Formoterol
Pronunciation: for-MOH-ter-ol.
- Generic name
- formoterol fumarate
- Drug class
- Long-acting beta-2 agonist (LABA) bronchodilator
- Form
- Nebulizer solution, dry powder inhaler, or metered-dose inhaler, depending on country and brand
- Route
- Inhaled
- Legal status
- Prescription-only
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Oxis Turbuhaler / Foradile (5) · Full directory
Boxed warning: Long-acting beta-2 agonists (LABAs) increase the risk of asthma-related death when used for asthma without an inhaled corticosteroid
Long-acting beta2-agonist (LABA) medicines, including formoterol, increase the risk of asthma-related hospitalisation and death when used for asthma without a concurrent inhaled corticosteroid. Formoterol used alone for asthma, without an inhaled corticosteroid, is contraindicated. When formoterol is prescribed for asthma, it must always be used together with an inhaled corticosteroid, exactly as directed by the prescriber. (1) (2)
What formoterol fumarate is and how it works
Formoterol is a prescription-only long-acting bronchodilator inhaler that relaxes the muscles around the airways, making breathing easier over an extended period. It is used as a regular, twice-daily maintenance treatment, not as a rescue inhaler for sudden breathlessness. (1) (2)
Take formoterol exactly as your prescriber directs, at the same times each day. If you have asthma, formoterol must always be used together with an inhaled corticosteroid your prescriber has given you -- never as your only asthma medicine. Keep a separate fast-acting rescue inhaler on hand for sudden symptoms, as advised by your prescriber.
Mechanism of action: how formoterol fumarate works
Formoterol is a selective long-acting beta-2 adrenergic receptor agonist that relaxes bronchial smooth muscle, producing bronchodilation with an onset within minutes and a duration of action of approximately 12 hours. (1) (2)
What formoterol fumarate is used for
Asthma (add-on, with an inhaled corticosteroid)
Used in adults, adolescents, and children (age threshold varies by country, typically 6 years and older) as an add-on maintenance treatment for asthma symptoms, always alongside an inhaled corticosteroid -- never as the only asthma medicine. Available in the UK, Canada, Australia, and New Zealand for this use; the US-labeled nebulizer solution reviewed here is approved for COPD only, not asthma. (2) (4) (6)
Chronic obstructive pulmonary disease (COPD)
Used for long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in COPD, including chronic bronchitis and emphysema. Not intended for sudden symptom relief. (1) (2)
Before taking formoterol fumarate
Do not take / not appropriate for
- Do not use formoterol as your only asthma medicine -- it must always be combined with an inhaled corticosteroid your prescriber has given you. (all countries) (1) (2)
- Do not use formoterol if you have had a serious allergic reaction to formoterol or any of its ingredients. (all countries) (2)
- Do not use formoterol as a rescue inhaler for a sudden asthma or COPD attack -- it is not fast enough acting for this and a separate reliever inhaler is needed. (all countries) (1)
Tell your clinician about
- Any heart problems, high blood pressure, or irregular heartbeat.
- Diabetes, since formoterol can raise blood sugar.
- Low potassium levels, or other medicines that can lower potassium.
- All other medicines you take, especially other bronchodilators, diuretics ('water tablets'), beta-blockers, or medicines that can affect heart rhythm.
- Pregnancy, plans for pregnancy, or breastfeeding.
How to take formoterol fumarate
- Use the inhaler device exactly as your prescriber and pharmacist show you -- technique differs between nebulizer solution, dry powder inhalers, and metered-dose inhalers.
- Use at the same times each day, usually morning and evening, about 12 hours apart.
- If you have asthma, always take your inhaled corticosteroid as prescribed alongside formoterol.
- Keep a separate fast-acting reliever inhaler available for sudden symptoms, as directed by your prescriber.
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)
Missed dose
If you miss a dose, take it when you remember unless it is almost time for your next dose -- then skip the missed dose and continue your regular schedule. Do not use a double dose to make up for a missed one. Contact your prescriber if you are unsure.
Overdose
Seek urgent medical attention if you think you have used too much formoterol or have symptoms such as chest pain, a fast or irregular heartbeat, tremor, severe headache, or feeling faint -- excessive use can cause serious, potentially life-threatening heart effects. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Tremor (shaking), headache, and dizziness.
What to notice: Tremor (shaking), headache, and dizziness.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Palpitations (a fast or pounding heartbeat) and muscle cramps.
What to notice: Palpitations (a fast or pounding heartbeat) and muscle cramps.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Nausea, dry mouth, and a runny or blocked nose.
What to notice: Nausea, dry mouth, and a runny or blocked nose.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Difficulty sleeping (insomnia).
What to notice: Difficulty sleeping (insomnia).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Serious warnings
Worsening breathing right after a dose (paradoxical bronchospasm) — emergency
Symptoms: Sudden worsening of wheeze, cough, or shortness of breath immediately after using the inhaler.
Action: Use your separate fast-acting reliever inhaler and seek emergency medical help immediately; a clinician will assess whether formoterol needs to be changed. (1) (2)
Serious heart effects — emergency
Symptoms: Chest pain, a fast or irregular heartbeat, or fainting.
Action: Seek emergency medical help immediately, especially if you have a heart condition or are using other medicines that affect the heart. (1) (6)
Using formoterol as the only asthma medicine (without an inhaled corticosteroid) — boxed_warning
Symptoms: No specific symptom -- this is a labeled increased risk of serious asthma flare-ups, hospitalisation, and death.
Action: Contact your prescriber promptly if you are not also taking a prescribed inhaled corticosteroid alongside formoterol for asthma; your prescriber will ensure you are on the correct combination of medicines. (1) (2)
Low potassium (hypokalaemia) or raised blood sugar — high caution
Symptoms: Muscle weakness, cramps, an irregular heartbeat, or (for blood sugar) increased thirst and urination.
Action: Tell your prescriber, especially if you have diabetes or take other medicines that can lower potassium; monitoring may be needed. (1) (2)
Interactions
- Other adrenergic/sympathomimetic bronchodilators can add to formoterol's effects and increase side effects. (1) (2)
- Diuretics ('water tablets'), corticosteroids, and xanthine medicines (e.g. theophylline) may increase the risk of low potassium or other side effects. (1) (2)
- Beta-blocker medicines can reduce formoterol's effectiveness and, in some cases, trigger severe bronchospasm. (1) (2)
- MAO inhibitors, tricyclic antidepressants, and other medicines that can affect heart rhythm (QTc-prolonging medicines) can increase the risk of serious heart effects. (1) (2)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
There is limited human data on formoterol in pregnancy. Animal studies showed effects on the developing fetus only at doses far higher than those used in people. Discuss the benefits and risks with your prescriber if you are pregnant or planning pregnancy. (1) (2) (3) (4) (5) (6)
Breastfeeding
It is not known whether formoterol passes into human breast milk. Discuss with your prescriber, who will weigh the benefits and risks. (1) (2) (3) (4) (5) (6)
Children
Available for asthma in children from around age 6 in the UK, Canada, Australia, and New Zealand (exact age threshold varies by country); the US nebulizer solution reviewed here is not established for pediatric use. (1) (2) (3) (4) (5) (6)
Elderly
No specific dose adjustment based on age alone is described in the sources reviewed, but cardiovascular monitoring may be more important in older adults. (1) (2) (3) (4) (5) (6)
Hepatic_impairment
Not specifically addressed in the sources reviewed -- tell your prescriber about any liver problems. (1) (2) (3) (4) (5) (6)
Renal_impairment
Not specifically addressed in the sources reviewed -- tell your prescriber about any kidney problems. (1) (2) (3) (4) (5) (6)
Source_ids
US-DAILYMED-FORMOTEROL-2026,UK-EMC-FORMOTEROL-OXIS-2026 (1) (2) (3) (4) (5) (6)
Monitoring
Before starting
- Confirmation of asthma vs COPD diagnosis
- Review of current inhaled corticosteroid use if asthma
- Baseline heart rate, blood pressure, and relevant heart conditions
- Blood potassium and blood sugar if at higher risk
During treatment
- Watching for worsening breathing symptoms or increased reliever-inhaler use, which should be reported to a prescriber.
- Periodic review of inhaler technique.
- Monitoring heart rate/rhythm, potassium, and blood sugar in those at higher risk.
Storage
For the nebulizer solution: refrigerate at 2-8°C (36-46°F) in the protective foil pouch until first use; once removed from the pouch it may be kept at room temperature (20-25°C) and must be used within 3 months or by the expiry date, whichever comes first; protect from light and heat. For dry powder inhalers: no special storage conditions are required beyond keeping the device tightly closed and dry, per the product's own leaflet.
Study the drug class: Beta-2 agonist bronchodilators
Professional information
Clinician-facing context only, sourced from the current US FDA and UK SmPC information reviewed; verify against the current full label before prescribing.
United States
Indication: COPD maintenance (nebulizer solution)
Dose summary: One 20 mcg unit-dose vial twice daily (~12 hours apart) via jet nebulizer; maximum 40 mcg/day. Not indicated for asthma in this formulation.
Renal context: Not established in the source reviewed. (1)
United Kingdom
Indication: Asthma (add-on to inhaled corticosteroid) and COPD
Dose summary: Adults 1-2 inhalations once/twice daily (max 8/day for asthma); children 6+ 2 inhalations once/twice daily (max 4/day); individualised.
Renal context: Not established in the source reviewed. (2)
Hepatic guidance
Not specifically addressed in the sources reviewed for this dossier.
Overdose note
Overdose is expected to produce exaggerated beta-2-agonist effects: tachycardia, tremor, headache, and potentially serious cardiovascular effects including arrhythmia; manage supportively with cardiac monitoring and correction of electrolyte disturbances (particularly hypokalaemia) as clinically indicated. (1) (2)
Frequently asked questions
Is formoterol available in the US, UK, Europe, Canada, Australia, and New Zealand?
Yes. It is approved in all of these regions, though the approved uses differ slightly -- for example, the reviewed US nebulizer solution is approved for COPD only, while UK, Canadian, Australian, and New Zealand products are also approved as an asthma add-on treatment (always combined with an inhaled corticosteroid). In the EU, formoterol is authorised nationally in member states rather than through a single EU-wide monotherapy approval. (1) (2) (3) (4) (5) (6)
Can I use formoterol instead of my rescue inhaler?
No. Formoterol is a long-acting maintenance medicine, not a fast-acting reliever. Always keep a separate rescue inhaler for sudden symptoms, as directed by your prescriber. (1)
Do I need to take anything else alongside formoterol for asthma?
Yes. If formoterol is prescribed for asthma, it must always be used together with an inhaled corticosteroid your prescriber gives you -- using it alone for asthma carries a labeled increased risk of serious asthma flare-ups. (1) (2)
References
- Formoterol Fumarate Inhalation Solution -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information · United States · dated 2026-01-01 · accessed 2026-07-29 · source 1
- Oxis Turbohaler 6, inhalation powder -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- AstraZeneca UK Limited · United Kingdom · dated 2026-01-01 · accessed 2026-07-29 · source 2
- Formoterol-containing combination products with EMA centralised marketing authorisation (e.g. Vylaer Spiromax [budesonide/formoterol], Bevespi Aerosphere [glycopyrronium/formoterol])European Medicines Agency (EMA) -- confirmed indirectly via centrally authorised formoterol-containing combination products · European Union · dated 2026-01-01 · accessed 2026-07-29 · source 3
- Foradil (formoterol fumarate) and Oxeze Turbuhaler (formoterol) Product MonographsHealth Canada product monograph (Foradil, Novartis/Health Canada Drug Product Database; Oxeze, AstraZeneca Canada Inc.) · Canada · dated 2026-01-01 · accessed 2026-07-29 · source 4
- OXIS TURBUHALER 6 / OXIS TURBUHALER 12 / FORADILE -- ARTG registrationsTherapeutic Goods Administration (TGA), Australia · Australia · dated 2026-01-01 · accessed 2026-07-29 · source 5
- Oxis Turbuhaler and Foradil -- New Zealand Data SheetsMedsafe (New Zealand regulator) · New Zealand · dated 2026-01-01 · accessed 2026-07-29 · source 6
Brand names by country
Single-ingredient formoterol fumarate names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Perforomist20 ug/2mL · viatris specialty llc
United Kingdom
- Oxis Turbohaler (2)MHRA licensed emc smpc confirmed · 6 mcg, 12 mcg · AstraZeneca UK Limited
Canada
- OXEZE
- FORADIL DRY
Australia
- Oxis Turbuhaler / Foradile (5)TGA ARTG registered confirmed · 6 mcg, 12 mcg · AstraZeneca Australia / Novartis
New Zealand
- Oxis Turbuhaler / Foradil (6)Medsafe approved confirmed · 6 mcg, 12 mcg · AstraZeneca New Zealand / Novartis
View brands in additional countries.
European Union
Formoterol (national brands vary by member state; e.g. Oxis, Foradil, Atimos, Modulite) (3)