FDA label
What is Symbicort used for?
Symbicort contains budesonide and formoterol. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Symbicort lists 2 uses: Treatment of Asthma; Maintenance Treatment of Chronic Obstructive Pulmonary Disease.
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Symbicort, aerosol
Indications and Usage, quoted from the label by Sportpharm LLC (NDA021929). Cross-references to other label sections are left out.
Treatment of Asthma
SYMBICORT is indicated for the treatment of asthma in patients 6 years of age and older.
SYMBICORT should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA).
Important Limitations of Use:
- SYMBICORT is NOT indicated for the relief of acute bronchospasm.
Maintenance Treatment of Chronic Obstructive Pulmonary Disease
SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. SYMBICORT 160/4.5 is also indicated to reduce exacerbations of COPD. SYMBICORT 160/4.5 is the only strength indicated for the treatment of COPD.
Important Limitations of Use:
- SYMBICORT is NOT indicated for the relief of acute bronchospasm.
Source: DailyMed label, set id a645756c-c692-4bc6-a858-7e7e249561bd, version 1, effective March 12, 2026. NDC 85766-184, one of 7 listings for this product.
Questions
What is Symbicort used for?
The FDA label for Symbicort lists 2 uses: Treatment of Asthma; Maintenance Treatment of Chronic Obstructive Pulmonary Disease.
What drug class is Symbicort?
FDA lists budesonide and formoterol in the Corticosteroid and beta2-Adrenergic Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Symbicort
- Is Symbicort a controlled substance?Federal schedule
- Generic for SymbicortFDA Orange Book
- What is Budesonide and Formoterol used for?FDA label uses
- Is Budesonide and Formoterol a controlled substance?Federal schedule
- Generic for Symbicort AerosphereFDA Orange Book
- Corticosteroids listFDA drug class
- Beta2-Adrenergic Agonists listFDA drug class
- Symbicort Medicare Part D coverageBy plan and state
- NDC 0186-0370Symbicort NDC record
- NDC 0186-0372Symbicort NDC record
- NDC 50090-1403Symbicort NDC record