Salmeterol

ATC code

R03AC12

Therapeutic class

Long-acting beta-2 adrenergic agonist (LABA) · Selective beta-2 adrenergic receptor agonist

Forms

inhalation powder, inhalation aerosol

Brand names

Serevent (US) · Beglan (ES) · Advair (US) · Seretide (EU)

Overall confidence

high

Regulatory sources consulted

openfda-label-b6d73632-205b-4d93-bc38-f520fd6c189b
aemps-cima-ft-59522
ansm-bdpm-rcp-69518205
PubMed PMID:40841147 ↗
PubMed PMID:38925076 ↗
PubMed PMID:39696097 ↗
PubMed PMID:35727177 ↗
CredibleMeds.org
OpenFDA · R03AC12
RxNorm rxcui 36117 ↗

Approved indications

Maintenance treatment of asthma and prevention of symptoms, in combination with an inhaled corticosteroid (ICS), in patients not adequately controlled on an ICS alone.
Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema.
Not indicated for the relief of acute bronchospasm.

Contraindications

Absolute

Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures.
Severe hypersensitivity to milk proteins (for powder formulations containing lactose) or to any of the components.

Clinical warnings

Boxed warning · Serious asthma-related events - hospitalizations, intubations, death. Long-acting beta-2 adrenergic agonists (LABA) such as salmeterol increase the risk of asthma-related death. Use only in combination with an inhaled corticosteroid (ICS) in patients with asthma. — FDA
Major warning · Paradoxical bronchospasm may occur, which can be life-threatening. If it occurs, discontinue treatment immediately. — ANSM
Cardiovascular and central nervous system effects, such as increased blood pressure, heart rate, and QTc interval prolongation. — FDA

Drug interactions

HighStrong CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)J02AB02
Mechanism: Potent inhibition of CYP3A4 significantly increases systemic exposure to salmeterol (AUC increased 15-fold with ketoconazole), increasing the risk of cardiovascular adverse effects.
Recommendation: Avoid co-administration. If unavoidable, monitor closely for cardiovascular adverse effects, including the QTc interval.
ANSM RCP
HighBeta-blockersC07
Mechanism: Pharmacologic antagonism at beta-2 receptors, blocking the bronchodilator effect of salmeterol and potentially causing severe bronchospasm in patients with asthma.
Recommendation: Concomitant use is generally contraindicated in patients with asthma. If necessary, consider cardioselective beta-blockers with extreme caution.
FDA labelANSM RCP
ModerateNon-potassium-sparing diureticsC03
Mechanism: Beta-agonists may acutely worsen ECG changes and/or hypokalemia induced by diuretics (loop or thiazide).
Recommendation: Use with caution. Consider monitoring potassium levels.
FDA label

Adverse events

Common (≥1%)

headache · palpitations · tremor · nasopharyngitis · cough

Rare but serious

paradoxical bronchospasm · hypokalemia · cardiac arrhythmias · anaphylaxis · hyperglycemia

Pregnancy and lactation

There are no adequate and well-controlled studies in pregnant women. Poorly controlled asthma during pregnancy is associated with adverse outcomes. Use only if the potential benefit justifies the potential risk to the fetus.

Recent literature (PubMed)

A review of the efficacy and safety of fluticasone propionate/formoterol fixed-dose combination.
Kilaru SC, et al. · Expert Rev Respir Med · 2022 · Relevance 4/5
Revisión que evalúa la combinación de fluticasona/formoterol. Concluye que tiene una eficacia no inferior y un perfil de seguridad comparable a otras combinaciones CSI/LABA, incluyendo fluticasona/salmeterol, para el tratamiento del asma persistente y la EPOC moderada-severa.
The effect of different inhaled corticosteroid and long-acting bronchodilator combinations on the airway microbiome in patients with severe COPD: a randomised trial (MUSIC).
Richardson H, et al. · Eur Respir J · 2025 · Relevance 4/5
Ensayo aleatorizado en EPOC grave que compara diferentes combinaciones de CSI/LABA. Se observó un aumento significativo en la carga bacteriana en esputo con fluticasona/salmeterol 500/50 µg (FS500) en comparación con budesonida/formoterol al cabo de 3 meses, sin diferencias en la carga bacteriana de las vías respiratorias altas.
[COPD inhaled therapy narrative review].
Villar Martínez M, et al. · Semergen · 2024 · Relevance 3/5
Revisión narrativa sobre la terapia inhalada en EPOC. Sugiere que en la terapia dual LABA/ICS, la combinación budesonida/formoterol parece ofrecer un mejor control que fluticasona/salmeterol, aunque no se observan fármacos superiores en las combinaciones triples o LAMA/LABA.
Evaluation of comparative efficacy of Umeclidinium/Vilanterol versus other bronchodilators in the management of chronic obstructive pulmonary disease: a systematic review and meta-analysis of RCTs.
Zhu H, et al. · BMC Pulm Med · 2024 · Relevance 2/5
Metaanálisis que evalúa la eficacia de Umeclidinio/Vilanterol (UMEC/VI) en EPOC. Los resultados muestran que las combinaciones LABA/LAMA y las terapias triples mejoran significativamente la función pulmonar y la calidad de vida. Salmeterol fue parte de los regímenes comparadores.