Drug information for TRANXENE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL 15MG Discontinued   CLORAZEPATE DIPOTASSIUM Clorazepate Dipotassium LUNDBECK LLC 17105
2011-07-21 Letter
2010-06-30 Other
2010-06-24 Medication Guide
2010-06-15 Letter
2010-06-14 Label
2009-04-29 Letter
2009-04-28 Label
2007-07-09 Review
2007-07-09 Review
2006-10-25 Review
2003-03-26 Letter
2002-02-07 Letter
2002-02-07 Letter
CAPSULE; ORAL 3.75MG Discontinued   CLORAZEPATE DIPOTASSIUM Clorazepate Dipotassium LUNDBECK LLC   "
CAPSULE; ORAL 7.5MG Discontinued   CLORAZEPATE DIPOTASSIUM Clorazepate Dipotassium LUNDBECK LLC   "
TABLET; ORAL 15MG Prescription AB (Reference Drug) CLORAZEPATE DIPOTASSIUM Clorazepate Dipotassium LUNDBECK LLC   "
TABLET; ORAL 3.75MG Prescription AB  CLORAZEPATE DIPOTASSIUM Clorazepate Dipotassium LUNDBECK LLC   "
TABLET; ORAL 7.5MG Prescription AB  CLORAZEPATE DIPOTASSIUM Clorazepate Dipotassium LUNDBECK LLC   "

Drug Adverse Effects information for TRANXENE

Role code Indications Reaction # Reports
PS BIPOLAR DISORDER AGITATION 3
PS BIPOLAR DISORDER CARDIO-RESPIRATORY ARREST 3
PS BIPOLAR DISORDER CYANOSIS 3
PS BIPOLAR DISORDER HYPOMANIA 3
PS BIPOLAR DISORDER WOUND 3
PS PRODUCT USED FOR UNKNOWN INDICATION AGITATION 2
PS PRODUCT USED FOR UNKNOWN INDICATION CARDIO-RESPIRATORY ARREST 2
PS PRODUCT USED FOR UNKNOWN INDICATION CYANOSIS 2
PS PRODUCT USED FOR UNKNOWN INDICATION HYPOMANIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION WOUND 2
SS ANXIETY OFF LABEL USE 1
SS ANXIETY RESPIRATORY DISTRESS 1
SS BIPOLAR DISORDER CARDIO-RESPIRATORY ARREST 5
SS DEPRESSION ANXIETY 10
SS DEPRESSION BIPOLAR DISORDER 3
SS DEPRESSION BULIMIA NERVOSA 3
SS DEPRESSION COMA 10
SS DEPRESSION COMPLETED SUICIDE 7
SS DEPRESSION DISCOMFORT 10
SS DEPRESSION EUPHORIC MOOD 10
SS DEPRESSION HEAD BANGING 3
SS DEPRESSION INCORRECT DOSE ADMINISTERED 7
SS DEPRESSION INTENTIONAL SELF-INJURY 3
SS DEPRESSION MALAISE 3
SS DEPRESSION MEDICATION ERROR 3
SS DEPRESSION NO THERAPEUTIC RESPONSE 3
SS DEPRESSION SUICIDE ATTEMPT 3
SS DIABETES MELLITUS BLOOD CREATININE INCREASED 1
SS DIABETES MELLITUS FALL 1
SS DIABETES MELLITUS GAIT DISTURBANCE 1
SS DIABETES MELLITUS HYPERGLYCAEMIA 1
SS DIABETES MELLITUS MUSCULAR WEAKNESS 1
SS DIABETES MELLITUS OVERDOSE 1
SS DIABETES MELLITUS SOMNOLENCE 1
SS FOETAL EXPOSURE TIMING UNSPECIFIED BRADYCARDIA NEONATAL 3
SS FOETAL EXPOSURE TIMING UNSPECIFIED CAESAREAN SECTION 3
SS FOETAL EXPOSURE TIMING UNSPECIFIED FOETAL HYPOKINESIA 3
SS FOETAL EXPOSURE TIMING UNSPECIFIED FOETAL MALNUTRITION 3
SS FOETAL EXPOSURE TIMING UNSPECIFIED HYPOCALCAEMIA 3
SS FOETAL EXPOSURE TIMING UNSPECIFIED HYPOGLYCAEMIA NEONATAL 3
SS FOETAL EXPOSURE TIMING UNSPECIFIED HYPOTONIA NEONATAL 3
SS FOETAL EXPOSURE TIMING UNSPECIFIED MALAISE 3
SS FOETAL EXPOSURE TIMING UNSPECIFIED MATERNAL DRUGS AFFECTING FOETUS 3
SS FOETAL EXPOSURE TIMING UNSPECIFIED OXYGEN SATURATION DECREASED 3
SS FOETAL EXPOSURE TIMING UNSPECIFIED PREMATURE BABY 3
SS PAIN OFF LABEL USE 2
SS PAIN RESPIRATORY DISTRESS 2
SS PRODUCT USED FOR UNKNOWN INDICATION BLOOD CREATININE INCREASED 14
SS PRODUCT USED FOR UNKNOWN INDICATION CARDIO-RESPIRATORY ARREST 2
SS PRODUCT USED FOR UNKNOWN INDICATION FALL 14
SS PRODUCT USED FOR UNKNOWN INDICATION GAIT DISTURBANCE 14
SS PRODUCT USED FOR UNKNOWN INDICATION HYPERGLYCAEMIA 14
SS PRODUCT USED FOR UNKNOWN INDICATION MUSCULAR WEAKNESS 14
SS PRODUCT USED FOR UNKNOWN INDICATION OVERDOSE 14
SS PRODUCT USED FOR UNKNOWN INDICATION SOMNOLENCE 14
SS RESTLESSNESS CARDIO-RESPIRATORY ARREST 2
SS SCHIZOPHRENIA ISCHAEMIC STROKE 5
C ACUTE MYELOID LEUKAEMIA OESOPHAGEAL HAEMORRHAGE 3
C ACUTE MYELOID LEUKAEMIA SEPTIC SHOCK 3
C AGITATION DEVICE RELATED INFECTION 1
C AGITATION ENTEROBACTER INFECTION 1
C AGITATION FALL 1
C AGITATION HIP FRACTURE 1
C AGITATION LEUKOCYTOSIS 1
C ANAEMIA DEVICE RELATED INFECTION 1
C ANAEMIA ENTEROBACTER INFECTION 1
C ANAEMIA FALL 1
C ANAEMIA HIP FRACTURE 1
C ANAEMIA LEUKOCYTOSIS 1
C ANALGESIC THERAPY ANAPHYLACTIC SHOCK 1
C ANTIFUNGAL PROPHYLAXIS OESOPHAGEAL HAEMORRHAGE 1
C ANTIFUNGAL PROPHYLAXIS SEPTIC SHOCK 1
C ANXIETY DELUSION 1
C ANXIETY OESOPHAGEAL HAEMORRHAGE 1
C ANXIETY SEPTIC SHOCK 2
C ANXIETY SUICIDE ATTEMPT 1
C BIPOLAR I DISORDER DELUSION 2
C BIPOLAR I DISORDER SEPTIC SHOCK 2
C BIPOLAR I DISORDER SUICIDE ATTEMPT 2
C CHEMOTHERAPY DRUG INEFFECTIVE 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE DYSPNOEA 1
C CONSTIPATION DEVICE RELATED INFECTION 1
C CONSTIPATION ENTEROBACTER INFECTION 1
C CONSTIPATION FALL 1
C CONSTIPATION HIP FRACTURE 1
C CONSTIPATION LEUKOCYTOSIS 1
C DELUSION DELUSION 1
C DELUSION SEPTIC SHOCK 1
C DELUSION SUICIDE ATTEMPT 1
C DEPRESSION ATRIAL SEPTAL DEFECT 1
C DEPRESSION DEVICE RELATED INFECTION 2
C DEPRESSION ENTEROBACTER INFECTION 2
C DEPRESSION FALL 2
C DEPRESSION FOETAL EXPOSURE DURING PREGNANCY 1
C DEPRESSION HIP FRACTURE 2
C DEPRESSION LEUKOCYTOSIS 2
C DEPRESSION PATENT DUCTUS ARTERIOSUS 1
C DEPRESSION PULMONARY ARTERY STENOSIS CONGENITAL 1
C DEPRESSION VENTRICULAR SEPTAL DEFECT 1
C DIABETES MELLITUS ANAEMIA 3
C DIABETES MELLITUS ANGIOPLASTY 3
C DIABETES MELLITUS ARRHYTHMIA 3
C DIABETES MELLITUS BACK PAIN 3
C DIABETES MELLITUS CARDIAC ASSISTANCE DEVICE USER 3
C DIABETES MELLITUS CARDIAC FAILURE CONGESTIVE 3
C DIABETES MELLITUS CORONARY ARTERY DISEASE 3
C DIABETES MELLITUS ELECTROCARDIOGRAM ABNORMAL 3
C DIABETES MELLITUS HYPERLIPIDAEMIA 3
C DIABETES MELLITUS HYPERTENSION 3
C DIABETES MELLITUS HYPOXIA 3
C DIABETES MELLITUS IMPLANTABLE DEFIBRILLATOR INSERTION 3
C DIABETES MELLITUS MOVEMENT DISORDER 3
C DIABETES MELLITUS MUSCULAR WEAKNESS 3
C DIABETES MELLITUS PAIN 3
C DIABETES MELLITUS VISION BLURRED 3
C DRUG DEPENDENCE CONVULSION 1
C DRUG DEPENDENCE DRUG WITHDRAWAL SYNDROME 1
C DRUG DEPENDENCE FALL 1
C DYSKINESIA HYPERTHERMIA 1
C DYSKINESIA LEUKOCYTOSIS 1
C ENDOMETRIAL CANCER DRUG INEFFECTIVE 8
C EPILEPSY DIPLOPIA 1
C EPILEPSY HYPERTHERMIA 1
C EPILEPSY LEUKOCYTOSIS 1
C EPILEPSY OSTEOPOROSIS 1
C FACTOR VIII DEFICIENCY DEVICE RELATED INFECTION 1
C FACTOR VIII DEFICIENCY ENTEROBACTER INFECTION 1
C FACTOR VIII DEFICIENCY FALL 1
C FACTOR VIII DEFICIENCY HIP FRACTURE 1
C FACTOR VIII DEFICIENCY LEUKOCYTOSIS 1
C FACTOR VIII INHIBITION DEVICE RELATED INFECTION 5
C FACTOR VIII INHIBITION ENTEROBACTER INFECTION 5
C FACTOR VIII INHIBITION FALL 5
C FACTOR VIII INHIBITION HIP FRACTURE 5
C FACTOR VIII INHIBITION LEUKOCYTOSIS 5
C FEBRILE NEUTROPENIA OESOPHAGEAL HAEMORRHAGE 1
C FEBRILE NEUTROPENIA SEPTIC SHOCK 1
C GASTROOESOPHAGEAL REFLUX DISEASE DYSGEUSIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE HOT FLUSH 1
C GASTROOESOPHAGEAL REFLUX DISEASE MALAISE 1
C GASTROOESOPHAGEAL REFLUX DISEASE THROMBOSIS 1
C HEPATITIS C RHABDOMYOLYSIS 1
C HICCUPS OESOPHAGEAL HAEMORRHAGE 2
C HICCUPS SEPTIC SHOCK 2
C HYPERKALAEMIA DEVICE RELATED INFECTION 1
C HYPERKALAEMIA ENTEROBACTER INFECTION 1
C HYPERKALAEMIA FALL 1
C HYPERKALAEMIA HIP FRACTURE 1
C HYPERKALAEMIA LEUKOCYTOSIS 1
C INFECTION AGITATION 2
C INFECTION CONFUSIONAL STATE 2
C INFECTION SCREAMING 2
C INFECTION PROPHYLAXIS DEVICE RELATED INFECTION 1
C INFECTION PROPHYLAXIS ENTEROBACTER INFECTION 1
C INFECTION PROPHYLAXIS FALL 1
C INFECTION PROPHYLAXIS HIP FRACTURE 1
C INFECTION PROPHYLAXIS LEUKOCYTOSIS 1
C LYMPHOCYTIC LYMPHOMA BLOOD DISORDER 1
C LYMPHOCYTIC LYMPHOMA DEAFNESS 1
C LYMPHOCYTIC LYMPHOMA PYREXIA 1
C LYMPHOCYTIC LYMPHOMA TINNITUS 1
C LYMPHOCYTIC LYMPHOMA TOXIC SKIN ERUPTION 1
C MENINGITIS OVERDOSE 2
C MENINGITIS RENAL FAILURE ACUTE 2
C MENORRHAGIA ABDOMINAL DISTENSION 2
C MENORRHAGIA ABDOMINAL PAIN 2
C MENORRHAGIA ANXIETY 2
C MENORRHAGIA CHOLECYSTITIS CHRONIC 2
C MENORRHAGIA CONSTIPATION 2
C MENORRHAGIA DEPRESSION 2
C MENORRHAGIA DIARRHOEA 2
C MENORRHAGIA DYSPEPSIA 2
C MENORRHAGIA FLATULENCE 2
C MENORRHAGIA GALLBLADDER DISORDER 2
C MENORRHAGIA INFECTIOUS MONONUCLEOSIS 2
C MENORRHAGIA SCAR 2
C MENORRHAGIA SUTURE RELATED COMPLICATION 2
C MENSTRUAL CYCLE MANAGEMENT ABDOMINAL DISTENSION 2
C MENSTRUAL CYCLE MANAGEMENT ABDOMINAL PAIN 2
C MENSTRUAL CYCLE MANAGEMENT ANXIETY 2
C MENSTRUAL CYCLE MANAGEMENT CHOLECYSTITIS CHRONIC 2
C MENSTRUAL CYCLE MANAGEMENT CONSTIPATION 2
C MENSTRUAL CYCLE MANAGEMENT DEPRESSION 2
C MENSTRUAL CYCLE MANAGEMENT DIARRHOEA 2
C MENSTRUAL CYCLE MANAGEMENT DYSPEPSIA 2
C MENSTRUAL CYCLE MANAGEMENT FLATULENCE 2
C MENSTRUAL CYCLE MANAGEMENT GALLBLADDER DISORDER 2
C MENSTRUAL CYCLE MANAGEMENT INFECTIOUS MONONUCLEOSIS 2
C MENSTRUAL CYCLE MANAGEMENT SCAR 2
C MENSTRUAL CYCLE MANAGEMENT SUTURE RELATED COMPLICATION 2
C MIGRAINE ABDOMINAL DISTENSION 2
C MIGRAINE ABDOMINAL PAIN 2
C MIGRAINE ANXIETY 2
C MIGRAINE CHOLECYSTITIS CHRONIC 2
C MIGRAINE CONSTIPATION 2
C MIGRAINE DEPRESSION 2
C MIGRAINE DIARRHOEA 2
C MIGRAINE DYSPEPSIA 2
C MIGRAINE FLATULENCE 2
C MIGRAINE GALLBLADDER DISORDER 2
C MIGRAINE INFECTIOUS MONONUCLEOSIS 2
C MIGRAINE SCAR 2
C MIGRAINE SUTURE RELATED COMPLICATION 2
C MYCOBACTERIAL INFECTION RHABDOMYOLYSIS 4
C NAUSEA OESOPHAGEAL HAEMORRHAGE 2
C NAUSEA SEPTIC SHOCK 2
C NEUROPATHY PERIPHERAL MALAISE 1
C OEDEMA PERIPHERAL ARTHRALGIA 1
C OEDEMA PERIPHERAL CARDIAC FAILURE 1
C OEDEMA PERIPHERAL CENTRAL OBESITY 1
C OEDEMA PERIPHERAL CUSHING'S SYNDROME 1
C OEDEMA PERIPHERAL CUSHINGOID 1
C OEDEMA PERIPHERAL ERYTHROSIS 1
C OEDEMA PERIPHERAL FLUID RETENTION 1
C OEDEMA PERIPHERAL MOVEMENT DISORDER 1
C OEDEMA PERIPHERAL NECK DEFORMITY 1
C OEDEMA PERIPHERAL OBESITY 1
C OEDEMA PERIPHERAL OEDEMA 1
C OEDEMA PERIPHERAL SKIN ATROPHY 1
C OEDEMA PERIPHERAL SKIN STRIAE 1
C OEDEMA PERIPHERAL WEIGHT INCREASED 1
C PAIN DEVICE RELATED INFECTION 2
C PAIN ENTEROBACTER INFECTION 2
C PAIN FALL 2
C PAIN HIP FRACTURE 2
C PAIN LEUKOCYTOSIS 2
C PEMPHIGOID ARTHRALGIA 1
C PEMPHIGOID CARDIAC FAILURE 1
C PEMPHIGOID CENTRAL OBESITY 1
C PEMPHIGOID CUSHING'S SYNDROME 1
C PEMPHIGOID CUSHINGOID 1
C PEMPHIGOID ERYTHROSIS 1
C PEMPHIGOID FLUID RETENTION 1
C PEMPHIGOID MOVEMENT DISORDER 1
C PEMPHIGOID NECK DEFORMITY 1
C PEMPHIGOID OBESITY 1
C PEMPHIGOID OEDEMA 1
C PEMPHIGOID SKIN ATROPHY 1
C PEMPHIGOID SKIN STRIAE 1
C PEMPHIGOID WEIGHT INCREASED 1
C PLEURAL MESOTHELIOMA BLOOD DISORDER 3
C PLEURAL MESOTHELIOMA DEAFNESS 3
C PLEURAL MESOTHELIOMA PYREXIA 3
C PLEURAL MESOTHELIOMA TINNITUS 3
C PLEURAL MESOTHELIOMA TOXIC SKIN ERUPTION 3
C PREMEDICATION BLOOD DISORDER 5
C PREMEDICATION DEAFNESS 5
C PREMEDICATION DEVICE RELATED INFECTION 3
C PREMEDICATION ENTEROBACTER INFECTION 3
C PREMEDICATION FALL 3
C PREMEDICATION HIP FRACTURE 3
C PREMEDICATION LEUKOCYTOSIS 3
C PREMEDICATION PYREXIA 5
C PREMEDICATION TINNITUS 5
C PREMEDICATION TOXIC SKIN ERUPTION 5
C PRODUCT USED FOR UNKNOWN INDICATION CONTRAINDICATION TO MEDICAL TREATMENT 3
C PRODUCT USED FOR UNKNOWN INDICATION CONVULSION 4
C PRODUCT USED FOR UNKNOWN INDICATION DRUG WITHDRAWAL SYNDROME 4
C PRODUCT USED FOR UNKNOWN INDICATION FALL 4
C PRODUCT USED FOR UNKNOWN INDICATION HYPERTHERMIA 1
C PRODUCT USED FOR UNKNOWN INDICATION HYPOTENSION 3
C PRODUCT USED FOR UNKNOWN INDICATION LEUKOCYTOSIS 1
C PRODUCT USED FOR UNKNOWN INDICATION LUNG DISORDER 3
C PRODUCT USED FOR UNKNOWN INDICATION PULMONARY EMBOLISM 1
C PRODUCT USED FOR UNKNOWN INDICATION RASH MACULO-PAPULAR 3
C PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE 3
C PRODUCT USED FOR UNKNOWN INDICATION RHABDOMYOLYSIS 8
C PRODUCT USED FOR UNKNOWN INDICATION SEPSIS 3
C PRODUCT USED FOR UNKNOWN INDICATION SKIN EXFOLIATION 3
C PRODUCT USED FOR UNKNOWN INDICATION TOXIC SKIN ERUPTION 3
C PROPHYLAXIS ANAPHYLACTIC SHOCK 1
C PROPHYLAXIS DEVICE RELATED INFECTION 1
C PROPHYLAXIS ENTEROBACTER INFECTION 1
C PROPHYLAXIS FALL 1
C PROPHYLAXIS HIP FRACTURE 1
C PROPHYLAXIS LEUKOCYTOSIS 1
C PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER OESOPHAGEAL HAEMORRHAGE 1
C PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER SEPTIC SHOCK 1
C PSYCHOTIC DISORDER HYPERTHERMIA 3
C PSYCHOTIC DISORDER LEUKOCYTOSIS 3
C RESPIRATORY TRACT INFECTION RHABDOMYOLYSIS 4
C SCHIZOPHRENIA PULMONARY EMBOLISM 1
C SCHIZOPHRENIA, PARANOID TYPE DEPRESSIVE SYMPTOM 1
C SCHIZOPHRENIA, PARANOID TYPE PSYCHOTIC DISORDER 1
C SCHIZOPHRENIA, PARANOID TYPE SUICIDAL IDEATION 1
C SKIN ULCER ALANINE AMINOTRANSFERASE INCREASED 1
C SKIN ULCER ASPARTATE AMINOTRANSFERASE INCREASED 1
C SKIN ULCER BLOOD BILIRUBIN INCREASED 1
C SKIN ULCER DIARRHOEA 1
C SKIN ULCER GAMMA-GLUTAMYLTRANSFERASE INCREASED 1
C SKIN ULCER LIVER FUNCTION TEST ABNORMAL 1
C SKIN ULCER PNEUMONIA 1
C SLEEP DISORDER DELUSION 1
C SLEEP DISORDER DEVICE RELATED INFECTION 1
C SLEEP DISORDER ENTEROBACTER INFECTION 1
C SLEEP DISORDER FALL 1
C SLEEP DISORDER HIP FRACTURE 1
C SLEEP DISORDER LEUKOCYTOSIS 1
C SLEEP DISORDER SEPTIC SHOCK 1
C SLEEP DISORDER SUICIDE ATTEMPT 1
C SUBSTANCE ABUSE RHABDOMYOLYSIS 1
C THROMBOSIS PROPHYLAXIS OESOPHAGEAL HAEMORRHAGE 1
C THROMBOSIS PROPHYLAXIS SEPTIC SHOCK 1
C TRANSFUSION DEVICE RELATED INFECTION 1
C TRANSFUSION ENTEROBACTER INFECTION 1
C TRANSFUSION FALL 1
C TRANSFUSION HIP FRACTURE 1
C TRANSFUSION LEUKOCYTOSIS 1
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