Last reviewed 2026-04-20 · How we verify

SALMETEROL XINAFOATE

Salmeterol xinafoate is a marketed drug primarily indicated for the treatment of asthma. A key strength is its established market presence, supported by a key composition patent expiring in 2028. The primary risk is the eventual patent expiry, which could lead to increased competition from generics.

At a glance

Approved indications

• Treatment of Asthma
• Prevention of Exercise-Induced Bronchospasm
• Maintenance Treatment of COPD

Boxed warnings

• WARNING: ASTHMA-RELATED DEATH Long-acting beta 2 -adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without inhaled corticosteroids [ICS]) increase the risk of asthma-related death. Data from a large placebo-controlled U.S. trial that compared the safety of salmeterol with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 subjects on placebo). Use of background ICS was not required in this study. 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. Use of SEREVENT DISKUS for the treatment of asthma as monotherapy without a concomitant ICS is contraindicated. Use SEREVENT DISKUS only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ICS. Do not use SEREVENT DISKUS for patients whose asthma is adequately controlled on low- or medium-dose ICS. Pediatric and Adolescent Patients Available data from controlled clinical trials suggest that LABA as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an ICS, a fixed-dose combination product containing both an ICS and a LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of an ICS and a LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an ICS and a LABA is recommended. WARNING: ASTHMA-RELATED DEATH See full prescribing information for complete boxed warning. • Long-acting beta 2 -adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without inhaled corticosteroids [ICS]) increase the risk of asthma - related death. A U.S. trial showed an increase in asthma - related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 out of 13,179 subjects on placebo). 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. ( 5.1 ) • Prescribe SEREVENT DISKUS only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ICS. Do not use SEREVENT DISKUS for patients whose asthma is adequately controlled on low- or medium-dose ICS. ( 1.1 , 5.1 ) • Available data from controlled clinical trials suggest that LABA as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent patients. ( 5.1 )

Common side effects

• Headache
• Upper respiratory tract infection
• Throat irritation
• Musculoskeletal pain
• Nausea and vomiting
• Muscle pain
• Viral respiratory infection
• Upper respiratory inflammation
• Viral gastrointestinal infection
• Gastrointestinal signs and symptoms
• Dizziness
• Hoarseness/dysphonia

Serious adverse events

• Myocardial infarction
• Arrhythmias
• Tachycardia
• Lower respiratory hemorrhage
• Lower respiratory infections
• Postoperative complications
• Bacterial infections
• Gastrointestinal infections
• Bacterial reproductive infections
• Candidiasis unspecified site

Drug interactions

• Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole)
• Monoamine oxidase inhibitors and tricyclic antidepressants
• Beta-blockers
• Non–potassium-sparing diuretics (such as loop or thiazide diuretics)

Key clinical trials

• Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (PHASE2)
• Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation (NA)
• A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma. (PHASE3)
• Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma (PHASE4)
• Advair HFA in Healthy and HAPE Predisposed Subjects (PHASE1, PHASE2)
• Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation (PHASE3)
• ANTES B+ Clinical Trial (PHASE4)
• Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion (NA)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• SALMETEROL XINAFOATE CI brief — competitive landscape report
• SALMETEROL XINAFOATE updates RSS · CI watch RSS