Formoterol is an active pharmaceutical ingredient in the Selective Beta-2-Adrenoreceptor Agonists group (R03AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
USOfficial regulatory label· revised September 26, 2024[1]
1 INDICATIONS AND USAGE Formoterol fumarate inhalation solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
1 ) Important limitations of use: Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. 2 ) Formoterol fumarate inhalation solution is not indicated to treat asthma.
1 Maintenance Treatment of COPD Formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
2 )]. Formoterol fumarate inhalation solution is not indicated to treat asthma. The safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established.
EUEuropean Union· EMA
2 products
Uses
EUOfficial regulatory label· revised September 19, 2025[2]
1).
How to take
EUOfficial regulatory label· revised September 19, 2025
GBUnited Kingdom· MHRA
5 products
5 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Drug interactions
Known interactions involving Formoterol. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]FDA DailyMed · 0796acea-70d6-47… · revised September 26, 2024 [PDF]
[2]European Medicines Agency · EMEA/H/C/004983 · revised September 19, 2025
[3]MHRA (UK) · PLPI187991227 · revised August 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
How to take
USOfficial regulatory label· revised September 26, 2024[1]
2 DOSAGE AND ADMINISTRATION The recommended dose of formoterol fumarate inhalation solution is 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.
Formoterol fumarate inhalation solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor. The safety and efficacy of formoterol fumarate inhalation solution have been established in clinical trials when administered using the PARI-LC Plus ® nebulizer (with a facemask or mouthpiece) and the PRONEB ® Ultra compressor.
The safety and efficacy of formoterol fumarate inhalation solution delivered from non-compressor based nebulizer systems have not been established. Formoterol fumarate inhalation solution should always be stored in the foil pouch, and only removed IMMEDIATELY BEFORE USE.
Contents of any partially used container should be discarded. If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD.
Under these circumstances, the therapeutic regimen should be re-evaluated and additional therapeutic options should be considered. The drug compatibility (physical and chemical), efficacy, and safety of formoterol fumarate inhalation solution when mixed with other drugs in a nebulizer have not been established.
For oral inhalation only. One 20 mcg/2 mL vial every 12 hours. ( 2 ) For use with a standard jet nebulizer (with a facemask or mouthpiece) connected to an air compressor. ( 2 )
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised September 26, 2024[1]
6 ADVERSE REACTIONS Long-acting beta 2 -adrenergic agonists, such as formoterol fumarate, as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of asthma-related events. 1 )]. gov/medwatch. 1 Beta 2 -Agonist Adverse Reaction Profile Adverse reactions to formoterol fumarate inhalation solution are expected to be similar in nature to other beta 2 -adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, muscle cramps, palpitations, nausea, dizziness, fatigue, malaise, insomnia, hypokalemia, hyperglycemia, and metabolic acidosis.
2 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults with COPD The data described below reflect exposure to formoterol fumarate inhalation solution 20 mcg twice daily by oral inhalation in 586 patients, including 232 exposed for 6 months and 155 exposed for at least 1 year. Formoterol fumarate inhalation solution was studied in a 12-week, placebo-and active-controlled trial (123 subjects treated with formoterol fumarate inhalation solution) and a 52-week, active-controlled trial (463 subjects treated with formoterol fumarate inhalation solution).
33 L. Patients with significant concurrent cardiac and other medical diseases were excluded from the trials. Table 1 shows adverse reactions from the 12-week, double-blind, placebo-controlled trial where the frequency was greater than or equal to 2% in the formoterol fumarate inhalation solution group and where the rate in the formoterol fumarate inhalation solution group exceeded the rate in the placebo group.
4% for placebo. There were no frequently occurring specific cardiovascular adverse events for formoterol fumarate inhalation solution (frequency greater than or equal to 1% and greater than placebo). 9% for placebo. 4) 0 0 Patients treated with formoterol fumarate inhalation solution 20 mcg twice daily in the 52-week open-label trial did not experience an increase in specific clinically significant adverse events above the number expected based on the medical condition and age of the patients.
3 Postmarketing Experience The following adverse reactions have been reported during post-approval use of formoterol fumarate inhalation solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Anaphylactic reactions, urticaria, angioedema (presenting as face, lip, tongue, eye, pharyngeal, or mouth edema), rash, and bronchospasm
USOfficial regulatory label· Warnings and precautions· revised September 26, 2024[1]
5 WARNINGS AND PRECAUTIONS LABA as monotherapy (without inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. 1 ) Do not initiate formoterol fumarate inhalation solution in acutely deteriorating patients.
2 ) Do not use for relief of acute symptoms. Concomitant short-acting beta 2 -agonists can be used as needed for acute relief. 2 ) Do not exceed the recommended dose. Excessive use of formoterol fumarate inhalation solution or use in conjunction with other medications containing long-acting beta 2 -agonists, can result in clinically significant cardiovascular effects, and may be fatal.
5 ) Life-threatening paradoxical bronchospasm can occur. Discontinue formoterol fumarate inhalation solution immediately. 4 ) Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, or with sensitivity to sympathomimetic drugs.
1 Serious Asthma-Related Events – Hospitalizations, Intubations, Death The safety and efficacy of formoterol fumarate in patients with asthma have not been established. Formoterol fumarate is not indicated for the treatment of asthma [see CONTRAINDICATIONS ( 4 )] .
Use of long-acting beta 2 -adrenergic agonists (LABA) as monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients.
These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone.
A 28-week, placebo-controlled US study comparing the safety of another LABA (salmeterol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs.
34). The increased risk of asthma-related death is considered a class effect of the long-acting beta 2 -adrenergic agonists, including formoterol fumarate inhalation solution. No study adequate to determine whether the rate of asthma related death is increased in patients treated with formoterol fumarate inhalation solution has been conducted.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised September 26, 2024[1]
1 )]. Formoterol fumarate is not indicated for the treatment of asthma. Use of a LABA, including formoterol fumarate, without an inhaled corticosteroid is contraindicated in patients with asthma. ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
Posology The recommended and maximum dose is two inhalations twice daily (two inhalations in the morning and two inhalations in the evening). If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time.
A double dose should not be taken to make up for a forgotten dose. 2). Renal impairment This medicinal product can be used at the recommended dose in patients with mild to moderate renal impairment. 2). 3 Hepatic impairment This medicinal product can be used at the recommended dose in patients with mild to moderate hepatic impairment.
2). Paediatric population There is no relevant use of this medicinal product in children and adolescents (under 18 years of age) for the indication of COPD. Method of administration For inhalation use. Instructions for use To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient's inhalation technique.
The patient should be advised to read the package leaflet carefully and follow the instructions for use as given in the leaflet. It is important to instruct the patients to: • Not use the inhaler if the drying agent, which is inside the foil pouch, has leaked out of its packet.
For best results the inhaler should be at room temperature before use. • Prime the inhaler by shaking it well and actuating into the air four times before first use or two times when the inhaler has not been used for more than seven days, after weekly washing or if it has been dropped.
• Rinse their mouth out with water after inhaling the dose to minimise the risk of oropharyngeal thrush. Do not swallow. On actuation of Trixeo Aerosphere, a volume of the suspension is expelled from the pressurised container. When the patient inhales through the mouthpiece at the same time as actuating the inhaler, the substance will follow the inspired air into the airways.
Patients who find it difficult to coordinate actuation with inhalation may use Trixeo Aerosphere with a spacer to ensure proper administration of the medicinal product. 2).
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised September 19, 2025[2]
Summary of the safety profile The safety profile is characterised by corticosteroid, anticholinergic and β2-adrenergic class effects related to the individual components of the combination. 7%). Tabulated list of adverse reactions The tabulated list of adverse reactions is based on the experience with this medicinal product in clinical trials and experience with the individual components.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
g. 4) Not known Cardiac disorders Palpitations Common Angina pectoris Cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia and extrasystoles) Tachycardia Uncommon Respiratory, thoracic and mediastinal disorders Dysphonia Cough Common Bronchospasm Throat irritation Uncommon Gastrointestinal disorders Nausea Common Dry mouth Uncommon Skin and subcutaneous tissue disorders Bruising Uncommon Musculoskeletal and connective tissue disorders Muscle spasms Common Renal and urinary disorders Urinary retention Uncommon 9 System Organ Class Preferred term Frequency General disorders and administration site conditions Chest pain Uncommon Description of selected adverse reactions Pneumonia KRONOS was a 24-week study in a total of 1,896 patients with moderate to very severe COPD (mean post-bronchodilator screening FEV1 50% of predicted, standard deviation [SD] 14%), 26% of whom had experienced a COPD exacerbation in the year prior to study entry.
3% (4 patients) for open-labelled formoterol fumarate dihydrate/budesonide Turbuhaler (FOR/BUD) TBH 6/200 micrograms (n=318). ETHOS was a 52-week study in a total of 8,529 patients (in the safety population) with moderate to very severe COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 43% of predicted, SD 10%).
5% (96 subjects) FOR/BUD MDI 5/160 micrograms (n=2136). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised September 19, 2025[2]
e. as a rescue therapy. Paradoxical bronchospasm Administration of formoterol/glycopyrronium/budesonide may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life-threatening.
Treatment with this medicinal product should be discontinued immediately if paradoxical bronchospasm occurs. The patient should be assessed, and alternative therapy instituted if necessary. 4 Deterioration of disease It is recommended that treatment with this medicinal product should not be stopped abruptly.
If patients find the treatment ineffective, they should continue treatment, but medical attention must be sought. Increasing use of reliever bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the therapy.
Sudden and progressive deterioration in the symptoms of COPD is potentially life-threatening and the patient should undergo urgent medical assessment. g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium and formoterol.
This medicinal product should be used with caution in patients with clinically significant uncontrolled and severe cardiovascular disease such as unstable ischemic heart disease, acute myocardial infarction, cardiomyopathy, cardiac arrhythmias, and severe heart failure.
Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc >450 milliseconds for males, or >470 milliseconds for females), either congenital or induced by medicinal products.
Systemic corticosteroid effects Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids.
Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma. Potential effects on bone density should be considered particularly in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised September 19, 2025[2]
1.
This is not medical advice. Consult a qualified healthcare professional.
Clinical studies with formoterol fumarate administered as a dry powder inhaler suggested a higher incidence of serious asthma exacerbations in patients who received formoterol than in those who received placebo. The sizes of these studies were not adequate to precisely quantify the differences in serious asthma exacerbation rates between treatment groups.
Available data do not suggest an increased risk of death with use of LABA in patients with COPD. 2 Deterioration of Disease and Acute Episodes Formoterol fumarate inhalation solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.
Formoterol fumarate inhalation solution has not been studied in patients with acutely deteriorating COPD. The use of formoterol fumarate inhalation solution in this setting is inappropriate. , as rescue therapy for the treatment of acute episodes of bronchospasm.
Formoterol fumarate inhalation solution has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled short-acting beta 2 -agonist. , four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms.
When prescribing formoterol fumarate inhalation solution, the healthcare provider should also prescribe an inhaled, short-acting beta 2 -agonist and instruct the patient how it should be used. Increasing inhaled beta 2 -agonist use is a signal of deteriorating disease for which prompt medical attention is indicated.
COPD may deteriorate acutely over a period of hours or chronically over several days or longer. If formoterol fumarate inhalation solution no longer controls the symptoms of bronchoconstriction, or the patient’s inhaled, short-acting beta 2 -agonist becomes less effective or the patient needs more inhalation of short-acting beta 2 -agonist than usual, these may be markers of deterioration of disease.
In this setting, a re-evaluation of the patient and the COPD treatment regimen should be undertaken at once. Increasing the daily dosage of formoterol fumarate inhalation solution beyond the recommended 20 mcg twice daily dose is not appropriate in this situation.
3 Excessive Use and Use with Other Long-Acting Beta 2 -Agonists As with other inhaled beta 2 -adrenergic drugs, formoterol fumarate inhalation solution should not be used more often, at higher doses than recommended, or in conjunction with other medications containing long-acting beta 2 -agonists, as an overdose may result.
Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. 4 Paradoxical Bronchospasm As with other inhaled beta 2 -agonists, formoterol fumarate inhalation solution can produce paradoxical bronchospasm that may be life-threatening.
If paradoxical bronchospasm occurs, formoterol fumarate inhalation solution should be discontinued immediately and alternative therapy instituted. 5 Cardiovascular Effects Formoterol fumarate inhalation solution, like other beta 2 -agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic and/or diastolic blood pressure, and/or symptoms.
If such effects occur, formoterol fumarate inhalation solution may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression.
The clinical significance of these findings is unknown. Therefore, formoterol fumarate inhalation solution, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
6 Coexisting Conditions Formoterol fumarate inhalation solution, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to sympathomimetic amines.
Doses of the related beta 2 -agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. 2 )]. The decrease in serum potassium is usually transient, not requiring supplementation.
Beta-agonist medications may produce transient hyperglycemia in some patients. Clinically significant changes in serum potassium and blood glucose were infrequent during clinical studies with long-term administration of formoterol fumarate inhalation solution at the recommended dose.
8 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of formoterol fumarate inhalation solution, as demonstrated by cases of anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm.
Visual disturbances Visual disturbance may be reported with systemic and topical corticosteroid use. 8). Transfer from oral therapy Particular care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time.
Patients who have required high dose corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress.
Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Pneumonia in patients with COPD An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.
There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies. There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
5 Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.
Hypokalaemia Potentially serious hypokalaemia may result from β2-agonist therapy. This has the potential to produce adverse cardiovascular effects. Particular caution is advised in severe COPD as this effect may be potentiated by hypoxia.
5). Hyperglycaemia Inhalation of high doses of β2-adrenergic agonists may produce increases in plasma glucose. Therefore, blood glucose should be monitored during treatment following established guidelines in patients with diabetes. Co-existing conditions This medicinal product should be used with caution in patients with thyrotoxicosis.
Anticholinergic activity Due to its anticholinergic activity, this medicinal product should be used with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using this medicinal product and to contact their doctor immediately should any of these signs or symptoms develop.
5). 2). Hepatic impairment In patients with severe […]