DILANTIN KAPSEAL

Dilantin Kapseal Adverse Events Reported to the FDA Over Time

How are Dilantin Kapseal adverse event reports trending over time?

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

Most Common Dilantin Kapseal Adverse Events Reported to the FDA

What are the most common Dilantin Kapseal adverse events reported to the FDA?

Convulsion	153 (8.41%)
Anticonvulsant Drug Level Decreased	49 (2.69%)
Dizziness	41 (2.25%)
Stevens-johnson Syndrome	38 (2.09%)
Condition Aggravated	35 (1.92%)
Grand Mal Convulsion	35 (1.92%)
Drug Ineffective	30 (1.65%)
Drug Interaction	26 (1.43%)
Fatigue	25 (1.37%)
Anticonvulsant Drug Level Increased	24 (1.32%)
Treatment Noncompliance	21 (1.15%)
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Fall	20 (1.1%)
Arthritis	19 (1.04%)
Drug Level Decreased	18 (.99%)
Drug Toxicity	18 (.99%)
Loss Of Consciousness	18 (.99%)
Somnolence	17 (.93%)
Asthenia	16 (.88%)
Anticonvulsant Drug Level Below The...	15 (.82%)
Insomnia	15 (.82%)
Depression	14 (.77%)
Feeling Abnormal	14 (.77%)
Headache	14 (.77%)
Weight Decreased	14 (.77%)
Cerebrovascular Accident	13 (.71%)
Nausea	13 (.71%)
Aura	12 (.66%)
Vomiting	12 (.66%)
Anticonvulsant Drug Level Above The...	11 (.6%)
Anxiety	11 (.6%)
Confusional State	11 (.6%)
Medication Error	11 (.6%)
Memory Impairment	11 (.6%)
Pain In Extremity	10 (.55%)
Petit Mal Epilepsy	10 (.55%)
Back Pain	9 (.49%)
Disturbance In Attention	9 (.49%)
Drug Level Increased	9 (.49%)
Nervousness	9 (.49%)
Tremor	9 (.49%)
Drug Effect Decreased	8 (.44%)
Nervous System Disorder	8 (.44%)
Road Traffic Accident	8 (.44%)
Weight Increased	8 (.44%)
Arthralgia	7 (.38%)
Balance Disorder	7 (.38%)
Body Height Decreased	7 (.38%)
Cerebral Atrophy	7 (.38%)
Hypersensitivity	7 (.38%)
Lymphadenopathy	7 (.38%)
Muscle Twitching	7 (.38%)
Neuropathy Peripheral	7 (.38%)
Osteoporosis	7 (.38%)
Overdose	7 (.38%)
Pyrexia	7 (.38%)
Sinusitis	7 (.38%)
Speech Disorder	7 (.38%)
Throat Irritation	7 (.38%)
Transient Ischaemic Attack	7 (.38%)
Abnormal Behaviour	6 (.33%)
Alcohol Use	6 (.33%)
Chest Pain	6 (.33%)
Contusion	6 (.33%)
Coordination Abnormal	6 (.33%)
Disease Recurrence	6 (.33%)
Gait Disturbance	6 (.33%)
Incoherent	6 (.33%)
Injury	6 (.33%)
Irritability	6 (.33%)
Malaise	6 (.33%)
Oedema Peripheral	6 (.33%)
Pregnancy	6 (.33%)
Thinking Abnormal	6 (.33%)
Abdominal Pain Upper	5 (.27%)
Asterixis	5 (.27%)
Brain Neoplasm	5 (.27%)
Burning Sensation	5 (.27%)
Demyelination	5 (.27%)
Disorientation	5 (.27%)
Drug Level Below Therapeutic	5 (.27%)
Dysarthria	5 (.27%)
Dysgraphia	5 (.27%)
Dysphonia	5 (.27%)
Epilepsy	5 (.27%)
Erectile Dysfunction	5 (.27%)
Feeling Hot	5 (.27%)
Hernia	5 (.27%)
Hypothyroidism	5 (.27%)
Ill-defined Disorder	5 (.27%)
Mood Swings	5 (.27%)
Multiple Allergies	5 (.27%)
Nystagmus	5 (.27%)
Paraesthesia	5 (.27%)
White Blood Cell Count Decreased	5 (.27%)
Yawning	5 (.27%)
Alanine Aminotransferase Increased	4 (.22%)
Aphasia	4 (.22%)
Ataxia	4 (.22%)
Benign Prostatic Hyperplasia	4 (.22%)
Blood Pressure Increased	4 (.22%)
Complex Partial Seizures	4 (.22%)

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

What are the most common Dilantin Kapseal adverse events reported to the FDA?

Seizures	214 (11.76%)
Neurological	184 (10.12%)
Toxicology And Therapeutic Drug Mon...	139 (7.64%)
Therapeutic And Nontherapeutic Effe...	72 (3.96%)
Epidermal And Dermal Conditions	51 (2.8%)
Injuries	51 (2.8%)
Gastrointestinal Signs	36 (1.98%)
Lifestyle Issues	35 (1.92%)
Respiratory	35 (1.92%)
Medication Errors	34 (1.87%)
Physical Examination Topics	33 (1.81%)
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Joint	31 (1.7%)
Mental Impairment	30 (1.65%)
Anxiety Disorders	26 (1.43%)
Movement Disorders	24 (1.32%)
Infections - Pathogen Unspecified	23 (1.26%)
Chemical Injury And Poisoning	22 (1.21%)
Central Nervous System Vascular	21 (1.15%)
Musculoskeletal And Connective Tiss...	21 (1.15%)
Allergic Conditions	17 (.93%)
Deliria	17 (.93%)
Sleep Disorders	17 (.93%)
Headaches	16 (.88%)
Dental And Gingival Conditions	15 (.82%)
Depressed Mood Disorders	14 (.77%)
Disturbances In Thinking	14 (.77%)
Muscle	14 (.77%)
Bone And Joint Injuries	13 (.71%)
Hepatobiliary	13 (.71%)
Bone Disorders	12 (.66%)
Spleen, Lymphatic And Reticulendoth...	12 (.66%)
Peripheral Neuropathies	10 (.55%)
Coronary Artery	9 (.49%)
Hepatic And Hepatobiliary	9 (.49%)
Thyroid Gland	9 (.49%)
Viral Infectious	9 (.49%)
Electrolyte And Fluid Balance Condi...	8 (.44%)
Mood Disorders	8 (.44%)
Nervous System Neoplasms Malignant ...	8 (.44%)
Vascular Hypertensive	8 (.44%)
Body Temperature Conditions	7 (.38%)
Investigations, Imaging And Histopa...	7 (.38%)
Procedural And Device Related Injur...	7 (.38%)
Renal Disorders	7 (.38%)
Structural Brain	7 (.38%)
Urinary Tract Signs	7 (.38%)
Vision	7 (.38%)
Appetite And General Nutritional	6 (.33%)
Cardiac And Vascular Investigations	6 (.33%)
Cardiac Disorder Signs	6 (.33%)
Demyelinating	6 (.33%)
Embolism And Thrombosis	6 (.33%)
Inner Ear And Viiith Cranial Nerve	6 (.33%)
Metabolic, Nutritional And Blood Ga...	6 (.33%)
Pregnancy, Labour, Delivery And Pos...	6 (.33%)
Psychiatric And Behavioural Symptom...	6 (.33%)
Hearing	5 (.27%)
Hematology Investigations	5 (.27%)
Lower Respiratory Tract Disorders	5 (.27%)
Musculoskeletal And Connective Tiss...	5 (.27%)
Sexual Function And Fertility	5 (.27%)
Skin Appendage Conditions	5 (.27%)
Vascular	5 (.27%)
Abdominal Hernias And Other Abdomin...	4 (.22%)
Anemias Nonhemolytic And Marrow Dep...	4 (.22%)
Arteriosclerosis, Stenosis, Vascula...	4 (.22%)
Bone And Joint Therapeutic Procedur...	4 (.22%)
Cardiac Arrhythmias	4 (.22%)
Cranial Nerve Disorders	4 (.22%)
Eating Disorders	4 (.22%)
Fungal Infectious	4 (.22%)
Glucose Metabolism Disorders	4 (.22%)
Menstrual Cycle And Uterine Bleedin...	4 (.22%)
Nervous System, Skull And Spine The...	4 (.22%)
Neurological, Special Senses And Ps...	4 (.22%)
Ocular Infections, Irritations And ...	4 (.22%)
Prostatic Disorders	4 (.22%)
Suicidal And Self-injurious Behavio...	4 (.22%)
Decreased And Nonspecific Blood Pre...	3 (.16%)
Encephalopathies	3 (.16%)
Enzyme	3 (.16%)
Gastrointestinal Conditions	3 (.16%)
Gastrointestinal Motility And Defec...	3 (.16%)
Gastrointestinal Therapeutic Proced...	3 (.16%)
Gastrointestinal Ulceration And Per...	3 (.16%)
Hematological And Lymphoid Tissue T...	3 (.16%)
Metabolic And Nutritional Disorders...	3 (.16%)
Miscellaneous And Site Unspecified ...	3 (.16%)
Nervous System Neoplasms Benign	3 (.16%)
Obstetric And Gynecological Therape...	3 (.16%)
Oral Soft Tissue Conditions	3 (.16%)
Product Quality Issues	3 (.16%)
Psychiatric	3 (.16%)
Schizophrenia And Other Psychotic	3 (.16%)
Sleep Disturbances	3 (.16%)
Tendon, Ligament And Cartilage	3 (.16%)
Therapeutic Procedures And Supporti...	3 (.16%)
Tissue	3 (.16%)
Vitamin Related	3 (.16%)
Water, Electrolyte And Mineral	3 (.16%)
Benign Neoplasms Gastrointestinal	2 (.11%)

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This graph shows the top categories of adverse events submitted to the FDA for Dilantin Kapseal, 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 Dilantin Kapseal 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.