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Review Lexotan Safety Reports submitted to FDA

Total Lexotan reports: 4.
Lexotan FDA safety alerts: No.
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FDA Reported Lexotan Side Effects: dizziness, anaphylactic shock, insomnia, gait disturbance, fear, dysarthria, depression, depressed mood, asthenia, anorexia, erythema.
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Lexotan Side Effects Report #5375831-4
Consumer or non-health professional from BRAZIL reported LEXOTAN problem on June 20, 2007. Female patient, 45 years of age, weighting 136.7 lb, was diagnosed with insomnia, pain, constipation, blood prolactin abnormal and was treated with LEXOTAN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, adenoma benign, carpal tunnel syndrome, dizziness, dyspnoea, dyspnoea exertional, erythema. LEXOTAN dosage: 3 MG/DAY. During the same period patient was treated with BEXTRA, ZELMAC, DOSTINEX, NIFUROXAZIDE. Patient recovered.

Lexotan Side Effects Report #5379724-8
LEXOTAN problem was reported by a Consumer or non-health professional from BRAZIL on June 28, 2007. Female patient, 32 years of age, was diagnosed with depression and was treated with LEXOTAN. After drug was administered, patient experienced the following problems/side effects: anorexia, asthenia, depressed mood, depression, dizziness, dysarthria, fear, gait disturbance, insomnia. LEXOTAN dosage: unknown. During the same period patient was treated with RIVOTRIL, TEGRETOL, EUTHYROX. Patient recovered.

Lexotan Side Effects Report #5375831-4
Consumer or non-health professional from BRAZIL reported LEXOTAN problem on June 20, 2007. Female patient, 45 years of age, weighting 136.7 lb, was diagnosed with insomnia, pain, constipation, blood prolactin abnormal and was treated with LEXOTAN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, adenoma benign, carpal tunnel syndrome, dizziness, dyspnoea, dyspnoea exertional, erythema. LEXOTAN dosage: 3 MG/DAY. During the same period patient was treated with BEXTRA, ZELMAC, DOSTINEX, NIFUROXAZIDE. Patient recovered.

Lexotan Side Effects Report #5379724-8
LEXOTAN problem was reported by a Consumer or non-health professional from BRAZIL on June 28, 2007. Female patient, 32 years of age, was diagnosed with depression and was treated with LEXOTAN. After drug was administered, patient experienced the following problems/side effects: anorexia, asthenia, depressed mood, depression, dizziness, dysarthria, fear, gait disturbance, insomnia. LEXOTAN dosage: unknown. During the same period patient was treated with RIVOTRIL, TEGRETOL, EUTHYROX. Patient recovered.


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abdominal pain, adenoma benign, carpal tunnel syndrome, dizziness, dyspnoea, dyspnoea exertional, erythema, , was diagnosed with insomnia, pain, constipation, blood prolactin abnormal and was diagnosed with depression and