Two medicines, side by side
Baclofen vs cyclobenzaprine
Baclofen and cyclobenzaprine are both labeled for muscle spasms and spasticity. Drugs@FDA records approvals of baclofen since 1977 and of cyclobenzaprine since 1977. Pharmacies paid $0.032 per baclofen 10 mg tablet and $0.0171 per cyclobenzaprine 10 mg tablet (NADAC, October 7, 2026). Cyclobenzaprine's other strengths are brand-only: $29.61 per tablet (Tonmya 2.8 mg tablet sl). In FDA's classes, baclofen is a gamma-aminobutyric acid-ergic agonist and cyclobenzaprine a muscle relaxant.
Check it at the source: the baclofen FDA label on DailyMed (effective August 12, 2024); the cyclobenzaprine FDA label on DailyMed (effective February 21, 2025).
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 cyclobenzaprine record
Cyclobenzaprine (Flexeril) · label of February 21, 2025
Used for
From the label: indicationsCyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. […]
On the market
- Earliest approval on file
- August 26, 1977
- Generic labelers
- 59 labelers
- Pharmacy cost
- $0.0171 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 5
Source: FDA drug labels via openFDA (Baclofen label of August 12, 2024, Cyclobenzaprine label of February 21, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do baclofen and cyclobenzaprine differ on the record?
In FDA's classes, baclofen is a gamma-aminobutyric acid-ergic agonist and cyclobenzaprine a muscle relaxant.
Generics: baclofen since 1988; cyclobenzaprine since 1988 (Drugs@FDA).
| Baclofen | Cyclobenzaprine | |
|---|---|---|
| Labeled for | Muscle spasms and spasticity | Muscle spasms and spasticity, Nerve pain and fibromyalgia |
| Pharmacologic class | gamma-Aminobutyric Acid-ergic Agonist | Muscle Relaxant |
| How it works (label) | n/a | n/a |
| Half-life (label) | n/a | Cyclobenzaprine is eliminated quite slowly, with an effective half-life of 18 hours (range 8 to 37 hours; n=18); plasma clearance is 0.7 L/min. |
| Earliest approval on file (Drugs@FDA) | November 22, 1977 | August 26, 1977 |
| First generic approved | July 21, 1988 | February 29, 1988 |
| Generic labelers (NDC) | 55 labelers | 59 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.032 per tablet (Baclofen 10 mg tablet) | $0.0171 per tablet (Cyclobenzaprine 10 mg tablet) |
| 12-month price change | -12% | -10% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 3 | 5 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 88,351 | 50,442 |
| 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?
Cyclobenzaprine label, warningsIf concomitant treatment with cyclobenzaprine hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see PRECAUTIONS :
Source: FDA drug labels via openFDA
What next?
- Alternatives to baclofen
- every medicine labeled for the same conditions