Symbicort (generic: budesonide/formoterol) is a prescription medication used to prevent breathing difficulties, wheezing, and shortness of breath in people with chronic obstructive pulmonary disease (COPD) and asthma. Symbicort contains 2 medications, budesonide, a steroid that decreases inflammation, and formoterol, which belongs to a group of drugs called beta agonists. Beta agonists, like formoterol, work by relaxing smooth muscle of the airways in the lungs, making it easier to breathe.
This medication comes in the form of an inhaler. It is taken every day as 2 puffs into the lungs, twice daily.
Common side effects of Symbicort include throat irritation and pain, headache, and thrush infection.
Symbicort is a prescription medication used to prevent bronchospasm (narrowing of the airways leading to wheezing, coughing, and difficulty breathing) in people with asthma and chronic pulmonary obstructive disease (COPD).
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information..
Symbicort can cause serious side effects:
See “Drug Precautions” and "Black Box Warning"
- Pneumonia and other lower respiratory tract infections. People with COPD have a higher chance of getting pneumonia and other lung infections. Inhaled corticosteroids may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of these symptoms:
- increase in mucus (sputum) production
- change in mucus color
- increased cough
- increased breathing problems
Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.
- Immune system effects and a higher chance for infections. Tell your healthcare provider about any signs of infection such as:
- body aches
- feeling tired
Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicine.
- Using too much of a LABA medicine may cause:
- chest pain
- increased blood pressure
- a fast and irregular heartbeat
Increased wheezing right after taking Symbicort. Always have a rescue inhaler with you to treat sudden wheezing.
Eye problems including glaucoma and cataracts. You should have regular eye exams while using Symbicort.
Lower bone mineral density. This can happen in people who have a high chance for low bone mineral density (osteoporosis). Your healthcare provider should check you for this during treatment with Symbicort.
Slowed growth in children. A child’s growth should be checked regularly while using Symbicort.
Swelling of your blood vessels. This can happen in people with asthma. Tell your healthcare provider right away if you have:
- a feeling of pins and needles or numbness of your arms or legs
- flu like symptoms
- pain and swelling of the sinuses
Decreases in blood potassium levels (hypokalemia)
Increases in blood sugar levels (hyperglycemia)
Common side effects of Symbicort include:
Patients with asthma:
- throat irritation
- upper respiratory tract infection
- throat pain
- inflammation of mucous membranes of the sinuses (sinusitis)
- back pain
- nasal congestion
- stomach discomfort
- thrush in the mouth and throat
Patients with COPD:
- throat irritation
- thrush in the mouth and throat
- lower respiratory tract infections, mostly infections and/or inflammation of the mucous membranes of the bronchial tubes (bronchitis)
- inflammation of mucous membranes in the sinuses (sinusitis)
- upper respiratory tract infection
Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the side effects of Symbicort. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Symbicort and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take:
- antifungal medicines (fluconazole, itraconazole, ketoconazole)
- anti-HIV medicines (indinavir, nelfinavir, ritonavir, saquinavir)
Symbicort can cause serious side effects, including:
1. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as formoterol (one of the medicines in Symbicort) have an increased risk of death from asthma problems. It is not known whether budesonide, the other medicine in Symbicort, reduces the risk of death from asthma problems seen with formoterol.
Call your healthcare provider if breathing problems worsen over time while using Symbicort. You may need different treatment.
Get emergency medical care if:
breathing problems worsen quickly, and
you use your rescue inhaler medicine, but it does not relieve your breathing problems.
2. Symbicort should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma-control medicine, such as an inhaled corticosteroid.
3. When your asthma is well controlled, your healthcare provider may tell you to stop taking Symbicort. Your healthcare provider will decide if you can stop Symbicort without loss of asthma control. Your healthcare provider may prescribe a different long-term asthma-control medicine for you, such as an inhaled corticosteroid.
4. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.
Do not use Symbicort:
- to treat sudden severe symptoms of asthma or COPD.
- if you are allergic to any of the ingredients in Symbicort. See the end of the Medication Guide for a list of ingredients in Symbicort.
Grapefruit and grapefruit juice may interact with Symicort and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
Tell your healthcare provider about all of your health conditions, including if you:
- have heart problems
- have high blood pressure
- have seizures
- have thyroid problems
- have diabetes
- have liver problems
- have osteoporosis
- have an immune system problem
- have eye problems such as increased pressure in the eye, glaucoma, or cataracts
- are allergic to any medicines
- are exposed to chicken pox or measles
- are pregnant or planning to become pregnant. It is not known if Symbicort may harm your unborn baby.
- are breastfeeding. Budesonide, one of the active ingredients in Symbicort, passes into breast milk. You and your healthcare provider should decide if you will take Symbicort while breastfeeding.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Symbicort and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take antifungal and anti-HIV medicines.
Tell your doctor if you are pregnant or planning to become pregnant. It is not known if Symbicort may harm your unborn baby.
Tell your doctor if you are breastfeeding. Budesonide, one of the active ingredients in Symbicort, passes into breast milk. You and your healthcare provider should decide if you will take Symbicort while breastfeeding.
See the step-by-step instructions for using Symbicort are found in the Medication Guide that comes with Symbicort. Do not use Symbicort unless your healthcare provider has taught you and you understand everything. Ask your healthcare provider or pharmacist if you have any questions.
- Use Symbicort exactly as prescribed. Do not use Symbicort more often than prescribed. Symbicort comes in 2 strengths. Your healthcare provider has prescribed the strength that is best for you. Note the differences between Symbicort and your other inhaled medications, including the differences in prescribed use and physical appearance.
- Symbicort should be taken every day as 2 puffs in the morning and 2 puffs in the evening.
- If you miss a dose of Symbicort, you should take your next dose at the same time you normally do. Do not take Symbicort more often or use more puffs than you have been prescribed.
- Rinse your mouth with water and spit the water out after each dose (2 puffs) of Symbicort. Do not swallow the water. This will help to lessen the chance of getting a fungus infection (thrush) in the mouth and throat.
- Do not spray Symbicort in your eyes. If you accidentally get Symbicort in your eyes, rinse your eyes with water, and if redness or irritation persists, consult your healthcare provider.
- Do not change or stop any medicines used to control or treat your breathing problems. Your healthcare provider will change your medicines as needed.
- While you are using Symbicort 2 times each day, do not use other medicines that contain a long-acting beta2-agonist (LABA) for any reason. Ask your healthcare provider or pharmacist if any of your other medicine are LABA medicines.
- Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
- Symbicort does not relieve sudden symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
- Call your healthcare provider or get medical care right away if:
- your breathing problems worsen with Symbicort
- you need to use your rescue inhaler medicine more often than usual
- your rescue inhaler medicine does not work as well for you at relieving symptoms
- you need to use 4 or more inhalations of rescue inhaler medicine for 2 or more days in a row
- you use one whole canister of your rescue inhaler medicine in 8 weeks’ time
- your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
- your symptoms do not improve after using Symbicort regularly for 1 week.
Take Symbicort exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. The dosage of Symbicort must be individualized.
If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
Adult and Adolescent Patients 12 Years of Age and Older: For patients 12 years of age and older, the dosage is 2 inhalations twice daily (morning and evening, approximately 12 hours apart).
The recommended starting dosages for Symbicort for patients 12 years of age and older are based upon patients' asthma severity.
The maximum recommended dosage is Symbicort 160/4.5 mcg twice daily.
Improvement in asthma control following inhaled administration of Symbicort can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.
For patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with Symbicort 80/4.5, replacement with Symbicort 160/4.5 may provide additional asthma control.
If a previously effective dosage regimen of Symbicort fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, (e.g., replacing the lower strength of Symbicort with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.
Chronic Obstructive Pulmonary Disease (COPD)
For patients with COPD the recommended dose is Symbicort 160/4.5, two inhalations twice daily.
If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
Taking large doses (more than the prescribed amount) of Symbicort over a long period of time may cause serious problems. Short-term overdose may not require treatment. However, if you take too much Symbicort, call your doctor or local Poison Control Center or seek emergency medical attention right away.
Symbicort is available as a metered-dose inhaler containing a combination of budesonide (80 or 160 mcg) and formoterol (4.5 mcg) as an inhalation aerosol in the following two strengths: 80/4.5 and 160/4.5. Each dosage strength contains 60 or 120 actuations per/canister. Each strength of Symbicort is supplied with a red plastic actuator with a gray dust cap.
- Active ingredients: micronized budesonide and micronized formoterol fumarate dihydrate
- Inactive ingredients: hydrofluroalkane (HFA 227), povidone K25 USP, and polyethylene glycol 1000 NF
- Store Symbicort at room temperature between 68°F to 77°F (20°C to 25°C).
- Store with the mouthpiece down.
- The contents of your Symbicort canister are under pressure. Do not puncture or throw the canister into a fire or incinerator. Do not use or store it near heat or open flame. Storage above 120ºF may cause the canister to burst.
- Throw away Symbicort when the counter reaches zero (“0”) or 3 months after you take Symbicort out of its foil pouch, whichever comes first.
- Keep Symbicort and all medicines out of the reach of children.
WARNING: ASTHMA-RELATED DEATH
Long-acting beta2-adrenergic agonists (LABA), such as formoterol one of the active ingredients in Symbicort, increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of the LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, Symbicort should only be used for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Symbicort) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Symbicort for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.