Simvastatin combined with Tamoxifen Citrate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Myelodysplastic Syndrome Other Serious 9/1/2004 Male 227 lb 2/15/2006 France
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 9/1/2004 Male 227 lb 2/15/2006 France
Primary
Concomitant
Hyponatraemia Other Serious 3/27/2006 73 Female 5/9/2006 Other Health Professional United Kingdom
Primary
Concomitant
Pollakiuria 73 Female 6/19/2006 Consumer United States
Primary
Concomitant
Off Label Use Other Serious 4/17/2006 79 Female 8/14/2006 United Kingdom
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 9/1/2006 Female 11/7/2006 United States
Primary
Concomitant
Rash Erythematous Other Serious 10/6/2006 62 Female 198 lb 11/14/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Rash Erythematous Disability 10/6/2006 62 Female 198 lb 11/17/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Skin Reaction Other Serious 10/6/2006 62 Female 198 lb 11/27/2006 United Kingdom
Primary
Secondary
Concomitant
Tooth Extraction Other Serious 10/3/2005 39 Female 128 lb 12/12/2006 Physician United Kingdom
Primary
Concomitant
Dysgeusia 11/18/2005 53 Female 165 lb 10/11/2006 Consumer United States
Primary
Concomitant
Tooth Extraction Other Serious 10/3/2005 39 Female 128 lb 5/12/2007 Physician United Kingdom
Primary
Concomitant
Alveolitis Disability 6/8/2007 64 Female 141 lb 9/4/2007 Consumer United Kingdom
Primary
Concomitant
Gait Disturbance Other Serious 7/27/2007 83 128 lb 9/6/2007 Physician United Kingdom
Primary
Concomitant
Hepatitis Other Serious 6/26/2007 72 Female 148 lb 9/25/2007 Other Health Professional United Kingdom
Primary
Concomitant
Oculomucocutaneous Syndrome Hospitalization 9/5/2007 65 Female 11/20/2007 Physician Japan
Primary
Concomitant
Oculomucocutaneous Syndrome Hospitalization 9/5/2007 65 Female 11/29/2007 Physician Japan
Primary
Concomitant
Oculomucocutaneous Syndrome Hospitalization 9/5/2007 65 Female 12/13/2007 Physician Japan
Primary
Concomitant
Pruritus Other Serious 10/30/2007 68 Female 12/19/2007 Other Health Professional United Kingdom
Primary
Concomitant
Weight Fluctuation 1/1/2005 76 Female 175 lb 10/8/2007 Physician United States
Primary
Concomitant
Pruritus Other Serious 10/30/2007 68 Female 1/7/2008 Other Health Professional United Kingdom
Primary
Concomitant
Stevens-johnson Syndrome Hospitalization 9/2/2007 Female 119 lb 1/7/2008 Physician Japan
Primary
Secondary
Stevens-johnson Syndrome Hospitalization 9/2/2007 Female 119 lb 2/12/2008 Physician Japan
Primary
Secondary
Weight Fluctuation 1/1/2005 76 Female 175 lb 1/10/2008 Consumer United States
Primary
Concomitant
Memory Impairment Other Serious 2/11/2008 72 Female 134 lb 3/6/2008 Consumer United States
Primary
Concomitant
Wheelchair User Other Serious 1/28/1992 4/9/2008 United States
Primary
Secondary
Concomitant
Infarction Life Threatening 5/4/2008 50 Female 110 lb 5/27/2008 Consumer Brazil
Primary
Concomitant
Urinary Incontinence Other Serious 6/2/2000 51 Female 5/29/2008 Physician United Kingdom
Primary
Concomitant
Urinary Incontinence Other Serious 6/2/2000 51 Female 6/18/2008 United Kingdom
Primary
Concomitant
Abdominal Strangulated Hernia Other Serious 6/1/2008 Female 212 lb 7/15/2008 Consumer United Kingdom
Primary
Concomitant
Sensory Disturbance Life Threatening 5/4/2008 50 Female 110 lb 7/17/2008 Consumer Brazil
Primary
Concomitant
Hepatitis Acute Other Serious 6/6/2008 66 Female 8/6/2008 Other Health Professional United Kingdom
Primary
Concomitant
Incisional Hernia, Obstructive Hospitalization 6/1/2008 Female 212 lb 8/15/2008 Consumer United Kingdom
Primary
Concomitant
Inappropriate Schedule Of Drug Administration 7/21/2008 Female 220 lb 9/12/2008 United States
Primary
Concomitant
Thrombosis Other Serious 71 Female 138 lb 10/7/2008 United States
Primary
Concomitant
Wound Dehiscence Other Serious 1/1/2002 2/14/2009 Physician United States
Primary
Secondary
Concomitant
Tendon Disorder Other Serious 1/1/2005 72 Female 139 lb 3/9/2009 Physician United States
Primary
Concomitant
Tendon Disorder Other Serious 1/1/2005 72 Female 139 lb 3/26/2009 Physician United States
Primary
Concomitant
Tendon Disorder Other Serious 1/1/2005 72 Female 139 lb 3/31/2009 Physician United States
Primary
Concomitant
Stent Placement Life Threatening 2/1/2006 Female 4/6/2009 Physician South Africa
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 2/24/2006 Female 131 lb 4/15/2009 Physician Brazil
Primary
Secondary
Concomitant
Mitral Valve Calcification Other Serious 7/1/2008 62 Female 163 lb 5/12/2009 Consumer Brazil
Primary
Concomitant
Interstitial Lung Disease Other Serious 1/1/2009 73 Female 5/11/2009 Physician United Kingdom
Primary
Concomitant
Interstitial Lung Disease Hospitalization 1/1/2009 73 Female 5/11/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 1/1/2009 73 Female 5/13/2009 Other Health Professional United Kingdom
Primary
Concomitant
Interstitial Lung Disease Hospitalization 1/1/2009 73 Female 5/19/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 1/1/2002 5/20/2009 Physician United States
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 1/1/2009 73 Female 5/14/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 73 Female 5/20/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 73 Female 5/20/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Skin Plaque Other Serious 2/1/2007 85 Female 150 lb 6/4/2009 Lawyer United States
Primary
Secondary
Concomitant
Skin Plaque Other Serious 2/1/2007 85 Female 150 lb 6/5/2009 Lawyer United States
Primary
Secondary
Concomitant
Peripheral Arterial Occlusive Disease Hospitalization 4/4/2007 56 7/21/2009 Physician Belgium
Primary
Secondary
Concomitant
Vertigo Other Serious 72 Female 8/19/2009 Physician Germany
Primary
Secondary
Drug Withdrawal Syndrome Hospitalization 4/17/2008 79 Female 9/16/2009 Other Health Professional United Kingdom
Primary
Concomitant
Vertigo Other Serious 72 Female 9/25/2009 Physician Germany
Primary
Secondary
Vertigo Other Serious 72 Female 9/25/2009 Physician Germany
Primary
Secondary
Spinal Osteoarthritis Other Serious 4/9/2005 Female 100 lb 11/2/2009 Other Health Professional United States
Primary
Concomitant
Tooth Impacted Other Serious 4/9/2005 Female 100 lb 11/17/2009 Other Health Professional United States
Primary
Concomitant
Viral Infection Other Serious 4/9/2005 Female 100 lb 12/2/2009 Other Health Professional United States
Primary
Concomitant
Viral Infection Other Serious 4/9/2005 Female 100 lb 12/3/2009 Other Health Professional United States
Primary
Concomitant
Viral Infection Other Serious 4/9/2005 Female 100 lb 12/17/2009 Other Health Professional United States
Primary
Concomitant
Viral Infection Other Serious 4/9/2005 Female 100 lb 1/19/2010 Other Health Professional United States
Primary
Concomitant
Viral Infection Other Serious 4/9/2005 Female 100 lb 2/11/2010 Other Health Professional United States
Primary
Concomitant
Vitreous Haemorrhage Other Serious 4/9/2005 Female 100 lb 2/23/2010 Other Health Professional United States
Primary
Concomitant
Stress Urinary Incontinence Other Serious Female 3/2/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Urinary Retention Other Serious 12/23/2009 Female 3/5/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Vitreous Haemorrhage Other Serious 4/9/2005 Female 100 lb 3/17/2010 Physician United States
Primary
Concomitant
Vascular Anomaly Other Serious 1/1/2003 4/6/2010 Physician United States
Primary
Concomitant
Wound Infection Staphylococcal Other Serious 1/1/2003 56 Female 155 lb 4/14/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vitreous Haemorrhage Other Serious 1/1/2005 74 Female 100 lb 4/14/2010 Other Health Professional United States
Primary
Concomitant
Vascular Anomaly Other Serious 1/1/2003 4/15/2010 Physician United States
Primary
Concomitant
Wound Infection Staphylococcal Other Serious 1/1/2003 56 Female 155 lb 4/23/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vascular Anomaly Other Serious 1/1/2003 4/26/2010 United States
Primary
Concomitant
Wound Infection Staphylococcal Other Serious 1/1/2003 56 Female 155 lb 4/26/2010 United States
Primary
Secondary
Concomitant
Urinary Retention Other Serious 12/23/2009 59 Female 4/27/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Vascular Anomaly Other Serious 1/1/2003 4/28/2010 United States
Primary
Concomitant
Vascular Anomaly Other Serious 1/1/2003 5/4/2010 United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/1/2003 5/10/2010 United States
Primary
Concomitant
Vitreous Haemorrhage Other Serious 1/1/2005 74 Female 100 lb 5/12/2010 Other Health Professional United States
Primary
Concomitant
Wheelchair User Other Serious 1/28/1992 45 Female 160 lb 5/14/2010 United States
Primary
Secondary
Concomitant
Wound Infection Staphylococcal Other Serious 1/1/2003 56 Female 155 lb 5/20/2010 United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/1/2003 5/27/2010 United States
Primary
Concomitant
Wound Infection Staphylococcal Other Serious 1/1/2003 56 Female 155 lb 5/27/2010 United States
Primary
Secondary
Concomitant
Wound Infection Staphylococcal Other Serious 1/1/2003 56 Female 155 lb 6/3/2010 United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/1/2003 6/4/2010 United States
Primary
Concomitant
Urinary Tract Infection Other Serious 1/1/1996 54 Female 6/18/2010 Physician United States
Primary
Concomitant
Wound Infection Staphylococcal Other Serious 1/1/2003 56 Female 155 lb 7/7/2010 United States
Primary
Secondary
Concomitant
Wound Infection Staphylococcal Other Serious 1/1/2003 56 Female 155 lb 8/2/2010 United States
Primary
Secondary
Concomitant
Weight Increased 1/1/2007 65 Female 179 lb 8/2/2010 Consumer United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/1/2003 8/24/2010 United States
Primary
Concomitant
Hallucinations, Mixed 12/1/2008 54 Female 9/15/2010 Consumer United States
Primary
Concomitant
Wound Infection Staphylococcal Other Serious 1/1/2003 56 Female 155 lb 9/30/2010 United States
Primary
Secondary
Concomitant
Injection Site Swelling 1/18/2010 12/21/2010 Consumer United States
Primary
Concomitant
Cough 71 Female 180 lb 12/6/2010 United States
Primary
Concomitant
Depression Other Serious 3/23/2010 64 Female 2/4/2011 Consumer United States
Primary
Concomitant
Anxiety Other Serious 1/29/2003 2/11/2011 United States
Primary
Concomitant
Gastrointestinal Tract Adenoma Other Serious 4/9/2005 75 Female 100 lb 3/24/2011 Other Health Professional United States
Primary
Concomitant
Blood Cholesterol Increased 10/18/2010 50 Female 3/25/2011 Consumer United States
Primary
Secondary
Concomitant
Constipation Other Serious 4/9/2005 75 Female 100 lb 5/4/2011 Lawyer United States
Primary
Concomitant
Bladder Disorder Hospitalization 1/29/2003 5/26/2011 Physician United States
Primary
Concomitant
Nausea Hospitalization 4/27/2011 75 Female 220 lb 5/26/2011 Physician United States
Primary
Concomitant
Angiopathy Other Serious 4/9/2005 75 Female 100 lb 6/14/2011 Other Health Professional United States
Primary
Concomitant
Oral Herpes Other Serious 4/9/2005 75 Female 100 lb 6/22/2011 Other Health Professional United States
Primary
Concomitant
Rectal Polyp Hospitalization Female 155 lb 6/24/2011 Lawyer United States
Primary
Secondary
Concomitant
Abdominal Pain Upper Other Serious 2/1/2003 6/24/2011 Physician United States
Primary
Secondary
Concomitant
Diplopia Hospitalization 1/5/2010 57 Female 172 lb 6/27/2011 Physician Israel
Primary
Concomitant
Haemorrhoids Hospitalization Female 155 lb 6/30/2011 Lawyer United States
Primary
Secondary
Concomitant
Lichenoid Keratosis Other Serious 1/1/2003 56 Female 155 lb 7/7/2011 Pharmacist United States
Primary
Secondary
Concomitant
Lymphadenectomy Hospitalization 1/1/2008 61 Female 170 lb 7/8/2011 Physician Brazil
Primary
Secondary
Concomitant
Gastrointestinal Tract Adenoma Other Serious 4/9/2005 75 Female 100 lb 7/11/2011 Other Health Professional United States
Primary
Concomitant
Rash Papular Other Serious 1/1/2005 72 Female 172 lb 7/16/2011 Other Health Professional United States
Primary
Concomitant
Amnesia Other Serious 1/29/2003 7/26/2011 Other Health Professional United States
Primary
Concomitant
Metastases To Spine Other Serious 2/1/2003 7/27/2011 Consumer United States
Primary
Secondary
Concomitant
Gait Disturbance Other Serious 2/1/2007 85 Female 149 lb 7/29/2011 Consumer United States
Primary
Secondary
Concomitant
Rectal Haemorrhage Hospitalization Female 155 lb 8/2/2011 Lawyer United States
Primary
Secondary
Concomitant
Excessive Granulation Tissue Hospitalization 1/1/2003 56 Female 155 lb 8/4/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Nephrogenic Systemic Fibrosis Other Serious 2/1/2007 85 Female 149 lb 8/8/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Breast Cancer Other Serious 1/1/2007 64 Female 187 lb 8/8/2011 Consumer Brazil
Primary
Secondary
Concomitant
Dysplastic Naevus Other Serious 1/1/2003 56 Female 155 lb 8/11/2011 United States
Primary
Secondary
Concomitant
Fall Other Serious Female 155 lb 8/15/2011 Physician United States
Primary
Secondary
Concomitant
Scoliosis Other Serious 2/1/2003 64 Male 8/31/2011 Lawyer United States
Primary
Secondary
Concomitant
Vaginal Discharge Other Serious Female 155 lb 9/4/2011 Lawyer United States
Primary
Secondary
Concomitant
Coombs Test Positive Hospitalization 4/27/2011 75 Female 220 lb 8/17/2011 Physician United States
Primary
Concomitant
Oedema Peripheral Other Serious 7/7/2011 70 Female 145 lb 9/19/2011 Physician United States
Primary
Secondary
Concomitant
Drug Hypersensitivity 9/6/2011 74 Male 216 lb 9/20/2011 Consumer United States
Primary
Concomitant
Sensitivity Of Teeth Other Serious Female 155 lb 9/21/2011 Physician United States
Primary
Secondary
Concomitant
Vitamin B12 Deficiency Other Serious 2/1/2003 64 Male 165 lb 9/21/2011 Physician United States
Primary
Secondary
Concomitant
Lymphadenopathy Death 10/1/2007 62 Female 136 lb 9/23/2011 Physician United States
Primary
Secondary
Concomitant
Pleural Fibrosis Other Serious Female 155 lb 9/26/2011 Lawyer United States
Primary
Secondary
Concomitant
Adrenal Insufficiency Other Serious 2/1/2003 64 Male 165 lb 10/6/2011 Consumer United States
Primary
Secondary
Concomitant
Osteoporosis Other Serious 7/4/2011 59 Female 155 lb 10/7/2011 Lawyer United States
Primary
Secondary
Concomitant
Peptic Ulcer Other Serious 2/1/2003 64 Male 165 lb 10/12/2011 Lawyer United States
Primary
Secondary
Concomitant
Lumbar Spinal Stenosis Other Serious 2/1/2003 64 Male 165 lb 10/18/2011 Lawyer United States
Primary
Secondary
Concomitant
Ischaemic Stroke Hospitalization 9/11/2011 91 Female 10/21/2011 Physician Israel
Primary
Concomitant
Diarrhoea Other Serious 1/29/2003 49 Female 132 lb 10/21/2011 Lawyer United States
Primary
Concomitant
Renal Failure Chronic Other Serious 7/4/2011 59 Female 155 lb 11/1/2011 Lawyer United States
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization 9/13/2011 91 Female 11/2/2011 Physician Israel
Primary
Concomitant
Rotator Cuff Syndrome Other Serious 4/9/2005 75 Female 100 lb 11/16/2011 Lawyer United States
Primary
Concomitant
Bladder Disorder Hospitalization 1/29/2003 49 Female 132 lb 11/16/2011 Other Health Professional United States
Primary
Concomitant
Vulvovaginitis Hospitalization 7/4/2011 59 Female 155 lb 11/17/2011 Physician United States
Primary
Secondary
Concomitant
Keratitis Other Serious 7/4/2011 59 Female 155 lb 11/22/2011 Lawyer United States
Primary
Secondary
Concomitant
Trigonitis Other Serious 4/9/2005 75 Female 100 lb 11/25/2011 Other Health Professional United States
Primary
Concomitant
Deep Vein Thrombosis Other Serious 7/4/2011 59 Female 155 lb 11/28/2011 Lawyer United States
Primary
Secondary
Concomitant
Inappropriate Schedule Of Drug Administration Hospitalization 1/1/2007 64 Female 187 lb 12/1/2011 Consumer Brazil
Primary
Secondary
Concomitant
Seborrhoeic Keratosis Other Serious 2/1/2003 64 Male 165 lb 12/28/2011 Physician United States
Primary
Secondary
Concomitant
Vulvovaginitis Hospitalization 7/4/2011 59 Female 155 lb 12/28/2011 Physician United States
Primary
Secondary
Concomitant
Tinnitus Hospitalization 1/1/2003 56 Female 155 lb 1/5/2012 Pharmacist United States
Primary
Secondary
Concomitant
Pollakiuria Other Serious 4/9/2005 75 Female 100 lb 1/10/2012 Physician United States
Primary
Concomitant
Seborrhoeic Keratosis Other Serious 2/1/2003 64 Male 165 lb 1/12/2012 Physician United States
Primary
Secondary
Concomitant

Drug Data