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METAXALONE

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Metaxalone Adverse Events Reported to the FDA Over Time

How are Metaxalone adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Metaxalone, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Metaxalone is flagged as the suspect drug causing the adverse event.

Most Common Metaxalone Adverse Events Reported to the FDA

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

Completed Suicide
94 (12.38%)
Cardio-respiratory Arrest
22 (2.9%)
Cardiac Arrest
21 (2.77%)
Death
18 (2.37%)
Respiratory Arrest
18 (2.37%)
Constipation
16 (2.11%)
Dehydration
15 (1.98%)
Delirium
15 (1.98%)
Drug Abuse
15 (1.98%)
Weight Decreased
15 (1.98%)
Drug Toxicity
14 (1.84%)
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Overdose
14 (1.84%)
Visual Impairment
14 (1.84%)
Agitation
12 (1.58%)
Insomnia
12 (1.58%)
Fatigue
11 (1.45%)
Depression
10 (1.32%)
Urinary Tract Infection
10 (1.32%)
Confusional State
9 (1.19%)
Decreased Appetite
9 (1.19%)
Disorientation
9 (1.19%)
Drug Ineffective
9 (1.19%)
Hallucination, Visual
9 (1.19%)
Alanine Aminotransferase Increased
8 (1.05%)
Aspartate Aminotransferase Increase...
8 (1.05%)
Memory Impairment
8 (1.05%)
Multiple Drug Overdose Intentional
8 (1.05%)
Poisoning
8 (1.05%)
Pseudodementia
8 (1.05%)
Blood Creatinine Increased
7 (.92%)
Haemoglobin Decreased
7 (.92%)
Mental Status Changes
7 (.92%)
Adverse Drug Reaction
6 (.79%)
Haematocrit Decreased
6 (.79%)
Loss Of Consciousness
6 (.79%)
Protein Total Decreased
6 (.79%)
Blood Urea Increased
5 (.66%)
Coma
5 (.66%)
Headache
5 (.66%)
Intentional Drug Misuse
5 (.66%)
Intentional Overdose
5 (.66%)
Multiple Drug Overdose
5 (.66%)
Nausea
5 (.66%)
Pruritus
5 (.66%)
Rash
5 (.66%)
Accidental Overdose
4 (.53%)
Cardiac Failure Congestive
4 (.53%)
Cerebral Infarction
4 (.53%)
Erythema
4 (.53%)
Muscle Spasms
4 (.53%)
Pneumonia
4 (.53%)
Product Substitution Issue
4 (.53%)
Somnolence
4 (.53%)
Vomiting
4 (.53%)
Blood Creatine Phosphokinase Increa...
3 (.4%)
Blood Potassium Increased
3 (.4%)
Depressed Level Of Consciousness
3 (.4%)
Drug Dependence
3 (.4%)
Hepatic Function Abnormal
3 (.4%)
Hypertension
3 (.4%)
International Normalised Ratio Incr...
3 (.4%)
Multiple Drug Overdose Accidental
3 (.4%)
Renal Failure
3 (.4%)
Troponin Increased
3 (.4%)
Urticaria
3 (.4%)
Abdominal Discomfort
2 (.26%)
Anxiety
2 (.26%)
Arthritis
2 (.26%)
Blood Alkaline Phosphatase Increase...
2 (.26%)
Blood Bicarbonate Decreased
2 (.26%)
Blood Bilirubin Increased
2 (.26%)
Blood Glucose Increased
2 (.26%)
Blood Sodium Decreased
2 (.26%)
Condition Aggravated
2 (.26%)
Convulsion
2 (.26%)
Dementia
2 (.26%)
Disturbance In Attention
2 (.26%)
Dizziness
2 (.26%)
Drug Effect Decreased
2 (.26%)
Drug Screen Positive
2 (.26%)
Incorrect Dose Administered
2 (.26%)
Medication Error
2 (.26%)
Musculoskeletal Stiffness
2 (.26%)
Neuropathy Peripheral
2 (.26%)
Pain
2 (.26%)
Posturing
2 (.26%)
Prothrombin Level Increased
2 (.26%)
Purpura Senile
2 (.26%)
Renal Tubular Necrosis
2 (.26%)
Respiratory Depression
2 (.26%)
Rhabdomyolysis
2 (.26%)
Stent Placement
2 (.26%)
Substance Abuse
2 (.26%)
Suicidal Ideation
2 (.26%)
Transaminases Increased
2 (.26%)
Abasia
1 (.13%)
Abnormal Behaviour
1 (.13%)
Acidosis
1 (.13%)
Acne
1 (.13%)
Activated Partial Thromboplastin Ti...
1 (.13%)
Adverse Reaction
1 (.13%)

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This graph shows the top adverse events submitted to the FDA for Metaxalone, 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 Metaxalone 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 Metaxalone

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

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This graph shows the top categories of adverse events submitted to the FDA for Metaxalone, 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 Metaxalone 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 Metaxalone According to Those Reporting Adverse Events

Why are people taking Metaxalone, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication
61
Product Used For Unknown Indication
36
Muscle Spasms
33
Pain
13
Muscle Relaxant Therapy
12
Suicide Attempt
8
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Back Pain
8
Back Disorder
6
Fibromyalgia
6
Rheumatoid Arthritis
5
Myalgia
4
Migraine
3
Intervertebral Disc Degeneration
3
Ill-defined Disorder
3
Ankylosing Spondylitis
3
Bone Disorder
2
Sciatic Nerve Neuropathy
2
Arthritis
2
Hypertension
2
Fluid Retention
1
Pain Management
1
Neck Pain
1
Sciatica
1
Intervertebral Disc Protrusion
1
Drug Abuser
1
Knee Operation
1
Spondylitis
1
Bursitis
1
Implant Site Pain
1
Sleep Disorder Therapy
1
Pain In Extremity
1
Restless Legs Syndrome
1

Drug Labels

LabelLabelerEffective
MetaxaloneBryant Ranch Prepack01-NOV-07
MetaxalonePhysicians Total Care, Inc.31-MAR-10
MetaxaloneKeltman Pharmaceuticals Inc.27-SEP-10
MetaxaloneRebel Distributors Corp.04-OCT-10
SkelaxinRebel Distributors Corp04-JAN-11
MetaxalonePD-Rx Pharmaceuticals, Inc.14-JAN-11
MetaxaloneUnit Dose Services14-JAN-11
MetaxaloneSt. Marys Medical Park Pharmacy30-JAN-11
MetaxaloneBlenheim Pharmacal, Inc.06-JUN-11
SkelaxinCardinal Health04-AUG-11
Metaxalone H.J. Harkins Company, Inc.15-AUG-11
SkelaxinKing Pharmaceuticals, Inc.06-SEP-11
SkelaxinPD-Rx Pharmaceuticals, Inc.06-SEP-11
MetaxaloneDispensing Solutions, Inc.22-SEP-11
MetaxaloneEon Labs, Inc.23-SEP-11
MetaxaloneLake Erie Medical & Surgical Supply DBA Quality Care Products LLC05-DEC-11
MetaxaloneRebel Distributors Corp13-DEC-11
SkelaxinLake Erie Medical & Surgical Supply DBA Quality Care Products LLC14-DEC-11
MetaxalonePreferred Pharmaceuticals, Inc14-FEB-12
MetaxaloneCorePharma, LLC16-FEB-12
MetaxaloneSTAT Rx USA LLC27-FEB-12
MetaxaloneREMEDYREPACK INC. 29-MAR-12
SkelaxinSTAT Rx USA LLC15-AUG-12
Metaxalone STAT Rx USA LLC28-SEP-12
MetaxaloneBryant Ranch Prepack12-OCT-12

Metaxalone Case Reports

What Metaxalone 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 Metaxalone. 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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