Benlysta combined with Folic Acid

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Infusion Site Rash 4/21/2011 39 Female 336 lb 8/18/2011 United States
Primary
Concomitant
Abdominal Pain Hospitalization 8/18/2011 61 Female 144 lb 9/7/2011 Other Health Professional United States
Primary
Concomitant
Gastrointestinal Disorder Hospitalization 9/20/2011 49 Female 194 lb 10/14/2011 United States
Primary
Concomitant
Nausea Hospitalization 11/8/2011 36 Female 150 lb 11/21/2011 Consumer 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
Fluid Retention 1/1/2011 44 Female 260 lb 10/5/2011 United States
Primary
Concomitant
Feeling Abnormal 8/2/2011 43 Female 318 lb 10/5/2011 Consumer United States
Primary
Concomitant
Blood Pressure Decreased 7/7/2011 50 Female 334 lb 10/5/2011 Other Health Professional United States
Primary
Concomitant
Diarrhoea 47 Female 117 lb 10/5/2011 United States
Primary
Concomitant
Joint Swelling 6/1/2011 28 Female 134 lb 10/5/2011 United States
Primary
Concomitant
Blood Pressure Increased 8/2/2011 56 Female 110 lb 10/5/2011 United States
Primary
Concomitant
Urticaria 6/7/2011 48 Female 99 lb 10/5/2011 United States
Primary
Secondary
Concomitant
Arrhythmia Hospitalization 11/1/2011 49 Female 207 lb 12/14/2011 Consumer United States
Primary
Concomitant
Sinusitis Hospitalization 43 Female 205 lb 1/18/2012 Consumer United States
Primary
Concomitant
Death Hospitalization 70 Male 163 lb 1/20/2012 Other Health Professional United States
Primary
Concomitant
Paraesthesia Hospitalization 41 Female 211 lb 1/25/2012 Consumer United States
Primary
Concomitant
Pneumonia Bacterial Other Serious 11/1/2011 59 Female 270 lb 2/2/2012 Consumer United States
Primary
Concomitant
Infusion Related Reaction Hospitalization 1/13/2012 59 Female 240 lb 1/31/2012 Consumer United States
Primary
Concomitant
Paraesthesia Hospitalization 1/11/2012 41 Female 211 lb 2/10/2012 Consumer United States
Primary
Concomitant
Abdominal Pain Hospitalization 8/31/2011 47 Female 250 lb 12/20/2011 Consumer United States
Primary
Concomitant
Productive Cough 12/1/2011 56 Female 176 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
Rash 62 Female 101 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
Back Pain 7/1/2011 50 Female 144 lb 12/20/2011 Physician United States
Primary
Concomitant
Weight Decreased 9/1/2011 34 Female 98 lb 12/20/2011 Consumer United States
Primary
Concomitant
Nausea 9/23/2011 35 Female 151 lb 12/20/2011 Consumer United States
Primary
Concomitant
Chills 11/1/2011 55 Female 12/20/2011 Consumer United States
Primary
Concomitant
Chest Pain 8/9/2011 36 Female 237 lb 12/20/2011 Other Health Professional United States
Primary
Concomitant
Rash 7/16/2011 57 Female 12/20/2011 Physician United States
Primary
Concomitant
Rash Macular 10/4/2011 50 Female 100 lb 12/20/2011 Consumer United States
Primary
Concomitant
Diarrhoea 10/6/2011 43 Female 195 lb 12/20/2011 Consumer United States
Primary
Concomitant
Dyspnoea 36 Female 110 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
Drug Ineffective 9/1/2011 57 Female 148 lb 12/20/2011 Consumer United States
Primary
Concomitant
Mood Altered 11/1/2011 42 Female 140 lb 12/20/2011 Consumer United States
Primary
Concomitant
Weight Increased 10/1/2011 47 Female 260 lb 12/20/2011 United States
Primary
Concomitant
Off Label Use 67 Female 170 lb 12/20/2011 United States
Primary
Concomitant
Fracture 11/3/2011 49 Female 126 lb 12/20/2011 Consumer United States
Primary
Concomitant
Throat Irritation 8/2/2011 56 Female 110 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
Muscle Spasms 6/7/2011 41 Female 195 lb 12/20/2011 Consumer United States
Primary
Concomitant
Flank Pain 7/25/2011 74 Female 160 lb 12/20/2011 Consumer United States
Primary
Concomitant
No Adverse Event 8/16/2011 58 Female 260 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
Rash Female 108 lb 12/20/2011 Consumer United States
Primary
Concomitant
Feeling Hot 11/14/2011 49 Female 240 lb 12/20/2011 Consumer United States
Primary
Concomitant
Myalgia 56 Female 175 lb 12/20/2011 Consumer United States
Primary
Concomitant
Joint Effusion 1/1/2011 44 Female 260 lb 12/20/2011 Consumer United States
Primary
Concomitant
Systemic Lupus Erythematosus 10/31/2011 47 Female 270 lb 12/20/2011 Consumer United States
Primary
Concomitant
Nausea 6/13/2011 44 Female 145 lb 12/20/2011 Consumer 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
Pain 52 Female 220 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
Diarrhoea 10/28/2011 55 Female 138 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
Diarrhoea 10/17/2011 45 Female 141 lb 12/20/2011 Consumer United States
Primary
Concomitant
Cold Sweat 9/21/2011 37 Female 115 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
Blood Glucose Decreased Death 12/24/2011 57 Female 140 lb 2/21/2012 Other Health Professional United States
Primary
Concomitant
Stenotrophomonas Infection Other Serious 10/1/2011 58 Female 270 lb 2/22/2012 United States
Primary
Concomitant
Thalamic Infarction Hospitalization 9/19/2011 49 Female 223 lb 2/29/2012 Other Health Professional United States
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
Abdominal Pain Upper Hospitalization 1/11/2012 41 Female 211 lb 3/22/2012 United States
Primary
Concomitant
Palpitations Other Serious 44 Female 259 lb 4/12/2012 Consumer United States
Primary
Concomitant
Pancreatitis Hospitalization 12/20/2011 47 Female 270 lb 1/9/2012 United States
Primary
Concomitant
Pyrexia Other Serious 1/30/2012 48 Female 196 lb 4/25/2012 Consumer United States
Primary
Concomitant
Paraesthesia Oral Other Serious 1/30/2012 48 Female 196 lb 5/2/2012 United States
Primary
Concomitant
Drug Effect Decreased Hospitalization 2/1/2012 35 Female 181 lb 5/3/2012 Germany
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
Memory Impairment Other Serious 70 Male 152 lb 7/9/2012 Consumer United States
Primary
Concomitant
Muscle Spasms Other Serious Female 176 lb 7/30/2012 Consumer United States
Primary
Concomitant
Sinusitis 11/3/2011 58 Female 178 lb 5/3/2012 Consumer Us
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
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
Productive Cough Other Serious 10/2011 56 Female 176 lb 5/3/2012 Consumer Us
Primary
Concomitant
Rash Other Serious 11/7/2011 62 Female 101 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
Nausea 10/14/2011 45 Female 145 lb 5/3/2012 Consumer Us
Primary
Concomitant
Rash Vesicular Other Serious 11/2/2011 25 Female 190 lb 5/3/2012 Consumer Us
Primary
Concomitant
Pruritus 9/23/2011 35 Female 151 lb 5/3/2012 Us
Primary
Concomitant
Syncope Other Serious 44 Female 259 lb 8/22/2012 Consumer Us
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
Throat Irritation Hospitalization 10/6/2011 43 Female 205 lb 10/24/2012 Consumer Us
Primary
Concomitant
Vomiting Hospitalization 5/28/2012 59 Female 11/6/2012 Other Health Professional Us
Primary
Concomitant
Septic Shock Death 12/24/2011 57 Female 140 lb 11/13/2012 Other Health Professional Us
Primary
Concomitant
Tricuspid Valve Incompetence Hospitalization 7/12/2011 44 Female 132 lb 11/14/2012 Consumer 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
Pyrexia 2011 Female 1/7/2013 Physician Us
Primary
Concomitant
Loss Of Consciousness Hospitalization 9/6/2012 57 Female 164 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
Mood Altered 10/2011 54 Female 235 lb 6/22/2012 Physician Us
Primary
Concomitant
Intestinal Obstruction Death 12/2012 59 Female 1/18/2013 Consumer Us
Primary
Concomitant
Myocardial Infarction Hospitalization 12/10/2012 57 Female 4/10/2013 Consumer Us
Primary
Concomitant
Vomiting Hospitalization 2012 75 Female 4/8/2013 Consumer Us
Primary
Concomitant
Infusion Related Reaction Other Serious 1/30/2013 44 Female 181 lb 4/17/2013 Consumer Us
Primary
Secondary
Concomitant
Tonic Clonic Movements Life Threatening 2/2013 70 Male 165 lb 4/10/2013 Consumer Us
Primary
Concomitant
Pharyngitis Streptococcal Other Serious 1/11/2012 44 Female 239 lb 3/22/2013 Other Health Professional Us
Primary
Concomitant
Depression 3/31/2012 48 Female 160 lb 6/22/2012 Consumer Us
Primary
Concomitant
Pneumonia Hospitalization 2/25/2012 50 Female 213 lb 6/22/2012 Consumer Us
Primary
Secondary
Concomitant
Pruritus Generalised 3/19/2012 38 Female 3/29/2013 Consumer Us
Primary
Concomitant
Myalgia 1/18/2013 48 Female 3/29/2013 Consumer Us
Primary
Concomitant
Rash Papular 5/2012 59 Female 3/29/2013 Consumer Us
Primary
Concomitant
Weight Increased 12/2011 26 Female 170 lb 3/29/2013 Physician Us
Primary
Concomitant
Infusion Related Reaction 6/8/2012 Female 10/9/2012 Us
Primary
Concomitant
Rhinorrhoea 5/23/2012 61 Female 206 lb 10/9/2012 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
Subarachnoid Haemorrhage Hospitalization 3/2013 53 Male 10/14/2013 Physician Fr
Primary
Concomitant
Rhinorrhoea Other Serious 10/2011 59 Female 109 lb 4/29/2013 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
Presyncope Other Serious 7/2012 61 Female 164 lb 7/1/2013 Other Health Professional Us
Primary
Concomitant
Viral Rash Other Serious 5/2013 62 Female 207 lb 7/3/2013 Physician Us
Primary
Concomitant
Urinary Tract Infection Hospitalization 4/3/2013 42 Female 5/31/2013 Consumer Us
Primary
Concomitant
Swelling Other Serious 9/26/2011 55 Female 138 lb 6/17/2013 Consumer Us
Primary
Concomitant
Viith Nerve Paralysis Other Serious 6/21/2012 35 Female 241 lb 7/16/2013 Consumer Us
Primary
Concomitant
Stomatitis Disability 3/29/2013 52 Female 7/9/2013 Consumer Us
Primary
Concomitant
Muscular Weakness 1/3/2012 51 Female 250 lb 7/5/2013 Consumer Us
Primary
Secondary
Concomitant
Therapeutic Response Decreased 3/25/2013 43 Female 7/5/2013 Consumer Us
Primary
Concomitant
White Blood Cell Count Increased Other Serious 12/2011 64 Female 159 lb 7/5/2013 Consumer Us
Primary
Concomitant
Hip Fracture Other Serious 4/2013 37 Female 217 lb 9/6/2013 Consumer Us
Primary
Concomitant
Systemic Lupus Erythematosus Rash Other Serious 12/2011 37 Female 7/9/2013 Consumer Us
Primary
Concomitant
Nausea Hospitalization 9/21/2011 37 Female 115 lb 10/25/2013 Other Health Professional Us
Primary
Concomitant
Breast Cancer Female Other Serious 8/15/2013 53 Female 8/20/2013 Consumer Us
Primary
Concomitant
Hypersensitivity Required Intervention 4/13/2012 43 Female 5/2/2013 Consumer Us
Primary
Concomitant

Drug Data