Formoterol

Formoterol: Long-Acting Beta-2 Agonist — Never Without Cortisone in Asthma, Also on Its Own in COPD

Formoterol is a long-acting beta-2 sympathomimetic (LABA) that widens the airways within a few minutes and keeps them open for around twelve hours. In asthma it may only be used together with inhaled cortisone, because it does not treat the inflammation and, on its own, can increase the risk of severe attacks. In COPD the situation is different: there, formoterol is also an established option as the sole maintenance medicine.

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1. At a Glance: Technical Data Sheet

PropertyDetails
Active ingredientFormoterol (usually as formoterol fumarate dihydrate)
ATC codeR03AC13
Drug classSelective, long-acting beta-2 sympathomimetic (LABA)
Dosage formsDry powder inhalers and metered-dose inhalers — as a single ingredient and in fixed combinations with inhaled cortisone (e.g. budesonide, beclometasone, fluticasone) or with long-acting anticholinergics
Half-lifeTerminal half-life after inhalation about 17 hours according to the SmPC; airway-widening effect around 12 hours
Maximum daily doseSingle-ingredient product in adults: 48 µg per day according to the SmPC; for combination products, the maximum number of puffs stated there applies
Onset of effectAfter 1 to 3 minutes
Prescription statusPrescription-only medicine
Notable featureIn asthma only together with inhaled cortisone; in COPD also possible as sole maintenance treatment; can show up in doping tests
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2. How it works: fast and long-lasting — but no protection against inflammation

The airways (bronchi) are surrounded by smooth muscle. When this muscle contracts, the airway narrows — you feel shortness of breath, tightness or wheezing. These muscle cells carry beta-2 receptors. Formoterol docks onto them and makes the muscle relax: the airways widen.¹

What makes formoterol special is the combination of two properties that other drugs have only separately. It works as fast as a reliever inhaler — after one to three minutes — and as long as a maintenance medicine, around twelve hours. Salbutamol works just as quickly, but only for a few hours; salmeterol, the other classic long-acting drug, lasts a long time but is slower to start working.

And this is exactly where the trap lies: formoterol opens the airways, but it does not treat the cause. In asthma, that cause is a chronic inflammation of the airway lining. A beta-2 agonist on its own can mask this inflammation — you feel better while it keeps smouldering.

The basic rule in asthma. In asthma, formoterol is intended only as an add-on to anti-inflammatory maintenance treatment with inhaled cortisone. The SmPC makes clear that it is neither suitable nor sufficient as sole first-line treatment, and the German National Disease Management Guideline on asthma provides for long-acting beta-2 agonists exclusively in combination with cortisone.¹,² Why this is different in COPD is explained in section 6.

The typical side effects also follow from the way it works. Beta-2 receptors are not found only in the airways: in skeletal muscle, activating them leads to tremor and cramps, in the heart to a faster pulse, and in the metabolism to a shift of potassium into the cells and to higher blood sugar. Because formoterol is inhaled, only part of it enters the bloodstream — which is why these effects are usually mild and dose-dependent.


3. Dosing: single-ingredient and combination products

The figures below describe what the SmPCs state. They are not a dosing instruction — which product and how many puffs are right for you is decided by the treating practice.¹

  • Formoterol as a single ingredient: usually one inhalation once or twice a day, in individual cases two. In asthma, the maximum daily dose for adults according to the SmPC is 48 µg; according to the SmPC, the long-term safety of regular doses above 36 µg per day in asthma and above 18 µg per day in COPD has not been established.
  • In COPD, according to the SmPC, as-needed inhalations are possible in addition to the regular dose, up to a set total number per day.
  • Fixed combinations with cortisone: here the SmPC of the particular product determines the number of puffs. With some combinations, the same device can also be used as a reliever (section 6).
  • Products are not interchangeable: manufacturers state the dose partly as the metered amount and partly as the delivered amount. According to the SmPC, you should not switch between formoterol products without medical supervision.
The most important warning sign is in the SmPC. If you need more than the usual doses on more than two days a week, your disease is not optimally controlled, according to the SmPC — then the maintenance treatment needs reviewing, rather than simply increasing the number of puffs.

4. Using it in everyday life

With inhaled medicines, technique matters at least as much as the dose. How the different types of device work is shown in detail in the guide inhaling correctly. For formoterol, a few extra points apply:

  1. Fixed times, about twelve hours apart. With twice-daily use, morning and evening — this matches the duration of effect and makes forgetting less likely.
  2. Capsules are for inhaling only, never for swallowing. With capsule inhalers, accidental swallowing has been reported, according to the SmPC. Press the piercing button only once, so that the capsule does not shatter.
  3. Dry powder inhaler: breathe in forcefully and deeply. The powder needs a fast breath to reach the lungs. Never breathe out into the device — moisture makes the powder clump.
  4. Metered-dose inhaler: coordinate the puff with breathing in, or use a spacer if that is difficult.
  5. After combination products with cortisone: rinse your mouth or eat something to prevent oral thrush and hoarseness — more on this under fluticasone.
  6. Missed dose: take it later if the next dose is still several hours away; otherwise carry on as normal. Never take a double dose.
  7. Store dry and below 25 °C, and leave capsules in their packaging until you use them.
Have your technique checked regularly. Bring your device to every appointment and inhale once under supervision — at the practice or at the pharmacy. If formoterol does not seem to be working, the SmPC says the way it is used should be checked first, before anyone changes the dose.

How often do you really need your reliever?

Count your reliever puffs — the history shows early on when control is slipping.

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5. Side effects: tremor, palpitations, cramps

Most side effects are dose-dependent and often ease after a few days to weeks, once the body has got used to the drug.¹

  • Trembling of the hands: the classic, especially at the start and after several puffs. Usually harmless; if it gets worse, it is worth looking at your total amount of beta-2 agonists.
  • Palpitations and a racing heart: a faster pulse is common; skipped beats or persistent racing should be checked by a doctor.
  • Headache, restlessness, sleep problems: mainly at the start.
  • Muscle cramps, for example calf cramps — these can also point to a low potassium level.
  • Irritation of the mouth and throat, coughing directly after inhaling.

Rarer, but more important: low potassium (hypokalaemia), especially together with water tablets, cortisone tablets or theophylline; higher blood sugar, which is why people with diabetes should measure more often at first; prolongation of the QT interval on the ECG and heart rhythm disorders, especially with pre-existing heart disease.¹

Two situations in which you act immediately. If your breathlessness gets worse rather than better straight after inhaling, this may be a paradoxical spasm of the airways: stop using formoterol, take your prescribed reliever inhaler and get medical help straight away. And in a severe asthma attack — you can only speak in broken phrases, your lips turn bluish, the reliever does not help or helps only briefly — call 112 (emergency number in Germany) immediately. More puffs are not the answer in this situation.

6. Asthma or COPD: why the cortisone rule is different

Formoterol is the same drug in both conditions — but the rules differ fundamentally. If you do not keep them apart, it is easy to draw the wrong conclusions: "My father takes it on its own for COPD, so I can leave out the cortisone for my asthma." That is exactly what is dangerous.

Asthma: formoterol only with inhaled cortisone

In asthma, the inflammation is at the centre. Inhaled cortisone — such as budesonide — is the foundation of treatment. Long-acting beta-2 agonists on their own can mask the inflammation, and large studies have shown that without cortisone they can increase the risk of severe, sometimes fatal asthma attacks. When they are combined with cortisone, this risk is not increased according to current knowledge.²,³

  • A fixed combination is preferred: cortisone and formoterol in one device make it impossible to take only the part you can feel by mistake.
  • A combination inhaler as a reliever: because formoterol works so quickly, a combination of budesonide or beclometasone with formoterol can, if prescribed accordingly, be both the maintenance and the reliever medicine at the same time. Every reliever puff then delivers cortisone as well. For adolescents from the age of 12 and adults, the German National Disease Management Guideline also names as-needed-only use as an alternative in the lower treatment steps — in Germany, as of the guideline, outside the licence (off-label).²
  • Going further internationally: the Global Initiative for Asthma (GINA) prefers this anti-inflammatory reliever approach and advises against using a short-acting beta-2 agonist without cortisone as the sole treatment in adolescents and adults.³
Formoterol on its own for asthma? Talk to your practice soon. If you have asthma and inhale a formoterol-only product but no cortisone — or if you regularly leave out your cortisone device — contact your practice soon. Do not simply stop formoterol; instead, have your treatment supplemented with the missing anti-inflammatory component. Background on worries about inhaled cortisone can be found in the cortisone guide.

COPD: formoterol also as the sole maintenance medicine

In COPD the inflammation is of a different kind and usually responds only a little to cortisone. The priority is widening the airways on a lasting basis. For mild to moderate symptoms, the German National Disease Management Guideline on COPD provides for a long-acting anticholinergic (LAMA) or a long-acting beta-2 agonist such as formoterol as single treatment, and for more severe symptoms a combination of the two.⁴ One example of a LAMA is tiotropium.

In COPD, inhaled cortisone is only added in specific cases — for example with repeated flare-ups (exacerbations) and higher eosinophil counts in the blood, or if there are also asthmatic features. Without this constellation, the benefit often does not outweigh the drawbacks, especially as inhaled cortisone can increase the risk of pneumonia in COPD.⁴,⁵

AsthmaCOPD
Role of formoterolOnly as an add-on to inhaled cortisoneAlone, with a LAMA or — in specific cases — with cortisone
Inhaled cortisoneFoundation of treatment, practically alwaysOnly with certain features
Formoterol as a relieverOnly in combination with cortisoneAccording to the SmPC, extra puffs possible up to the daily limit
Typical mistakeLeaving out the cortisone because you "can't feel it doing anything"Continuing cortisone long term without a clear indication
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And what if both come together? If COPD shows clear asthmatic features, or if asthma has also been confirmed, the asthma rule applies again: no long-acting beta-2 agonist without cortisone. This assessment is made by the treating practice on the basis of your medical history, lung function and blood values.

7. Interactions: beta blockers, potassium, QT interval

The most important interactions of formoterol concern the heart, the potassium balance and drugs with the opposite mode of action.¹

CombinationConsequenceWhat to do
Beta blockers, including as eye drops — especially non-selective ones such as propranololThe effect of formoterol is weakened or cancelled out; in asthma, risk of the airways narrowingAvoid according to the SmPC unless there are compelling reasons; heart-selective drugs such as bisoprolol are often tolerated — the practice decides
Water tablets such as furosemide, cortisone tablets such as prednisolone, theophyllineIncreased potassium lossCheck potassium, especially during exacerbations and in heart disease
Digitalis preparationsA low potassium level increases the risk of rhythm disordersKeep an eye on potassium
QT-prolonging drugs, e.g. tricyclic antidepressants such as amitriptyline, some antipsychotics, erythromycinIncreased risk of heart rhythm disordersInform the prescribing practice, ECG if needed
MAO inhibitors, tricyclic antidepressantsStronger effect on the heart and circulationCombine only with caution
Other beta-2 agonists and sympathomimetics (e.g. ephedrine in cold remedies)Side effects add upNever two long-acting beta-2 agonists at the same time; use the reliever according to plan
Anticholinergics such as tiotropiumAirway widening is increasedAn intended combination in COPD
Anaesthetic gases (halogenated anaesthetics)Increased risk of rhythm disordersMention before surgery; see medications before surgery
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Beta blockers are the trickiest combination, because they often come from the cardiology or ophthalmology side: even eye drops for glaucoma can narrow the airways in asthma. Alcohol has no specific interaction with formoterol; larger amounts of caffeine can increase palpitations and tremor. Whether anything on your list clashes is shown by the brite interaction check; the basics are in the guide drug interactions.


8. Where it fits and what to check: formoterol compared

If you have several inhalers, it is easy to lose track of which device is for what. This overview shows where formoterol fits in:

DrugGroupOnset / durationRole
SalbutamolShort-acting beta-2 agonistMinutes / a few hoursThe classic reliever inhaler
FormoterolLong-acting beta-2 agonist1–3 minutes / around 12 hoursMaintenance treatment; combined with cortisone also as a reliever
SalmeterolLong-acting beta-2 agonistSlower / around 12 hoursMaintenance treatment only, not as a reliever
TiotropiumLong-acting anticholinergicSlower / around 24 hoursMaintenance treatment, mainly in COPD
BudesonideInhaled cortisoneDays to weeksControls inflammation; the foundation in asthma
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Which checks make sense: at every appointment, your inhaler technique, symptom control — such as waking at night, a dry cough at night or limitations in everyday life — and how much reliever you use. Lung function regularly. With high doses, water tablets or heart disease, your potassium level; with diabetes, blood sugar at the start; with heart disease and QT-prolonging concomitant medicines, an ECG.¹,²

Your reliever use is your early warning system. Note down every extra puff with the date. If your use rises over two or three weeks, that is an objective signal that control is slipping — long before an attack comes. In your health history you can see this trend at a glance and show it at your appointment.

9. Special situations: pregnancy, heart, sport, stopping

Pregnancy and breastfeeding

Well-controlled asthma is the most important goal in pregnancy — for mother and child. On the basis of very extensive experience, Embryotox classifies formoterol as a drug of choice and considers its use in line with the asthma guidelines to be justifiable throughout pregnancy and during breastfeeding.⁶ So if you become pregnant, do not stop your inhalers, but talk to your practice; more in the guide medications during pregnancy.

Heart, thyroid, diabetes

According to the SmPC, particular caution is needed with an overactive thyroid, severe high blood pressure, coronary heart disease, heart rhythm disorders, severe heart failure, certain heart muscle diseases, aneurysms and an already prolonged QT interval.¹ This does not mean that formoterol is ruled out — many people with COPD in particular also have heart disease — but dose limits are strictly observed and new symptoms such as skipped heartbeats are taken seriously. In diabetes, blood sugar is checked more often at the start.

Sport and doping

According to the SmPC, formoterol can lead to positive results in doping tests. Under the Prohibited List of the World Anti-Doping Agency (WADA), inhaled formoterol is permitted up to a set maximum daily amount — if you take part in competitions, check the current list with NADA (Germany's National Anti Doping Agency). According to the SmPC, exercise-induced asthma that regularly requires extra puffs despite treatment is a sign of inadequate asthma control. More in the guide medications and exercise.

Stopping

There is no physical withdrawal syndrome. The risk lies elsewhere: in asthma, according to the guideline, treatment is only reduced after a period of stable control, and then step by step.² Which component is reduced first is decided by the practice — leaving out the cortisone and keeping only the beta-2 agonist is not an option. In COPD, leaving it out usually simply means more breathlessness and less stamina. What a planned attempt at reduction looks like is explained in the guide stopping medications.


10. Formoterol experiences: what patients really ask

"Formoterol works so quickly — can I use it as a reliever inhaler?"

That depends on the product and on your plan. If you have been explicitly prescribed a combination inhaler of cortisone and formoterol for as-needed use as well, yes — up to the set maximum number of puffs. A formoterol-only product, on the other hand, is not a reliever inhaler in asthma: every extra puff would widen the airways without tackling the inflammation. In COPD, according to the SmPC, extra puffs are possible up to a daily limit. Ask for your plan in writing — including which device is the right one in an emergency.

"I shake after inhaling. Should I be worried?"

Usually not. Tremor is the most typical side effect of beta-2 agonists and often eases after a few days to weeks. Watch whether it is linked to the number of puffs — if you are also taking a lot of salbutamol, the effects add up. If a racing heart, restlessness or muscle cramps come on top, have your pulse and potassium level checked.

"I feel fine. Do I even still need the cortisone in my combination inhaler?"

Feeling fine is often precisely thanks to the cortisone — the inflammation is under control, not gone. If you have asthma and leave out the cortisone while keeping only the beta-2 agonist, you will often go on feeling fine for weeks while the inflammation returns. A reduction is quite possible once control is stable, but as a planned step with your practice, not by quietly leaving it out.

"I have COPD and only a formoterol device. Isn't the cortisone missing?"

Not necessarily. In COPD, according to the guideline, a long-acting beta-2 agonist on its own is a standard treatment if the symptoms are mild to moderate and exacerbations are not frequent. In COPD, cortisone is only added in specific cases. But do ask whether you have been checked for asthmatic features — if so, the asthma rule applies.

Beta blocker eye drops and formoterol? The check takes a look

The interaction check reviews all your medicines — including those from other practices.

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FAQ: Common questions about formoterol

Formoterol widens the airways but does not treat the inflammation that underlies asthma. On its own, it can mask this inflammation and increase the risk of severe attacks. That is why in asthma it is only used together with inhaled cortisone, most safely in a combination device.
Yes. In COPD, according to the German National Disease Management Guideline, a long-acting beta-2 agonist such as formoterol is a standard maintenance treatment, on its own or combined with a long-acting anticholinergic. Inhaled cortisone is only added with certain features, such as frequent exacerbations with raised eosinophils. If there are also asthmatic features, however, the asthma rule applies.
According to the SmPC, the airway-widening effect sets in after one to three minutes and is still clearly present after twelve hours. This combination of a rapid onset and a long duration distinguishes formoterol from salbutamol, which works for only a few hours, and from salmeterol, which is slower to start working.
Only if it has been explicitly prescribed that way. Certain combinations of cortisone and formoterol are intended as maintenance and reliever medicine in one device, with a fixed maximum number of puffs per day. A formoterol-only product is not a reliever inhaler in asthma. Ask for your plan in writing.
Formoterol also acts on beta-2 receptors in the skeletal muscles. The tremor is a common, usually harmless side effect that often eases after a few days to weeks. If it gets worse, or if a racing heart and muscle cramps come on top, your dose, concomitant medicines and potassium level should be checked.
On the basis of extensive experience, the Embryotox advisory centre classifies formoterol as a drug of choice in pregnancy, in asthma together with inhaled cortisone. Well-controlled asthma protects mother and child. Do not stop your inhalers, but discuss your treatment with your practice.
Under the Prohibited List of the World Anti-Doping Agency, inhaled formoterol is permitted up to a set maximum daily amount. According to the SmPC, its use can nevertheless show up in doping tests. Competitive athletes should check the current list with NADA and document their treatment.

Sources

  1. Summary of Product Characteristics (SmPC) for formoterol 12 micrograms hard capsules with inhalation powder (e.g. Formoterol AL), sections 4.1 to 4.8, 5.1 and 5.2; supplemented by the SmPCs of the combination products — German source. fachinfo.de
  2. German National Disease Management Guideline (Nationale VersorgungsLeitlinie) on asthma, 5th edition (German Medical Association, National Association of Statutory Health Insurance Physicians, AWMF; AWMF reg. no. nvl-002, 2024) — German source. leitlinien.de
  3. Global Initiative for Asthma (GINA): Global Strategy for Asthma Management and Prevention, 2025 Update. ginasthma.org
  4. German National Disease Management Guideline (Nationale VersorgungsLeitlinie) on COPD, 2nd edition (AWMF reg. no. nvl-003, 2021; chapter on exacerbations added in 2024) — German source. leitlinien.de
  5. Global Initiative for Chronic Obstructive Lung Disease (GOLD): Global Strategy for the Diagnosis, Management, and Prevention of COPD, 2025 Report. goldcopd.org
  6. Embryotox, Charité Berlin — German pharmacovigilance and advisory centre for embryonic toxicology: formoterol in pregnancy and breastfeeding. Accessed 2026. embryotox.de

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Medical disclaimer: This article is for general information and does not replace medical advice, diagnosis or treatment. Never use formoterol for asthma without the prescribed cortisone treatment, and do not leave out inhaled cortisone on your own. Do not increase the number of puffs on your own — a rising need is a warning sign that has to be assessed by a doctor. In a severe asthma attack, if your breathlessness gets worse after inhaling, or if you have a racing heart with chest pain, call 112 (emergency number in Germany) immediately. The choice of medicine and the dose are always set individually by the treating practice. Last updated: September 2026.