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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