Drug information for GABITRIL

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 10MG Discontinued   TIAGABINE HYDROCHLORIDE tiagabine CEPHALON 20646
2012-01-30 Letter
2010-11-03 Other
2010-10-13 Letter
2010-10-13 Medication Guide
2010-10-11 Label
2010-01-07 Review
2009-05-12 Label
2009-05-04 Letter
2005-12-06 Letter
2005-12-05 Label
2005-04-15 Other Important Information from FDA
2005-04-15 Healthcare Professional Sheet
2005-02-17 Letter
2005-02-17 Label
TABLET; ORAL 12MG Prescription   TIAGABINE HYDROCHLORIDE tiagabine CEPHALON   "
TABLET; ORAL 16MG Prescription   TIAGABINE HYDROCHLORIDE tiagabine CEPHALON   "
TABLET; ORAL 20MG Discontinued   TIAGABINE HYDROCHLORIDE tiagabine CEPHALON   "
TABLET; ORAL 2MG Prescription AB  TIAGABINE HYDROCHLORIDE tiagabine CEPHALON   "
TABLET; ORAL 4MG Prescription AB (Reference Drug) TIAGABINE HYDROCHLORIDE tiagabine CEPHALON   "
TABLET; ORAL 6MG Discontinued   TIAGABINE HYDROCHLORIDE tiagabine CEPHALON   "
TABLET; ORAL 8MG Discontinued   TIAGABINE HYDROCHLORIDE tiagabine CEPHALON   "

Drug Adverse Effects information for GABITRIL

Role code Indications Reaction # Reports
PS COMPLEX PARTIAL SEIZURES BLOOD CREATINE PHOSPHOKINASE INCREASED 2
PS COMPLEX PARTIAL SEIZURES CONFUSIONAL STATE 2
PS COMPLEX PARTIAL SEIZURES CONVULSION 2
PS COMPLEX PARTIAL SEIZURES DIZZINESS 2
PS COMPLEX PARTIAL SEIZURES DRUG INEFFECTIVE 2
PS COMPLEX PARTIAL SEIZURES PETIT MAL EPILEPSY 1
PS CONVULSION AUTISM 1
PS CONVULSION CONVULSION 1
PS CONVULSION DYSPHEMIA 1
PS CONVULSION EUPHORIC MOOD 1
PS CONVULSION MYOCARDIAL INFARCTION 1
PS CONVULSION STATUS EPILEPTICUS 2
PS CONVULSION WEIGHT DECREASED 1
PS EPILEPSY STATUS EPILEPTICUS 1
PS INITIAL INSOMNIA FALL 1
PS INITIAL INSOMNIA LOWER LIMB FRACTURE 1
PS NEURALGIA BLOOD CREATINE PHOSPHOKINASE INCREASED 1
PS NEURALGIA CONFUSIONAL STATE 1
PS NEURALGIA CONVULSION 1
PS NEURALGIA DIZZINESS 1
PS NEURALGIA DRUG INEFFECTIVE 1
PS PAIN CONFUSIONAL STATE 4
PS PAIN LACERATION 4
PS PAIN LOSS OF CONSCIOUSNESS 4
PS PAIN SPEECH DISORDER 4
SS CONVULSION AUTISM 6
SS CONVULSION CONVULSION 6
SS CONVULSION DYSPHEMIA 6
SS CONVULSION EUPHORIC MOOD 6
SS CONVULSION HEAD INJURY 2
SS CONVULSION INCREASED APPETITE 2
SS CONVULSION LOGORRHOEA 2
SS CONVULSION LOSS OF CONSCIOUSNESS 2
SS CONVULSION POLLAKIURIA 2
SS CONVULSION PSYCHOMOTOR HYPERACTIVITY 2
SS CONVULSION WEIGHT DECREASED 6
SS DEPRESSION HEAD INJURY 4
SS DEPRESSION INCREASED APPETITE 4
SS DEPRESSION LOGORRHOEA 4
SS DEPRESSION LOSS OF CONSCIOUSNESS 4
SS DEPRESSION POLLAKIURIA 4
SS DEPRESSION PSYCHOMOTOR HYPERACTIVITY 4
SS EPILEPSY DRUG INEFFECTIVE 3
SS EPILEPSY MULTI-ORGAN FAILURE 3
SS EPILEPSY PNEUMONIA ASPIRATION 3
SS EPILEPSY STATUS EPILEPTICUS 3
SS INITIAL INSOMNIA FALL 1
SS INITIAL INSOMNIA LOWER LIMB FRACTURE 1
SS MAJOR DEPRESSION HEAD INJURY 4
SS MAJOR DEPRESSION INCREASED APPETITE 4
SS MAJOR DEPRESSION LOGORRHOEA 4
SS MAJOR DEPRESSION LOSS OF CONSCIOUSNESS 4
SS MAJOR DEPRESSION POLLAKIURIA 4
SS MAJOR DEPRESSION PSYCHOMOTOR HYPERACTIVITY 4
SS MATERNAL EXPOSURE DURING PREGNANCY CEREBELLAR HYPOPLASIA 1
SS MATERNAL EXPOSURE DURING PREGNANCY CONGENITAL FOOT MALFORMATION 1
SS MATERNAL EXPOSURE DURING PREGNANCY CONGENITAL HAND MALFORMATION 1
SS MATERNAL EXPOSURE DURING PREGNANCY DYSMORPHISM 1
SS MATERNAL EXPOSURE DURING PREGNANCY HEART DISEASE CONGENITAL 1
SS MATERNAL EXPOSURE DURING PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY 1
SS MOOD SWINGS HEAD INJURY 2
SS MOOD SWINGS INCREASED APPETITE 2
SS MOOD SWINGS LOGORRHOEA 2
SS MOOD SWINGS LOSS OF CONSCIOUSNESS 2
SS MOOD SWINGS POLLAKIURIA 2
SS MOOD SWINGS PSYCHOMOTOR HYPERACTIVITY 2
SS PAIN CONFUSIONAL STATE 16
SS PAIN HEAD INJURY 2
SS PAIN INCREASED APPETITE 2
SS PAIN LACERATION 16
SS PAIN LOGORRHOEA 2
SS PAIN LOSS OF CONSCIOUSNESS 18
SS PAIN POLLAKIURIA 2
SS PAIN PSYCHOMOTOR HYPERACTIVITY 2
SS PAIN SPEECH DISORDER 16
C OBSESSIVE-COMPULSIVE DISORDER DIABETIC NEPHROPATHY 2
C OBSESSIVE-COMPULSIVE DISORDER DIABETIC NEUROPATHY 2
C OBSESSIVE-COMPULSIVE DISORDER DIABETIC RETINOPATHY 2
C OBSESSIVE-COMPULSIVE DISORDER NEPHRITIS 2
C OBSESSIVE-COMPULSIVE DISORDER TYPE 2 DIABETES MELLITUS 2
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