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

budesonide/formoterol

Name: budesonide/formoterol - FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

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

Compiled by PlainMeds Editorial, Drug Information Editorial Team

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.

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Drug Pricing (NADAC)

Brand Price

$22.05/unit

Generic Available

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.

How to Take It

Use Symbicort exactly as your doctor tells you. For asthma, adults and children 12+ usually take 2 inhalations twice a day. Children 6-12 usually take 2 inhalations of the 80/4.5 strength twice a day. For COPD, adults usually take 2 inhalations of the 160/4.5 strength twice a day. Rinse your mouth with water after each dose.

This is a plain-language summary of budesonide/formoterol's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Symbicort will harm your unborn baby. Discuss the risks and benefits with your doctor. It is also not known if Symbicort passes into breast milk.

This is a plain-language summary of budesonide/formoterol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.

This is a plain-language summary of budesonide/formoterol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.

Storage

Store Symbicort at room temperature away from heat and direct sunlight.

Side Effects (from patient reports)

Based on 33,524 FDA adverse event reports.

Difficulty breathing

6,363
Asthma

4,697
Tiredness

3,354
Cough

3,164
Headache

2,978
Condition worsened

2,696
Diarrhea

2,696
Nausea

2,621
Pneumonia

2,556
Wheezing

2,399

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.

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.

What to do: Use this combination with caution and talk to your doctor about monitoring for side effects of increased steroid exposure.

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.

What to do: Use this combination with caution. Your doctor may need to watch you more closely for side effects while you are taking both medications.

moderate itraconazole

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.

What to do: Talk to your doctor before using these together. They may need to adjust your treatment or monitor you for signs of having too much steroid in your system.

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.

What to do: Use this combination with caution. Your doctor should monitor your heart health and blood pressure closely while you are taking these drugs.

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.

What to do: Your doctor may need to adjust your dosage or watch for signs of increased steroid side effects.

This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.

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 most commonly reported side effects of budesonide/formoterol include Nasopharyngitis (common cold), Headache, Upper respiratory tract infection, Sore throat, Sinusitis. Based on 33,524 FDA adverse event reports. Always consult your healthcare provider about potential side effects.

Does budesonide/formoterol interact with other medications?

Yes, budesonide/formoterol has 5 known drug interactions. Notable interactions include ketoconazole, clarithromycin, itraconazole. Always inform your doctor about all medications you are taking.

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.

Is budesonide/formoterol safe during pregnancy?

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Symbicort will harm your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.