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CLOBAZAM

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Clobazam Adverse Events Reported to the FDA Over Time

How are Clobazam adverse event reports trending over time?

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

Most Common Clobazam Adverse Events Reported to the FDA

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

Convulsion
82 (2.86%)
Drug Exposure During Pregnancy
73 (2.55%)
Drug Ineffective
48 (1.67%)
Drug Interaction
43 (1.5%)
Somnolence
42 (1.46%)
Status Epilepticus
38 (1.33%)
Epilepsy
33 (1.15%)
Hip Dysplasia
31 (1.08%)
Pyrexia
31 (1.08%)
Maternal Drugs Affecting Foetus
29 (1.01%)
Memory Impairment
29 (1.01%)
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Condition Aggravated
25 (.87%)
Depressed Level Of Consciousness
25 (.87%)
Aphasia
24 (.84%)
Hypospadias
24 (.84%)
Abnormal Behaviour
23 (.8%)
Anxiety
22 (.77%)
Stevens-johnson Syndrome
22 (.77%)
Blister
21 (.73%)
Cerebral Atrophy
21 (.73%)
Confusional State
21 (.73%)
Drug Toxicity
21 (.73%)
Fatigue
21 (.73%)
Brain Oedema
19 (.66%)
Fall
18 (.63%)
Hypoxia
18 (.63%)
Aura
17 (.59%)
Coma
17 (.59%)
Congenital Anomaly
16 (.56%)
Diplopia
16 (.56%)
Dystonia
16 (.56%)
Self Esteem Decreased
16 (.56%)
Tearfulness
16 (.56%)
Urinary Incontinence
16 (.56%)
Bradycardia
15 (.52%)
Headache
15 (.52%)
Hypotonia
15 (.52%)
Pneumonia
15 (.52%)
Sweat Gland Disorder
15 (.52%)
Agitation
14 (.49%)
Akinesia
14 (.49%)
Thrombocytopenia
14 (.49%)
Caesarean Section
13 (.45%)
Congenital Hydronephrosis
13 (.45%)
Developmental Delay
13 (.45%)
Gamma-glutamyltransferase Increased
13 (.45%)
Alanine Aminotransferase Increased
12 (.42%)
Encephalopathy
12 (.42%)
Grand Mal Convulsion
12 (.42%)
Movement Disorder
12 (.42%)
Myoclonus
12 (.42%)
Vomiting
12 (.42%)
Atonic Seizures
11 (.38%)
Atrial Septal Defect
11 (.38%)
Necrosis
11 (.38%)
Premature Baby
11 (.38%)
Ventricular Septal Defect
11 (.38%)
Angioedema
10 (.35%)
Asthenia
10 (.35%)
Cognitive Disorder
10 (.35%)
Insomnia
10 (.35%)
Ischaemia
10 (.35%)
Petit Mal Epilepsy
10 (.35%)
Urinary Tract Infection
10 (.35%)
Aggression
9 (.31%)
Dysmorphism
9 (.31%)
Gait Disturbance
9 (.31%)
General Physical Health Deteriorati...
9 (.31%)
Joint Dislocation
9 (.31%)
Malaise
9 (.31%)
Small For Dates Baby
9 (.31%)
Spina Bifida
9 (.31%)
Suicide Attempt
9 (.31%)
Toxic Epidermal Necrolysis
9 (.31%)
Wrist Deformity
9 (.31%)
Anorectal Disorder
8 (.28%)
Bone Marrow Failure
8 (.28%)
Cardiac Murmur
8 (.28%)
Death
8 (.28%)
Haemoglobin Decreased
8 (.28%)
Hand Deformity
8 (.28%)
Lethargy
8 (.28%)
Limb Reduction Defect
8 (.28%)
Lower Respiratory Tract Infection
8 (.28%)
Neutropenic Sepsis
8 (.28%)
Respiratory Arrest
8 (.28%)
Anal Atresia
7 (.24%)
Dizziness
7 (.24%)
Hepatic Function Abnormal
7 (.24%)
Hyponatraemia
7 (.24%)
Hypotension
7 (.24%)
Kidney Malformation
7 (.24%)
Klebsiella Infection
7 (.24%)
Learning Disorder
7 (.24%)
Leukopenia
7 (.24%)
Microcephaly
7 (.24%)
Overdose
7 (.24%)
Peripheral Sensorimotor Neuropathy
7 (.24%)
Pilonidal Cyst Congenital
7 (.24%)
Rash Maculo-papular
7 (.24%)
Transaminases Increased
7 (.24%)

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

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

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

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

Epilepsy
347
Drug Use For Unknown Indication
117
Convulsion
113
Product Used For Unknown Indication
58
Partial Seizures
29
Temporal Lobe Epilepsy
26
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Drug Exposure During Pregnancy
23
Convulsion Prophylaxis
20
Infantile Spasms
16
Anxiety
15
Ill-defined Disorder
15
Lennox-gastaut Syndrome
13
Complex Partial Seizures
11
Myoclonic Epilepsy
11
Grand Mal Convulsion
10
Status Epilepticus
8
Depression
5
Sleep Disorder Therapy
5
Sydenhams Chorea
4
Tonic Convulsion
4
Juvenile Myoclonic Epilepsy
4
Suicide Attempt
4
Simple Partial Seizures
3
Post-traumatic Epilepsy
3
Partial Seizures With Secondary Gen...
3
Neurological Symptom
2
Hypertonia
2
Foetal Exposure During Pregnancy
2
Petit Mal Epilepsy
2
Disorientation
2
Confusional State
2
Seizure Cluster
1
Taeniasis
1
Frontal Lobe Epilepsy
1
Anxiolytic Therapy
1
Sturge-weber Syndrome
1
Exaggerated Startle Response
1
Paraesthesia
1
Prophylaxis Of Nausea And Vomiting
1
Encephalopathy
1
Abnormal Behaviour
1
Suicidal Ideation
1
Migraine
1
Insomnia
1
Generalised Non-convulsive Epilepsy
1
Quadriparesis
1
Mental Disorder
1
Maternal Exposure During Pregnancy
1
Atonic Seizures
1
Sedative Therapy
1
Prophylaxis
1

Drug Labels

LabelLabelerEffective
OnfiLundbeck LLC15-DEC-12

Clobazam Case Reports

What Clobazam 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 Clobazam. 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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