Simvastatin combined with Tylenol (Caplet)

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Vascular Dementia Other Serious 9/23/2002 72 Male 240 lb 2/28/2006 Physician United States
Primary
Concomitant
Fluid Overload Other Serious 9/9/2005 71 Female 179 lb 1/4/2006 Other Health Professional United States
Primary
Concomitant
Renal Failure Other Serious 1/13/2004 Female 157 lb 3/17/2006 Canada
Primary
Secondary
Concomitant
Somnolence Hospitalization 12/30/2004 80 Male 170 lb 3/30/2006 Pharmacist United States
Primary
Concomitant
Cardiomyopathy Hospitalization 3/17/2006 45 Male 192 lb 3/31/2006 Pharmacist United States
Primary
Concomitant
Urinary Tract Infection Hospitalization 7/9/2001 74 Male 165 lb 4/13/2006 Physician United States
Primary
Concomitant
Agitation Hospitalization 4/1/2006 Male 280 lb 4/14/2006 Physician United States
Primary
Concomitant
Refusal Of Treatment By Patient Hospitalization 4/1/2006 Male 280 lb 4/26/2006 Physician United States
Primary
Concomitant
Renal Failure Other Serious 1/13/2004 Female 157 lb 5/12/2006 Canada
Primary
Secondary
Concomitant
Middle Insomnia 1/1/2006 64 Female 128 lb 4/3/2006 Consumer United States
Primary
Concomitant
Vomiting 1/16/2006 55 Female 196 lb 4/3/2006 Consumer United States
Primary
Concomitant
Initial Insomnia 1/22/2006 61 Female 141 lb 4/3/2006 Consumer United States
Primary
Concomitant
Pneumonitis 2/24/2006 79 Male 163 lb 4/3/2006 Pharmacist United States
Primary
Concomitant
Middle Insomnia 10/1/2005 87 Male 200 lb 4/3/2006 Consumer United States
Primary
Concomitant
Middle Insomnia 12/1/2005 78 Male 174 lb 4/3/2006 Consumer United States
Primary
Concomitant
Agitation Hospitalization 4/1/2006 Male 280 lb 6/15/2006 Physician United States
Primary
Concomitant
Weight Increased Hospitalization 4/13/2006 67 Male 6/29/2006 Physician United States
Primary
Secondary
Concomitant
Insomnia 4/1/2006 67 Female 230 lb 7/12/2006 Consumer United States
Primary
Concomitant
Nausea Other Serious 2/24/2006 50 Female 12/8/2006 Other Health Professional United States
Primary
Concomitant
Urinary Tract Infection Hospitalization 3/1/2007 63 Female 193 lb 7/10/2007 Consumer United States
Primary
Concomitant
Rhabdomyolysis Hospitalization 2/8/2006 59 Male 7/16/2007 Pharmacist United States
Primary
Concomitant
Jaundice Hospitalization 4/4/2006 78 Female 7/23/2007 Pharmacist United States
Primary
Concomitant
Middle Insomnia 5/1/2007 78 Male 180 lb 7/10/2007 Consumer United States
Primary
Secondary
Concomitant
Nausea Other Serious 2/24/2006 50 Female 196 lb 6/8/2007 Other Health Professional United States
Primary
Concomitant
Transient Ischaemic Attack Hospitalization 1/1/2004 Female 150 lb 9/10/2007 Physician United States
Primary
Concomitant
Candida Sepsis Other Serious 2/6/2006 69 Male 245 lb 7/27/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Foreign Body Trauma Other Serious 9/24/2007 82 Female 170 lb 10/3/2007 Consumer United States
Primary
Concomitant
Diarrhoea 6/21/2007 80 Female 188 lb 9/21/2007 Physician United States
Primary
Concomitant
Sensory Loss Required Intervention 9/11/2006 83 Female 10/29/2007 Pharmacist United States
Primary
Concomitant
Throat Tightness 11/1/2007 62 Male 328 lb 2/16/2008 United States
Primary
Concomitant
Pain In Extremity Other Serious Female 254 lb 2/26/2008 Consumer United States
Primary
Concomitant
Flank Pain Hospitalization 2/22/2008 Female 153 lb 2/26/2008 Other Health Professional United States
Primary
Concomitant
Hyperkalaemia Hospitalization 9/4/2007 Female 2/28/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Hyperkalaemia Hospitalization 9/4/2007 3/5/2008 Consumer Canada
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Other Serious 3/3/2008 60 Female 3/7/2008 Other Health Professional United States
Primary
Concomitant
Metastatic Neoplasm Hospitalization 2/22/2008 Female 153 lb 3/13/2008 Other Health Professional United States
Primary
Concomitant
Hyperkalaemia Hospitalization 9/4/2007 Female 3/17/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Non-cardiac Chest Pain Hospitalization 9/3/2007 4/4/2008 Consumer Canada
Primary
Secondary
Concomitant
Non-cardiac Chest Pain Hospitalization 9/3/2007 6/12/2008 Consumer Canada
Primary
Secondary
Concomitant
Sepsis Hospitalization 8/28/2008 Female 270 lb 9/12/2008 Other Health Professional United States
Primary
Concomitant
Staphylococcal Infection Hospitalization 8/18/2008 Female 161 lb 8/29/2008 Physician United States
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 5/19/2008 90 Female 110 lb 9/2/2008 Pharmacist United States
Primary
Secondary
Concomitant
Oesophageal Pain Other Serious Female 161 lb 9/23/2008 Consumer United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 38 Female 9/17/2008 Pharmacist
Primary
Concomitant
Urinary Tract Infection Hospitalization 9/19/2008 Male 198 lb 9/22/2008 Physician United States
Primary
Secondary
Concomitant
Encephalopathy Hospitalization 8/7/2008 Female 10/3/2008 United States
Primary
Secondary
Concomitant
Therapeutic Response Decreased Other Serious 9/8/2008 Male 10/9/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Other Serious 8/7/2008 Female 154 lb 10/14/2008 United States
Primary
Concomitant
Urticaria Female 10/20/2008 Consumer
Primary
Concomitant
Chest Pain Hospitalization Female 194 lb 10/21/2008 Consumer United States
Primary
Concomitant
Encephalopathy Hospitalization 8/7/2008 Female 286 lb 11/18/2008 United States
Primary
Secondary
Concomitant
Sudden Death Death 10/1/2008 34 Male 11/7/2008 Physician United States
Primary
Concomitant
Vaginal Haemorrhage Other Serious 11/19/2008 59 Female 200 lb 11/25/2008 Consumer United States
Primary
Concomitant
Therapeutic Agent Toxicity Other Serious 10/12/2008 Female 222 lb 11/4/2008 Physician United States
Primary
Concomitant
Haematochezia Other Serious 11/24/2008 76 Male 160 lb 12/4/2008 Consumer United States
Primary
Secondary
Concomitant
Nicotine Dependence 7/13/2008 58 Male 12/5/2008 Consumer United States
Primary
Concomitant
Death Death 9/15/2008 Male 12/5/2008 Physician United States
Primary
Concomitant
Swelling 85 Female 174 lb 12/10/2008 Consumer United States
Primary
Concomitant
Rhabdomyolysis Hospitalization 46 Female 200 lb 12/18/2008 Pharmacist United States
Primary
Concomitant
Encephalopathy Hospitalization 7/7/2008 Female 286 lb 12/22/2008 Physician United States
Primary
Secondary
Concomitant
Malaise 35 Male 12/23/2008 Consumer United States
Primary
Concomitant
Oedema Peripheral 12/5/2008 69 Female 168 lb 1/5/2009 Consumer United States
Primary
Concomitant
Encephalopathy Hospitalization 7/7/2008 Female 286 lb 1/5/2009 Physician United States
Primary
Secondary
Concomitant
Myalgia 10/17/2008 Male 1/12/2009 Consumer
Primary
Concomitant
Deep Vein Thrombosis Hospitalization 12/26/2008 Male 164 lb 1/15/2009 Physician United States
Primary
Concomitant
Death Death 9/15/2008 Male 1/16/2009 Physician United States
Primary
Concomitant
Weight Increased Other Serious 1/1/2007 Female 191 lb 1/21/2009 Consumer United States
Primary
Concomitant
Somnolence Other Serious 1/23/2009 48 Female 2/16/2009 Physician United States
Primary
Secondary
Concomitant
Somnolence Other Serious 1/23/2009 48 Female 2/18/2009 Physician United States
Primary
Secondary
Concomitant
Unresponsive To Stimuli Other Serious 9/1/2007 80 Male 2/19/2009 Lawyer United States
Primary
Concomitant
Respiratory Failure Hospitalization 1/27/2009 Male 151 lb 2/9/2009 United States
Primary
Secondary
Concomitant
Somnambulism Other Serious 5/18/2007 Female 200 lb 2/24/2009 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 1/27/2009 Male 151 lb 2/26/2009 United States
Primary
Secondary
Concomitant
Ulcer Haemorrhage Hospitalization 2/16/2009 Male 2/23/2009 Consumer United States
Primary
Concomitant
Neuroendocrine Tumour Other Serious 5/17/2008 Male 243 lb 3/6/2009 United States
Primary
Concomitant
Oedema Peripheral 12/5/2008 69 Female 168 lb 3/16/2009 Consumer United States
Primary
Concomitant
Sarcoma Of Skin Other Serious 68 Female 132 lb 3/16/2009 Consumer United States
Primary
Concomitant
Sarcoma Of Skin Other Serious 68 Female 132 lb 3/16/2009 Consumer United States
Primary
Concomitant
Intentional Overdose Other Serious 1/1/1986 Male 260 lb 3/23/2009 Consumer United States
Primary
Concomitant
Hypersensitivity Other Serious 1/1/2009 Female 166 lb 4/1/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Neuroendocrine Tumour Other Serious 5/17/2008 Male 243 lb 4/3/2009 United States
Primary
Concomitant
Flatulence Other Serious 10/1/2008 Male 192 lb 5/14/2009 Physician United States
Primary
Concomitant
Wrist Fracture Other Serious Female 5/22/2009 Physician United States
Primary
Concomitant
Renal Failure Other Serious 5/1/2009 Male 5/27/2009 Physician United States
Primary
Concomitant
Retinal Haemorrhage Other Serious Female 5/28/2009 Physician United States
Primary
Concomitant
Vomiting Other Serious 5/21/2009 Male 203 lb 6/2/2009 United States
Primary
Secondary
Concomitant
Pain Other Serious 5/6/2005 Female 6/5/2009 Canada
Primary
Concomitant
Vomiting Hospitalization 5/21/2009 Male 203 lb 6/10/2009 United States
Primary
Secondary
Concomitant
Urine Output Decreased Hospitalization 7/19/2008 81 Male 145 lb 6/8/2009 United States
Primary
Secondary
Concomitant
Irritability Other Serious 5/24/2009 75 Female 152 lb 6/15/2009 Consumer Brazil
Primary
Secondary
Concomitant
Dehydration Hospitalization 5/20/2009 Male 6/18/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 4/21/2009 Female 189 lb 6/19/2009 Physician United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 5/1/2009 Male 220 lb 6/19/2009 Physician United States
Primary
Concomitant
Wheezing Other Serious 1/1/2009 Female 160 lb 6/19/2009 Consumer United States
Primary
Concomitant
Pain Other Serious 5/6/2005 Female 6/25/2009 Physician Canada
Primary
Concomitant
Wheezing Hospitalization 4/8/2009 176 lb 6/25/2009 Physician United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 1/1/2009 Male 160 lb 6/25/2009 Consumer United States
Primary
Concomitant
Renal Failure Chronic Other Serious 7/20/2008 65 Female 6/23/2009 Lawyer United States
Primary
Concomitant
Syncope Death 76 Male 6/21/2009 Lawyer United States
Primary
Concomitant
Sepsis Life Threatening 5/21/2009 Male 203 lb 6/30/2009 United States
Primary
Secondary
Concomitant
Swelling Hospitalization 6/15/2009 58 Female 7/2/2009 Other Health Professional United States
Primary
Concomitant
Haemoglobin Decreased Hospitalization 5/1/2009 72 Male 7/2/2009 Other Health Professional United States
Primary
Concomitant
Expired Drug Administered 4/25/2009 72 Female 7/6/2009 Consumer United States
Primary
Concomitant
Vomiting Hospitalization 12/12/2008 Male 183 lb 7/6/2009 Physician United States
Primary
Concomitant
Vomiting Hospitalization 12/17/2008 Male 195 lb 7/6/2009 Physician United States
Primary
Concomitant
Cellulitis Hospitalization 6/23/2009 78 Male 172 lb 7/7/2009 United States
Primary
Secondary
Concomitant
Rash Macular 79 Female 7/10/2009 Pharmacist United States
Primary
Concomitant
Urinary Incontinence Other Serious 76 Female 7/17/2009 United States
Primary
Secondary
Concomitant
Pain 85 Male 139 lb 7/22/2009 Consumer United States
Primary
Concomitant
Gout Male 7/24/2009 Other Health Professional United States
Primary
Concomitant
Drug Ineffective 4/1/2009 Male 7/27/2009 Other Health Professional United States
Primary
Concomitant
Weight Decreased Hospitalization 83 Female 180 lb 7/29/2009 United States
Primary
Concomitant
Pain 85 Male 139 lb 7/22/2009 Consumer United States
Primary
Concomitant
Type 2 Diabetes Mellitus Other Serious 1/1/2002 41 Male 332 lb 7/30/2009 United States
Primary
Concomitant
Ventricular Tachycardia Other Serious 86 Female 7/27/2009 Other Health Professional United States
Primary
Concomitant
Cellulitis Hospitalization 6/23/2009 78 Male 172 lb 7/31/2009 United States
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious 1/1/2003 Female 8/4/2009 Consumer United States
Primary
Concomitant
Thyroidectomy Hospitalization 8/1/2008 Female 8/5/2009 Physician United States
Primary
Concomitant
Cellulitis Hospitalization 6/23/2009 78 Male 172 lb 8/10/2009 Physician United States
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 6/9/2009 Female 189 lb 8/10/2009 Physician United States
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 80 Male 7/31/2009 United States
Primary
Concomitant
Varices Oesophageal Hospitalization 11/23/2007 67 Male 8/12/2009 Consumer United States
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 4/15/2009 51 Male 245 lb 8/14/2009 Pharmacist United States
Primary
Concomitant
Cellulitis Hospitalization 6/23/2009 78 Male 172 lb 8/20/2009 Physician United States
Primary
Secondary
Concomitant
Wound Infection Other Serious 1/1/2009 60 Female 8/21/2009 Other Health Professional United States
Primary
Concomitant
Nightmare 5/1/2009 Female 8/22/2009 United States
Primary
Concomitant
Pruritus 5/1/2009 Male 180 lb 8/22/2009 Physician United States
Primary
Concomitant
Flushing 5/1/2009 Male 232 lb 8/23/2009 United States
Primary
Concomitant
Rash 7/6/2009 Male 275 lb 8/23/2009 United States
Primary
Concomitant
Infection Other Serious 7/29/2009 Female 126 lb 8/26/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Chest Pain Hospitalization 8/23/2009 50 Female 211 lb 8/25/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Cellulitis Hospitalization 6/23/2009 78 Male 172 lb 8/28/2009 Physician United States
Primary
Secondary
Concomitant
Skin Burning Sensation Male 220 lb 8/29/2009 United States
Primary
Concomitant
Weight Increased Other Serious Female 8/28/2009 Consumer United States
Primary
Concomitant
Pain Other Serious 5/6/2005 Female 8/28/2009 Other Health Professional Canada
Primary
Concomitant
Weight Decreased Hospitalization 80 Male 8/26/2009 United States
Primary
Concomitant
Therapeutic Agent Toxicity Hospitalization 65 Female 155 lb 8/24/2009 United States
Primary
Concomitant
White Blood Cell Count Increased Other Serious 8/1/2007 76 Male 198 lb 9/3/2009 Lawyer United States
Primary
Concomitant
Ventricular Tachycardia Other Serious 86 Female 8/27/2009 United States
Primary
Concomitant
Supraventricular Tachyarrhythmia Hospitalization 57 Male 8/31/2009 United States
Primary
Concomitant
Osteomyelitis Hospitalization 6/23/2009 78 Male 168 lb 9/8/2009 Physician United States
Primary
Secondary
Concomitant
Myocardial Infarction Other Serious 1/1/2008 Male 9/3/2009 Consumer United States
Primary
Concomitant
Infection Other Serious 7/29/2009 Female 126 lb 9/10/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 11/23/2007 66 Male 802 lb 9/3/2009 Lawyer United States
Primary
Concomitant
Renal Failure Acute Other Serious 6/1/2009 Female 9/11/2009 Physician United States
Primary
Concomitant
Tachycardia Hospitalization 57 Male 9/9/2009 United States
Primary
Concomitant
Faeces Discoloured Hospitalization 8/11/2009 82 Female 181 lb 9/17/2009 Physician United States
Primary
Secondary
Concomitant
Sepsis Other Serious 7/29/2009 Female 126 lb 9/18/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Hospitalization 9/14/2009 70 Female 9/15/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pancreatitis Other Serious 3/30/2001 48 Male 265 lb 9/23/2009 United States
Primary
Concomitant

Drug Data