Certolizumab Pegol combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Electrocardiogram St-t Change Hospitalization 2/26/2009 70 Female 170 lb 5/26/2009 Physician Latvia
Primary
Concomitant
Uterine Cancer Hospitalization 2/20/2007 47 Female 159 lb 5/26/2009 Russian Federation
Primary
Concomitant
Wound Infection Pseudomonas Hospitalization 9/18/2007 58 Female 170 lb 6/17/2009 Poland
Primary
Concomitant
Histoplasmosis Other Serious 12/26/2008 66 Female 190 lb 6/17/2009 Argentina
Primary
Concomitant
Weight Decreased Hospitalization 5/6/2009 54 Male 146 lb 6/16/2009 Physician Russian Federation
Primary
Concomitant
Pyelonephritis Chronic Other Serious 6/2/2009 67 Female 173 lb 6/22/2009 Consumer Lithuania
Primary
Concomitant
Tuberculosis Test Positive Other Serious 5/25/2009 43 Female 220 lb 6/19/2009 Lithuania
Primary
Concomitant
Wound Infection Hospitalization 4/23/2009 68 Female 179 lb 6/24/2009 Germany
Primary
Concomitant
Ear Infection Hospitalization 4/12/2008 65 Female 134 lb 6/22/2009 Russian Federation
Primary
Concomitant
Pulmonary Tuberculosis Other Serious 5/25/2009 43 Female 220 lb 6/29/2009 Other Health Professional Lithuania
Primary
Concomitant
Pulmonary Tuberculosis Other Serious 6/2/2009 67 Female 173 lb 7/2/2009 Physician Lithuania
Primary
Concomitant
Postoperative Wound Infection Hospitalization 4/23/2009 68 Female 179 lb 7/10/2009 Physician Germany
Primary
Secondary
Concomitant
Histoplasmosis Other Serious 12/26/2008 66 Female 190 lb 7/15/2009 Consumer Argentina
Primary
Concomitant
Wound Infection Staphylococcal Hospitalization 4/23/2008 68 Female 179 lb 7/24/2009 Physician Germany
Primary
Concomitant
Pneumococcal Sepsis Life Threatening 6/22/2009 52 Female 119 lb 7/28/2009 Other Health Professional Poland
Primary
Concomitant
Pyelonephritis Acute Other Serious 6/2/2009 67 Female 173 lb 7/31/2009 Physician Lithuania
Primary
Concomitant
Urinary Tract Infection Hospitalization 7/27/2009 67 Female 166 lb 8/11/2009 Physician Germany
Primary
Secondary
Concomitant
Qrs Axis Abnormal Life Threatening 6/22/2009 52 Female 119 lb 8/14/2009 Physician Poland
Primary
Concomitant
Wound Dehiscence Hospitalization 4/2/2009 68 Female 179 lb 8/28/2009 Physician Germany
Primary
Concomitant
Wound Dehiscence Death 40 Female United States
Primary
Concomitant
Tuberculosis Liver Death 11/15/2007 Male 225 lb 9/9/2009 United States
Primary
Concomitant
Rheumatoid Arthritis Hospitalization 8/18/2009 70 Female 194 lb 9/4/2009 Consumer Russian Federation
Primary
Concomitant
Optic Nerve Disorder Hospitalization 12/16/2004 63 Male 185 lb 9/10/2009 Physician Germany
Primary
Concomitant
Wound Dehiscence Hospitalization 4/2/2009 68 Female 179 lb 9/18/2009 Physician Germany
Primary
Concomitant
Skin Ulcer Hospitalization 5/24/2007 68 Female 9/18/2009 Physician United Kingdom
Primary
Concomitant
Renal Function Test Abnormal Life Threatening 6/22/2009 52 Female 119 lb 9/25/2009 Physician Poland
Primary
Concomitant
Hip Fracture Hospitalization 6/29/2009 75 Male 159 lb 9/28/2009 Argentina
Primary
Concomitant
Tuberculin Test Positive Hospitalization 4/12/2008 65 Female 134 lb 9/29/2009 Other Health Professional Russian Federation
Primary
Concomitant
Pneumonia Hospitalization 9/17/2009 77 Female 172 lb 10/2/2009 United States
Primary
Secondary
Concomitant
Uterine Leiomyoma Life Threatening 9/21/2009 58 Female 212 lb 10/5/2009 Lithuania
Primary
Concomitant
Urinary Tract Infection Hospitalization 7/27/2009 67 Female 166 lb 10/6/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Pyelonephritis Hospitalization 9/23/2009 58 Female 131 lb 10/6/2009 Physician Lithuania
Primary
Concomitant
Viral Infection Hospitalization 9/22/2009 55 Female 302 lb 10/8/2009 United States
Primary
Secondary
Concomitant
Uterine Haemorrhage Hospitalization 9/17/2009 58 Female 226 lb 10/8/2009 Physician Lithuania
Primary
Concomitant
Urine Odour Abnormal Hospitalization 9/17/2009 77 Female 172 lb 10/13/2009 United States
Primary
Secondary
Concomitant
Thyroid Neoplasm Other Serious 7/29/2009 58 Female 152 lb 10/13/2009 Other Health Professional Israel
Primary
Concomitant
Wrist Fracture Hospitalization 9/2/2009 75 Female 130 lb 10/13/2009 Physician New Zealand
Primary
Concomitant
Uterine Polyp Hospitalization 9/15/2009 71 Female 159 lb 10/14/2009 Other Health Professional Lithuania
Primary
Concomitant
Vomiting Life Threatening 1/20/2006 54 Female 128 lb 10/20/2009 Hungary
Primary
Concomitant
Uterine Polyp Hospitalization 9/15/2009 71 Female 159 lb 10/22/2009 Lithuania
Primary
Concomitant
Spinal Osteoarthritis Other Serious 10/13/2009 74 Female 119 lb 10/26/2009 Argentina
Primary
Concomitant
Osteoporosis Hospitalization 10/15/2009 78 Male 165 lb 10/28/2009 Israel
Primary
Concomitant
Red Blood Cell Count Decreased Hospitalization 9/23/2009 58 Female 131 lb 10/27/2009 Other Health Professional Lithuania
Primary
Concomitant
White Blood Cells Urine Positive Hospitalization 9/15/2009 71 Female 159 lb 11/3/2009 Lithuania
Primary
Concomitant
Wrist Fracture Hospitalization 9/2/2009 75 Female 130 lb 11/4/2009 Physician New Zealand
Primary
Concomitant
Spinal Osteoarthritis Other Serious 10/13/2009 74 Female 119 lb 11/5/2009 Physician Argentina
Primary
Concomitant
Lymphadenopathy Other Serious 7/29/2009 58 Female 152 lb 11/5/2009 Physician Israel
Primary
Concomitant
Uterine Haemorrhage Hospitalization 9/17/2009 58 Female 226 lb 11/9/2009 Other Health Professional Lithuania
Primary
Concomitant
Latent Tuberculosis Other Serious 8/21/2007 49 Male 224 lb 11/10/2009 Czech Republic
Primary
Concomitant
Swelling Hospitalization 10/21/2009 30 Female 11/10/2009 Japan
Primary
Concomitant
Pyrexia Hospitalization 10/28/2009 62 Female 132 lb 11/10/2009 Other Health Professional Russian Federation
Primary
Concomitant
Red Blood Cell Count Decreased Hospitalization 12/4/2007 62 Female 137 lb 11/16/2009 Lithuania
Primary
Concomitant
Uterine Leiomyoma Life Threatening 9/21/2009 58 Female 212 lb 11/18/2009 Lithuania
Primary
Concomitant
Urinary Tract Infection Hospitalization 11/11/2009 71 Female 266 lb 11/25/2009 Physician United States
Primary
Concomitant
Breast Cancer Female Other Serious 11/9/2009 60 Female 168 lb 11/25/2009 Hungary
Primary
Concomitant
Purulent Discharge Hospitalization 10/21/2009 30 Female 11/25/2009 Other Health Professional Japan
Primary
Concomitant
Latent Tuberculosis Other Serious 8/21/2007 49 Male 224 lb 11/25/2009 Czech Republic
Primary
Concomitant
Spinal Osteoarthritis Other Serious 10/13/2009 74 Female 119 lb 11/23/2009 Physician Argentina
Primary
Concomitant
Latent Tuberculosis Other Serious 8/21/2007 49 Male 224 lb 12/1/2009 Czech Republic
Primary
Concomitant
Swelling Hospitalization 10/21/2009 30 Female 12/1/2009 Japan
Primary
Concomitant
Pneumonia Hospitalization 10/28/2009 62 Female 132 lb 12/2/2009 Physician Russian Federation
Primary
Concomitant
Hypertension Hospitalization 11/22/2009 61 Male 203 lb 12/3/2009 Physician Czech Republic
Primary
Concomitant
Staphylococcal Infection Other Serious 11/17/2009 Female 162 lb 12/11/2009 Physician Argentina
Primary
Concomitant
Colitis Hospitalization 11/22/2009 Female 118 lb 12/12/2009 United States
Primary
Concomitant
Pneumonia Hospitalization 12/4/2009 Female 121 lb 12/16/2009 Consumer United States
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 11/9/2009 Female 121 lb 12/16/2009 Physician United States
Primary
Concomitant
Sepsis Hospitalization 12/3/2009 Female 121 lb 1/4/2010 United States
Primary
Concomitant
Polycythaemia Other Serious 11/4/2009 56 Female 137 lb 2/1/2010 Czech Republic
Primary
Concomitant
Pneumonia Hospitalization 1/31/2010 Female 218 lb 2/12/2010 Other Health Professional United States
Primary
Concomitant
Pneumonia Other Serious 2/13/2010 Male 192 lb 2/23/2010 Physician United States
Primary
Concomitant
Weight Decreased Hospitalization 12/1/2008 Male 143 lb 2/25/2010 Physician United States
Primary
Concomitant
Pyelonephritis Hospitalization 11/9/2009 Female 121 lb 2/10/2010 United States
Primary
Concomitant
Viral Infection Hospitalization 9/22/2009 Female 300 lb 2/10/2010 United States
Primary
Concomitant
Colitis Hospitalization 11/22/2009 Female 118 lb 2/10/2010 United States
Primary
Concomitant
Sepsis Other Serious 2/12/2010 Male 192 lb 3/1/2010 United States
Primary
Concomitant
Wheezing Hospitalization 2/16/2010 Female 105 lb 3/3/2010 United States
Primary
Concomitant
Streptococcal Infection Hospitalization 1/25/2010 Female 194 lb 3/5/2010 Physician United States
Primary
Concomitant
Influenza Hospitalization 10/5/2009 Female 167 lb 3/8/2010 United States
Primary
Concomitant
Squamous Cell Carcinoma Other Serious 2/25/2010 Female 161 lb 3/16/2010 United States
Primary
Concomitant
Sepsis Other Serious 2/13/2010 Male 192 lb 3/16/2010 Physician United States
Primary
Concomitant
Weight Decreased Hospitalization 12/1/2008 Male 143 lb 3/18/2010 Physician United States
Primary
Concomitant
Wheezing Hospitalization 9/22/2009 Female 300 lb 3/15/2010 Physician United States
Primary
Concomitant
Upper Respiratory Tract Infection Hospitalization 8/27/2009 Female 228 lb 3/17/2010 Physician United States
Primary
Concomitant
Viral Pericarditis Hospitalization 3/9/2010 Male 3/22/2010 Other Health Professional United States
Primary
Concomitant
Tachycardia Hospitalization 1/27/2010 Male 144 lb 3/18/2010 United States
Primary
Concomitant
Weight Decreased Hospitalization 2/16/2010 Female 105 lb 3/30/2010 Other Health Professional United States
Primary
Concomitant
Viral Pericarditis Hospitalization 3/4/2010 Male 203 lb 3/30/2010 Physician United States
Primary
Concomitant
Weight Decreased Hospitalization 2/16/2010 50 Female 105 lb 3/30/2010 United States
Primary
Concomitant
Tuberculosis Test Positive Other Serious 2/1/2010 46 Female 187 lb 4/1/2010 United States
Primary
Concomitant
Throat Irritation Hospitalization 1/31/2010 53 Female 218 lb 4/6/2010 Physician United States
Primary
Concomitant
Sepsis Hospitalization 10/5/2009 41 Female 167 lb 4/8/2010 United States
Primary
Concomitant
Tenderness Hospitalization 1/25/2010 36 Female 194 lb 4/12/2010 Physician United States
Primary
Concomitant
Sinus Tachycardia Hospitalization 1/31/2010 53 Female 218 lb 4/15/2010 Consumer United States
Primary
Concomitant
Pneumonia Hospitalization 4/5/2010 62 Female 4/20/2010 United States
Primary
Concomitant
Gastroenteritis Hospitalization 4/9/2010 47 Female 165 lb 4/21/2010 United States
Primary
Concomitant
Red Blood Cell Count Decreased Hospitalization 6/17/2009 51 Female 122 lb 4/23/2010 Other Health Professional United States
Primary
Concomitant
Ulcer Hospitalization 10/11/2009 47 Female 210 lb 4/27/2010 Other Health Professional United States
Primary
Concomitant
Pulmonary Oedema Hospitalization 2/10/2010 69 Female 4/30/2010 United States
Primary
Concomitant
Tuberculin Test Positive Other Serious 2/1/2010 46 Female 187 lb 5/3/2010 United States
Primary
Concomitant
Open Wound Other Serious 2/24/2009 45 Male 178 lb 5/4/2010 Physician United States
Primary
Concomitant
Sinus Bradycardia Hospitalization 10/5/2009 41 Female 167 lb 5/5/2010 Physician United States
Primary
Concomitant
Sepsis Other Serious 2/13/2010 44 Male 192 lb 5/12/2010 Physician United States
Primary
Concomitant
Vomiting Hospitalization 1/1/2008 62 Male 243 lb 5/17/2010 Consumer United States
Primary
Concomitant
Urticaria Other Serious 12/22/2009 45 Female 196 lb 5/19/2010 United States
Primary
Concomitant
Wheezing Hospitalization 9/22/2009 55 Female 300 lb 5/19/2010 Physician United States
Primary
Concomitant
Pulmonary Fibrosis Hospitalization 2/2/2010 57 Female 150 lb 5/20/2010 United States
Primary
Concomitant
Ischaemic Cerebral Infarction Hospitalization 10/11/2009 47 Female 210 lb 6/7/2010 United States
Primary
Concomitant
Hospitalisation Hospitalization 5/1/2010 52 Female 178 lb 6/8/2010 United States
Primary
Concomitant
Haemorrhoids Other Serious 9/28/2009 60 Female 142 lb 6/9/2010 United States
Primary
Concomitant
Viral Pericarditis Hospitalization 3/4/2010 64 Male 203 lb 6/11/2010 United States
Primary
Concomitant
Liver Function Test Abnormal Hospitalization 5/1/2010 52 Female 392 lb 6/11/2010 United States
Primary
Concomitant
White Blood Cell Count Increased Other Serious 3/12/2009 46 Female 258 lb 6/14/2010 United States
Primary
Concomitant
Viral Pericarditis Hospitalization 3/9/2010 64 Male 6/14/2010 United States
Primary
Concomitant
Scar Other Serious 10/20/2009 68 Male 212 lb 6/16/2010 Physician United States
Primary
Concomitant
Pyelonephritis Other Serious 12/23/2008 42 Female 376 lb 6/14/2010 Other Health Professional United States
Primary
Concomitant
Vomiting Hospitalization 7/5/2009 57 Female 196 lb 6/15/2010 Other Health Professional United States
Primary
Concomitant
Urine Potassium Increased Hospitalization 11/9/2009 81 Male 203 lb 6/16/2010 United States
Primary
Concomitant
Pneumonia Hospitalization 6/12/2010 58 Female 155 lb 6/21/2010 United States
Primary
Concomitant
Vomiting Other Serious 1/1/2009 18 Female 106 lb 6/29/2010 Other Health Professional United States
Primary
Concomitant
Peptic Ulcer Hospitalization 4/6/2010 47 Female 165 lb 6/29/2010 United States
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 2/1/2009 72 Male 197 lb 7/7/2010 Other Health Professional United States
Primary
Concomitant
Cellulitis Hospitalization 6/19/2010 69 Male 166 lb 7/7/2010 Other Health Professional United States
Primary
Concomitant
Lobar Pneumonia Hospitalization 4/5/2010 62 Female 7/8/2010 United States
Primary
Concomitant
Mycobacterium Tuberculosis Complex Test Positive Other Serious 2/25/2010 46 Female 187 lb 7/8/2010 United States
Primary
Concomitant
Cellulitis Hospitalization 6/19/2010 69 Male 166 lb 7/13/2010 Physician United States
Primary
Concomitant
Pneumonia Hospitalization 6/12/2010 58 Female 155 lb 7/16/2010 Other Health Professional United States
Primary
Concomitant
Treatment Noncompliance Other Serious 3/4/2009 25 Female 134 lb 7/19/2010 Other Health Professional United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 7/7/2010 15 Male 7/20/2010 Other Health Professional United States
Primary
Concomitant
Ventricular Hypertrophy Hospitalization 6/23/2010 66 Female 192 lb 7/22/2010 Other Health Professional United States
Primary
Concomitant
Pharyngitis Other Serious 7/7/2010 15 Male 130 lb 7/27/2010 Other Health Professional United States
Primary
Concomitant
Sputum Culture Positive Hospitalization 5/26/2010 81 Male 204 lb 8/4/2010 United States
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 6/1/2009 59 Female 199 lb 8/20/2010 Physician United States
Primary
Concomitant
Lymphadenopathy Other Serious 11/27/2009 67 Female 237 lb 8/23/2010 Consumer United States
Primary
Concomitant
Streptococcal Infection Hospitalization 1/25/2010 36 Female 194 lb 8/31/2010 Physician United States
Primary
Concomitant
Respiratory Rate Increased Hospitalization 10/11/2009 47 Female 210 lb 9/7/2010 United States
Primary
Concomitant
Grand Mal Convulsion Other Serious 11/28/2009 45 Male 138 lb 9/22/2010 Other Health Professional United States
Primary
Concomitant
Pneumonia Life Threatening 8/30/2010 49 Female 128 lb 10/11/2010 Other Health Professional United States
Primary
Concomitant
Pneumonia Life Threatening 8/30/2010 49 Female 128 lb 10/13/2010 Physician United States
Primary
Concomitant
Troponin I Increased Other Serious 5/26/2010 81 Male 204 lb 10/15/2010 United States
Primary
Concomitant
Liver Function Test Abnormal Hospitalization 5/1/2010 52 Female 392 lb 10/22/2010 United States
Primary
Concomitant
Upper-airway Cough Syndrome Hospitalization 1/31/2010 53 Female 218 lb 10/27/2010 Physician United States
Primary
Concomitant
Respiratory Alkalosis Other Serious 9/30/2010 56 Female 279 lb 10/28/2010 Other Health Professional United States
Primary
Concomitant
Treatment Noncompliance Other Serious 5/27/2010 62 Male 255 lb 10/29/2010 United States
Primary
Concomitant
Staphylococcus Test Positive Hospitalization 6/19/2010 69 Male 166 lb 11/5/2010 Physician United States
Primary
Concomitant
Weight Decreased Life Threatening 8/30/2010 49 Female 128 lb 11/5/2010 Physician United States
Primary
Concomitant
Ovarian Adenoma Hospitalization 1/28/2010 60 Female 11/8/2010 Other Health Professional Japan
Primary
Concomitant
Weight Decreased Life Threatening 8/30/2010 49 Female 128 lb 11/10/2010 Other Health Professional United States
Primary
Concomitant
Syncope Hospitalization 10/23/2008 72 Male 197 lb 11/22/2010 Physician United States
Primary
Concomitant
Vomiting Hospitalization Female 11/5/2010 Physician United States
Primary
Concomitant
Therapeutic Response Decreased Other Serious 7/7/2010 15 Male 130 lb 11/29/2010 Other Health Professional United States
Primary
Concomitant

Drug Data