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 →
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.
How to Take It
Take baclofen exactly as your doctor tells you. Your doctor will likely start you on a low dose and increase it slowly. You may need to take it three or four times a day. Do not take more than 80 mg per day.
This is a plain-language summary of baclofen's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is not known if baclofen will harm your unborn baby. Baclofen can pass into breast milk.
This is a plain-language summary of baclofen's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of baclofen's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store baclofen at room temperature, away from heat and moisture.
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
- Tiredness
Tiredness
6,148 reports
- Pain
Pain
5,657 reports
- Fall
Fall
5,421 reports
- Feeling sick to your stomach
Feeling sick to your stomach
4,595 reports
- Headache
Headache
4,358 reports
- Trouble walking
Trouble walking
4,107 reports
- Dizziness
Dizziness
3,548 reports
- Urinary tract infection
Urinary tract infection
3,492 reports
- Weakness
Weakness
3,402 reports
- MS flare-up
MS flare-up
3,386 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) 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?
Is baclofen safe during pregnancy?
Has baclofen been recalled?
Is baclofen currently in shortage?
Active Recalls
Presence of Foreign Tablets/Capsules
Golden State Medical Supply Inc.
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: January 21, 2026
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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