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Phenytek (Phenytoin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Phenytek (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 (8)
Life Threatening Events (1)
Disability (1)

Reports by Reaction Type

Loss of Consciousness (5)Convulsion (5)Balance Disorder (4)Dyspnoea (4)Dizziness (3)Drug Level Fluctuating (2)Fatigue (2)Coordination Abnormal (2)Back Pain (2)Pain in Extremity (2)Amnesia (2)Product Substitution Issue (1)

Possible Phenytek side effects in 41 year old female

Reported by a pharmacist from United States on 2012-05-31

Patient: 41 year old female

Reactions: Drug Ineffective, Anticonvulsant Drug Level Decreased, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Phenytek
    Administration route: Oral
    Indication: Convulsion

Dilantin
    Administration route: Oral
    Indication: Convulsion

Other drugs received by patient: Calcium



Possible Phenytek side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-27

Patient: male, weighing 74.8 kg (164.6 pounds)

Reactions: Back Pain, Dyspnoea, Pain in Extremity, Amnesia, Convulsion, Loss of Consciousness, Drug Level Fluctuating, Fatigue, Balance Disorder, Dizziness, Coordination Abnormal

Drug(s) suspected as cause:
Dilantin
    Dosage: 500 mg, unk
    Indication: Convulsion
    Start date: 1998-01-01

Dilantin
    Dosage: 50 mg

Dilantin
    Dosage: unk
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1998-01-01

Phenytek
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1998-01-01



Possible Phenytek side effects in male

Reported by a physician from United States on 2012-01-26

Patient: male, weighing 74.8 kg (164.6 pounds)

Reactions: Back Pain, Dyspnoea, Pain in Extremity, Amnesia, Loss of Consciousness, Convulsion, Drug Level Fluctuating, Fatigue, Balance Disorder, Dizziness, Coordination Abnormal

Drug(s) suspected as cause:
Dilantin
    Dosage: 500 mg, unk
    Indication: Convulsion
    Start date: 1998-01-01

Dilantin
    Dosage: 50 mg

Phenytek
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1998-01-01

Dilantin
    Dosage: unk
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1998-01-01



Possible Phenytek side effects in 73 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-11

Patient: 73 year old male, weighing 62.6 kg (137.7 pounds)

Reactions: Anticonvulsant Drug Level Increased, Gait Disturbance, Fall

Drug(s) suspected as cause:
Prozac
    Dosage: 20mg po qd
    Administration route: Oral
    Indication: Major Depression
    Start date: 2010-06-04

Phenytek
    Dosage: 200mg po bid
    Administration route: Oral
    Indication: Convulsion



Possible Phenytek side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-27

Patient: male, weighing 74.8 kg (164.6 pounds)

Reactions: Dyspnoea, Balance Disorder, Convulsion, Loss of Consciousness

Drug(s) suspected as cause:
Dilantin
    Dosage: unk
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1998-01-01

Dilantin
    Dosage: 50 mg

Dilantin
    Dosage: 500 mg, unk
    Indication: Convulsion
    Start date: 1998-01-01

Phenytek
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1998-01-01



Possible Phenytek side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-14

Patient: male, weighing 74.8 kg (164.6 pounds)

Reactions: Dyspnoea, Balance Disorder, Convulsion, Loss of Consciousness

Drug(s) suspected as cause:
Dilantin
    Dosage: 500 mg
    Indication: Convulsion
    Start date: 1998-01-01

Dilantin
    Dosage: unk
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1998-01-01

Phenytek
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1998-01-01



Possible Phenytek side effects in female

Reported by a consumer/non-health professional from United States on 2011-10-13

Patient: female

Reactions: Subdural Haematoma, Cerebral Haemorrhage

Drug(s) suspected as cause:
Phenytek



Possible Phenytek side effects in 47 year old male

Reported by a consumer/non-health professional from United States on 2011-10-11

Patient: 47 year old male, weighing 70.3 kg (154.7 pounds)

Reactions: Product Substitution Issue, Cervical Vertebral Fracture, Product Measured Potency Issue, Dizziness, Reaction To Drug Excipients, Toxicity To Various Agents, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Phenytek

Other drugs received by patient: Phenytek

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