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Dilantin-125 (Phenytoin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Dilantin-125 (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 (365)
Death (20)
Life Threatening Events (4)
Disability (1)

Reports by Reaction Type

Convulsion (108)Stevens-Johnson Syndrome (90)Drug Hypersensitivity (18)Drug Ineffective (16)Grand MAL Convulsion (16)Headache (14)Anticonvulsant Drug Level Decreased (14)Rash (12)Drug Level Decreased (10)Malaise (9)Toxic Epidermal Necrolysis (9)Drug Interaction (7)

Below are a few examples of reports where side effects / adverse reactions may be related to Dilantin-125 (Phenytoin). For a complete list or a specific selection of reports, please use the links above.

Possible Dilantin-125 side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Brain Neoplasm Malignant, Diabetes Mellitus, Lung Neoplasm Malignant, Blood Cholesterol Increased, Depression, Hypertension

Drug(s) suspected as cause:
Dilantin-125
    Dosage: unk

Lipitor
    Dosage: unk

Zoloft
    Dosage: unk



Possible Dilantin-125 side effects in 62 year old male

Reported by a physician from United States on 2012-08-27

Patient: 62 year old male, weighing 93.0 kg (204.6 pounds)

Reactions: Peripheral Coldness, Back Pain, Neuropathy Peripheral, Arthritis, Intervertebral Disc Compression

Drug(s) suspected as cause:
Dilantin Kapseal
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Convulsion

Dilantin Kapseal
    Indication: Epilepsy

Dilantin-125
    Dosage: 200 mg, 2x/day
    Administration route: Oral

Other drugs received by patient: Enalapril Maleate; Phenobarbital TAB; Finasteride; Doxazosin Mesylate; Naproxen; Acetylsalicylic Acid



Possible Dilantin-125 side effects in 82 year old female

Reported by a lawyer from United States on 2012-08-24

Patient: 82 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Blood Urea Increased, Decubitus Ulcer, Dehydration, Blood Creatinine Increased

Drug(s) suspected as cause:
Dilantin
    Dosage: 100 mg, 3x/day (every 8 hours)
    Start date: 2011-03-19
    End date: 2011-03-24

Dilantin
    Dosage: 100mg/2ml every 8 hours
    Start date: 2011-03-19

Dilantin
    Dosage: 750 mg, unk
    Start date: 2011-03-19

Dilantin
    Dosage: 100 mg, 2x/day
    Administration route: Oral
    Indication: Convulsion
    Start date: 2011-03-13

Dilantin-125
    Dosage: 125mg/ 5ml
    Administration route: Oral
    Indication: Convulsion
    Start date: 2011-03-21
    End date: 2011-03-24

Other drugs received by patient: Potassium Chloride; Norvasc; Colace; Prilosec; Aricept; Ativan; Heparin; Levaquin; Neurontin; Cozaar; Vitamin D; Cerebyx; Ferrous Sulfate



Possible Dilantin-125 side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Nervous System Disorder, Sensory Loss

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in 9 year old male

Reported by a lawyer from United States on 2012-08-23

Patient: 9 year old male, weighing 40.0 kg (88.0 pounds)

Reactions: Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in 63 year old male

Reported by a physician from United States on 2012-08-22

Patient: 63 year old male

Reactions: Tubulointerstitial Nephritis, Hypersensitivity, Renal Failure Acute

Drug(s) suspected as cause:
Dilantin-125

Other drugs received by patient: Lasix; Lanoxin



Possible Dilantin-125 side effects in 61 year old

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

Patient: 61 year old

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 65 year old male

Reactions: Neuropathy Peripheral, Pain in Extremity, Paraesthesia

Drug(s) suspected as cause:
Dilantin-125
    Dosage: unk

Lyrica
    Dosage: 50 mg, unk
    Indication: Neuropathy Peripheral

Lyrica
    Dosage: 200 mg, unk



Possible Dilantin-125 side effects in 52 year old female

Reported by a physician from United States on 2012-08-21

Patient: 52 year old female

Reactions: Grand MAL Convulsion, Postictal Headache, Anticonvulsant Drug Level Increased, Toxicity To Various Agents, Fall, Loss of Consciousness, Convulsion

Drug(s) suspected as cause:
Dilantin-125
    Dosage: unk
    Administration route: Oral
    Indication: Convulsion
    Start date: 2006-01-01

Dilantin-125
    Dosage: 100 mg, 2x/day
    Administration route: Oral

Neurontin
    Dosage: unk

Other drugs received by patient: Phenobarbital; Buspirone; Mobic



Possible Dilantin-125 side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Tooth Disorder

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in 43 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 43 year old female, weighing 95.0 kg (209.0 pounds)

Reactions: Anticonvulsant Drug Level Decreased, Coma, Headache, Toxicity To Various Agents, Stress, Convulsion, Bronchitis, Emotional Disorder, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilantin-125
    Dosage: 100 mg,5x/day
    Start date: 2006-01-01
    End date: 2011-01-01

Klonopin
    Dosage: 2 mg, 3x/day
    Administration route: Oral
    Indication: Convulsion
    Start date: 2004-01-01

Other drugs received by patient: Bentyl; Bentyl; Benadryl; Symbicort; Acetaminophen, Aspirin, and Codeine Phosphate; Nexium; Nexium; Bentyl; Nexium; Bentyl; Promethazine Hydrochloride; Promethazine Hydrochloride; Symbicort; Bentyl



Possible Dilantin-125 side effects in 86 year old female

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

Patient: 86 year old female

Reactions: Drug Level Increased, Vertigo, Drug Interaction, Ataxia, Cardioactive Drug Level Increased, Prothrombin Time Prolonged, Lethargy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilantin-125

Other drugs received by patient possibly interacting with the suspect drug:
Amiodarone HCL
    Dosage: 400 mg/day

Amiodarone HCL
    Dosage: 600 mg/day
    Indication: Ventricular Tachycardia

Dilantin-125
    Indication: Electroencephalogram Abnormal

Other drugs received by patient: Digoxin; Furosemide; Warfarin; Potassium



Possible Dilantin-125 side effects in 46 year old female

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

Patient: 46 year old female

Reactions: Stevens-Johnson Syndrome

Drug(s) suspected as cause:
Dilantin
    Dosage: 100mg capsules two in morning and two in evening
    Administration route: Oral
    Indication: Grand MAL Convulsion
    Start date: 2009-04-21

Dilantin
    Dosage: 100mg tablets, two tablets twice daily
    Administration route: Oral
    Start date: 2010-01-04
    End date: 2010-01-05

Dilantin-125
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Start date: 2009-08-18

Dilantin-125
    Dosage: 300 mg, 1x/day
    Indication: Grand MAL Convulsion
    Start date: 2009-01-01

Other drugs received by patient: Citalopram; Chlorzoxazone; Butalbital and Caffeine and Paracetamol; Meclizine; Tramadol; Lyrica; Phenergan HCL; Seroquel



Possible Dilantin-125 side effects in 43 year old male

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

Patient: 43 year old male

Reactions: Stevens-Johnson Syndrome

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in 70 year old

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

Patient: 70 year old

Reactions: Stevens-Johnson Syndrome

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in 64 year old male

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

Patient: 64 year old male

Reactions: Diabetes Mellitus, Gastric Haemorrhage

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: female

Reactions: Nervous System Disorder, Memory Impairment, Eye Disorder, Convulsion

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in 36 year old male

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

Patient: 36 year old male

Reactions: Lymphadenopathy, Lung Disorder, Rash Generalised, Interstitial Lung Disease, Drug Hypersensitivity, Aspartate Aminotransferase Increased, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in 45 year old

Reported by a physician from United States on 2012-08-09

Patient: 45 year old

Reactions: Major Depression

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in 43 year old female

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

Patient: 43 year old female, weighing 95.0 kg (209.0 pounds)

Reactions: Anticonvulsant Drug Level Decreased, Coma, Toxicity To Various Agents, Headache, Stress, Convulsion, Bronchitis, Emotional Disorder, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilantin-125
    Dosage: 100 mg,5x/day
    Start date: 2006-01-01
    End date: 2011-01-01

Klonopin
    Dosage: 2 mg, 3x/day
    Administration route: Oral
    Indication: Convulsion
    Start date: 2004-01-01

Other drugs received by patient: Bentyl; Promethazine Hydrochloride; Nexium; Acetaminophen, Aspirin, and Codeine Phosphate; Benadryl; Bentyl; Bentyl; Nexium; Symbicort; Symbicort; Bentyl; Promethazine Hydrochloride; Bentyl; Nexium



Possible Dilantin-125 side effects in 75 year old male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 75 year old male

Reactions: Therapeutic Response Unexpected, Mental Status Changes

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in 86 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: 86 year old female

Reactions: Drug Level Increased, Ataxia, Vertigo, Drug Interaction, Cardioactive Drug Level Increased, Prothrombin Time Prolonged, Lethargy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilantin-125

Other drugs received by patient possibly interacting with the suspect drug:
Amiodarone HCL
    Dosage: 600 mg/day
    Indication: Ventricular Tachycardia

Amiodarone HCL
    Dosage: 400 mg/day

Dilantin-125
    Indication: Electroencephalogram Abnormal

Other drugs received by patient: Potassium; Digoxin; Furosemide; Warfarin



Possible Dilantin-125 side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female

Reactions: Gingivitis

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: female

Reactions: Tubulointerstitial Nephritis, Hypersensitivity, Hepatitis, Stevens-Johnson Syndrome

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 79 year old female, weighing 45.4 kg (99.8 pounds)

Reactions: Drug Ineffective, Pain, Macular Degeneration

Drug(s) suspected as cause:
Aflibercept
    Dosage: unk
    Indication: Macular Degeneration
    Start date: 2012-07-01

Dilantin-125
    Dosage: 230 mg,daily
    Indication: Convulsion
    Start date: 1970-01-01

Keppra
    Dosage: 500 mg, 2x/day
    Indication: Convulsion

Ranibizumab
    Dosage: 1 mg, unk
    Indication: Macular Degeneration
    Start date: 2012-01-01

Other drugs received by patient: Synthroid



Possible Dilantin-125 side effects in

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient:

Reactions: Road Traffic Accident

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: male

Reactions: Convulsion

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: female

Reactions: Malaise, Rash

Drug(s) suspected as cause:
Dilantin-125
    Dosage: unk

Lyrica
    Dosage: unk



Possible Dilantin-125 side effects in

Reported by a lawyer from United States on 2012-07-31

Patient:

Reactions: Stevens-Johnson Syndrome

Drug(s) suspected as cause:
Dilantin-125



Possible Dilantin-125 side effects in

Reported by a lawyer from United States on 2012-07-31

Patient:

Reactions: Stevens-Johnson Syndrome

Drug(s) suspected as cause:
Dilantin-125

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