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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