{ "query": "tizanidine", "ingredient": "tizanidine", "slug": "tizanidine", "rxcui": "57258", "brands": [ "Zanaflex", "Ontralfy" ], "names": [ "tizanidine", "tizanidine hydrochloride" ], "classes": [], "alternatives": [], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 126 }, "boxed_warning": "", "indications_and_usage": "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 )", "contraindications": "Tizanidine capsules are contraindicated in patients: \u2022 taking strong CYP1A2 inhibitors [see Drug Interactions ( 7.1 )]. \u2022 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 )]. \u2022 Concomitant use with strong CYP1A2 inhibitors ( 4 , 7.1 ) \u2022 Patients with a history of hypersensitivity to tizanidine or the ingredients in tizanidine ( 4 , 5.5 )", "warnings_and_cautions": "\u2022 Hypotension: monitor for signs and symptoms of hypotension, in particular in patients receiving concurrent antihypertensives; tizanidine should not be used with other \u03b12-adrenergic agonists ( 5.1 , 7.7) \u2022 Risk of liver injury: monitor ALTs; discontinue tizanidine if liver injury occurs ( 5.2 ) \u2022 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 ) \u2022 Hallucinations: consider discontinuation of tizanidine ( 5.4 ) 5.1 Hypotension Tizanidine is an \u03b12-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...", "warnings": "", "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in other sections of the prescribing information: \u2022 Hypotension [see Warnings and Precautions ( 5.1 )] \u2022 Liver Injury [see Warnings and Precautions ( 5.2 )] \u2022 Sedation [see Warnings and Precautions ( 5.3 )] \u2022 Hallucinosis/Psychotic-Like Symptoms [see Warnings and Precautions ( 5.4 )] \u2022 Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] \u2022 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...", "drug_abuse_and_dependence": "9.1 Controlled Substance Tizanidine capsules contains tizanidine, which is not a controlled substance. 9.2 Abuse Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Abuse potential was not evaluated in human studies. Rats were able to distinguish tizanidine from saline in a standard discrimination paradigm, after training, but failed to generalize the effects of morphine, cocaine, diazepam, or phenobarbital to tizanidine. 9.3 Dependence Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Tizanidine is closely related to clonidine, which is often abused in combination with narcotics and is known to cause symptoms of rebound upon abrupt withdrawal. Cases of rebound symptoms on sudden withdrawal of tizanidine have been reported. The case reports suggest that these patients were also misusing narcotics. Withdrawal symptoms included hypertension, tachycardia, hypertonia, tremor, and anxiety. Withdrawal symptoms are more likely to occu...", "controlled_substance": "9.1 Controlled Substance Tizanidine capsules contains tizanidine, which is not a controlled substance.", "recent_major_changes": "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", "information_for_patients": "Serious Drug Interactions Advise patients they should not take tizanidine if they are taking fluvoxamine or ciprofloxacin because of the increased risk of serious adverse reactions including severe lowering of blood pressure and sedation. Instruct patients to inform their healthcare providers when they start or stop taking any medication because of the risks associated with interaction between tizanidine and other medicines [see Contraindications ( 4 ) and Drug Interactions ( 7 )] . Tizanidine Dosing and Administration Tell patients to take tizanidine exactly as prescribed (consistently either with or without food) and not to switch between tablets and capsules [see Dosage and Administration ( 2 )] . Inform patients that they should not take more tizanidine than prescribed because of the risk of adverse events at single doses greater than 8 mg or total daily doses greater than 36 mg. Tell patients that they should not suddenly discontinue tizanidine, because rebound hypertension and tachycardia may occur [see Warnings and Precautions ( 5.6 )]. Hypotension Warn patients that they may experience hypotension and to be careful when changing from a lying or sitting to a standing positio...", "spl_medguide": "", "clinical_studies": "The efficacy of tizanidine for the treatment of spasticity was demonstrated in two adequate and well-controlled studies in patients with multiple sclerosis or spinal cord injury (Studies 1 and 2). Single-Dose Study in Patients with Multiple Sclerosis with Spasticity In Study 1, 140 patients with spasticity caused by multiple sclerosis were randomized to receive single oral doses of 8 mg or 16 mg of tizanidine, or placebo. Patients and assessors were blinded to treatment assignment and efforts were made to reduce the likelihood that assessors would become aware indirectly of treatment assignment (e.g., they did not provide direct care to patients and were prohibited from asking questions about side effects). Response was assessed by physical examination; muscle tone was rated on a 5-point scale (Ashworth score) as follows: 0 = normal muscle tone 1 = slight spastic catch 2 = more marked muscle resistance 3 = considerable increase in tone, making passive movement difficult 4 = a muscle immobilized by spasticity Spasm counts were also collected. Assessments were made at 1, 2, 3 and 6 hours after treatment. A statistically significant reduction of the Ashworth score for tizanidine compa...", "brand_name": "Tizanidne hydrochloride", "manufacturer": "Bryant Ranch Prepack", "application_number": "ANDA212196", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20260325", "set_id": "04febb37-00d6-4279-8c5f-171950278c8f", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 40334, "serious": 23975, "death": 2693, "hospitalization": 11204, "primary_suspect": 40218, "top_reactions": [ [ "Fatigue", 3083 ], [ "Nausea", 2798 ], [ "Pain", 2790 ], [ "Drug Ineffective", 2681 ], [ "Headache", 2552 ], [ "Fall", 2200 ], [ "Diarrhoea", 1912 ], [ "Dizziness", 1771 ], [ "Off Label Use", 1640 ], [ "Arthralgia", 1555 ], [ "Dyspnoea", 1501 ], [ "Vomiting", 1449 ], [ "Chronic Kidney Disease", 1436 ], [ "Asthenia", 1415 ], [ "Anxiety", 1330 ] ], "by_year": { "2019": 4295, "2020": 3964, "2021": 3203, "2022": 2878, "2023": 3034, "2024": 2655, "2025": 2727, "2026": 1526 }, "by_year_primary": { "2019": 4293, "2020": 3958, "2021": 3194, "2022": 2850, "2023": 3012, "2024": 2646, "2025": 2701, "2026": 1513 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20240102", "reason": "Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.", "firm": "Dr. Reddy's Laboratories, Inc.", "status": "Completed" }, { "class": "Class II", "date": "20230623", "reason": "Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.", "firm": "Amerisource Health Services LLC", "status": "Terminated" }, { "class": "Class II", "date": "20230621", "reason": "Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.", "firm": "Dr Reddy's Laboratories Limited", "status": "Ongoing" }, { "class": "Class II", "date": "20210719", "reason": "Failed Tablet/Capsule Specification: Some tablets are shaved", "firm": "Dr. Reddy's Laboratories, Inc.", "status": "Terminated" }, { "class": "Class II", "date": "20201124", "reason": "Failed Dissolution Specifications; Out of Specification (low) results were obtained.", "firm": "Ascend Laboratories LLC", "status": "Terminated" }, { "class": "Class II", "date": "20180904", "reason": "Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .", "firm": "Dr. Reddy's Laboratories, Inc.", "status": "Terminated" }, { "class": "Class III", "date": "20130319", "reason": "Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.", "firm": "Dr. Reddy'S Laboratories", "status": "Terminated" } ], "recall_total": 7, "drugsfda": { "applications": 32, "nda": 3, "anda": 29, "first_approval": "19961127", "rems": false, "rems_last": "", "labeling_supplements": 11, "labeling_recent": 3, "sponsors": [ "ALEMBIC", "ALKEM LABS LTD", "ANI PHARMS", "APOTEX", "APOTEX INC", "AUROBINDO PHARMA LTD", "AUROBINDO PHARMA USA", "CADILA" ], "unapproved": false, "first_approval_fmt": "11/27/1996" }, "trials": { "total": 45, "completed": 24, "terminated": 5, "with_results": 7, "industry": 17, "phase3": 9, "results_share": 0.2916666666666667, "terminated_share": 0.1111111111111111 }, "pubmed": { "rct": 53, "meta": 4, "recent_rct": 2, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "tizanidine", "Zanaflex", "Ontralfy" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 6985252, "beneficiaries": 2073257, "spend": 77047981.18, "by_brand": [ { "brand": "Tizanidine HCl", "claims": 6984387, "per_claim": 10.966378013, "is_generic": true }, { "brand": "Zanaflex", "claims": 865, "per_claim": 525.4949711, "is_generic": false } ], "per_claim": 11.03009328510983 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 6860, "fills": 6985252, "per_million": 982.0690792544063, "ratio": 0.35467204773580413, "median": 2768.949753790441 }, "scores": { "safety": { "score": 100, "letter": "A", "why": [ "982 FDA reports naming it as the suspect drug per million Medicare fills, 0.4x the median drug on this site", "Death share in reports is near or below the FAERS average (0.7x)" ], "weight": 0.35 }, "evidence": { "score": 31, "letter": "F", "why": [ "53 randomized trials and 4 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "Only 29% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 85, "letter": "B", "why": [ "Recalls since 2016: 0 Class I, 6 Class II, 0 Class III across 29 generic makers (-6)", "3 label changes approved since 2021 (-4)", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $0 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 70, "letter": "C", "why": [ "Generic versions approved (29 applications)", "No same-class alternatives found: little leverage to switch (-30)" ], "weight": 0.1 } }, "total": 78, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are fatigue, nausea, pain. How would we recognize and handle those?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }