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DANTRIUM

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Dantrium Adverse Events Reported to the FDA Over Time

How are Dantrium adverse event reports trending over time?

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

Most Common Dantrium Adverse Events Reported to the FDA

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

Respiratory Failure
28 (2.02%)
Pyrexia
25 (1.81%)
Neuroleptic Malignant Syndrome
22 (1.59%)
Aspartate Aminotransferase Increase...
20 (1.44%)
Alanine Aminotransferase Increased
18 (1.3%)
Gamma-glutamyltransferase Increased
18 (1.3%)
Vomiting
18 (1.3%)
Liver Disorder
17 (1.23%)
Altered State Of Consciousness
16 (1.16%)
Condition Aggravated
16 (1.16%)
Convulsion
16 (1.16%)
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Dysphagia
16 (1.16%)
Drug Interaction
15 (1.08%)
Muscular Weakness
15 (1.08%)
Hyponatraemia
14 (1.01%)
Pneumonia
14 (1.01%)
Drug Toxicity
13 (.94%)
Thrombocytopenia
13 (.94%)
Acute Respiratory Failure
12 (.87%)
Platelet Count Decreased
12 (.87%)
Rhabdomyolysis
12 (.87%)
Urinary Tract Infection
12 (.87%)
Blood Creatine Phosphokinase Increa...
11 (.79%)
Drug Ineffective
11 (.79%)
Off Label Use
11 (.79%)
Renal Failure
11 (.79%)
Hepatic Function Abnormal
10 (.72%)
Cardiac Failure
9 (.65%)
Confusional State
9 (.65%)
Cytolytic Hepatitis
9 (.65%)
Cardiac Arrest
8 (.58%)
Cardio-respiratory Arrest
8 (.58%)
Haemoglobin Decreased
8 (.58%)
Hyperkalaemia
8 (.58%)
Jaundice
8 (.58%)
Medication Error
8 (.58%)
Pancytopenia
8 (.58%)
Somnolence
8 (.58%)
Blood Alkaline Phosphatase Increase...
7 (.51%)
Blood Bilirubin Increased
7 (.51%)
Bradycardia
7 (.51%)
Disseminated Intravascular Coagulat...
7 (.51%)
Disturbance In Attention
7 (.51%)
Dyspnoea
7 (.51%)
Hyperthermia Malignant
7 (.51%)
Nausea
7 (.51%)
Pulmonary Oedema
7 (.51%)
Renal Impairment
7 (.51%)
Tachycardia
7 (.51%)
Acne
6 (.43%)
Blood Pressure Increased
6 (.43%)
Brain Oedema
6 (.43%)
Dehydration
6 (.43%)
Diplopia
6 (.43%)
Dysarthria
6 (.43%)
Eye Movement Disorder
6 (.43%)
Hepatitis Fulminant
6 (.43%)
Hyperhidrosis
6 (.43%)
Infusion Site Irritation
6 (.43%)
Insomnia
6 (.43%)
Malaise
6 (.43%)
Metabolic Acidosis
6 (.43%)
Mucosal Inflammation
6 (.43%)
Phlebitis
6 (.43%)
Anaemia
5 (.36%)
Anxiety
5 (.36%)
Aplastic Anaemia
5 (.36%)
Arrhythmia
5 (.36%)
Blood Creatinine Increased
5 (.36%)
Blood Lactate Dehydrogenase Increas...
5 (.36%)
C-reactive Protein Increased
5 (.36%)
Cardiac Disorder
5 (.36%)
Cerebral Infarction
5 (.36%)
Coma
5 (.36%)
Dizziness
5 (.36%)
Epilepsy
5 (.36%)
Gastrointestinal Haemorrhage
5 (.36%)
Hypotension
5 (.36%)
Hypothermia
5 (.36%)
Pain
5 (.36%)
Renal Tubular Disorder
5 (.36%)
Respiratory Depression
5 (.36%)
Vaginal Haemorrhage
5 (.36%)
Agitation
4 (.29%)
Balance Disorder
4 (.29%)
Blood Albumin Decreased
4 (.29%)
Blood Folate Decreased
4 (.29%)
Cholestasis
4 (.29%)
Depressed Level Of Consciousness
4 (.29%)
Drug Exposure During Pregnancy
4 (.29%)
Drug Level Increased
4 (.29%)
Dysuria
4 (.29%)
Ejection Fraction Decreased
4 (.29%)
Electrocardiogram Abnormal
4 (.29%)
Electrocardiogram Pr Prolongation
4 (.29%)
Fatigue
4 (.29%)
Haematuria
4 (.29%)
Heart Rate Increased
4 (.29%)
Hypotonia
4 (.29%)
Inappropriate Antidiuretic Hormone ...
4 (.29%)
Muscle Spasticity
4 (.29%)

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

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

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

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

Neuroleptic Malignant Syndrome
65
Muscle Spasticity
48
Muscle Spasms
37
Hyperthermia Malignant
33
Drug Use For Unknown Indication
30
Cerebral Palsy
16
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Product Used For Unknown Indication
14
Muscle Tightness
10
Musculoskeletal Stiffness
8
Multiple Sclerosis
8
Hypotonia
7
Relapsing-remitting Multiple Sclero...
6
Blood Creatine Phosphokinase Increa...
6
Cerebrovascular Spasm
6
Spinal Ligament Ossification
5
Torticollis
4
Quadriparesis
4
Spastic Paralysis
4
Spinal Cord Injury Thoracic
3
Myalgia
3
Gait Spastic
3
Pain
3
Epilepsy
3
Convulsion
3
Spinocerebellar Disorder
3
Analgesic Effect
3
Dystonia
2
Spinal Cord Disorder
2
Hemiplegia
2
Spinal Cord Paralysis
2
Pain In Extremity
2
Insomnia
2
Quadriplegia
2
Paraplegia
2
Muscle Relaxant Therapy
2
Analgesic Therapy
2
Myoclonus
2
Carotid Artery Occlusion
1
Cervical Myelopathy
1
Analgesia
1
Cerebrovascular Accident
1
Urinary Tract Infection
1
Drug Exposure During Pregnancy
1
Hepatic Function Abnormal
1
Muscle Cramp
1
Off Label Use
1
Muscle Rigidity
1
Spastic Paraplegia
1
Scoliosis
1
Muscle Disorder
1
Prophylaxis
1

Drug Labels

LabelLabelerEffective
DantriumJHP Pharmaceuticals LLC01-OCT-09
DantriumJHP Pharmaceuticals LLC25-JUL-12

Dantrium Case Reports

What Dantrium 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 Dantrium. 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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