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Review Riluzole Safety Reports submitted to FDA

Total Riluzole reports: 13.
Riluzole FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 9.
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FDA Reported Riluzole Side Effects: marrow hyperplasia, lymphadenopathy, blood alkaline phosphatase increased, atrial fibrillation, aspartate aminotransferase increased, alanine aminotransferase increased, pathological fracture, flatulence, faeces pale, back pain, abdominal pain.
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Riluzole Side Effects Report #5623974-X
Physician from UNITED STATES reported RILUZOLE problem on Feb 08, 2008. Female patient, weighting 22.27 lb, was diagnosed with spinal muscular atrophy and was treated with RILUZOLE. After drug was administered, patient experienced the following problems/side effects: gastrostomy tube insertion. RILUZOLE dosage: 25MG TWICE ADAY PO. During the same period patient was treated with TYLENOL, GLYCOLAX. Patient was hospitalized. Patient recovered.

Riluzole Side Effects Report #5507537-2
RILUZOLE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 05, 2007. Female patient, weighting 178.0 lb, was diagnosed with bipolar disorder, depression and was treated with RILUZOLE. After drug was administered, patient experienced the following problems/side effects: tardive dyskinesia. RILUZOLE dosage: 50 MG TWICE DAILY PO. Patient recovered.

Riluzole Side Effects Report #5505010-9
Physician from UNITED STATES reported RILUZOLE problem on Oct 31, 2007. Male patient, weighting 172.0 lb, was diagnosed with obsessive-compulsive disorder and was treated with RILUZOLE. After drug was administered, patient experienced the following problems/side effects: pancreatitis. RILUZOLE dosage: 60 MG EVERY 12 HOURS 47. During the same period patient was treated with CLOMIPRAMINE, ESCITALOPRAM, QUETIAPINE FUMARATE. Patient was hospitalized. Patient recovered.

Riluzole Side Effects Report #5401240-5
RILUZOLE problem was reported by a Health Professional from GERMANY on July 16, 2007. Female patient, weighting 105.8 lb, was diagnosed with multiple system atrophy and was treated with RILUZOLE. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, chills, convulsion, loss of consciousness, oculogyric crisis, visual acuity reduced. RILUZOLE dosage: unknown. During the same period patient was treated with PRAMIPEXOLE DIHYDROCHLORIDE. Patient recovered.


Riluzole Side Effects Report #5401242-9
Health Professional from GERMANY reported RILUZOLE problem on July 16, 2007. Male patient, weighting 198.4 lb, was diagnosed with multiple system atrophy and was treated with RILUZOLE. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, hypotension, pulmonary embolism. RILUZOLE dosage: unknown. During the same period patient was treated with LEVODOPA, BROMOCRIPTINE MESYLATE. Patient was hospitalized. Patient recovered.

Riluzole Side Effects Report #5401244-2
RILUZOLE problem was reported by a Physician from GERMANY on July 16, 2007. Male patient, weighting 198.4 lb, was diagnosed with multiple system atrophy, hypertension and was treated with RILUZOLE. After drug was administered, patient experienced the following problems/side effects: cardiovascular disorder, pneumonia, pulmonary oedema, respiratory failure. RILUZOLE dosage: unknown. During the same period patient was treated with DRIDASE, ASTONIN H, CARNIGENTE. Patient was hospitalized and became disabled. Patient recovered.

Riluzole Side Effects Report #5401245-4
Health Professional from GERMANY reported RILUZOLE problem on July 16, 2007. Male patient, 74 years of age, weighting 163.1 lb, was diagnosed with multiple system atrophy, nausea, hypertension and was treated with RILUZOLE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, back pain, faeces pale, flatulence, pathological fracture. RILUZOLE dosage: unknown. During the same period patient was treated with MADOPAR, DOMPERIDON, DIGITOXIN, ENALAPRIL MALEATE, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Riluzole Side Effects Report #5401240-5
RILUZOLE problem was reported by a Health Professional from GERMANY on July 16, 2007. Female patient, weighting 105.8 lb, was diagnosed with multiple system atrophy and was treated with RILUZOLE. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, chills, convulsion, loss of consciousness, oculogyric crisis, visual acuity reduced. RILUZOLE dosage: unknown. During the same period patient was treated with PRAMIPEXOLE DIHYDROCHLORIDE. Patient recovered.

Riluzole Side Effects Report #5401242-9
Health Professional from GERMANY reported RILUZOLE problem on July 16, 2007. Male patient, weighting 198.4 lb, was diagnosed with multiple system atrophy and was treated with RILUZOLE. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, hypotension, pulmonary embolism. RILUZOLE dosage: unknown. During the same period patient was treated with LEVODOPA, BROMOCRIPTINE MESYLATE. Patient was hospitalized. Patient recovered.


Riluzole Side Effects Report #5401244-2
RILUZOLE problem was reported by a Physician from GERMANY on July 16, 2007. Male patient, weighting 198.4 lb, was diagnosed with multiple system atrophy, hypertension and was treated with RILUZOLE. After drug was administered, patient experienced the following problems/side effects: cardiovascular disorder, pneumonia, pulmonary oedema, respiratory failure. RILUZOLE dosage: unknown. During the same period patient was treated with DRIDASE, ASTONIN H, CARNIGENTE. Patient was hospitalized and became disabled. Patient recovered.

Riluzole Side Effects Report #5401245-4
Health Professional from GERMANY reported RILUZOLE problem on July 16, 2007. Male patient, 74 years of age, weighting 163.1 lb, was diagnosed with multiple system atrophy, nausea, hypertension and was treated with RILUZOLE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, back pain, faeces pale, flatulence, pathological fracture. RILUZOLE dosage: unknown. During the same period patient was treated with MADOPAR, DOMPERIDON, DIGITOXIN, ENALAPRIL MALEATE, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Riluzole Side Effects Report #5278512-0
RILUZOLE problem was reported by a Physician from UNITED STATES on Mar 07, 2007. Male patient, 50 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUZOLE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, atrial fibrillation, blood alkaline phosphatase increased, lymphadenopathy, marrow hyperplasia, nausea, pericarditis constrictive. RILUZOLE dosage: 50 MG BID UNK. During the same period patient was treated with ZOLPIDEM. Patient was hospitalized. Patient recovered.

Riluzole Side Effects Report #5290162-9
Physician from BELGIUM reported RILUZOLE problem on Mar 14, 2007. Male patient, 69 years of age, was diagnosed with amyotrophic lateral sclerosis and was treated with RILUZOLE. After drug was administered, patient experienced the following problems/side effects: alveolitis allergic, blood lactate dehydrogenase increased, interstitial lung disease, no therapeutic response, pulmonary fibrosis, restrictive pulmonary disease. RILUZOLE dosage: 50 MG 2X/DAY. During the same period patient was treated with LANSOPRAZOLE. Patient recovered.


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