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PHENYTOIN SODIUM

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Phenytoin Sodium Adverse Events Reported to the FDA Over Time

How are Phenytoin Sodium adverse event reports trending over time?

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

Most Common Phenytoin Sodium Adverse Events Reported to the FDA

What are the most common Phenytoin Sodium 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%)
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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%)

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

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

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

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

Convulsion
5676
Epilepsy
2507
Drug Use For Unknown Indication
558
Grand Mal Convulsion
554
Product Used For Unknown Indication
428
Convulsion Prophylaxis
409
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Ill-defined Disorder
381
Status Epilepticus
220
Prophylaxis
148
Partial Seizures
76
Petit Mal Epilepsy
67
Complex Partial Seizures
51
Cerebrovascular Accident
41
Head Injury
27
Drug Exposure During Pregnancy
27
Temporal Lobe Epilepsy
23
Simple Partial Seizures
22
Infantile Spasms
19
Metastases To Central Nervous Syste...
17
Brain Injury
16
Cerebral Haemorrhage
16
Pain
16
Affective Disorder
16
Trigeminal Neuralgia
16
Post-traumatic Epilepsy
16
Migraine
14
Brain Neoplasm
14
Meningioma
14
Partial Seizures With Secondary Gen...
14
Frontal Lobe Epilepsy
12
Glioblastoma Multiforme
12
Prophylaxis Of Nausea And Vomiting
12
Aneurysm
11
Subarachnoid Haemorrhage
11
Intracranial Aneurysm
10
Lennox-gastaut Syndrome
10
Suicide Attempt
10
Cerebral Atrophy
9
Arteriovenous Malformation
9
Neuralgia
9
Injury
9
Neuropathy Peripheral
8
Syncope
8
Nervous System Disorder
8
Foetal Exposure During Pregnancy
8
Muscle Spasms
7
Ischaemia
7
Hemiplegia
7
Postoperative Care
7
Loss Of Consciousness
7
Depression
7

Drug Labels

LabelLabelerEffective
Phenytoin SodiumSUN PHARMACEUTICAL INDUSTRIES LIMITED05-DEC-09
DilantinPhysicians Total Care, Inc.04-MAR-10
Phenytoin SodiumSUN PHARMACEUTICAL INDUSTRIES LIMITED05-APR-10
Phenytoin SodiumContract Pharmacy Services-PA06-APR-10
Phenytoin Sodium ExtendedAvPAK04-AUG-10
Phenytoin SodiumState of Florida DOH Central Pharmacy12-AUG-10
Phenytoin SodiumGeneral Injectables & Vaccines, Inc25-AUG-10
Phenytoin SodiumRebel Distributors Corp04-JAN-11
Phenytoin SodiumHospira, Inc.04-APR-11
Extended Phenytoin SodiumMajor Pharmaceuticals07-APR-11
Phenytoin SodiumGeneral Injectables & Vaccines, Inc25-APR-11
Phenytoin SodiumGeneral Injectables & Vaccines, Inc26-APR-11
Phenytoin SodiumMylan Pharmaceuticals Inc.01-MAY-11
Phenytoin SodiumX-GEN Pharmaceuticals, Inc.02-MAY-11
Phenytoin SodiumNCS HealthCare of KY, Inc dba Vangard Labs15-JUN-11
Phenytoin SodiumHospira, Inc.02-AUG-11
Phenytoin SodiumCardinal Health30-SEP-11
Phenytoin SodiumTaro Pharmaceuticals U.S.A., Inc.22-NOV-11
Phenytoin SodiumWest-ward Pharmaceutical Corp.26-JAN-12
Phenytoin SodiumMylan Institutional Inc.03-FEB-12
Phenytoin SodiumPhysicians Total Care, Inc.12-FEB-12
Extended Phenytoin SodiumPD-Rx Pharmaceuticals, Inc.28-FEB-12
Phenytoin SodiumMcKesson Contract Packaging27-MAR-12
Extended Phenytoin SodiumAmneal Pharmaceuticals, LLC25-APR-12
Phenytoin SodiumCardinal Health23-MAY-12
DilantinAphena Pharma Solutions - Tennessee, Inc.20-JUN-12
Extended Phenytoin SodiumWockhardt USA LLC.20-JUL-12
Extended Phenytoin SodiumAmerican Health Packaging24-JUL-12
Phenytoin SodiumWest-ward Pharmaceutical Corp.01-AUG-12
Phenytoin SodiumBryant Ranch Prepack23-OCT-12
Phenytoin SodiumCardinal Health16-NOV-12
Phenytoin Sodium General Injectables & Vaccines, Inc.26-NOV-12
Phenytoin SodiumGeneral Injectables & Vaccines, Inc19-DEC-12
DilantinParke-Davis Div of Pfizer Inc21-DEC-12
Extended Phenytoin SodiumREMEDYREPACK INC. 26-DEC-12
Extended Phenytoin SodiumWockhardt Limited04-JAN-13
Phenytoin SodiumCardinal Health18-MAR-13
Phenytoin SodiumREMEDYREPACK INC. 20-MAR-13
Phenytoin SodiumCardinal Health22-MAR-13
Phenytoin SodiumCardinal Health03-APR-13
Extended Phenytoin SodiumREMEDYREPACK INC. 09-APR-13
Extended Phenytoin SodiumREMEDYREPACK INC. 09-APR-13
Phenytoin SodiumCardinal Health15-APR-13

Phenytoin Sodium Case Reports

What Phenytoin Sodium 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 Phenytoin Sodium. 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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