metaxalone
Pharmaranks rates Metaxalone 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Metaxalone is a muscle relaxant used to treat Muscle Cramp, Muscle Rigidity, Muscle Spasticity, Myositis.
Muscle Relaxant · by Lannett Co Inc
Generic of Skelaxin
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Metaxalone
- Drug class
- Muscle Relaxant
- Form
- Tablet
- Strength
- Metaxalone 800MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- muscle cramp, muscle rigidity, muscle spasticity
- Manufacturer
- Lannett Co Inc
- Half-life
- about 9 hours (terminal half-life 9.0 ± 4.8 hours after a 400 mg oral dose, fasted; ~8 hours at 800 mg) (how long it stays in your system)
- What the pharmacy pays
- ~$11.97 for 30 — not your price
- FDA application
- ANDA204770
What is Metaxalone?
From the FDA label:Metaxalone is available as an 800 mg pink, capsule shaped, scored tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy)methyl]-2-oxazolidinone. The empirical formula is C 12 H 15 NO 3 , which corresponds to a molecular weight of 221.25. The structural formula is: Metaxalone is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: carboxymethylcellulose sodium, alginic acid, stearic acid, hydrogenated castor oil, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulfate, and FD&C Red #40 Aluminum Lake. structural formula
How to use
The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.
Side effects
The most frequent reactions to metaxalone include: CNS : drowsiness, dizziness, headache, and nervousness or “irritability”; Digestive : nausea, vomiting, gastrointestinal upset. Other adverse reactions are: Immune System : anaphylaxis, hypersensitivity reaction, rash with or without pruritus; Hematologic : leukopenia; hemolytic anemia; Hepatobiliary : jaundice; CNS : cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range and with metaxalone as a single agent taken at doses higher than the recommended dose (see WARNINGS , PRECAUTIONS: Drug Interactions , and OVERDOSAGE ).
Warnings
Important safety information
Serotonin Syndrome Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with Metaxalone used within the recommended dosage range (see PRECAUTIONS: Drug Interactions ) and with Metaxalone as a single agent taken at doses higher than the recommended dose (see OVERDOSAGE ). 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 serotonergic neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and drugs that impair metabolism of serotonin (including monoamine oxidase (MAO) inhibitors, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) (see PRECAUTIONS: Drug Interactions ). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms generally occurs within several hours to a few days, but may occur later than that. Discontinue Metaxalone if serotonin syndrome is suspected. Risks from Concomitant Use with Alcohol or other CNS Depressants The sedative effects of Metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants (TCAs)) may be additive. Exercise caution with patients who take more than one of these CNS depressants simultaneously. Follow patients closely for signs and symptoms of respiratory depression and sedation (see PRECAUTIONS: Drug Interactions ).
Who should not take Metaxalone
Known hypersensitivity to any components of this product. Known tendency to drug induced, hemolytic, or other anemias. Significantly impaired renal or hepatic function.
Overdose — what happens if you take too much
Deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with antidepressants, and have been reported with this class of drug in combination with alcohol. Serotonin syndrome has been reported when metaxalone was used at doses higher than the recommended dose (see WARNINGS and ADVERSE REACTIONS ). When determining the LD 50 in rats and mice, progressive sedation, hypnosis, and finally respiratory failure were noted as the dosage increased. In dogs, no LD 50 could be determined as the higher doses produced an emetic action in 15 to 30 minutes. Treatment - Gastric lavage and supportive therapy. Consultation with a regional poison control center is recommended.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
CNS Depressants : The sedative effects of Metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants (TCAs)) may be additive. Exercise caution with patients who take more than one of these CNS depressants simultaneously. Follow patients closely for signs and symptoms of respiratory depression and sedation (see WARNINGS ). Serotonergic Drugs : Serotonin syndrome has resulted from concomitant use of serotonergic drugs with Metaxalone used within the recommended dosage range (see WARNINGS ). If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Metaxalone if serotonin syndrome is suspected. 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).
How long does Metaxalone stay in your body?
The elimination half-life of metaxalone is about 9 hours (terminal half-life 9.0 ± 4.8 hours after a 400 mg oral dose, fasted; ~8 hours at 800 mg) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the terminal (elimination) half-life the label reports; the label describes single log-linear (terminal) decline, not a separate distribution phase. Metaxalone is NOT a prodrug and the label names no active metabolite — it is hepatically metabolized to "unidentified metabolites" excreted in urine, so no metabolite outlasting the parent is described. Half-life is markedly shortened by food: with a high-fat meal it fell to ~2.4 h (vs 9.0 h) at 400 mg and ~4.2 h (vs 8.0 h) at 800 mg, alongside more complete absorption and higher exposure. Sex difference: mean half-life ~11.1 h in females vs ~7.6 h in males, with higher exposure in females. Age: the label does not give a separate elderly half-life but says metaxalone PK is significantly more affected by age under fasted conditions, with bioavailability/exposure rising with age (AUC∞ ~15,000 in ~26-yr-olds vs ~24,000 ng·h/mL in ~72-yr-olds at 800 mg fasted). Hepatic/renal impairment: the label states the impact of hepatic and renal disease on metaxalone PK has NOT been determined and advises using it with caution in these patients — so no adjusted half-life is available.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Metaxalone tablet — DailyMed label, Clinical Pharmacology / Pharmacokinetics.
Drug class
How this class works, per Cyclobenzaprine - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Metaxalone ranks — best-rated muscle relaxant for:
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Metaxalone treat?
- Metaxalone (Metaxalone) may be used to treat muscle cramp, muscle rigidity, muscle spasticity, myositis, pain, spasm, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Metaxalone work?
- Metaxalone is a muscle relaxant. Most muscle relaxants work in the brain and spinal cord rather than on the muscle itself: they damp down the overactive nerve signals and reflexes that keep muscles tense, easing spasms and tightness. Some specialized agents instead act directly on muscle calcium release.
- How is Metaxalone rated?
- pharmaranks gives Metaxalone a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Metaxalone cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $11.97 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Amrix — about $0.63 on the same basis.
- Is there a coupon or discount for Metaxalone?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Metaxalone. To pay less, Metaxalone is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Metaxalone?
- Metaxalone is marketed by Lannett Co Inc. You can see Lannett Co Inc's full profile, rating, and other products on pharmaranks.
- Is Metaxalone a brand-name or generic drug?
- Metaxalone is a generic medication; its active ingredient is Metaxalone. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Metaxalone available over the counter?
- No. Metaxalone is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Metaxalone come in?
- Metaxalone is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Metaxalone?
- Metaxalone is classified as muscle relaxant, per the FDA's Established Pharmacologic Class.
- Is Metaxalone FDA-registered?
- Metaxalone is on record with the U.S. FDA under application number ANDA204770. You can verify this on its official FDA label.
- Has Metaxalone been recalled by the FDA?
- Metaxalone has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Metaxalone safe?
- There's no single safe-or-not verdict. pharmaranks gives Metaxalone a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Metaxalone?
- Metaxalone's side effects are taken directly from its FDA label. From the label: The most frequent reactions to metaxalone include: CNS : drowsiness, dizziness, headache, and nervousness or “irritability”; Digestive : nausea, vomiting, gastrointestinal upset. Other adverse reactions are: Immune System : anaphylaxis, hypersensitivity reaction, rash with or without pruritus;… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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metaxalone
70/100