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Tizanidine

Tizanidine is a muscle-relaxing medicine (a central alpha-2 agonist) used to manage spasticity, sold as tablets, capsules and, under the brand Ontralfy, an oral solution.

Brand names ZanaflexOntralfy
Drug class Central Alpha-2 Adrenergic Agonist
Rx Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 132 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 4, 2026 🚨Recall on record · 2
Tizanidine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Tizanidine (Zanaflex) treats spasticity, meaning stiff, tight muscles that are hard to control, by calming the nerve signals in the brain and spinal cord that make muscles tighten; it is one of the usual first choices, used since about 1996 and available as a generic. Most people tolerate it when the dose is raised slowly, though drowsiness, dry mouth and dizziness are common early on. Watch for low blood pressure that makes you lightheaded or faint, which alcohol worsens, and never combine it with the antidepressant fluvoxamine or the antibiotic ciprofloxacin, which drive its levels sharply up. Its effect is short-lived, so time doses for when looser muscles matter most.

Clinical pearls

  • Take it the same way every time, always with food or always without, because food changes how much you absorb.
  • Tablets and capsules are absorbed differently, so do not swap one form for the other without a new plan.
  • Even over-the-counter famotidine (Pepcid), plus cimetidine, amiodarone and verapamil, can raise tizanidine levels, so have every new medicine checked.
  • After long or high-dose use, do not stop suddenly; a slow taper prevents rebound high blood pressure, fast heartbeat and stiffness.
How you get itPrescription only
Comes asTablet, Capsule, Oral solution
Earliest FDA record1996
Companies listing it with the FDA50
FDA label last updatedMar 1, 2022
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Tizanidine, written from its FDA label.

What Tizanidine is used for

▾

Tizanidine is used for one main purpose across its products.

  • Tizanidine tablets and capsules (including Zanaflex): management of spasticity, reserved for the times when relief matters most.
  • Ontralfy oral solution: treatment of spasticity in adults.
  • One Zanaflex capsule label: treatment of spasticity in adults.

How Tizanidine works

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Tizanidine is a central alpha-2-adrenergic agonist. It works in the brain and spinal cord. It is thought to reduce spasticity by increasing presynaptic inhibition of motor neurons, which means it dampens the signals that tell muscles to tighten.

Its effects are greatest on polysynaptic pathways. The overall result is less stimulation of the spinal motor neurons.

Tizanidine dosage

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Tizanidine is taken by mouth as tablets, capsules, or (as Ontralfy) an oral solution. The capsule label describes dosing every 6 to 8 hours as needed, with no more than 3 doses in 24 hours. Doses are raised step by step.

  • Take it consistently with or without food, because food changes how it is absorbed.
  • Tablets and capsules behave differently in the body, so tell your prescriber if you are switched between forms.
  • Your prescriber may check liver tests before you start and again after you reach your top dose.
  • Do not stop suddenly after long or high-dose use. Follow your prescriber's directions and the product label.

Dosing details from the FDA-approved label

From the Tizanidine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Tizanidine hydrochloride capsules (recommended starting dose)
    • 2 mg by mouth every 6 to 8 hours, as needed, up to a maximum of 3 doses in 24 hours
    • Dosage can be increased by 2 mg to 4 mg per dose every 1 to 4 days
    • Maximum: maximum total daily dosage is 36 mg
    • Pharmacokinetics differs between tablets and capsules and with or without food; consistent administration with respect to food is recommended
Read the label’s full dosing text

2 DOSAGE & ADMINISTRATION 2.1 Dosing Information Tizanidine Tablets, USP tablets may be prescribed with or without food. Once the formulation has been selected and the decision to take with or without food has been made, this regimen should not be altered. Food has complex effects on tizanidine pharmacokinetics, which differ with the different formulations. Tizanidine Capsules and Tizanidine Tablets, USP are bioequivalent to each other under fasting conditions (more than 3 hours after a meal), but not under fed conditions (within 30 minutes of a meal). These pharmacokinetic differences may result in clinically significant differences when switching administration of tablet and capsules and when switching administration between the fed or fasted state. These changes may result in increased adverse events, or delayed or more rapid onset of activity, depending upon the nature of the switch. For this reason, the prescriber should be thoroughly familiar with the changes in kinetics associated with these different conditions [ see Clinical Pharmacology ( 12.3 ) ]. The recommended starting dose is 2 mg. Because the effect of Tizanidine Tablets, USP peaks at approximately 1 to 2 hours post-dose and dissipates between 3 to 6 hours post-dose, treatment can be repeated at 6 to 8 hour intervals, as needed, to a maximum of three doses in 24 hours. Dosage can be gradually increased by 2 mg to 4 mg at each dose, with 1 to 4 days between dosage increases, until a satisfactory reduction of muscle tone is achieved. The total daily dose should not exceed 36 mg. Single doses greater than 16 mg have not been studied. 2.2 Dosing in Patients with Renal Impairment Tizanidine Tablets, USP should be used with caution in patients with renal insufficiency (creatinine clearance < 25 mL/min), as clearance is reduced by more than 50%. In these patients, during titration, the individual doses should be reduced. If higher doses are required, individual doses rather than dosing frequency should be increased [ see Warnings and Precautions ( Error! Hyperlink reference not valid. ) ]. 2.3 Dosing in Patients with Hepatic Impairment Tizanidine Tablets, USP should be used with caution in patients with any hepatic impairment. In these patients, during titration, the individual doses should be reduced. If higher doses are required, individual doses rather than dosing frequency should be increased.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Tizanidine side effects

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The most common side effects in studies were:

Common side effects

  • Dry mouth
  • Sleepiness (somnolence)
  • Weakness, fatigue or tiredness (asthenia)
  • Dizziness
  • Urinary tract infection
  • Constipation
  • Abnormal liver tests
  • Vomiting

When to get medical help

  • Fainting, or a significant drop in blood pressure (hypotension) with dizziness or lightheadedness
  • Signs of liver injury or abnormal liver tests, which your prescriber may monitor
  • Seeing or believing things that are not real (hallucinations or delusions)
  • Signs of a severe allergic reaction: trouble breathing, hives, or swelling of the throat or tongue. Stop the medicine and get medical care right away.
  • Heavy drowsiness that interferes with daily activities
  • Slow heartbeat (bradycardia)
  • Symptoms after stopping suddenly: rebound high blood pressure, fast heartbeat, or increased muscle tightness
  • Overdose signs: extreme sleepiness, confusion, slow heartbeat, low blood pressure or slow breathing. Call poison control or seek emergency care.

About three-quarters of patients rated these as mild to moderate, and they appeared to be dose related. Call your doctor about fainting, hallucinations, signs of liver problems, or a severe allergic reaction. Allergic reactions can include trouble breathing or swelling of the throat or tongue.

Tizanidine warnings and precautions

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  • Low blood pressure: it can cause dizziness or fainting, especially when you stand up, and especially with blood pressure medicines.
  • Liver injury: liver tests are recommended, and use is cautioned in liver impairment.
  • Sedation: it can interfere with everyday activities. Alcohol and other sedating medicines add to it.
  • Hallucinations: in two studies, 3% of patients had formed visual hallucinations or delusions.
  • Allergic reactions: anaphylaxis has been reported.
  • Withdrawal: stopping suddenly can cause rebound high blood pressure, fast heartbeat and increased muscle tightness.

Tizanidine interactions

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Many medicines change how the body clears tizanidine, so always check with your pharmacist.

  • Fluvoxamine and ciprofloxacin: must not be combined, because they greatly raise tizanidine levels.
  • Other CYP1A2 inhibitors (such as zileuton, amiodarone, cimetidine, famotidine, acyclovir, ticlopidine): can cause low blood pressure, slow heartbeat or heavy drowsiness.
  • Oral contraceptives: not recommended together unless necessary.
  • Alcohol: raises drug levels and adds to drowsiness.
  • Benzodiazepines, opioids, tricyclic antidepressants: sedation can add up.
  • Other alpha-2 agonists and blood pressure medicines: blood pressure effects can add up.

Interactions listed in the FDA-approved label

From the Tizanidine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Fluvoxamine: Changes in pharmacokinetics of tizanidine with fluvoxamine resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment. Concomitant use is contraindicated.
  • Ciprofloxacin: Changes in pharmacokinetics of tizanidine with ciprofloxacin resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment. Concomitant use is contraindicated.
  • Other CYP1A2 inhibitors (such as zileuton, fluoroquinolones other than strong CYP1A2 inhibitors, antiarrythmics (amiodarone, mexiletine, propafenone, and verapamil), cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine): Potential drug interactions because of CYP1A2 inhibition. Should be avoided. If use is clinically necessary, initiate therapy with 2 mg dose and increase in 2–4 mg steps daily based on patient response; if hypotension, bradycardia, or excessive drowsiness occur, reduce or discontinue tizanidine therapy.
  • Oral contraceptives: Concomitant use with tizanidine is not recommended. If concomitant use is clinically necessary, initiate with a single 2 mg dose and increase in 2–4 mg steps daily based on patient response; if hypotension, bradycardia, or excessive drowsiness occur, reduce or discontinue tizanidine therapy.
  • Alcohol: Alcohol increases the overall amount of drug in the bloodstream after a dose of tizanidine, associated with an increase in adverse reactions; the CNS depressant effects of tizanidine and alcohol are additive.
  • Other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants): The sedative effects may be additive. Monitor patients who take tizanidine with another CNS depressant for symptoms of excess sedation.
  • α2-adrenergic agonists: Hypotensive effects may be cumulative. It is not recommended that tizanidine be used with other α2-adrenergic agonists.
Read the label’s full interactions text

7 DRUG INTERACTIONS 7.1 Fluvoxamine Concomitant use of fluvoxamine and Tizanidine Tablets, USP is contraindicated. Changes in pharmacokinetics of tizanidine when administered with fluvoxamine resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment. [ see Contraindications (4) and Clinical Pharmacology ( 12.3 ) ] 7.2 Ciprofloxacin Concomitant use of ciprofoxacin and Tizanidine Tablets, USP is contraindicated. Changes in pharmacokinetics of tizanidine when administered with ciprofloxacin resulted in significantly decreased blood pressure, increased drowsiness, and increased psychomotor impairment. [ see Contraindications (4) and Clinical Pharmacology ( 12.3 ) ] 7.3 CYP1A2 Inhibitors other than Fluvoxamine and Ciprofloxacin Because of potential drug interactions, concomitant use of Tizanidine Tablets, USP with other CYP1A2 inhibitors, such as zileuton, fluoroquinolones other than strong CYP1A2 inhibitors (which are contraindicated), antiarrythmics (amiodarone, mexiletine, propafenone, and verapamil), cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. If their use is clinically necessary, therapy should be initiated with 2 mg dose and increased in 2–4 mg steps daily based on patient response to therapy. If adverse reactions such as hypotension, bradycardia, or excessive drowsiness occur, reduce or discontinue Tizanidine Tablets, USP therapy. [ see Warnings and Precautions ( Error! Hyperlink reference not valid. ) and Clinical Pharmacology ( 12.3 ) ] 7.4 Oral Contraceptives Concomitant use of Tizanidine Tablets, USP with oral contraceptives is not recommended. However, if concomitant use is clinically necessary, initiate Tizanidine Tablets, USP with a single 2 mg dose and increase in 2–4 mg steps daily based on patient response to therapy.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Tizanidine

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  • Do not use it with strong CYP1A2 inhibitors or after an allergic reaction to tizanidine.
  • Liver problems: use with caution, and dose reduction is recommended.
  • Kidney problems: clearance is reduced, so lower doses are recommended and you should be monitored.
  • Older adults: the drug clears about four times slower, so use caution.
  • Pregnancy: animal studies showed harm to offspring, and there are no adequate human data.
  • Breastfeeding: no human data. Weigh the benefits and risks with your prescriber.
  • Children: safety and effectiveness have not been established.

Tizanidine overdose

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Overdose can cause lethargy, sleepiness, confusion, coma, slow heartbeat, low blood pressure and slow breathing. Some cases have been fatal, often with other sedating drugs. Call a poison control center or seek emergency care right away. Symptoms generally resolve within one to three days with appropriate treatment.

What Tizanidine does in the body

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Tizanidine's calming effects on the central nervous system add to those of alcohol. It lowers blood pressure and can cause sedation. Its effect is felt most on polysynaptic pathways in the spinal cord.

How your body processes Tizanidine

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Tizanidine is almost completely absorbed after you swallow it, but only about 40% reaches the bloodstream because the liver breaks down much of it first. Levels peak at about 1 hour when fasting, and the half-life is roughly 2 to 2.5 hours. About 95% of a dose is metabolized, mainly by the CYP1A2 enzyme, and the metabolites are not known to be active. Most is removed in urine (about 60%) and feces (about 20%).

How to store Tizanidine

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Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) . Dispense in containers with child resistant closure.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

143

Supplements & herbs that interact with Tizanidine

143 supplements and herbal products have documented interactions with Tizanidine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 11
  • Moderate · 101
  • Minor · 31
Every supplement checked against Tizanidine — ranked by severity The full interaction hub: 11 major · 101 moderate · 31 minor · every one linked to its full report. Check Tizanidine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Tizanidine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Tizanidine — the kind of thing our pharmacy team would talk through with you at the counter.

What is tizanidine for?

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It helps manage spasticity, meaning stiff, tight muscles that are hard to control. It wears off quickly, so it is meant for the times and activities when you most need relief.

Should I take it with food?

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Food changes how much tizanidine you absorb, and tablets and capsules react differently. The key is to be consistent, either always with food or always without. Tell me or your prescriber if you switch between tablets and capsules.

What side effects should I expect?

▾
Dry mouth, sleepiness, tiredness or weakness, and dizziness are the most common. Many people find them mild to moderate. Call your doctor if you faint, see things that are not there, or have swelling of the face, throat or tongue, or trouble breathing.

Can I drink alcohol while taking it?

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It is best to avoid it. Alcohol raises the amount of tizanidine in your blood and adds to drowsiness and side effects. The same goes for other sedating medicines, so check with me first.

Are there medicines I must avoid?

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Yes. Fluvoxamine and ciprofloxacin must never be taken with tizanidine, because they can cause a big drop in blood pressure and heavy drowsiness. Many others, including some heart rhythm medicines, famotidine, cimetidine and oral contraceptives, need caution. Always show me your full medicine list.

Can I stop it suddenly?

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Don't stop it on your own, especially if you have taken high doses for a long time. Stopping suddenly can cause rebound high blood pressure, fast heartbeat and tighter muscles. Your prescriber will lower the dose gradually.

Is Tizanidine available over the counter?

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No. Tizanidine is a prescription medicine: every Tizanidine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Tizanidine first available?

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The earliest FDA record we hold for Tizanidine is from 1996: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Tizanidine was first used.

Who makes Tizanidine?

▾
50 companies currently list Tizanidine products in the FDA's NDC Directory, including Bryant Ranch Prepack, Asclemed USA, Inc., Advanced Rx of Tennessee, LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Tizanidine on HelloPharmacist

Detailed data & references for Tizanidine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Tizanidine forms and strengths (how it comes)

Tizanidine is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Zanaflex
How this form is used
What it may be used for
  • Tizanidine tablets are used to manage spasticity.
  • Zanaflex is labeled for spasticity and is available as a capsule or tablet.
Important instructions
  • Tizanidine tablets: taking them with food raises how much drug is absorbed, so be consistent about food.
  • Tizanidine tablets and capsules are not bioequivalent when taken with food, so do not switch forms without your prescriber's guidance.
Available strengths 2 strengths
234 FDA-listed product records ⓘ

Capsule

By mouth
Brands Zanaflex
How this form is used
What it may be used for
  • Tizanidine hydrochloride capsules are used to manage spasticity.
  • Zanaflex capsules are described for spasticity, with one label specifying adults.
Important instructions
  • Tizanidine hydrochloride capsules: the label describes dosing every 6 to 8 hours as needed, up to 3 times in 24 hours.
  • Tizanidine capsules are absorbed differently from tablets and with or without food, so take them consistently with respect to food.
  • Tizanidine capsules: opening them and sprinkling the contents on applesauce was not bioequivalent to swallowing an intact capsule, so ask your pharmacist before doing this.
Available strengths 4 strengths
130 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Ontralfy
How this form is used
What it may be used for
  • Ontralfy is used to treat spasticity in adults.
Available strengths 1 strength
1 FDA-listed product record ⓘ

Tizanidine on the U.S. market: products, makers and brands

How Tizanidine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

50 companies list 183 Tizanidine product records with the FDA, mostly as tablet, capsule, oral solution; the earliest marketing or approval year on record is 1996. Brand names on the directory include Zanaflex, Ontralfy; the rest are generics.

3
Dose forms ⓘ
50
Labelers (makers, repackagers, distributors)
5
Brand names
183
FDA-listed product records ⓘ
1996
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (11) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack9%
Asclemed USA, Inc.6%
Advanced Rx of Tennessee, LLC5%
A-S Medication Solutions4%
PD-Rx Pharmaceuticals, Inc.4%
Preferred Pharmaceuticals Inc.4%
Other makers67%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Tizanidine is used (Medicaid data)

A general measure of how commonly Tizanidine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Tizanidine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

2,254,693
Medicaid prescriptions filled (Q1–Q4 2025)
$23.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tizanidine prescribed? Of the 1,601 medications we measure, Tizanidine ranks #98 by Medicaid prescriptions — more than 94% of them.

Where Tizanidine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Tizanidine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 4 mg oral tablet is the most-dispensed Tizanidine product — about 71% of these Medicaid prescriptions.

tizanidine 4 MG Oral Tablet Most dispensed

1,603,196 Medicaid prescriptions (Q1–Q4 2025) 71% of Tizanidine prescriptions shown $16.4M gross reimbursement (before rebates) ≈ $10 per prescription (gross)

Summed across the 19 of 367 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313413

tizanidine 2 MG Oral Tablet

585,836 Medicaid prescriptions (Q1–Q4 2025) 26% of Tizanidine prescriptions shown $5.6M gross reimbursement (before rebates) ≈ $9.53 per prescription (gross)

Summed across the 13 of 220 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313412

tizanidine 4 MG Oral Capsule

32,215 Medicaid prescriptions (Q1–Q4 2025) 1% of Tizanidine prescriptions shown $575,432 gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 8 of 81 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 485485

tizanidine 6 MG Oral Capsule

17,230 Medicaid prescriptions (Q1–Q4 2025) <1% of Tizanidine prescriptions shown $440,514 gross reimbursement (before rebates) ≈ $26 per prescription (gross)

Summed across the 7 of 100 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 485484

tizanidine 2 MG Oral Capsule

16,216 Medicaid prescriptions (Q1–Q4 2025) <1% of Tizanidine prescriptions shown $237,317 gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 8 of 47 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 485486

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tizanidine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 55 of 815 listed Tizanidine NDCs with Medicaid activity.

Compare Tizanidine products

A representative set of FDA-listed product records for Tizanidine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 105 of 183 products — FDA National Drug Code Directory. See every product, package size and price: browse all 183 Tizanidine NDCs →

Tizanidine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 5 Tizanidine recalls since July 2021. Two of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Jun 26, 2023 · Preferred Pharmaceuticals, Inc.
Failed Stability Specifications
  • Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68… Lots: Lot#: a) H1621S, Exp: 12/31/2023; b) H2321C, Exp: 12/31/2023; c) H0421B, Exp: 12/31/2023; d) H1721E, H1921T, H3121M, Exp: 12/31/2023, e) H2021G, Exp: 12/31/2023 FDA record D-0894-2023 →
Ongoing Class II Jun 21, 2023 · Dr Reddy's Laboratories Limited
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
  • Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10 Lots: Lot: T2100585, T2100586, T2100587, Exp 12/2023 FDA record D-0923-2023 →
Class II Jan 2, 2024 · Completed · Dr. Reddy's Laboratories, Inc.
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
  • Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15 Lots: Lot #: T2304007, Exp 7/31/2026 FDA record D-0223-2024 →
Class II Jun 23, 2023 · Terminated · Amerisource Health Services LLC
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
  • Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-0… Lots: Lot 1004835, Exp 7/31/2023 FDA record D-0892-2023 →
Class II Jul 19, 2021 · Terminated · Dr. Reddy's Laboratories, Inc.
Failed Tablet/Capsule Specification: Some tablets are shaved
  • Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15. Lots: Lot #: T2000471, exp date 09/2023 FDA record D-0750-2021 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Tizanidine RxCUI 57258 3 dose forms · 7 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 485483 In current FDA listings
    Clinical drug / strength (SCD) 2 MG RxCUI 485486 4 MG RxCUI 485485 6 MG RxCUI 485484 8 MG RxCUI 2723708
  2. Dose form (SCDF) Oral Solution RxCUI 2709431 In current FDA listings
    Clinical drug / strength (SCD) 0.4 MG/ML RxCUI 2709432
  3. Dose form (SCDF) Oral Tablet RxCUI 374146 In current FDA listings
    Clinical drug / strength (SCD) 2 MG RxCUI 313412 4 MG RxCUI 313413

Look up RxCUI 57258 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Tizanidine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule, Gelatin Coated · Oral 4 mg $0.097 per capsule NDC details & price history
Capsule, Gelatin Coated · Oral 2 mg $0.090 per capsule NDC details & price history
Capsule, Gelatin Coated · Oral 6 mg $0.141 per capsule NDC details & price history
Capsule 2 mg $0.090 per capsule NDC details & price history
Capsule 4 mg $0.097 per capsule NDC details & price history
Capsule 6 mg $0.141 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Tizanidine brand names

Tizanidine is sold under 2 brand names in the FDA directory — Zanaflex, Ontralfy. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Zanaflex Ontralfy

Who makes Tizanidine: manufacturers and labelers

50 companies list Tizanidine products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Asclemed USA, Inc., Advanced Rx of Tennessee, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 17 Asclemed USA, Inc. 11 Advanced Rx of Tennessee, LLC 9 A-S Medication Solutions 8 PD-Rx Pharmaceuticals, Inc. 8 Preferred Pharmaceuticals Inc. 8 Proficient Rx LP 6 Remedyrepack Inc. 6 Apotex Corp. 5 Aurobindo Pharma Limited 5 Zydus Lifesciences Limited 5 Advagen Pharma Limited 4 Advanced Rx Pharmacy of Tennessee, LLC 4 Aphena Pharma Solutions - Tennessee, LLC 4 Covis Pharma US, Inc 4 Direct_Rx 4 Legacy Pharma USA, Inc. 4 NuCare Pharmaceuticals,Inc. 4 Actavis Pharma, Inc. 3 Alembic Pharmaceuticals Inc. 3 Alembic Pharmaceuticals Limited 3 Cadila Pharmaceuticals Limited 3 Ingenus Pharmaceuticals, LLC 3 Kanchan Healthcare Inc 3

…and 26 more on the FDA NDC directory.

Tizanidine drug class (RxNorm)

Tizanidine belongs to the Central alpha-2 Adrenergic Agonist class.

Pharmacologic class Central alpha-2 Adrenergic Agonist
Drug family (ATC) Other centrally acting agents
How it works Adrenergic alpha2-Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Tizanidine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 1, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tizanidine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Tizanidine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
132
Finished products in the current FDA directory
183
Companies listing them (makers, repackagers, distributors)
50
FDA labeler codes behind them ⓘ
55
Linked representative label ⓘ
Proficient Rx LP
Linked label effective
Mar 1, 2022
Composite sections available
22
Linked SPL Set ID
76dc85bd-3cde-4940-a99b-663b70bf9f54
Linked SPL Document ID
2b2e33aa-55ad-4969-85d1-9cbfb62cabbb
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Proficient Rx LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →