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ZONEGRAN

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Zonegran Adverse Events Reported to the FDA Over Time

How are Zonegran adverse event reports trending over time?

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

Most Common Zonegran Adverse Events Reported to the FDA

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

Convulsion
105 (3.9%)
Drug Interaction
64 (2.38%)
Drug Exposure During Pregnancy
52 (1.93%)
Rash
37 (1.37%)
Vomiting
29 (1.08%)
Nephrolithiasis
28 (1.04%)
Aggression
26 (.97%)
Agitation
26 (.97%)
Drug Ineffective
26 (.97%)
Fatigue
26 (.97%)
Condition Aggravated
24 (.89%)
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Somnolence
24 (.89%)
Headache
23 (.85%)
Weight Decreased
22 (.82%)
Grand Mal Convulsion
21 (.78%)
Asthenia
20 (.74%)
Diarrhoea
20 (.74%)
Stevens-johnson Syndrome
20 (.74%)
Pruritus
19 (.71%)
Psychotic Disorder
19 (.71%)
Confusional State
18 (.67%)
Status Epilepticus
18 (.67%)
Back Pain
17 (.63%)
Loss Of Consciousness
17 (.63%)
Thrombocytopenia
17 (.63%)
Neutropenia
16 (.59%)
Pneumonia
16 (.59%)
Therapeutic Response Unexpected Wit...
16 (.59%)
Depression
15 (.56%)
Nausea
15 (.56%)
Pyrexia
15 (.56%)
Vision Blurred
15 (.56%)
Abdominal Pain Upper
14 (.52%)
Dizziness
14 (.52%)
Epilepsy
14 (.52%)
Fall
14 (.52%)
Sleep Disorder
14 (.52%)
Abnormal Behaviour
13 (.48%)
Anxiety
13 (.48%)
Memory Impairment
13 (.48%)
Pneumonia Aspiration
13 (.48%)
Restlessness
13 (.48%)
Speech Disorder
13 (.48%)
Anorexia
12 (.45%)
Feeling Abnormal
12 (.45%)
Hallucination
12 (.45%)
Hypersensitivity
12 (.45%)
Abortion Spontaneous
11 (.41%)
Bradycardia
11 (.41%)
Drug Toxicity
11 (.41%)
Haemorrhage
11 (.41%)
Myalgia
11 (.41%)
Pancytopenia
11 (.41%)
Tremor
11 (.41%)
Chest Pain
10 (.37%)
Coma
10 (.37%)
Dyspnoea
10 (.37%)
Mental Impairment
10 (.37%)
Paraesthesia
10 (.37%)
Amnesia
9 (.33%)
Aplastic Anaemia
9 (.33%)
Aspartate Aminotransferase Increase...
9 (.33%)
Balance Disorder
9 (.33%)
Calculus Urinary
9 (.33%)
Depressed Mood
9 (.33%)
Disturbance In Attention
9 (.33%)
Dysphagia
9 (.33%)
Hypoaesthesia
9 (.33%)
Hypotension
9 (.33%)
Leukopenia
9 (.33%)
Medication Error
9 (.33%)
Product Substitution Issue
9 (.33%)
Pyelonephritis
9 (.33%)
Rash Generalised
9 (.33%)
Respiratory Failure
9 (.33%)
Suicidal Ideation
9 (.33%)
Abdominal Pain
8 (.3%)
Affective Disorder
8 (.3%)
Alopecia
8 (.3%)
Cardiac Arrest
8 (.3%)
Cataract
8 (.3%)
Completed Suicide
8 (.3%)
Depressed Level Of Consciousness
8 (.3%)
Haemoglobin Decreased
8 (.3%)
Prostate Cancer
8 (.3%)
Vertigo
8 (.3%)
Blood Glucose Increased
7 (.26%)
Brugada Syndrome
7 (.26%)
Crying
7 (.26%)
Decreased Appetite
7 (.26%)
Irritability
7 (.26%)
Metabolic Acidosis
7 (.26%)
Neuroleptic Malignant Syndrome
7 (.26%)
Pulmonary Embolism
7 (.26%)
Renal Failure
7 (.26%)
Renal Failure Acute
7 (.26%)
Spina Bifida
7 (.26%)
Urticaria
7 (.26%)
White Blood Cell Count Decreased
7 (.26%)
Abasia
6 (.22%)
Blood Alkaline Phosphatase Increase...
6 (.22%)

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

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

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

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

Epilepsy
339
Convulsion
181
Drug Use For Unknown Indication
56
Migraine
43
Parkinsons Disease
23
Partial Seizures
19
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Drug Exposure During Pregnancy
16
Product Used For Unknown Indication
15
Bipolar Disorder
12
Pain
11
Grand Mal Convulsion
9
Complex Partial Seizures
9
Neuralgia
7
Headache
7
Convulsion Prophylaxis
6
Neuropathic Pain
5
Depression
5
Trigeminal Neuralgia
5
Simple Partial Seizures
4
Petit Mal Epilepsy
4
Fibromyalgia
3
Arthralgia
3
Prophylaxis
3
Tremor
3
Migraine Prophylaxis
3
Neuropathy
3
Essential Tremor
2
Bulimia Nervosa
2
Lennox-gastaut Syndrome
2
Withdrawal Syndrome
2
Back Pain
2
Post-anoxic Myoclonus
2
Post-traumatic Epilepsy
2
Myoclonic Epilepsy
2
Maternal Exposure Timing Unspecifie...
2
Schizophrenia
2
Encephalitis Herpes
2
Osteoarthritis
1
Weight Control
1
Head Injury
1
Pain Management
1
Generalised Non-convulsive Epilepsy
1
Impulse-control Disorder
1
Rheumatoid Arthritis
1
Limb Injury
1
Off Label Use
1
Brain Oedema
1
Pain In Extremity
1
Stevens-johnson Syndrome
1
Analgesic Therapy
1
Weight Abnormal
1

Drug Labels

LabelLabelerEffective
ZonegranEisai Inc.30-JAN-12

Zonegran Case Reports

What Zonegran 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 Zonegran. 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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