Prescription medication · Corticosteroid / Long-Acting Beta-2 Agonist Combination

budesonide/formoterol

Also sold as Symbicort. Symbicort is used to treat asthma in people 6 years and older.

Data updated 2026-05-15

33,524
FDA reports
5
InteractionsFew interactions
$22.05
Brand price (NADAC)

What the data shows

budesonide/formoterol (Symbicort) is a prescription Corticosteroid / Long-Acting Beta-2 Agonist Combination, with 33,524 FDA adverse-event reports on file, with 5 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

budesonide/formoterol (Symbicort) is a prescription Corticosteroid / Long-Acting Beta-2 Agonist Combination. Symbicort is used to treat asthma in people 6 years and older.

Symbicort is a combination medicine that contains a steroid and a long-acting bronchodilator. It helps to control asthma and COPD symptoms.

Verify with FDA → · CMS NADAC pricing →

Drug Pricing (NADAC)

Brand Price

$22.05/unit

Generic Available

No

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

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What it does

Symbicort is used to treat asthma in people 6 years and older.

Common side effects

Nasopharyngitis (common cold), Headache, Upper respiratory tract infection

Key warnings

Long-acting beta-agonists (LABAs) like formoterol may increase the risk of asthma-related death if used alone.

The sections below are summarized in plain English from budesonide/formoterol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Symbicort contains two medicines. Budesonide reduces inflammation in the lungs. Formoterol relaxes the muscles around your airways, making it easier to breathe.

Side Effects (from patient reports)

Based on 33,524 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for budesonide/formoterol, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS)

Serious Warnings

Long-acting beta-agonists (LABAs) like formoterol may increase the risk of asthma-related death if used alone. Do not use Symbicort to treat sudden asthma symptoms. Symbicort can also increase your risk of pneumonia, especially if you have COPD. Tell your doctor if you have signs of pneumonia like fever, cough, or increased mucus production.

Known Drug Interactions

moderate ketoconazole

After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. 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) ] .

Mechanism: Ketoconazole blocks the specific liver enzyme that normally breaks down budesonide. This causes the steroid levels in your body to rise higher than intended.

moderate clarithromycin

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) ] .

Mechanism: Clarithromycin slows down the process your body uses to get rid of the steroid in the inhaler. This can cause the medicine to build up to higher levels in your system.

moderate itraconazole

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) ] .

Mechanism: Itraconazole blocks the enzyme that breaks down the steroid part of this inhaler. This can lead to higher levels of the medicine in your body than intended.

moderate formoterol

May potentiate effect of formoterol on vascular system. 7.2 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants SYMBICORT should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of formoterol, a component of SYMBICORT, on the vascular system may be potentiated by these agents. 7.3 Beta-Adrenergic Receptor Blocking Agents Beta-blockers (including eye drops) may not only block the pulmonary effect of beta-agonists, such as formoterol, a...

Mechanism: These medicines can work together to increase the effects of formoterol on your heart and blood vessels. This can lead to changes in your heart rate or blood pressure.

minor budesonide

(7.4) 7.1 Inhibitors of Cytochrome P4503A4 The main route of metabolism of corticosteroids, including budesonide, a component of SYMBICORT, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of CYP3A4 may inhibit the metabolism of, and increase the systemic exposure to, budesonide.

Mechanism: Certain medications can slow down how your body breaks down budesonide. This causes the drug to stay in your system longer and reach higher levels.

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I use Symbicort for a sudden asthma attack?
No, Symbicort is not a rescue inhaler. Use a short-acting beta-agonist inhaler for sudden symptoms.
How long does it take for Symbicort to start working?
Some people may feel better within 15 minutes, but it may take 2 weeks or longer to see the full benefit.
Can I use other long-acting beta-agonists while using Symbicort?
No, do not use other LABA medicines while using Symbicort.
Do I need to clean my Symbicort inhaler?
No, do not try to clean or take apart your Symbicort inhaler.
What should I do if Symbicort doesn't seem to be working?
Talk to your doctor. They may need to adjust your dose or consider other treatment options.
Can Symbicort affect my growth?
Yes, Symbicort may slow down growth in children. Your doctor will monitor your child's growth.
Does Symbicort have any effect on my bones?
Symbicort may decrease bone mineral density. Your doctor may check your bone density.
Can Symbicort cause thrush?
Yes, Symbicort can cause thrush (oral candidiasis). Rinse your mouth with water after each dose to help prevent this.
What should I do if I get a cough while using Symbicort?
Tell your doctor if you develop a cough or other respiratory symptoms.
Are there foods or other medicines I should avoid while using Symbicort?
Tell your doctor about all the medicines you take, including over-the-counter drugs and supplements. Be careful when taking Symbicort with certain antidepressants.
What are the common side effects of budesonide/formoterol?
The registry lists Nasopharyngitis (common cold), Headache, Upper respiratory tract infection, Sore throat, Sinusitis among the most-reported FAERS reaction terms for budesonide/formoterol. The compiled record contains 33,524 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does budesonide/formoterol interact with other medications?
The registry has 5 documented interaction rows for budesonide/formoterol. Notable source-record pairings include ketoconazole, clarithromycin, itraconazole. These rows are not a complete medication review.
What drug class is budesonide/formoterol?
budesonide/formoterol belongs to the Corticosteroid / Long-Acting Beta-2 Agonist Combination drug class. It requires a prescription (Rx). Symbicort is used to treat asthma in people 6 years and older.
What pregnancy or breastfeeding source fields are listed for budesonide/formoterol?
The FDA label for budesonide/formoterol contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

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What the FDA Data Shows for budesonide/formoterol

The FDA label for budesonide/formoterol (sold under brand names such as Symbicort) classifies it as a prescription-only medication in the Corticosteroid / Long-Acting Beta-2 Agonist Combination class. Symbicort is used to treat asthma in people 6 years and older. Official labeling lists 12 commonly reported side effects, including Nasopharyngitis (common cold), Headache, Upper respiratory tract infection.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 33,524 voluntary reports. The database also lists 5 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: April 15, 2024

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Read our methodology - how this data is sourced, computed, and verified.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page