Two medicines, side by side
Formoterol vs salmeterol
Formoterol and salmeterol are both labeled for COPD. Drugs@FDA records approvals of formoterol since 2001 and of salmeterol since 1994. Pharmacies paid $1.30 per mL (Formoterol 20 mcg/2 mL neb vial) and $6.74 per unit (Serevent diskus 50 mcg) (NADAC, October 7, 2026); the strengths differ and one is a brand and one a generic, so the two prices are not like for like. How each works, in its label's words: Formoterol, “Formoterol fumarate is a long-acting, beta 2 -adrenergic receptor agonist (beta 2 -agonist).”; Salmeterol, “Salmeterol is a selective LABA.”
Check it at the source: the formoterol FDA label on DailyMed (effective May 31, 2019); the salmeterol FDA label on DailyMed (effective October 10, 2022).
Highlights of the formoterol record
Formoterol (Perforomist) · label of May 31, 2019
Used for
From the label: indicationsPERFOROMIST Inhalation Solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: • Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. […]
On the market
- Earliest approval on file
- February 16, 2001
- Generic labelers
- 11 labelers
- Pharmacy cost
- $1.30 per mL
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Highlights of the salmeterol record
Salmeterol (Serevent) · label of October 10, 2022
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.
Used for
From the label: indicationsSEREVENT 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. […]
On the market
- Earliest approval on file
- February 4, 1994
- Generic labelers
- none listed
- Pharmacy cost
- $6.74 per unit
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Formoterol label of May 31, 2019, Salmeterol label of October 10, 2022); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do formoterol and salmeterol differ on the record?
How each works, in its label's words: Formoterol, “Formoterol fumarate is a long-acting, beta 2 -adrenergic receptor agonist (beta 2 -agonist).”; Salmeterol, “Salmeterol is a selective LABA.”
Only the salmeterol label carries a boxed warning.
Both are in FDA's class beta2-adrenergic agonists.
Half-life, in each label's words: Formoterol, “Based on plasma concentrations measured following the 244 mcg dose, the mean terminal elimination half-life was …”; Salmeterol, “The terminal elimination half-life was about 5.5 hours (1 volunteer only).”
Generics: formoterol since 2021; salmeterol none approved (Drugs@FDA).
| Formoterol | Salmeterol | |
|---|---|---|
| Labeled for | COPD | Asthma, COPD |
| Pharmacologic class | beta2-Adrenergic Agonist | beta2-Adrenergic Agonist |
| How it works (label) | Formoterol fumarate is a long-acting, beta 2 -adrenergic receptor agonist (beta 2 -agonist). Inhaled formoterol fumarate acts locally in the lung as a bronchodilator. | Salmeterol is a selective LABA. In vitro studies show salmeterol to be at least 50 times more selective for beta 2 -adrenoceptors than albuterol. |
| Half-life (label) | Based on plasma concentrations measured following the 244 mcg dose, the mean terminal elimination half-life was determined to be 7 hours. | The terminal elimination half-life was about 5.5 hours (1 volunteer only). |
| Earliest approval on file (Drugs@FDA) | February 16, 2001 | February 4, 1994 |
| First generic approved | June 22, 2021 | none |
| Generic labelers (NDC) | 11 labelers | none listed |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $1.30 per mL (Formoterol 20 mcg/2 mL neb vial) | $6.74 per unit (Serevent diskus 50 mcg) |
| 12-month price change | -64% | -0.1% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 4,695 | 8,572 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Formoterol label, warnings and precautionsA 28-week, placebo-controlled US study comparing the safety of another LABA (salmeterol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs. 3/13,179 in patients treated with placebo;
Source: FDA drug labels via openFDA
What next?
- Alternatives to formoterol
- every medicine labeled for the same conditions