KEPPRA XR

Keppra Xr Adverse Events Reported to the FDA Over Time

How are Keppra Xr adverse event reports trending over time?

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

Most Common Keppra Xr Adverse Events Reported to the FDA

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

Convulsion	64 (7.63%)
Pregnancy	38 (4.53%)
Upper Respiratory Tract Infection	26 (3.1%)
Premature Baby	21 (2.5%)
Inappropriate Schedule Of Drug Admi...	18 (2.15%)
Rash	17 (2.03%)
Cerebrovascular Accident	16 (1.91%)
Headache	16 (1.91%)
Dyspepsia	14 (1.67%)
Otitis Media	14 (1.67%)
Death	13 (1.55%)
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Haemangioma	13 (1.55%)
Caesarean Section	12 (1.43%)
Malaise	11 (1.31%)
Drug Exposure During Pregnancy	10 (1.19%)
Gestational Diabetes	10 (1.19%)
Subarachnoid Haemorrhage	10 (1.19%)
Uterine Contractions During Pregnan...	10 (1.19%)
Anticonvulsant Drug Level Increased	9 (1.07%)
Grand Mal Convulsion	9 (1.07%)
Pre-eclampsia	9 (1.07%)
Abnormal Palmar/plantar Creases	8 (.95%)
Aneurysm	8 (.95%)
Cardiac Murmur	8 (.95%)
Cough	8 (.95%)
Dysmorphism	8 (.95%)
Fall	8 (.95%)
Jaw Fracture	8 (.95%)
Medication Error	8 (.95%)
Rhinorrhoea	8 (.95%)
Seasonal Allergy	8 (.95%)
Torticollis	8 (.95%)
Umbilical Hernia	8 (.95%)
Wheezing	8 (.95%)
Abortion Spontaneous	7 (.83%)
Acne	6 (.72%)
Aggression	6 (.72%)
Breast Feeding	6 (.72%)
Dermatitis	6 (.72%)
Fatigue	6 (.72%)
Gastrooesophageal Reflux Disease	6 (.72%)
Insomnia	6 (.72%)
Laceration	6 (.72%)
Lactose Intolerance	6 (.72%)
Lipoma	6 (.72%)
Nausea	6 (.72%)
Product Substitution Issue	6 (.72%)
Sickle Cell Trait	6 (.72%)
Urachal Abnormality	6 (.72%)
Constipation	5 (.6%)
Muscle Twitching	5 (.6%)
Myocardial Infarction	5 (.6%)
Syncope	5 (.6%)
Abdominal Pain	4 (.48%)
Accident	4 (.48%)
Adverse Event	4 (.48%)
Anaemia	4 (.48%)
Bradycardia Foetal	4 (.48%)
Haemoglobin Decreased	4 (.48%)
Hypotonia	4 (.48%)
Jaundice	4 (.48%)
Joint Injury	4 (.48%)
Ligament Injury	4 (.48%)
Ligament Rupture	4 (.48%)
Suture Insertion	4 (.48%)
Thinking Abnormal	4 (.48%)
Trisomy 21	4 (.48%)
Twin Pregnancy	4 (.48%)
Vaginal Haemorrhage	4 (.48%)
Vitamin B12 Decreased	4 (.48%)
Dizziness	3 (.36%)
Pneumonia	3 (.36%)
Abnormal Behaviour	2 (.24%)
Alopecia	2 (.24%)
Amino Acid Level Decreased	2 (.24%)
Atrial Fibrillation	2 (.24%)
Back Injury	2 (.24%)
Brain Neoplasm	2 (.24%)
Choking	2 (.24%)
Coma	2 (.24%)
Depression	2 (.24%)
Dysarthria	2 (.24%)
Dyspnoea	2 (.24%)
Emotional Disorder	2 (.24%)
Epilepsy	2 (.24%)
Eye Operation	2 (.24%)
Gastrointestinal Anastomotic Leak	2 (.24%)
Glossodynia	2 (.24%)
Hallucination	2 (.24%)
Hallucination, Visual	2 (.24%)
Head Injury	2 (.24%)
Hip Fracture	2 (.24%)
Incorrect Dose Administered	2 (.24%)
Injury	2 (.24%)
Intercepted Drug Dispensing Error	2 (.24%)
Loss Of Consciousness	2 (.24%)
Maternal Drugs Affecting Foetus	2 (.24%)
Mental Disorder	2 (.24%)
Muscle Spasms	2 (.24%)
Nasal Discomfort	2 (.24%)
No Adverse Event	2 (.24%)

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

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

Seizures	79 (9.42%)
Pregnancy, Labour, Delivery And Pos...	53 (6.32%)
Infections - Pathogen Unspecified	49 (5.84%)
Injuries	36 (4.29%)
Medication Errors	32 (3.81%)
Epidermal And Dermal Conditions	28 (3.34%)
Central Nervous System Vascular	26 (3.1%)
Gastrointestinal Signs	26 (3.1%)
Respiratory	25 (2.98%)
Neurological	23 (2.74%)
Neonatal And Perinatal Conditions	21 (2.5%)
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Bone And Joint Injuries	17 (2.03%)
Headaches	16 (1.91%)
Muscle	16 (1.91%)
Chemical Injury And Poisoning	13 (1.55%)
Fatal Outcomes	13 (1.55%)
Miscellaneous And Site Unspecified ...	13 (1.55%)
Obstetric And Gynecological Therape...	12 (1.43%)
Gastrointestinal Motility And Defec...	11 (1.31%)
Glucose Metabolism Disorders	10 (1.19%)
Personality Disorders	10 (1.19%)
Allergic Conditions	9 (1.07%)
Cardiac And Vascular Investigations	9 (1.07%)
Disturbances In Thinking	9 (1.07%)
Maternal Complications Of Pregnancy	9 (1.07%)
Toxicology And Therapeutic Drug Mon...	9 (1.07%)
Abdominal Hernias And Other Abdomin...	8 (.95%)
Abortions And Stillbirth	8 (.95%)
Aneurysms And Artery Dissections	8 (.95%)
Bronchial Disorders	8 (.95%)
Musculoskeletal And Connective Tiss...	8 (.95%)
Skin And Subcutaneous Tissue Disord...	8 (.95%)
Skin Appendage Conditions	8 (.95%)
Cardiac Arrhythmias	7 (.83%)
Product Quality Issues	7 (.83%)
Sleep Disorders	7 (.83%)
Blood And Lymphatic System Disorder...	6 (.72%)
Coronary Artery	6 (.72%)
Food Intolerance Syndromes	6 (.72%)
Gender Related Factors	6 (.72%)
Psychiatric	6 (.72%)
Renal And Urinary Tract Disorders C...	6 (.72%)
Soft Tissue Neoplasms Benign	6 (.72%)
Therapeutic And Nontherapeutic Effe...	6 (.72%)
Anxiety Disorders	5 (.6%)
Anemias Nonhemolytic And Marrow Dep...	4 (.48%)
Chromosomal Abnormalities And Abnor...	4 (.48%)
Depressed Mood Disorders	4 (.48%)
Hematology Investigations	4 (.48%)
Hepatic And Hepatobiliary	4 (.48%)
Lifestyle Issues	4 (.48%)
Metabolic, Nutritional And Blood Ga...	4 (.48%)
Mood Disorders	4 (.48%)
Movement Disorders	4 (.48%)
Neuromuscular	4 (.48%)
Therapeutic Procedures And Supporti...	4 (.48%)
Tongue Conditions	4 (.48%)
Vulvovaginal Disorders	4 (.48%)
Bacterial Infectious	3 (.36%)
Nervous System Neoplasms Malignant ...	3 (.36%)
Respiratory And Mediastinal Neoplas...	3 (.36%)
Suicidal And Self-injurious Behavio...	3 (.36%)
Vision	3 (.36%)
Bone And Joint Therapeutic Procedur...	2 (.24%)
Changes In Physical Activity	2 (.24%)
Eye Therapeutic Procedures	2 (.24%)
Lower Respiratory Tract Disorders	2 (.24%)
Pleural	2 (.24%)
Procedural And Device Related Injur...	2 (.24%)
Protein And Chemistry Analyses	2 (.24%)
Psychiatric And Behavioural Symptom...	2 (.24%)
Bone Disorders	1 (.12%)
Cranial Nerve Disorders	1 (.12%)
Decreased And Nonspecific Blood Pre...	1 (.12%)
Dental And Gingival Conditions	1 (.12%)
Eating Disorders	1 (.12%)
Endocrine Neoplasms Malignant And U...	1 (.12%)
Gastrointestinal Stenosis And Obstr...	1 (.12%)
Hepatobiliary Neoplasms Malignant A...	1 (.12%)
Joint	1 (.12%)
Mental Impairment	1 (.12%)
Musculoskeletal And Connective Tiss...	1 (.12%)
Nephropathies	1 (.12%)
Nervous System, Skull And Spine The...	1 (.12%)
Physical Examination Topics	1 (.12%)
Postpartum And Puerperal	1 (.12%)
Renal Disorders	1 (.12%)
Schizophrenia And Other Psychotic	1 (.12%)
Skin And Subcutaneous Tissue	1 (.12%)
Skin Neoplasms Malignant And Unspec...	1 (.12%)
Skin Vascular Abnormalities	1 (.12%)
Sleep Disturbances	1 (.12%)
Structural Brain	1 (.12%)
Uterine, Pelvic And Broad Ligament	1 (.12%)
Vitamin Related	1 (.12%)
Water, Electrolyte And Mineral	1 (.12%)

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This graph shows the top categories of adverse events submitted to the FDA for Keppra Xr, 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 Xr 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.