Prescription medicine
Tizanidine Brand names: Zanaflex, Ontralfy
Tizanidine (Zanaflex) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 49 generic labelers, and pharmacies paid $0.0331 per tizanidine HCl 4 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the tizanidine FDA label on DailyMed (effective January 2, 2026, Legacy Pharma USA, Inc.); the NDA 20397 record on Drugs@FDA; every tizanidine label on DailyMed.
Highlights of the record
FDA label of January 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageZanaflex is indicated for the treatment of spasticity in adults.
Forms and strengths
- 2 mg
- 4 mg
- 6 mg
- 8 mg
- 2 mg/5ml
Tablet; capsule; gelatin-coated capsule; solution.
On the market
- Earliest approval on file
- November 27, 1996 Zanaflex, Legacy; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 29 first June 27, 2002; 21 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 53 of which 49 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- May 7, 2042 Ontralfy oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0331 per tablet Tizanidine HCl 4 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 9 since 2012 0 Class I among all firms' recalls; latest January 2, 2024; 4 more by firms not listed as its makers
- FAERS reports
- 41,179 through July 30, 2026
What is tizanidine used for?
From the label: indications and usageZanaflex is indicated for the treatment of spasticity in adults. Zanaflex is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity.
Conditions named in the indications of tizanidine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Central alpha-2 Adrenergic Agonist.
Source: FDA drug label (Zanaflex), Legacy Pharma USA, Inc., effective January 2, 2026 (SPL set 60c27d35-7349-4fc6-86ad-70fffdbe3e08), via openFDA; the full label on DailyMed
Is there a generic for tizanidine (Zanaflex)?
The FDA approved the first generic tizanidine on June 27, 2002. 29 generic applications are approved; 21 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tizanidine from 49 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Zanaflex capsules; a patent listed only for Ontralfy oral solution runs to May 7, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1996 earliest approval on file
- 2002 first generic approved
- 2042 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tizanidine (Zanaflex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0331 per Tizanidine HCl 4 mg tablet, down 12% from $0.0376 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tizanidine HCl 4 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tizanidine HCl 2 mg capsule | Generic | $0.0901 per capsule | $2.70 | +3% |
| Tizanidine HCl 2 mg tablet | Generic | $0.0317 per tablet | $0.951 | -18% |
| Tizanidine HCl 4 mg capsule | Generic | $0.0967 per capsule | $2.90 | -19% |
| Tizanidine HCl 4 mg tablet | Generic | $0.0331 per tablet | $0.992 | -12% |
| Tizanidine HCl 6 mg capsule | Generic | $0.141 per capsule | $4.22 | -19% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tizanidine been recalled?
The FDA's Enforcement Report lists 13 recalls naming tizanidine since 2012: 0 Class I (the most serious), 11 Class II, 2 Class III; 2 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of tizanidine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 2, 2024 | Class II | Dr. Reddy's Laboratories, Inc. | Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets. |
| June 26, 2023 | Class II | Preferred Pharmaceuticals, Inc. | Failed Stability Specifications |
| June 23, 2023 | Class II | 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 … |
| June 21, 2023 | Class II | Dr Reddy's Laboratories Limited | Failed dissolution specification: Out of specification results observed in 24-month long term stability testing. |
| July 19, 2021 | Class II | Dr. Reddy's Laboratories, Inc. | Failed Tablet/Capsule Specification: Some tablets are shaved |
| November 24, 2020 | Class II | Ascend Laboratories LLC | Failed Dissolution Specifications; Out of Specification (low) results were obtained. |
| September 4, 2018 | Class II | Dr. Reddy's Laboratories, Inc. | Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets . |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tizanidine label say about other medicines?
The tizanidine label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 21 other medicines name tizanidine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acyclovir | drug interactions | Concomitant use of Zanaflex with moderate or weak CYP1A2 inhibitors (e.g., zileuton, antiarrhythmics [amiodarone, mexiletine, propafenone, and verapamil], cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. |
| Amiodarone | drug interactions | Concomitant use of Zanaflex with moderate or weak CYP1A2 inhibitors (e.g., zileuton, antiarrhythmics [amiodarone, mexiletine, propafenone, and verapamil], cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. |
| Cimetidine | drug interactions | Concomitant use of Zanaflex with moderate or weak CYP1A2 inhibitors (e.g., zileuton, antiarrhythmics [amiodarone, mexiletine, propafenone, and verapamil], cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. |
| Ciprofloxacin | drug interactions | Concomitant use of Zanaflex with strong cytochrome P450 1A2 (CYP1A2) inhibitors (e.g., fluvoxamine, ciprofloxacin) is contraindicated. |
| Famotidine | drug interactions | Concomitant use of Zanaflex with moderate or weak CYP1A2 inhibitors (e.g., zileuton, antiarrhythmics [amiodarone, mexiletine, propafenone, and verapamil], cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. |
| Fluvoxamine | drug interactions | Concomitant use of Zanaflex with strong cytochrome P450 1A2 (CYP1A2) inhibitors (e.g., fluvoxamine, ciprofloxacin) is contraindicated. |
| Mexiletine | drug interactions | Concomitant use of Zanaflex with moderate or weak CYP1A2 inhibitors (e.g., zileuton, antiarrhythmics [amiodarone, mexiletine, propafenone, and verapamil], cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. |
| Propafenone | drug interactions | Concomitant use of Zanaflex with moderate or weak CYP1A2 inhibitors (e.g., zileuton, antiarrhythmics [amiodarone, mexiletine, propafenone, and verapamil], cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. |
| Verapamil | drug interactions | Concomitant use of Zanaflex with moderate or weak CYP1A2 inhibitors (e.g., zileuton, antiarrhythmics [amiodarone, mexiletine, propafenone, and verapamil], cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. |
| Zileuton | drug interactions | Concomitant use of Zanaflex with moderate or weak CYP1A2 inhibitors (e.g., zileuton, antiarrhythmics [amiodarone, mexiletine, propafenone, and verapamil], cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided. |
Other labels that name tizanidine
- Cannabidiol
- Deferasirox
- Drospirenone and ethinyl estradiol
- Drospirenone and ethinyl estradiol and levomefolate
- Estradiol
- Ethinyl estradiol and etonogestrel
- Ethinyl estradiol and ferrous bisglycinate and levonorgestrel
- Ethinyl estradiol and ferrous fumarate and levonorgestrel
- Ethinyl estradiol and levonorgestrel
- Ethinyl estradiol and norelgestromin
- Ethinyl estradiol and norgestimate
- Ethinyl estradiol and segesterone
- Leflunomide
- Osilodrostat
- Primaquine
- Teriflunomide
- Vemurafenib
Source: FDA drug label (Zanaflex), Legacy Pharma USA, Inc., effective January 2, 2026 (SPL set 60c27d35-7349-4fc6-86ad-70fffdbe3e08), via openFDA; the full label on DailyMed
What do FAERS reports show for tizanidine?
The FDA Adverse Event Reporting System holds 41,179 reports that list tizanidine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,781 are coded as a death and 11,827 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tizanidine?
8 other medicines are given the same way (oral) and in the same FDA class as tizanidine or labeled mainly for the same use (muscle spasms and spasticity), the same class first. Muscle spasms and spasticity lists all 12 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cyclobenzaprine | Muscle spasms and spasticity | 60 labelers | $0.0171 per tablet 10 mg tablet | No current entry |
| Baclofen | Muscle spasms and spasticity | 52 labelers | $0.032 per tablet 10 mg tablet | No current entry |
| Methocarbamol | Muscle spasms and spasticity | 54 labelers | $0.0395 per tablet 500 mg tablet | No current entry |
| Metaxalone | Muscle spasms and spasticity | 33 labelers | $0.452 per tablet 800 mg tablet | No current entry |
| Carisoprodol | Muscle spasms and spasticity | 24 labelers | $0.0706 per tablet 350 mg tablet | No current entry |
| Chlorzoxazone | Muscle spasms and spasticity | 19 labelers | $0.210 per tablet 500 mg tablet | No current entry |
| Dantrolene | Muscle spasms and spasticity | 7 labelers | $0.409 per capsule 25 mg capsule | No current entry |
| Orphenadrine | Muscle spasms and spasticity | 14 labelers | $0.454 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as tizanidine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tizanidine compare with medicines for the same use?
9 side-by-side pages set tizanidine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tizanidine
- 8 medicines for the same use
- Other central alpha-2 adrenergic agonists
- the pharmacologic class, with prices and generics
- Tizanidine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other