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TIZANIDINE

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Tizanidine Adverse Events Reported to the FDA Over Time

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.

Most Common Tizanidine Adverse Events Reported to the FDA

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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Drug Ineffective
54 (.99%)
Fall
51 (.94%)
Asthenia
48 (.88%)
Headache
48 (.88%)
Muscle Spasms
46 (.85%)
Bradycardia
45 (.83%)
Pain
45 (.83%)
Cardio-respiratory Arrest
43 (.79%)
Overdose
42 (.77%)
Vomiting
41 (.75%)
Memory Impairment
39 (.72%)
Alanine Aminotransferase Increased
38 (.7%)
Convulsion
38 (.7%)
Aspartate Aminotransferase Increase...
37 (.68%)
Pyrexia
35 (.64%)
Tremor
35 (.64%)
Drug Toxicity
32 (.59%)
Fatigue
31 (.57%)
Dry Mouth
30 (.55%)
Delirium
29 (.53%)
Suicide Attempt
29 (.53%)
Condition Aggravated
28 (.51%)
Drug Withdrawal Syndrome
28 (.51%)
Rash
28 (.51%)
Disorientation
27 (.5%)
Feeling Abnormal
27 (.5%)
Hallucination
26 (.48%)
Coma
25 (.46%)
Dyspnoea
25 (.46%)
Poisoning
25 (.46%)
Urinary Tract Infection
25 (.46%)
Aggression
24 (.44%)
Depressed Level Of Consciousness
24 (.44%)
Malaise
24 (.44%)
Tachycardia
24 (.44%)
Death
23 (.42%)
Gait Disturbance
23 (.42%)
Syncope
23 (.42%)
Gamma-glutamyltransferase Increased
22 (.4%)
Intentional Drug Misuse
22 (.4%)
Sedation
22 (.4%)
Back Pain
21 (.39%)
Electrocardiogram Qt Prolonged
21 (.39%)
Hypertension
21 (.39%)
Renal Failure Acute
21 (.39%)
Agitation
20 (.37%)
Heart Rate Decreased
20 (.37%)
Road Traffic Accident
20 (.37%)
Cardiac Disorder
19 (.35%)
Depression
19 (.35%)
Hallucination, Visual
19 (.35%)
Hyperhidrosis
19 (.35%)
Hypoaesthesia
19 (.35%)
Sinus Bradycardia
19 (.35%)
Blood Pressure Increased
18 (.33%)
Diarrhoea
18 (.33%)
Facial Bones Fracture
18 (.33%)
Heart Rate Increased
18 (.33%)
Multiple Drug Overdose Intentional
18 (.33%)
Vision Blurred
18 (.33%)
Amnesia
17 (.31%)
Blood Creatinine Increased
17 (.31%)
Contusion
17 (.31%)
Dehydration
17 (.31%)
Insomnia
17 (.31%)
Intentional Overdose
17 (.31%)
Blood Lactate Dehydrogenase Increas...
16 (.29%)
Chest Pain
16 (.29%)
Dysarthria
16 (.29%)
Hepatic Function Abnormal
16 (.29%)
Pain In Extremity
16 (.29%)
Torsade De Pointes
16 (.29%)
Anaemia
15 (.28%)
Anxiety
15 (.28%)
Blood Alkaline Phosphatase Increase...
15 (.28%)
Drug Level Increased
15 (.28%)
Haemoptysis
15 (.28%)
Hepatic Enzyme Increased
15 (.28%)
Medication Error
15 (.28%)
Muscular Weakness
15 (.28%)
Periorbital Haematoma
15 (.28%)
Pneumonia
15 (.28%)
Skin Laceration
15 (.28%)
Speech Disorder
15 (.28%)
Abdominal Pain
14 (.26%)
General Physical Health Deteriorati...
14 (.26%)
Paraesthesia
14 (.26%)
Drug Screen Positive
13 (.24%)
Liver Disorder
13 (.24%)
Multiple Drug Overdose
13 (.24%)

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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.

Adverse Event Categories for Tizanidine

What are the most common Tizanidine adverse events reported to the FDA?

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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.

Common Uses of Tizanidine According to Those Reporting Adverse Events

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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Pain
149
Fibromyalgia
78
Multiple Sclerosis
78
Myalgia
48
Neck Pain
38
Musculoskeletal Stiffness
37
Migraine
28
Muscle Tightness
26
Sleep Disorder
24
Muscle Disorder
24
Headache
21
Neuralgia
17
Ill-defined Disorder
17
Pain In Extremity
16
Back Disorder
16
Spinal Osteoarthritis
15
Insomnia
14
Intervertebral Disc Protrusion
14
Musculoskeletal Pain
13
Sleep Disorder Therapy
12
Arthritis
12
Spinal Disorder
11
Arthralgia
11
Hypertonia
11
Dystonia
10
Hypotonia
10
Cervicobrachial Syndrome
9
Restless Legs Syndrome
8
Sciatica
8
Muscular Weakness
8
Suicide Attempt
8
Spastic Paralysis
8
Torticollis
8
Lumbar Spine Flattening
7
Ankylosing Spondylitis
7
Rheumatoid Arthritis
7
Injury
7
Prophylaxis
7
Intervertebral Disc Degeneration
7
Nerve Injury
6
Back Injury
6
Cerebral Palsy
6
Muscle Cramp
5
Neck Injury
5
Relapsing-remitting Multiple Sclero...
5

Drug Labels

LabelLabelerEffective
TizanidineBryant Ranch Prepack03-JUL-02
TizanidineBryant Ranch Prepack03-JUL-02
TizanidineMylan Pharmaceuticals Inc.14-JAN-09
TizanidineUDL Laboratories, Inc.04-FEB-09
TizanidineUnit Dose Services30-SEP-09
TizanidineUnit Dose Services30-SEP-09
TizanidineDr.Reddy's Laboratories Limited30-SEP-09
Tizanidine HydrochlorideRebel Distributors01-DEC-09
Tizanidine HydrochlorideCOREPHARMA LLC.08-DEC-09
TizanidineAltura Pharmaceuticals, Inc.28-APR-10
TizanidinePhysicians Total Care, Inc.01-JUN-10
Tizanidine HydrochlorideKeltman Pharmaceuticals Inc.07-JUL-10
Tizanidine HydrochlorideMajor Pharmaceuticals30-JUL-10
Tizanidine HydrochlorideAmerican Health Packaging22-MAR-11
TizanidineApotex Corp.08-JUN-11
TizanidineCardinal Health21-JUN-11
TizanidineGolden State Medical Supply, Inc.01-JUL-11
TizanidinePreferred Pharmaceuticals, Inc11-AUG-11
Tizanidine HydrochloridePD-Rx Pharmaceuticals, Inc.23-SEP-11
Tizanidine HydrochlorideApotex Corp.31-OCT-11
Tizanidine HydrochloridePD-Rx Pharmaceuticals, Inc.05-DEC-11
TizanidineH.J. Harkins Company, Inc.21-DEC-11
Tizanidine HydrochlorideLake Erie Medical DBA Quality Care Products LLC28-DEC-11
Tizanidine HydrochlorideLake Erie Medical DBA Quality Care Products LLC03-JAN-12
Tizanidine HydrochlorideSTAT Rx USA LLC09-FEB-12
TizanidineMcKesson Contract Packaging27-FEB-12
Tizanidine HydrochlorideEon Labs, Inc.08-MAY-12
TizanidineCARACO PHARMACEUTICAL LABORATORIES, LTD.08-MAY-12
Tizanidine HydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLC02-AUG-12
TizanidineMedsource Pharmaceuticals13-AUG-12
TizanidineMedsource Pharmaceuticals13-AUG-12
Tizanidine STAT Rx USA LLC21-AUG-12
Tizanidine HydrochlorideMylan Pharmaceuticals Inc.18-SEP-12
TizanidineAidarex Pharmaceuticals LLC05-OCT-12
TizanidineNCS HealthCare of KY, Inc dba Vangard Labs08-NOV-12
TizanidineUnichem Pharmaceuticals (USA), Inc.07-DEC-12
TizanidineREMEDYREPACK INC. 19-FEB-13
Tizanidine HydrochlorideWatson Laboratories, Inc.01-MAR-13
TizanidineCardinal Health22-MAR-13

Tizanidine Case Reports

What Tizanidine safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

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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