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KEPPRA

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Keppra Adverse Events Reported to the FDA Over Time

How are Keppra adverse event reports trending over time?

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

Most Common Keppra Adverse Events Reported to the FDA

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

Convulsion
1548 (3.92%)
Drug Exposure During Pregnancy
1104 (2.79%)
Pregnancy
541 (1.37%)
Maternal Drugs Affecting Foetus
521 (1.32%)
Somnolence
510 (1.29%)
Thrombocytopenia
471 (1.19%)
Grand Mal Convulsion
435 (1.1%)
Condition Aggravated
391 (.99%)
Fatigue
355 (.9%)
Status Epilepticus
330 (.83%)
Depression
309 (.78%)
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Caesarean Section
307 (.78%)
Aggression
301 (.76%)
Dizziness
299 (.76%)
Premature Baby
278 (.7%)
Headache
275 (.7%)
Drug Ineffective
269 (.68%)
Suicidal Ideation
266 (.67%)
Epilepsy
239 (.6%)
Fall
234 (.59%)
Vomiting
229 (.58%)
Abortion Spontaneous
222 (.56%)
Confusional State
214 (.54%)
Drug Interaction
213 (.54%)
Leukopenia
212 (.54%)
Abnormal Behaviour
208 (.53%)
Nausea
203 (.51%)
Rash
197 (.5%)
Asthenia
193 (.49%)
Weight Decreased
187 (.47%)
White Blood Cell Count Decreased
181 (.46%)
Suicide Attempt
178 (.45%)
Pyrexia
177 (.45%)
Loss Of Consciousness
176 (.45%)
Agitation
175 (.44%)
Platelet Count Decreased
173 (.44%)
Anxiety
161 (.41%)
Memory Impairment
161 (.41%)
Death
158 (.4%)
Pancytopenia
156 (.39%)
Tremor
154 (.39%)
Anaemia
151 (.38%)
Incorrect Dose Administered
147 (.37%)
Feeling Abnormal
140 (.35%)
Insomnia
139 (.35%)
Neutropenia
137 (.35%)
Overdose
134 (.34%)
Product Substitution Issue
133 (.34%)
Gait Disturbance
131 (.33%)
Coma
129 (.33%)
Balance Disorder
128 (.32%)
Urinary Tract Infection
127 (.32%)
Amnesia
123 (.31%)
Hyponatraemia
123 (.31%)
Pneumonia
121 (.31%)
Anger
120 (.3%)
Haemoglobin Decreased
120 (.3%)
Psychotic Disorder
120 (.3%)
Dyspnoea
119 (.3%)
Irritability
118 (.3%)
Petit Mal Epilepsy
116 (.29%)
Pruritus
116 (.29%)
Treatment Noncompliance
115 (.29%)
Disturbance In Attention
114 (.29%)
Drug Exposure Via Breast Milk
114 (.29%)
Malaise
114 (.29%)
Speech Disorder
114 (.29%)
Alanine Aminotransferase Increased
112 (.28%)
Hallucination
107 (.27%)
Hypotension
103 (.26%)
Dysphagia
101 (.26%)
Diarrhoea
100 (.25%)
Premature Labour
100 (.25%)
Aspartate Aminotransferase Increase...
94 (.24%)
Ventricular Septal Defect
94 (.24%)
Complex Partial Seizures
92 (.23%)
Pancreatitis
91 (.23%)
Cerebrovascular Accident
90 (.23%)
Weight Increased
88 (.22%)
Renal Failure
86 (.22%)
Drug Toxicity
83 (.21%)
Cytolytic Hepatitis
82 (.21%)
Medication Error
82 (.21%)
Small For Dates Baby
82 (.21%)
Cholestasis
81 (.2%)
Lethargy
81 (.2%)
Partial Seizures
81 (.2%)
Blood Creatine Phosphokinase Increa...
80 (.2%)
Disorientation
79 (.2%)
Toxic Epidermal Necrolysis
77 (.19%)
Decreased Appetite
76 (.19%)
General Physical Health Deteriorati...
76 (.19%)
Cough
75 (.19%)
Inappropriate Schedule Of Drug Admi...
74 (.19%)
Jaundice
74 (.19%)
Developmental Delay
73 (.18%)
Drug Hypersensitivity
73 (.18%)
Gamma-glutamyltransferase Increased
73 (.18%)
Agranulocytosis
72 (.18%)
Abdominal Pain
71 (.18%)
Depressed Level Of Consciousness
70 (.18%)

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

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

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

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

Epilepsy
3744
Convulsion
2476
Drug Use For Unknown Indication
394
Product Used For Unknown Indication
352
Partial Seizures
267
Grand Mal Convulsion
158
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Complex Partial Seizures
155
Convulsion Prophylaxis
142
Status Epilepticus
112
Prophylaxis
75
Myoclonic Epilepsy
65
Partial Seizures With Secondary Gen...
48
Simple Partial Seizures
46
Petit Mal Epilepsy
44
Myoclonus
43
Migraine
38
Temporal Lobe Epilepsy
32
Drug Exposure During Pregnancy
26
Bipolar Disorder
20
Ill-defined Disorder
19
Post-traumatic Epilepsy
17
Glioblastoma
17
Encephalitis
16
Juvenile Myoclonic Epilepsy
14
Generalised Non-convulsive Epilepsy
13
Foetal Exposure During Pregnancy
13
Tremor
12
Pain
11
Infantile Spasms
11
Neuralgia
11
Lennox-gastaut Syndrome
11
Infarction
10
Glioblastoma Multiforme
9
Cerebrovascular Accident
9
Idiopathic Generalised Epilepsy
9
Laryngospasm
9
Brain Neoplasm Malignant
9
Neuropathic Pain
8
Depression
8
Metastases To Central Nervous Syste...
8
Traumatic Brain Injury
8
Brain Neoplasm
8
Clonus
8
Post-anoxic Myoclonus
8
Tuberous Sclerosis
8
Nervous System Disorder
8
Clonic Convulsion
7
Electroencephalogram Abnormal
7
Loss Of Consciousness
7
Anxiety
7
Affective Disorder
7

Drug Labels

LabelLabelerEffective
KeppraPD-Rx Pharmaceuticals, Inc.05-OCT-09
KeppraxrUCB, Inc.15-OCT-09
KeppraUCB Farchim S.A.07-APR-10
KeppraUCB Farchim S.A.19-APR-10
KeppraRebel Distributors Corp28-DEC-10
KeppraSTAT RX USA LLC23-MAR-11
KeppraCardinal Health10-OCT-11
KeppraUCB, Inc.19-DEC-11
KeppraPhysicians Total Care, Inc.07-JUN-12
KeppraUCB, Inc.12-JUN-12
KeppraREMEDYREPACK INC. 28-FEB-13

Keppra Case Reports

What Keppra 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 Keppra. 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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