Drug information for ONFI

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 10MG Prescription   CLOBAZAM clobazam LUNDBECK LLC 202067
2011-11-22 Review

2011-11-01 Medication Guide

2011-10-25 Letter

2011-10-24 Label
TABLET; ORAL 20MG Prescription  (Reference Drug) CLOBAZAM clobazam LUNDBECK LLC   "
TABLET; ORAL 5MG Prescription   CLOBAZAM clobazam LUNDBECK LLC   "

Drug Adverse Effects information for ONFI

Role code Indications Reaction # Reports
PS ANXIETY APNOEA 1
PS ANXIETY COMA 1
PS ANXIETY HEART RATE DECREASED 1
PS ANXIETY HEART RATE INCREASED 1
PS ANXIETY LOSS OF CONSCIOUSNESS 1
PS ANXIETY SELF-MEDICATION 1
PS ANXIETY UNRESPONSIVE TO STIMULI 1
PS CONTRACEPTION CONDITION AGGRAVATED 1
PS CONTRACEPTION DIARRHOEA 1
PS CONTRACEPTION DIZZINESS 1
PS CONTRACEPTION EPILEPSY 1
PS CONTRACEPTION HEADACHE 1
PS CONTRACEPTION HEPATIC FAILURE 1
PS CONTRACEPTION HEPATIC STEATOSIS 1
PS CONTRACEPTION HEPATITIS TOXIC 1
PS CONTRACEPTION INFLUENZA LIKE ILLNESS 1
PS CONTRACEPTION MULTIPLE INJURIES 1
PS CONTRACEPTION NAUSEA 1
PS CONVULSION AGGRESSION 1
PS CONVULSION ANXIETY 5
PS CONVULSION AURA 5
PS CONVULSION AUTOIMMUNE THYROIDITIS 1
PS CONVULSION CONDITION AGGRAVATED 1
PS CONVULSION CONFUSIONAL STATE 1
PS CONVULSION CONVULSION 1
PS CONVULSION DECREASED APPETITE 1
PS CONVULSION DIPLOPIA 5
PS CONVULSION DISTURBANCE IN ATTENTION 1
PS CONVULSION DRUG HYPERSENSITIVITY 5
PS CONVULSION DRUG LEVEL ABOVE THERAPEUTIC 1
PS CONVULSION ENCEPHALITIS 1
PS CONVULSION EPILEPSY 1
PS CONVULSION FATIGUE 6
PS CONVULSION FEELING ABNORMAL 1
PS CONVULSION GRAND MAL CONVULSION 1
PS CONVULSION HYPONATRAEMIA 2
PS CONVULSION IMPAIRED WORK ABILITY 5
PS CONVULSION INAPPROPRIATE AFFECT 1
PS CONVULSION MALAISE 1
PS CONVULSION MEMORY IMPAIRMENT 5
PS CONVULSION MOOD ALTERED 1
PS CONVULSION MULTIPLE DRUG OVERDOSE ACCIDENTAL 1
PS CONVULSION PARTIAL SEIZURES 1
PS CONVULSION PARTNER STRESS 5
PS CONVULSION POOR QUALITY SLEEP 1
PS CONVULSION RASH VESICULAR 1
PS CONVULSION RESPIRATORY ARREST 1
PS CONVULSION RESTING TREMOR 1
PS CONVULSION SELF ESTEEM DECREASED 5
PS CONVULSION SLOW SPEECH 5
PS CONVULSION SOMNOLENCE 3
PS CONVULSION STEVENS-JOHNSON SYNDROME 5
PS CONVULSION TEARFULNESS 5
PS CONVULSION TOXICITY TO VARIOUS AGENTS 1
PS CONVULSION URINARY INCONTINENCE 5
PS CONVULSION WEIGHT DECREASED 1
PS DEPRESSION HYPONATRAEMIA 1
PS DEPRESSION SOMNOLENCE 1
PS ECZEMA CONDITION AGGRAVATED 1
PS ECZEMA DIZZINESS 1
PS ECZEMA EPILEPSY 1
PS ECZEMA HEADACHE 1
PS ECZEMA MULTIPLE INJURIES 1
PS EPILEPSY ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC 2
PS EPILEPSY CONDITION AGGRAVATED 4
PS EPILEPSY DEPRESSED LEVEL OF CONSCIOUSNESS 2
PS EPILEPSY DIZZINESS 4
PS EPILEPSY EPILEPSY 4
PS EPILEPSY HAEMATOMA 3
PS EPILEPSY HEADACHE 4
PS EPILEPSY MATERNAL DRUGS AFFECTING FOETUS 3
PS EPILEPSY MULTIPLE INJURIES 4
PS EPILEPSY PREMATURE SEPARATION OF PLACENTA 3
PS EPILEPSY STATUS EPILEPTICUS 2
PS FOETAL EXPOSURE DURING PREGNANCY IMMATURE RESPIRATORY SYSTEM 2
PS FOETAL EXPOSURE DURING PREGNANCY INFECTION 2
PS FOETAL EXPOSURE DURING PREGNANCY LARYNGOMALACIA 2
PS FOETAL EXPOSURE DURING PREGNANCY MATERNAL DRUGS AFFECTING FOETUS 2
PS FOETAL EXPOSURE DURING PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY 2
PS FOETAL EXPOSURE DURING PREGNANCY PREGNANCY 2
PS LENNOX-GASTAUT SYNDROME MUSCLE RIGIDITY 1
PS LENNOX-GASTAUT SYNDROME STATUS EPILEPTICUS 1
PS METASTATIC MALIGNANT MELANOMA LEUKOPENIA 2
PS METASTATIC MALIGNANT MELANOMA RASH MACULO-PAPULAR 2
PS METASTATIC MALIGNANT MELANOMA THROMBOCYTOPENIA 2
PS MYOCLONIC EPILEPSY DIARRHOEA 2
PS MYOCLONIC EPILEPSY HEPATIC FAILURE 2
PS MYOCLONIC EPILEPSY HEPATIC STEATOSIS 2
PS MYOCLONIC EPILEPSY HEPATITIS TOXIC 2
PS MYOCLONIC EPILEPSY INFLUENZA LIKE ILLNESS 2
PS MYOCLONIC EPILEPSY NAUSEA 2
PS PAIN CHOLESTASIS 1
PS PAIN CONDITION AGGRAVATED 1
PS PAIN DRUG LEVEL ABOVE THERAPEUTIC 1
PS PAIN EPILEPSY 1
PS PAIN FATIGUE 1
PS PAIN HEPATIC CIRRHOSIS 1
PS PAIN MULTIPLE DRUG OVERDOSE ACCIDENTAL 1
PS PAIN RESPIRATORY ARREST 1
PS PAIN TOXICITY TO VARIOUS AGENTS 1
PS PAIN IN EXTREMITY HAEMATOMA 1
PS PAIN IN EXTREMITY MATERNAL DRUGS AFFECTING FOETUS 1
PS PAIN IN EXTREMITY PREMATURE SEPARATION OF PLACENTA 1
PS PRODUCT USED FOR UNKNOWN INDICATION ASPIRATION 3
PS PRODUCT USED FOR UNKNOWN INDICATION BRADYCARDIA 3
PS PRODUCT USED FOR UNKNOWN INDICATION CAESAREAN SECTION 3
PS PRODUCT USED FOR UNKNOWN INDICATION CARDIAC ARREST 3
PS PRODUCT USED FOR UNKNOWN INDICATION CHOLESTASIS 4
PS PRODUCT USED FOR UNKNOWN INDICATION CONDITION AGGRAVATED 6
PS PRODUCT USED FOR UNKNOWN INDICATION CRYING 1
PS PRODUCT USED FOR UNKNOWN INDICATION DELIRIUM 1
PS PRODUCT USED FOR UNKNOWN INDICATION DIZZINESS 3
PS PRODUCT USED FOR UNKNOWN INDICATION EPILEPSY 2
PS PRODUCT USED FOR UNKNOWN INDICATION FOETAL GROWTH RESTRICTION 3
PS PRODUCT USED FOR UNKNOWN INDICATION GASTROOESOPHAGEAL REFLUX DISEASE 3
PS PRODUCT USED FOR UNKNOWN INDICATION GENERAL PHYSICAL HEALTH DETERIORATION 3
PS PRODUCT USED FOR UNKNOWN INDICATION HAEMATOMA 1
PS PRODUCT USED FOR UNKNOWN INDICATION HALLUCINATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 2
PS PRODUCT USED FOR UNKNOWN INDICATION HEPATIC CIRRHOSIS 4
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERTENSION 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPONATRAEMIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPOTHERMIA 3
PS PRODUCT USED FOR UNKNOWN INDICATION INTERNATIONAL NORMALISED RATIO INCREASED 3
PS PRODUCT USED FOR UNKNOWN INDICATION LEUKOPENIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION LOW BIRTH WEIGHT BABY 3
PS PRODUCT USED FOR UNKNOWN INDICATION MATERNAL DRUGS AFFECTING FOETUS 4
PS PRODUCT USED FOR UNKNOWN INDICATION MULTIPLE DRUG OVERDOSE 3
PS PRODUCT USED FOR UNKNOWN INDICATION MULTIPLE INJURIES 2
PS PRODUCT USED FOR UNKNOWN INDICATION NOSOCOMIAL INFECTION 3
PS PRODUCT USED FOR UNKNOWN INDICATION PREMATURE SEPARATION OF PLACENTA 1
PS PRODUCT USED FOR UNKNOWN INDICATION RASH MACULO-PAPULAR 2
PS PRODUCT USED FOR UNKNOWN INDICATION RENAL DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION RESPIRATORY ARREST 3
PS PRODUCT USED FOR UNKNOWN INDICATION SALIVARY HYPERSECRETION 3
PS PRODUCT USED FOR UNKNOWN INDICATION SEPSIS 3
PS PRODUCT USED FOR UNKNOWN INDICATION SOMNOLENCE 4
PS PRODUCT USED FOR UNKNOWN INDICATION THROMBOCYTOPENIA 2
PS SCHIZOPHRENIA BRADYCARDIA 1
PS SCHIZOPHRENIA CARDIAC ARREST 1
PS SCHIZOPHRENIA GENERAL PHYSICAL HEALTH DETERIORATION 1
PS SCHIZOPHRENIA HYPOTHERMIA 1
PS SCHIZOPHRENIA INTERNATIONAL NORMALISED RATIO INCREASED 1
PS SCHIZOPHRENIA MULTIPLE DRUG OVERDOSE 1
PS SCHIZOPHRENIA NOSOCOMIAL INFECTION 1
PS SCHIZOPHRENIA RESPIRATORY ARREST 1
PS SCHIZOPHRENIA SALIVARY HYPERSECRETION 1
PS SCHIZOPHRENIA SEPSIS 1
PS SCHIZOPHRENIA SOMNOLENCE 1
PS STATUS EPILEPTICUS CHOLESTASIS 1
PS STATUS EPILEPTICUS CONDITION AGGRAVATED 1
PS STATUS EPILEPTICUS HEPATIC CIRRHOSIS 1
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