Prescription medicine
Salmeterol Brand names: Serevent
Salmeterol (Serevent) is a prescription medicine with an FDA approval on record since 1994. No generic is listed; pharmacies paid $6.74 per unit (Serevent diskus 50 mcg) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the salmeterol FDA label on DailyMed (effective October 10, 2022, GlaxoSmithKline LLC); the NDA 20236 record on Drugs@FDA; every salmeterol label on DailyMed.
Highlights of the record
FDA label of October 10, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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. […]
Used for
From the label: indications and usageSEREVENT DISKUS is a LABA indicated for:
Treatment of asthma in patients aged 4 years and older with an ICS.
Forms and strengths
Powder (metered).
On the market
- Earliest approval on file
- February 4, 1994 Serevent, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $6.74 per unit Serevent diskus 50 mcg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,572 through July 30, 2026
What is salmeterol used for?
From the label: indications and usageSEREVENT 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. […]
Conditions named in the indications of salmeterol's FDA labels, with every medicine labeled for each:
From other salmeterol labelsCOPD: Treatment of Chronic Obstructive Pulmonary Disease SEREVENT DISKUS is indicated for the long-term twice-daily administration in the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) …
FDA pharmacologic class: beta2-Adrenergic Agonist.
Source: FDA drug label (SEREVENT DISKUS), GlaxoSmithKline LLC, effective October 10, 2022 (SPL set 12d9728e-6b5c-4aee-bfb0-745e542ed2e4), via openFDA; the full label on DailyMed
What does the patient leaflet for salmeterol say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SEREVENT DISKUS?SEREVENT DISKUS can cause serious side effects, including: • People with asthma who take long-acting beta 2 -adrenergic agonist (LABA) medicines, such as salmeterol (the medicine in SEREVENT DISKUS), have an increased risk of death from asthma problems if they use SEREVENT DISKUS without also using a medicine called an inhaled corticosteroid (ICS). • Call your healthcare provider if breathing problems worsen over time while using SEREVENT DISKUS. You may need different treatment. • Get emergency medical care if: • your breathing problems worsen quickly. • you use your rescue inhaler, but it does not relieve your breathing problems. • Do not use SEREVENT DISKUS as your only asthma medicine. SEREVENT DISKUS must only be used with an ICS. • SEREVENT DISKUS should be used only if your healthcare provider decides that your asthma is not well controlled with an ICS. • Children and adolescents who take LABA medicines as their only asthma medicine may have an increased risk of being hospitalized for asthma problems.
From the patient leaflet: How should I store SEREVENT DISKUS?Store SEREVENT DISKUS at room temperature between 68°F and 77°F (20°C and 25°C). • Store SEREVENT DISKUS in a dry place away from heat and sunlight. • Store SEREVENT DISKUS in the unopened foil pouch and only open when ready for use. • Safely throw away SEREVENT DISKUS in the trash 6 weeks after you open the foil pouch or when the counter reads “0”, whichever comes first. Write the date you open the pouch on the label on the inhaler. Keep SEREVENT DISKUS and all medicines out of the reach of children.
Source: FDA drug label (SEREVENT DISKUS), GlaxoSmithKline LLC, effective October 10, 2022 (SPL set 12d9728e-6b5c-4aee-bfb0-745e542ed2e4), via openFDA; the full label on DailyMed
Is there a generic for salmeterol (Serevent)?
No generic salmeterol is approved (Drugs@FDA, October 8, 2026).
- 1994 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for salmeterol (Serevent)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $6.74 per unit (Serevent diskus 50 mcg), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Serevent diskus 50 mcg (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Serevent diskus 50 mcg | Brand | $6.74 per unit | n/a | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the salmeterol label say about other medicines?
The salmeterol label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 27 other medicines name salmeterol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Albuterol | warnings and precautions | In the SNS trial, the rate of asthma-related death was numerically, though not statistically significantly, greater in subjects with asthma treated with salmeterol (42 mcg twice daily) than those treated with albuterol (180 mcg 4 times daily) added to usual asthma therapy. |
| Arformoterol | warnings and precautions | Patients using SEREVENT DISKUS should not use another medicine containing a LABA (e.g., formoterol fumarate, arformoterol tartrate, indacaterol) for any reason. |
| Atazanavir | drug interactions | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with SEREVENT DISKUS is not recommended because increased cardiovascular adverse effects may occur. |
| Clarithromycin | drug interactions | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with SEREVENT DISKUS is not recommended because increased cardiovascular adverse effects may occur. |
| Formoterol | warnings and precautions | Patients using SEREVENT DISKUS should not use another medicine containing a LABA (e.g., formoterol fumarate, arformoterol tartrate, indacaterol) for any reason. |
| Itraconazole | drug interactions | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with SEREVENT DISKUS is not recommended because increased cardiovascular adverse effects may occur. |
| Ketoconazole | drug interactions | Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. |
| Nefazodone | drug interactions | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with SEREVENT DISKUS is not recommended because increased cardiovascular adverse effects may occur. |
| Nelfinavir | drug interactions | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with SEREVENT DISKUS is not recommended because increased cardiovascular adverse effects may occur. |
| Ritonavir | drug interactions | Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. |
Other labels that name salmeterol
Source: FDA drug label (SEREVENT DISKUS), 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 for salmeterol?
The FDA Adverse Event Reporting System holds 8,572 reports that list salmeterol among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as salmeterol?
9 other medicines are given the same way (oral) and in the same FDA class as salmeterol or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Albuterol | Asthma | 14 labelers | $0.288 per tablet 2 mg tablet | Resolved |
| Dexamethasone | Asthma | 41 labelers | $0.193 per tablet 4 mg tablet | In shortage |
| Montelukast | Asthma | 36 labelers | $0.0419 per tablet 10 mg tablet | A presentation being discontinued |
| Theophylline | Asthma | 26 labelers | $0.330 per tablet 300 mg tablet | No current entry |
| Budesonide | Asthma | 14 labelers | $0.498 per capsule 3 mg capsule | No current entry |
| Zafirlukast | Asthma | 5 labelers | $0.623 per tablet 20 mg tablet | No current entry |
| Zileuton | Asthma | 5 labelers | $2.05 per tablet 600 mg tablet | No current entry |
| Ephedrine | Asthma | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as salmeterol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does salmeterol compare with medicines for the same use?
1 side-by-side page set salmeterol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to salmeterol
- 9 medicines for the same use
- Other beta-2 agonists
- the pharmacologic class, with prices and generics
- Salmeterol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other