This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Tizanidine capsules are indicated for the treatment of spasticity in adults. Tizanidine capsules are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 )
Tizanidine capsules are contraindicated in patients: • taking strong CYP1A2 inhibitors [see Drug Interactions ( 7.1 )]. • with a history of hypersensitivity to tizanidine or the ingredients in tizanidine capsules. Symptoms have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.5 )]. • Concomitant use with strong CYP1A2 inhibitors ( 4 , 7.1 ) • Patients with a history of hypersensitivity to tizanidine or the ingredients in tizanidine ( 4 , 5.5 )
• Hypotension: monitor for signs and symptoms of hypotension, in particular in patients receiving concurrent antihypertensives; tizanidine should not be used with other α2-adrenergic agonists ( 5.1 , 7.7) • Risk of liver injury: monitor ALTs; discontinue tizanidine if liver injury occurs ( 5.2 ) • Sedation: Tizanidine may interfere with everyday activities; sedative effects of tizanidine, alcohol, and other central nervous system (CNS) depressants are additive ( 5.3 , 7.4 ) • Hallucinations: consider discontinuation of tizanidine ( 5.4 ) 5.1 Hypotension Tizanidine is an α2-adrenergic agonist that can produce hypotension [see Adverse Reactions ( 6.1 ) and Drug Interactions ( 7.5 )]. Syncope has been reported in patients treated with tizanidine in the postmarketing setting. The risk of hypotension may be minimized by dose titration; monitoring for signs and symptoms of hypotension prior to dosage increase may minimize the risks associated with hypotension. In addition, patients moving from a supine to fixed upright position may be at increased risk for hypotension and orthostatic effects. Monitor for hypotension when Tizanidine is used in patients receiving concurrent antihypertensiv...
The following clinically significant adverse reactions are described elsewhere in other sections of the prescribing information: • Hypotension [see Warnings and Precautions ( 5.1 )] • Liver Injury [see Warnings and Precautions ( 5.2 )] • Sedation [see Warnings and Precautions ( 5.3 )] • Hallucinosis/Psychotic-Like Symptoms [see Warnings and Precautions ( 5.4 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] • Withdrawal Adverse Reactions [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (greater than 10% of patients taking tizanidine and greater than in patients taking placebo) were dry mouth, somnolence, asthenia, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. The safety of tizanidine has been evaluated in three double-bli...
Indications and Usage ( 1 ) 11/2024 Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) 11/2024 Contraindications ( 4 ) 11/2024 Warnings and Precautions ( 5.1 , 5.2 , 5.4 , 5.5 ) 11/2024
Source: FDA SPL label for Tizanidne hydrochloride (Bryant Ranch Prepack), effective 20260325. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 4,295 | 3,964 | 3,203 | 2,878 | 3,034 | 2,655 | 2,727 | 1,526 |
982 reports blaming this drug for every million Medicare prescriptions filled, which is 0.4× the typical drug on this site. (6,860 reports in 2024–2026, against 6,985,252 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 01/2024 | Class II | Dr. Reddy's Laboratories, Inc. | Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets. |
| 06/2023 | 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 results for dissolution. |
| 06/2023 | Class II | Dr Reddy's Laboratories Limited | Failed dissolution specification: Out of specification results observed in 24-month long term stability testing. |
| 07/2021 | Class II | Dr. Reddy's Laboratories, Inc. | Failed Tablet/Capsule Specification: Some tablets are shaved |
| 11/2020 | Class II | Ascend Laboratories LLC | Failed Dissolution Specifications; Out of Specification (low) results were obtained. |
| 09/2018 | Class II | Dr. Reddy's Laboratories, Inc. | Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets . |
| 03/2013 | Class III | Dr. Reddy'S Laboratories | Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Tizanidine HCl | 6,984,387 | $11 |
| Zanaflex | 865 | $525 |
No same-class alternatives found in RxClass.