PHENYTOIN SODIUM CAP

Phenytoin Sodium Cap Adverse Events Reported to the FDA Over Time

How are Phenytoin Sodium Cap adverse event reports trending over time?

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

Most Common Phenytoin Sodium Cap Adverse Events Reported to the FDA

What are the most common Phenytoin Sodium Cap adverse events reported to the FDA?

Convulsion	74 (6.4%)
Stevens-johnson Syndrome	61 (5.28%)
Pyrexia	23 (1.99%)
Drug Rash With Eosinophilia And Sys...	17 (1.47%)
Epilepsy	17 (1.47%)
Drug Ineffective	16 (1.38%)
Liver Disorder	16 (1.38%)
Rash	16 (1.38%)
Anticonvulsant Drug Level Below The...	15 (1.3%)
C-reactive Protein Increased	14 (1.21%)
Erythema	14 (1.21%)
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Altered State Of Consciousness	13 (1.12%)
Loss Of Consciousness	13 (1.12%)
White Blood Cell Count Increased	13 (1.12%)
Anticonvulsant Drug Level Decreased	12 (1.04%)
Lymphadenopathy	12 (1.04%)
Drug Level Below Therapeutic	10 (.87%)
Aspartate Aminotransferase Increase...	9 (.78%)
Fall	9 (.78%)
Malaise	9 (.78%)
Rash Generalised	9 (.78%)
Somnolence	9 (.78%)
Anticonvulsant Drug Level Increased	8 (.69%)
Death	8 (.69%)
Dizziness	8 (.69%)
Drug Interaction	8 (.69%)
Dysphagia	8 (.69%)
Lip Erosion	8 (.69%)
Ocular Hyperaemia	8 (.69%)
Pneumonia	8 (.69%)
Toxic Epidermal Necrolysis	8 (.69%)
Vomiting	8 (.69%)
Alanine Aminotransferase Increased	7 (.61%)
Anticonvulsant Drug Level Above The...	7 (.61%)
Confusional State	7 (.61%)
Grand Mal Convulsion	7 (.61%)
Partial Seizures	7 (.61%)
Urinary Tract Infection	7 (.61%)
Anxiety	6 (.52%)
Drug Effect Decreased	6 (.52%)
Drug Eruption	6 (.52%)
Fatigue	6 (.52%)
Generalised Erythema	6 (.52%)
Headache	6 (.52%)
Lymphocyte Percentage Decreased	6 (.52%)
Multi-organ Failure	6 (.52%)
Nausea	6 (.52%)
Neutrophil Percentage Increased	6 (.52%)
Rash Maculo-papular	6 (.52%)
Road Traffic Accident	6 (.52%)
Status Epilepticus	6 (.52%)
Therapeutic Agent Toxicity	6 (.52%)
Bacterial Infection	5 (.43%)
Blood Pressure Increased	5 (.43%)
Cognitive Disorder	5 (.43%)
Constipation	5 (.43%)
Convulsions Local	5 (.43%)
Disorientation	5 (.43%)
Drug Level Decreased	5 (.43%)
Dysuria	5 (.43%)
Erythema Multiforme	5 (.43%)
Gastrostomy Tube Insertion	5 (.43%)
Hepatic Function Abnormal	5 (.43%)
Hyperammonaemia	5 (.43%)
Muscle Rigidity	5 (.43%)
Near Drowning	5 (.43%)
Oral Mucosa Erosion	5 (.43%)
Palpitations	5 (.43%)
Pseudomonas Infection	5 (.43%)
Restlessness	5 (.43%)
Vulvar Erosion	5 (.43%)
Weight Decreased	5 (.43%)
Blood Alkaline Phosphatase Increase...	4 (.35%)
Cerebrovascular Accident	4 (.35%)
Decreased Appetite	4 (.35%)
Depression	4 (.35%)
Diarrhoea	4 (.35%)
Drug Toxicity	4 (.35%)
Medication Error	4 (.35%)
Meningioma	4 (.35%)
Nervousness	4 (.35%)
Overdose	4 (.35%)
Pancreatitis	4 (.35%)
Pneumonia Aspiration	4 (.35%)
Poor Venous Access	4 (.35%)
Renal Failure	4 (.35%)
Septic Shock	4 (.35%)
Therapeutic Response Unexpected Wit...	4 (.35%)
Asthenia	3 (.26%)
Back Pain	3 (.26%)
Blister	3 (.26%)
Blood Lactate Dehydrogenase Increas...	3 (.26%)
Blood Pressure Decreased	3 (.26%)
Cardiac Failure Congestive	3 (.26%)
Cellulitis	3 (.26%)
Coordination Abnormal	3 (.26%)
Cyanosis	3 (.26%)
Disease Progression	3 (.26%)
Drug Level Increased	3 (.26%)
Dysarthria	3 (.26%)
Gait Disturbance	3 (.26%)

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This graph shows the top adverse events submitted to the FDA for Phenytoin Sodium Cap, 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 Phenytoin Sodium Cap 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 Phenytoin Sodium Cap

What are the most common Phenytoin Sodium Cap adverse events reported to the FDA?

Epidermal And Dermal Conditions	178 (15.4%)
Seizures	117 (10.12%)
Neurological	67 (5.8%)
Toxicology And Therapeutic Drug Mon...	64 (5.54%)
Hematology Investigations	42 (3.63%)
Therapeutic And Nontherapeutic Effe...	35 (3.03%)
Hepatic And Hepatobiliary	29 (2.51%)
Injuries	26 (2.25%)
Infections - Pathogen Unspecified	25 (2.16%)
Body Temperature Conditions	23 (1.99%)
Gastrointestinal Signs	23 (1.99%)
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Hepatobiliary	22 (1.9%)
Medication Errors	17 (1.47%)
Protein And Chemistry Analyses	17 (1.47%)
Oral Soft Tissue Conditions	16 (1.38%)
Anxiety Disorders	14 (1.21%)
Bacterial Infectious	14 (1.21%)
Chemical Injury And Poisoning	13 (1.12%)
Spleen, Lymphatic And Reticulendoth...	13 (1.12%)
Deliria	12 (1.04%)
Respiratory	12 (1.04%)
Mental Impairment	11 (.95%)
Movement Disorders	11 (.95%)
Gastrointestinal Motility And Defec...	10 (.87%)
Lower Respiratory Tract Disorders	9 (.78%)
Ocular Infections, Irritations And ...	9 (.78%)
Product Quality Issues	9 (.78%)
Urinary Tract Signs	9 (.78%)
Cardiac And Vascular Investigations	8 (.69%)
Cardiac Disorder Signs	8 (.69%)
Enzyme	8 (.69%)
Fatal Outcomes	8 (.69%)
Headaches	8 (.69%)
Central Nervous System Vascular	7 (.61%)
Gastrointestinal Therapeutic Proced...	7 (.61%)
Physical Examination Topics	7 (.61%)
White Blood Cell	7 (.61%)
Coronary Artery	6 (.52%)
Dental And Gingival Conditions	6 (.52%)
Musculoskeletal And Connective Tiss...	6 (.52%)
Nervous System Neoplasms Malignant ...	6 (.52%)
Renal Disorders	6 (.52%)
Vulvovaginal Disorders	6 (.52%)
Changes In Physical Activity	5 (.43%)
Disturbances In Thinking	5 (.43%)
Muscle	5 (.43%)
Personality Disorders	5 (.43%)
Protein And Amino Acid Metabolism	5 (.43%)
Skin Appendage Conditions	5 (.43%)
Skin Vascular Abnormalities	5 (.43%)
Vascular	5 (.43%)
Administration Site Reactions	4 (.35%)
Appetite And General Nutritional	4 (.35%)
Depressed Mood Disorders	4 (.35%)
Exocrine Pancreas Conditions	4 (.35%)
Heart Failures	4 (.35%)
Psychiatric	4 (.35%)
Renal And Urinary Tract Investigati...	4 (.35%)
Suicidal And Self-injurious Behavio...	4 (.35%)
Allergic Conditions	3 (.26%)
Cardiac Arrhythmias	3 (.26%)
Glucose Metabolism Disorders	3 (.26%)
Penile And Scrotal Disorders	3 (.26%)
Reproductive Neoplasms Male Maligna...	3 (.26%)
Skin And Subcutaneous Tissue	3 (.26%)
Structural Brain	3 (.26%)
Therapeutic Procedures And Supporti...	3 (.26%)
Viral Infectious	3 (.26%)
Anemias Nonhemolytic And Marrow Dep...	2 (.17%)
Bone And Joint Injuries	2 (.17%)
Bone Disorders	2 (.17%)
Coagulopathies And Bleeding Diathes...	2 (.17%)
Cornification And Dystrophic Skin	2 (.17%)
Electrolyte And Fluid Balance Condi...	2 (.17%)
Encephalopathies	2 (.17%)
Hepatic And Biliary Neoplasms Benig...	2 (.17%)
Immune	2 (.17%)
Injuries By Physical Agents	2 (.17%)
Lifestyle Issues	2 (.17%)
Microbiology And Serology	2 (.17%)
Miscellaneous And Site Unspecified ...	2 (.17%)
Mood Disorders	2 (.17%)
Peripheral Neuropathies	2 (.17%)
Vision	2 (.17%)
Angiedema And Urticaria	1 (.09%)
Bone And Joint Therapeutic Procedur...	1 (.09%)
Central Nervous System Infections A...	1 (.09%)
Connective Tissue Disorders	1 (.09%)
Decreased And Nonspecific Blood Pre...	1 (.09%)
Embolism And Thrombosis	1 (.09%)
Fungal Infectious	1 (.09%)
Gallbladder	1 (.09%)
Gastrointestinal	1 (.09%)
Gastrointestinal Neoplasms Malignan...	1 (.09%)
Hemolyses And Related Conditions	1 (.09%)
Hepatobiliary Neoplasms Malignant A...	1 (.09%)
Hepatobiliary Therapeutic Procedure...	1 (.09%)
Inner Ear And Viiith Cranial Nerve	1 (.09%)
Investigations, Imaging And Histopa...	1 (.09%)
Joint	1 (.09%)
Metabolic, Nutritional And Blood Ga...	1 (.09%)

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This graph shows the top categories of adverse events submitted to the FDA for Phenytoin Sodium Cap, 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 Phenytoin Sodium Cap 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.