Two medicines, side by side
Metaxalone vs baclofen
Metaxalone and baclofen are both labeled for muscle spasms and spasticity. Drugs@FDA records approvals of metaxalone since 1962 and of baclofen since 1977. Pharmacies paid $0.452 per metaxalone 800 mg tablet and $0.032 per baclofen 10 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, metaxalone is a muscle relaxant and baclofen a gamma-aminobutyric acid-ergic agonist.
Check it at the source: the metaxalone FDA label on DailyMed (effective January 11, 2023); the baclofen FDA label on DailyMed (effective August 12, 2024).
Highlights of the metaxalone record
Metaxalone (Skelaxin) · label of January 11, 2023
Used for
From the label: indicationsMetaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
On the market
- Earliest approval on file
- August 13, 1962
- Generic labelers
- 33 labelers
- Pharmacy cost
- $0.452 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Highlights of the baclofen record
Baclofen (Gablofen) · label of August 12, 2024
Used for
From the label: indicationsBaclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. […]
On the market
- Earliest approval on file
- November 22, 1977
- Generic labelers
- 55 labelers
- Pharmacy cost
- $0.032 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 3
Source: FDA drug labels via openFDA (Metaxalone label of January 11, 2023, Baclofen label of August 12, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do metaxalone and baclofen differ on the record?
In FDA's classes, metaxalone is a muscle relaxant and baclofen a gamma-aminobutyric acid-ergic agonist.
Generics: metaxalone since 2010; baclofen since 1988 (Drugs@FDA).
| Metaxalone | Baclofen | |
|---|---|---|
| Labeled for | Muscle spasms and spasticity | Muscle spasms and spasticity |
| Pharmacologic class | Muscle Relaxant | gamma-Aminobutyric Acid-ergic Agonist |
| How it works (label) | Mechanism of Action The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system (CNS) depression. | n/a |
| Half-life (label) | Thereafter, metaxalone concentrations decline log-linearly with a terminal half-life of 9.0 ± 4.8 hours. | n/a |
| Earliest approval on file (Drugs@FDA) | August 13, 1962 | November 22, 1977 |
| First generic approved | March 31, 2010 | July 21, 1988 |
| Generic labelers (NDC) | 33 labelers | 55 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.452 per tablet (Metaxalone 800 mg tablet) | $0.032 per tablet (Baclofen 10 mg tablet) |
| 12-month price change | -3% | -12% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 3 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 3,327 | 88,351 |
| 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)
What do the labels say about using others of their kind?
Metaxalone label, warningsRisks from Concomitant Use with Alcohol or other CNS Depressants The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants (TCAs)) may be additive.
Source: FDA drug labels via openFDA
What next?
- Alternatives to metaxalone
- every medicine labeled for the same conditions