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Sabril Adverse Events Reported to the FDA Over Time

How are Sabril adverse event reports trending over time?

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

Most Common Sabril Adverse Events Reported to the FDA

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

Convulsion
109 (6.65%)
Death
89 (5.43%)
Drug Ineffective
41 (2.5%)
Somnolence
32 (1.95%)
Retinal Disorder
30 (1.83%)
Visual Field Defect
28 (1.71%)
Condition Aggravated
26 (1.59%)
Pneumonia
21 (1.28%)
Retinogram Abnormal
21 (1.28%)
Grand Mal Convulsion
19 (1.16%)
Dyspnoea
18 (1.1%)
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Fall
17 (1.04%)
Respiratory Distress
17 (1.04%)
Tremor
16 (.98%)
Urinary Tract Infection
16 (.98%)
Vomiting
16 (.98%)
Lethargy
15 (.92%)
Ear Infection
14 (.85%)
Malaise
14 (.85%)
Fatigue
13 (.79%)
Retinal Toxicity
12 (.73%)
Irritability
11 (.67%)
Pneumonia Aspiration
11 (.67%)
Respiratory Failure
11 (.67%)
Blindness
10 (.61%)
Dehydration
10 (.61%)
Abnormal Behaviour
9 (.55%)
Insomnia
9 (.55%)
Sepsis
9 (.55%)
Viral Infection
9 (.55%)
Visual Acuity Reduced
9 (.55%)
Weight Increased
9 (.55%)
Aggression
8 (.49%)
Agitation
8 (.49%)
Bradycardia
8 (.49%)
Dizziness
8 (.49%)
Hypotonia
8 (.49%)
Status Epilepticus
8 (.49%)
Sudden Unexplained Death In Epileps...
8 (.49%)
Brain Operation
7 (.43%)
Dyskinesia
7 (.43%)
Gait Disturbance
7 (.43%)
Infantile Spasms
7 (.43%)
Oedema Peripheral
7 (.43%)
Optic Atrophy
7 (.43%)
Psychomotor Hyperactivity
7 (.43%)
Pyrexia
7 (.43%)
Respiratory Disorder
7 (.43%)
Apnoea
6 (.37%)
Crying
6 (.37%)
Decreased Appetite
6 (.37%)
Drug Interaction
6 (.37%)
Encephalopathy
6 (.37%)
Hypertension
6 (.37%)
Muscle Twitching
6 (.37%)
Oxygen Saturation Decreased
6 (.37%)
Rash
6 (.37%)
Renal Failure
6 (.37%)
Aspiration
5 (.31%)
Bronchiolitis
5 (.31%)
Chest Pain
5 (.31%)
Confusional State
5 (.31%)
Diarrhoea
5 (.31%)
Electroencephalogram Abnormal
5 (.31%)
Flushing
5 (.31%)
Gastrooesophageal Reflux Disease
5 (.31%)
Hepatic Failure
5 (.31%)
Respiratory Syncytial Virus Infecti...
5 (.31%)
Restlessness
5 (.31%)
Surgery
5 (.31%)
Abdominal Pain Upper
4 (.24%)
Amnesia
4 (.24%)
Cardiac Arrest
4 (.24%)
Central Nervous System Lesion
4 (.24%)
Constipation
4 (.24%)
Depression
4 (.24%)
Dermatitis Bullous
4 (.24%)
Epilepsy
4 (.24%)
Eye Movement Disorder
4 (.24%)
Headache
4 (.24%)
Hyperthermia Malignant
4 (.24%)
Hypophagia
4 (.24%)
Mood Altered
4 (.24%)
Muscle Spasms
4 (.24%)
Nervous System Disorder
4 (.24%)
Photosensitivity Reaction
4 (.24%)
Pseudoporphyria
4 (.24%)
Respiratory Arrest
4 (.24%)
Sedation
4 (.24%)
Sleep Disorder
4 (.24%)
Stevens-johnson Syndrome
4 (.24%)
Underweight
4 (.24%)
Unresponsive To Stimuli
4 (.24%)
Weight Decreased
4 (.24%)
Accidental Exposure
3 (.18%)
Akathisia
3 (.18%)
Anaemia
3 (.18%)
Arthralgia
3 (.18%)
Aura
3 (.18%)
Blood Lactate Dehydrogenase Increas...
3 (.18%)
Cardiac Failure
3 (.18%)

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

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

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

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

Infantile Spasms
282
Epilepsy
144
Convulsion
91
Product Used For Unknown Indication
86
Complex Partial Seizures
54
Drug Use For Unknown Indication
28
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Partial Seizures
23
Grand Mal Convulsion
16
Tuberous Sclerosis
11
Temporal Lobe Epilepsy
9
Lennox-gastaut Syndrome
4
Simple Partial Seizures
3
Status Epilepticus
3
Unevaluable Event
3
Prostate Cancer
2
Generalised Non-convulsive Epilepsy
2
Drug Exposure During Pregnancy
2
Muscle Spasms
2
Congenital Anomaly
1
Accidental Exposure
1
Enzyme Abnormality
1
Myoclonic Epilepsy
1

Drug Labels

LabelLabelerEffective
SabrilLundbeck LLC19-DEC-12
SabrilLundbeck LLC19-DEC-12

Sabril Case Reports

What Sabril 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 Sabril. 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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