Two medicines, side by side
Dantrolene vs baclofen
Dantrolene and baclofen are both labeled for muscle spasms and spasticity. Drugs@FDA records approvals of dantrolene since 1974 and of baclofen since 1977. Pharmacies paid $0.409 per dantrolene sodium 25 mg capsule 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, dantrolene is a skeletal muscle relaxant and baclofen a gamma-aminobutyric acid-ergic agonist.
Check it at the source: the dantrolene FDA label on DailyMed (effective August 21, 2026); the baclofen FDA label on DailyMed (effective August 12, 2024).
Highlights of the dantrolene record
Dantrolene (Ryanodex) · label of August 21, 2026
Dantrolene sodium has a potential for hepatotoxicity, and should not be used in conditions other than those recommended. Symptomatic hepatitis (fatal and non-fatal) has been reported at various dose levels of the drug. The incidence reported in patients taking up to 400 mg/day is much lower than in those taking doses of 800 mg or more per day. Even sporadic short courses of these higher dose levels within a treatment regimen markedly increased the risk of serious hepatic injury.
Used for
From the label: indicationsIn Chronic Spasticity: Dantrolene sodium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. […]
On the market
- Earliest approval on file
- January 15, 1974
- Generic labelers
- 10 labelers
- Pharmacy cost
- $0.409 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 3
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 (Dantrolene label of August 21, 2026, Baclofen label of August 12, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do dantrolene and baclofen differ on the record?
In FDA's classes, dantrolene is a skeletal muscle relaxant and baclofen a gamma-aminobutyric acid-ergic agonist.
Only the dantrolene label carries a boxed warning.
Generics: dantrolene since 2005; baclofen since 1988 (Drugs@FDA).
| Dantrolene | Baclofen | |
|---|---|---|
| Labeled for | Muscle spasms and spasticity | Muscle spasms and spasticity |
| Pharmacologic class | Skeletal Muscle Relaxant | gamma-Aminobutyric Acid-ergic Agonist |
| How it works (label) | n/a | n/a |
| Half-life (label) | The mean biologic half-life of dantrolene sodium in adults is 8.7 hours after a 100-mg dose. | n/a |
| Earliest approval on file (Drugs@FDA) | January 15, 1974 | November 22, 1977 |
| First generic approved | March 1, 2005 | July 21, 1988 |
| Generic labelers (NDC) | 10 labelers | 55 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.409 per capsule (Dantrolene sodium 25 mg capsule) | $0.032 per tablet (Baclofen 10 mg tablet) |
| 12-month price change | +3% | -12% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 3 | 3 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 1,745 | 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 next?
- Alternatives to dantrolene
- every medicine labeled for the same conditions