Drug information for RILUTEK

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 50MG Prescription AB (Reference Drug) RILUZOLE Riluzole SANOFI AVENTIS US 20599
2010-01-20 Letter
2009-11-17 Label
2009-07-23 Label
2009-07-23 Label
2009-07-17 Letter
2009-07-17 Letter
2004-09-24 Letter
2003-06-08 Letter
2003-06-08 Letter
2003-06-08 Letter

Drug Adverse Effects information for RILUTEK

Role code Indications Reaction # Reports
PS AMYOTROPHIC LATERAL SCLEROSIS AGRANULOCYTOSIS 2
PS AMYOTROPHIC LATERAL SCLEROSIS DIAPHRAGMATIC DISORDER 1
PS AMYOTROPHIC LATERAL SCLEROSIS DYSPNOEA 1
PS AMYOTROPHIC LATERAL SCLEROSIS FATIGUE 1
PS AMYOTROPHIC LATERAL SCLEROSIS HEPATIC FUNCTION ABNORMAL 1
PS AMYOTROPHIC LATERAL SCLEROSIS HYPERTENSION 1
PS AMYOTROPHIC LATERAL SCLEROSIS MYOCARDITIS 2
PS AMYOTROPHIC LATERAL SCLEROSIS PRURITUS 1
PS AMYOTROPHIC LATERAL SCLEROSIS PULMONARY EMBOLISM 1
PS AMYOTROPHIC LATERAL SCLEROSIS PYREXIA 1
PS AMYOTROPHIC LATERAL SCLEROSIS RASH 1
PS CARDIOVASCULAR EVENT PROPHYLAXIS AGRANULOCYTOSIS 2
PS DEEP VEIN THROMBOSIS AGRANULOCYTOSIS 2
PS TACHYCARDIA HYPERTENSION 1
SS AMYOTROPHIC LATERAL SCLEROSIS DIAPHRAGMATIC DISORDER 1
SS AMYOTROPHIC LATERAL SCLEROSIS DYSPNOEA 1
SS AMYOTROPHIC LATERAL SCLEROSIS FATIGUE 1
SS AMYOTROPHIC LATERAL SCLEROSIS HEPATIC FUNCTION ABNORMAL 2
SS AMYOTROPHIC LATERAL SCLEROSIS PRURITUS 2
SS AMYOTROPHIC LATERAL SCLEROSIS PULMONARY EMBOLISM 1
SS AMYOTROPHIC LATERAL SCLEROSIS PYREXIA 2
SS AMYOTROPHIC LATERAL SCLEROSIS RASH 2
C AMYOTROPHIC LATERAL SCLEROSIS BLOOD ALKALINE PHOSPHATASE INCREASED 21
C AMYOTROPHIC LATERAL SCLEROSIS CHEST PAIN 24
C AMYOTROPHIC LATERAL SCLEROSIS DYSPNOEA 1
C AMYOTROPHIC LATERAL SCLEROSIS EMPHYSEMA 1
C AMYOTROPHIC LATERAL SCLEROSIS HYPERPHOSPHATASAEMIA 6
C AMYOTROPHIC LATERAL SCLEROSIS INTERSTITIAL LUNG DISEASE 1
C AMYOTROPHIC LATERAL SCLEROSIS MULTIPLE FRACTURES 24
C AMYOTROPHIC LATERAL SCLEROSIS OSTEOMALACIA 21
C AMYOTROPHIC LATERAL SCLEROSIS PARALYSIS 1
C AMYOTROPHIC LATERAL SCLEROSIS PULMONARY FIBROSIS 1
C AMYOTROPHIC LATERAL SCLEROSIS RESPIRATORY ARREST 1
C HEPATITIS B BLOOD ALKALINE PHOSPHATASE INCREASED 14
C HEPATITIS B CHEST PAIN 16
C HEPATITIS B HYPERPHOSPHATASAEMIA 4
C HEPATITIS B MULTIPLE FRACTURES 17
C HEPATITIS B OSTEOMALACIA 14
C HYPERTENSION BLOOD ALKALINE PHOSPHATASE INCREASED 7
C HYPERTENSION CHEST PAIN 8
C HYPERTENSION HYPERPHOSPHATASAEMIA 2
C HYPERTENSION MULTIPLE FRACTURES 8
C HYPERTENSION OSTEOMALACIA 7
C MICTURITION URGENCY AMYOTROPHIC LATERAL SCLEROSIS 1
C MICTURITION URGENCY APATHY 1
C MICTURITION URGENCY ASTHENIA 1
C MICTURITION URGENCY ATROPHY 1
C MICTURITION URGENCY BALANCE DISORDER 1
C MICTURITION URGENCY BLOOD ALBUMIN DECREASED 1
C MICTURITION URGENCY BLOOD CHLORIDE INCREASED 1
C MICTURITION URGENCY BLOOD IMMUNOGLOBULIN G INCREASED 1
C MICTURITION URGENCY BLOOD PRESSURE DECREASED 1
C MICTURITION URGENCY CONSTIPATION 1
C MICTURITION URGENCY CRYING 1
C MICTURITION URGENCY DYSARTHRIA 1
C MICTURITION URGENCY EMOTIONAL DISORDER 1
C MICTURITION URGENCY FINGER DEFORMITY 1
C MICTURITION URGENCY FLATULENCE 1
C MICTURITION URGENCY GAIT DISTURBANCE 1
C MICTURITION URGENCY HYPOKINESIA 1
C MICTURITION URGENCY HYPOTONIA 1
C MICTURITION URGENCY IMMUNODEFICIENCY 1
C MICTURITION URGENCY LYMPHOCYTE COUNT DECREASED 1
C MICTURITION URGENCY LYMPHOCYTE COUNT INCREASED 1
C MICTURITION URGENCY MALAISE 1
C MICTURITION URGENCY MOBILITY DECREASED 1
C MICTURITION URGENCY MONOCYTE COUNT INCREASED 1
C MICTURITION URGENCY MOTOR DYSFUNCTION 1
C MICTURITION URGENCY MUSCLE CONTRACTIONS INVOLUNTARY 1
C MICTURITION URGENCY MUSCULAR WEAKNESS 1
C MICTURITION URGENCY NERVOUS SYSTEM DISORDER 1
C MICTURITION URGENCY NEUROGENIC BLADDER 1
C MICTURITION URGENCY NEUROPATHY PERIPHERAL 1
C MICTURITION URGENCY PROTEIN TOTAL DECREASED 1
C MICTURITION URGENCY RED BLOOD CELL COUNT DECREASED 1
C MICTURITION URGENCY RELAPSING-REMITTING MULTIPLE SCLEROSIS 1
C MICTURITION URGENCY URINARY INCONTINENCE 1
C MICTURITION URGENCY WHITE BLOOD CELL COUNT DECREASED 1
C MULTIPLE SCLEROSIS AMYOTROPHIC LATERAL SCLEROSIS 1
C MULTIPLE SCLEROSIS APATHY 1
C MULTIPLE SCLEROSIS ASTHENIA 1
C MULTIPLE SCLEROSIS ATROPHY 1
C MULTIPLE SCLEROSIS BALANCE DISORDER 1
C MULTIPLE SCLEROSIS BLOOD ALBUMIN DECREASED 1
C MULTIPLE SCLEROSIS BLOOD CHLORIDE INCREASED 1
C MULTIPLE SCLEROSIS BLOOD IMMUNOGLOBULIN G INCREASED 1
C MULTIPLE SCLEROSIS BLOOD PRESSURE DECREASED 1
C MULTIPLE SCLEROSIS CONSTIPATION 1
C MULTIPLE SCLEROSIS CRYING 1
C MULTIPLE SCLEROSIS DYSARTHRIA 1
C MULTIPLE SCLEROSIS EMOTIONAL DISORDER 1
C MULTIPLE SCLEROSIS FINGER DEFORMITY 1
C MULTIPLE SCLEROSIS FLATULENCE 1
C MULTIPLE SCLEROSIS GAIT DISTURBANCE 1
C MULTIPLE SCLEROSIS HYPOKINESIA 1
C MULTIPLE SCLEROSIS HYPOTONIA 1
C MULTIPLE SCLEROSIS IMMUNODEFICIENCY 1
C MULTIPLE SCLEROSIS LYMPHOCYTE COUNT DECREASED 1
C MULTIPLE SCLEROSIS LYMPHOCYTE COUNT INCREASED 1
C MULTIPLE SCLEROSIS MALAISE 1
C MULTIPLE SCLEROSIS MOBILITY DECREASED 1
C MULTIPLE SCLEROSIS MONOCYTE COUNT INCREASED 1
C MULTIPLE SCLEROSIS MOTOR DYSFUNCTION 1
C MULTIPLE SCLEROSIS MUSCLE CONTRACTIONS INVOLUNTARY 1
C MULTIPLE SCLEROSIS MUSCULAR WEAKNESS 1
C MULTIPLE SCLEROSIS NERVOUS SYSTEM DISORDER 1
C MULTIPLE SCLEROSIS NEUROGENIC BLADDER 1
C MULTIPLE SCLEROSIS NEUROPATHY PERIPHERAL 1
C MULTIPLE SCLEROSIS PROTEIN TOTAL DECREASED 1
C MULTIPLE SCLEROSIS RED BLOOD CELL COUNT DECREASED 1
C MULTIPLE SCLEROSIS RELAPSING-REMITTING MULTIPLE SCLEROSIS 1
C MULTIPLE SCLEROSIS URINARY INCONTINENCE 1
C MULTIPLE SCLEROSIS WHITE BLOOD CELL COUNT DECREASED 1
C PAIN BLOOD ALKALINE PHOSPHATASE INCREASED 7
C PAIN CHEST PAIN 8
C PAIN HYPERPHOSPHATASAEMIA 2
C PAIN MULTIPLE FRACTURES 8
C PAIN OSTEOMALACIA 7
C RHEUMATOID ARTHRITIS DEATH 1
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