Salmeterol Xinafoate side effects: what 8,570 FDA adverse event reports show
Drug class
Laba
Brand names
Serevent Diskus
Who reports
8,570 reports · 59% serious · 960 with death outcome · 64% female
Used for
SEREVENT DISKUS is a LABA indicated for: • Treatment of asthma in patients aged 4 years and older with an ICS. ( 1.1 ) • Prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older. ( 1.2 ) • Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). ( 1.3 ) Important limitation of use: Not indicated for relief of acute bronchospasm.
What it is
The active component of SEREVENT DISKUS is salmeterol xinafoate, a beta 2 -adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol.
Boxed 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.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,027 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Antacid therapy | 28 | 742.7 486.5–1,133.8ROR 745.1 · χ² 15,298 / p <1e-300 | 408.9 EB05 296.9 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=28 · 100% clinician | no trial data cached |
| Fractional exhaled nitric oxide increased | 32 | 555.7 378.6–815.6ROR 557.8 · χ² 13,955 / p <1e-300 | 355.6 EB05 263.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 0% (drug 64%) | no trial data cached |
| Sleep disorder therapy | 22 | 327.8 210.1–511.5ROR 328.6 · χ² 6,026 / p <1e-300 | 231.0 EB05 160.8 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=22 · 100% clinician | no trial data cached |
| Central nervous system mass | 11 | 327.8 174.7–615.2ROR 328.2 · χ² 2,874 / p <1e-300 | 192.7 EB05 114.8 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Analgesic therapy | 33 | 295.0 205.7–423.2ROR 296.2 · χ² 8,357 / p <1e-300 | 228.3 EB05 170.1 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious n=33 · 100% clinician | no trial data cached |
| Drug therapy | 33 | 281.5 196.4–403.4ROR 282.6 · χ² 8,010 / p <1e-300 | 220.1 EB05 164.0 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious n=33 · 100% clinician | no trial data cached |
| Anticoagulant therapy | 28 | 274.7 186.0–405.9ROR 275.6 · χ² 6,613 / p <1e-300 | 211.3 EB05 153.4 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=28 · 100% clinician | no trial data cached |
| Wall motion score index abnormal | 11 | 270.9 145.3–505.1ROR 271.3 · χ² 2,423 / p <1e-300 | 171.7 EB05 102.3 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Cerebral artery thrombosis | 46 | 239.3 176.9–323.7ROR 240.6 · χ² 9,716 / p <1e-300 | 199.8 EB05 155.9 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 0% (drug 64%) | no trial data cached |
| Airway remodelling | 11 | 237.1 127.7–440.2ROR 237.4 · χ² 2,144 / p <1e-300 | 157.5 EB05 93.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Ventilation perfusion mismatch | 23 | 222.1 145.0–340.2ROR 222.7 · χ² 4,435 / p <1e-300 | 174.2 EB05 122.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 64%) · 100% clinician | no trial data cached |
| Brain scan abnormal | 46 | 219.0 162.1–295.9ROR 220.2 · χ² 8,954 / p <1e-300 | 185.5 EB05 144.7 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=46 · ♀ 0% (drug 64%) | no trial data cached |
| Appendicolith | 31 | 217.5 150.7–314.0ROR 218.3 · χ² 5,932 / p <1e-300 | 177.9 EB05 131.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=31 · 100% clinician | no trial data cached |
| Status asthmaticus | 37 | 205.3 146.9–287.0ROR 206.2 · χ² 6,746 / p <1e-300 | 172.6 EB05 130.8 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=37 | no trial data cached |
| Hoarseness | 35 | 189.4 134.4–267.0ROR 190.2 · χ² 5,909 / p <1e-300 | 160.5 EB05 120.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | ♀ 86% (drug 64%) · 100% consumer | no trial data cached |
| Chronic obstructive airways disease exacerbated | 22 | 163.9 106.5–252.3ROR 164.3 · χ² 3,185 / p <1e-300 | 135.7 EB05 94.5 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
| Total lung capacity abnormal | 19 | 128.5 81.0–203.7ROR 128.8 · χ² 2,162 / p <1e-300 | 108.9 EB05 73.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Dyspnoea exacerbated | 26 | 128.3 86.6–190.3ROR 128.7 · χ² 3,000 / p <1e-300 | 112.1 EB05 80.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | 71% consumer | no trial data cached |
| Congenital hiatus hernia | 11 | 127.7 69.6–234.0ROR 127.8 · χ² 1,195 / p 3e-262 | 100.6 EB05 60.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Spirometry abnormal | 27 | 117.9 80.1–173.3ROR 118.2 · χ² 2,872 / p <1e-300 | 104.3 EB05 75.3 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=27 · ♀ 0% (drug 64%) | no trial data cached |
| Mite allergy | 26 | 103.9 70.2–153.8ROR 104.2 · χ² 2,443 / p <1e-300 | 93.0 EB05 66.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 64%) | no trial data cached |
| Atopy | 11 | 100.6 55.0–183.8ROR 100.7 · χ² 948 / p 2e-208 | 83.1 EB05 49.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Pulmonary vasculitis | 19 | 91.2 57.7–144.1ROR 91.4 · χ² 1,547 / p <1e-300 | 81.0 EB05 54.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Multi-organ disorder | 66 | 84.1 65.9–107.4ROR 84.8 · χ² 5,158 / p <1e-300 | 79.5 EB05 64.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=66 · ♀ 100% (drug 64%) | no trial data cached |
| Hypoaesthesia eye | 19 | 82.0 52.0–129.5ROR 82.2 · χ² 1,394 / p <1e-300 | 73.7 EB05 49.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Mycotic allergy | 27 | 81.0 55.2–118.7ROR 81.2 · χ² 1,986 / p <1e-300 | 74.4 EB05 53.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 0% (drug 64%) | no trial data cached |
| Dust allergy | 25 | 65.1 43.8–96.8ROR 65.3 · χ² 1,475 / p <1e-300 | 60.6 EB05 43.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 0% (drug 64%) | no trial data cached |
| Allergic granulomatous angiitis | 21 | 63.4 41.1–97.7ROR 63.5 · χ² 1,196 / p 2e-262 | 58.6 EB05 40.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Antineutrophil cytoplasmic antibody positive | 18 | 62.0 38.8–98.9ROR 62.1 · χ² 994 / p 2e-218 | 57.0 EB05 38.1 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=18 | no trial data cached |
| Bronchitis acute | 10 | 61.7 33.0–115.6ROR 61.8 · χ² 525 / p 2e-116 | 54.3 EB05 31.5 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=9 | no trial data cached |
| Inhalation therapy | 15 | 58.9 35.3–98.2ROR 59.0 · χ² 778 / p 2e-171 | 53.8 EB05 34.6 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Peak expiratory flow rate decreased | 10 | 56.7 30.3–106.0ROR 56.7 · χ² 481 / p 6e-107 | 50.4 EB05 29.3 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Obstructive sleep apnoea syndrome | 31 | 55.6 38.9–79.3ROR 55.8 · χ² 1,571 / p <1e-300 | 52.7 EB05 38.9 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=31 · ♀ 0% (drug 64%) | no trial data cached |
| Myoglobin blood increased | 32 | 52.1 36.7–73.9ROR 52.3 · χ² 1,521 / p <1e-300 | 49.6 EB05 36.8 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=32 · ♀ 0% (drug 64%) | no trial data cached |
| Postnasal drip | 11 | 49.2 27.1–89.3ROR 49.2 · χ² 463 / p 6e-103 | 44.7 EB05 26.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Areflexia | 51 | 47.3 35.9–62.4ROR 47.6 · χ² 2,223 / p <1e-300 | 45.7 EB05 36.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 9% (drug 64%) | no trial data cached |
| Conjunctivitis allergic | 26 | 44.3 30.0–65.2ROR 44.4 · χ² 1,038 / p 6e-228 | 42.2 EB05 30.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 64%) | no trial data cached |
| Blood cortisol decreased | 11 | 42.2 23.3–76.6ROR 42.3 · χ² 395 / p 3e-88 | 38.9 EB05 23.2 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Anoxic encephalopathy | 11 | 42.0 23.2–76.2ROR 42.1 · χ² 393 / p 7e-88 | 38.8 EB05 23.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Eosinophilic granulomatosis with polyangiitis | 34 | 41.9 29.9–58.8ROR 42.1 · χ² 1,294 / p 1e-283 | 40.3 EB05 30.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 0% (drug 64%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 1,259 | 5.5 5.2–5.7ROR 6.2 · χ² 4,695 / p <1e-300 | 5.4 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Drug ineffective (drug did not work) | 1,228 | 2.3 2.2–2.4ROR 2.5 · χ² 943 / p 2e-207 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.9 · 81% consumer | no trial data cached |
| Asthma | 910 | 20.0 18.8–21.3ROR 22.3 · χ² 16,378 / p <1e-300 | 19.9 EB05 18.8 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 22.6 | no trial data cached |
| Cough | 589 | 5.2 4.8–5.6ROR 5.5 · χ² 1,994 / p <1e-300 | 5.1 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Headache | 465 | 1.8 1.7–2.0ROR 1.9 · χ² 175 / p 2e-40 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Pneumonia (lung infection) | 408 | 3.1 2.8–3.4ROR 3.2 · χ² 583 / p 3e-129 | 3.1 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Nausea | 400 | 1.2 1.1–1.4ROR 1.3 · χ² 19 / p 6e-6 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Wheezing | 372 | 15.5 14.0–17.1ROR 16.1 · χ² 5,006 / p <1e-300 | 15.4 EB05 14.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 | no trial data cached |
| Dizziness | 367 | 1.8 1.6–2.0ROR 1.8 · χ² 134 / p 3e-31 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Chest discomfort | 355 | 8.5 7.7–9.5ROR 8.9 · χ² 2,360 / p <1e-300 | 8.5 EB05 7.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Fatigue (tiredness) | 354 | 1.1 1.0–1.2ROR 1.1 · χ² 4 / p 0.020 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Pharmaceutical product complaint | 318 | 29.9 26.8–33.3ROR 31.0 · χ² 8,756 / p <1e-300 | 29.5 EB05 26.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · 86% consumer | no trial data cached |
| Chest pain | 307 | 4.1 3.6–4.5ROR 4.2 · χ² 708 / p 3e-156 | 4.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Malaise (feeling unwell) | 296 | 1.6 1.5–1.8ROR 1.7 · χ² 76 / p 1e-18 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Diarrhoea (diarrhea) | 283 | 1.1 1.0–1.2ROR 1.1 · χ² 2 / p 0.109 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Fractional exhaled nitric oxide increased — n=32, PRR 555.7
- Cerebral artery thrombosis — n=46, PRR 239.3
- Ventilation perfusion mismatch — n=23, PRR 222.1
- Appendicolith — n=31, PRR 217.5
- Hoarseness — n=35, PRR 189.4
- Dyspnoea exacerbated — n=26, PRR 128.3
- Mite allergy — n=26, PRR 103.9
- Multi-organ disorder — n=66, PRR 84.1
- Mycotic allergy — n=27, PRR 81.0
- Dust allergy — n=25, PRR 65.1
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Salmeterol Xinafoate?
In FDA FAERS, the most frequently co-reported reaction terms for Salmeterol Xinafoate are dyspnoea, asthma, cough, headache, pneumonia, nausea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Salmeterol Xinafoate have an FDA boxed warning?
Yes. The current FDA label carries a boxed 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.
Do FAERS signals prove that Salmeterol Xinafoate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 12d9728e-6b5c-4aee-bfb0-745e542ed2e4, effective 20221010; matched on
openfda.generic_name.exact:"SALMETEROL XINAFOATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,067 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.