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Review Salagen Safety Reports submitted to FDA

Total Salagen reports: 10.
Salagen FDA safety alerts: No.
   Reported hospitalizations: 4.
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FDA Reported Salagen Side Effects: stent placement, myocardial infarction, exercise tolerance decreased, dyspnoea exertional, urinary retention, abdominal pain lower, pyrexia, dysphonia, neuropathy peripheral, burning sensation.
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Salagen Side Effects Report #5659526-5
Physician from SPAIN reported SALAGEN problem on Mar 04, 2008. Female patient, 83 years of age, was diagnosed with sjogren's syndrome and was treated with SALAGEN. After drug was administered, patient experienced the following problems/side effects: anorexia, asthenia, depression, hypersomnia. SALAGEN dosage: 15 MG/D. Patient recovered.

Salagen Side Effects Report #5612067-3
SALAGEN problem was reported by a Physician from ITALY on Jan 28, 2008. Female patient, 31 years of age, was diagnosed with aptyalism and was treated with SALAGEN. After drug was administered, patient experienced the following problems/side effects: flushing, skin exfoliation, tachycardia. SALAGEN dosage: 5 MG. Patient was hospitalized. Patient recovered.

Salagen Side Effects Report #5621729-3
Physician from ITALY reported SALAGEN problem on Feb 01, 2008. Female patient, 31 years of age, was diagnosed with aptyalism and was treated with SALAGEN. After drug was administered, patient experienced the following problems/side effects: flushing, skin exfoliation, tachycardia. SALAGEN dosage: 5 MG. Patient was hospitalized. Patient recovered.

Salagen Side Effects Report #5545282-8
SALAGEN problem was reported by a Consumer or non-health professional from ITALY on Dec 04, 2007. Female patient, 84 years of age, was diagnosed with sjogren's syndrome and was treated with SALAGEN. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation. SALAGEN dosage: 15 MG/DAY. Patient recovered.

Salagen Side Effects Report #5553660-6
Consumer or non-health professional from ITALY reported SALAGEN problem on Dec 05, 2007. Female patient, 84 years of age, was diagnosed with sjogren's syndrome and was treated with SALAGEN. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation. SALAGEN dosage: 15 MG/DAY. Patient recovered.

Salagen Side Effects Report #5513986-9
SALAGEN problem was reported by a Consumer or non-health professional from JAPAN on Nov 08, 2007. Female patient, 72 years of age, was diagnosed with dry mouth and was treated with SALAGEN. After drug was administered, patient experienced the following problems/side effects: cardiac failure, dyspnoea exertional, exercise tolerance decreased, myocardial infarction, stent placement. SALAGEN dosage: 5 MG, TID. During the same period patient was treated with THYRADIN. Patient was hospitalized. Patient recovered.

Salagen Side Effects Report #5498529-0
Consumer or non-health professional from JAPAN reported SALAGEN problem on Oct 18, 2007. Male patient was diagnosed with dry mouth and was treated with SALAGEN. After drug was administered, patient experienced the following problems/side effects: abdominal pain lower, urinary retention. SALAGEN dosage: 5 MG, TID. Patient recovered.

Salagen Side Effects Report #5465273-5
SALAGEN problem was reported by a Consumer or non-health professional from JAPAN on Sept 18, 2007. Female patient, 72 years of age, was diagnosed with dry mouth and was treated with SALAGEN. After drug was administered, patient experienced the following problems/side effects: dyspnoea exertional, exercise tolerance decreased, myocardial infarction, stent placement. SALAGEN dosage: 5 MG, TID. Patient was hospitalized. Patient recovered.

Salagen Side Effects Report #5377268-0
Consumer or non-health professional from JAPAN reported SALAGEN problem on June 19, 2007. Male patient was diagnosed with dry mouth and was treated with SALAGEN. After drug was administered, patient experienced the following problems/side effects: abdominal pain lower, urinary retention. SALAGEN dosage: 5 MG, TID. Patient recovered.

Salagen Side Effects Report #5377268-0
SALAGEN problem was reported by a Consumer or non-health professional from JAPAN on June 19, 2007. Male patient was diagnosed with dry mouth and was treated with SALAGEN. After drug was administered, patient experienced the following problems/side effects: abdominal pain lower, urinary retention. SALAGEN dosage: 5 MG, TID. Patient recovered.


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anorexia, asthenia, depression, hypersomnia, flushing, skin exfoliation, tachycardia, flushing, skin exfoliation, tachycardia, , was diagnosed with sjogren's syndrome and was diagnosed with aptyalism and was diagnosed with aptyalism and