Leflunomide combined with Plaquenil

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Endocarditis Enterococcal Hospitalization 78 Female 1/19/2006 United States
Primary
Secondary
Malignant Melanoma Other Serious 59 Female 10/2/2006 Consumer United States
Primary
Concomitant
Streptococcal Infection Life Threatening 6/1/2006 Female 10/20/2006 Physician Australia
Primary
Concomitant
Prostate Cancer Other Serious 11/1/2006 Male 12/6/2006 Physician United States
Primary
Concomitant
Pregnancy Other Serious 11/15/2006 35 Female 242 lb 4/11/2007 Other Health Professional United States
Primary
Concomitant
Tuberculosis Skin Test Positive Hospitalization 5/1/2006 Female 166 lb 9/14/2007 Physician United States
Primary
Concomitant
Sinusitis 8/13/2007 Female 12/8/2007 Consumer United States
Primary
Concomitant
Neuroma 6/1/2007 Female 12/13/2007 Physician United States
Primary
Concomitant
Injection Site Irritation 9/6/2007 Female 12/14/2007 Consumer United States
Primary
Concomitant
Loss Of Consciousness Other Serious 6/1/2007 Female 130 lb 7/23/2008 Consumer Canada
Primary
Concomitant
Tinnitus Other Serious 6/1/2007 Female 130 lb 8/22/2008 Consumer Canada
Primary
Concomitant
Pleural Effusion Other Serious 12/1/2003 Female 143 lb 11/26/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Pleural Effusion Death 1/1/2003 47 Female 12/3/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Sinus Congestion 2/11/2008 Female 12/5/2008 Consumer United States
Primary
Concomitant
Rash Life Threatening 47 Female 121 lb 12/3/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Injection Site Irritation 7/4/2007 Female 12/11/2008 Consumer United States
Primary
Concomitant
Drug Ineffective 5/17/2008 Female 12/11/2008 Consumer United States
Primary
Concomitant
Sinusitis Female 12/12/2008 Consumer United States
Primary
Concomitant
Rash Erythematous 7/1/2008 Female 12/12/2008 United States
Primary
Concomitant
Nausea 10/15/2008 Female 142 lb 12/12/2008 Consumer United States
Primary
Concomitant
Muscle Spasms 1/15/2007 Female 12/13/2008 Consumer United States
Primary
Concomitant
Injection Site Pruritus 2/1/2008 Female 12/15/2008 Consumer United States
Primary
Concomitant
Injection Site Warmth 10/31/2007 Female 12/15/2008 Consumer United States
Primary
Concomitant
Injection Site Warmth 10/10/2006 Female 12/15/2008 Consumer United States
Primary
Concomitant
Injection Site Erythema 7/31/2008 Female 12/17/2008 Consumer United States
Primary
Concomitant
Injection Site Pain Female 12/17/2008 Consumer United States
Primary
Concomitant
Liver Function Test Abnormal Hospitalization Female 141 lb 1/13/2009 Other Health Professional United States
Primary
Concomitant
Respiratory Failure Other Serious 3/12/2008 Female 174 lb 1/20/2009 United Kingdom
Primary
Concomitant
Renal Failure Death 1/1/2009 Female 1/22/2009 Physician United States
Primary
Concomitant
Tendon Rupture Required Intervention 12/1/2007 74 Male 195 lb 3/27/2009 Physician United States
Primary
Secondary
Concomitant
Liver Function Test Abnormal Hospitalization Female 141 lb 4/30/2009 Other Health Professional United States
Primary
Concomitant
Osteonecrosis Other Serious 7/10/2008 Male 161 lb 5/11/2009
Primary
Concomitant
Sinusitis Hospitalization 1/1/2007 Female 185 lb 9/10/2009 Other Health Professional United States
Primary
Concomitant
Drug Dose Omission 6/19/2009 Male 150 lb 9/19/2009 Consumer
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization Female 9/22/2009 Physician United States
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization Female 9/30/2009 Physician United States
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization Female 10/27/2009 Physician United States
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 6/1/2009 Female 11/19/2009 Physician United States
Primary
Concomitant
Injection Site Pain 5/1/2009 Female 11/28/2009 Consumer United States
Primary
Concomitant
Injection Site Haematoma Female 11/30/2009 Consumer United States
Primary
Concomitant
Upper Respiratory Tract Infection 8/21/2009 Female 11/30/2009 Consumer United States
Primary
Concomitant
Injection Site Pain 11/1/2007 Female 12/7/2009 Consumer United States
Primary
Concomitant
Injection Site Pruritus 1/8/2009 Female 156 lb 12/7/2009 Physician United States
Primary
Concomitant
Rash Erythematous 1/23/2009 Male 12/7/2009 Consumer United States
Primary
Concomitant
Local Swelling 3/28/2009 Male 12/8/2009 Consumer United States
Primary
Concomitant
Injection Site Pain 10/1/2008 Female 12/8/2009 Consumer United States
Primary
Concomitant
Nasopharyngitis 3/1/2009 Female 12/8/2009 Consumer United States
Primary
Concomitant
Injection Site Pain 4/23/2009 Male 12/9/2009 Consumer United States
Primary
Concomitant
Injection Site Rash 5/29/2009 Female 12/9/2009 Consumer United States
Primary
Concomitant
Sinusitis 4/20/2007 Female 12/9/2009 Consumer United States
Primary
Concomitant
Injection Site Haematoma 6/1/2009 Female 12/9/2009 Consumer United States
Primary
Concomitant
Paraesthesia 5/1/2009 Female 12/9/2009 Consumer United States
Primary
Concomitant
Injection Site Rash 2/1/2009 Female 12/10/2009 Consumer United States
Primary
Concomitant
Injection Site Rash 7/1/2009 Female 12/10/2009 Consumer United States
Primary
Concomitant
Urticaria 8/2/2009 Female 12/10/2009 Consumer United States
Primary
Concomitant
Musculoskeletal Stiffness 7/1/2009 Female 12/10/2009 Consumer United States
Primary
Concomitant
Injection Site Rash 8/13/2009 Female 12/10/2009 Consumer United States
Primary
Concomitant
Injection Site Rash 9/8/2009 Female 12/10/2009 Consumer United States
Primary
Concomitant
Pain In Extremity 1/1/2009 Female 12/10/2009 Consumer United States
Primary
Concomitant
Therapeutic Response Decreased 8/10/2009 Female 12/10/2009 Consumer United States
Primary
Concomitant
Unevaluable Event Death 58 Female 1/12/2010 United States
Primary
Concomitant
Pulmonary Embolism Hospitalization 12/27/2009 Male 1/28/2010 Consumer United States
Primary
Concomitant
Pain Death 58 Female 1/22/2010 United States
Primary
Concomitant
Dyspnoea Other Serious 2/14/2010 28 Female 2/25/2010 Consumer Canada
Primary
Secondary
Dyspnoea 2/14/2010 28 Female 3/1/2010 Consumer Canada
Primary
Secondary
Arthralgia 11/11/2009 Female 150 lb 2/10/2010 Consumer United States
Primary
Concomitant
Vitamin D Decreased Other Serious 3/1/2008 Male 3/11/2010 Physician United States
Primary
Concomitant
Vomiting Other Serious 80 Male 3/26/2010 Pharmacist United Kingdom
Primary
Concomitant
Unevaluable Event Death 58 Female 5/26/2010 Lawyer United States
Primary
Concomitant
Productive Cough Hospitalization 8/21/2009 66 Male 174 lb 6/18/2010 Other Health Professional United Kingdom
Primary
Concomitant
Therapeutic Agent Toxicity Death 58 Female 7/8/2010 Lawyer United States
Primary
Secondary
Concomitant
Convulsion Other Serious Female 160 lb 7/30/2010 Physician Canada
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 6/1/2009 72 Female 8/23/2010 Physician United States
Primary
Concomitant
Pain 8/1/2009 65 Female 150 lb 9/14/2010 Other Health Professional United States
Primary
Concomitant
Proteinuria Other Serious 4/1/2009 29 Female 10/7/2010 Physician United States
Primary
Secondary
Weight Decreased Hospitalization 6/1/2010 65 Female 10/22/2010 Physician Canada
Primary
Secondary
Concomitant
Injection Site Pain Other Serious 1/1/2010 50 Female 185 lb 11/3/2010 Consumer United States
Primary
Concomitant
Lung Neoplasm Malignant Other Serious 12/2/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Injection Site Pain 4/6/2010 62 Male 260 lb 1/28/2011 United States
Primary
Concomitant
Respiratory Disorder 2/1/2010 61 Female 132 lb 1/29/2011 Consumer United States
Primary
Concomitant
Drug Ineffective Female 1/30/2011 Consumer United States
Primary
Concomitant
Injection Site Haematoma 9/28/2010 73 Female 110 lb 1/30/2011 Consumer United States
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Death 6/1/2009 72 Female 2/3/2011 Physician United States
Primary
Concomitant
Upper Limb Fracture Hospitalization 1/1/2009 57 Female 198 lb 4/14/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 6/1/2009 72 Female 5/16/2011 Physician United States
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Death 6/1/2009 72 Female 5/18/2011 Consumer United States
Primary
Concomitant
Pelvic Pain Hospitalization 5/19/2011 29 Female 132 lb 7/26/2011 Consumer Italy
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Death 6/1/2009 72 Female 8/5/2011 Physician United States
Primary
Concomitant
Pelvic Pain Hospitalization 5/19/2011 29 Female 132 lb 8/11/2011 Consumer Italy
Primary
Secondary
Concomitant
Convulsion Other Serious 7/1/2010 58 Female 145 lb 8/16/2011 Consumer Canada
Primary
Concomitant
Lung Neoplasm Malignant Other Serious 8/19/2011 Physician Canada
Primary
Secondary
Concomitant
Pelvic Pain Hospitalization 5/19/2011 29 Female 132 lb 9/6/2011 Consumer United States
Primary
Secondary
Concomitant
Demyelination Other Serious 7/1/2010 58 Female 145 lb 9/8/2011 Physician Canada
Primary
Concomitant
Convulsion Hospitalization 8/31/2011 61 Female 9/9/2011 Consumer United States
Primary
Concomitant
Radiation Injury Other Serious 7/1/2010 58 Female 145 lb 9/9/2011 Physician Canada
Primary
Concomitant
Convulsion Death 8/31/2011 61 Female 9/13/2011 Physician United States
Primary
Concomitant
Tendon Rupture Hospitalization 12/1/2010 55 Female 145 lb 9/21/2011 Consumer Canada
Primary
Concomitant
Muscular Weakness Other Serious 1/1/2002 66 Female 122 lb 9/27/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Abdominal Pain 1/3/2011 61 Male 165 lb 10/30/2011 Consumer United States
Primary
Concomitant
Thrombosis Hospitalization 10/8/2011 70 Female 10/25/2011 Consumer Canada
Primary
Concomitant
Renal Failure Other Serious 12/1/2010 55 Female 145 lb 11/7/2011 Physician Canada
Primary
Concomitant
Pneumonia Other Serious 9/2/2011 73 Female 11/15/2011 Other Health Professional Canada
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 6/1/2009 72 Female 1/4/2012 Other Health Professional United States
Primary
Concomitant
Dyspnoea Hospitalization 5/6/2011 80 Male 1/17/2012 Consumer United States
Primary
Concomitant
Arthralgia Hospitalization 8/18/2011 70 Female 1/26/2012 Consumer Canada
Primary
Concomitant
Upper Respiratory Tract Infection 10/1/2010 57 Female 150 lb 1/27/2012 Consumer United States
Primary
Concomitant
Diarrhoea 3/7/2011 63 Female 1/27/2012 Consumer United States
Primary
Concomitant
Fall Other Serious 6/1/2011 63 Female 119 lb 1/28/2012 Physician United States
Primary
Concomitant
Tremor Female 158 lb 1/28/2012 Consumer United States
Primary
Concomitant
Injection Site Haemorrhage 10/8/2011 58 Female 1/28/2012 Consumer United States
Primary
Concomitant
Blood Chloride Decreased Hospitalization 5/6/2011 80 Male 3/9/2012 Consumer United States
Primary
Concomitant
Pelvic Pain Hospitalization 5/19/2011 29 Female 132 lb 4/12/2012 Physician Italy
Primary
Secondary
Concomitant
Pain Death 11/15/2006 76 Female 198 lb 4/24/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 1/1/2005 62 Female 5/4/2012 Physician United States
Primary
Concomitant
Heart Rate Increased Hospitalization 2/28/2012 69 Male 191 lb 5/9/2012 Consumer United States
Primary
Concomitant
Pneumonia Hospitalization 5/14/2012 70 Female 148 lb 5/29/2012 Consumer Canada
Primary
Concomitant
Dysaesthesia Hospitalization 1/1/2005 63 Female 6/4/2012 Physician United States
Primary
Concomitant
Drug Interaction Other Serious 1/1/2005 63 Female 6/20/2012 Physician United States
Primary
Concomitant
Pyrexia Other Serious 55 Female 154 lb 6/18/2012 Consumer United States
Primary
Concomitant
Knee Operation Other Serious 7/3/2012 62 Female 143 lb 7/12/2012 Consumer Canada
Primary
Concomitant
Gastrooesophageal Reflux Disease Disability 1/1/2005 7/27/2012 Consumer United States
Primary
Concomitant
Abdominal Operation Other Serious 7/1/2012 43 Female 320 lb 8/2/2012 Consumer United States
Primary
Concomitant
Asthenia Hospitalization 5/17/2012 55 Male 5/21/2012 Pharmacist United States
Primary
Secondary
Concomitant
Rash Disability 1/1/2005 8/7/2012 Consumer United States
Primary
Concomitant
Post Procedural Complication Other Serious 7/1/2012 43 Female 320 lb 8/17/2012 Physician United States
Primary
Concomitant
Skin Exfoliation 2011 Female 272 lb 1/29/2013 Consumer Country Not Specified
Primary
Concomitant
Viral Infection Other Serious 2005 9/26/2012 Consumer Us
Primary
Concomitant
Pulmonary Oedema Hospitalization 5/14/2012 71 Female 148 lb 9/18/2012 Consumer Ca
Primary
Concomitant
Renal Failure Acute Hospitalization 7/3/2012 88 Female 183 lb 9/12/2012 Physician Us
Primary
Concomitant
Urinary Tract Infection Hospitalization 5/2002 12/20/2012 Consumer Us
Primary
Concomitant
Urinary Tract Infection Other Serious 8/9/2012 31 Female 9/7/2012 Other Health Professional Gb
Primary
Concomitant
Spinal Disorder Hospitalization Female 170 lb 9/25/2012 Physician Country Not Specified
Primary
Concomitant
Low Density Lipoprotein Increased Other Serious 1/6/2012 48 Female 165 lb 10/3/2012 Physician Tr
Primary
Secondary
Concomitant
Ventricular Dysfunction Disability 49 Female 12/10/2012 Physician Cz
Primary
Concomitant
Rash Pruritic Male 210 lb 1/29/2013 Physician Country Not Specified
Primary
Concomitant
Psoriasis 1/31/2012 70 Female 1/28/2013 Consumer Country Not Specified
Primary
Concomitant
Injection Site Bruising 64 Female 1/28/2013 Consumer Country Not Specified
Primary
Concomitant
Paraesthesia 6/2012 Female 262 lb 1/30/2013 Consumer Country Not Specified
Primary
Concomitant
Scab 50 Female 1/31/2013 Consumer Country Not Specified
Primary
Concomitant
Rash Macular Male 1/29/2013 Consumer Country Not Specified
Primary
Concomitant
Injection Site Pain 3/23/2012 65 Female 1/29/2013 Consumer Country Not Specified
Primary
Concomitant
Pain 4/2012 65 Female 1/29/2013 Consumer Country Not Specified
Primary
Concomitant
Skin Wound 5/2012 Female 131 lb 1/29/2013 Consumer Country Not Specified
Primary
Secondary
Concomitant
Muscle Spasms 50 Female 1/30/2013 Other Health Professional Country Not Specified
Primary
Concomitant
Injection Site Pain Female 1/30/2013 Consumer Country Not Specified
Primary
Concomitant
Crohn's Disease 9/2012 Male 1/31/2013 Consumer Country Not Specified
Primary
Concomitant
Productive Cough 12/6/2012 53 Female 330 lb 1/31/2013 Consumer Country Not Specified
Primary
Concomitant
Myocardial Infarction Death 2/11/2013 81 Male 2/15/2013 Consumer Ca
Primary
Concomitant
Urinary Tract Infection 6/2012 66 Female 266 lb 2/19/2013 Consumer Us
Primary
Concomitant
Urinary Tract Infection 4/8/2012 65 Female 1/29/2013 Consumer Country Not Specified
Primary
Concomitant

Drug Data