Benlysta combined with Methotrexate

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Diarrhoea Other Serious 4/21/2011 39 Female 5/5/2011 Consumer United States
Primary
Concomitant
Diarrhoea Other Serious 4/21/2011 39 Female 336 lb 7/27/2011 United States
Primary
Concomitant
Infusion Site Rash 4/21/2011 39 Female 336 lb 8/18/2011 United States
Primary
Concomitant
Pain Hospitalization 8/1/2011 52 Female 144 lb 8/30/2011 United States
Primary
Concomitant
Systemic Lupus Erythematosus Hospitalization 8/1/2011 20 Female 8/31/2011 Physician United States
Primary
Concomitant
Speech Disorder Hospitalization 8/1/2011 52 Female 144 lb 9/29/2011 Consumer United States
Primary
Concomitant
Dehydration Hospitalization 10/1/2011 48 Female 328 lb 10/27/2011 United States
Primary
Secondary
Concomitant
Meningitis Viral Hospitalization 10/24/2011 35 Female 182 lb 11/10/2011 Other Health Professional United States
Primary
Concomitant
Thalamic Infarction Hospitalization 9/19/2011 49 Female 223 lb 11/23/2011 Other Health Professional United States
Primary
Concomitant
Hepatic Steatosis Life Threatening 9/19/2011 49 Female 492 lb 12/5/2011 Other Health Professional United States
Primary
Concomitant
Infusion Site Warmth 4/21/2011 39 Female 336 lb 10/5/2011 Consumer United States
Primary
Concomitant
Convulsion 7/8/2011 40 Female 130 lb 10/5/2011 United States
Primary
Concomitant
Asthenia 6/14/2011 31 Female 123 lb 10/5/2011 Physician United States
Primary
Concomitant
Feeling Abnormal 8/2/2011 43 Female 318 lb 10/5/2011 Consumer United States
Primary
Concomitant
Flushing 7/18/2011 41 Male 200 lb 10/5/2011 Other Health Professional United States
Primary
Concomitant
Urticaria 6/7/2011 48 Female 99 lb 10/5/2011 United States
Primary
Secondary
Concomitant
Meningitis Viral Hospitalization 10/24/2011 37 Female 178 lb 12/22/2011 Other Health Professional United States
Primary
Concomitant
Dyspnoea Death 12/24/2011 57 Female 1/13/2012 Consumer United States
Primary
Concomitant
Sinusitis Hospitalization 43 Female 205 lb 1/18/2012 Consumer United States
Primary
Concomitant
Paraesthesia Hospitalization 41 Female 211 lb 1/25/2012 Consumer United States
Primary
Concomitant
Systemic Lupus Erythematosus Other Serious 38 Female 2/1/2012 Other Health Professional United Kingdom
Primary
Concomitant
Headache Hospitalization 11/18/2011 27 Female 89 lb 1/30/2012 United States
Primary
Concomitant
Kidney Infection Hospitalization 1/1/2012 27 Female 89 lb 2/14/2012 Consumer United States
Primary
Concomitant
Paraesthesia Hospitalization 1/11/2012 41 Female 211 lb 2/10/2012 Consumer United States
Primary
Concomitant
Chills Other Serious 9/8/2011 31 Female 160 lb 12/20/2011 Other Health Professional United States
Primary
Concomitant
Condition Aggravated Hospitalization 8/19/2011 63 Male 213 lb 12/20/2011 Consumer United States
Primary
Concomitant
Drug Ineffective 10/19/2011 46 Female 125 lb 12/20/2011 Consumer United States
Primary
Concomitant
Bone Pain 9/1/2011 66 Female 150 lb 12/20/2011 Consumer United States
Primary
Concomitant
Musculoskeletal Stiffness 11/2/2011 59 Female 154 lb 12/20/2011 Consumer United States
Primary
Concomitant
Rash Vesicular 11/2/2011 25 Female 190 lb 12/20/2011 Consumer United States
Primary
Concomitant
White Blood Cell Count Increased 10/5/2011 64 Female 12/20/2011 Consumer United States
Primary
Concomitant
Productive Cough 1/1/2011 39 Female 240 lb 12/20/2011 Consumer United States
Primary
Concomitant
Alopecia 9/15/2011 58 Female 116 lb 12/20/2011 Consumer United States
Primary
Concomitant
Night Sweats 10/7/2011 61 Female 115 lb 12/20/2011 Consumer United States
Primary
Concomitant
Nausea 10/12/2011 59 Female 158 lb 12/20/2011 Consumer United States
Primary
Concomitant
Back Pain 7/1/2011 50 Female 144 lb 12/20/2011 Physician United States
Primary
Concomitant
Diarrhoea 7/25/2011 59 Female 294 lb 12/20/2011 Consumer United States
Primary
Concomitant
Chills 11/1/2011 55 Female 12/20/2011 Consumer United States
Primary
Concomitant
Diarrhoea 7/18/2011 41 Male 200 lb 12/20/2011 Other Health Professional United States
Primary
Concomitant
Diarrhoea 10/6/2011 43 Female 195 lb 12/20/2011 Consumer United States
Primary
Concomitant
Pharyngeal Oedema 10/5/2011 63 Male 217 lb 12/20/2011 Consumer United States
Primary
Concomitant
Arthralgia 11/6/2011 62 Female 128 lb 12/20/2011 Consumer United States
Primary
Concomitant
Fatigue 10/19/2011 26 Female 143 lb 12/20/2011 Consumer United States
Primary
Concomitant
Urticaria 11/9/2011 50 Female 260 lb 12/20/2011 Other Health Professional United States
Primary
Concomitant
Drug Ineffective 9/1/2011 57 Female 148 lb 12/20/2011 Consumer United States
Primary
Concomitant
Dry Eye 12/8/2011 68 Female 150 lb 12/20/2011 Consumer United States
Primary
Concomitant
Platelet Count Decreased Female 12/20/2011 Consumer United States
Primary
Concomitant
Urticaria 7/1/2011 48 Female 140 lb 12/20/2011 United States
Primary
Concomitant
Pain 12/5/2011 66 Female 150 lb 12/20/2011 Consumer United States
Primary
Concomitant
Off Label Use 67 Female 170 lb 12/20/2011 United States
Primary
Concomitant
Photophobia 9/1/2011 28 Female 112 lb 12/20/2011 Consumer United States
Primary
Concomitant
Upper Respiratory Tract Infection 11/10/2011 41 Female 205 lb 12/20/2011 Consumer United States
Primary
Concomitant
Dizziness 11/9/2011 32 Female 250 lb 12/20/2011 Consumer United States
Primary
Concomitant
Muscle Spasms 6/7/2011 41 Female 195 lb 12/20/2011 Consumer United States
Primary
Concomitant
Dizziness 11/3/2011 44 Female 235 lb 12/20/2011 Consumer United States
Primary
Concomitant
Myalgia 56 Female 175 lb 12/20/2011 Consumer United States
Primary
Concomitant
Stress 7/8/2011 40 Female 130 lb 12/20/2011 Consumer United States
Primary
Concomitant
Erythema 10/14/2011 40 Female 185 lb 12/20/2011 Consumer United States
Primary
Concomitant
Nausea 9/23/2011 43 Female 150 lb 12/20/2011 Consumer United States
Primary
Concomitant
Stomatitis 10/7/2011 60 Female 133 lb 12/20/2011 United States
Primary
Concomitant
Cystitis 7/25/2011 74 Female 160 lb 12/20/2011 United States
Primary
Concomitant
Migraine 6/13/2011 45 Female 147 lb 12/20/2011 United States
Primary
Concomitant
Drug Ineffective 0 Female 145 lb 12/20/2011 United States
Primary
Concomitant
Infusion Site Pain 8/19/2011 28 Female 91 lb 12/20/2011 Consumer United States
Primary
Concomitant
Arthralgia 7/29/2011 64 Female 184 lb 12/20/2011 Consumer United States
Primary
Concomitant
Urinary Tract Infection 7/12/2011 50 Female 250 lb 12/20/2011 Consumer United States
Primary
Concomitant
Pollakiuria 11/4/2011 35 Female 143 lb 12/20/2011 Consumer United States
Primary
Concomitant
Nausea 8/26/2011 44 Female 205 lb 12/20/2011 United States
Primary
Concomitant
Drug Ineffective 11/3/2011 52 Female 128 lb 12/20/2011 United States
Primary
Concomitant
Urinary Tract Infection 54 Female 169 lb 12/20/2011 United States
Primary
Concomitant
Headache 10/13/2011 60 Female 156 lb 12/20/2011 United States
Primary
Concomitant
Urticaria 11/8/2011 39 Female 140 lb 12/20/2011 Other Health Professional United States
Primary
Concomitant
Nausea 9/2/2011 Female 12/20/2011 Physician United States
Primary
Concomitant
Dehydration Hospitalization 10/1/2011 41 Female 182 lb 2/23/2012 Consumer United States
Primary
Concomitant
Blood Glucose Decreased Death 12/24/2011 57 Female 140 lb 2/21/2012 Other Health Professional United States
Primary
Concomitant
Thalamic Infarction Hospitalization 9/19/2011 49 Female 223 lb 2/29/2012 Other Health Professional United States
Primary
Concomitant
Influenza Hospitalization 40 3/6/2012 Consumer Sweden
Primary
Concomitant
Vision Blurred Other Serious 1/22/2012 55 Female 135 lb 3/12/2012 United States
Primary
Concomitant
Abdominal Pain Upper Hospitalization 1/11/2012 41 Female 211 lb 3/12/2012 United States
Primary
Concomitant
Herpes Zoster Other Serious 2/20/2012 47 Female 156 lb 3/19/2012 Consumer United States
Primary
Concomitant
Palpitations Other Serious 44 Female 259 lb 4/12/2012 Consumer United States
Primary
Concomitant
Amnesia Hospitalization 40 Female 5/1/2012 Sweden
Primary
Concomitant
Systemic Lupus Erythematosus Other Serious 38 Female 5/4/2012 Physician United Kingdom
Primary
Concomitant
Drug Effect Decreased Hospitalization 2/1/2012 35 Female 181 lb 5/3/2012 Germany
Primary
Concomitant
Dystonia Other Serious 34 Female 5/7/2012 Physician United States
Primary
Concomitant
Hypoaesthesia Oral Other Serious 4/13/2012 43 Female 5/4/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Lupus Nephritis Hospitalization 2/1/2012 35 Female 181 lb 5/14/2012 Physician Germany
Primary
Concomitant
Dystonia Other Serious 4/23/2012 Female 5/30/2012 Consumer United States
Primary
Concomitant
Aphasia Death 5/15/2012 29 Female 180 lb 6/11/2012 Consumer United States
Primary
Concomitant
Nausea Hospitalization 6/13/2012 34 Female 121 lb 6/29/2012 Physician Germany
Primary
Concomitant
General Physical Health Deterioration Hospitalization 5/15/2012 29 Female 180 lb 7/3/2012 United States
Primary
Concomitant
Memory Impairment Other Serious 70 Male 152 lb 7/9/2012 Consumer United States
Primary
Concomitant
Contrast Media Reaction Other Serious 32 Female 7/19/2012 Consumer United States
Primary
Secondary
Concomitant
Dizziness Death 5/15/2012 29 Female 162 lb 8/8/2012 United States
Primary
Concomitant
Upper Respiratory Tract Infection Other Serious 11/22/2011 41 Female 205 lb 5/3/2012 Us
Primary
Concomitant
Palpitations 10/19/2011 43 Female 205 lb 5/3/2012 Us
Primary
Concomitant
Platelet Count Decreased Female 5/3/2012 Consumer Us
Primary
Concomitant
Productive Cough Other Serious 11/23/2011 32 Female 264 lb 5/3/2012 Consumer Us
Primary
Concomitant
Urinary Tract Infection 7/25/2011 74 Female 159 lb 5/3/2012 Us
Primary
Concomitant
Off Label Use Other Serious 1/16/2012 68 Female 176 lb 5/3/2012 Us
Primary
Concomitant
Fatigue Other Serious 10/19/2011 26 Female 143 lb 5/3/2012 Other Health Professional Us
Primary
Concomitant
Drug Ineffective Other Serious 9/2011 57 Female 148 lb 5/3/2012 Us
Primary
Concomitant
Skin Exfoliation Other Serious 2011 39 Female 240 lb 5/3/2012 Us
Primary
Concomitant
Trichorrhexis Other Serious 9/15/2011 58 Female 116 lb 6/22/2012 Us
Primary
Concomitant
Back Pain 7/1/2011 50 Female 144 lb 5/3/2012 Physician Us
Primary
Concomitant
Pulmonary Congestion 7/25/2011 59 Female 294 lb 5/3/2012 Consumer Us
Primary
Concomitant
Pruritus 9/1/2011 66 Female 150 lb 6/22/2012 Consumer Us
Primary
Concomitant
Skin Lesion Other Serious 11/2/2011 59 Female 154 lb 5/3/2012 Other Health Professional Us
Primary
Concomitant
Rash Vesicular Other Serious 11/2/2011 25 Female 190 lb 5/3/2012 Consumer Us
Primary
Concomitant
Wheezing Other Serious 11/9/2011 50 Female 260 lb 5/3/2012 Other Health Professional Us
Primary
Concomitant
Urticaria 11/8/2011 39 Female 140 lb 5/3/2012 Other Health Professional Us
Primary
Concomitant
Syncope Other Serious 44 Female 259 lb 8/22/2012 Consumer Us
Primary
Concomitant
Wheezing Death 5/15/2012 29 Female 162 lb 8/14/2012 Consumer Us
Primary
Concomitant
Vision Blurred Hospitalization 6/13/2012 35 Female 121 lb 8/15/2012 Physician De
Primary
Concomitant
Spleen Disorder Hospitalization 38 Female 9/11/2012 De
Primary
Secondary
Concomitant
Tremor Other Serious 6/1/2012 52 Male 300 lb 10/3/2012 Other Health Professional Us
Primary
Concomitant
Transaminases Increased Other Serious Female 154 lb 10/9/2012 Physician Es
Primary
Concomitant
Throat Irritation Hospitalization 10/6/2011 43 Female 205 lb 10/24/2012 Consumer Us
Primary
Concomitant
Viral Infection Other Serious 6/27/2012 41 Female 185 lb 1/18/2013 Physician Ca
Primary
Concomitant
Septic Shock Death 12/24/2011 57 Female 140 lb 11/13/2012 Other Health Professional Us
Primary
Concomitant
Vulvovaginal Pruritus 12/1/2011 44 Female 235 lb 1/7/2013 Consumer Us
Primary
Concomitant
Pruritus 4/2012 65 Female 104 lb 1/7/2013 Pharmacist Us
Primary
Concomitant
Rhinorrhoea 2/22/2012 50 Female 119 lb 1/7/2013 Physician Us
Primary
Concomitant
Swollen Tongue 8/28/2012 53 Female 225 lb 1/7/2013 Consumer Us
Primary
Concomitant
Anaphylactic Reaction Other Serious 10/3/2012 30 Female 241 lb 1/7/2013 Consumer Us
Primary
Concomitant
Pruritus 11/12/2012 53 Female 1/7/2013 Consumer Us
Primary
Concomitant
Pyrexia 39 Female 1/7/2013 Consumer Us
Primary
Concomitant
Urticaria Other Serious 8/2011 47 Female 1/7/2013 Other Health Professional Us
Primary
Concomitant
Intestinal Obstruction Death 12/2012 59 Female 1/18/2013 Consumer Us
Primary
Concomitant
Weight Decreased Hospitalization Female 187 lb 5/2/2013 Other Health Professional Ca
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 12/10/2012 57 Female 4/10/2013 Consumer Us
Primary
Concomitant
Myocardial Infarction Hospitalization 57 Female 130 lb 2/6/2013 Pharmacist Us
Primary
Concomitant
Urinary Incontinence Life Threatening 2/15/2013 47 Female 151 lb 4/10/2013 Consumer Us
Primary
Concomitant
Upper Respiratory Tract Infection Hospitalization Female 3/4/2013 Consumer Us
Primary
Secondary
Vomiting Hospitalization 2012 75 Female 4/8/2013 Consumer Us
Primary
Concomitant
Tachycardia Hospitalization 3/7/2013 57 Male 214 lb 4/10/2013 Other Health Professional Us
Primary
Secondary
Concomitant
Infusion Related Reaction Other Serious 1/30/2013 44 Female 181 lb 4/17/2013 Consumer Us
Primary
Secondary
Concomitant
Insomnia 4/15/2012 72 Female 200 lb 6/22/2012 Us
Primary
Concomitant
Insomnia 4/15/2012 72 Female 200 lb 10/9/2012 Us
Primary
Concomitant
Depression 3/31/2012 48 Female 160 lb 6/22/2012 Consumer Us
Primary
Concomitant
Pruritus Generalised 3/19/2012 38 Female 3/29/2013 Consumer Us
Primary
Concomitant
Pyrexia 9/8/2012 49 Female 184 lb 3/29/2013 Consumer Us
Primary
Concomitant
Pain In Extremity Female 224 lb 10/9/2012 Consumer Us
Primary
Concomitant
Weight Decreased Hospitalization 39 Female 4/18/2013 Consumer Us
Primary
Concomitant
Weight Increased 42 Female 210 lb 10/9/2012 Consumer Us
Primary
Concomitant
Respiratory Rate Increased Other Serious 1/2013 44 Female 181 lb 6/17/2013 Other Health Professional Us
Primary
Secondary
Concomitant
Systemic Mycosis Death 8/2012 31 Male 6/10/2013 Physician Us
Primary
Concomitant
Vomiting Other Serious 1/16/2013 26 Female 5/6/2013 Consumer Us
Primary
Concomitant
Systemic Lupus Erythematosus Other Serious 64 Female 6/18/2013 Consumer Us
Primary
Concomitant
Weight Decreased Other Serious 36 Female 5/24/2013 Consumer Us
Primary
Concomitant