Drug information for SILENOR
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
EQ 3MG BASE
Prescription
DOXEPIN HYDROCHLORIDE
Doxepin
SOMAXON
22036
2012-01-20 Letter
2011-02-11 Review
2011-02-11 Summary Review
2010-04-01 Other
2010-03-31 Medication Guide
2010-03-22 Letter
2010-03-18 Label
TABLET; ORAL
EQ 6MG BASE
Prescription
(Reference Drug)
DOXEPIN HYDROCHLORIDE
Doxepin
SOMAXON
"
Drug Adverse Effects information for SILENOR
Role code
Indications
Reaction
# Reports
PS
INSOMNIA
VISION BLURRED
1
C
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
DIARRHOEA
1
C
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
HAEMATOCHEZIA
1
C
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
NAUSEA
1
C
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
RECTAL HAEMORRHAGE
3
C
CROHN'S DISEASE
DIARRHOEA
1
C
CROHN'S DISEASE
HAEMATOCHEZIA
1
C
CROHN'S DISEASE
NAUSEA
1
C
CROHN'S DISEASE
RECTAL HAEMORRHAGE
3
C
DEPRESSION
DIARRHOEA
1
C
DEPRESSION
HAEMATOCHEZIA
1
C
DEPRESSION
NAUSEA
1
C
DEPRESSION
RECTAL HAEMORRHAGE
3
C
FIBROMYALGIA
DIARRHOEA
1
C
FIBROMYALGIA
HAEMATOCHEZIA
1
C
FIBROMYALGIA
NAUSEA
1
C
FIBROMYALGIA
RECTAL HAEMORRHAGE
3
C
GASTROOESOPHAGEAL REFLUX DISEASE
DIARRHOEA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
HAEMATOCHEZIA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
NAUSEA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
RECTAL HAEMORRHAGE
3
C
INSOMNIA
DIARRHOEA
3
C
INSOMNIA
HAEMATOCHEZIA
3
C
INSOMNIA
NAUSEA
3
C
INSOMNIA
RECTAL HAEMORRHAGE
9
C
NAUSEA
DIARRHOEA
1
C
NAUSEA
HAEMATOCHEZIA
1
C
NAUSEA
NAUSEA
1
C
NAUSEA
RECTAL HAEMORRHAGE
3
C
PRODUCT USED FOR UNKNOWN INDICATION
DIARRHOEA
4
C
PRODUCT USED FOR UNKNOWN INDICATION
HAEMATOCHEZIA
4
C
PRODUCT USED FOR UNKNOWN INDICATION
NAUSEA
4
C
PRODUCT USED FOR UNKNOWN INDICATION
RECTAL HAEMORRHAGE
12
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