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Review Brotizolam Safety Reports submitted to FDA

Total Brotizolam reports: 4.
Brotizolam FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 2.
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FDA Reported Brotizolam Side Effects:
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Brotizolam Side Effects Report #5630006-6
Physician from JAPAN reported BROTIZOLAM problem on Feb 06, 2008. Male patient, 20 years of age, was diagnosed with epilepsy and was treated with BROTIZOLAM. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, back pain, blood lactate dehydrogenase increased, c-reactive protein increased, diarrhoea, gamma-glutamyltransferase increased, lymphocyte count decreased, lymphocyte stimulation test positive. BROTIZOLAM dosage: unknown. During the same period patient was treated with RIVOTRIL, TEGRETOL. Patient was hospitalized. Patient recovered.

Brotizolam Side Effects Report #5631835-5
BROTIZOLAM problem was reported by a Physician from JAPAN on Feb 14, 2008. Male patient, 20 years of age, weighting 147.7 lb, was diagnosed with epilepsy and was treated with BROTIZOLAM. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, back pain, blood lactate dehydrogenase increased, c-reactive protein increased, diarrhoea, gamma-glutamyltransferase increased, lymphocyte count decreased, lymphocyte stimulation test positive. BROTIZOLAM dosage: unknown. During the same period patient was treated with RIVOTRIL, TEGRETOL. Patient was hospitalized. Patient recovered.

Brotizolam Side Effects Report #5521271-4
Consumer or non-health professional from reported BROTIZOLAM problem on Nov 12, 2007. Female patient, 22 years of age, was treated with BROTIZOLAM. After drug was administered, patient experienced the following problems/side effects: asphyxia, aspiration, completed suicide, overdose, vomiting. BROTIZOLAM dosage: unknown. During the same period patient was treated with PAROXETINE, PEROSPIROE, FLUNITRAZEPAM, ETIZOLAM. Patient died.

Brotizolam Side Effects Report #5498112-7
BROTIZOLAM problem was reported by a Consumer or non-health professional from on Oct 24, 2007. Female patient, 22 years of age, was treated with BROTIZOLAM. After drug was administered, patient experienced the following problems/side effects: asphyxia, aspiration, completed suicide, overdose, vomiting. BROTIZOLAM dosage: unknown. During the same period patient was treated with PAROXETINE, PEROSPIROE, FLUNITRAZEPAM, ETIZOLAM. Patient died.


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alanine aminotransferase increased, aspartate aminotransferase increased, back pain, blood lactate dehydrogenase increased, c-reactive protein increased, diarrhoea, gamma-glutamyltransferase increased, lymphocyte count decreased, lymphocyte stimulation test positive, , was diagnosed with epilepsy and was diagnosed with epilepsy and