissue or clean, dry cloth. Do not take the inhaler apart or submerge it in water. (You can detach and wash the spacer with water and soap, but be sure to dry it completely before use.)

Symbicort MDI inhalers can be stored at room temperature, ideally between 68 and 77 degrees F. Store the inhaler with the mouthpiece down. Do not puncture the canister or place it near a heat source as this can cause bursting.

Never use an inhaler past its expiration date. Keep it out of the reach of children and pets.

Side Effects

As with any drug, Symbicort may cause side effects. If they occur, they tend to be mild and will generally improve as your body adapts to treatment. If symptoms persist or worsen, let your doctor know.

Common

The side effects for both Symbicort formulations are similar, although people tend to have more gastrointestinal side effects with the higher-dose formulation. It is for this reason that the lowest possible dose should be used whenever possible.

The frequency of symptoms, however, varies between Symbicort 80/4.5-mcg inhaler and Symbicort 160/4.5-mcg inhaler.

Among the side effects affecting at least 1% of Symbicort users, in order of frequency of occurrence:

Symbicort 80/4.5 mcg
  • Common cold (10.5%)

  • Upper respiratory infection (7.6%)

  • Headache (6.5%)

  • Sore throat (6.1%)

  • Sinus infection (5.8%)

  • Influenza (3.2%)

  • Back pain (3.2%)

  • Stuffy nose (2.5%)

  • Vomiting (1.4%)

  • Oral thrush (1.4%)

  • Stomach ache (1.1%)

Symbicort 160/4.5 mcg
  • Headache (11.3%)

  • Upper respiratory infection (10.5%)

  • Common cold (9.7%)

  • Sore throat (8.9%)

  • Stomach ache (6.5%)

  • Sinus infection (4.8%)

  • Vomiting (3.2%)

  • Oral thrush (3.2%)

  • Stuffy nose (3.2%)

  • Influenza (2.4%)

  • Back pain (1.6%)

One of the most common symptoms of inhaled corticosteroid use is oral candidiasis (thrush). Rinsing your mouth thoroughly after each treatment and using a spacer can go a long way toward avoiding this common fungal infection.

Severe

People with asthma who use inhaled corticosteroids are at an increased risk of pneumonia due to the drug's immunosuppressive effects. If you develop pneumonia or a severe lower respiratory infection, Symbicort may need to be temporarily stopped to avoid the worsening of symptoms.

People with COPD who use inhaled corticosteroids are also at an increased risk of pneumonia. But, interestingly, budenoside appears to be the one steroid that does not increase the risk in these individuals.

On rare occasions, Symbicort can cause a reaction known as paradoxical bronchospasm in which respiratory symptoms worsen rather than improve after use. Although this is more common with rescue inhalers than with LABA-containing inhalers, it can still occur.

Equally rare is a potentially life-threatening allergy known as anaphylaxis in which exposure to budesonide or formoterol can trigger a severe whole-body reaction. If left untreated, anaphylaxis can lead to shock, coma, cardiac or respiratory failure, and death.

If used in people with pre-existing adrenal insufficiency, Symbicort may further suppress cortisol production to the point where it causes an adrenal crisis. This can lead to shock and death, particularly in young children.

All of the conditions should be treated as a medical emergency.

When to Seek Emergency Care
Signs and Symptoms May Indicate
High fever, chills, extreme fatigue, shortness of breath, shallow breathing, bloody or greenish phlegm, and sharp chest pains while inhaling or coughing Pneumonia
Wheezing, shortness of breath, coughing, and chest pain after using an asthma inhaler Paradoxical bronchospasm
Rash or hives, shortness of breath, wheezing, rapid heart rate, flushing, dizziness, confusion, clammy skin, swelling of the face or tongue, and a "feeling of impending doom" Anaphylaxis
Abdominal or flank pain, dizziness, fatigue, high fever, nausea, vomiting, confusion, profuse sweating, rapid heart rate, and rapid breathing Adrenal crisis

Warnings and Interactions

Combination corticosteroid/LABA inhalers have long carried a black box warning advising consumers that this class of drug may increase the risk of asthma-related death. The warning was based on a single, 28-week trial in 2006 in which a related LABA, called salmeterol, caused 13 deaths out of 13,179 users.

Subsequent research has shown that, while single-ingredient LABAs still pose a risk, combination inhalers like Symbicort pose no such harm (mainly because the LABA dose is so low). In 2017, the FDA finally approved the removal of the black box warning on all combination steroid/LABA inhalers.

Taking higher doses of Symbicort will not improve your asthma or COPD symptoms. Doing so may lead to tremors, shakiness, chest pain, fast or irregular heartbeat, nausea, vomiting, and seizures. Severe overdoses may require hospitalization with cardiac monitoring and intravenous beta-blocker drugs to counteract the effects of the LABA.

Do not take a beta-blocker if you experience signs of overdose. The treatment needs to be medically supervised, and some beta-blockers can trigger an asthma attack if used inappropriately.

Concerning Combinations

Symbicort can interact with certain drugs that use the same liver enzyme, cytochrome P450 (CYP450), for metabolization. The competition for CYP450 can cause adverse changes in the blood concentration of one or both drugs.

Among the drugs of greatest concern are those that strongly inhibit CYP450, including:

  • Azole-class antifungals like Nizoral (ketoconazole) and Sporanox (itraconazole)
  • HIV protease inhibitor drugs like Norvir (ritonavir), Kaletra (ritonavir/lopinavir), Reyataz (atazanavir), Crixivan (indinavir), and Invirase (saquinavir)
  • Macrolide antibiotics like clarithromycin and Zithromax (azithromycin)
  • Ketolide antibiotics like Ketek (telithromycin)
  • Serzone (nefazodone), a type of antidepressant

Other drugs can cause adverse effects and should be used with extreme caution, including:

  • Beta-blockers, including beta-blocker eye drops, may cause bronchospasms in some people with asthma who use Symbicort
  • Diuretics ("water pills") may cause cardiac irregularities and hypokalemia when used with Symbicort.
  • Monoamine oxidase inhibitor (MAOI) antidepressants can trigger cardiac symptoms when used with Symbicort.

In some cases, change in dosage or separation of doses by one or several hours may be all that is needed to mitigate the interactions. In other cases, a drug substitution may be needed.

To avoid interactions, let your doctor know about all of the drugs you take, including prescription, over-the-counter, herbal, or recreational drugs.

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  1. U.S. Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations. March 20, 2020.

  2. AstraZeneca. Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use. Updated January 2017.

  3. Rogliani P, Ora J, Puxeddu E, Cazzola M. Airflow obstruction: is it asthma or is it COPD?. Int J Chron Obstruct Pulmon Dis. 2016;11:3007-13. doi:10.2147/COPD.S54927

  4. Tashkin DP, Strange C. Inhaled corticosteroids for chronic obstructive pulmonary disease: what is their role in therapy?. Int J Chron Obstruct Pulmon Dis. 2018;13:2587-601. doi:10.2147/COPD.S172240

  5. Wark P. Bronchitis (acute). BMJ Clin Evid. 2015;2015:1508.

  6. American Lung Association. Assess and monitor your asthma control. Updated April 8, 2020.

  7. Morales DR. LABA monotherapy in asthma: an avoidable problem. Br J Gen Pract. 2013;63(617):627-8. doi:10.3399/bjgp13X675250

  8. Tang W, Sun L, Fizgerald JM. A paradigm shift in the treatment of mild asthma?J Thorac Dis. 2018;10(10):5655-8. doi:10.21037/jtd.2018.09.127

  9. Roth OZ, Ostroff JL. A review of the 2019 GOLD guidelines for COPD. US Pharm. 2019;44(7):HS8-HS16.

  10. Knarborg M, Bendstrup E, Hilberg O. Increasing awareness of corticosteroid hypersensitivity reactions is important. Respirol Case Rep. 2013;1(2):43-5. doi:10.1002/rcr2.13

  11. Yasir M, Goyal A, Bansal P, Sonthalia S. Corticosteroid adverse effects. In: StatPearls. Updated April 13, 2020.

  12. Umaretiya PJ, Swanson JB, Kwon HJ, Grose C, Lohse CM, Juhn YJ. Asthma and risk of breakthrough varicella infection in children. Allergy Asthma Proc. 2016;37(3):207-15. doi:10.2500/aap.2016.37.3951

  13. Qian C, Coulombe J, Suissa S, Ernst P. Pneumonia risk in asthma patients using inhaled corticosteroids: a quasi-cohort study. Br J Clin Pharmol. 2017;83:2077-86. doi:10.1111/bcp.13295

  14. Yang M, Du Y, Chen H, Jiang D, Xu Z. Inhaled corticosteroids and risk of pneumonia in patients with chronic obstructive pulmonary disease: A meta-analysis of randomized controlled trials. Int Immunopharmacol. 2019;77:105950. doi:10.1016/j.intimp.2019.105950

  15. Kalayci O, Abdelateef H, Pozo Beltrán CF, et al. Challenges and choices in the pharmacological treatment of non-severe pediatric asthma: A commentary for the practicing physician. World Allergy Organ J. 2019;12(9):100054. doi:10.1016/j.waojou.2019.100054

  16. Sannarangappa V, Jalleh R. Inhaled corticosteroids and secondary adrenal insufficiencyOpen Respir Med J. 2014;8:93-100. doi:10.2174/1874306401408010093

  17. Hasford J, Virchow JC. Excess mortality in patients with asthma on long-acting beta2-agonists. Eur Respir J. 2006;28(5):900-2. doi:10.1183/09031936.00085606

  18. U.S. Food and Drug Administration. FDA drug safety communication: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS). December 20, 2017.