How are Tizanidine adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Tizanidine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Tizanidine is flagged as the suspect drug causing the adverse event.
What are the most common Tizanidine adverse events reported to the FDA?
Hypotension | 118 (2.17%) |
Completed Suicide | 113 (2.08%) |
Drug Interaction | 107 (1.97%) |
Somnolence | 73 (1.34%) |
Dizziness | 70 (1.29%) |
Loss Of Consciousness | 68 (1.25%) |
Respiratory Arrest | 63 (1.16%) |
Blood Pressure Decreased | 62 (1.14%) |
Cardiac Arrest | 60 (1.1%) |
Confusional State | 60 (1.1%) |
Nausea | 59 (1.08%) |
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This graph shows the top adverse events submitted to the FDA for Tizanidine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Tizanidine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.
What are the most common Tizanidine adverse events reported to the FDA?
Neurological | 514 (9.44%) |
Cardiac Arrhythmias | 264 (4.85%) |
Therapeutic And Nontherapeutic Effe... | 226 (4.15%) |
Cardiac And Vascular Investigations | 189 (3.47%) |
Respiratory | 167 (3.07%) |
Medication Errors | 155 (2.85%) |
Suicidal And Self-injurious Behavio... | 154 (2.83%) |
Gastrointestinal Signs | 150 (2.76%) |
Injuries | 147 (2.7%) |
Hepatobiliary | 137 (2.52%) |
Decreased And Nonspecific Blood Pre... | 135 (2.48%) |
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This graph shows the top categories of adverse events submitted to the FDA for Tizanidine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Tizanidine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.
Why are people taking Tizanidine, according to those reporting adverse events to the FDA?
Muscle Spasms | 625 |
Muscle Relaxant Therapy | 316 |
Product Used For Unknown Indication | 306 |
Drug Use For Unknown Indication | 283 |
Muscle Spasticity | 271 |
Back Pain | 152 |
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Label | Labeler | Effective |
---|---|---|
Tizanidine | Bryant Ranch Prepack | 03-JUL-02 |
Tizanidine | Bryant Ranch Prepack | 03-JUL-02 |
Tizanidine | Mylan Pharmaceuticals Inc. | 14-JAN-09 |
Tizanidine | UDL Laboratories, Inc. | 04-FEB-09 |
Tizanidine | Unit Dose Services | 30-SEP-09 |
Tizanidine | Unit Dose Services | 30-SEP-09 |
Tizanidine | Dr.Reddy's Laboratories Limited | 30-SEP-09 |
Tizanidine Hydrochloride | Rebel Distributors | 01-DEC-09 |
Tizanidine Hydrochloride | COREPHARMA LLC. | 08-DEC-09 |
Tizanidine | Altura Pharmaceuticals, Inc. | 28-APR-10 |
Tizanidine | Physicians Total Care, Inc. | 01-JUN-10 |
Tizanidine Hydrochloride | Keltman Pharmaceuticals Inc. | 07-JUL-10 |
Tizanidine Hydrochloride | Major Pharmaceuticals | 30-JUL-10 |
Tizanidine Hydrochloride | American Health Packaging | 22-MAR-11 |
Tizanidine | Apotex Corp. | 08-JUN-11 |
Tizanidine | Cardinal Health | 21-JUN-11 |
Tizanidine | Golden State Medical Supply, Inc. | 01-JUL-11 |
Tizanidine | Preferred Pharmaceuticals, Inc | 11-AUG-11 |
Tizanidine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | 23-SEP-11 |
Tizanidine Hydrochloride | Apotex Corp. | 31-OCT-11 |
Tizanidine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | 05-DEC-11 |
Tizanidine | H.J. Harkins Company, Inc. | 21-DEC-11 |
Tizanidine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | 28-DEC-11 |
Tizanidine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | 03-JAN-12 |
Tizanidine Hydrochloride | STAT Rx USA LLC | 09-FEB-12 |
Tizanidine | McKesson Contract Packaging | 27-FEB-12 |
Tizanidine Hydrochloride | Eon Labs, Inc. | 08-MAY-12 |
Tizanidine | CARACO PHARMACEUTICAL LABORATORIES, LTD. | 08-MAY-12 |
Tizanidine Hydrochloride | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 02-AUG-12 |
Tizanidine | Medsource Pharmaceuticals | 13-AUG-12 |
Tizanidine | Medsource Pharmaceuticals | 13-AUG-12 |
Tizanidine | STAT Rx USA LLC | 21-AUG-12 |
Tizanidine Hydrochloride | Mylan Pharmaceuticals Inc. | 18-SEP-12 |
Tizanidine | Aidarex Pharmaceuticals LLC | 05-OCT-12 |
Tizanidine | NCS HealthCare of KY, Inc dba Vangard Labs | 08-NOV-12 |
Tizanidine | Unichem Pharmaceuticals (USA), Inc. | 07-DEC-12 |
Tizanidine | REMEDYREPACK INC. | 19-FEB-13 |
Tizanidine Hydrochloride | Watson Laboratories, Inc. | 01-MAR-13 |
Tizanidine | Cardinal Health | 22-MAR-13 |
What Tizanidine safety concerns are being reported by doctors and researchers in the medical literature?
This report contains aggregated drug side effects and adverse events for Tizanidine. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.
DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.
DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.
Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.
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