PHENYTOIN

Phenytoin Adverse Events Reported to the FDA Over Time

How are Phenytoin adverse event reports trending over time?

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

Most Common Phenytoin Adverse Events Reported to the FDA

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

Convulsion	3172 (6.31%)
Stevens-johnson Syndrome	1393 (2.77%)
Anticonvulsant Drug Level Decreased	739 (1.47%)
Drug Ineffective	666 (1.32%)
Drug Interaction	655 (1.3%)
Dizziness	646 (1.28%)
Anticonvulsant Drug Level Increased	644 (1.28%)
Grand Mal Convulsion	568 (1.13%)
Fall	530 (1.05%)
Drug Toxicity	504 (1%)
Balance Disorder	390 (.78%)
	Show More
Rash	385 (.77%)
Headache	381 (.76%)
Somnolence	372 (.74%)
Pyrexia	369 (.73%)
Confusional State	363 (.72%)
Feeling Abnormal	349 (.69%)
Tremor	339 (.67%)
Fatigue	333 (.66%)
Malaise	329 (.65%)
Drug Level Decreased	314 (.62%)
Nausea	313 (.62%)
Toxic Epidermal Necrolysis	313 (.62%)
Condition Aggravated	305 (.61%)
Asthenia	296 (.59%)
Anticonvulsant Drug Level Below The...	281 (.56%)
Vomiting	281 (.56%)
Drug Rash With Eosinophilia And Sys...	276 (.55%)
Loss Of Consciousness	271 (.54%)
Weight Decreased	261 (.52%)
Gait Disturbance	250 (.5%)
Drug Level Increased	249 (.5%)
Ataxia	233 (.46%)
Vision Blurred	226 (.45%)
Drug Hypersensitivity	215 (.43%)
Dysphagia	210 (.42%)
Pain	206 (.41%)
Lethargy	201 (.4%)
Insomnia	195 (.39%)
Status Epilepticus	194 (.39%)
Depression	190 (.38%)
Dyspnoea	185 (.37%)
Dysarthria	183 (.36%)
Hypersensitivity	183 (.36%)
Hypertension	179 (.36%)
Epilepsy	178 (.35%)
Overdose	176 (.35%)
Completed Suicide	173 (.34%)
Coordination Abnormal	172 (.34%)
Nystagmus	171 (.34%)
Cerebrovascular Accident	164 (.33%)
Anticonvulsant Drug Level Above The...	158 (.31%)
Memory Impairment	158 (.31%)
Therapeutic Response Unexpected Wit...	158 (.31%)
Anxiety	156 (.31%)
Hypotension	155 (.31%)
Therapeutic Agent Toxicity	155 (.31%)
Pneumonia	152 (.3%)
Medication Error	149 (.3%)
Alanine Aminotransferase Increased	147 (.29%)
Pruritus	144 (.29%)
Diplopia	140 (.28%)
Mental Status Changes	135 (.27%)
Hypoaesthesia	133 (.26%)
Urinary Tract Infection	133 (.26%)
Oedema Peripheral	132 (.26%)
Coma	131 (.26%)
Amnesia	130 (.26%)
Drug Level Below Therapeutic	129 (.26%)
Aspartate Aminotransferase Increase...	128 (.25%)
Drug Exposure During Pregnancy	128 (.25%)
Renal Failure Acute	128 (.25%)
Treatment Noncompliance	127 (.25%)
Sepsis	124 (.25%)
Speech Disorder	124 (.25%)
Diarrhoea	119 (.24%)
Weight Increased	119 (.24%)
Aura	117 (.23%)
Paraesthesia	117 (.23%)
Drug Effect Decreased	116 (.23%)
Nervousness	115 (.23%)
Death	113 (.22%)
Petit Mal Epilepsy	113 (.22%)
Osteoporosis	109 (.22%)
Depressed Level Of Consciousness	108 (.21%)
Drug Level Fluctuating	106 (.21%)
Rash Generalised	104 (.21%)
Activities Of Daily Living Impaired	103 (.2%)
Liver Function Test Abnormal	102 (.2%)
Product Substitution Issue	102 (.2%)
Erythema Multiforme	99 (.2%)
Road Traffic Accident	99 (.2%)
Incorrect Dose Administered	98 (.19%)
Myocardial Infarction	98 (.19%)
Agitation	95 (.19%)
Pain In Extremity	95 (.19%)
Chest Pain	91 (.18%)
Aphasia	90 (.18%)
Dehydration	90 (.18%)
Abasia	87 (.17%)
Tachycardia	87 (.17%)

Share/Embed Graph Export Data

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

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

Seizures	4432 (8.81%)
Neurological	4408 (8.76%)
Epidermal And Dermal Conditions	3867 (7.69%)
Toxicology And Therapeutic Drug Mon...	2917 (5.8%)
Therapeutic And Nontherapeutic Effe...	1895 (3.77%)
Injuries	1207 (2.4%)
Gastrointestinal Signs	1131 (2.25%)
Infections - Pathogen Unspecified	981 (1.95%)
Chemical Injury And Poisoning	889 (1.77%)
Medication Errors	872 (1.73%)
Respiratory	767 (1.53%)
	Show More
Movement Disorders	702 (1.4%)
Hepatobiliary	659 (1.31%)
Hepatic And Hepatobiliary	589 (1.17%)
Hematology Investigations	561 (1.12%)
Vision	560 (1.11%)
Physical Examination Topics	551 (1.1%)
Anxiety Disorders	534 (1.06%)
Deliria	532 (1.06%)
Mental Impairment	515 (1.02%)
Lifestyle Issues	513 (1.02%)
Cardiac Arrhythmias	487 (.97%)
Allergic Conditions	470 (.93%)
Headaches	465 (.92%)
Body Temperature Conditions	403 (.8%)
Dental And Gingival Conditions	390 (.78%)
Central Nervous System Vascular	380 (.76%)
Muscle	368 (.73%)
Bone And Joint Injuries	367 (.73%)
Musculoskeletal And Connective Tiss...	340 (.68%)
Renal Disorders	290 (.58%)
Psychiatric	274 (.54%)
Suicidal And Self-injurious Behavio...	272 (.54%)
Cardiac And Vascular Investigations	271 (.54%)
Anemias Nonhemolytic And Marrow Dep...	266 (.53%)
Joint	266 (.53%)
White Blood Cell	263 (.52%)
Gastrointestinal Motility And Defec...	261 (.52%)
Sleep Disorders	261 (.52%)
Bone Disorders	259 (.51%)
Depressed Mood Disorders	249 (.5%)
Lower Respiratory Tract Disorders	229 (.46%)
Water, Electrolyte And Mineral	223 (.44%)
Electrolyte And Fluid Balance Condi...	219 (.44%)
Appetite And General Nutritional	216 (.43%)
Oral Soft Tissue Conditions	209 (.42%)
Bacterial Infectious	201 (.4%)
Decreased And Nonspecific Blood Pre...	195 (.39%)
Product Quality Issues	195 (.39%)
Mood Disorders	194 (.39%)
Vascular Hypertensive	191 (.38%)
Skin Appendage Conditions	187 (.37%)
Glucose Metabolism Disorders	183 (.36%)
Urinary Tract Signs	182 (.36%)
Enzyme	174 (.35%)
Disturbances In Thinking	173 (.34%)
Metabolic, Nutritional And Blood Ga...	173 (.34%)
Viral Infectious	173 (.34%)
Cardiac Disorder Signs	161 (.32%)
Coronary Artery	159 (.32%)
Personality Disorders	146 (.29%)
Protein And Chemistry Analyses	143 (.28%)
Eye	138 (.27%)
Encephalopathies	130 (.26%)
Fatal Outcomes	128 (.25%)
Embolism And Thrombosis	126 (.25%)
Psychiatric And Behavioural Symptom...	126 (.25%)
Spleen, Lymphatic And Reticulendoth...	122 (.24%)
Therapeutic Procedures And Supporti...	121 (.24%)
Upper Respiratory Tract Disorders	121 (.24%)
Renal And Urinary Tract Investigati...	120 (.24%)
Inner Ear And Viiith Cranial Nerve	118 (.23%)
Neuromuscular	116 (.23%)
Lipid Analyses	111 (.22%)
Platelet	109 (.22%)
Angiedema And Urticaria	104 (.21%)
Ocular Infections, Irritations And ...	104 (.21%)
Gastrointestinal Hemorrhages	102 (.2%)
Peripheral Neuropathies	100 (.2%)
Skin Vascular Abnormalities	98 (.19%)
Vascular	98 (.19%)
Procedural And Device Related Injur...	96 (.19%)
Neurological, Special Senses And Ps...	95 (.19%)
Ocular Neuromuscular	90 (.18%)
Structural Brain	90 (.18%)
Tissue	90 (.18%)
Acid-base	85 (.17%)
Fungal Infectious	84 (.17%)
Immune	84 (.17%)
Myocardial	82 (.16%)
Increased Intracranial Pressure And...	80 (.16%)
Vascular Hemorrhagic	80 (.16%)
Cardiac And Vascular Disorders Cong...	76 (.15%)
Musculoskeletal And Connective Tiss...	76 (.15%)
Nervous System Neoplasms Malignant ...	75 (.15%)
Tongue Conditions	75 (.15%)
Arteriosclerosis, Stenosis, Vascula...	74 (.15%)
Thyroid Gland	72 (.14%)
Coagulopathies And Bleeding Diathes...	70 (.14%)
Hearing	70 (.14%)
Bronchial Disorders	68 (.14%)

Share/Embed Graph Export Data

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