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Herbesser Safety Reports submitted to FDA

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Total Herbesser reports: 18.
Herbesser FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 13.
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FDA Reported Herbesser Side Effects: shock, bradycardia, heart rate decreased, nodal rhythm, skin discolouration, hypotension, fatigue, dizziness, large intestine carcinoma, sick sinus syndrome, treatment noncompliance.
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Herbesser Side Effects Report #5251987-9
Physician from JAPAN reported HERBESSER problem on June 20, 2006. Female patient, 81 years of age, was diagnosed with angina pectoris, myocardial infarction, cardiac failure, prophylaxis and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, dementia, disorientation, fall, heart rate decreased, memory impairment. HERBESSER dosage: 30 MG TID PO. During the same period patient was treated with DIGOSIN, BETRILOL, LASIX, RENIVACE, GRAMALIL. Patient was hospitalized. Patient recovered.

Herbesser Side Effects Report #5251988-0
HERBESSER problem was reported by a Physician from JAPAN on Oct 13, 2006. Male patient, 76 years of age, was diagnosed with arteriospasm coronary, hypertension, hypertrophic cardiomyopathy and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, bradycardia, cardiac arrest, cardio-respiratory arrest, electrocardiogram qt prolonged, loss of consciousness, mydriasis, ventricular fibrillation. HERBESSER dosage: 100 MG Q DAY PO. During the same period patient was treated with BEPRICOR, ARTIST, TANATRIL, LOCHOL, BLOPRESS. Patient was hospitalized. Patient died on 07/05/2006.

Herbesser Side Effects Report #5252036-9
Physician from JAPAN reported HERBESSER problem on June 20, 2006. Female patient, 71 years of age, was diagnosed with hypertension, tachycardia and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: arrhythmia, blood pressure increased, dehydration, lip swelling, pyrexia, rash pustular, shock. HERBESSER dosage: 30 MG Q DAY PO. During the same period patient was treated with MONTELUKAST, BLOPRESS, MEVALOTIN, VANCOMYCIN HYDROCHLORIDE, HABEKACIN, PREDONINE. Patient was hospitalized. Patient recovered.

Herbesser Side Effects Report #5270171-6
HERBESSER problem was reported by a Physician from JAPAN on Feb 26, 2007. Female patient, 71 years of age, was diagnosed with hypertension, tachycardia and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: blood pressure systolic decreased, dehydration, eating disorder, haematocrit decreased, haemoglobin decreased, lip swelling, red blood cell count decreased, shock. HERBESSER dosage: 30 MG Q DAY PO. During the same period patient was treated with MONTELUKAST, BLOPRESS, MEVALOTIN, VANCOMYCIN, HABEKACIN, PREDONINE. Patient was hospitalized. Patient recovered.

Herbesser Side Effects Report #5302197-8
Pharmacist from JAPAN reported HERBESSER problem on Mar 27, 2007. Male patient, 83 years of age, was diagnosed with hypercholesterolaemia and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: bradycardia, myocardial infarction. HERBESSER dosage: 200 MG QD PO. During the same period patient was treated with LIPITOR, ITOROL, GASTER, FRANDOL, TICLOPIDINE, RENIVACE, DEPAS, AMARYL. Patient recovered.

Herbesser Side Effects Report #5314702-6
HERBESSER problem was reported by a Pharmacist from JAPAN on Apr 11, 2007. Male patient, 83 years of age, was diagnosed with hypercholesterolaemia and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: bradycardia, sinus arrest. HERBESSER dosage: 200 MG QD ORAL. During the same period patient was treated with LIPITOR, ITOROL, GASTER, FRANDOL, TICLOPIDINE, ASPIRIN, RENIVACE, DEPAS. Patient was hospitalized. Patient recovered.

Herbesser Side Effects Report #5325808-X
Physician from JAPAN reported HERBESSER problem on Apr 24, 2007. Male patient, 78 years of age, was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: bradycardia, no therapeutic response, shock, treatment noncompliance. HERBESSER dosage: 100 MG QD ORAL. During the same period patient was treated with BLOPRESS, KERLONE, ADALAT. Patient recovered.

Herbesser Side Effects Report #5336567-9
HERBESSER problem was reported by a Pharmacist from JAPAN on May 09, 2007. Male patient, 83 years of age, was diagnosed with hypercholesterolaemia and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: sinus arrest, sinus bradycardia. HERBESSER dosage: 200 MG QD ORAL. During the same period patient was treated with LIPITOR, ITOROL, GASTER, FRANDOL, TICLOPIDINE, ASPIRIN, RENIVACE, DEPAS. Patient was hospitalized. Patient recovered.

Herbesser Side Effects Report #5361173-X
Physician from JAPAN reported HERBESSER problem on May 29, 2007. Female patient, 79 years of age, was diagnosed with hypertension and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: sick sinus syndrome. HERBESSER dosage: 100 MG ORAL. Patient was hospitalized. Patient recovered.

Herbesser Side Effects Report #5361229-1
HERBESSER problem was reported by a Physician from JAPAN on May 29, 2007. Female patient was diagnosed with hypertension, hypercholesterolaemia and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: large intestine carcinoma. HERBESSER dosage: (100 MG QD ORAL). During the same period patient was treated with LOCHOL. Patient recovered.

Herbesser Side Effects Report #5372078-2
Physician from JAPAN reported HERBESSER problem on June 07, 2007. Male patient was diagnosed with hypertension and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: bradycardia, dizziness, fatigue, hypotension, shock, treatment noncompliance. HERBESSER dosage: (100 MG QD ORAL). During the same period patient was treated with BLOPRESS, KERLONG, ADALAT. Patient was hospitalized. Patient recovered.

Herbesser Side Effects Report #5069574-4
HERBESSER problem was reported by a Physician from JAPAN on June 15, 2006. Female patient, 77 years of age, was diagnosed with hypertension and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: anorexia, blood pressure increased, erythema multiforme, food allergy, hypersensitivity, skin discolouration, skin lesion. HERBESSER dosage: 30 MG QAM PO. Patient was hospitalized. Patient recovered.

Herbesser Side Effects Report #5121941-6
Physician from JAPAN reported HERBESSER problem on June 23, 2006. Male patient, 79 years of age, was diagnosed with angina pectoris and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: eosinophil count increased, pruritus, rash papular, sensory disturbance, skin discolouration. HERBESSER dosage: 100 MG Q DAY PO. During the same period patient was treated with ARTIST, MAGMITT, THYRADIN, TICLOPIDINE, CLARITHROMYCIN, MUCOSOLATE, URINORM. Patient was hospitalized. Patient recovered.

Herbesser Side Effects Report #5387774-0
HERBESSER problem was reported by a Physician from JAPAN on June 26, 2007. Female patient was diagnosed with hypertension, angina pectoris, constipation, bladder cancer and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: chest discomfort, dysphoria, nodal rhythm, sick sinus syndrome, vomiting. HERBESSER dosage: (100 MG QD ORAL). During the same period patient was treated with METHYCOBAL, ISOSORBIDE DINITRATE, NORVASC, MAGNESIUM OXIDE, HICEE, HERBAL PREPARATION. Patient was hospitalized. Patient recovered.

Herbesser Side Effects Report #5388052-6
Physician from JAPAN reported HERBESSER problem on June 26, 2007. Female patient was diagnosed with hypertension, hypercholesterolaemia and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: large intestine carcinoma. HERBESSER dosage: 100 MG QD ORAL. During the same period patient was treated with LOCHOL. Patient recovered.

Herbesser Side Effects Report #5392806-X
HERBESSER problem was reported by a Physician from JAPAN on July 02, 2007. Male patient was diagnosed with hypertension and was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: bradycardia, dizziness, fatigue, hypotension, shock. HERBESSER dosage: (100 MG QD ORAL). During the same period patient was treated with BLOPRESS, KERLONG, ADALAT. Patient was hospitalized. Patient recovered.

Herbesser Side Effects Report #5408395-7
Health Professional from JAPAN reported HERBESSER problem on July 20, 2007. Female patient, 24 years of age, was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: blood potassium decreased, blood pressure decreased, depressed level of consciousness, electrocardiogram qrs complex prolonged, electrocardiogram qt prolonged, heart rate decreased, nodal rhythm, suicide attempt. HERBESSER dosage: 1800 MG 1X ORAL. During the same period patient was treated with RYTHMODAN, KALLIDINOGENASE. Patient was hospitalized. Patient recovered.

Herbesser Side Effects Report #5408397-0
HERBESSER problem was reported by a Physician from JAPAN on July 20, 2007. Male patient, 47 years of age, was treated with HERBESSER. After drug was administered, patient experienced the following problems/side effects: back pain, heart rate decreased, shock. HERBESSER dosage: unknown. During the same period patient was treated with CARVEDILOL, PILSICAINIDE HYDROCHLORIDE. Patient recovered.

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