Drug information for DILANTIN-125
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
SUSPENSION; ORAL
125MG/5ML
Prescription
AB (Reference Drug)
PHENYTOIN
Phenytoin
PARKE DAVIS
8762
2011-12-16 Medication Guide
2011-12-14 Label
2011-12-14 Label
2011-12-14 Label
2011-12-14 Label
2011-12-14 Label
2011-12-01 Letter
2011-12-01 Letter
2011-12-01 Letter
2011-12-01 Letter
2011-12-01 Letter
2011-05-31 Letter
2011-02-02 Other
2011-01-25 Medication Guide
2011-01-25 Label
2011-01-24 Letter
2009-04-29 Letter
2009-04-28 Label
2003-03-26 Letter
2001-11-20 Letter
2001-11-20 Letter
2001-11-20 Letter
2001-11-20 Letter
Drug Adverse Effects information for DILANTIN-125
Role code
Indications
Reaction
# Reports
PS
ANXIETY
DRUG HYPERSENSITIVITY
6
PS
ATRIAL FIBRILLATION
ACCIDENT
2
PS
ATRIAL FIBRILLATION
ANTICONVULSANT DRUG LEVEL ABNORMAL
2
PS
ATRIAL FIBRILLATION
CONVULSION
2
PS
ATRIAL FIBRILLATION
FATIGUE
2
PS
ATRIAL FIBRILLATION
SOMNOLENCE
2
PS
CONVULSION
ACCIDENT
2
PS
CONVULSION
ANTICONVULSANT DRUG LEVEL ABNORMAL
2
PS
CONVULSION
ANTICONVULSANT DRUG LEVEL DECREASED
4
PS
CONVULSION
ANTICONVULSANT DRUG LEVEL INCREASED
4
PS
CONVULSION
ANXIETY
1
PS
CONVULSION
AURICULAR SWELLING
1
PS
CONVULSION
CONVULSION
14
PS
CONVULSION
DRUG HYPERSENSITIVITY
2
PS
CONVULSION
DYSPNOEA
1
PS
CONVULSION
ENAMEL ANOMALY
6
PS
CONVULSION
ERYTHEMA
1
PS
CONVULSION
FATIGUE
2
PS
CONVULSION
GASTROINTESTINAL STROMAL TUMOUR
1
PS
CONVULSION
GINGIVAL DISORDER
6
PS
CONVULSION
HIP FRACTURE
1
PS
CONVULSION
HYPOACUSIS
2
PS
CONVULSION
INSOMNIA
1
PS
CONVULSION
MALAISE
2
PS
CONVULSION
MOOD SWINGS
1
PS
CONVULSION
NO ADVERSE EVENT
3
PS
CONVULSION
PANIC ATTACK
1
PS
CONVULSION
RASH
1
PS
CONVULSION
RASH GENERALISED
1
PS
CONVULSION
SOMNOLENCE
2
PS
CONVULSION
STEVENS-JOHNSON SYNDROME
4
PS
CONVULSION
SUICIDAL IDEATION
1
PS
CONVULSION
SWELLING
1
PS
CONVULSION
TOOTH EXTRACTION
6
PS
DEPRESSION
DRUG HYPERSENSITIVITY
4
PS
DIURETIC THERAPY
GASTROINTESTINAL STROMAL TUMOUR
2
PS
DIURETIC THERAPY
HIP FRACTURE
1
PS
DYSPNOEA
ACCIDENT
2
PS
DYSPNOEA
ANTICONVULSANT DRUG LEVEL ABNORMAL
2
PS
DYSPNOEA
CONVULSION
2
PS
DYSPNOEA
FATIGUE
2
PS
DYSPNOEA
SOMNOLENCE
2
PS
EPILEPSY
ANTICONVULSANT DRUG LEVEL DECREASED
1
PS
EPILEPSY
BURNING SENSATION
3
PS
EPILEPSY
CONVULSION
1
PS
EPILEPSY
FATIGUE
4
PS
EPILEPSY
GINGIVAL BLEEDING
3
PS
EPILEPSY
INJURY
1
PS
EPILEPSY
INSOMNIA
3
PS
EPILEPSY
IRRITABILITY
1
PS
EPILEPSY
LIP SWELLING
3
PS
EPILEPSY
MALABSORPTION
1
PS
EPILEPSY
NERVOUSNESS
1
PS
EPILEPSY
ORAL DISCOMFORT
3
PS
EPILEPSY
ORAL DISORDER
3
PS
EPILEPSY
OVERDOSE
3
PS
EPILEPSY
RASH
3
PS
EPILEPSY
SOMNOLENCE
1
PS
EPILEPSY
TOOTHACHE
3
PS
GASTRIC DISORDER
ACCIDENT
4
PS
GASTRIC DISORDER
ANTICONVULSANT DRUG LEVEL ABNORMAL
4
PS
GASTRIC DISORDER
CONVULSION
4
PS
GASTRIC DISORDER
FATIGUE
4
PS
GASTRIC DISORDER
SOMNOLENCE
4
PS
GRAND MAL CONVULSION
CONVULSION
1
PS
GRAND MAL CONVULSION
GRAND MAL CONVULSION
1
PS
GRAND MAL CONVULSION
MUSCLE DISORDER
1
PS
GRAND MAL CONVULSION
PYREXIA
1
PS
HYPERTENSION
AURICULAR SWELLING
1
PS
HYPERTENSION
ERYTHEMA
1
PS
HYPERTENSION
RASH GENERALISED
1
PS
HYPERTENSION
SWELLING
1
PS
INJURY
CONVULSION
6
PS
INJURY
ENAMEL ANOMALY
6
PS
INJURY
GINGIVAL DISORDER
6
PS
INJURY
TOOTH EXTRACTION
6
PS
INSOMNIA
DRUG HYPERSENSITIVITY
2
PS
MINERAL SUPPLEMENTATION
ACCIDENT
2
PS
MINERAL SUPPLEMENTATION
ANTICONVULSANT DRUG LEVEL ABNORMAL
2
PS
MINERAL SUPPLEMENTATION
CONVULSION
2
PS
MINERAL SUPPLEMENTATION
FATIGUE
2
PS
MINERAL SUPPLEMENTATION
SOMNOLENCE
2
PS
NAUSEA
DRUG HYPERSENSITIVITY
6
PS
PAIN
GASTROINTESTINAL STROMAL TUMOUR
2
PS
PAIN
HIP FRACTURE
1
PS
RHEUMATOID ARTHRITIS
ABNORMAL BEHAVIOUR
1
PS
RHEUMATOID ARTHRITIS
ACTIVITIES OF DAILY LIVING IMPAIRED
1
PS
RHEUMATOID ARTHRITIS
AMNESIA
1
PS
RHEUMATOID ARTHRITIS
APALLIC SYNDROME
1
PS
RHEUMATOID ARTHRITIS
APHASIA
1
PS
RHEUMATOID ARTHRITIS
BRAIN ABSCESS
1
PS
RHEUMATOID ARTHRITIS
CONFUSIONAL STATE
1
PS
RHEUMATOID ARTHRITIS
HEADACHE
1
PS
RHEUMATOID ARTHRITIS
IMPAIRED SELF-CARE
1
PS
RHEUMATOID ARTHRITIS
SINUSITIS
1
PS
RHEUMATOID ARTHRITIS
SPEECH DISORDER
1
PS
RHEUMATOID ARTHRITIS
UNEVALUABLE EVENT
1
PS
RHEUMATOID ARTHRITIS
WEIGHT INCREASED
1
PS
SLEEP DISORDER
DRUG HYPERSENSITIVITY
6
PS
SUPPLEMENTATION THERAPY
ABNORMAL BEHAVIOUR
2
PS
SUPPLEMENTATION THERAPY
ACTIVITIES OF DAILY LIVING IMPAIRED
2
PS
SUPPLEMENTATION THERAPY
AMNESIA
2
PS
SUPPLEMENTATION THERAPY
APALLIC SYNDROME
2
PS
SUPPLEMENTATION THERAPY
APHASIA
2
PS
SUPPLEMENTATION THERAPY
BRAIN ABSCESS
2
PS
SUPPLEMENTATION THERAPY
CONFUSIONAL STATE
2
PS
SUPPLEMENTATION THERAPY
HEADACHE
2
PS
SUPPLEMENTATION THERAPY
IMPAIRED SELF-CARE
2
PS
SUPPLEMENTATION THERAPY
SINUSITIS
2
PS
SUPPLEMENTATION THERAPY
SPEECH DISORDER
2
PS
SUPPLEMENTATION THERAPY
UNEVALUABLE EVENT
2
PS
SUPPLEMENTATION THERAPY
WEIGHT INCREASED
2
PS
TRIGEMINAL NEURALGIA
STEVENS-JOHNSON SYNDROME
2
PS
VOMITING
DRUG HYPERSENSITIVITY
6
SS
ATRIAL FIBRILLATION
ACCIDENT
6
SS
ATRIAL FIBRILLATION
ANTICONVULSANT DRUG LEVEL ABNORMAL
6
SS
ATRIAL FIBRILLATION
CONVULSION
6
SS
ATRIAL FIBRILLATION
FATIGUE
6
SS
ATRIAL FIBRILLATION
SOMNOLENCE
6
SS
CONVULSION
ACCIDENT
6
SS
CONVULSION
AMNESIA
2
SS
CONVULSION
ANTICONVULSANT DRUG LEVEL ABNORMAL
6
SS
CONVULSION
ANTICONVULSANT DRUG LEVEL DECREASED
4
SS
CONVULSION
ANXIETY
4
SS
CONVULSION
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
2
SS
CONVULSION
BLISTER
2
SS
CONVULSION
CHEST PAIN
2
SS
CONVULSION
CONVULSION
18
SS
CONVULSION
DRUG INEFFECTIVE
2
SS
CONVULSION
DRUG LEVEL BELOW THERAPEUTIC
2
SS
CONVULSION
DYSPNOEA
2
SS
CONVULSION
ENAMEL ANOMALY
6
SS
CONVULSION
FATIGUE
6
SS
CONVULSION
FINGER AMPUTATION
2
SS
CONVULSION
GASTROINTESTINAL STROMAL TUMOUR
1
SS
CONVULSION
GINGIVAL DISORDER
6
SS
CONVULSION
GRAND MAL CONVULSION
4
SS
CONVULSION
INSOMNIA
4
SS
CONVULSION
INSULIN TOLERANCE TEST ABNORMAL
2
SS
CONVULSION
JOINT DISLOCATION
2
SS
CONVULSION
MOOD SWINGS
4
SS
CONVULSION
PANIC ATTACK
4
SS
CONVULSION
SCAR
2
SS
CONVULSION
SKIN NECROSIS
2
SS
CONVULSION
SOFT TISSUE NECROSIS
2
SS
CONVULSION
SOMNOLENCE
6
SS
CONVULSION
STEVENS-JOHNSON SYNDROME
12
SS
CONVULSION
SUICIDAL IDEATION
4
SS
CONVULSION
TOOTH EXTRACTION
6
SS
CONVULSION
TOXIC EPIDERMAL NECROLYSIS
2
SS
CONVULSION
UNRESPONSIVE TO STIMULI
2
SS
DIURETIC THERAPY
GASTROINTESTINAL STROMAL TUMOUR
1
SS
DYSPNOEA
ACCIDENT
6
SS
DYSPNOEA
ANTICONVULSANT DRUG LEVEL ABNORMAL
6
SS
DYSPNOEA
CONVULSION
6
SS
DYSPNOEA
FATIGUE
6
SS
DYSPNOEA
SOMNOLENCE
6
SS
EPILEPSY
ANTICONVULSANT DRUG LEVEL DECREASED
1
SS
EPILEPSY
CONVULSION
1
SS
EPILEPSY
FATIGUE
1
SS
EPILEPSY
INJURY
1
SS
EPILEPSY
IRRITABILITY
1
SS
EPILEPSY
MALABSORPTION
1
SS
EPILEPSY
NERVOUSNESS
1
SS
EPILEPSY
SOMNOLENCE
1
SS
FIBROMYALGIA
HEADACHE
1
SS
FIBROMYALGIA
INSOMNIA
1
SS
GASTRIC DISORDER
ACCIDENT
12
SS
GASTRIC DISORDER
ANTICONVULSANT DRUG LEVEL ABNORMAL
12
SS
GASTRIC DISORDER
CONVULSION
12
SS
GASTRIC DISORDER
FATIGUE
12
SS
GASTRIC DISORDER
SOMNOLENCE
12
SS
INJURY
CONVULSION
6
SS
INJURY
ENAMEL ANOMALY
6
SS
INJURY
GINGIVAL DISORDER
6
SS
INJURY
TOOTH EXTRACTION
6
SS
MINERAL SUPPLEMENTATION
ACCIDENT
6
SS
MINERAL SUPPLEMENTATION
ANTICONVULSANT DRUG LEVEL ABNORMAL
6
SS
MINERAL SUPPLEMENTATION
CONVULSION
6
SS
MINERAL SUPPLEMENTATION
FATIGUE
6
SS
MINERAL SUPPLEMENTATION
SOMNOLENCE
6
SS
PAIN
GASTROINTESTINAL STROMAL TUMOUR
1
I
ATRIAL FIBRILLATION
ACCIDENT
4
I
ATRIAL FIBRILLATION
CONVULSION
4
I
ATRIAL FIBRILLATION
DRUG INTERACTION
4
I
ATRIAL FIBRILLATION
DRUG LEVEL FLUCTUATING
4
I
ATRIAL FIBRILLATION
FATIGUE
4
I
ATRIAL FIBRILLATION
SOMNOLENCE
4
I
BLOOD PRESSURE ABNORMAL
CONVULSION
1
I
BLOOD PRESSURE ABNORMAL
DRUG INTERACTION
1
I
BLOOD PRESSURE ABNORMAL
SERUM SEROTONIN DECREASED
1
I
CONVULSION
ACCIDENT
4
I
CONVULSION
CONVULSION
5
I
CONVULSION
DRUG INTERACTION
5
I
CONVULSION
DRUG LEVEL FLUCTUATING
4
I
CONVULSION
FATIGUE
4
I
CONVULSION
SERUM SEROTONIN DECREASED
1
I
CONVULSION
SOMNOLENCE
4
I
DEEP VEIN THROMBOSIS
ANTICONVULSANT DRUG LEVEL DECREASED
2
I
DEEP VEIN THROMBOSIS
DRUG INTERACTION
2
I
DEEP VEIN THROMBOSIS
EAR INFECTION
2
I
DEEP VEIN THROMBOSIS
STATUS EPILEPTICUS
2
I
DIURETIC THERAPY
CONVULSION
1
I
DIURETIC THERAPY
DRUG INTERACTION
1
I
DIURETIC THERAPY
SERUM SEROTONIN DECREASED
1
I
DYSPNOEA
ACCIDENT
4
I
DYSPNOEA
CONVULSION
4
I
DYSPNOEA
DRUG INTERACTION
4
I
DYSPNOEA
DRUG LEVEL FLUCTUATING
4
I
DYSPNOEA
FATIGUE
4
I
DYSPNOEA
SOMNOLENCE
4
I
EAR INFECTION
ANTICONVULSANT DRUG LEVEL DECREASED
2
I
EAR INFECTION
DRUG INTERACTION
2
I
EAR INFECTION
EAR INFECTION
2
I
EAR INFECTION
STATUS EPILEPTICUS
2
I
EPILEPSY
ANTICONVULSANT DRUG LEVEL DECREASED
2
I
EPILEPSY
DRUG INTERACTION
2
I
EPILEPSY
EAR INFECTION
2
I
EPILEPSY
STATUS EPILEPTICUS
2
I
GASTRIC DISORDER
ACCIDENT
8
I
GASTRIC DISORDER
CONVULSION
8
I
GASTRIC DISORDER
DRUG INTERACTION
8
I
GASTRIC DISORDER
DRUG LEVEL FLUCTUATING
8
I
GASTRIC DISORDER
FATIGUE
8
I
GASTRIC DISORDER
SOMNOLENCE
8
I
GASTROINTESTINAL PAIN
CONVULSION
1
I
GASTROINTESTINAL PAIN
DRUG INTERACTION
1
I
GASTROINTESTINAL PAIN
SERUM SEROTONIN DECREASED
1
I
MINERAL SUPPLEMENTATION
ACCIDENT
4
I
MINERAL SUPPLEMENTATION
CONVULSION
4
I
MINERAL SUPPLEMENTATION
DRUG INTERACTION
4
I
MINERAL SUPPLEMENTATION
DRUG LEVEL FLUCTUATING
4
I
MINERAL SUPPLEMENTATION
FATIGUE
4
I
MINERAL SUPPLEMENTATION
SOMNOLENCE
4
I
PAIN
CONVULSION
1
I
PAIN
DRUG INTERACTION
1
I
PAIN
SERUM SEROTONIN DECREASED
1
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