Certolizumab Pegol (Certolizumab Pegol) combined with Folic Acid

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
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
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
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
Staphylococcal Infection Hospitalization 10/21/2009 Female 1/19/2010 Japan
Primary
Concomitant
Syncope Life Threatening 10/4/2009 Female 130 lb 1/21/2010 Consumer Argentina
Primary
Concomitant
Vaginal Haemorrhage Hospitalization 12/9/2009 Female 198 lb 1/21/2010 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
Red Blood Cell Sedimentation Rate Increased Life Threatening 9/21/2009 Female 212 lb 2/11/2010 Other Health Professional Lithuania
Primary
Concomitant
H1n1 Influenza Hospitalization 1/28/2010 Female 2/10/2010 Japan
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
Drug Effect Decreased Hospitalization 6/1/2009 Female 105 lb 2/26/2010 Physician Japan
Primary
Secondary
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
Tuberculosis Hospitalization 1/1/2010 Female 141 lb 3/5/2010 Physician Germany
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
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
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
Urinary Tract Infection Hospitalization 2/24/2010 Female 115 lb 3/19/2010 Korea, Republic Of
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
H1n1 Influenza Hospitalization 1/27/2010 Female 3/25/2010 Japan
Primary
Secondary
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
Red Blood Cell Count Decreased Hospitalization 1/17/2010 Female 141 lb 3/30/2010 Physician Germany
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
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
Renal Colic Hospitalization 12/14/2009 56 Female 115 lb 4/5/2010 Russian Federation
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
Renal Colic Hospitalization 12/14/2009 56 Female 115 lb 4/6/2010 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
Uterine Leiomyoma Hospitalization 12/16/2009 49 Female 165 lb 4/14/2010 Czech Republic
Primary
Concomitant
Benign Ovarian Tumour Other Serious 1/29/2010 60 Female 4/13/2010 Japan
Primary
Concomitant
Benign Ovarian Tumour Other Serious 1/29/2010 60 Female 4/16/2010 Japan
Primary
Concomitant
Renal Colic Hospitalization 12/14/2009 56 Female 115 lb 4/19/2010 Russian Federation
Primary
Concomitant
Weight Decreased Hospitalization 5/6/2009 54 146 lb 4/21/2010 Russian Federation
Primary
Concomitant
Wound Infection Staphylococcal Hospitalization 10/7/2009 39 Female 134 lb 4/23/2010 Physician Lithuania
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
Uterine Leiomyoma Hospitalization 12/16/2009 49 Female 165 lb 4/27/2010 Czech Republic
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
Rhinorrhoea Hospitalization 10/15/2009 78 Male 165 lb 5/6/2010 Israel
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
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
Radiculopathy Other Serious 7/28/2009 54 Female 192 lb 5/26/2010 Physician 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
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
White Blood Cell Count Decreased Hospitalization 2/5/2010 63 Female 5/31/2010 Japan
Primary
Secondary
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
Tuberculosis Other Serious 5/3/2009 52 Female 142 lb 6/16/2010 Lithuania
Primary
Concomitant
Tuberculosis Other Serious 5/3/2009 52 Female 142 lb 6/16/2010 Lithuania
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
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
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
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
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
Weight Decreased Hospitalization 5/15/2010 59 Female 128 lb 6/30/2010 Other Health Professional Russian Federation
Primary
Concomitant
Endometriosis Hospitalization 5/19/2010 56 Female 7/1/2010 Japan
Primary
Concomitant
Pyrexia Hospitalization 6/17/2010 40 Female 7/6/2010 Japan
Primary
Concomitant
Transient Ischaemic Attack Hospitalization 4/7/2010 61 Female 7/1/2010 Japan
Primary
Secondary
Concomitant
Uterine Leiomyoma Hospitalization 10/7/2009 56 Female 7/6/2010 Japan
Primary
Concomitant
Staphylococcus Test Positive Other Serious 10/28/2009 62 Female 132 lb 7/6/2010 Russian Federation
Primary
Concomitant
Large Intestine Carcinoma Other Serious 6/1/2010 65 Female 7/7/2010 Japan
Primary
Concomitant
Vertebral Artery Stenosis Other Serious 6/16/2010 71 Female 126 lb 7/7/2010 Other Health Professional Korea, Republic Of
Primary
Concomitant
Spinal Osteoarthritis Hospitalization 3/24/2010 56 Female 205 lb 7/8/2010 Physician Lithuania
Primary
Concomitant
Pyelonephritis Hospitalization 6/17/2010 40 Female 7/8/2010 Japan
Primary
Concomitant
Tooth Abscess Hospitalization 7/6/2010 38 Male 153 lb 7/12/2010 Other Health Professional New Zealand
Primary
Concomitant
Abdominal Hernia Hospitalization 3/24/2010 64 Female 220 lb 7/9/2010 Other Health Professional Estonia
Primary
Concomitant
Condition Aggravated Other Serious 3/6/2009 53 Female 220 lb 7/12/2010 Argentina
Primary
Concomitant
Dyspnoea Hospitalization 7/5/2010 52 Female 203 lb 7/13/2010 Other Health Professional Australia
Primary
Concomitant
Rheumatoid Arthritis Hospitalization 4/7/2010 61 Female 7/13/2010 Japan
Primary
Concomitant
Renal Tuberculosis Hospitalization 12/17/2009 67 Female 7/13/2010 Japan
Primary
Concomitant
Rash Macular Hospitalization 2/15/2010 60 Female 203 lb 7/14/2010 Czech Republic
Primary
Concomitant
Ventricular Dysfunction Hospitalization 5/15/2010 59 Female 128 lb 7/14/2010 Other Health Professional Russian Federation
Primary
Concomitant
Tooth Abscess Hospitalization 7/6/2010 38 Male 153 lb 7/15/2010 Physician New Zealand
Primary
Concomitant
Respiratory Tract Infection Hospitalization 6/17/2010 62 Female 176 lb 7/14/2010 Russian Federation
Primary
Concomitant
Spinal Osteoarthritis Other Serious 9/16/2009 74 Female 119 lb 7/15/2010 Other Health Professional Argentina
Primary
Concomitant
Therapeutic Response Decreased Other Serious 12/23/2009 79 Male 7/15/2010 Other Health Professional United Kingdom
Primary
Concomitant
Weight Decreased Hospitalization 3/1/2008 74 Female 159 lb 7/14/2010 Other Health Professional Czech Republic
Primary
Concomitant
Colon Cancer Hospitalization 6/1/2010 65 Female 7/16/2010 Japan
Primary
Concomitant
Renal Abscess Hospitalization 6/17/2010 40 Female 7/16/2010 Japan
Primary
Concomitant
Tooth Abscess Hospitalization 7/6/2010 38 Male 153 lb 7/20/2010 Physician New Zealand
Primary
Concomitant
Pulmonary Tuberculosis Hospitalization 1/17/2010 64 Female 141 lb 7/19/2010 Other Health Professional Germany
Primary
Concomitant
Sleep Apnoea Syndrome Hospitalization 7/5/2010 52 Female 203 lb 7/22/2010 Other Health Professional Australia
Primary
Concomitant
Spondylolisthesis Other Serious 6/10/2010 54 Female 220 lb 7/22/2010 Physician Israel
Primary
Concomitant
Spondylolisthesis Other Serious 6/10/2010 54 Female 220 lb 7/23/2010 Other Health Professional Israel
Primary
Concomitant
Lung Neoplasm Hospitalization 6/30/2010 64 Male 161 lb 7/26/2010 Physician Poland
Primary
Concomitant
Vomiting Other Serious 6/16/2010 71 Female 126 lb 7/27/2010 Physician Korea, Republic Of
Primary
Concomitant
Tinnitus Other Serious 8/4/2008 67 Female 190 lb 7/28/2010 Physician Argentina
Primary
Concomitant
Lung Neoplasm Hospitalization 7/7/2010 64 Male 161 lb 7/28/2010 Physician Poland
Primary
Concomitant
Thrombocytopenia Hospitalization 11/30/2009 53 Female 183 lb 7/28/2010 Physician Ukraine
Primary
Concomitant
Respiratory Distress Other Serious 7/5/2010 52 Female 203 lb 7/28/2010 Other Health Professional Australia
Primary
Concomitant
Goitre Hospitalization 4/27/2010 68 Female 126 lb 7/28/2010 Other Health Professional Poland
Primary
Concomitant
Fall Hospitalization 12/17/2009 67 Female 7/29/2010 Japan
Primary
Concomitant

Drug Data