LABA Pregnancy: §4.6: no adequate data in pregnant women; in animal studies formoterol caused implantation losses and decreased early postnatal survival and birth weight at considerably higher systemic exposures than clinical use. 'Treatment with formoterol may be considered at all stages of pregnancy if needed to obtain asthma control, and if the expected benefit to the mother is greater than any possible risk to the fetus. The potential risk for human is unknown.' Breastfeeding: passage into human milk is not known (small amounts detected in rat milk) — use only if the expected benefit to the mother is greater than any possible risk to the child.

Formoterol fumarate

Brand names: Atimos, Foradil, Oxis

Formoterol is a long-acting beta-2 agonist bronchodilator with a rapid onset, used in the maintenance treatment of asthma and COPD, generally in combination with an inhaled corticosteroid in asthma.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Asthma (adults, including the elderly, and adolescents above 12 years) — regular maintenance therapy: 1 inhalation (12 micrograms) twice daily; for more severe disease this can be increased to 2 inhalations (24 micrograms) twice daily. COPD — regular maintenance therapy: 1 inhalation (12 micrograms) twice daily

Route: Inhalation — via the Easyhaler inspiratory flow-driven dry powder inhaler (shake and actuate before each inhalation; breathe in forcefully and deeply; never breathe out through the mouthpiece)

Frequency: Twice daily

Max: Asthma: 'The maximum daily dose is 4 inhalations (2 inhalations inhaled twice daily)' = 48 micrograms/day. COPD: 'The maximum daily dose is 2 inhalations (1 inhalation inhaled twice daily)' = 24 micrograms/day. Children 6 to 12 years (asthma): maximum daily dose 24 micrograms. §4.4 adds that long-term safety of regular treatment above 48 micrograms/day in adults with asthma, 24 micrograms/day in children with asthma and 24 micrograms/day in COPD has not been established

SOURCE: eMC UK SPC, productName 'Formoterol Easyhaler 12 micrograms per dose inhalation powder' (https://www.medicines.org.uk/emc/product/312/smpc), §4.2 — each inhalation delivers 12 micrograms (metered dose). PAEDIATRIC (non-numeric-per-kg, so paedDose is null): §4.2 verbatim — 'Children 6 to 12 years. Asthma. Regular maintenance therapy: 1 inhalation (12 micrograms) to be inhaled twice daily. The maximum daily dose is 24 micrograms. Chronic Obstructive Pulmonary Disease: Not appropriate. Children under the age of 6 years: Formoterol Easyhaler is not recommended for use in children under the age of 6 years.' DURATION OF ACTION: about 12 hours; 'The treatment should always aim for the lowest effective dose.' PLACE IN THERAPY (§4.2/§4.4): a long-acting beta2-agonist is for maintenance bronchodilator therapy; a short-acting beta2-agonist should be used for acute attacks. Formoterol Easyhaler must not be used as first (or sole) treatment for asthma — asthmatic patients requiring a long-acting beta2-agonist should also receive optimal maintenance anti-inflammatory corticosteroid therapy and must be told not to stop or change their steroid therapy. SWITCHING DEVICES: when transferring from other inhalation devices, individualise treatment considering the previous active substance, dose regimen and delivery method. US CROSS-CHECK — DIFFERENT DOSAGE FORM, DO NOT MERGE: the openFDA record is formoterol fumarate INHALATION SOLUTION for nebulisation (Micro Labs Limited, label date 2024-09-26): 'one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose greater than 40 mcg is not recommended', for oral inhalation via a standard jet nebuliser with an air compressor; that US product is indicated for COPD only, is contraindicated as LABA monotherapy in asthma and 'is not indicated for use in children'. Those numbers apply to the nebuliser solution, not to the 12-microgram dry powder inhaler above. SECTIONS NOT RETRIEVED: UK SPC §4.5 was not included in the fetched bundle — the interactions listed below are taken from the US label §7 and are tagged as such.

Dose adjustments

Renal

§4.2: 'There are no data available for use of Formoterol Easyhaler in patients with hepatic or renal impairment. As formoterol is primarily eliminated via liver metabolism an increased exposure can be expected in patients with severe liver cirrhosis.' No numeric adjustment is stated.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to the excipient lactose monohydrate, which contains small amounts of milk proteins (§4.3)
Not recommended for use in children under 6 years of age (§4.2)
Not appropriate for COPD in children 6 to 12 years (§4.2)
US label §4 (different product — inhalation solution): 'Use of a LABA, including formoterol fumarate, without an inhaled corticosteroid is contraindicated in patients with asthma.'

Side effects

Headache and tremor (common); palpitations (common); tachycardia (uncommon)
Agitation, restlessness, sleep disturbances, anxiety (uncommon); muscle cramps and myalgia (uncommon)
Hypokalaemia (rare); hyperglycaemia (very rare) — beta2-agonists may raise insulin, free fatty acids, glycerol and ketone bodies
Cardiac arrhythmias e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles (rare); angina pectoris and QTc prolongation (very rare)
Aggravated bronchospasm, paradoxical bronchospasm, oropharyngeal irritation (rare); hypersensitivity reactions including severe hypotension, urticaria, angioedema, pruritus, exanthema and peripheral oedema (rare) — lactose monohydrate contains small amounts of milk proteins and can cause allergic reactions

Interactions

US label §7.1 — Adrenergic drugs: additional adrenergic drugs by any route should be used with caution because the sympathetic effects of formoterol may be potentiated
US label §7.2/7.3 — Xanthine derivatives, steroids and diuretics (especially non-potassium-sparing loop or thiazide diuretics) may potentiate hypokalaemia and ECG changes; use with caution
US label §7.4 — MAO inhibitors, tricyclic antidepressants and drugs that prolong the QTc interval may potentiate the effect on the cardiovascular system; use with extreme caution
US label §7.5 — Beta-blockers may decrease effectiveness; use with caution and only when medically necessary
UK SPC §4.4 (cross-reference to §4.5): caution when co-administering theophylline and formoterol in patients with pre-existing cardiac conditions, and in patients with known or suspected QTc prolongation (QTc > 0.44 sec) or on drugs affecting the QTc interval — formoterol itself may induce QTc prolongation. NOTE: UK SPC §4.5 itself was not retrieved in this bundle

Clinical monograph

How it works

It stimulates beta-2 adrenoceptors on airway smooth muscle, increasing cyclic AMP and producing prolonged bronchodilation, with a faster onset than some other long-acting agents.

Prescribing in practice

In asthma it must always be used together with an inhaled corticosteroid and never as monotherapy, owing to the risk of asthma-related serious events with LABA monotherapy.
It can cause dose-related tremor, palpitations and hypokalaemia, particularly with high doses or concomitant hypokalaemia-inducing drugs.
Use with caution in patients with cardiovascular disease, arrhythmias or prolonged QT interval.

Monitoring

Monitor symptom control and for adverse effects such as tremor, tachycardia and serum potassium where high doses or risk factors are present.

Counselling the patient

In asthma, always continue your steroid preventer inhaler alongside this medicine.
Report worsening breathlessness or increasing need for your inhalers.
Some shakiness or a faster heartbeat can occur and usually settles.

Evidence & guidelines

MHRA and asthma guidance require long-acting beta-2 agonists to be co-prescribed with an inhaled corticosteroid in asthma to reduce the risk of serious events.

Reference: BTS/SIGN; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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