Fixed-dose combination
Budesonide and Formoterol is a fixed-dose combination of a corticosteroid and a beta2-adrenergic agonist indicated for treatment of asthma in patients 6 years of age and older, among other approved uses. MedsAcross supplies Budesonide and Formoterol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
SYMBICORT is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist indicated for: • Treatment of asthma in patients 6 years of age and older. • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. Important limitations: • Not indicated for the relief of acute bronchospasm.
Source: US FDA prescribing information
SYMBICORT SYMBICORT contains both budesonide and formoterol, therefore, the mechanisms of action described below for the individual components apply to SYMBICORT. These drugs represent two classes of medications (a synthetic corticosteroid and a long-acting selective beta 2 -adrenoceptor agonist) that have different effects on clinical, physiological, and inflammatory indices of COPD and asthma. Budesonide Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. In standard in vitro and animal models, budesonide has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol (rat croton oil ear edema assay).
Source: US FDA prescribing information
For oral inhalation only. • Treatment of asthma in patients 12 years and older: 2 inhalations of SYMBICORT 80/4.5 or 160/4.5 twice daily. Starting dosage is based on asthma severity. • Treatment of asthma in patients aged 6 to less than 12 years: 2 inhalations of SYMBICORT 80/4.5 twice daily. • Maintenance treatment in COPD: 2 inhalations of SYMBICORT 160/4.5 twice daily.
Source: US FDA prescribing information
The use of SYMBICORT is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required. • Hypersensitivity to any of the ingredients in SYMBICORT. • Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. • Hypersensitivity to any of the ingredients in SYMBICORT.
Source: US FDA prescribing information
• Serious asthma-related events: Long-acting beta2-adrenergic agonists as monotherapy increase the risk. • Deterioration of disease and acute episodes: Do not initiate in acutely deteriorating asthma or COPD or to treat acute symptoms. • Use with additional long-acting beta 2 -agonist: Do not use in combination because of risk of overdose. • Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. • Pneumonia: Increased risk in patients with COPD. Monitor patients for signs and symptoms of pneumonia and other potential lung infections.
Source: US FDA prescribing information
LABA use may result in the following: • Serious asthma-related events – hospitalizations, intubations, death. • Cardiovascular and central nervous system effects. Systemic and inhaled corticosteroid use may result in the following: • Candida albicans infection • Pneumonia or lower respiratory tract infections in patients with COPD • Immunosuppression • Hypercorticism and adrenal suppression • Growth effects in pediatric patients • Glaucoma and cataracts Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Source: US FDA prescribing information
In clinical studies, concurrent administration of SYMBICORT and other drugs, such as short-acting beta 2 -agonists, intranasal corticosteroids, and antihistamines/decongestants has not resulted in an increased frequency of adverse reactions. No formal drug interaction studies have been performed with SYMBICORT. • Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects. • Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol on vascular system. • Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. • Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non-potassium-sparing diuretics may worsen with concomitant beta-agonists.
Source: US FDA prescribing information
Store at controlled room temperature 20°C to 25°C (68°F to 77°F). For best results, the canister should be at room temperature before use. Store the inhaler with the mouthpiece down. Do not store near heat or open flame.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
6 presentations of Budesonide and Formoterol, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Budesonide and Formoterol 160 mcg/4.5 mcg inhalerInhalationGeneric name | Budesonide and Formoterol | — | US FDA | Available on request |
| Budesonide and Formoterol 80 mcg/4.5 mcg inhalerInhalationGeneric name | Budesonide and Formoterol | — | US FDA | Available on request |
| Symbicort 160 mcg/4.5 mcg inhalerInhalation | Budesonide and Formoterol | AstraZeneca Pharmaceuticals | US FDA | Available on request |
| Symbicort 80 mcg/4.5 mcg inhalerInhalation | Budesonide and Formoterol | AstraZeneca Pharmaceuticals | US FDA | Available on request |
| Breyna 160 mcg/4.5 mcg inhalerInhalation | Budesonide and Formoterol | Mylan Pharmaceuticals | US FDA | Available on request |
| Breyna 80 mcg/4.5 mcg inhalerInhalation | Budesonide and Formoterol | Mylan Pharmaceuticals | US FDA | Available on request |
2 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Budesonide and Formoterol in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 6 presentations of Budesonide and Formoterol and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Budesonide and Formoterol, including Breyna, Symbicort.
Yes. The US FDA first approved Budesonide and Formoterol on 21 July 2006, according to Drugs@FDA.
Yes. Budesonide and Formoterol has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Budesonide and Formoterol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Budesonide and Formoterol is classified under ATC code R03AK07 (Budesonide and Formoterol).
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