Drug information for DIASTAT

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
GEL; RECTAL 10MG/2ML (5MG/ML) Discontinued   DIAZEPAM Diazepam VALEANT 20648
2007-07-06 Review

2006-03-31 Other Important Information from FDA

2006-03-27 Label

2006-03-27 Patient Package Insert

2005-09-22 Letter

2001-04-11 Letter
GEL; RECTAL 15MG/3ML (5MG/ML) Discontinued   DIAZEPAM Diazepam VALEANT   "
GEL; RECTAL 2.5MG/0.5ML (5MG/ML) Prescription   DIAZEPAM Diazepam VALEANT   "
GEL; RECTAL 20MG/4ML (5MG/ML) Discontinued   DIAZEPAM Diazepam VALEANT   "
GEL; RECTAL 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Discontinued   DIAZEPAM Diazepam VALEANT   "

Drug Adverse Effects information for DIASTAT

Role code Indications Reaction # Reports
C ABDOMINAL DISCOMFORT ANGINA PECTORIS 1
C ARTHRALGIA ANGINA PECTORIS 1
C ASTROCYTOMA CONVULSION 1
C ASTROCYTOMA DRY SKIN 2
C ASTROCYTOMA ERYTHEMA 2
C ASTROCYTOMA FOLLICULITIS 2
C ASTROCYTOMA HAND-FOOT-AND-MOUTH DISEASE 2
C ASTROCYTOMA INFANTILE SPASMS 2
C ASTROCYTOMA INFLUENZA LIKE ILLNESS 1
C ASTROCYTOMA LETHARGY 2
C ASTROCYTOMA MALAISE 1
C ASTROCYTOMA PYREXIA 2
C ASTROCYTOMA RASH 2
C ASTROCYTOMA RASH PRURITIC 2
C ASTROCYTOMA SCAB 2
C ASTROCYTOMA SCRATCH 2
C ASTROCYTOMA SINUS HEADACHE 1
C ASTROCYTOMA SKIN ODOUR ABNORMAL 2
C ASTROCYTOMA STARING 2
C ASTROCYTOMA UPPER RESPIRATORY TRACT INFECTION 1
C CONSTIPATION ANGINA PECTORIS 1
C CONVULSION ANGINA PECTORIS 4
C DEPRESSION ANGINA PECTORIS 1
C EPILEPSY CONVULSION 6
C EPILEPSY MENTAL STATUS CHANGES 6
C FAILURE TO THRIVE CONDITION AGGRAVATED 2
C FAILURE TO THRIVE CONVULSION 2
C FAILURE TO THRIVE DRUG DOSE OMISSION 1
C FAILURE TO THRIVE NAUSEA 2
C FAILURE TO THRIVE OFF LABEL USE 2
C FAILURE TO THRIVE VOMITING 2
C HEADACHE ANGINA PECTORIS 2
C INSOMNIA CONVULSION 1
C INSOMNIA MENTAL STATUS CHANGES 1
C LENNOX-GASTAUT SYNDROME DECREASED APPETITE 1
C LENNOX-GASTAUT SYNDROME GRAND MAL CONVULSION 1
C LENNOX-GASTAUT SYNDROME SEIZURE CLUSTER 1
C LENNOX-GASTAUT SYNDROME VAGAL NERVE STIMULATOR IMPLANTATION 1
C LENNOX-GASTAUT SYNDROME WEIGHT DECREASED 1
C MIGRAINE ANGINA PECTORIS 1
C MULTIPLE SCLEROSIS ANGINA PECTORIS 2
C MUSCLE SPASTICITY ANGINA PECTORIS 1
C PAIN ANGINA PECTORIS 1
C PRODUCT USED FOR UNKNOWN INDICATION ANGINA PECTORIS 2
C PROPHYLAXIS ANGINA PECTORIS 3
C SEASONAL ALLERGY ANGINA PECTORIS 1
C TUBEROUS SCLEROSIS APHAGIA 1
C TUBEROUS SCLEROSIS ARTHROPOD BITE 1
C TUBEROUS SCLEROSIS BLOOD SODIUM DECREASED 1
C TUBEROUS SCLEROSIS GRAND MAL CONVULSION 1
C TUBEROUS SCLEROSIS HYPOPHAGIA 1
C TUBEROUS SCLEROSIS MOUTH ULCERATION 1
C TUBEROUS SCLEROSIS NASAL CONGESTION 1
C TUBEROUS SCLEROSIS ORAL PAIN 1
C TUBEROUS SCLEROSIS PYREXIA 1
C TUBEROUS SCLEROSIS RHINORRHOEA 1
C TUBEROUS SCLEROSIS SWELLING 1
C TUBEROUS SCLEROSIS URINARY TRACT INFECTION 1
C TUBEROUS SCLEROSIS VOMITING 1
C TUBEROUS SCLEROSIS WHITE BLOOD CELL COUNT DECREASED 1
C VITAMIN SUPPLEMENTATION ANGINA PECTORIS 3
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