Certolizumab Pegol (Certolizumab Pegol) combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Swelling Hospitalization 10/21/2009 Female 12/12/2009 Japan
Primary
Concomitant
Breast Cancer Stage Ii Other Serious 11/3/2009 Female 168 lb 12/12/2009 Other Health Professional Hungary
Primary
Concomitant
Staphylococcal Infection Other Serious 11/17/2009 Female 162 lb 12/15/2009 Argentina
Primary
Concomitant
Staphylococcal Infection Other Serious 10/28/2009 Female 132 lb 12/15/2009 Physician Russian Federation
Primary
Concomitant
Uterine Polyp Other Serious 9/15/2009 Female 159 lb 12/16/2009 Physician Lithuania
Primary
Concomitant
Pain Other Serious 11/3/2009 Female 168 lb 12/23/2009 Other Health Professional Hungary
Primary
Concomitant
Breast Cancer Stage I Hospitalization 11/30/2009 Female 183 lb 12/24/2009 Ukraine
Primary
Concomitant
Staphylococcal Infection Other Serious 11/17/2009 Female 162 lb 12/28/2009 Physician Argentina
Primary
Concomitant
Swelling Hospitalization 10/21/2009 Female 12/30/2009 Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 9/21/2008 154 lb 12/30/2009 Physician Czech Republic
Primary
Concomitant
Pyrexia Other Serious 10/13/2009 Female 119 lb 1/4/2010 Physician Argentina
Primary
Concomitant
Vaginal Haemorrhage Hospitalization 12/9/2009 Female 198 lb 1/7/2010 Russian Federation
Primary
Concomitant
Hypertension Other Serious 12/1/2009 Female 176 lb 1/11/2010 Physician Israel
Primary
Concomitant
Pneumonia Hospitalization 1/2/2010 Female 152 lb 1/12/2010 Physician Argentina
Primary
Concomitant
Protein Urine Present Hospitalization 12/12/2009 Male 240 lb 1/14/2010 Physician Czech Republic
Primary
Concomitant
Staphylococcal Infection Hospitalization 10/21/2009 Female 1/19/2010 Japan
Primary
Concomitant
Histoplasmosis Other Serious 12/26/2008 Female 190 lb 1/19/2010 Argentina
Primary
Concomitant
Syncope Life Threatening 10/4/2009 Female 130 lb 1/21/2010 Consumer Argentina
Primary
Concomitant
Renal Failure Hospitalization 1/2/2010 Female 152 lb 1/21/2010 Consumer Argentina
Primary
Concomitant
Vaginal Haemorrhage Hospitalization 12/9/2009 Female 198 lb 1/21/2010 Russian Federation
Primary
Concomitant
Rheumatoid Arthritis Hospitalization 8/18/2009 Female 194 lb 1/27/2010 Physician Russian Federation
Primary
Concomitant
Staphylococcal Infection Other Serious 11/17/2009 Female 162 lb 2/1/2010 Argentina
Primary
Concomitant
Spinal Osteoarthritis Other Serious 9/16/2009 Female 119 lb 2/2/2010 Physician Argentina
Primary
Concomitant
Rheumatoid Arthritis Hospitalization 8/18/2009 Female 194 lb 2/4/2010 Physician Russian Federation
Primary
Concomitant
Red Blood Cell Sedimentation Rate Increased Life Threatening 9/21/2009 Female 212 lb 2/11/2010 Other Health Professional Lithuania
Primary
Concomitant
Scar Hospitalization 12/12/2009 Male 240 lb 2/10/2010 Czech Republic
Primary
Concomitant
H1n1 Influenza Hospitalization 1/28/2010 Female 2/10/2010 Japan
Primary
Concomitant
Tracheobronchitis Other Serious 9/21/2008 Female 154 lb 2/9/2010 Consumer Czech Republic
Primary
Concomitant
Vaginal Haemorrhage Hospitalization 12/9/2009 Female 198 lb 2/17/2010 Russian Federation
Primary
Concomitant
Breast Cancer Stage I Hospitalization 11/30/2009 Female 183 lb 2/19/2010 Ukraine
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 1/27/2010 Female 2/19/2010 Japan
Primary
Concomitant
Vomiting Life Threatening 10/4/2009 Female 130 lb 2/24/2010 Physician Argentina
Primary
Concomitant
Tuberculosis Of Intrathoracic Lymph Nodes Hospitalization 7/10/2007 Female 146 lb 3/1/2010 Physician Russian Federation
Primary
Concomitant
Ovarian Neoplasm Other Serious 1/28/2010 Female 3/1/2010 Other Health Professional Japan
Primary
Concomitant
Vulvovaginal Pain Hospitalization 2/16/2010 Female 3/1/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 11/22/2009 Male 203 lb 3/4/2010 Other Health Professional Czech Republic
Primary
Concomitant
Rash Macular Hospitalization 2/15/2010 Female 203 lb 3/2/2010 Czech Republic
Primary
Concomitant
Synovial Rupture Hospitalization 12/16/2009 Female 3/2/2010 Japan
Primary
Secondary
Concomitant
Scar Hospitalization 12/12/2009 Male 240 lb 3/5/2010 Other Health Professional Czech Republic
Primary
Concomitant
Spinal Osteoarthritis Other Serious 9/16/2009 Female 119 lb 3/8/2010 Physician Argentina
Primary
Concomitant
Supraventricular Tachycardia Other Serious 4/14/2009 Male 3/8/2010 Russian Federation
Primary
Concomitant
Renal Failure Hospitalization 1/2/2010 Female 152 lb 3/8/2010 Argentina
Primary
Concomitant
Pulmonary Fibrosis Hospitalization 7/5/2009 Female 154 lb 3/8/2010 Argentina
Primary
Concomitant
Viral Test Positive Hospitalization 1/27/2010 Female 3/5/2010 Japan
Primary
Concomitant
Vomiting Hospitalization 12/18/2009 Female 3/10/2010 Japan
Primary
Concomitant
Thrombocytopenia Hospitalization 2/24/2010 Female 115 lb 3/10/2010 Korea, Republic Of
Primary
Concomitant
Scab Hospitalization 2/16/2010 Female 3/9/2010 Japan
Primary
Secondary
Concomitant
Hip Fracture Hospitalization 6/29/2009 Male 159 lb 3/9/2010 Argentina
Primary
Concomitant
Thrombosis Hospitalization 2/17/2010 Female 168 lb 3/11/2010 Czech Republic
Primary
Concomitant
Hip Fracture Hospitalization 6/29/2009 Male 159 lb 3/12/2010 Physician Argentina
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 2/5/2010 Female 3/15/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Drug Ineffective Hospitalization 6/1/2009 Female 105 lb 3/16/2010 Consumer Japan
Primary
Secondary
Concomitant
Ovarian Neoplasm Other Serious 1/29/2010 Female 3/16/2010 Other Health Professional Japan
Primary
Concomitant
Pneumonia Hospitalization 8/4/2009 Female 3/17/2010 Other Health Professional Germany
Primary
Concomitant
Nausea Hospitalization 1/27/2010 Female 3/19/2010 Other Health Professional Japan
Primary
Concomitant
Breast Cancer Female Other Serious 3/8/2010 Female 3/19/2010 Other Health Professional Japan
Primary
Concomitant
Pyrexia Hospitalization 9/14/2008 Female 114 lb 3/19/2010 Estonia
Primary
Concomitant
Urinary Tract Infection Hospitalization 2/24/2010 Female 115 lb 3/19/2010 Korea, Republic Of
Primary
Concomitant
Protein Urine Present Hospitalization 12/11/2009 Male 240 lb 3/19/2010 Czech Republic
Primary
Concomitant
Ovarian Neoplasm Other Serious 1/29/2010 Female 3/23/2010 Japan
Primary
Concomitant
Thrombocytopenia Hospitalization 11/30/2009 Female 183 lb 3/23/2010 Physician Ukraine
Primary
Concomitant
Scab Hospitalization 2/16/2010 Female 3/22/2010 Japan
Primary
Secondary
Concomitant
Vertigo Hospitalization 1/1/2004 Female 143 lb 3/23/2010 Other Health Professional Serbia
Primary
Concomitant
Pain Other Serious 11/3/2009 Female 168 lb 3/24/2010 Hungary
Primary
Concomitant
Urinary Sediment Present Life Threatening 6/22/2009 Female 119 lb 3/24/2010 Poland
Primary
Concomitant
Thyroid Neoplasm Other Serious 7/29/2009 Female 152 lb 3/25/2010 Physician Israel
Primary
Concomitant
Wrist Fracture Hospitalization 9/2/2009 Female 130 lb 3/25/2010 Physician New Zealand
Primary
Concomitant
Thrombosis Hospitalization 2/17/2010 Female 168 lb 3/25/2010 Czech Republic
Primary
Concomitant
Breast Cancer Other Serious 3/8/2010 Female 3/29/2010 Japan
Primary
Concomitant
Meningioma Hospitalization 7/7/2009 55 Female 136 lb 4/1/2010 Other Health Professional Czech Republic
Primary
Concomitant
Latent Tuberculosis Other Serious 3/6/2010 43 Female 119 lb 3/31/2010 Argentina
Primary
Concomitant
Drug Effect Decreased Hospitalization 6/1/2009 58 Female 105 lb 4/1/2010 Japan
Primary
Secondary
Concomitant
Ovarian Neoplasm Other Serious 1/29/2010 60 Female 4/1/2010 Japan
Primary
Concomitant
Uterine Haemorrhage Hospitalization 9/17/2009 59 Female 226 lb 4/1/2010 Lithuania
Primary
Concomitant
White Blood Cell Count Increased Other Serious 9/15/2009 71 Female 159 lb 4/1/2010 Lithuania
Primary
Concomitant
Uterine Leiomyoma Life Threatening 9/21/2009 58 Female 212 lb 4/5/2010 Physician Lithuania
Primary
Concomitant
Uterine Cancer Hospitalization 12/9/2009 56 Female 198 lb 4/5/2010 Russian Federation
Primary
Concomitant
Upper Limb Fracture Other Serious 3/13/2010 60 Male 209 lb 4/5/2010 Australia
Primary
Concomitant
Limb Injury Hospitalization 2/18/2010 44 Female 146 lb 4/6/2010 Other Health Professional Russian Federation
Primary
Concomitant
Muscle Spasms Hospitalization 3/25/2010 56 Female 4/8/2010 Lithuania
Primary
Concomitant
Sinusitis Hospitalization 8/28/2009 31 Female 151 lb 4/9/2010 Other Health Professional Ukraine
Primary
Concomitant
Osteoarthritis Hospitalization 3/25/2010 56 Female 205 lb 4/9/2010 Lithuania
Primary
Concomitant
Uterine Cancer Hospitalization 12/9/2009 56 Female 198 lb 4/8/2010 Russian Federation
Primary
Concomitant
Unevaluable Event Other Serious 3/6/2010 43 Female 119 lb 4/14/2010 Argentina
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 7/7/2009 55 Female 136 lb 4/14/2010 Pharmacist Czech Republic
Primary
Concomitant
Vertigo Hospitalization 1/1/2004 57 Female 143 lb 4/13/2010 Physician Serbia
Primary
Concomitant
Benign Ovarian Tumour Other Serious 1/29/2010 60 Female 4/13/2010 Japan
Primary
Concomitant
Synovitis Hospitalization 2/18/2010 44 Female 146 lb 4/15/2010 Russian Federation
Primary
Concomitant
Toe Operation Other Serious 3/8/2010 50 Female 4/16/2010 Japan
Primary
Concomitant
Benign Ovarian Tumour Other Serious 1/29/2010 60 Female 4/16/2010 Japan
Primary
Concomitant
Pulmonary Embolism Life Threatening 4/6/2010 58 Female 141 lb 4/20/2010 Other Health Professional Germany
Primary
Concomitant
Weight Decreased Hospitalization 5/6/2009 54 146 lb 4/21/2010 Russian Federation
Primary
Concomitant
Pleurisy Hospitalization 11/9/2009 55 Female 203 lb 4/27/2010 Physician Ukraine
Primary
Concomitant
Cholelithiasis Other Serious 1/24/2008 30 Female 130 lb 4/27/2010 Argentina
Primary
Concomitant
Vomiting Hospitalization 3/9/2010 51 Female 117 lb 4/27/2010 Korea, Republic Of
Primary
Concomitant
Vomiting Other Serious 3/13/2010 60 Male 209 lb 4/29/2010 Australia
Primary
Concomitant
Pneumonia Hospitalization 8/3/2009 43 Female 4/27/2010 Physician Germany
Primary
Concomitant
Benign Ovarian Tumour Other Serious 1/29/2010 60 Female 4/29/2010 Japan
Primary
Concomitant
Pneumonia Pneumococcal Hospitalization 12/18/2009 68 Female 5/10/2010 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 2/5/2010 63 Female 5/12/2010 Japan
Primary
Secondary
Concomitant
Lobar Pneumonia Other Serious 2/1/2010 45 Female 161 lb 5/12/2010 Physician Canada
Primary
Concomitant
Tuberculosis Other Serious 6/2/2009 67 Female 173 lb 5/12/2010 Consumer Lithuania
Primary
Concomitant
Wound Abscess Hospitalization 11/21/2009 55 Female 190 lb 5/12/2010 Physician Germany
Primary
Concomitant
Pneumonia Hospitalization 5/15/2010 59 Female 194 lb 5/20/2010 Other Health Professional Russian Federation
Primary
Concomitant
Rheumatoid Arthritis Hospitalization 12/18/2009 68 Female 5/19/2010 Japan
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 3/8/2010 50 Female 5/21/2010 Japan
Primary
Concomitant
Radiculopathy Other Serious 7/28/2009 54 Female 192 lb 5/26/2010 Physician Lithuania
Primary
Concomitant
Pulmonary Tuberculosis Hospitalization 4/21/2009 42 Female 223 lb 5/25/2010 Lithuania
Primary
Concomitant
Latent Tuberculosis Other Serious 8/21/2007 49 Male 224 lb 5/25/2010 Czech Republic
Primary
Concomitant
Serositis Hospitalization 11/21/2009 55 Female 190 lb 5/27/2010 Physician Germany
Primary
Concomitant
Metrorrhagia Hospitalization 5/19/2010 56 Female 6/1/2010 Japan
Primary
Concomitant
Breast Cancer Male Other Serious 3/8/2010 50 Female 6/1/2010 Japan
Primary
Concomitant
Polyarthritis Hospitalization 11/30/2009 68 Female 196 lb 6/2/2010 Argentina
Primary
Concomitant
Lobar Pneumonia Other Serious 2/1/2010 45 Female 161 lb 6/2/2010 Canada
Primary
Concomitant
Pulmonary Embolism Life Threatening 4/6/2010 58 Female 141 lb 6/1/2010 Germany
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 2/5/2010 63 Female 5/31/2010 Japan
Primary
Secondary
Concomitant
Breast Cancer Female Other Serious 3/8/2010 50 Female 6/4/2010 Japan
Primary
Concomitant
Computerised Tomogram Abnormal Other Serious 12/1/2009 72 Female 176 lb 6/4/2010 Physician Israel
Primary
Concomitant
Endometrial Cancer Hospitalization 5/19/2010 56 Female 6/7/2010 Other Health Professional Japan
Primary
Concomitant
Headache Hospitalization 3/22/2010 66 Female 161 lb 6/7/2010 Physician Czech Republic
Primary
Concomitant
Tuberculosis Test Positive Other Serious 8/21/2007 49 Male 224 lb 6/8/2010 Other Health Professional Czech Republic
Primary
Concomitant
Headache Hospitalization 3/22/2010 66 Female 161 lb 6/9/2010 Physician Czech Republic
Primary
Concomitant
Transient Ischaemic Attack Hospitalization 4/7/2010 61 Female 6/9/2010 Japan
Primary
Secondary
Concomitant
Headache Hospitalization 3/22/2010 66 Female 161 lb 6/10/2010 Other Health Professional Czech Republic
Primary
Concomitant
Metrorrhagia Hospitalization 5/19/2010 56 Female 6/11/2010 Japan
Primary
Concomitant
Urinary Tract Infection Other Serious 8/4/2009 55 Female 6/14/2010 Germany
Primary
Concomitant
Red Blood Cell Sedimentation Rate Increased Hospitalization 10/17/2009 54 Female 166 lb 6/14/2010 Physician Ukraine
Primary
Concomitant
Oral Herpes Other Serious 10/17/2009 54 Female 166 lb 6/16/2010 Ukraine
Primary
Concomitant
Tuberculosis Other Serious 5/3/2009 52 Female 142 lb 6/16/2010 Lithuania
Primary
Concomitant
Oral Herpes Other Serious 10/17/2009 54 166 lb 6/16/2010 Ukraine
Primary
Concomitant
Tuberculosis Other Serious 5/3/2009 52 Female 142 lb 6/16/2010 Lithuania
Primary
Concomitant
Respiratory Tract Infection Hospitalization 5/30/2010 57 Male 204 lb 6/21/2010 Physician Russian Federation
Primary
Concomitant
Staphylococcus Test Positive Other Serious 10/28/2009 62 Female 132 lb 6/23/2010 Russian Federation
Primary
Concomitant
Upper Respiratory Tract Infection Hospitalization 5/15/2010 59 Female 128 lb 6/23/2010 Other Health Professional Russian Federation
Primary
Concomitant
Uterine Cancer Hospitalization 5/5/2010 43 Female 254 lb 6/24/2010 Germany
Primary
Concomitant
Vomiting Hospitalization 6/16/2010 71 Female 126 lb 6/24/2010 Other Health Professional Korea, Republic Of
Primary
Concomitant
Uterine Leiomyoma Life Threatening 9/21/2009 58 Female 212 lb 6/25/2010 Physician Lithuania
Primary
Concomitant
Joint Destruction Other Serious 3/8/2010 50 Female 6/25/2010 Japan
Primary
Concomitant
Ventricular Extrasystoles Other Serious 12/28/2009 55 Male 6/25/2010 Japan
Primary
Secondary
Concomitant
Lymphadenopathy Other Serious 7/29/2009 58 Female 152 lb 6/25/2010 Consumer Israel
Primary
Concomitant
Large Intestine Carcinoma Other Serious 6/1/2010 65 Female 6/29/2010 Japan
Primary
Concomitant
Staphylococcal Infection Hospitalization 7/7/2009 46 Female 143 lb 6/28/2010 Physician Lithuania
Primary
Concomitant
Uterine Cancer Hospitalization 5/5/2010 43 Female 254 lb 6/29/2010 Germany
Primary
Concomitant
Lung Neoplasm Malignant Hospitalization 11/22/2009 61 Male 203 lb 6/28/2010 Consumer Czech Republic
Primary
Concomitant
Pyelonephritis Hospitalization 9/18/2009 58 Female 131 lb 6/28/2010 Consumer Lithuania
Primary
Concomitant
Uterine Cancer Hospitalization 5/5/2010 43 Female 254 lb 6/29/2010 Germany
Primary
Concomitant
Weight Decreased Hospitalization 5/15/2010 59 Female 128 lb 6/29/2010 Other Health Professional Russian Federation
Primary
Concomitant
Tumour Necrosis Hospitalization 12/17/2009 67 Female 7/1/2010 Japan
Primary
Concomitant
Rheumatoid Arthritis Hospitalization 4/7/2010 61 Female 7/1/2010 Japan
Primary
Secondary
Concomitant
Endometriosis Hospitalization 5/19/2010 56 Female 7/1/2010 Japan
Primary
Concomitant

Drug Data