What the label lists and what reports show
Salmeterol side effects
Salmeterol's FDA label: “Most common adverse reactions (incidence ≥5%) are: • Asthma: Headache, influenza, nasal/sinus congestion, pharyngitis, rhinitis, tracheitis/bronchitis.” FAERS holds 8,572 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (1,259 reports).
- No generic listed
- Boxed warning
Check it at the source: the salmeterol FDA label on DailyMed (effective October 10, 2022, GlaxoSmithKline LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of SEREVENT DISKUS?SEREVENT DISKUS can cause serious side effects, including: • See “What is the most important information I should know about SEREVENT DISKUS?” • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using SEREVENT DISKUS and call your healthcare provider right away. • effects on heart. ο increased blood pressure ο chest pain ο a fast or irregular heartbeat, awareness of heartbeat • effects on nervous system. ο tremor ο nervousness • serious allergic reactions. […]
Source: FDA drug label, GlaxoSmithKline LLC, effective October 10, 2022 (SPL set 12d9728e-6b5c-4aee-bfb0-745e542ed2e4), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥5%) are: • Asthma: Headache, influenza, nasal/sinus congestion, pharyngitis, rhinitis, tracheitis/bronchitis.
Table 3. Adverse Reactions with SEREVENT DISKUS with ≥3% Incidence in U.S. Controlled Clinical Trials in Subjects with Chronic Obstructive Pulmonary Disease a
| Reaction | Adverse Event SEREVENT DISKUS 50 mcg Twice Daily (n = 341) | Percent of Subjects Placebo (n = 576) |
|---|---|---|
| Hypertension | 4 | 2 |
| Throat irritation | 7 | 6 |
| Nasal congestion/blockage | 4 | 3 |
| Sinusitis | 4 | 2 |
| Ear signs and symptoms | 3 | 1 |
| Nausea and vomiting | 3 | 3 |
| Cough | 5 | 4 |
| Rhinitis | 4 | 2 |
| Viral respiratory infection | 5 | 4 |
| Musculoskeletal pain | 12 | 10 |
| Muscle cramps and spasms | 3 | 1 |
| Headache | 14 | 11 |
| Dizziness | 4 | 2 |
| Average duration of exposure (days) | 138.5 | 128.9 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedLABA, including salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without ICS) increase the risk of asthma-related death. Data from a large 28-week placebo-controlled U.S. trial that compared the safety of salmeterol or placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. Available data from controlled clinical trials suggest that LABA as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see Warnings and Precautions ( 5.1 ), Clinical Studies ( 14.1 )]. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reactions (incidence ≥5%) are: • Asthma: Headache, influenza, nasal/sinus congestion, pharyngitis, rhinitis, tracheitis/bronchitis. ( 6.1 ) • COPD: Cough, headache, musculoskeletal pain, throat irritation, viral respiratory infection. …
Source: FDA drug label, GlaxoSmithKline LLC, effective October 10, 2022 (SPL set 12d9728e-6b5c-4aee-bfb0-745e542ed2e4), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,572 reports list salmeterol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 960 are coded as a death and 2,485 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Salmeterol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions