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Locol Side Effects submitted to FDA

Total Locol reports: 11.
Locol FDA safety alerts: No.
   Reported hospitalizations: 4.
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FDA Reported Locol Side Effects: blood creatine phosphokinase increased, myalgia, hypertension, aortic arteriosclerosis, myoglobin blood increased, vomiting, diarrhoea, biliary colic, lenticular opacities, enuresis, electroencephalogram abnormal,
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Locol Side Effects Report #5601434-X
Physician from GERMANY reported LOCOL problem on Jan 17, 2008. Female patient, 68 years of age, weighting 145.5 lb, was diagnosed with hypercholesterolaemia, back pain and was treated with LOCOL. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased, c-reactive protein increased, gamma-glutamyltransferase increased, glomerular filtration rate decreased, hepatic enzyme increased. LOCOL dosage: unknown. During the same period patient was treated with KATADOLON. Patient recovered.



Locol Side Effects Report #5563353-7
LOCOL problem was reported by a Physician from GERMANY on Dec 10, 2007. Female patient, 85 years of age, was diagnosed with hypercholesterolaemia, pain and was treated with LOCOL. After drug was administered, patient experienced the following problems/side effects: condition aggravated, gastrointestinal infection, haemorrhage, headache, knee arthroplasty, muscular weakness, myalgia, paraesthesia. LOCOL dosage: 80 MG, QD. During the same period patient was treated with OPIOIDS. Patient was hospitalized. Patient recovered.



Locol Side Effects Report #5564314-4
Physician from GERMANY reported LOCOL problem on Dec 12, 2007. Male patient, 66 years of age, weighting 176.4 lb, was diagnosed with hypercholesterolaemia and was treated with LOCOL. After drug was administered, patient experienced the following problems/side effects: bone pain, spinal osteoarthritis, tendon rupture. LOCOL dosage: 80 MG, QD. Patient recovered.



Locol Side Effects Report #5564320-X
LOCOL problem was reported by a Physician from GERMANY on Dec 12, 2007. Male patient, 66 years of age, weighting 176.4 lb, was diagnosed with hypercholesterolaemia and was treated with LOCOL. After drug was administered, patient experienced the following problems/side effects: tendon rupture. LOCOL dosage: unknown. Patient recovered.




Locol Side Effects Report #5388930-8
Consumer or non-health professional from GERMANY reported LOCOL problem on July 10, 2007. Female patient, 66 years of age, was diagnosed with hypercholesterolaemia, hypertension and was treated with LOCOL. After drug was administered, patient experienced the following problems/side effects: biliary colic, diarrhoea, vomiting. LOCOL dosage: 80 MG, QD. During the same period patient was treated with RAMIPRIL, BELOC ZOK. Patient was hospitalized. Patient recovered.



Locol Side Effects Report #5388968-0
LOCOL problem was reported by a Health Professional from GERMANY on July 06, 2007. Female patient was diagnosed with hypercholesterolaemia and was treated with LOCOL. After drug was administered, patient experienced the following problems/side effects: aortic arteriosclerosis, blood creatine phosphokinase increased, hypertension, myoglobin blood increased. LOCOL dosage: 20 MG, QD. During the same period patient was treated with INEGY, ATORVASTATIN CALCIUM, SIMVASTATIN, NIASPAN. Patient recovered.



Locol Side Effects Report #5388930-8
Consumer or non-health professional from GERMANY reported LOCOL problem on July 10, 2007. Female patient, 66 years of age, was diagnosed with hypercholesterolaemia, hypertension and was treated with LOCOL. After drug was administered, patient experienced the following problems/side effects: biliary colic, diarrhoea, vomiting. LOCOL dosage: 80 MG, QD. During the same period patient was treated with RAMIPRIL, BELOC ZOK. Patient was hospitalized. Patient recovered.



Locol Side Effects Report #5388968-0
LOCOL problem was reported by a Health Professional from GERMANY on July 06, 2007. Female patient was diagnosed with hypercholesterolaemia and was treated with LOCOL. After drug was administered, patient experienced the following problems/side effects: aortic arteriosclerosis, blood creatine phosphokinase increased, hypertension, myoglobin blood increased. LOCOL dosage: 20 MG, QD. During the same period patient was treated with INEGY, ATORVASTATIN CALCIUM, SIMVASTATIN, NIASPAN. Patient recovered.



Locol Side Effects Report #5361840-8
Health Professional from GERMANY reported LOCOL problem on June 06, 2007. Female patient was diagnosed with hypercholesterolaemia and was treated with LOCOL. After drug was administered, patient experienced the following problems/side effects: aortic arteriosclerosis, blood creatine phosphokinase increased, hypertension. LOCOL dosage: 20 MG, QD. During the same period patient was treated with INEGY, ATORVASTATIN CALCIUM. Patient recovered.




Locol Side Effects Report #5362361-9
LOCOL problem was reported by a Health Professional from GERMANY on June 06, 2007. Female patient was diagnosed with hypercholesterolaemia and was treated with LOCOL. After drug was administered, patient experienced the following problems/side effects: aortic arteriosclerosis, blood creatine phosphokinase increased, hypertension. LOCOL dosage: 20 MG, QD. During the same period patient was treated with INEGY, ATORVASTATIN CALCIUM. Patient recovered.



Locol Side Effects Report #5338006-0
Health Professional from BRAZIL reported LOCOL problem on May 25, 2007. Female patient, 51 years of age, weighting 136.7 lb, was diagnosed with blood cholesterol, hypothyroidism and was treated with LOCOL. After drug was administered, patient experienced the following problems/side effects: abdominal pain, appendicitis, myalgia, surgery. LOCOL dosage: 80 MG, QHS. During the same period patient was treated with EUTHYROX. Patient was hospitalized. Patient recovered.




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, Locol was diagnosed with hypercholesterolaemia, back pain and Locol was diagnosed with hypercholesterolaemia, pain and