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Phenytoin (Phenytoin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Phenytoin and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (526)
Death (95)
Life Threatening Events (39)
Disability (12)

Reports by Reaction Type

Convulsion (90)Toxicity To Various Agents (53)Drug Ineffective (48)Drug Rash With Eosinophilia and Systemic Symptoms (43)Drug Interaction (40)Fall (25)Maternal Exposure During Pregnancy (23)Dizziness (22)Ataxia (22)Rash (22)Grand MAL Convulsion (22)Toxic Epidermal Necrolysis (21)

Below are a few examples of reports where side effects / adverse reactions may be related to Phenytoin. For a complete list or a specific selection of reports, please use the links above.

Possible Phenytoin side effects in 6 year old male

Reported by a pharmacist from United Kingdom on 2012-08-27

Patient: 6 year old male

Reactions: Drug Level Below Therapeutic, Convulsion

Drug(s) suspected as cause:
Phenytoin



Possible Phenytoin side effects in 50 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 50 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Pruritus, Vomiting, Nasopharyngitis, Anticonvulsant Drug Level Decreased, Convulsion, Malaise, Balance Disorder, Transient Ischaemic Attack, Ear Congestion, Feeling Abnormal, Sluggishness, Blister, Influenza

Drug(s) suspected as cause:
Dilantin
    Dosage: unk
    Administration route: Oral
    Indication: Epilepsy
    End date: 2012-08-01

Phenytoin
    Dosage: unk
    Indication: Epilepsy
    Start date: 2011-12-01

Other drugs received by patient: Lipitor; Topamax; Simvastatin; Aspirin



Possible Phenytoin side effects in female

Reported by a health professional (non-physician/pharmacist) from Singapore on 2012-08-22

Patient: female

Reactions: Drug Eruption, Hypotension, Rash Maculo-Papular

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Phenytoin

Other drugs received by patient: Glipizide; Metformin; Simvastatin



Possible Phenytoin side effects in 62 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 62 year old male, weighing 86.2 kg (189.6 pounds)

Reactions: Hypoaesthesia Oral, Somnolence, Feeling Drunk, Tremor

Drug(s) suspected as cause:
Dilantin
    Dosage: 100 mg, 4x/day
    Administration route: Oral
    Indication: Grand MAL Convulsion
    Start date: 1966-01-01
    End date: 2012-08-15

Phenytoin
    Dosage: 100 mg, 4x/day
    Indication: Grand MAL Convulsion
    Start date: 2012-08-16

Other drugs received by patient: Phenobarbital; Primidone



Possible Phenytoin side effects in 46 year old female

Reported by a physician from India on 2012-08-21

Patient: 46 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Incorrect Drug Administration Duration, Bronchospasm, Respiratory Distress, Cough

Drug(s) suspected as cause:
Phenytoin

Other drugs received by patient: Phenytoin



Possible Phenytoin side effects in 63 year old male

Reported by a physician from United States on 2012-08-20

Patient: 63 year old male

Reactions: Hypersensitivity, Pyrexia, Rash, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Phenytoin



Possible Phenytoin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient:

Reactions: Tubulointerstitial Nephritis

Drug(s) suspected as cause:
Phenytoin



Possible Phenytoin side effects in 47 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-17

Patient: 47 year old male

Reactions: Drug Level Changed

Drug(s) suspected as cause:
Phenytoin



Possible Phenytoin side effects in 5 year old male

Reported by a physician from Japan on 2012-08-16

Patient: 5 year old male

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Clobazam
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Gabapentin
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Topiramate
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Acetazolamide; Nitrazepam; Corticotropin; Vitamin B6; Zonisamide



Possible Phenytoin side effects in 16 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: 16 year old male

Reactions: Sepsis, Toxic Epidermal Necrolysis, Rash Morbilliform, Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Phenytoin



Possible Phenytoin side effects in female

Reported by a health professional (non-physician/pharmacist) from Peru on 2012-08-16

Patient: female

Reactions: Hallucination, Visual, Dyskinesia

Drug(s) suspected as cause:
Phenytoin

Other drugs received by patient: Valproic Acid



Possible Phenytoin side effects in 17 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 17 year old female

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Clobazam
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Gabapentin
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Levetiracetam
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Vitamin B6; Corticotropin; Zonisamide; Nitrazepam; Potassium Bromide; Benzodiazepine Derivatives



Possible Phenytoin side effects in 8 year old female

Reported by a physician from United States on 2012-08-16

Patient: 8 year old female

Reactions: Tubulointerstitial Nephritis, Pruritus, Hypersensitivity, Headache, Pyrexia, Nephrotic Syndrome, Eosinophilia, Diarrhoea, Liver Function Test Abnormal, Rash Morbilliform

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Phenytoin

Other drugs received by patient: Penicillin G



Possible Phenytoin side effects in 24 year old male

Reported by a physician from Japan on 2012-08-16

Patient: 24 year old male

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Levetiracetam
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Nitrazepam; Corticotropin; Zonisamide; Ethosuximide; Vitamin B6



Possible Phenytoin side effects in 20 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: 20 year old male

Reactions: Sepsis, Toxic Epidermal Necrolysis, Drug Rash With Eosinophilia and Systemic Symptoms, Dermatitis Exfoliative

Adverse event resulted in: death

Drug(s) suspected as cause:
Phenytoin



Possible Phenytoin side effects in 7 year old male

Reported by a physician from Japan on 2012-08-16

Patient: 7 year old male

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Clobazam
    Indication: Lennox-Gastaut Syndrome

Clonazepam
    Indication: Lennox-Gastaut Syndrome

Lamotrigine
    Indication: Lennox-Gastaut Syndrome

Phenobarbital TAB
    Indication: Lennox-Gastaut Syndrome

Phenytoin
    Indication: Lennox-Gastaut Syndrome

Topiramate
    Indication: Lennox-Gastaut Syndrome

Valproic Acid
    Indication: Lennox-Gastaut Syndrome

Other drugs received by patient: Ethosuximide; Zonisamide



Possible Phenytoin side effects in 8 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 8 year old female

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Diazepam
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Topiramate
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Benzodiazepine Derivatives; Corticotropin; Potassium Bromide



Possible Phenytoin side effects in 6 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 6 year old female

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Clobazam
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Diazepam
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Topiramate
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Corticotropin; Ethosuximide; Zonisamide



Possible Phenytoin side effects in 20 year old male

Reported by a physician from Japan on 2012-08-16

Patient: 20 year old male

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Clobazam
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Gabapentin
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Sultiame; Corticotropin; Zonisamide



Possible Phenytoin side effects in 38 year old female

Reported by a physician from United States on 2012-08-16

Patient: 38 year old female

Reactions: Myositis, Dermatitis Exfoliative, Drug Rash With Eosinophilia and Systemic Symptoms, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Phenytoin

Other drugs received by patient: Diphenhydramine Hydrochloride; Phenobarbital; Diazepam



Possible Phenytoin side effects in 6 year old male

Reported by a physician from Japan on 2012-08-16

Patient: 6 year old male

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Clonazepam
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Sultiame; Potassium Bromide; Benzodiazepine Derivatives; Zonisamide; Nitrazepam; Corticotropin



Possible Phenytoin side effects in 63 year old female

Reported by a pharmacist from United States on 2012-08-16

Patient: 63 year old female

Reactions: Tubulointerstitial Nephritis, Toxic Epidermal Necrolysis

Drug(s) suspected as cause:
Phenytoin
    Dosage: 600 mg, daily
    Administration route: Oral

Phenytoin
    Dosage: 300 mg/day
    Administration route: Oral
    Indication: Postictal State

Other drugs received by patient: Chlorthalidone; Clonidine



Possible Phenytoin side effects in 25 year old male

Reported by a physician from Korea, Republic of on 2012-08-15

Patient: 25 year old male

Reactions: Hepatitis Acute, Pyelonephritis

Drug(s) suspected as cause:
Keppra
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2012-08-06

Phenytoin
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-08-08

Other drugs received by patient: Valproate Sodium



Possible Phenytoin side effects in 53 year old female

Reported by a pharmacist from United States on 2012-08-14

Patient: 53 year old female

Reactions: Drug Level Increased, Hypothermia, Blood Albumin Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Phenytoin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Risperidone
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Phenytoin side effects in 23 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-14

Patient: 23 year old female

Reactions: Tubulointerstitial Nephritis

Drug(s) suspected as cause:
Carbamazepine
    Dosage: unk

Diazepam
    Dosage: unk

Lorazepam
    Dosage: unk

Paraldehyde
    Dosage: unk

Phenobarbital TAB
    Dosage: unk

Phenytoin
    Dosage: unk



Possible Phenytoin side effects in 53 year old female

Reported by a physician from United States on 2012-08-14

Patient: 53 year old female

Reactions: Alveolitis Allergic

Drug(s) suspected as cause:
Phenytoin

Other drugs received by patient: Docusate



Possible Phenytoin side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Phenytoin



Possible Phenytoin side effects in female

Reported by a physician from Peru on 2012-08-14

Patient: female

Reactions: Choreoathetosis, Hallucination, Visual, Dyskinesia

Drug(s) suspected as cause:
Phenytoin

Other drugs received by patient: Valproic Acid



Possible Phenytoin side effects in 4 year old female

Reported by a physician from India on 2012-08-10

Patient: 4 year old female

Reactions: Extensor Plantar Response, Nystagmus, Anticonvulsant Drug Level Increased, Depressed Level of Consciousness, Hyporeflexia, Accidental Drug Intake by Child, Thrombocytopenia, Head Titubation

Drug(s) suspected as cause:
Phenytoin



Possible Phenytoin side effects in

Reported by a physician from United States on 2012-08-10

Patient:

Reactions: Mucosal Inflammation, Sepsis, Candidiasis

Adverse event resulted in: death

Drug(s) suspected as cause:
Artificial Saliva
    Dosage: 30ml four times per day
    Administration route: Oral
    Indication: Prophylaxis

Busulfan
    Indication: Product Used FOR Unknown Indication

Cryotherapy
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Gemcitabine Hydrochloride
    Indication: Product Used FOR Unknown Indication

Glutamine
    Dosage: 15g four times per day
    Indication: Product Used FOR Unknown Indication

Granulocyte Macrophage Colony Stimulating Factor
    Dosage: 5mck per day
    Indication: Product Used FOR Unknown Indication

Melphalan Hydrochloride
    Dosage: 60mgm2 per day
    Indication: Product Used FOR Unknown Indication

Palifermin
    Dosage: 60mck per day
    Indication: Prophylaxis

Phenytoin
    Dosage: 600mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

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