Prescription medication · GABA-B Agonist (Muscle Relaxant)
baclofen
Also sold as Lioresal, Gablofen. Baclofen is used to treat muscle spasticity (stiffness) caused by multiple sclerosis.
Data updated 2026-05-15
- 83,476
- FDA reportsOften reported
- In shortage
- FDA status
What the data shows
baclofen (Lioresal) is a prescription GABA-B Agonist (Muscle Relaxant), more reported than most tracked drugs (83,476 FDA reports).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
baclofen (Lioresal) is a prescription GABA-B Agonist (Muscle Relaxant). Baclofen is used to treat muscle spasticity (stiffness) caused by multiple sclerosis.
Baclofen is a muscle relaxant. It helps to relieve muscle spasms and stiffness.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
baclofen is currently listed as to be discontinued by the FDA. Affected manufacturer: Upsher-Smith Laboratories, LLC.
View all drug shortages →Drug Pricing (NADAC)
Generic Price
$0.03/unit
Generic Available
Yes (20 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: BACLOFEN 10 MG TABLET
Same CMS presentation as the headline generic unit price above (5 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: +7.5% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| February 21, 2024 | $0.0435/EA | - | 1 |
| June 19, 2024 | $0.0419/EA | -3.6% | 3 |
| October 23, 2024 | $0.0404/EA | -3.7% | 1 |
| November 20, 2024 | $0.0318/EA | -21.2% | 2 |
| December 18, 2024 | $0.0342/EA | +7.5% | 45 |
What it does
Baclofen is used to treat muscle spasticity (stiffness) caused by multiple sclerosis.
Common side effects
Drowsiness, Dizziness, Weakness
Key warnings
If you stop taking baclofen suddenly, you may experience withdrawal symptoms.
The sections below are summarized in plain English from baclofen's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Baclofen works by affecting the nerves in your spinal cord. It decreases the signals that cause your muscles to tighten. This helps to relieve muscle stiffness and spasms.
Side Effects (from patient reports)
Based on 83,476 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for baclofen, by number of reports
- Fatigue
Fatigue
6,149 reports
- Pain
Pain
5,656 reports
- Fall
Fall
5,421 reports
- Nausea
Nausea
4,596 reports
- Headache
Headache
4,356 reports
- Gait Disturbance
Gait Disturbance
4,107 reports
- Dizziness
Dizziness
3,547 reports
- Urinary Tract Infection
Urinary Tract Infection
3,489 reports
- Asthenia
Asthenia
3,401 reports
- Multiple Sclerosis Relapse
Multiple Sclerosis Relapse
3,388 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for baclofen each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where baclofen sits
baclofen has more FDA adverse-event reports than 83% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is baclofen; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 83,476 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
83,476
Reports Mentioning Death
6,213
7.4% of reports — not proof of cause
Hospitalization Reports
27,326
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 6,149 |
| 2 | PAIN | 5,656 |
| 4 | FALL | 5,421 |
| 5 | NAUSEA | 4,596 |
| 6 | HEADACHE | 4,356 |
| 7 | GAIT DISTURBANCE | 4,107 |
| 9 | DIZZINESS | 3,547 |
| 10 | URINARY TRACT INFECTION | 3,489 |
| 11 | ASTHENIA | 3,401 |
| 12 | MULTIPLE SCLEROSIS RELAPSE | 3,388 |
| 13 | MUSCLE SPASMS | 3,311 |
| 14 | DIARRHOEA | 3,051 |
| 15 | VOMITING | 2,826 |
| 16 | SOMNOLENCE | 2,701 |
| 17 | INSOMNIA | 2,664 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
If you stop taking baclofen suddenly, you may experience withdrawal symptoms. Talk to your doctor before stopping this medication.
Common Questions
What is baclofen used for?
How often should I take baclofen?
What should I do if I feel too sleepy after taking baclofen?
Can I drive while taking baclofen?
Can I drink alcohol while taking baclofen?
What happens if I stop taking baclofen suddenly?
Does baclofen interact with other medications?
Can baclofen cure my condition?
What should I do if baclofen doesn't seem to be working?
Is it okay to share my baclofen with someone else?
What are the common side effects of baclofen?
What drug class is baclofen?
What pregnancy or breastfeeding source fields are listed for baclofen?
Has baclofen been recalled?
Is baclofen currently in shortage?
Active Recalls
Presence of Foreign Tablets/Capsules
Golden State Medical Supply Inc.
Related Medications in GABA-B Agonist (Muscle Relaxant)
Other drugs grouped near baclofen - same-class peers and common alternatives.
botulinum toxin A
Botox
Botox is a drug that blocks nerve signals to muscles.
Compare with baclofen →
carisoprodol
Soma
Carisoprodol is a muscle relaxant.
Compare with baclofen →
chlorzoxazone
Parafon Forte
Chlorzoxazone is a muscle relaxant.
Compare with baclofen →
cyclobenzaprine
Flexeril, Amrix
Cyclobenzaprine is a muscle relaxant.
Compare with baclofen →
dantrolene
Dantrium
Dantrolene is a muscle relaxant.
Compare with baclofen →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for baclofen: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 83,476.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 7.44%.
- irbesartan Δ 0.04 pts · 43,004 reports · Angiotensin II Receptor Blocker (ARB) 7.48%death share
- mepolizumab Δ 0.08 pts · 47,215 reports · Anti-IL-5 Monoclonal Antibody 7.52%death share
- amitriptyline Δ 0.09 pts · 16,403 reports · Tricyclic Antidepressant (TCA) 7.53%death share
- guaifenesin Δ 0.09 pts · 29,404 reports · Expectorant 7.36%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on baclofen
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
What the FDA Data Shows for baclofen
The FDA label for baclofen (sold under brand names such as Lioresal, Gablofen) classifies it as a prescription-only medication in the GABA-B Agonist (Muscle Relaxant) class. Baclofen is used to treat muscle spasticity (stiffness) caused by multiple sclerosis. Official labeling lists 4 commonly reported side effects, including Drowsiness, Dizziness, Weakness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 83,476 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.03.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: January 21, 2026
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages