Arformoterol

Mechanism-of-action class: Adrenergic beta2-Agonists.

• Arformoterol Tartrate 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: Arformoterol Tartrate Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease.ICD-10: J20.9, J44.9

• Arformoterol Tartrate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. Use of a LABA, including Arformoterol Tartrate Inhalation Solution, without an inhaled cortisteroid is contraindicated in patients with asthma [see Warnings and Precautions (5) ] .contraindicated

The recommended dose of Arformoterol Tartrate Inhalation Solution is one 15 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose of greater than 30 mcg (15 mcg twice daily) is not recommended. Arformoterol Tartrate Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor (see the accompanying Patient Information ). Arformoterol Tartrate Inhalation Solution should not be swallowed. Arformoterol Tartrate Inhalation Solution should be stored refrigerated in foil pouches. After opening the pouch, unused unit-dose vials should be returned to, and stored in, the pouch. An opened unit-dose vial should be used right away. 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 reevaluated and additional therapeutic options should be considered. No dose adjustment is required for patients with renal or hepatic impairment. However, since the clearance of Arformoterol Tartrate Inhalation Solution is prolonged in patients with hepatic impairment, they should be monitored closely. The drug compatibility (physical and chemical), efficacy, and safety of Arformoterol Tartrate Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 ) Do not initiate Arformoterol Tartrate Inhalation Solution in acutely deteriorating patients. ( 5.2 ) Do not use for relief of acute symptoms. Concomitant short-acting beta2-agonists can be used as needed for acute relief. ( 5.2 ) Do not exceed the recommended dose. Excessive use of Arformoterol Tartrate Inhalation Solution, or use in conjunction with other medications containing long-acting beta2-agonists, can result in clinically significant cardiovascular effects, and may be fatal. ( 5.3 , 5.5 ) Life-threatening paradoxical bronchospasm can occur. Discontinue Arformoterol Tartrate 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, Deaths The safety and efficacy of Arformoterol Tartrate Inhalation Solution in patients with asthma have not been established. Arformoterol Tartrate Inhalation Solution is not indicated for the treatment of asthma [see Contraindications (4) ]. Use of long-acting beta2-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 beta2-adrenergic agonists, such as Arformoterol Tartrate, as monotherapy (without inhaled corticosteroids) for asthma increase the risk of asthma-related events. Arformoterol Tartrate Inhalation Solution is not indicated for the treatment of asthma [see Warnings and Precautions (5.1 )]. Most common adverse reactions (≥2% incidence and more common than placebo) are pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema and lung disorder. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Fosun Pharma USA Inc. at 1-866-611-3762 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Beta 2 -Agonist Adverse Reaction Profile Adverse reactions to Arformoterol Tartrate 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, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia. 6.2 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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 clinical practice. Adults with COPD in Short-Term Trials (12 weeks) The safety data described below for adults ≥35 years of age are based on 2 clinical trials of 12 weeks.

Hepatic Impairment Use with caution in patients with hepatic impairment. ( 8.6 ) 8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women. Arformoterol Tartrate Inhalation Solution should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the fetus. Women should be advised to contact their physician if they become pregnant while taking Arformoterol Tartrate Inhalation Solution. In animal reproduction studies with arformoterol administered by the oral route to rats and rabbits at exposures approximately 370 and 8,400 times the adult exposure at the maximum recommended human daily inhalation dose (MRHDID) of 15 mcg every 12 hours, respectively, there were findings of structural abnormalities, embryofetal and infant mortality, and alterations of growth. These adverse effects generally occurred at large multiples of the MRHDID when arformoterol was administered by the oral route to achieve high systemic exposures. No evidence of fetal harm was observed in rabbits at an exposure approximately 4,900 times the MRHDID. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

The expected signs and symptoms associated with overdosage of Arformoterol Tartrate 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, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an overdose of Arformoterol Tartrate Inhalation Solution. Treatment of overdosage consists of discontinuation of Arformoterol Tartrate 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 Arformoterol Tartrate Inhalation Solution.

• Jun 22, 2021ANDAANDA213762Slate Run Pharma
• Jun 22, 2021ANDAANDA207306Cipla
• Feb 7, 2022ANDAANDA213068Lupin
• Mar 2, 2022ANDAANDA214736Ritedose Corp
• May 10, 2022ANDAANDA214779Alembic
• May 26, 2022ANDAANDA215385Sun Pharm
• Nov 15, 2022ANDAANDA216128Mankind Pharma
• Apr 2, 2024ANDAANDA214901Aiping Pharm Inc

1. 1Dyspnoea4421%
2. 2Fatigue2713%
3. 3Pneumonia2110%
4. 4Cough188.7%
5. 5Drug Ineffective188.7%
6. 6Chronic Obstructive Pulmonary Disease146.8%
7. 7Asthenia136.3%
8. 8Diarrhoea125.8%
9. 9Oxygen Saturation Decreased125.8%
10. 10Peripheral Swelling125.8%
11. 11Memory Impairment115.3%
12. 12Nausea115.3%
13. 13Pain104.8%
14. 14Pulmonary Oedema104.8%
15. 15Headache94.3%

Recent PubMed references pinned to Arformoterol 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 Arformoterol 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 Arformoterol work?

Mechanism-of-action class: Adrenergic beta2-Agonists.

What is Arformoterol used for?

According to FDA labeling, Arformoterol carries indications including: Arformoterol Tartrate 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: Arformoterol Tartrate 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 Arformoterol?

Arformoterol is classified as beta2-Adrenergic Agonist, Adrenergic beta2-Agonists, Bronchodilation.

What are the brand names for Arformoterol?

Arformoterol is marketed under brand names including Brovana.

What are the contraindications for Arformoterol?

Arformoterol labeling lists contraindications including: Arformoterol Tartrate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. Use of a LABA, including Arformoterol Tartrate Inhalation Solution, without an inhaled cortisteroid is contraindicated in patients with asthma [see Warnings and Precautions (5) ] .. Always consult the full prescribing information and a clinician.