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Salmeterol Side Effects

The most commonly reported side effects of salmeterol include dyspnoea, asthma, and cough, based on 135,982 FDA adverse event reports from 2004 to 2025. 7.1% of reports found the drug to be ineffective.

Salmeterol side effects

Percentages show how often each reaction appears relative to total reports for salmeterol.

1
Dyspnoea11.6%15,831
2
Asthma7.3%9,918
3
Drug Ineffective7.1%9,624
4
Cough5.3%7,227
5
Pneumonia5.1%6,903
6
Wheezing3.8%5,227
7
Malaise3.8%5,155
8
Fatigue3.7%5,095
9
Dyspnoea3.6%4,894
10
Drug Ineffective3.4%4,650
11
Headache3.4%4,602
12
Off Label Use3.2%4,302
13
Product Quality Issue3.1%4,267
14
Pain3.1%4,245
15
Nausea2.8%3,774

These are voluntary reports and do not establish that salmeterol caused these reactions.

Report severity

52.6%Serious71,592 reports
27.0%Hospitalizations36,745 reports
6.0%Fatal8,193 reports

Seriousness is determined by the reporter, not by OpenClaim.

Salmeterol drug interactions

Other drugs that appear in adverse event reports alongside salmeterol. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Fluticasone43.8%59,626
2
Albuterol8.7%11,772
3
Tiotropium-bromide6.0%8,224
4
Omalizumab4.1%5,591
5
Montelukast-sodium2.9%3,951
6
Prednisone2.6%3,550
7
Dupilumab2.4%3,314
8
Adalimumab2.3%3,149
9
Mepolizumab2.1%2,793
10
Budesonide1.9%2,574
11
Vilanterol-trifenatate1.9%2,540
12
Ipratropium-bromide1.8%2,490
13
Lenalidomide1.4%1,904
14
Formoterol1.4%1,841
15
Sodium-oxybate1.3%1,820

Taken alongside

1
Fluticasone52.5%71,409
2
Albuterol34.7%47,225
3
Montelukast-sodium15.2%20,621
4
Tiotropium-bromide11.4%15,521
5
Acetaminophen11.0%14,956
6
Aspirin10.9%14,791
7
Prednisone10.0%13,628
8
Levothyroxine-sodium9.5%12,867
9
Furosemide9.3%12,660
10
Ergocalciferol8.9%12,148
11
Omeprazole8.7%11,794
12
Atorvastatin-calcium7.4%10,079
13
Ipratropium-bromide7.1%9,589
14
Lisinopril6.3%8,600
15
Gabapentin6.2%8,391

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports salmeterol side effects

63.0% of salmeterol adverse event reports involve female patients and 31.6% involve male patients. The largest age group is adult at 51%. These figures reflect who reports side effects, not underlying risk.

Sex

Female63.0%
Male31.6%
Unknown5.4%

Age group

< 20.1%
2–111.9%
12–171.7%
18–6451.1%
65+45.2%

What is salmeterol used for

Conditions and purposes for which patients were taking salmeterol when the adverse event was reported.

AbasiaAbuliaAccidentAccidental Exposure To ProductAcneAcute Myocardial InfarctionAcute Respiratory Distress SyndromeAcute SinusitisAdhesionAdverse Drug ReactionAdverse EventAffective DisorderAgitationAllergic BronchitisAllergic Cough

Showing 15 of 580 indications

Salmeterol brand names and reporting trend

Salmeterol is sold under the brand name Fluticasone Propionate And Salmeterol Xinafoate.

Brand names

Fluticasone Propionate And Salmeterol Xinafoate5,540

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking salmeterol with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.