Asacol combined with Folic Acid

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Rotator Cuff Syndrome Other Serious 1/1/2005 83 Male 2/9/2006 United States
Primary
Concomitant
Drug Exposure During Pregnancy Other Serious 9/1/2005 Female 130 lb 3/15/2006 Physician Canada
Primary
Concomitant
Infusion Related Reaction Other Serious 3/21/2006 4/11/2006 Physician United States
Primary
Concomitant
Viral Infection Other Serious 1/1/2002 Female 104 lb 4/12/2006 Physician United States
Primary
Secondary
Concomitant
Pregnancy Other Serious 2/28/2006 United States
Primary
Concomitant
Hip Fracture Other Serious 1/1/2006 Male 5/17/2006 Physician United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 3/17/2003 78 Female 135 lb 5/11/2006 United States
Primary
Concomitant
Therapy Non-responder Other Serious 3/17/2003 78 Female 135 lb 5/25/2006 United States
Primary
Concomitant
Viral Infection Other Serious 1/1/2002 Female 104 lb 6/13/2006 Physician United States
Primary
Secondary
Concomitant
Viral Infection Other Serious 1/1/2002 Female 104 lb 8/2/2006 Physician United States
Primary
Secondary
Concomitant
Gynaecomastia Other Serious 9/1/2005 25 Male 204 lb 7/29/2006 United Kingdom
Primary
Concomitant
Insomnia 4/30/2006 46 Male 182 lb 7/12/2006 Consumer United States
Primary
Concomitant
Vision Blurred Other Serious 5/18/2006 Female 255 lb 8/28/2006 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 7/1/2006 65 Female 262 lb 9/1/2006 Physician United States
Primary
Secondary
Concomitant
Anaemia Other Serious 2/22/2005 70 Female 140 lb 8/10/2005 Other Health Professional United States
Primary
Secondary
Concomitant
Histoplasmosis Other Serious 9/22/2006 Female 152 lb 10/16/2006 Physician United States
Primary
Concomitant
Histoplasmosis Other Serious 9/19/2006 Female 153 lb 11/10/2006 Physician United States
Primary
Concomitant
Histoplasmosis Hospitalization 5/1/2006 Female 12/8/2006 Physician United States
Primary
Concomitant
T-cell Lymphoma Other Serious 1/1/2006 Male 180 lb 12/15/2006 Physician United States
Primary
Concomitant
T-cell Lymphoma Other Serious 1/1/2006 Male 180 lb 12/19/2006 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 7/1/2006 65 Female 262 lb 12/12/2006 Physician United States
Primary
Secondary
Concomitant
Skin Cancer Other Serious Female 130 lb 12/29/2006 Consumer United States
Primary
Concomitant
T-cell Lymphoma Other Serious 1/1/2006 Male 180 lb 1/22/2007 Physician United States
Primary
Concomitant
Pain Hospitalization Female 210 lb 1/16/2007 Consumer United States
Primary
Concomitant
Groin Pain Other Serious 48 Male 210 lb 11/17/2005 United States
Primary
Concomitant
Weight Increased 5/1/2006 63 Female 174 lb 10/16/2006 Consumer United States
Primary
Secondary
Concomitant
Skin Cancer Other Serious Female 149 lb 2/26/2007 Consumer United States
Primary
Concomitant
Urinary Tract Infection Other Serious 5/1/2000 Female 149 lb 3/7/2007 Physician United States
Primary
Concomitant
Tendonitis Other Serious 1/1/1996 22 Male 175 lb 3/19/2007 Lawyer United States
Primary
Concomitant
Wegener's Granulomatosis Other Serious 1/1/2005 39 Female 115 lb 3/22/2007 Consumer United States
Primary
Concomitant
Large Granular Lymphocytosis Other Serious 10/1/2006 Male 3/27/2007 Physician United States
Primary
Concomitant
Macular Oedema Other Serious 1/1/2007 Male 216 lb 4/3/2007 Physician United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 1/1/2005 39 Female 145 lb 4/25/2007 Physician United States
Primary
Concomitant
Treatment Noncompliance Hospitalization 2/1/2007 65 Male 205 lb 5/3/2007 Consumer United States
Primary
Concomitant
Postoperative Abscess Other Serious 1/1/2006 Male 180 lb 5/21/2007 Physician United States
Primary
Concomitant
Wound Secretion Required Intervention 1/1/2001 71 Female 303 lb 5/25/2007 United States
Primary
Secondary
Concomitant
Tendonitis Other Serious 1/1/1996 22 Male 175 lb 6/4/2007 Lawyer United States
Primary
Concomitant
Weight Increased Required Intervention 1/1/2001 71 Female 303 lb 6/29/2007 Consumer United States
Primary
Secondary
Concomitant
Weight Increased 5/1/2006 63 Female 174 lb 7/23/2007 Consumer United States
Primary
Secondary
Concomitant
Retching 1/1/2007 Female 135 lb 7/26/2007 Consumer United States
Primary
Secondary
Concomitant
Multiple Sclerosis Other Serious 1/1/2003 51 Female 238 lb 8/7/2007 Other Health Professional United States
Primary
Concomitant
Tremor Other Serious 1/1/2007 18 Female 120 lb 8/9/2007 Physician United States
Primary
Concomitant
Postictal State Other Serious 6/18/2007 18 Female 120 lb 8/30/2007 Consumer United States
Primary
Secondary
Concomitant
Spondylolisthesis Other Serious 1/1/2003 51 Female 238 lb 9/4/2007 Other Health Professional United States
Primary
Concomitant
Liver Function Test Abnormal Other Serious 2/28/2006 Female 171 lb 9/10/2007 Physician United States
Primary
Concomitant
Trigeminal Neuralgia Other Serious 1/1/2006 Female 132 lb 9/27/2007 Consumer United States
Primary
Concomitant
Tendonitis Other Serious 1/1/1996 22 Male 175 lb 10/12/2007 Lawyer United States
Primary
Concomitant
Tendonitis Other Serious 1/1/1996 22 Male 175 lb 11/9/2007 Lawyer United States
Primary
Concomitant
Stevens-johnson Syndrome Other Serious 10/30/2004 Female 11/28/2007 Lawyer United States
Primary
Concomitant
Throat Irritation 69 Female 150 lb 12/21/2007 Consumer United States
Primary
Concomitant
Tendonitis Other Serious 1/1/1996 22 Male 175 lb 2/4/2008 Lawyer United States
Primary
Concomitant
Listeria Sepsis Hospitalization 3/21/2007 Female 132 lb 2/15/2008 Other Health Professional United Kingdom
Primary
Concomitant
Dry Skin 1/1/2007 54 Male 12/13/2007 Consumer United States
Primary
Concomitant
Tendonitis Other Serious 1/1/1996 22 Male 175 lb 3/17/2008 Lawyer United States
Primary
Concomitant
Throat Irritation Life Threatening 9/11/2007 69 Female 150 lb 3/27/2008 Consumer United States
Primary
Concomitant
Pain 2/1/2008 72 Female 201 lb 3/27/2008 Consumer United States
Primary
Concomitant
Haematochezia Other Serious 1/1/2008 70 Female 141 lb 3/28/2008 Other Health Professional Canada
Primary
Concomitant
Tendonitis Other Serious 1/1/1992 Male 175 lb 4/4/2008 Lawyer United States
Primary
Concomitant
Listeria Sepsis Hospitalization 3/21/2007 Female 132 lb 6/10/2008 Other Health Professional United Kingdom
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious 3/31/2008 Female 168 lb 6/13/2008 Physician United States
Primary
Concomitant
Stevens-johnson Syndrome Other Serious 10/30/2004 Female 6/17/2008 Lawyer United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 3/31/2008 Female 168 lb 6/20/2008 Physician United States
Primary
Concomitant
Anaphylactic Reaction Other Serious 11/9/2007 69 Female 6/30/2008 Other Health Professional United States
Primary
Concomitant
Pain 2/1/2008 72 Female 201 lb 6/30/2008 Consumer United States
Primary
Concomitant
Weight Increased Hospitalization 1/1/2004 63 Male 7/14/2008 Consumer United States
Primary
Concomitant
Splenomegaly Hospitalization 1/1/2007 Female 259 lb 8/6/2008 Consumer United States
Primary
Concomitant
Weight Increased Hospitalization 1/1/2004 63 Male 8/12/2008 Consumer United States
Primary
Concomitant
Postoperative Abscess Other Serious 1/1/2006 Male 180 lb 8/20/2008 Physician United Kingdom
Primary
Concomitant
Splenomegaly Hospitalization 1/1/2007 Female 259 lb 8/18/2008 Physician United States
Primary
Concomitant
Cartilage Injury Other Serious 4/17/2008 Male 174 lb 8/28/2008 Other Health Professional United States
Primary
Concomitant
Malnutrition Hospitalization 8/13/2008 Female 78 lb 9/8/2008 Physician United States
Primary
Concomitant
Colectomy Other Serious 8/21/2008 Female 78 lb 9/8/2008 Physician United States
Primary
Concomitant
Colitis Ulcerative Hospitalization 8/13/2008 Female 78 lb 10/7/2008 Physician United States
Primary
Concomitant
Oropharyngeal Pain 1/1/2008 50 Male 225 lb 10/7/2008 Consumer United States
Primary
Concomitant
Postoperative Abscess Other Serious 1/1/2006 Male 180 lb 10/17/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/25/2007 Female 10/27/2008 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/25/2007 Female 11/4/2008 Physician United States
Primary
Secondary
Concomitant
Weight Increased Hospitalization 1/1/2004 63 Male 11/13/2008 Consumer United States
Primary
Concomitant
Vomiting In Pregnancy Other Serious 11/1/2004 Female 11/19/2008 Physician United States
Primary
Concomitant
Vomiting In Pregnancy Other Serious 11/1/2004 Female 11/26/2008 Physician United States
Primary
Concomitant
Pulmonary Congestion Other Serious Female 140 lb 12/2/2008 Consumer United States
Primary
Concomitant
Umbilical Hernia Other Serious 1/1/2006 Male 180 lb 12/12/2008 Physician United States
Primary
Secondary
Concomitant
Weight Increased Other Serious 10/2/2008 Female 143 lb 12/17/2008 Other Health Professional United States
Primary
Concomitant
Urinary Tract Infection Other Serious 1/1/2005 54 Male 260 lb 1/13/2009 Physician United States
Primary
Concomitant
Syncope Life Threatening 7/2/2008 63 Female 1/26/2009 Pharmacist United States
Primary
Concomitant
Tuberculin Test Positive Hospitalization 1/26/2008 Female 175 lb 2/27/2009
Primary
Concomitant
Postoperative Abscess Other Serious 1/1/2006 Male 180 lb 3/3/2009 Pharmacist United States
Primary
Secondary
Concomitant
Diverticulitis Hospitalization 2/13/2009 Female 123 lb 3/9/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Psoriasis Female 210 lb 3/14/2009 Physician United States
Primary
Concomitant
Incorrect Dose Administered 2/23/2009 Female 3/14/2009 Consumer United States
Primary
Concomitant
Oral Herpes Other Serious 2/1/2008 Male 4/10/2009 Consumer United States
Primary
Secondary
Concomitant
Drug Ineffective Female 102 lb 4/23/2009 Pharmacist United States
Primary
Concomitant
Colitis Ulcerative Hospitalization 8/13/2008 Female 78 lb 4/27/2009 Physician United States
Primary
Concomitant
Upper Respiratory Tract Infection 11/1/2007 5/4/2009 Physician United States
Primary
Concomitant
Upper Respiratory Tract Infection 11/1/2007 Male 5/22/2009 Physician United States
Primary
Concomitant
Insomnia 11/13/2008 30 Female 140 lb 5/18/2009 Consumer United States
Primary
Concomitant
Urticaria 4/15/2009 Male 167 lb 6/11/2009 Consumer Puerto Rico
Primary
Concomitant
Rectal Haemorrhage 2/23/2009 Female 103 lb 6/11/2009 United States
Primary
Concomitant
Colonic Polyp Male 185 lb 6/12/2009 United States
Primary
Concomitant
Injection Site Haemorrhage 1/1/2009 Female 150 lb 6/12/2009 Consumer United States
Primary
Concomitant
Myalgia 1/1/2008 Female 155 lb 6/12/2009 Consumer United States
Primary
Concomitant
Sensory Disturbance Other Serious 1/1/2009 47 Female 6/16/2009 United Kingdom
Primary
Concomitant
Sensory Disturbance Other Serious 1/1/2009 47 Female 174 lb 6/24/2009 Other Health Professional United Kingdom
Primary
Concomitant
Upper Respiratory Tract Infection Other Serious 1/1/2009 Female 184 lb 7/6/2009 Physician United States
Primary
Concomitant
Pain 10/1/2008 Female 107 lb 7/9/2009 Consumer United States
Primary
Concomitant
Oropharyngeal Discomfort 1/1/2009 67 Male 6/25/2009 Consumer United States
Primary
Secondary
Concomitant
Wrist Fracture Other Serious 1/1/2007 Female 127 lb 7/31/2009 Consumer United States
Primary
Concomitant
Visual Impairment Other Serious 2/1/2008 Male 8/17/2009 Consumer United States
Primary
Secondary
Concomitant
Vertigo 4/1/2009 64 Female 173 lb 8/1/2009 Consumer United States
Primary
Concomitant
Furuncle Female 8/7/2009 Other Health Professional United States
Primary
Concomitant
Palpitations 6/16/2009 Female 161 lb 9/19/2009 United States
Primary
Concomitant
Death Death 4/24/2009 Male 199 lb 9/19/2009 United States
Primary
Concomitant
Drug Dose Omission 6/25/2009 Female 126 lb 9/19/2009 Consumer United States
Primary
Concomitant
Pain In Extremity 6/18/2009 Female 240 lb 9/19/2009 United States
Primary
Concomitant
Inflammatory Bowel Disease Other Serious 8/22/2007 Male 99 lb 10/1/2009 United States
Primary
Concomitant
Malnutrition Hospitalization 8/13/2008 Female 78 lb 10/13/2009 Physician United States
Primary
Concomitant
Leukaemia Death 12/14/2004 67 Female 11/16/2009 Physician United States
Primary
Concomitant
Bronchioloalveolar Carcinoma Hospitalization 2/1/2009 Female 109 lb 11/30/2009 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 8/1/2009 Male 119 lb 12/4/2009 Physician Netherlands
Primary
Secondary
Concomitant
Oedema Peripheral 1/1/2009 60 Female 155 lb 10/30/2009 Consumer United States
Primary
Concomitant
Sepsis Hospitalization 8/1/2009 Male 119 lb 1/4/2010 Physician Netherlands
Primary
Secondary
Concomitant
Malnutrition Hospitalization 8/13/2008 Female 78 lb 1/22/2010 Physician United States
Primary
Concomitant
Tachycardia Other Serious 7/28/1998 Female 126 lb 1/28/2010 United States
Primary
Secondary
Concomitant
Vulvovaginal Mycotic Infection 6/1/2007 Female 120 lb 1/29/2010 United States
Primary
Concomitant
Postnasal Drip 8/1/2009 Female 125 lb 1/29/2010 United States
Primary
Concomitant
Drug Dose Omission 8/1/2009 Female 1/29/2010 United States
Primary
Concomitant
Wound Haemorrhage 10/29/2009 Female 195 lb 1/30/2010 Consumer United States
Primary
Concomitant
Respiratory Tract Infection 3/15/2008 Female 140 lb 1/30/2010 United States
Primary
Concomitant
Puncture Site Haemorrhage 10/29/2009 Female 195 lb 1/30/2010 Consumer United States
Primary
Concomitant
Injection Site Nodule 11/6/2009 Female 143 lb 1/30/2010 United States
Primary
Concomitant
Nocturia 9/1/2009 Male 123 lb 1/30/2010 United States
Primary
Concomitant
Withdrawal Syndrome 1/1/2010 Female 108 lb 2/2/2010 Other Health Professional United States
Primary
Concomitant
Joint Swelling Other Serious 1/1/2010 Female 187 lb 2/5/2010 Other Health Professional Canada
Primary
Concomitant
Rash Male 196 lb 2/16/2010 Physician United States
Primary
Concomitant
Malnutrition Hospitalization 8/13/2008 Female 78 lb 2/25/2010 Physician United States
Primary
Concomitant
Hepatic Cirrhosis Other Serious 2/22/2010 Male 3/1/2010 Consumer
Primary
Concomitant
Syncope Hospitalization 2/14/2010 Male 181 lb 3/5/2010
Primary
Concomitant
Pain In Extremity Female 158 lb 2/10/2010 Consumer United States
Primary
Concomitant
Colitis Ulcerative Hospitalization 8/13/2008 12 Female 78 lb 4/1/2010 Physician United States
Primary
Concomitant
Tooth Infection Other Serious 6/1/2009 62 Female 4/2/2010 Physician United States
Primary
Concomitant
Paraesthesia Other Serious 1/1/2010 50 Male 165 lb 4/8/2010 Other Health Professional Canada
Primary
Concomitant
Hepatic Cirrhosis Other Serious 2/22/2010 68 Male 4/9/2010 Consumer
Primary
Concomitant
Tooth Infection Other Serious 6/1/2009 62 Female 4/14/2010 Physician United States
Primary
Concomitant
Postoperative Heterotopic Calcification Other Serious 9/1/2009 47 Female 140 lb 4/15/2010 United States
Primary
Concomitant
Colitis Ulcerative Hospitalization 8/13/2008 12 Female 78 lb 4/29/2010 Physician United States
Primary
Concomitant
Postoperative Abscess Other Serious 1/1/2006 21 Male 180 lb 5/19/2010 Pharmacist United States
Primary
Secondary
Concomitant
Liver Function Test Abnormal Hospitalization Male 180 lb 5/11/2010 Consumer United States
Primary
Concomitant
Migraine Other Serious 6/4/2010 19 Male 6/18/2010 Consumer South Africa
Primary
Concomitant
Tonsillar Hypertrophy 1/1/2008 15 Male 170 lb 6/24/2010 Consumer United States
Primary
Concomitant
Spinal Cord Compression Hospitalization 1/1/2010 48 184 lb 6/29/2010 Physician United States
Primary
Concomitant

Drug Data