Drug information for KAPVAY
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET, EXTENDED RELEASE; ORAL
0.1MG
Prescription
(Reference Drug)
CLONIDINE HYDROCHLORIDE
Clonidine
SHIONOGI INC
22331
2010-10-07 Label
2010-10-07 Label
2010-10-07 Label
2010-10-04 Letter
2010-10-04 Letter
2009-11-10 Review
2009-10-07 Letter
2009-10-07 Label
TABLET, EXTENDED RELEASE; ORAL
0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Discontinued
CLONIDINE HYDROCHLORIDE
Clonidine
SHIONOGI INC
"
Drug Adverse Effects information for KAPVAY
Role code
Indications
Reaction
# Reports
PS
AFFECTIVE DISORDER
CONVULSION
2
PS
AFFECTIVE DISORDER
SEDATION
2
PS
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
ANAPHYLACTIC REACTION
1
PS
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
HALLUCINATION, VISUAL
2
PS
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
INSOMNIA
2
PS
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
SCREAMING
2
PS
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
SOMNOLENCE
2
PS
INSOMNIA
HALLUCINATION, VISUAL
1
PS
INSOMNIA
INSOMNIA
1
PS
INSOMNIA
SCREAMING
1
PS
INSOMNIA
SOMNOLENCE
1
PS
OFF LABEL USE
HALLUCINATION, VISUAL
1
PS
OFF LABEL USE
INSOMNIA
1
PS
OFF LABEL USE
SCREAMING
1
PS
OFF LABEL USE
SOMNOLENCE
1
SS
AFFECTIVE DISORDER
CONVULSION
2
SS
AFFECTIVE DISORDER
HALLUCINATION, VISUAL
2
SS
AFFECTIVE DISORDER
IRREGULAR SLEEP PHASE
2
SS
AFFECTIVE DISORDER
MOOD ALTERED
2
SS
AFFECTIVE DISORDER
PSYCHOMOTOR HYPERACTIVITY
2
SS
AFFECTIVE DISORDER
SEDATION
4
SS
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
HALLUCINATION, VISUAL
2
SS
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
INSOMNIA
2
SS
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
SCREAMING
2
SS
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
SOMNOLENCE
2
SS
INSOMNIA
HALLUCINATION, VISUAL
2
SS
INSOMNIA
INSOMNIA
2
SS
INSOMNIA
SCREAMING
2
SS
INSOMNIA
SOMNOLENCE
2
SS
OFF LABEL USE
HALLUCINATION, VISUAL
2
SS
OFF LABEL USE
INSOMNIA
2
SS
OFF LABEL USE
SCREAMING
2
SS
OFF LABEL USE
SOMNOLENCE
2
SS
PETIT MAL EPILEPSY
HALLUCINATION, VISUAL
2
SS
PETIT MAL EPILEPSY
IRREGULAR SLEEP PHASE
2
SS
PETIT MAL EPILEPSY
MOOD ALTERED
2
SS
PETIT MAL EPILEPSY
PSYCHOMOTOR HYPERACTIVITY
2
SS
PETIT MAL EPILEPSY
SEDATION
2
C
SMOKING CESSATION THERAPY
BLISTER
1
C
SMOKING CESSATION THERAPY
ERYTHEMA
1
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