Drug information for LOTRONEX
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
EQ 0.5MG BASE
Prescription
ALOSETRON HYDROCHLORIDE
alosetron
PROMETHEUS LABS
21107
2010-10-01 Other
2010-10-01 Label
2010-09-15 Medication Guide
2010-09-07 Label
2010-09-07 Letter
2010-09-07 Letter
2008-05-06 Medication Guide
2008-05-06 Label
2008-04-09 Letter
2007-11-19 Review
2007-11-19 Review
2007-11-19 Review
2007-11-19 Review
2006-03-23 Letter
2006-03-14 Label
2005-02-23 Letter
2005-02-23 Label
2005-02-08 Letter
2005-02-04 Label
2003-12-29 Label
2003-12-24 Letter
2003-12-17 Other Important Information from FDA
2003-03-26 Letter
2002-06-07 Label
2002-06-07 Letter
2000-08-29 Review
2000-02-09 Label
2000-02-09 Letter
TABLET; ORAL
EQ 1MG BASE
Prescription
(Reference Drug)
ALOSETRON HYDROCHLORIDE
alosetron
PROMETHEUS LABS
"
Drug Adverse Effects information for LOTRONEX
Role code
Indications
Reaction
# Reports
PS
DIARRHOEA
GASTROINTESTINAL INFECTION
1
PS
DIARRHOEA
HEPATIC FAILURE
1
PS
DIARRHOEA
INCORRECT DOSE ADMINISTERED
1
PS
DIARRHOEA
INTESTINAL PERFORATION
1
PS
DIARRHOEA
VOMITING
1
C
ASTHENIA
ABDOMINAL DISCOMFORT
1
C
ASTHENIA
APHAGIA
1
C
ASTHENIA
ASTHENIA
1
C
ASTHENIA
BALANCE DISORDER
1
C
ASTHENIA
BOWEL MOVEMENT IRREGULARITY
1
C
ASTHENIA
DYSARTHRIA
1
C
ASTHENIA
INSOMNIA
1
C
ASTHENIA
MEMORY IMPAIRMENT
1
C
ASTHENIA
MULTIPLE SCLEROSIS
1
C
ASTHENIA
NEUROPATHY PERIPHERAL
1
C
ASTHENIA
VISUAL ACUITY REDUCED
1
C
ASTHENIA
WEIGHT DECREASED
1
C
BIPOLAR DISORDER
ABDOMINAL DISCOMFORT
3
C
BIPOLAR DISORDER
APHAGIA
3
C
BIPOLAR DISORDER
ASTHENIA
3
C
BIPOLAR DISORDER
BALANCE DISORDER
3
C
BIPOLAR DISORDER
BOWEL MOVEMENT IRREGULARITY
3
C
BIPOLAR DISORDER
DYSARTHRIA
3
C
BIPOLAR DISORDER
INSOMNIA
3
C
BIPOLAR DISORDER
MEMORY IMPAIRMENT
3
C
BIPOLAR DISORDER
MULTIPLE SCLEROSIS
3
C
BIPOLAR DISORDER
NEUROPATHY PERIPHERAL
3
C
BIPOLAR DISORDER
VISUAL ACUITY REDUCED
3
C
BIPOLAR DISORDER
WEIGHT DECREASED
3
C
BLOOD CHOLESTEROL
ABDOMINAL DISCOMFORT
1
C
BLOOD CHOLESTEROL
APHAGIA
1
C
BLOOD CHOLESTEROL
ASTHENIA
1
C
BLOOD CHOLESTEROL
BALANCE DISORDER
1
C
BLOOD CHOLESTEROL
BOWEL MOVEMENT IRREGULARITY
1
C
BLOOD CHOLESTEROL
DYSARTHRIA
1
C
BLOOD CHOLESTEROL
INSOMNIA
1
C
BLOOD CHOLESTEROL
MEMORY IMPAIRMENT
1
C
BLOOD CHOLESTEROL
MULTIPLE SCLEROSIS
1
C
BLOOD CHOLESTEROL
NEUROPATHY PERIPHERAL
1
C
BLOOD CHOLESTEROL
VISUAL ACUITY REDUCED
1
C
BLOOD CHOLESTEROL
WEIGHT DECREASED
1
C
MULTIPLE SCLEROSIS
ABDOMINAL DISCOMFORT
2
C
MULTIPLE SCLEROSIS
ABDOMINAL PAIN
1
C
MULTIPLE SCLEROSIS
APHAGIA
1
C
MULTIPLE SCLEROSIS
ASTHENIA
1
C
MULTIPLE SCLEROSIS
BACK PAIN
1
C
MULTIPLE SCLEROSIS
BALANCE DISORDER
1
C
MULTIPLE SCLEROSIS
BOWEL MOVEMENT IRREGULARITY
1
C
MULTIPLE SCLEROSIS
CONSTIPATION
1
C
MULTIPLE SCLEROSIS
DECREASED APPETITE
1
C
MULTIPLE SCLEROSIS
DIARRHOEA
1
C
MULTIPLE SCLEROSIS
DYSARTHRIA
1
C
MULTIPLE SCLEROSIS
DYSPHAGIA
1
C
MULTIPLE SCLEROSIS
INSOMNIA
1
C
MULTIPLE SCLEROSIS
MEMORY IMPAIRMENT
1
C
MULTIPLE SCLEROSIS
MULTIPLE SCLEROSIS
1
C
MULTIPLE SCLEROSIS
NEUROPATHY PERIPHERAL
1
C
MULTIPLE SCLEROSIS
VISUAL ACUITY REDUCED
1
C
MULTIPLE SCLEROSIS
WEIGHT DECREASED
2
C
SLEEP DISORDER
ABDOMINAL DISCOMFORT
2
C
SLEEP DISORDER
APHAGIA
2
C
SLEEP DISORDER
ASTHENIA
2
C
SLEEP DISORDER
BALANCE DISORDER
2
C
SLEEP DISORDER
BOWEL MOVEMENT IRREGULARITY
2
C
SLEEP DISORDER
DYSARTHRIA
2
C
SLEEP DISORDER
INSOMNIA
2
C
SLEEP DISORDER
MEMORY IMPAIRMENT
2
C
SLEEP DISORDER
MULTIPLE SCLEROSIS
2
C
SLEEP DISORDER
NEUROPATHY PERIPHERAL
2
C
SLEEP DISORDER
VISUAL ACUITY REDUCED
2
C
SLEEP DISORDER
WEIGHT DECREASED
2
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