Formoterol

Formoterol fumarate is a long-acting, beta 2 -adrenergic receptor agonist (beta 2 -agonist). Inhaled formoterol fumarate acts locally in the lung as a bronchodilator.

• 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. ( 1.1 ) Important limitations of use: Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease.ICD-10: J20.9, J44.9

• Use of a LABA, including formoterol fumarate, without an inhaled corticosteroid is contraindicated in patients with asthma [see WARNINGS and PRECAUTIONS ( 5.1 )]. Formoterol fumarate is not indicated for the treatment of asthma.contraindicated

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.

LABA as monotherapy (without inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 ) Do not initiate formoterol fumarate inhalation solution in acutely deteriorating patients. ( 5.2 ) Do not use for relief of acute symptoms. Concomitant short-acting beta 2 -agonists can be used as needed for acute relief. ( 5.2 ) 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. ( 5.3 , 5.5 ) Life-threatening paradoxical bronchospasm can occur. Discontinue formoterol fumarate inhalation solution immediately. ( 5.4 ) Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, or with sensitivity to sympathomimetic drugs. ( 5.6 , 5.7 ) 5.1 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.

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. Formoterol fumarate is not indicated for the treatment of asthma [see WARNINGS AND PRECAUTIONS ( 5.1 )]. Most common adverse reactions ( > 2% and more common than placebo) are diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc., at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. 6.2 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.

8.1 Pregnancy Risk Summary There are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Beta-agonists may interfere with uterine contractility (see Clinical Considerations) . In animal reproduction studies, oral administration of formoterol fumarate to pregnant rats and rabbits caused increased fetal malformations (rats and rabbits), decreased fetal weight (rats), and increased neonatal mortality (rats) following administration of doses that produced exposures approximately 730 to 29,000 times the MRHD on a mg/m 2 or AUC basis. These adverse effects generally occurred at large multiples of the MRHD when formoterol fumarate was administered by the oral route to achieve high systemic exposures. No effects were observed in a study with rats that received formoterol fumarate by the inhalation route at an exposure approximately 300 times the MRHD (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Metabolism

Information on the pharmacokinetics of formoterol (dry powder and/or inhalation solution) in plasma and/or urine is available in healthy subjects as well as patients with chronic obstructive pulmonary disease after oral inhalation of doses at and above the therapeutic dose. Urinary excretion of unchanged formoterol was used as an indirect measure of systemic exposure.

The expected signs and symptoms with overdosage of formoterol fumarate inhalation solution are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms listed under ADVERSE REACTIONS. Signs and symptoms may include angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, and metabolic acidosis. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an overdose of formoterol fumarate inhalation solution. Treatment of overdosage consists of discontinuation of formoterol fumarate inhalation solution together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of formoterol fumarate inhalation solution.

• Jul 21, 2006NDANDA021929Astrazeneca
• May 11, 2007NDANDA022007Viatris Specialty
• Jun 22, 2010NDANDA022518Organon Llc
• Apr 25, 2016NDANDA208294Astrazeneca
• Mar 29, 2019NDANDA210595Azurity
• Jul 23, 2020NDANDA212122Astrazeneca Ab
• Jun 22, 2021ANDAANDA091141Teva Pharms Usa Inc
• Nov 22, 2021ANDAANDA215078Alembic

1. 1Dyspnoea22,37718%
2. 2Asthma14,11111%
3. 3Cough10,1078.1%
4. 4Drug Ineffective8,5636.8%
5. 5Pneumonia7,0955.7%
6. 6Off Label Use6,8745.5%
7. 7Wheezing6,7475.4%
8. 8Fatigue6,6945.3%
9. 9Drug Dose Omission5,7894.6%
10. 10Headache5,7374.6%
11. 11Death5,4704.4%
12. 12Malaise5,4134.3%
13. 13Product Quality Issue5,0664.0%
14. 14Chronic Obstructive Pulmonary Disease5,0324.0%
15. 15Nausea4,8423.9%

Recent PubMed references pinned to Formoterol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Symptom Improvement with BDP/FF/G Fixed Triple Inhalation Powder in Moderate to Severe COPD Patients Uncontrolled with Dual Therapies: A Non-Interventional, Open-Label, Single-Arm, Prospective Study (RESPONSE Slovenia).
  COPD · 2026 · Harlander M, Šubic T, Eržen R, et al.
  PMID 42262307DOI 10.1080/15412555.2026.2681198
• Comparative Effectiveness and Safety of Fluticasone-Umeclidinium-Vilanterol and Beclomethasone-Glycopyrronium-Formoterol Single-Inhaler Triple Therapies for COPD: Real-World Observational Study.
  International journal of chronic obstructive pulmonary disease · 2026 · Cherian M, Dell'Aniello S, Suissa S, et al.
  PMID 42136913DOI 10.2147/COPD.S585037
• Outcomes of patients with COPD before and after initiation of treatment with budesonide/glycopyrrolate/formoterol fumarate: Results from the US ARCTOS study.
  Respiratory medicine · 2026 · Sethi S, Gozalo L, McMorrow D, et al.
  PMID 42009263DOI 10.1016/j.rmed.2026.108826
• Safety and tolerability of the low global warming potential propellant HFA-152a in patients with asthma receiving beclometasone dipropionate/formoterol fumarate/glycopyrronium: The TRECOS study.
  Respiratory medicine · 2026 · Singh D, Mancini L, Melis G, et al.
  PMID 41951188DOI 10.1016/j.rmed.2026.108814
• Evaluating Arrhythmia Risk in Patients with Chronic Obstructive Pulmonary Disease Treated with Aclidinium/Formoterol Fumarate and Other Inhaled Bronchodilators: A Post-Authorization Safety Study.
  International journal of chronic obstructive pulmonary disease · 2026 · Rebordosa C, Aguado J, Bartsch J, et al.
  PMID 41868726DOI 10.2147/COPD.S554888
• Fluticasone- vs Budesonide-Based Dual Therapy for COPD.
  JAMA network open · 2026 · Feldman WB, Ambati VL, Suissa S, et al.
  PMID 41801200DOI 10.1001/jamanetworkopen.2026.0959
• The β(2)-adrenoceptor agonist formoterol attenuates hallmarks of adrenal Cushing's syndrome.
  British journal of pharmacology · 2026 · Cleveland KH, Lee KS, Ponnalagu D, et al.
  PMID 41781352DOI 10.1111/bph.70370
• BDP/FF/GB single-inhaler triple therapy in COPD: real-world effectiveness, safety, and adherence in a pooled analysis of 5,000 patients.
  Respiratory medicine · 2026 · Brusselle G, Bakakos P, Stolz D, et al.
  PMID 41771375DOI 10.1016/j.rmed.2026.108743

The 10 most recently updated of 597 ClinicalTrials.gov registrations naming Formoterol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Clinical Trial Comparing TQC3927 Inhaled Powder With Glycopyrronium Bromide and Formoterol Inhaled Aerosol (Biovoping® Lingchang®) for the Treatment of Chronic Obstructive Pulmonary Disease
  Not yet recruiting · Phase 2 · Interventional · 90 enrolled · Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
  NCT07633314updated 2026-06-08
• A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation
  Recruiting · Phase 4 · Interventional · 56 enrolled · AstraZeneca
  NCT07073950updated 2026-06-03
• Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD
  Completed · Phase 3 · Interventional · 1,368 enrolled · Chiesi Farmaceutici S.p.A.
  NCT01917331updated 2026-06-03
• TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)
  Completed · Phase 3 · Interventional · 1,437 enrolled · Chiesi Farmaceutici S.p.A.
  NCT02676089updated 2026-05-29
• Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
  Recruiting · Phase 2 · Interventional · 1,147 enrolled · Sanofi
  NCT06676319updated 2026-05-27
• Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (TRIVERSYTI)
  Completed · Phase 3 · Interventional · 708 enrolled · Chiesi Farmaceutici S.p.A.
  NCT03197818updated 2026-05-27
• A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Different Devices in Participants Aged 4 to Less Than 12 Years Old With Asthma
  Active not recruiting · Phase 1 · Interventional · 15 enrolled · AstraZeneca
  NCT07433569updated 2026-05-26
• Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo
  Recruiting · Observational · 1,400 enrolled · AstraZeneca
  NCT07069829updated 2026-05-26
• An Exploratory Study on Triple Inhaler Therapy in Patients With Early Lung Function Impairment
  Not yet recruiting · Interventional · 23 enrolled · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  NCT07595796updated 2026-05-19
• A Translational Study to Describe Clinical Characteristics, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes in Chinese Population
  Recruiting · Observational · 355 enrolled · AstraZeneca
  NCT06419413updated 2026-05-19

Frequently asked questions

How does Formoterol work?

Formoterol fumarate is a long-acting, beta 2 -adrenergic receptor agonist (beta 2 -agonist). Inhaled formoterol fumarate acts locally in the lung as a bronchodilator.

What is Formoterol used for?

According to FDA labeling, Formoterol carries indications including: 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. ( 1.1 ) Important limitations of use: Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Formoterol?

Formoterol is classified as Selective beta-2-adrenoreceptor agonists, beta2-Adrenergic Agonist, Adrenergic beta2-Agonists, Monoamine Oxidase Inhibitors, Bronchodilation.

What are the brand names for Formoterol?

Formoterol is marketed under brand names including Bevespi, Breyna, Breztri, Duaklir, Dulera, Perforomist, Symbicort.

What are the contraindications for Formoterol?

Formoterol labeling lists contraindications including: Use of a LABA, including formoterol fumarate, without an inhaled corticosteroid is contraindicated in patients with asthma [see WARNINGS and PRECAUTIONS ( 5.1 )]. Formoterol fumarate is not indicated for the treatment of asthma.. Always consult the full prescribing information and a clinician.