Budesonide/formoterol (Symbicort)

Pronunciation: byoo-DES-oh-nide / for-MOH-ter-ol.

Generic name
budesonide/formoterol
Brand names
Symbicort (United States, Canada, Australia, New Zealand), Symbicort Turbohaler (United Kingdom, European Union), Symbicort Rapihaler (Australia)
Drug class
Combination inhaled corticosteroid (ICS) and long-acting beta2-adrenergic agonist (LABA)
Form
Inhalation aerosol (metered-dose inhaler) or inhalation powder (dry powder inhaler), depending on market
Route
Oral inhalation
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Symbicort Turbuhaler / Symbicort Rapihaler (6) · Full directory

What budesonide/formoterol is and how it works

Symbicort is a prescription-only combination inhaler containing an inhaled corticosteroid (budesonide) and a long-acting beta2-agonist (formoterol), used regularly to control asthma and chronic obstructive pulmonary disease (COPD). It is not a rescue inhaler for a sudden asthma or COPD attack in most markets. (1) (4)

Use Symbicort exactly as your prescriber directs, usually twice daily, even when you feel well -- it works best as regular, ongoing treatment rather than an as-needed rescue medicine. In the United States, Symbicort is not used to relieve sudden breathing difficulty; keep a separate fast-acting reliever inhaler on hand for that, as directed by your prescriber. (Some other countries license certain Symbicort products for combined maintenance-and-reliever use -- follow your own country's product information and your prescriber's instructions.)

Mechanism of action: how budesonide/formoterol works

Budesonide is an anti-inflammatory corticosteroid with high glucocorticoid receptor affinity; formoterol is a selective, long-acting beta2-adrenergic agonist with a rapid onset of bronchodilation. Combining the two provides both anti-inflammatory control and sustained bronchodilation. (1)

What budesonide/formoterol is used for

Asthma (age 6 and older)

Used for regular maintenance treatment of asthma in patients 6 years of age and older. Not indicated for relief of a sudden asthma attack in the United States. (1)

Chronic obstructive pulmonary disease (COPD)

Used for maintenance treatment of airflow obstruction and to reduce exacerbations (flare-ups) in COPD, including chronic bronchitis and/or emphysema. (1)

Before taking budesonide/formoterol

Do not take / not appropriate for

  • Symbicort is not for the primary treatment of a severe, ongoing asthma attack (status asthmaticus) or other acute asthma/COPD episodes requiring intensive medical measures -- these need different, faster emergency treatment. (all countries) (1)
  • Do not use Symbicort if you have had a serious allergic reaction to budesonide, formoterol, or any of its ingredients. (all countries) (1)
  • Do not use Symbicort together with another medicine containing a long-acting beta2-agonist (LABA), because of an increased risk of overdose-related effects. (all countries) (1)

Tell your clinician about

  • Any heart problems, high blood pressure, an irregular heartbeat, or a seizure disorder.
  • Any current or past infections, including tuberculosis, or any eye infection with the herpes virus.
  • Whether you have ever had chickenpox or measles, or have not been exposed to them, since inhaled corticosteroids can allow a more serious course of either illness in susceptible people.
  • Any liver problems, diabetes, low potassium levels, osteoporosis or reduced bone density, glaucoma, or cataracts.
  • If you are currently taking, or have recently taken, oral (tablet) corticosteroids.
  • All other medicines, especially other asthma or COPD inhalers, beta-blockers, diuretics ('water tablets'), antidepressants (particularly MAOIs or tricyclics), or strong CYP3A4-inhibiting medicines such as ritonavir, ketoconazole, clarithromycin, itraconazole, or nelfinavir.
  • Pregnancy, plans for pregnancy, or breastfeeding.
(1)

How to take budesonide/formoterol

  • Use Symbicort regularly, exactly as your prescriber directs, even when you have no symptoms -- it is a maintenance treatment, not typically a rescue inhaler in the United States.
  • Rinse your mouth with water and spit it out (without swallowing) after each use, to help reduce the risk of oral thrush (candidiasis).
  • Do not stop or change your dose on your own; any change to your Symbicort dose, or to any oral corticosteroid you are also tapering off, should be directed by your prescriber.
  • If you have been using an oral (tablet) corticosteroid, your prescriber will supervise how it is tapered when starting Symbicort, since adrenal function can be affected during this transition.
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)

Missed dose

Take the next dose at its regular scheduled time; contact your prescriber or pharmacist for guidance if you are unsure, rather than taking an extra dose to make up for the one you missed.

Overdose

Seek urgent medical attention or contact a poison control centre if too much Symbicort has been used, or if you notice symptoms such as a fast or irregular heartbeat, chest pain, tremor, nausea, or seizures. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Nasopharyngitis (common cold-like symptoms) and upper respiratory tract infections.

What to notice: Nasopharyngitis (common cold-like symptoms) and upper respiratory tract infections.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Headache.

What to notice: Headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Sore throat (pharyngolaryngeal pain), sinusitis, and nasal congestion.

What to notice: Sore throat (pharyngolaryngeal pain), sinusitis, and nasal congestion.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Oral thrush (candidiasis) -- reduce the risk by rinsing your mouth with water after each use.

What to notice: Oral thrush (candidiasis) -- reduce the risk by rinsing your mouth with water after each use.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Back pain, stomach discomfort, and vomiting have also been reported.

What to notice: Back pain, stomach discomfort, and vomiting have also been reported.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Worsening breathing symptoms right after use (paradoxical bronchospasm) — emergency

Symptoms: Wheezing or breathing difficulty that gets worse immediately after using Symbicort, instead of better.

Action: Seek emergency medical help immediately and use your rescue inhaler if you have one; a clinician will decide whether Symbicort needs to be stopped and an alternative treatment started. (1)

Signs of a serious allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; hives; widespread rash; or sudden difficulty breathing.

Action: Seek emergency medical help immediately. (1)

Heart-related symptoms from excess beta-agonist stimulation — high caution

Symptoms: Chest pain, a fast or irregular heartbeat, tremor, or seizures.

Action: Contact your prescriber promptly, or seek emergency care for severe or sudden symptoms. (1)

Signs of adrenal insufficiency, especially when reducing an oral corticosteroid — high caution

Symptoms: Unusual tiredness, weakness, nausea, low blood pressure, or dizziness.

Action: Contact your prescriber promptly; adrenal function is monitored closely during any transition from oral corticosteroids. (1)

Vision changes — high caution

Symptoms: Blurred vision, eye pain, or halos around lights, which may suggest glaucoma, raised eye pressure, or cataracts.

Action: Contact your prescriber or an eye specialist promptly for assessment. (1)

Interactions

  • Strong CYP3A4-inhibiting medicines (such as ritonavir, ketoconazole, clarithromycin, itraconazole, or nelfinavir) can increase systemic corticosteroid effects -- tell your prescriber if you take any of these. (1)
  • MAOIs and tricyclic antidepressants may increase formoterol's effect on the heart and blood vessels -- these combinations need extra caution from your prescriber. (1)
  • Beta-blocker medicines may block Symbicort's airway-opening effect and can trigger severe bronchospasm. (1)
  • Diuretics ('water tablets') combined with a beta-agonist can worsen heart rhythm changes or low potassium levels. (1)
  • Other medicines containing a long-acting beta2-agonist should not be combined with Symbicort because of an increased risk of overdose-related effects. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

There are no adequate and well-controlled studies of Symbicort in pregnant women. Animal studies showed effects on the developing fetus at certain doses, though studies of inhaled budesonide alone have not shown a clear increase in the risk of birth abnormalities. Discuss the benefits and risks with your prescriber. (1) (2) (3) (4) (5) (6) (7)

Breastfeeding

There is no available data on the effects of Symbicort on a breastfed infant; budesonide passes into human milk in small amounts (roughly 0.3-1% of the maternal inhaled dose). Discuss with your prescriber. (1) (2) (3) (4) (5) (6) (7)

Children

Approved from age 6 for asthma in the United States; age thresholds and licensed uses vary by country. (1) (2) (3) (4) (5) (6) (7)

Elderly

No specific dose adjustment based on age alone is described in the source reviewed, but cardiovascular risk factors should be assessed regardless of age. (1) (2) (3) (4) (5) (6) (7)

Hepatic_impairment

Budesonide and formoterol are mainly cleared by the liver, so increased drug exposure can be expected with severe liver disease -- tell your prescriber about any liver problems. (1) (2) (3) (4) (5) (6) (7)

Renal_impairment

Not specifically detailed in the sources reviewed for this dossier; tell your prescriber about any kidney problems. (1) (2) (3) (4) (5) (6) (7)

Monitoring

Before starting

  • Baseline lung function assessment
  • Review of cardiovascular risk factors and current medicines
  • Bone density assessment where long-term inhaled corticosteroid use is anticipated

During treatment

  • Periodic lung function monitoring to guide treatment.
  • Growth monitoring in children and adolescents.
  • Periodic bone mineral density assessment with long-term use.
  • Watching for oral thrush, vision changes, and signs of adrenal suppression, especially when reducing oral corticosteroids.
(1)

Storage

Store at room temperature and follow the specific storage and priming/shaking instructions in the leaflet for your particular inhaler device; do not puncture, break, or burn the canister, and discard according to local guidance once the dose counter (where fitted) reaches zero.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information; verify against the current full label before prescribing.

United States

Indication: Asthma (age 6+) and COPD

Dose summary: Asthma, age 12+: 2 inhalations of 80/4.5 or 160/4.5 mcg twice daily, starting strength based on severity. Asthma, age 6-11: 2 inhalations of 80/4.5 mcg twice daily. COPD: 2 inhalations of 160/4.5 mcg twice daily. Not indicated for acute bronchospasm relief.

Renal context: Not established in the source reviewed for this dossier. (1)

Mechanism of action

Hepatic guidance

Budesonide and formoterol are eliminated primarily by hepatic metabolism; increased systemic exposure can be expected in severe hepatic impairment, warranting closer monitoring.

Overdose note

Formoterol overdose is likely to lead to exaggerated beta-adrenergic effects (tachycardia, tremor, headache, seizures); budesonide overdose is unlikely to produce acute effects but chronic excessive dosing may lead to systemic corticosteroid effects. Manage per local poison-control and clinical toxicology guidance. (1)

Frequently asked questions

Is Symbicort (budesonide/formoterol) available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes, it is approved and available in all of these regions, though the exact device (metered-dose inhaler or dry powder Turbuhaler) and licensed uses vary by country. (1) (3) (4) (5) (6) (7)

Does Symbicort carry a boxed warning?

No, not currently. The FDA removed the earlier boxed warning about serious asthma-related outcomes from Symbicort and similar combination inhaled-corticosteroid/LABA inhalers in December 2017, after four large clinical trials in over 41,000 patients found that combining a LABA with an inhaled corticosteroid did not significantly increase serious asthma-related hospitalisation, intubation, or death compared with the inhaled corticosteroid alone. The current label still carries a Warnings and Precautions statement that using a LABA alone, without an inhaled corticosteroid, increases the risk of asthma-related death -- which is part of why Symbicort always combines the two. (1) (2)

Can I use Symbicort as a rescue inhaler if I suddenly can't breathe?

In the United States, Symbicort is not indicated for the relief of a sudden asthma or COPD attack -- keep a separate fast-acting reliever inhaler on hand for that, as your prescriber directs. Some other countries license specific Symbicort products for combined maintenance-and-reliever use; follow your own country's product information and your prescriber's instructions. (1) (4)

What is the mechanism of action of budesonide/formoterol?

Budesonide is an anti-inflammatory corticosteroid with high glucocorticoid receptor affinity; formoterol is a selective, long-acting beta2-adrenergic agonist with a rapid onset of bronchodilation. Combining the two provides both anti-inflammatory control and sustained bronchodilation. (1)

What is the generic name of Budesonide/formoterol (Symbicort)?

The generic name is budesonide/formoterol. It is sold under brand names including Symbicort (United States, Canada, Australia, New Zealand), Symbicort Turbohaler (United Kingdom, European Union), Symbicort Rapihaler (Australia). (1)

What class of drug is budesonide/formoterol?

Budesonide/formoterol (Symbicort) is classed as: Combination inhaled corticosteroid (ICS) and long-acting beta2-adrenergic agonist (LABA). (1)

References

  1. SYMBICORT (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, AstraZeneca Pharmaceuticals LP · United States · accessed 2026-07-29 · source 1
  2. FDA Updates SYMBICORT Label With LABA Safety Class Revisions and Removes Boxed Warning for Serious Asthma-Related Outcomes (December 2017)U.S. Food and Drug Administration / trade press summarising the FDA safety communication · United States · accessed 2026-07-29 · source 2
  3. Symbicort forte Turbuhaler, Symbicort Turbuhaler, Symbicort mite Turbuhaler -- Public Assessment ReportSwedish Medical Products Agency (Lakemedelsverket/MPA) -- Reference Member State public assessment report for the EU mutual recognition procedure · European Union · accessed 2026-07-29 · source 3
  4. Symbicort Turbohaler 200 micrograms/6 micrograms per actuation -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- AstraZeneca UK Limited · United Kingdom · accessed 2026-07-29 · source 4
  5. SYMBICORT TURBUHALER (budesonide/formoterol fumarate dihydrate) Product MonographHealth Canada product monograph, AstraZeneca Canada Inc. · Canada · accessed 2026-07-29 · source 5
  6. Symbicort Turbuhaler / Symbicort Rapihaler -- ARTG registrationTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 6
  7. Symbicort Turbuhaler New Zealand Data SheetMedsafe (New Zealand regulator) · New Zealand · accessed 2026-07-29 · source 7

Brand names by country

Single-ingredient budesonide/formoterol names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Symbicort (1)FDA approved currently labeled · 80/4.5 mcg, 160/4.5 mcg · AstraZeneca Pharmaceuticals LP

United Kingdom

  • Symbicort Turbohaler (4)MHRA licensed emc smpc confirmed · 100/6 mcg, 200/6 mcg, 400/12 mcg · AstraZeneca UK Limited

Canada

  • Symbicort Turbuhaler (5)Health Canada approved confirmed · 100/6 mcg, 200/6 mcg, 400/12 mcg (Symbicort Forte) · AstraZeneca Canada Inc.

Australia

  • Symbicort Turbuhaler / Symbicort Rapihaler (6)TGA ARTG registered confirmed · 100/6 mcg, 200/6 mcg, 400/12 mcg (Turbuhaler), various (Rapihaler) · AstraZeneca Pty Ltd

New Zealand

  • Symbicort Turbuhaler (7)Medsafe approved confirmed · 100/6 mcg, 200/6 mcg, 400/12 mcg · AstraZeneca New Zealand Limited
View brands in additional countries.

European Union

Symbicort Turbuhaler (3)

This page provides general reference information about budesonide/formoterol (Symbicort) and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions should be made with your prescriber.

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