Prescription medicine
Budesonide and formoterol Brand names: Symbicort, Breyna
Budesonide and formoterol (Symbicort) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $17.26 per gram (Budesonide-formoterol 160-4.5) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the budesonide and formoterol FDA label on DailyMed (effective July 24, 2019, AstraZeneca Pharmaceuticals LP); the NDA 21929 record on Drugs@FDA; every budesonide and formoterol label on DailyMed.
Highlights of the record
FDA label of July 24, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSYMBICORT 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.
Forms and strengths
Aerosol; aerosol (metered).
On the market
- Earliest approval on file
- July 21, 2006 Symbicort, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first March 15, 2022; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 2 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- May 28, 2030 Symbicort Aerosphere aerosol; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $17.26 per gram Budesonide-formoterol 160-4.5
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 97,711 through July 30, 2026
What is budesonide and formoterol used for?
From the label: indications and usageSYMBICORT 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. ( 1.1 )
Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. ( 1.2 ) Important limitations:
Not indicated for the relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma SYMBICORT is indicated for the treatment of asthma in patients 6 years of age and older. […]
Conditions named in the indications of budesonide and formoterol's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Corticosteroid and beta2-Adrenergic Agonist.
Source: FDA drug label (SYMBICORT), AstraZeneca Pharmaceuticals LP, effective July 24, 2019 (SPL set fafa4cf1-99c2-43d5-73ad-51f256de3be0), via openFDA; the full label on DailyMed
Is there a generic for budesonide and formoterol (Symbicort)?
The FDA approved the first generic budesonide and formoterol on March 15, 2022. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists budesonide and formoterol from 2 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Symbicort aerosol; a patent listed only for Symbicort Aerosphere aerosol runs to May 28, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2006 earliest approval on file
- 2022 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for budesonide and formoterol (Symbicort)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $17.26 per gram (Budesonide-formoterol 160-4.5), down 8% from $18.71 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Budesonide-formoterol 80-4.5 (generic)
- Symbicort 80-4.5 mcg inhaler (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Breyna 160-4.5 mcg inhaler | Generic | $21.62 per gram | n/a | -6% |
| Breyna 80-4.5 mcg inhaler | Generic | $18.54 per gram | n/a | -8% |
| Budesonide-formoterol 160-4.5 | Generic | $17.26 per gram | n/a | -8% |
| Budesonide-formoterol 80-4.5 | Generic | $15.67 per gram | n/a | -4% |
| Symbicort 160-4.5 mcg inhaler | Brand | $23.72 per gram | n/a | +0.1% |
| Symbicort 80-4.5 mcg inhaler | Brand | $19.26 per gram | n/a | +0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has budesonide and formoterol been recalled?
The FDA's Enforcement Report lists 1 recall naming budesonide and formoterol since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the budesonide and formoterol label say about other medicines?
The budesonide and formoterol label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name budesonide and formoterol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Arformoterol | warnings and precautions | Patients using SYMBICORT should not use an additional LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate) for any reason, including prevention of exercise-induced bronchospasm (EIB) or the treatment of asthma or COPD. |
| Atazanavir | drug interactions | Caution should be exercised when considering the coadministration of SYMBICORT with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.9) ]. |
| Clarithromycin | drug interactions | Caution should be exercised when considering the coadministration of SYMBICORT with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.9) ]. |
| Fluticasone | warnings and precautions | Three trials included adult and adolescent patients aged ≥12 years: one trial compared budesonide/formoterol (SYMBICORT) to budesonide [see Clinical Studies (14.1) ]; one trial compared fluticasone propionate/salmeterol inhalation powder to fluticasone propionate inhalation powder; … |
| Itraconazole | drug interactions | Caution should be exercised when considering the coadministration of SYMBICORT with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.9) ]. |
| Ketoconazole | drug interactions | After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. |
| Mometasone | warnings and precautions | … propionate/salmeterol inhalation powder to fluticasone propionate inhalation powder; and one trial compared mometasone furoate/formoterol to mometasone furoate. |
| Nefazodone | drug interactions | Caution should be exercised when considering the coadministration of SYMBICORT with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.9) ]. |
| Nelfinavir | drug interactions | Caution should be exercised when considering the coadministration of SYMBICORT with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.9) ]. |
| Prednisone | warnings and precautions | Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. |
| Ritonavir | drug interactions | Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution. |
| Salmeterol | warnings and precautions | Serious Asthma-Related Events – Hospitalizations, Intubations and Death Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death [see Salmeterol Multicenter Asthma Research Trial (SMART)]. |
Source: FDA drug label (SYMBICORT), AstraZeneca Pharmaceuticals LP, effective July 24, 2019 (SPL set fafa4cf1-99c2-43d5-73ad-51f256de3be0), via openFDA; the full label on DailyMed
What do FAERS reports show for budesonide and formoterol?
The FDA Adverse Event Reporting System holds 97,711 reports that list budesonide and formoterol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,692 are coded as a death and 28,466 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as budesonide and formoterol?
15 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as budesonide and formoterol or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (respiratory (inhalation)) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Albuterol | Asthma | 33 labelers | $0.0612 per mL 2.5 mg/3 mL solution | Resolved |
| Fluticasone and salmeterol | Asthma, COPD | 8 labelers | $1.07 per unit 100-50 | A presentation being discontinued |
| Fluticasone | Asthma | 1 labeler | $11.82 per gram 44 mcg inhaler | No current entry |
| Albuterol and ipratropium | COPD | 14 labelers | $0.0787 per mL 0.5-3(2.5) mg/3 mL | No current entry |
| Arformoterol | COPD | 15 labelers | $0.633 per mL 15 mcg/2 mL solution | No current entry |
| Beclomethasone | Asthma | 2 labelers | $20.57 per gram 40 mcg | No current entry |
| Fluticasone and vilanterol | Asthma, COPD | none listed | $3.90 per unit 100-25 | No current entry |
| Mometasone | Asthma | none listed | $6.84 per gram 50 mcg inhaler | No current entry |
Every medicine labeled for the same conditions as budesonide and formoterol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does budesonide and formoterol compare with medicines for the same use?
1 side-by-side page set budesonide and formoterol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to budesonide and formoterol
- 15 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Budesonide and formoterol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other