Prescription medication · Muscle Relaxant
metaxalone
Also sold as Skelaxin. Metaxalone treats the pain and discomfort caused by muscle problems.
- 3,268
- FDA reportsLightly reported
- 18
- InteractionsSeveral interactions
- $2.61
- Generic price (NADAC)
What the data shows
metaxalone (Skelaxin) is a prescription Muscle Relaxant, among the least-reported drugs the FDA tracks (3,268 FDA reports), with 18 documented drug interactions.
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.
metaxalone (Skelaxin) is a prescription Muscle Relaxant. Metaxalone treats the pain and discomfort caused by muscle problems.
Metaxalone is a muscle relaxant. It helps relieve discomfort from painful muscle and bone problems.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$2.61/unit
Generic Available
Yes (5 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Metaxalone treats the pain and discomfort caused by muscle problems.
Common side effects
Drowsiness, Dizziness, Headache
Key warnings
Metaxalone can cause sleepiness.
The sections below are summarized in plain English from metaxalone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
The exact way metaxalone works is not fully known. It is thought to work by making you feel sleepy. This can help to relieve muscle pain.
How to Take It
Take one 800 mg tablet three to four times a day. You can take it with or without food. Follow your doctor's instructions carefully. Do not take more than prescribed.
This is a plain-language summary of metaxalone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if metaxalone can harm an unborn baby. Talk to your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.
This is a plain-language summary of metaxalone'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 metaxalone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature, between 68ºF and 77ºF.
Side Effects (from patient reports)
Based on 3,268 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for metaxalone, by number of reports
- Suicide
Suicide
261 reports
- Tiredness
Tiredness
196 reports
- Pain
Pain
195 reports
- Feeling sick to your stomach
Feeling sick to your stomach
190 reports
- Headache
Headache
166 reports
- Poisoning from different things
Poisoning from different things
163 reports
- Fall
Fall
162 reports
- Diarrhea
Diarrhea
132 reports
- Dizziness
Dizziness
120 reports
- Death
Death
114 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 metaxalone 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 metaxalone sits
metaxalone has more FDA adverse-event reports than 19% 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 metaxalone; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 3,268 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
3,268
Reports Mentioning Death
599
18.3% of reports — not proof of cause
Hospitalization Reports
771
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | COMPLETED SUICIDE | 261 |
| 3 | FATIGUE | 196 |
| 4 | PAIN | 195 |
| 5 | NAUSEA | 190 |
| 6 | HEADACHE | 166 |
| 7 | TOXICITY TO VARIOUS AGENTS | 163 |
| 8 | FALL | 161 |
| 9 | DIARRHOEA | 132 |
| 10 | DIZZINESS | 120 |
| 11 | DEATH | 114 |
| 12 | DYSPNOEA | 114 |
| 13 | CHRONIC KIDNEY DISEASE | 111 |
| 14 | RENAL FAILURE | 107 |
| 15 | VOMITING | 105 |
| 16 | BACK PAIN | 99 |
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
Metaxalone can cause sleepiness. Do not drive or operate heavy machinery until you know how it affects you. Using metaxalone with alcohol, opioids, or other drugs that cause sleepiness can be dangerous. A potentially life-threatening condition called serotonin syndrome has been reported when metaxalone is used with certain other drugs.
Known Drug Interactions
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and...
Mechanism: Both of these medications can slow down your breathing and affect your brain's serotonin levels. Combining them makes these side effects more likely and more severe.
What to do: Your healthcare provider should monitor you closely for signs of respiratory distress. Avoid this combination unless specifically directed by your doctor.
Examples of serotonergic drugs include: selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: Taking these two drugs together can cause a build-up of serotonin in your body, which can be life-threatening if levels become too high.
What to do: Tell your doctor immediately if you experience shivering, sweating, or a very high fever while taking these medications.
Examples of serotonergic drugs include: selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: Both of these drugs can increase the levels of a brain chemical called serotonin. Taking them together may cause serotonin to build up to unsafe levels in your body.
What to do: Your doctor should monitor you closely for signs of serotonin syndrome, such as confusion, sweating, or muscle stiffness.
Examples of serotonergic drugs include: selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: Linezolid acts as a monoamine oxidase inhibitor, which can cause serotonin levels to rise when taken with metaxalone. This combination increases the risk of a serious reaction called serotonin syndrome.
What to do: Talk to your healthcare provider about the risks, as they may need to adjust your treatment or watch for side effects.
Examples of serotonergic drugs include: selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: These medications both affect the chemical systems in your brain and nerves. Using them at the same time can lead to an unhealthy buildup of serotonin.
What to do: Use this combination with caution and tell your doctor immediately if you feel agitated, dizzy, or have a fast heartbeat.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I drive while taking metaxalone?
Can I drink alcohol while taking metaxalone?
What should I do if I experience side effects?
Can I take metaxalone with other medications?
Is metaxalone addictive?
How long does it take for metaxalone to work?
Can I stop taking metaxalone suddenly?
What if the medicine doesn't seem to be working?
Can children take metaxalone?
What are the common side effects of metaxalone?
Does metaxalone interact with other medications?
What drug class is metaxalone?
Is metaxalone safe during pregnancy?
Related Medications in Muscle Relaxant
Other drugs grouped near metaxalone - same-class peers and common alternatives.
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carisoprodol
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chlorzoxazone
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cyclobenzaprine
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Cyclobenzaprine is a muscle relaxant.
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What the FDA Data Shows for metaxalone
The FDA label for metaxalone (sold under brand names such as Skelaxin) classifies it as a prescription-only medication in the Muscle Relaxant class. Metaxalone treats the pain and discomfort caused by muscle problems. Official labeling lists 7 commonly reported side effects, including Drowsiness, Dizziness, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 3,268 voluntary reports. The database also lists 18 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $2.61.
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, 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).
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: July 25, 2022
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