Simvastatin Safety Reports submitted to FDA
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More Rx Information: A B C D E F G H I J K L M N O P Q R S T U V W X Y ZTotal Simvastatin reports: 593.
Simvastatin FDA safety alerts: 2008 .
Reported deaths: 48 Reported hospitalizations: 216.
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FDA Reported Simvastatin Side Effects: rhabdomyolysis, myalgia, blood creatine phosphokinase increased, renal failure acute, asthenia, pain in extremity, fatigue, muscular weakness, nausea, dizziness, muscle spasms.
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Simvastatin Side Effects Report #5341713-7Health Professional from UNITED KINGDOM reported SIMVASTATIN problem on May 15, 2007. Female patient, weighting 132.3 lb, was diagnosed with type iia hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, hepatotoxicity, lethargy, malaise, myalgia. SIMVASTATIN dosage: 10 MG, ORAL. During the same period patient was treated with TOLTERODINE TARTRATE. Patient recovered.
Simvastatin Side Effects Report #5341721-6
SIMVASTATIN problem was reported by a Pharmacist from UNITED STATES on May 29, 2007. Male patient, 77 years of age, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: hepatic enzyme increased, rhabdomyolysis, transaminases increased. SIMVASTATIN dosage: 80MG EVERY DAY PO. During the same period patient was treated with NIACIN. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5343563-4
Health Professional from UNITED KINGDOM reported SIMVASTATIN problem on May 17, 2007. Female patient, 74 years of age, was diagnosed with blood cholesterol increased and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: feeling abnormal. SIMVASTATIN dosage: 40 MG, QD, ORAL. Patient recovered.
Simvastatin Side Effects Report #5343564-6
SIMVASTATIN problem was reported by a Health Professional from UNITED KINGDOM on May 17, 2007. Male patient, 71 years of age, weighting 229.3 lb, was diagnosed with diabetes mellitus non-insulin-dependent and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, acute coronary syndrome, atrial fibrillation, disease recurrence, intestinal ischaemia, left ventricular failure, myocardial infarction, pancreatitis acute. SIMVASTATIN dosage: 20 MG, QD, ORAL. During the same period patient was treated with AVANDIA, ASPIRIN, ATENOLOL, BISOPROLOL FUMARATE, FUROSEMIDE, METFORMIN. Patient was hospitalized and became disabled. Patient recovered.
Simvastatin Side Effects Report #5343585-3
Health Professional from TAIWAN, PROVINCE OF CHINA reported SIMVASTATIN problem on May 16, 2007. Male patient, 70 years of age, was diagnosed with gout and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: gait disturbance, muscle contractions involuntary, myopathy, myotonia, nerve conduction studies abnormal, sensorimotor disorder. SIMVASTATIN dosage: unknown. During the same period patient was treated with COLCHICUM JTL LIQ. Patient recovered.
Simvastatin Side Effects Report #5343919-X
SIMVASTATIN problem was reported by a Health Professional from UNITED STATES on May 16, 2007. Male patient, 71 years of age, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: myasthenia gravis. SIMVASTATIN dosage: unknown. During the same period patient was treated with PRAVASTATIN. Patient recovered.
Simvastatin Side Effects Report #5343921-8
Consumer or non-health professional from UNITED STATES reported SIMVASTATIN problem on May 16, 2007. Female patient, 51 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: rhabdomyolysis. SIMVASTATIN dosage: 20 MG, BID, ORAL. During the same period patient was treated with RITONAVIR, ZIDOVUDINE, LAMIVUDINE, INDINIVIR SULPHATE, OMEPRAZOLE, ISOPHANE INSULIN, METFORMIN HYDROCHLORIDE, MECLIZINE. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5346640-7
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on May 23, 2007. Male patient was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: arteriovenous malformation, convulsion. SIMVASTATIN dosage: 20 MG, ORAL. During the same period patient was treated with AMLODIPINE, ASPIRIN, INDAPAMIDE, LISINOPRIL, NEBIVOLOL, OXAZEPAM. Patient recovered.
Simvastatin Side Effects Report #5346797-8
Health Professional from UNITED KINGDOM reported SIMVASTATIN problem on May 18, 2007. Male patient, 41 years of age, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: glycogen storage disease type ii. SIMVASTATIN dosage: 10 MG, QD. During the same period patient was treated with BEZAFIBRATE. Patient recovered.
Simvastatin Side Effects Report #5346798-X
SIMVASTATIN problem was reported by a Health Professional from UNITED KINGDOM on May 18, 2007. Male patient, 68 years of age, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: arthralgia, cardiac murmur, catheter related infection, confusional state, contusion, headache, jaundice, joint effusion, joint swelling. SIMVASTATIN dosage: 20 MG, QD. During the same period patient was treated with AMLODIPINE MALEATE. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5346805-4
Health Professional from FINLAND reported SIMVASTATIN problem on May 18, 2007. Male patient, 49 years of age, was diagnosed with bronchitis and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: rhabdomyolysis. SIMVASTATIN dosage: 80 MG, QD. During the same period patient was treated with CLARITHROMYCIN. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5346807-8
SIMVASTATIN problem was reported by a Health Professional from UNITED KINGDOM on May 18, 2007. Female patient, 31 years of age, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: glycogen storage disease type v. SIMVASTATIN dosage: 10 MG, QD. Patient recovered.
Simvastatin Side Effects Report #5347432-5
Pharmacist from UNITED STATES reported SIMVASTATIN problem on June 04, 2007. Male patient, 45 years of age, weighting 280.0 lb, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, myalgia. SIMVASTATIN dosage: 40MG 1 TIME PO. Patient recovered.
Simvastatin Side Effects Report #5347448-9
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED STATES on June 04, 2007. Male patient, 65 years of age, weighting 173.0 lb, was diagnosed with blood cholesterol increased and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: anaemia, insomnia, polymyalgia rheumatica. SIMVASTATIN dosage: 30 MG DAILY PO. During the same period patient was treated with CRESTOR. Patient recovered.
Simvastatin Side Effects Report #5348408-4
Consumer or non-health professional from UNITED KINGDOM reported SIMVASTATIN problem on May 21, 2007. Male patient, 72 years of age, was diagnosed with hypercholesterolaemia, staphylococcal sepsis and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, lower respiratory tract infection, myocardial ischaemia, myopathy, renal failure chronic. SIMVASTATIN dosage: 20 MG, QD, ORAL. During the same period patient was treated with FUSIDIC ACID. Patient died on 04/16/2006.
Simvastatin Side Effects Report #5348417-5
SIMVASTATIN problem was reported by a Physician from DENMARK on May 24, 2007. Male patient, 81 years of age, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: demyelination, paralysis, peroneal nerve injury. SIMVASTATIN dosage: 40 MG, ORAL. Patient recovered.
Simvastatin Side Effects Report #5348663-0
Health Professional from UNITED STATES reported SIMVASTATIN problem on May 21, 2007. Male patient, 82 years of age, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: hyperkalaemia, renal failure acute, rhabdomyolysis. SIMVASTATIN dosage: 20 MG, QD. During the same period patient was treated with WARFARIN. Patient recovered.
Simvastatin Side Effects Report #5352191-6
SIMVASTATIN problem was reported by a Health Professional from UNITED KINGDOM on May 23, 2007. Male patient was diagnosed with blood cholesterol increased and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: arteriovenous malformation, convulsion. SIMVASTATIN dosage: 20 MG, ORAL. During the same period patient was treated with AMLODIPINE MALEATE, ASPIRIN, INDAPAMIDE, LISINOPRIL, NEBIVOLOL, OXAZEPAM. Patient recovered.
Simvastatin Side Effects Report #5352938-9
Physician from UNITED STATES reported SIMVASTATIN problem on May 24, 2007. Male patient, 59 years of age, weighting 196.0 lb, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: abasia, blood pressure decreased, culture tissue specimen positive, culture urine positive, cytomegalovirus infection, enterococcal infection, gastric haemorrhage, haemodialysis, hepatic haemorrhage. SIMVASTATIN dosage: 40 MG DAILY PO. During the same period patient was treated with LISINOPRIL, ASPIRIN. Patient was hospitalized. Patient died on 10/01/2005.
Simvastatin Side Effects Report #5353573-9
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on May 31, 2007. Male patient was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: lip swelling. SIMVASTATIN dosage: 40 MG;QD. Patient recovered.
Simvastatin Side Effects Report #5353574-0
Consumer or non-health professional from UNITED KINGDOM reported SIMVASTATIN problem on May 31, 2007. Male patient, 56 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: lichen planus, scar. SIMVASTATIN dosage: 40 MG, ORAL. Patient recovered.
Simvastatin Side Effects Report #5353626-5
SIMVASTATIN problem was reported by a Physician from UNITED STATES on June 08, 2007. Male patient, 65 years of age, weighting 200.0 lb, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: pain in extremity. SIMVASTATIN dosage: 10MG ORAL. During the same period patient was treated with CARDURA, AVODART. Patient recovered.
Simvastatin Side Effects Report #5355734-1
Health Professional from UNITED STATES reported SIMVASTATIN problem on June 11, 2007. Female patient, 69 years of age, weighting 120.4 lb, was diagnosed with dyslipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, hepatotoxicity, liver function test abnormal. SIMVASTATIN dosage: unknown. During the same period patient was treated with METFORMIN, ACTOS, COUMADIN, LOW DOSE ASPIRIN, METOPROLOL SUCCINATE, LASIX. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5357410-8
SIMVASTATIN problem was reported by a Health Professional from UNITED KINGDOM on May 29, 2007. Male patient was diagnosed with blood cholesterol increased and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: arteriovenous malformation, convulsion. SIMVASTATIN dosage: 20 MG, ORAL. Patient recovered.
Simvastatin Side Effects Report #5357703-4
Health Professional from FRANCE reported SIMVASTATIN problem on June 11, 2007. Male patient, weighting 158.7 lb, was diagnosed with pancreatic carcinoma metastatic and was treated with SIMVASTATIN. SIMVASTATIN dosage: unknown. During the same period patient was treated with LEUCOVORIN CALCIUM, IRINOTECAN, ZOFRAN, OXALIPLATIN, METFORMIN, FLUOROURACIL, ATROPINE, KARDEGIC. Patient died on 05/24/2006.
Simvastatin Side Effects Report #5361135-2
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 05, 2007. Female patient, 73 years of age, was diagnosed with blood cholesterol increased and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: hypoaesthesia. SIMVASTATIN dosage: 40 MG, QD, ORAL. During the same period patient was treated with ASPIRIN, ATENOLOL, BENDROFLUMETHIAZIDE. Patient recovered.
Simvastatin Side Effects Report #5361326-0
Consumer or non-health professional from UNITED KINGDOM reported SIMVASTATIN problem on June 04, 2007. Female patient, 81 years of age, weighting 147.7 lb, was diagnosed with blood cholesterol increased and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: tendonitis. SIMVASTATIN dosage: 10 MG, ORAL. During the same period patient was treated with BECLOMETHASONE DIPROPIONATE, BENDROFLUMETHIAZIDE, CANDESARTAN CILEXETIL, LACTULOSE, MOVELAT, SALBUTAMOL. Patient recovered.
Simvastatin Side Effects Report #5362797-6
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 01, 2007. Male patient was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: lip swelling. SIMVASTATIN dosage: 40 MG (40 MG, 1 IN 1 D). Patient recovered.
Simvastatin Side Effects Report #5362798-8
Consumer or non-health professional from UNITED KINGDOM reported SIMVASTATIN problem on June 01, 2007. Male patient, 56 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: lichen planus. SIMVASTATIN dosage: (40 MG). Patient recovered.
Simvastatin Side Effects Report #5363004-0
SIMVASTATIN problem was reported by a Health Professional from UNITED KINGDOM on June 05, 2007. Male patient, 63 years of age, weighting 174.2 lb, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: face oedema, myalgia. SIMVASTATIN dosage: 40 MG, UNK, ORAL. Patient recovered.
Simvastatin Side Effects Report #5363005-2
Health Professional from UNITED KINGDOM reported SIMVASTATIN problem on June 05, 2007. Male patient, 55 years of age, weighting 165.3 lb, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: convulsion, partial seizures. SIMVASTATIN dosage: unknown. During the same period patient was treated with ATORVASTATIN CALCIUM, FLUOXETINE. Patient recovered.
Simvastatin Side Effects Report #5363007-6
SIMVASTATIN problem was reported by a Health Professional from UNITED KINGDOM on June 05, 2007. Male patient, 73 years of age, weighting 198.4 lb, was diagnosed with blood cholesterol increased and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: fatigue, myalgia. SIMVASTATIN dosage: 20 MG, UNK, ORAL. During the same period patient was treated with ALLOPURINOL, AMLODIPINE, SOTALOL, WARFARIN. Patient recovered.
Simvastatin Side Effects Report #5363338-X
Consumer or non-health professional from UNITED KINGDOM reported SIMVASTATIN problem on June 06, 2007. Female patient, 76 years of age, weighting 152.1 lb, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: dermatitis, lichenoid keratosis. SIMVASTATIN dosage: 20 MG, UNK, ORAL. During the same period patient was treated with ALLOPURINOL, AMLODIPINE, ASPIRIN, ATENOLOL, METFORMIN. Patient recovered.
Simvastatin Side Effects Report #5363501-8
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 04, 2007. Female patient, 81 years of age, was diagnosed with blood cholesterol increased and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: tendonitis. SIMVASTATIN dosage: (10 MG). Patient recovered.
Simvastatin Side Effects Report #5364341-6
Consumer or non-health professional from UNITED KINGDOM reported SIMVASTATIN problem on June 06, 2007. Male patient, 71 years of age, weighting 229.3 lb, was diagnosed with diabetes mellitus non-insulin-dependent and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: acute coronary syndrome, atrial fibrillation, intestinal ischaemia, left ventricular failure, pancreatitis acute, pulmonary oedema. SIMVASTATIN dosage: 20 MG, QD, ORAL. During the same period patient was treated with ROSIGLITAZONE, ASPIRIN, ATENOLOL, FUROSEMIDE, BISOPROLOL FUMARATE, METFORMIN, DICLOFENAC, LISINOPRIL. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5365452-1
SIMVASTATIN problem was reported by a Consumer or non-health professional from AUSTRALIA on June 12, 2007. Male patient, 70 years of age, was diagnosed with blood cholesterol increased, blood pressure abnormal, cardiac disorder and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: arterial occlusive disease, circulatory collapse, heart rate irregular. SIMVASTATIN dosage: unknown. During the same period patient was treated with DILTIAZEM HYDROCHLORIDE, RAMIPRIL, CLOPIDOGREL BISULPHATE, CLOPIDOGREL BISULPHATE, ASPIRIN, PSYLLIUM HUSK. Patient recovered.
Simvastatin Side Effects Report #5366999-4
Pharmacist from UNITED STATES reported SIMVASTATIN problem on June 19, 2007. Male patient, weighting 168.0 lb, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased. SIMVASTATIN dosage: unknown. Patient recovered.
Simvastatin Side Effects Report #5367239-2
SIMVASTATIN problem was reported by a Pharmacist from UNITED STATES on June 19, 2007. Male patient, 51 years of age, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood urea increased. SIMVASTATIN dosage: 80MG EVERY DAY PO. Patient recovered.
Simvastatin Side Effects Report #5368273-9
Health Professional from UNITED KINGDOM reported SIMVASTATIN problem on June 04, 2007. Female patient, 81 years of age, weighting 147.7 lb, was diagnosed with blood cholesterol increased and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: tendonitis. SIMVASTATIN dosage: 10 MG, ORAL. During the same period patient was treated with BECLOMETHASONE DIPROPIONATE, CANDESARTAN CILEXETIL, LACTULOSE, SALBUTAMOOL. Patient recovered.
Simvastatin Side Effects Report #5368434-9
SIMVASTATIN problem was reported by a Health Professional from UNITED KINGDOM on June 05, 2007. Male patient, 81 years of age, was diagnosed with prophylaxis, oesophagitis and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: renal failure acute, renal impairment, rhabdomyolysis. SIMVASTATIN dosage: 40 MG, ORAL. During the same period patient was treated with FLUCONAZOLE, OCTREOTIDE ACETATE, PARACETAMOL. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5368439-8
Health Professional from UNITED KINGDOM reported SIMVASTATIN problem on June 05, 2007. Male patient, 55 years of age, weighting 165.3 lb, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: clonic convulsion, partial seizures. SIMVASTATIN dosage: 40 MG, QD. During the same period patient was treated with ATORVASTATIN CALCIUM, FLUOXETINE. Patient recovered.
Simvastatin Side Effects Report #5368595-1
SIMVASTATIN problem was reported by a Health Professional from UNITED KINGDOM on June 11, 2007. Female patient, 31 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, glycogen storage disease type v. SIMVASTATIN dosage: 10 MG. Patient recovered.
Simvastatin Side Effects Report #5368597-5
Physician from UNITED KINGDOM reported SIMVASTATIN problem on June 11, 2007. Male patient, 41 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: back pain, blood creatine phosphokinase increased, glycogen storage disease type ii, muscle spasms, myopathy. SIMVASTATIN dosage: 10 MG, DAILY. During the same period patient was treated with LISINOPRIL, BEZAFIBRATE. Patient recovered.
Simvastatin Side Effects Report #5368942-0
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 05, 2007. Male patient, 81 years of age, was diagnosed with prophylaxis, oesophagitis and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: renal impairment, rhabdomyolysis. SIMVASTATIN dosage: 40MG, ORAL. During the same period patient was treated with FLUCONAZOLE, OCTREOTIDE, PARACETAMOL. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5369868-9
Health Professional from UNITED KINGDOM reported SIMVASTATIN problem on June 06, 2007. Male patient, 71 years of age, weighting 229.3 lb, was diagnosed with diabetes mellitus non-insulin-dependent and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, acute coronary syndrome, atrial fibrillation, disease recurrence, hyperhidrosis, intestinal ischaemia, left ventricular failure, pancreatitis acute, pulmonary oedema. SIMVASTATIN dosage: 20 MG, QD, ORAL. During the same period patient was treated with AVANDIA, ASPIRIN, ATENOLOL, FUROSEMIDE, DICLOFENAC, LISINOPRIL. Patient was hospitalized and became disabled. Patient recovered.
Simvastatin Side Effects Report #5369869-0
SIMVASTATIN problem was reported by a Health Professional from UNITED KINGDOM on June 06, 2007. Female patient, 76 years of age, weighting 152.1 lb, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: dermatitis, lichenoid keratosis. SIMVASTATIN dosage: 20 MG, UNK, UNK. During the same period patient was treated with AMLODIPINE MALEATE, ASPIRIN, ATENOLOL, METFORMIN HYDROCHLORIDE. Patient recovered.
Simvastatin Side Effects Report #5369884-7
Consumer or non-health professional from GERMANY reported SIMVASTATIN problem on June 11, 2007. Male patient, 48 years of age, weighting 178.6 lb, was diagnosed with low density lipoprotein increased, hypernatraemia, gastritis and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, crush syndrome, dialysis, hypokinesia, renal failure, respiratory failure, rhabdomyolysis. SIMVASTATIN dosage: 40 MG, ORAL. During the same period patient was treated with ALLOPURINOL, NEXIUM. Patient died.
Simvastatin Side Effects Report #5369920-8
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 05, 2007. Male patient, 55 years of age, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: clonic convulsion, partial seizures. SIMVASTATIN dosage: 40 MG (40 MG, 1 IN 1 D). Patient recovered.
Simvastatin Side Effects Report #5370401-6
Pharmacist from UNITED STATES reported SIMVASTATIN problem on June 25, 2007. Male patient, weighting 186.1 lb, was diagnosed with hypercholesterolaemia, arrhythmia, heart rate abnormal and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: muscular weakness, renal failure acute. SIMVASTATIN dosage: 80MG QHS PO. During the same period patient was treated with AMIODARONE. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5370680-5
SIMVASTATIN problem was reported by a Health Professional from on June 25, 2007. Male patient, weighting 180.8 lb, was diagnosed with hypercholesterolaemia, coronary artery disease, diabetes mellitus, hypertension, peripheral arterial occlusive disease and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: angina unstable. SIMVASTATIN dosage: 10 MG. During the same period patient was treated with IVABRADINUM, GLICLAZIDE, QUINAPRIL, CLOPIDOGREL, ACETYLSALICYLIC ACID SRT. Patient died on 06/02/2007.
Simvastatin Side Effects Report #5370684-2
Physician from GERMANY reported SIMVASTATIN problem on June 18, 2007. Male patient, weighting 183.0 lb, was diagnosed with hyperlipidaemia, hypertension and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: ventricular extrasystoles. SIMVASTATIN dosage: unknown. During the same period patient was treated with RAMIPRIL, BELOC ZOC, ISCOVER. Patient recovered.
Simvastatin Side Effects Report #5371337-7
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 06, 2007. Male patient, 71 years of age, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: acute coronary syndrome, atrial fibrillation, intestinal ischaemia, left ventricular failure, pancreatitis acute, pulmonary oedema. SIMVASTATIN dosage: 20 MG (20 MG, 1 IN 1 D) ORAL. During the same period patient was treated with ROSIGLITAZONE. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5371339-0
Consumer or non-health professional from UNITED KINGDOM reported SIMVASTATIN problem on June 11, 2007. Male patient, 68 years of age, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: acute coronary syndrome, anaemia, arthralgia, cardiac murmur, catheter sepsis, contusion, headache, joint effusion. SIMVASTATIN dosage: 20 MG (20 MG, 1 IN 1 D) ??. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5371684-9
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 11, 2007. Female patient, 31 years of age, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: glycogen storage disease type v. SIMVASTATIN dosage: 40 MG (10 MG, 4 IN 1 D). Patient recovered.
Simvastatin Side Effects Report #5371685-0
Consumer or non-health professional from UNITED KINGDOM reported SIMVASTATIN problem on June 11, 2007. Male patient, 41 years of age, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: glycogen storage disease type ii. SIMVASTATIN dosage: 40 MG (10 MG, 4 IN 1 D). Patient recovered.
Simvastatin Side Effects Report #5372166-0
SIMVASTATIN problem was reported by a Physician from NORWAY on June 15, 2007. Female patient was diagnosed with angina unstable, myocardial infarction and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: haemoglobin decreased, myocardial infarction, peritoneal haematoma, traumatic haematoma. SIMVASTATIN dosage: unknown. During the same period patient was treated with PREDNISOLONE, NEXIUM, FURIX, SELO ZOK, PLAVIX, ACETYLSALICYLIC ACID SRT, ACETYLSALICYLIC ACID SRT. Patient died on 12/01/2005.
Simvastatin Side Effects Report #5372927-8
Consumer or non-health professional from UNITED KINGDOM reported SIMVASTATIN problem on Dec 15, 2006. Male patient, 56 years of age, was diagnosed with myocardial ischaemia, lower respiratory tract infection, supraventricular tachycardia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: liver function test abnormal, myositis, pericardial effusion, pleural effusion, pulmonary embolism. SIMVASTATIN dosage: 40 MG, ORAL. During the same period patient was treated with AMIODARONE, CLARITHROMYCIN, ADENOSINE, AMLODIPINE, ASPIRIN, CEFTRIAXONE, FERROUS SULPHATE, LANSOPRAZOLE. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5374666-6
SIMVASTATIN problem was reported by a Pharmacist from UNITED STATES on June 27, 2007. Male patient, 74 years of age, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: myalgia. SIMVASTATIN dosage: 40MG EVERY DAY PO. Patient recovered.
Simvastatin Side Effects Report #5375936-8
Pharmacist from UNITED STATES reported SIMVASTATIN problem on June 27, 2007. Female patient, 72 years of age, weighting 70.11 lb, was diagnosed with diabetes mellitus, hyperlipidaemia, hypertension and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: asthenia, blood creatine phosphokinase increased, myalgia. SIMVASTATIN dosage: unknown. During the same period patient was treated with LOTREL. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5376168-X
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 14, 2007. Male patient, 58 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: blood creatine increased, blood urea increased, csf protein increased, dyspnoea, eosinophilia, guillain-barre syndrome, haemoglobin decreased, hyponatraemia, international normalised ratio increased. SIMVASTATIN dosage: unknown. During the same period patient was treated with PRAVASTATIN, AMLODIPINE, BISOPROLOL FUMARATE, RAMIPRIL, SPIRONOLACTONE, WARFARIN. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5376281-7
Pharmacist from UNITED STATES reported SIMVASTATIN problem on June 27, 2007. Male patient, child 5 years of age, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: cystitis interstitial, musculoskeletal pain, pelvic pain. SIMVASTATIN dosage: 40MG 1D PO. During the same period patient was treated with PRAVASTATIN. Patient recovered.
Simvastatin Side Effects Report #5043179-3
SIMVASTATIN problem was reported by a Health Professional from UNITED STATES on July 03, 2006. Male patient, 59 years of age, weighting 217.0 lb, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, accidental overdose, aspartate aminotransferase increased, blood creatine phosphokinase increased, confusional state, mood altered, personality change. SIMVASTATIN dosage: 40 MG DAILY. During the same period patient was treated with GEMFIBROZIL, LITHIUM CARBONATE, PROPRANOLOL, BUPROPION, LEVOTHYROXINE, BUSPAR, RISPERIDONE. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5043210-5
Pharmacist from UNITED STATES reported SIMVASTATIN problem on July 03, 2006. Male patient, 64 years of age, weighting 253.5 lb, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: myalgia. SIMVASTATIN dosage: unknown. During the same period patient was treated with LORATADINE, TERAZOSIN, LOSARTAN POTASSIUM, OLANZAPINE, VARDENAFIL, FLUNISOLIDE, TRAZODONE, OMEPRAZOLE. Patient recovered.
Simvastatin Side Effects Report #5047430-5
SIMVASTATIN problem was reported by a Pharmacist from UNITED STATES on July 10, 2006. Male patient, weighting 211.0 lb, was diagnosed with coronary artery disease, hyperlipidaemia, blood triglycerides increased and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: blood triglycerides increased, condition aggravated, low density lipoprotein increased, rhabdomyolysis, treatment noncompliance. SIMVASTATIN dosage: 60 MG HS PO. During the same period patient was treated with GEMFIBROZIL. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5049478-3
Pharmacist from UNITED STATES reported SIMVASTATIN problem on July 11, 2006. Male patient, 59 years of age, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: haemodialysis, myalgia, renal failure acute. SIMVASTATIN dosage: 80 MG QHS PO. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5050684-2
SIMVASTATIN problem was reported by a Health Professional from GERMANY on June 27, 2006. Female patient, 64 years of age, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: cardiac failure acute, hyperlipidaemia, rhabdomyolysis. SIMVASTATIN dosage: 80 MG. During the same period patient was treated with CYCLOSPORINE. Patient died.
Simvastatin Side Effects Report #5051774-0
Pharmacist from UNITED STATES reported SIMVASTATIN problem on July 12, 2006. Male patient, 70 years of age, weighting 235.0 lb, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: myalgia. SIMVASTATIN dosage: unknown. During the same period patient was treated with OMEPRAZOLE, VARDENAFIL, ALBUTEROL SPIROS, FLUOXETINE, CETIRIZINE, FLUTICASONE PROP, CLOTRIMAZOLE. Patient recovered.
Simvastatin Side Effects Report #5051796-X
SIMVASTATIN problem was reported by a Pharmacist from UNITED STATES on July 12, 2006. Male patient, 68 years of age, weighting 195.6 lb, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased. SIMVASTATIN dosage: 40 MG, 40 MG HS, ORAL. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5051807-1
Consumer or non-health professional from UNITED STATES reported SIMVASTATIN problem on July 13, 2006. Male patient, 62 years of age, weighting 229.1 lb, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain. SIMVASTATIN dosage: unknown. Patient recovered.
Simvastatin Side Effects Report #5052135-0
SIMVASTATIN problem was reported by a Pharmacist from UNITED STATES on July 12, 2006. Male patient, weighting 224.2 lb, was diagnosed with dyslipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: myocardial infarction, rhabdomyolysis. SIMVASTATIN dosage: 40MG DAILY PO. During the same period patient was treated with GEMFIBROZIL. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5053003-0
Consumer or non-health professional from UNITED STATES reported SIMVASTATIN problem on June 26, 2006. Female patient, 51 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: rhabdomyolysis. SIMVASTATIN dosage: 20 MG, BID, ORAL. During the same period patient was treated with RITONAVIR, ZIDOVUDINE, LAMIVUDINE, INDINIVIR SULPHATE, OMEPRAZOLE, ISOPHANE INSULIN, METFORMIN, MECLIZINE. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5053279-X
SIMVASTATIN problem was reported by a Health Professional from GREECE on June 26, 2006. Male patient, 58 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, gastroduodenitis, pancreatitis acute, ulcer, vomiting. SIMVASTATIN dosage: 40 MG, ORAL. During the same period patient was treated with ASPIRIN, INSULIN. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5053986-9
Consumer or non-health professional from JAPAN reported SIMVASTATIN problem on June 26, 2006. Male patient, 49 years of age, was diagnosed with hypercholesterolaemia, pneumocystis jiroveci pneumonia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: haemodialysis, malaise, muscular weakness, pyrexia, renal impairment, rhabdomyolysis. SIMVASTATIN dosage: 10 MG, QD, ORAL. During the same period patient was treated with FLUCONAZOLE FAMILY, ALLOPURINOL ORAL FAMILY, AMLODIPINE, MECOBALAMIN, SUCRALFATE, SANILVUDINE, LAMIVUDINE, NELFINAVIR. Patient was hospitalized and became disabled. Patient recovered.
Simvastatin Side Effects Report #5053989-4
SIMVASTATIN problem was reported by a Consumer or non-health professional from DENMARK on June 26, 2006. Male patient, 55 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: pancreatitis acute. SIMVASTATIN dosage: unknown. Patient recovered.
Simvastatin Side Effects Report #5054015-3
Consumer or non-health professional from SWITZERLAND reported SIMVASTATIN problem on June 26, 2006. Male patient, 59 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: epidermal necrosis, lymphocytic infiltration, systemic lupus erythematosus. SIMVASTATIN dosage: 20 MG, QD, ORAL. Patient recovered.
Simvastatin Side Effects Report #5055018-5
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED STATES on June 30, 2006. Male patient, 55 years of age, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: condition aggravated, dysarthria, myasthenia gravis. SIMVASTATIN dosage: unknown. During the same period patient was treated with ATORVASTATIN CALCIUM, LOVASTATIN, PRAVASTATIN. Patient recovered.
Simvastatin Side Effects Report #5055343-8
Consumer or non-health professional from SWITZERLAND reported SIMVASTATIN problem on June 26, 2006. Female patient, 67 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: muscular weakness, myalgia, myositis. SIMVASTATIN dosage: unknown. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5055345-1
SIMVASTATIN problem was reported by a Consumer or non-health professional from ITALY on June 26, 2006. Male patient, 55 years of age, was diagnosed with hypercholesterolaemia, hypertension and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: nightmare, restlessness, sleep disorder. SIMVASTATIN dosage: 10 MG, QD; ORAL. During the same period patient was treated with METOPROLOL TARTRATE, NIFEDIPINE FAMILY, ASPIRIN, PRAVASTATIN FAMILY, ATENOLOL. Patient recovered.
Simvastatin Side Effects Report #5055435-3
Consumer or non-health professional from UNITED KINGDOM reported SIMVASTATIN problem on June 26, 2006. Male patient, 66 years of age, was diagnosed with hypercholesterolaemia, adenocarcinoma and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: aspartate aminotransferase increased, blood bilirubin increased, blood lactate dehydrogenase increased, blood urine present, deep vein thrombosis, gamma-glutamyltransferase increased, protein urine absent, rhabdomyolysis. SIMVASTATIN dosage: unknown. During the same period patient was treated with CYPROTERONE ACETATE, ALLOPURINOL, CANDESARTAN, AMLODIPINE, OMEPRAZOLE. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5055453-5
SIMVASTATIN problem was reported by a Consumer or non-health professional from FRANCE on June 26, 2006. Male patient, 65 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: haematoma, musculoskeletal pain, tendonitis. SIMVASTATIN dosage: 20 MG, QD, ORAL. During the same period patient was treated with ATORVASTATIN CALCIUM, DILTIAZEM RPG LP PROLONGED RELEASE CAPSULE. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5055454-7
Consumer or non-health professional from UNITED KINGDOM reported SIMVASTATIN problem on June 26, 2006. Male patient, 65 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal distension, abdominal tenderness, body temperature increased, colitis ulcerative, dehydration, large intestine perforation, megacolon, multi-organ failure, proctalgia. SIMVASTATIN dosage: unknown. During the same period patient was treated with ATENOLOL, ENALAPRIL MALEATE. Patient was hospitalized. Patient died.
Simvastatin Side Effects Report #5055455-9
SIMVASTATIN problem was reported by a Consumer or non-health professional from FRANCE on June 26, 2006. Male patient, 49 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: tendonitis. SIMVASTATIN dosage: 20 MG, QD, ORAL. During the same period patient was treated with FENOFIBRATE RPG. Patient recovered.
Simvastatin Side Effects Report #5055456-0
Consumer or non-health professional from FRANCE reported SIMVASTATIN problem on June 26, 2006. Male patient, 56 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: tendonitis, tenosynovitis. SIMVASTATIN dosage: 10 MG, QD, ORAL. During the same period patient was treated with ENALAPRIL MALEATE, NIFEDIPINE, ATENOLOL. Patient recovered.
Simvastatin Side Effects Report #5055466-3
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED STATES on June 26, 2006. Female patient, 68 years of age, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, asthenia, cognitive disorder, fatigue, memory impairment, muscular weakness, pain in extremity. SIMVASTATIN dosage: 20 MG, QD, ORAL. During the same period patient was treated with ATORVASTATIN CALCIUM, ESTRADIOL, ATENOLOL. Patient recovered.
Simvastatin Side Effects Report #5055809-0
Pharmacist from UNITED STATES reported SIMVASTATIN problem on July 18, 2006. Female patient, 80 years of age, weighting 201.7 lb, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: hepatitis acute, hepatotoxicity. SIMVASTATIN dosage: 10 MG QD PO. Patient recovered.
Simvastatin Side Effects Report #5055929-0
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 29, 2006. Male patient, 49 years of age, weighting 178.6 lb, was diagnosed with blood cholesterol and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: epistaxis, lethargy, pain. SIMVASTATIN dosage: 10 MG, ORAL. Patient recovered.
Simvastatin Side Effects Report #5055930-7
Consumer or non-health professional from UNITED KINGDOM reported SIMVASTATIN problem on June 28, 2006. Male patient, 67 years of age, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, flatulence, nausea. SIMVASTATIN dosage: 40 MG, ORAL. During the same period patient was treated with SILDENAFIL CITRATE FAMILY. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5055939-3
SIMVASTATIN problem was reported by a Consumer or non-health professional from GERMANY on June 30, 2006. Female patient, 77 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: autoimmune thrombocytopenia, contusion, epistaxis. SIMVASTATIN dosage: 10 MG, QD, ORAL. During the same period patient was treated with DILTIAZEM BASICS, INSULIN. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5055944-7
Consumer or non-health professional from UNITED KINGDOM reported SIMVASTATIN problem on June 28, 2006. Female patient, 65 years of age, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: tachyarrhythmia, ventricular extrasystoles. SIMVASTATIN dosage: 20 MG, ORAL. During the same period patient was treated with AMOXICILLIN CAPSULE, IBUPROFEN FAMILY, PARACETAMOL FAMILY. Patient recovered.
Simvastatin Side Effects Report #5056553-6
SIMVASTATIN problem was reported by a Consumer or non-health professional from UNITED STATES on June 26, 2006. Male patient, 53 years of age, was diagnosed with prophylaxis, blood pressure and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: activated partial thromboplastin time prolonged, anorexia, malaise, nausea, prothrombin time prolonged, rhabdomyolysis, vomiting. SIMVASTATIN dosage: 40 MG, QD, ORAL. During the same period patient was treated with DILTIAZEM, ASPIRIN. Patient recovered.
Simvastatin Side Effects Report #5059877-1
Consumer or non-health professional from GERMANY reported SIMVASTATIN problem on June 30, 2006. Female patient, 40 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: rhabdomyolysis. SIMVASTATIN dosage: 80 MG QD ORAL. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5060813-2
SIMVASTATIN problem was reported by a Pharmacist from UNITED STATES on July 20, 2006. Male patient was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: arthralgia, blood creatine phosphokinase increased, muscular weakness. SIMVASTATIN dosage: 80 MG DAILY PO 2 MONTHS -INC FROM 40 MG-. During the same period patient was treated with ALLOPURINOL, ASPIRIN, HYDROCHLOROTHIAZIDE, LISINOPRIL, TRAVOPROST. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5061321-5
Pharmacist from UNITED STATES reported SIMVASTATIN problem on July 19, 2006. Male patient, 81 years of age, weighting 186.0 lb, was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: renal failure, rhabdomyolysis. SIMVASTATIN dosage: unknown. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5061444-0
SIMVASTATIN problem was reported by a Health Professional from UNITED STATES on June 30, 2006. Male patient, 45 years of age, was diagnosed with hyperlipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, asthenia, blood potassium increased, bronchopulmonary aspergillosis, coordination abnormal, enterococcal infection, haemodialysis, hyperlipidaemia. SIMVASTATIN dosage: 40 MG, QD, ORAL. During the same period patient was treated with CYCLOSPORINE, GEMFIBROZIL, ITRACONAZOLE, MYCOPHENOLATE MOFETIL, PREDNISOLONE, PREDNISONE. Patient was hospitalized. Patient died.
Simvastatin Side Effects Report #5061581-0
Health Professional from UNITED STATES reported SIMVASTATIN problem on June 30, 2006. Male patient, 70 years of age, was diagnosed with dyslipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: myalgia, rhabdomyolysis. SIMVASTATIN dosage: 40 MG, QD, ORAL. During the same period patient was treated with FENOFIBRATE, ATENOLOL, LEVOTHYROXINE, ROSIGLITAZONE, RANITIDINE, TERAZOSIN HYDROCHLORIDE. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5062463-0
SIMVASTATIN problem was reported by a Consumer or non-health professional from CANADA on June 30, 2006. Male patient, 70 years of age, weighting 149.9 lb, was diagnosed with dyslipidaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, intestinal perforation, nausea, pancreatic necrosis, pancreatitis acute, systemic inflammatory response syndrome, vomiting. SIMVASTATIN dosage: unknown. During the same period patient was treated with FENOFIBRATE. Patient was hospitalized. Patient died.
Simvastatin Side Effects Report #5062464-2
Consumer or non-health professional from ISRAEL reported SIMVASTATIN problem on June 30, 2006. Female patient, 75 years of age, was diagnosed with low density lipoprotein increased, hypothyroidism and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, blood thyroid stimulating hormone increased, fatigue, impaired gastric emptying, liver function test abnormal. SIMVASTATIN dosage: 10 MG, QD, ORAL. During the same period patient was treated with LEVOTHYROXINE, ALENDRONATE, CALCIUM SUPPLEMENTS. Patient recovered.
Simvastatin Side Effects Report #5062466-6
SIMVASTATIN problem was reported by a Consumer or non-health professional from ISRAEL on June 30, 2006. Male patient, 81 years of age, was diagnosed with blood thyroid stimulating hormone increased, hypothyroidism and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: blood thyroid stimulating hormone increased, thyroxine free decreased. SIMVASTATIN dosage: 10 MG, QD, ORAL. During the same period patient was treated with LEVOTHYROXINE, FELODIPINE. Patient recovered.
Simvastatin Side Effects Report #5062468-X
Consumer or non-health professional from SPAIN reported SIMVASTATIN problem on July 03, 2006. Female patient, 72 years of age, was diagnosed with myocardial ischaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, asthenia, blood lactate dehydrogenase increased, blood pressure systolic increased, body temperature decreased, hypotension, movement disorder, myalgia. SIMVASTATIN dosage: unknown. During the same period patient was treated with DILTIAZEM, ASPIRIN, ISOSORBIDE MONONITRATE. Patient was hospitalized. Patient recovered.
Simvastatin Side Effects Report #5062469-1
SIMVASTATIN problem was reported by a Consumer or non-health professional from FRANCE on June 30, 2006. Male patient, 69 years of age, was diagnosed with hypercholesterolaemia and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: asthenia, back pain, chylothorax, cough, dyspnoea exertional, inflammation, pleural effusion, pleurisy. SIMVASTATIN dosage: 20 MG, QD, ORAL. Patient was hospitalized. Patient recovered.
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Drug Information: Simvastatin
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a692030.html
(sim' va stat in)Why is this medication prescribed?
Simvastatin is used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of cholesterol (a fat-like substance) and certain other fatty substances in your blood. Simvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body.
Buildup of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats may help to decrease your chances of getting heart disease, angina (chest pain), strokes, and heart attacks. In addition to taking a cholesterol-lowering medication, making certain changes in your daily habits can also lower your cholesterol blood levels. You should eat a diet that is low in saturated fat and cholesterol (see SPECIAL DIETARY), exercise 30 minutes on most, if not all days, and lose weight if you are overweight.
How should this medicine be used?
Simvastatin comes as a tablet to take by mouth. It usually is taken one to three times a day . Take simvastatin at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take simvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of simvastatin and gradually increase your dose, not more than once every 4 weeks.
Continue to take simvastatin even if you feel well. Do not stop taking simvastatin without talking to your doctor.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking simvastatin,
- tell your doctor and pharmacist if you are allergic to simvastatin or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); antifungal medications such as itraconazole (Sporanox) and ketoconazole (Nizoral); anticoagulants ('blood thinners') such as warfarin (Coumadin); cholestyramine (Questran), clarithromycin (Biaxin), clofibrate (Atromid-S), cyclosporine (Sandimmune, Neoral), danazol; digoxin (Lanoxin), erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors such as indinavir (Crixivan), ritonavir (Norvir) and saquinavir (Invirase, Fortovase); nefazodone (Serzone); other cholesterol-lowering medications such as fenofibrate (Tricor), gemfibrozil (Lopid), and niacin (nicotinic acid, Niacor, Niaspan); nefazodone (Serzone), and telithromycin (Ketek); and verapamil (Calan, Covera, Isoptin, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have liver disease. Your doctor will probably tell you not to take simvastatin.
- tell your doctor if you drink large amounts of alcohol, if you have ever had liver disease or if you have or have ever had kidney disease.
- tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking simvastatin, stop taking simvastatin and call your doctor immediately. Simvastatin can harm the fetus.
- Do not breast-feed while you are taking this medication.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking simvastatin.
- ask your doctor about the safe use of alcoholic beverages while you are taking simvastatin. Alcohol can increase the risk of serious side effects.
What special dietary instructions should I follow?
Avoid drinking large quantities (more than 1 quart a day) of grapefruit juice while taking simvastatin.
Eat a low-cholesterol, low-fat diet. This kind of diet includes cottage cheese, fat-free milk, fish (not canned in oil), vegetables, poultry, egg whites, and polyunsaturated oils and margarines (corn, safflower, canola, and soybean oils). Avoid foods with excess fat in them such as meat (especially liver and fatty meat), egg yolks, whole milk, cream, butter, shortening, lard, pastries, cakes, cookies, gravy, peanut butter, chocolate, olives, potato chips, coconut, cheese (other than cottage cheese), coconut oil, palm oil, and fried foods.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue the regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Simvastatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- constipation
If you experience the following symptoms, call your doctor immediately:
- muscle pain, tenderness, or weakness
- lack of energy
- fever
- yellowing of the skin or eyes
- pain in the upper right part of the stomach
- nausea
- extreme tiredness
- unusual bleeding or bruising
- loss of appetite
- flu-like symptoms
- rash
- hives
- itching
- difficulty breathing or swallowing
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- hoarseness
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during treatment to check your response to simvastatin.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking simvastatin.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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