Two medicines, side by side
Baclofen vs diazepam
Baclofen and diazepam are both labeled for muscle spasms and spasticity. Drugs@FDA records approvals of baclofen since 1977 and of diazepam since 1963. Pharmacies paid $0.032 per baclofen 10 mg tablet and $0.0283 per diazepam 10 mg tablet (NADAC, October 7, 2026). In FDA's classes, baclofen is a gamma-aminobutyric acid-ergic agonist and diazepam a benzodiazepine.
Check it at the source: the baclofen FDA label on DailyMed (effective August 12, 2024); the diazepam FDA label on DailyMed (effective August 11, 2026).
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
Highlights of the diazepam record
Diazepam (Valium) · label of August 11, 2026
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.
Used for
From the label: indicationsValium is indicated for the management of anxiety disorders or for the short- term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. […]
On the market
- Earliest approval on file
- November 15, 1963
- Generic labelers
- 45 labelers
- Pharmacy cost
- $0.0283 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 8
Source: FDA drug labels via openFDA (Baclofen label of August 12, 2024, Diazepam label of August 11, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do baclofen and diazepam differ on the record?
In FDA's classes, baclofen is a gamma-aminobutyric acid-ergic agonist and diazepam a benzodiazepine.
Only the diazepam label carries a boxed warning.
Generics: baclofen since 1988; diazepam since 1985 (Drugs@FDA).
DEA schedule: baclofen none; diazepam CIV.
| Baclofen | Diazepam | |
|---|---|---|
| Labeled for | Muscle spasms and spasticity | Anxiety, Muscle spasms and spasticity |
| Pharmacologic class | gamma-Aminobutyric Acid-ergic Agonist | Benzodiazepine |
| How it works (label) | n/a | n/a |
| Half-life (label) | n/a | The initial distribution phase has a half-life of approximately 1 hour, although it may range up to >3 hours. |
| Earliest approval on file (Drugs@FDA) | November 22, 1977 | November 15, 1963 |
| First generic approved | July 21, 1988 | September 4, 1985 |
| Generic labelers (NDC) | 55 labelers | 45 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.032 per tablet (Baclofen 10 mg tablet) | $0.0283 per tablet (Diazepam 10 mg tablet) |
| 12-month price change | -12% | -5% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 3 | 8 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 88,351 | 121,010 |
| DEA schedule | none | CIV |
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?
Diazepam label, drug interactionsCentrally Acting Agents If Valium is to be combined with other centrally acting agents, careful consideration should be given to the pharmacology of the agents employed particularly with compounds that may potentiate or be potentiated by the action of Valium, such as phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, sedative antihistamines …
Source: FDA drug labels via openFDA
What next?
- Alternatives to baclofen
- every medicine labeled for the same conditions