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Review Provasin Safety Reports submitted to FDA

Total Provasin reports: 14.
Provasin FDA safety alerts: No.
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FDA Reported Provasin Side Effects: cutaneous vasculitis, tachycardia, flushing, blood pressure fluctuation, sensation of heaviness, malaise, heart rate decreased, eye operation, dyspnoea, cardiac disorder, blood pressure inadequately controlled.
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Provasin Side Effects Report #5421979-5
Pharmacist from GERMANY reported PROVASIN problem on Aug 20, 2007. Female patient, 70 years of age, was diagnosed with hypertension and was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: blood pressure inadequately controlled, cardiac disorder, dyspnoea, eye operation, heart rate decreased, malaise, sensation of heaviness. PROVASIN dosage: unknown. During the same period patient was treated with PROVAS COMP, VERAPAMIL. Patient recovered.

Provasin Side Effects Report #5389843-8
PROVASIN problem was reported by a Consumer or non-health professional from GERMANY on July 11, 2007. Female patient, 66 years of age, was diagnosed with hypertension and was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: cutaneous vasculitis. PROVASIN dosage: unknown. Patient recovered.

Provasin Side Effects Report #5391937-8
Consumer or non-health professional from GERMANY reported PROVASIN problem on July 11, 2007. Female patient, 66 years of age, was diagnosed with hypertension and was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: cutaneous vasculitis. PROVASIN dosage: unknown. Patient recovered.

Provasin Side Effects Report #5391950-0
PROVASIN problem was reported by a Physician from GERMANY on July 13, 2007. Male patient, 55 years of age, weighting 196.2 lb, was diagnosed with hypertension and was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: blood pressure fluctuation, flushing, tachycardia. PROVASIN dosage: 160 MG/DAY. During the same period patient was treated with AMLODIPINE. Patient recovered.


Provasin Side Effects Report #5397370-7
Consumer or non-health professional from GERMANY reported PROVASIN problem on July 23, 2007. Female patient, 79 years of age, was diagnosed with hypertension and was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: confusional state, memory impairment, nervous system disorder. PROVASIN dosage: 80 MG, QD. Patient recovered.

Provasin Side Effects Report #5389843-8
PROVASIN problem was reported by a Consumer or non-health professional from GERMANY on July 11, 2007. Female patient, 66 years of age, was diagnosed with hypertension and was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: cutaneous vasculitis. PROVASIN dosage: unknown. Patient recovered.

Provasin Side Effects Report #5391937-8
Consumer or non-health professional from GERMANY reported PROVASIN problem on July 11, 2007. Female patient, 66 years of age, was diagnosed with hypertension and was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: cutaneous vasculitis. PROVASIN dosage: unknown. Patient recovered.

Provasin Side Effects Report #5391950-0
PROVASIN problem was reported by a Physician from GERMANY on July 13, 2007. Male patient, 55 years of age, weighting 196.2 lb, was diagnosed with hypertension and was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: blood pressure fluctuation, flushing, tachycardia. PROVASIN dosage: 160 MG/DAY. During the same period patient was treated with AMLODIPINE. Patient recovered.

Provasin Side Effects Report #5397370-7
Consumer or non-health professional from GERMANY reported PROVASIN problem on July 23, 2007. Female patient, 79 years of age, was diagnosed with hypertension and was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: confusional state, memory impairment, nervous system disorder. PROVASIN dosage: 80 MG, QD. Patient recovered.


Provasin Side Effects Report #5363197-5
PROVASIN problem was reported by a Pharmacist from GERMANY on June 12, 2007. Female patient, 70 years of age, was diagnosed with hypertension and was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: blood pressure inadequately controlled, cardiac disorder, dyspnoea, eye operation, heart rate decreased, malaise, sensation of heaviness. PROVASIN dosage: unknown. During the same period patient was treated with PROVAS COMP, VERAPAMIL. Patient recovered.

Provasin Side Effects Report #5368161-8
Physician from GERMANY reported PROVASIN problem on June 15, 2007. Male patient, 55 years of age, weighting 196.2 lb, was diagnosed with hypertension and was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: blood pressure fluctuation, flushing, tachycardia. PROVASIN dosage: 160 MG/DAY. During the same period patient was treated with AMLODIPINE. Patient recovered.

Provasin Side Effects Report #5317539-7
PROVASIN problem was reported by a Physician from GERMANY on Apr 24, 2007. Female patient, 67 years of age, was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: cutaneous vasculitis. PROVASIN dosage: unknown. Patient recovered.

Provasin Side Effects Report #5323445-4
Physician from GERMANY reported PROVASIN problem on May 07, 2007. Female patient, 66 years of age, was diagnosed with hypertension and was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: cutaneous vasculitis. PROVASIN dosage: unknown. Patient recovered.

Provasin Side Effects Report #5334803-6
PROVASIN problem was reported by a Consumer or non-health professional from GERMANY on May 18, 2007. Female patient, 79 years of age, was diagnosed with hypertension and was treated with PROVASIN. After drug was administered, patient experienced the following problems/side effects: confusional state, memory impairment, nervous system disorder. PROVASIN dosage: 80 MG, QD. Patient recovered.


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