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GABITRIL

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Gabitril Adverse Events Reported to the FDA Over Time

How are Gabitril adverse event reports trending over time?

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

Most Common Gabitril Adverse Events Reported to the FDA

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

Convulsion
218 (6.17%)
Loss Of Consciousness
88 (2.49%)
Confusional State
75 (2.12%)
Fall
75 (2.12%)
Dizziness
70 (1.98%)
Completed Suicide
67 (1.89%)
Tremor
55 (1.56%)
Drug Interaction
50 (1.41%)
Nausea
47 (1.33%)
Headache
46 (1.3%)
Grand Mal Convulsion
43 (1.22%)
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Agitation
37 (1.05%)
Aphasia
37 (1.05%)
Abnormal Behaviour
36 (1.02%)
Amnesia
36 (1.02%)
Aggression
34 (.96%)
Status Epilepticus
34 (.96%)
Disorientation
33 (.93%)
Vision Blurred
32 (.9%)
Drug Ineffective
31 (.88%)
Speech Disorder
31 (.88%)
Dyskinesia
30 (.85%)
Anxiety
29 (.82%)
Panic Attack
27 (.76%)
Mental Status Changes
24 (.68%)
Coma
23 (.65%)
Overdose
23 (.65%)
Somnolence
23 (.65%)
Vomiting
23 (.65%)
Cardiac Arrest
21 (.59%)
Condition Aggravated
21 (.59%)
Feeling Abnormal
21 (.59%)
Insomnia
21 (.59%)
Muscle Twitching
21 (.59%)
Paraesthesia
21 (.59%)
Cognitive Disorder
20 (.57%)
Memory Impairment
20 (.57%)
Asthenia
19 (.54%)
Complex Partial Seizures
19 (.54%)
Migraine
19 (.54%)
Suicide Attempt
19 (.54%)
Coordination Abnormal
18 (.51%)
Delirium
18 (.51%)
Respiratory Arrest
18 (.51%)
Urinary Incontinence
18 (.51%)
Depressed Level Of Consciousness
17 (.48%)
Fatigue
17 (.48%)
Drug Toxicity
16 (.45%)
Electroencephalogram Abnormal
16 (.45%)
Medication Error
16 (.45%)
Disturbance In Attention
15 (.42%)
Encephalopathy
15 (.42%)
Hypoaesthesia
15 (.42%)
Pain In Extremity
15 (.42%)
Epilepsy
14 (.4%)
Hallucination
14 (.4%)
Intentional Overdose
14 (.4%)
Weight Decreased
14 (.4%)
Asthma
13 (.37%)
Blood Potassium Decreased
13 (.37%)
Diplopia
13 (.37%)
Drug Withdrawal Syndrome
13 (.37%)
Nightmare
13 (.37%)
Skin Laceration
13 (.37%)
Depression
12 (.34%)
Dystonia
12 (.34%)
Paralysis
12 (.34%)
Partial Seizures
12 (.34%)
Pneumonia
12 (.34%)
Postictal State
12 (.34%)
Balance Disorder
11 (.31%)
Blood Pressure Diastolic Increased
11 (.31%)
Constipation
11 (.31%)
Dysarthria
11 (.31%)
Hypoglycaemia
11 (.31%)
Muscle Spasms
11 (.31%)
Psychotic Disorder
11 (.31%)
Refusal Of Treatment By Patient
11 (.31%)
Suicidal Ideation
11 (.31%)
Syncope
11 (.31%)
Blood Pressure Increased
10 (.28%)
Head Injury
10 (.28%)
Incontinence
10 (.28%)
Irritability
10 (.28%)
Communication Disorder
9 (.25%)
Diarrhoea
9 (.25%)
Feeling Drunk
9 (.25%)
Food Allergy
9 (.25%)
Hyperhidrosis
9 (.25%)
Incoherent
9 (.25%)
Incorrect Dose Administered
9 (.25%)
Intentional Drug Misuse
9 (.25%)
Multiple Drug Overdose
9 (.25%)
Muscle Tightness
9 (.25%)
Oedema Peripheral
9 (.25%)
Transient Ischaemic Attack
9 (.25%)
Treatment Noncompliance
9 (.25%)
Accidental Overdose
8 (.23%)
Blood Magnesium Decreased
8 (.23%)
Cerebrovascular Accident
8 (.23%)
Conversion Disorder
8 (.23%)

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

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

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

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

Anxiety
63
Drug Use For Unknown Indication
49
Convulsion
43
Bipolar Disorder
39
Generalised Anxiety Disorder
30
Neuralgia
27
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Sleep Disorder
26
Epilepsy
24
Insomnia
23
Complex Partial Seizures
17
Product Used For Unknown Indication
16
Pain
16
Depression
14
Panic Attack
12
Headache
11
Ill-defined Disorder
10
Back Pain
8
Temporal Lobe Epilepsy
8
Fibromyalgia
7
Agoraphobia
7
Affective Disorder
7
Migraine Prophylaxis
6
Neuropathy Peripheral
6
Post-traumatic Stress Disorder
6
Radiculopathy
6
Trigeminal Neuralgia
6
Neuropathic Pain
5
Bipolar I Disorder
5
Mood Swings
5
Aggression
5
Migraine
5
Nervousness
4
Schizophrenia
4
Panic Disorder
4
Partial Seizures
4
Nightmare
4
Neck Pain
4
Myoclonic Epilepsy
4
Suicide Attempt
3
Psychogenic Pain Disorder
3
Muscle Spasms
3
Completed Suicide
3
Petit Mal Epilepsy
3
Agitation
2
Mental Disorder
2
Obsessive-compulsive Disorder
2
Amnesia
2
Drug Detoxification
2
Anger
2
Attention Deficit/hyperactivity Dis...
2
Grand Mal Convulsion
2

Drug Labels

LabelLabelerEffective
GabitrilSTAT RX USA LLC18-AUG-11
GabitrilLake Erie Medical & Surgial Supply DBA Quality Care Products LLC18-NOV-11
GabitrilCephalon, Inc.04-JUN-12

Gabitril Case Reports

What Gabitril 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 Gabitril. 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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