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 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 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 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 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
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 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 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 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 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 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
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
Possible Phenytoin side effects in
Reported by a physician from United States on 2012-08-10
Patient:
Reactions: Bone Marrow Failure, Lung Infection Pseudomonal
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
|
