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Dilantin (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 (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 (761)
Death (37)
Life Threatening Events (11)
Disability (43)

Reports by Reaction Type

Convulsion (190)Stevens-Johnson Syndrome (147)Drug Ineffective (43)Amnesia (41)Anticonvulsant Drug Level Decreased (40)Dizziness (39)Headache (37)Anticonvulsant Drug Level Increased (36)Malaise (33)Pain (31)Fall (30)Tremor (26)

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

Possible Dilantin side effects in 38 year old male

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

Patient: 38 year old male, weighing 98.4 kg (216.5 pounds)

Reactions: Weight Decreased, Pain, Hepatic Failure, Headache, Somnolence, Myalgia, Weight Increased, Overdose, Malaise, Fatigue, Musculoskeletal Stiffness, Depression, Swelling, Nervous System Disorder, Feeling Abnormal, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilantin
    Dosage: unk
    Indication: Convulsion

Ibuprofen
    Dosage: 4000 mg in a day
    Indication: Headache

Lyrica
    Dosage: 300 mg, 3x/day
    Administration route: Oral
    Indication: Convulsion

Lyrica
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Start date: 2012-06-01

Lyrica
    Dosage: 300 mg, 2x/day
    Administration route: Oral
    End date: 2012-06-01

Other drugs received by patient: Morphine; Hydrocodone; Lamictal; Butalbital



Possible Dilantin side effects in 64 year old male

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

Patient: 64 year old male, weighing 83.0 kg (182.6 pounds)

Reactions: Drug Dose Omission, Drug Ineffective, Convulsion

Drug(s) suspected as cause:
Depakote
    Dosage: 500 mg, 2x/day
    Indication: Epilepsy

Dilantin
    Dosage: 100 mg, unk

Dilantin
    Dosage: 100 mg, 3x/day
    Indication: Epilepsy

Phenytoin Sodium
    Dosage: unk



Possible Dilantin side effects in 54 year old female

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

Patient: 54 year old female

Reactions: Capsule Physical Issue, Poor Quality Drug Administered, Feeling Abnormal

Drug(s) suspected as cause:
Dilantin
    Dosage: unk
    Administration route: Oral

Dilantin
    Dosage: 100 mg, unk
    Administration route: Oral
    Indication: Convulsion
    Start date: 1981-01-01

Other drugs received by patient: Depakene



Possible Dilantin side effects in 21 year old female

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

Patient: 21 year old female, weighing 59.0 kg (129.8 pounds)

Reactions: Abortion Spontaneous

Drug(s) suspected as cause:
Dilantin



Possible Dilantin 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 side effects in 32 year old female

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

Patient: 32 year old female, weighing 58.9 kg (129.6 pounds)

Reactions: Abortion Spontaneous

Drug(s) suspected as cause:
Dilantin



Possible Dilantin 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 Dilantin side effects in female

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

Patient: female

Reactions: Dental Discomfort

Drug(s) suspected as cause:
Dilantin



Possible Dilantin side effects in male

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

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Dilantin
    Dosage: 2 capsules of 100 mg in the morning and 3 capsules of 100 mg in the evening(2x/day)
    Administration route: Oral
    Indication: Convulsion
    Start date: 2008-01-01

Keppra
    Dosage: unk
    Indication: Convulsion
    Start date: 2007-01-01
    End date: 2012-02-02



Possible Dilantin side effects in 48 year old female

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

Patient: 48 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Carotid Artery Thrombosis, Blood Cholesterol Increased

Drug(s) suspected as cause:
Dilantin



Possible Dilantin side effects in 26 year old female

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

Patient: 26 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Abortion Spontaneous

Drug(s) suspected as cause:
Dilantin



Possible Dilantin side effects in

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

Patient:

Reactions: Bedridden, Emphysema, Off Label Use, Lung Disorder, Amnesia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aspirin
    Dosage: 81 mg, prn
    Indication: Chest Pain

Atenolol
    Dosage: 25 mg, qd
    Administration route: Oral
    Indication: Hypertension

Ativan
    Dosage: 1 mg, tid
    Administration route: Oral
    Indication: Nervousness

Atropine Sulfate
    Dosage: 2.5 mg, qid
    Administration route: Oral
    Indication: Crohn's Disease

Depakote
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Convulsion

Dilantin
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Convulsion

Furosemide
    Dosage: 40 mg, bid
    Administration route: Oral
    Indication: Diuretic Therapy

Generlac
    Dosage: 30 mg, prn
    Indication: Crohn's Disease

Humulin R
    Dosage: 24 units
    Indication: Diabetes Mellitus

Imdur
    Dosage: 30 mg, tid
    Indication: Cardiac Disorder

Lantus
    Dosage: 80 units in the moring and 90 units at night
    Indication: Diabetes Mellitus

Lantus
    Dosage: unk

Methocarbamol
    Indication: Neuropathy Peripheral

Methocarbamol
    Dosage: 750 mg, prn
    Administration route: Oral
    Indication: Muscle Spasms

Nitrostat
    Dosage: 0.4 mg, prn
    Indication: Chest Pain

Norvasc
    Administration route: Oral
    Indication: Palpitations

Potassium Chloride

Potassium Chloride (KV / 24)
    Dosage: 8 meq, qd
    Indication: Blood Potassium

Remeron
    Dosage: 30 mg, qd
    Administration route: Oral
    Indication: Insomnia

Tylenol
    Dosage: unk unk, qd
    Indication: Migraine

Zantac
    Dosage: 30 mg, tid
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Zocor
    Dosage: 40 mg, qd
    Administration route: Oral



Possible Dilantin side effects in 56 year old male

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

Patient: 56 year old male, weighing 90.7 kg (199.5 pounds)

Reactions: Drug Ineffective, Mental Disability, Depression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilantin

Other drugs received by patient: Carvedilol



Possible Dilantin side effects in female

Reported by a pharmacist from Canada on 2012-08-23

Patient: female

Reactions: Drug Level Fluctuating, Wrong Technique in Drug Usage Process, Incorrect Dose Administered, Convulsion

Drug(s) suspected as cause:
Dilantin



Possible Dilantin side effects in 36 year old female

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

Patient: 36 year old female, weighing 61.2 kg (134.7 pounds)

Reactions: Speech Disorder, Pain, Nervous System Disorder, Memory Impairment, Epilepsy

Drug(s) suspected as cause:
Depakote
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2009-01-01

Dilantin
    Dosage: 200mg in morning and 300mg at night
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2011-01-15

Neurontin

Neurontin
    Dosage: unk, 3x/day
    Administration route: Oral
    Start date: 2003-01-01

Neurontin
    Indication: Migraine

Neurontin
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Indication: Nerve Injury
    Start date: 2007-01-01

Other drugs received by patient: Percocet; Topamax; Amitriptyline; Amitriptyline; Estradiol



Possible Dilantin side effects in

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

Patient:

Reactions: Bedridden, Emphysema, Amnesia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aspirin

Atenolol
    Administration route: Oral

Ativan
    Administration route: Oral

Depakote
    Administration route: Oral

Dilantin
    Administration route: Oral

Furosemide
    Administration route: Oral

Generlac

Humulin R

Isosorbide Mononitrate

Lantus
    Dosage: 80 iu, qam

Lantus
    Dosage: 90 df, qpm

Lomotil
    Administration route: Oral

Methocarbamol
    Administration route: Oral

Nitrostat

Norvasc
    Administration route: Oral

Potassium Chloride

Remeron
    Administration route: Oral

Tylenol W / Codeine NO. 3

Zantac

Zocor
    Administration route: Oral



Possible Dilantin side effects in

Reported by a physician from India on 2012-08-22

Patient:

Reactions: Drug Ineffective, Anticonvulsant Drug Level Decreased, Ataxia

Drug(s) suspected as cause:
Dilantin
    Dosage: 1 ml, 2x/day
    Administration route: Oral
    Indication: Convulsion
    Start date: 2012-01-01

Phenytoin Sodium
    Indication: Convulsion



Possible Dilantin side effects in female

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

Patient: female, weighing 95.3 kg (209.7 pounds)

Reactions: Adverse Drug Reaction, Headache, Toxicity To Various Agents, Drug Level, Stress, Convulsion, Emotional Distress, Depressed Level of Consciousness, Bronchitis, Cervix Carcinoma, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilantin
    Indication: Convulsion
    End date: 2011-01-01

Klonopin
    Administration route: Oral
    Indication: Convulsion

Other drugs received by patient: Excedrin (United States); Laxatives (Unk Ingredients); Albuterol; Nexium; Bentyl; Bentyl; Phenergan HCL; Bentyl; Bentyl; Phenergan HCL; Nexium; Symbicort; Benadryl



Possible Dilantin 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 Dilantin side effects in 39 year old female

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

Patient: 39 year old female, weighing 61.0 kg (134.2 pounds)

Reactions: Pain, Convulsion

Drug(s) suspected as cause:
Dilantin
    Dosage: 200mg in morning and 300mg at night chewable tablets in a day
    Administration route: Oral
    Indication: Convulsion
    Start date: 2011-01-01

Dilantin
    Indication: Epilepsy

Neurontin
    Dosage: unk, 3x/day
    Administration route: Oral
    Indication: Nerve Injury
    Start date: 2003-01-01

Neurontin
    Indication: Migraine

Other drugs received by patient: Topamax; Estradiol; Topamax; Amitriptyline



Possible Dilantin side effects in 62 year old male

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

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
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Ill-Defined Disorder

Dilantin Kapseal
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Convulsion

Dilantin Kapseal
    Indication: Epilepsy

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



Possible Dilantin side effects in 10 year old female

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

Patient: 10 year old female

Reactions: Toxicity To Various Agents

Drug(s) suspected as cause:
Dilantin



Possible Dilantin side effects in male

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

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Dilantin
    Dosage: 2 capsules of 100 mg in the morning and 3 capsules of 100 mg in the evening(2x/day)
    Administration route: Oral
    Indication: Convulsion
    Start date: 2008-01-01

Keppra
    Dosage: unk
    Indication: Convulsion
    Start date: 2007-01-01
    End date: 2012-02-02



Possible Dilantin side effects in 74 year old female

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

Patient: 74 year old female, weighing 119.0 kg (261.8 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Dilantin

Other drugs received by patient: Synthroid



Possible Dilantin side effects in 47 year old male

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

Patient: 47 year old male, weighing 71.2 kg (156.6 pounds)

Reactions: Accident, Drug Level Increased, Pain, Injury, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilantin
    Dosage: 100 mg, 4x/day
    Administration route: Oral

Dilantin
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Indication: Convulsion

Keppra
    Dosage: 250 mg, 2x/day
    Indication: Convulsion
    Start date: 2012-01-01



Possible Dilantin side effects in 49 year old female

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

Patient: 49 year old female, weighing 81.0 kg (178.2 pounds)

Reactions: Dermatitis Allergic, Cellulitis, Eye Irritation, Conjunctivitis, Pain, Toxic Epidermal Necrolysis, Death, Eye Swelling, Stevens-Johnson Syndrome, Deep Vein Thrombosis, Blister

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Dilantin
    Dosage: unk
    Administration route: Oral
    Start date: 2007-03-01
    End date: 2007-05-01

Dilantin
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Start date: 2007-03-14
    End date: 2007-03-29

Other drugs received by patient: Vinblastine; Cisplatin; Temodar



Possible Dilantin side effects in male

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

Patient: male, weighing 71.2 kg (156.6 pounds)

Reactions: Headache, Hypoaesthesia, Malaise, Palpitations, Anticonvulsant Drug Level Increased, Pollakiuria, Compulsive LIP Biting, Feeling Abnormal

Drug(s) suspected as cause:
Dilantin
    Dosage: 100 mg, unk
    Administration route: Oral

Dilantin
    Dosage: 100 mg, 4x/day
    Administration route: Oral

Dilantin
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Indication: Convulsion



Possible Dilantin side effects in 41 year old female

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

Patient: 41 year old female

Reactions: Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilantin
    Dosage: 300 mg, 1x/day at bed time
    Administration route: Oral
    Indication: Convulsion
    Start date: 2008-12-28

Dilantin
    Dosage: 300 mg, at bedtime
    Administration route: Oral
    Start date: 2009-01-24

Dilantin
    Dosage: 300 mg, (100mg capsule orally in the morning and 100mg 2 capsules at bed time)
    Administration route: Oral
    Start date: 2009-01-03

Dilantin
    Dosage: 100 mg, unk
    Administration route: Oral
    Start date: 2009-01-02

Dilantin
    Dosage: 1000 mg, unk
    Start date: 2009-01-03



Possible Dilantin side effects in 34 year old male

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

Patient: 34 year old male, weighing 124.0 kg (272.8 pounds)

Reactions: Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilantin
    Dosage: 200 mg, 2x/day
    Indication: Convulsion Prophylaxis
    Start date: 2011-01-20
    End date: 2011-01-20

Dilantin
    Dosage: 500 mg, unk
    Administration route: Oral
    Start date: 2011-01-24
    End date: 2011-01-24

Dilantin
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Start date: 2011-01-21
    End date: 2011-01-26

Dilantin
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Start date: 2011-01-27
    End date: 2011-02-10

Other drugs received by patient: Benadryl; Insulin; Decadron Phosphate; Prilosec; Protonix; Hydromorphone; Vancomycin; Morphine; Tylenol; Maxipime; Paxil; Norco; Hydroxyzine



Possible Dilantin side effects in 54 year old male

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

Patient: 54 year old male

Reactions: Convulsion

Drug(s) suspected as cause:
Dilantin

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