Two medicines, side by side
Baclofen vs botulinum toxin type a
Baclofen and botulinum toxin type a are both labeled for muscle spasms and spasticity. In FDA's classes, baclofen is a gamma-aminobutyric acid-ergic agonist and botulinum toxin type a a neuromuscular blocker.
Check it at the source: the baclofen FDA label on DailyMed (effective August 12, 2024); the botulinum toxin type a FDA label on DailyMed (effective July 10, 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 botulinum toxin type a record
Botulinum toxin type a (Botox) · label of July 10, 2026
DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection.
Used for
From the label: indicationsXEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of: Chronic sialorrhea in patients 2 years of age and older ( 1.1 ) Upper limb spasticity in patients 2 years of age and older ( 1.2 ) Cervical dystonia in adults ( 1.3 ) Blepharospasm in adults ( 1.4 ) the appearance of upper facial lines in adults: moderate to severe glabellar lines associated […]
On the market
- Earliest approval on file
- n/a
- Generic labelers
- none listed
- Pharmacy cost
- Not in the survey
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Baclofen label of August 12, 2024, Botulinum toxin type a label of July 10, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do baclofen and botulinum toxin type a differ on the record?
In FDA's classes, baclofen is a gamma-aminobutyric acid-ergic agonist and botulinum toxin type a a neuromuscular blocker.
Only the botulinum toxin type a label carries a boxed warning.
Generics: baclofen since 1988; botulinum toxin type a none approved (Drugs@FDA).
| Baclofen | Botulinum toxin type a | |
|---|---|---|
| Labeled for | Muscle spasms and spasticity | Muscle spasms and spasticity, Migraine, Overactive bladder |
| Pharmacologic class | gamma-Aminobutyric Acid-ergic Agonist | Acetylcholine Release Inhibitor, Neuromuscular Blocker |
| How it works (label) | n/a | XEOMIN blocks cholinergic transmission at the neuromuscular and salivary neuroglandular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings. |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | November 22, 1977 | n/a |
| First generic approved | July 21, 1988 | none |
| Generic labelers (NDC) | 55 labelers | none listed |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.032 per tablet (Baclofen 10 mg tablet) | n/a |
| 12-month price change | -12% | n/a |
| Boxed warning | No | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 3 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 88,351 | 97,018 |
| 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 baclofen
- every medicine labeled for the same conditions