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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