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Review Visicol Safety Reports submitted to FDA

Total Visicol reports: 19.
Visicol FDA safety alerts: 2006 .
Reported deaths: 2    Reported hospitalizations: 17.
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FDA Reported Visicol Side Effects: nephrocalcinosis, renal failure acute, nausea, asthenia, malaise, oesophageal obstruction, foreign body trauma, drooling, atrial fibrillation, decreased appetite, dehydration.
Visicol Usage.
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Visicol Side Effects Report #5663881-X
Physician from JAPAN reported VISICOL problem on Mar 07, 2008. Male patient, 74 years of age, was diagnosed with colonoscopy and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: dehydration, hypoglycaemia, hypotension, malaise, no therapeutic response, renal failure, vomiting. VISICOL dosage: unknown. During the same period patient was treated with CANDESARTAN CILEXETIL, AMLODIPINE BESYLATE, SENNOSIDE, THYROID, GLUCAGON. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5678148-3
VISICOL problem was reported by a Physician from JAPAN on Mar 14, 2008. Male patient, 63 years of age, was diagnosed with computerised tomogram abdomen and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: asthenia, blood calcium decreased, hypokalaemia, hypotension, nausea. VISICOL dosage: 50 MG, ORAL. During the same period patient was treated with DILTIAZEM. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5678634-6
Physician from JAPAN reported VISICOL problem on Mar 07, 2008. Female patient, 86 years of age, was diagnosed with endoscopy large bowel and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: arrhythmia, blood pressure systolic increased, cold sweat, convulsion, dehydration, electrocardiogram qt prolonged, loss of consciousness, malaise, nausea. VISICOL dosage: unknown. During the same period patient was treated with SENNOSIDE, FLUNITRAZEPAM, BROTIZOLAM. Patient recovered.

Visicol Side Effects Report #5689657-5
VISICOL problem was reported by a Physician from JAPAN on Mar 25, 2008. Male patient, 74 years of age, was diagnosed with bowel preparation, colonoscopy and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: anaemia, anorexia, blood pressure decreased, dehydration, hypoalbuminaemia, kidney enlargement, pleural effusion, renal failure acute. VISICOL dosage: unknown. During the same period patient was treated with BIFIDOBACTERIUM, TANNALBIN, FOSFOMYCIN CALCIUM, AZOSEMIDE, CARBOCISTEINE, DIGESTIVE ENZYME PREPARATION. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5689673-3
Physician from JAPAN reported VISICOL problem on Mar 25, 2008. Female patient, 57 years of age, was diagnosed with bowel preparation, colonoscopy and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: abdominal distension, cold sweat, colitis ischaemic, colonic stenosis, diarrhoea, haematochezia, nausea, vomiting. VISICOL dosage: unknown. During the same period patient was treated with RABEPRAZOLE, URSODIOL. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5631929-4
VISICOL problem was reported by a Physician from JAPAN on Feb 05, 2008. Male patient, 74 years of age, was diagnosed with colonoscopy and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: anaemia, dehydration, hyperkalaemia, hypoalbuminaemia, pleural effusion, renal failure acute. VISICOL dosage: unknown. During the same period patient was treated with BIFIDOBACTERIUM, TANNALBIN, FOSFOMYCIN CALCIUM, AZOSEMIDE, CARBOCISTEINE, DIGESTIVE ENZYME PREPARATION, LEVOFLOXACIN. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5635919-7
Physician from JAPAN reported VISICOL problem on Feb 14, 2008. Male patient, 33 years of age, was diagnosed with endoscopy large bowel, bowel preparation, colonoscopy and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: abdominal pain, ileus, pyrexia. VISICOL dosage: unknown. During the same period patient was treated with PICOSULPHATE, PICOSULPHATE. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5642542-7
VISICOL problem was reported by a Physician from JAPAN on Feb 08, 2008. Male patient, 74 years of age, was diagnosed with colonoscopy and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: dehydration, hypoglycaemia, hypotension, malaise, renal failure. VISICOL dosage: unknown. During the same period patient was treated with CANDESARTAN CILEXETIL, AMLODIPINE BESYLATE, SENNOSIDE, THYROID, GLUCAGON. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5565835-0
Physician from JAPAN reported VISICOL problem on Dec 05, 2007. Male patient, 73 years of age, was diagnosed with endoscopy large bowel and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: post procedural complication, renal failure acute. VISICOL dosage: unknown. During the same period patient was treated with TRIPAMIDE, OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5578207-X
VISICOL problem was reported by a Physician from JAPAN on Dec 21, 2007. Male patient, 33 years of age, was diagnosed with endoscopy large bowel and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: ileus. VISICOL dosage: unknown. During the same period patient was treated with PICOSULPHATE. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5578212-3
Physician from JAPAN reported VISICOL problem on Dec 21, 2007. Male patient, 54 years of age, was diagnosed with endoscopy large bowel and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: haematemesis, mallory-weiss syndrome. VISICOL dosage: unknown. During the same period patient was treated with SENNOSIDE, MAGNESIUM CITRATE, PICOSULPHATE, METOCLOPRAMIDE, DIMETICONE. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5582847-1
VISICOL problem was reported by a Physician from JAPAN on Dec 27, 2007. Male patient, 73 years of age, was diagnosed with endoscopy large bowel and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: abdominal distension, dyspnoea, renal failure acute. VISICOL dosage: unknown. During the same period patient was treated with TRIPAMIDE, OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5582848-3
Physician from JAPAN reported VISICOL problem on Dec 27, 2007. Male patient, 54 years of age, was diagnosed with endoscopy large bowel and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: mallory-weiss syndrome. VISICOL dosage: unknown. During the same period patient was treated with SENNOSIDE, MAGNESIUM CITRATE, PICOSULPHATE, METOCLOPRAMIDE, DIMETICONE. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5582862-8
VISICOL problem was reported by a Physician from JAPAN on Dec 27, 2007. Male patient, 33 years of age, was diagnosed with endoscopy large bowel and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: ileus, pyrexia. VISICOL dosage: unknown. During the same period patient was treated with PICOSULPHATE. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5512807-8
Physician from JAPAN reported VISICOL problem on Nov 01, 2007. Male patient, 73 years of age, was diagnosed with endoscopy large bowel and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: abdominal distension, blood creatinine increased, blood urea increased, dyspnoea, malaise, oedema peripheral, renal failure acute. VISICOL dosage: unknown. During the same period patient was treated with TRIPAMIDE, OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5519300-7
VISICOL problem was reported by a Physician from JAPAN on Nov 09, 2007. Female patient, 73 years of age, was diagnosed with endoscopy large bowel and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: abdominal pain, cardiac failure acute, cardio-respiratory arrest, no therapeutic response, vomiting. VISICOL dosage: unknown. During the same period patient was treated with LORNOXICAM, SERRAPEPTASE, ALUMINUM HYDROXIDE, TRIMEBUTINE MALEATE, BIFIDOBACTERIUM, AMLODIPINE BESYLATE, PROPIVERINE, DIAZEPAM. Patient was hospitalized. Patient died on 10/13/2007.

Visicol Side Effects Report #5527930-1
Physician from JAPAN reported VISICOL problem on Nov 16, 2007. Female patient, 73 years of age, was diagnosed with endoscopy large bowel and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: abdominal pain, cardiac failure acute, cardio-respiratory arrest, large intestine carcinoma, no therapeutic response, vomiting. VISICOL dosage: unknown. During the same period patient was treated with PICOSULPHATE, SENNOSIDE, DIMETICONE, LORNOXICAM, SERRAPEPTASE, ALUMINUM HYDROXIDE, TRIMEBUTINE MALEATE, BIFIDOBACTERIUM. Patient was hospitalized. Patient died on 10/13/2007.

Visicol Side Effects Report #5508883-9
VISICOL problem was reported by a Physician from UNITED STATES on Sept 27, 2006. Female patient, 55 years of age, was diagnosed with colonoscopy and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: nephrocalcinosis, renal failure acute. VISICOL dosage: unknown. During the same period patient was treated with ASPIRIN, PLAVIX, BENICAR, PROZAC, CELEBREX, WELLBUTRIN, TOPROL, CRESTOR. Patient was hospitalized. Patient recovered.

Visicol Side Effects Report #5470141-9
Physician from UNITED STATES reported VISICOL problem on Sept 19, 2007. Female patient, 60 years of age, weighting 118.2 lb, was diagnosed with colonoscopy and was treated with VISICOL. After drug was administered, patient experienced the following problems/side effects: decreased appetite, malaise, nausea, nephrocalcinosis. VISICOL dosage: unknown. During the same period patient was treated with METOPROLOL TARTRATE, LOTREL, ATORVASTATIN CALCIUM, LEVOTHYROXINE, DETROL. Patient recovered.


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