Folic Acid combined with Vitamin B12 /00056201/

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Myelodysplastic Syndrome Other Serious 3/30/2006 80 Male 205 lb 10/2/2006 Physician United States
Primary
Secondary
Concomitant
Therapeutic Response Unexpected Other Serious 2/1/2007 66 Male 9/4/2007 Consumer United States
Primary
Concomitant
Skin Turgor Decreased Hospitalization 2/11/2007 82 Female 9/26/2007 Other Health Professional United States
Primary
Concomitant
Prothrombin Time Prolonged Other Serious 3/6/2006 71 Female 122 lb 10/16/2007 United States
Primary
Concomitant
Skin Turgor Decreased Hospitalization 2/11/2007 82 Female 11/28/2007 Other Health Professional United States
Primary
Concomitant
Skin Irritation Other Serious 9/24/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Drug Administration Error Other Serious 9/11/2008 10/10/2008 Other Health Professional United States
Primary
Concomitant
Sepsis Hospitalization 74 Male 154 lb 2/16/2009 Physician United Kingdom
Primary
Concomitant
Onychomycosis 10/9/2008 Female 3/23/2009 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 4/10/2007 5/1/2009 United States
Primary
Concomitant
Pyrexia Hospitalization 8/1/2007 5/1/2009 Physician United States
Primary
Concomitant
Paroxysmal Nocturnal Haemoglobinuria Hospitalization 5/10/2008 5/1/2009 United States
Primary
Concomitant
Pancytopenia Hospitalization 3/20/2008 5/1/2009 Physician United States
Primary
Concomitant
Syncope 9/18/2008 5/1/2009 Pharmacist United States
Primary
Concomitant
Haemoglobin Decreased 11/2/2008 5/1/2009 Physician United States
Primary
Concomitant
Headache Male 5/4/2009 Physician United States
Primary
Concomitant
Abdominal Discomfort Male 5/4/2009 Physician United States
Primary
Concomitant
Neck Pain Male 5/4/2009 Consumer United States
Primary
Concomitant
Nasopharyngitis 1/25/2009 Female 5/4/2009 Physician United States
Primary
Concomitant
Odynophagia 8/8/2007 5/4/2009 Other Health Professional United States
Primary
Concomitant
Teeth Brittle 4/10/2007 5/4/2009 Other Health Professional United States
Primary
Concomitant
Pyrexia 9/26/2007 5/4/2009 Physician United States
Primary
Concomitant
Infusion Site Haematoma 5/4/2009 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 4/10/2007 Female 252 lb 5/22/2009 United States
Primary
Concomitant
Pyrexia Hospitalization 8/1/2007 Male 219 lb 5/22/2009 Physician United States
Primary
Concomitant
Odynophagia 8/8/2007 Male 215 lb 5/22/2009 Other Health Professional United States
Primary
Concomitant
Teeth Brittle 4/10/2007 Male 214 lb 5/22/2009 Other Health Professional United States
Primary
Concomitant
Pyrexia 9/26/2007 Male 160 lb 5/22/2009 Physician United States
Primary
Concomitant
Paroxysmal Nocturnal Haemoglobinuria Hospitalization 5/10/2008 Male 5/22/2009 United States
Primary
Concomitant
Pancytopenia Hospitalization 3/20/2008 Female 5/22/2009 Physician United States
Primary
Concomitant
Syncope 9/18/2008 Male 220 lb 5/23/2009 Pharmacist United States
Primary
Concomitant
Procedural Hypotension Female 5/23/2009 Physician United States
Primary
Concomitant
Haemoglobin Decreased 11/2/2008 Male 5/23/2009 Physician United States
Primary
Concomitant
Nasopharyngitis 3/21/2009 Male 5/23/2009 Physician United States
Primary
Concomitant
Hypotension Other Serious 5/8/2009 Female 6/17/2009 Physician United States
Primary
Concomitant
Nasopharyngitis 3/21/2009 7/24/2009 Physician United States
Primary
Concomitant
Respiratory Tract Infection Female 7/24/2009 Other Health Professional United States
Primary
Concomitant
Headache 4/12/2009 Male 7/24/2009 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 3/1/2009 47 Female 142 lb 7/24/2009 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased 4/1/2009 Male 7/24/2009 Other Health Professional United States
Primary
Concomitant
Hypotension Other Serious 5/8/2009 Female 7/24/2009 Physician United States
Primary
Concomitant
Myelodysplastic Syndrome 1/1/2009 Female 153 lb 7/27/2009 Physician United States
Primary
Concomitant
Arthralgia Male 7/27/2009 Physician United States
Primary
Concomitant
Blood Lactate Dehydrogenase Increased 6/17/2009 Male 7/27/2009 Other Health Professional United States
Primary
Concomitant
Fall Male 7/27/2009 Other Health Professional United States
Primary
Concomitant
Oropharyngeal Spasm Other Serious 9/9/2009 9/25/2009 Other Health Professional Canada
Primary
Concomitant
Myelodysplastic Syndrome 1/1/2009 Female 153 lb 10/16/2009 Consumer United States
Primary
Concomitant
Haemoglobin Decreased 7/1/2009 Female 10/16/2009 Physician United States
Primary
Concomitant
Malaise 6/29/2009 Male 10/16/2009 Physician United States
Primary
Secondary
Concomitant
Somnolence 8/25/2009 Male 10/16/2009 Other Health Professional United States
Primary
Concomitant
Ocular Hyperaemia 9/16/2009 Male 10/16/2009 Other Health Professional Canada
Primary
Concomitant
Lymphadenopathy 9/10/2009 Female 10/16/2009 Consumer United States
Primary
Concomitant
Oropharyngeal Spasm Other Serious 9/9/2009 10/16/2009 Other Health Professional Canada
Primary
Concomitant
Haemoglobin Decreased 7/1/2009 Female 10/16/2009 Other Health Professional United States
Primary
Concomitant
Pregnancy Induced Hypertension Hospitalization 33 Female 150 lb 12/18/2009 Physician Spain
Primary
Secondary
Concomitant
Pregnancy Induced Hypertension Hospitalization 33 Female 150 lb 12/29/2009 Physician Spain
Primary
Secondary
Concomitant
Diabetes Mellitus Inadequate Control Hospitalization 1/5/2009 42 Male 12/31/2009 Other Health Professional Croatia (Local Name: Hrvatska)
Primary
Concomitant
Reticulocyte Count Increased 9/9/2009 1/24/2010 Consumer United States
Primary
Concomitant
Tooth Fracture 11/5/2009 1/24/2010 Other Health Professional United States
Primary
Concomitant
Fluid Overload 10/22/2009 1/24/2010 Consumer United States
Primary
Concomitant
Chromaturia 11/1/2009 Female 1/24/2010 Other Health Professional United States
Primary
Concomitant
Vomiting 12/4/2009 Female 1/24/2010 Consumer United States
Primary
Concomitant
Haemoglobin Decreased 12/14/2009 1/24/2010 Consumer United States
Primary
Concomitant
Myalgia Hospitalization 12/1/2009 Male 2/5/2010 Other Health Professional United States
Primary
Concomitant
Viral Infection Hospitalization 12/1/2009 Male 2/17/2010 Other Health Professional United States
Primary
Concomitant
Paraesthesia 12/1/2009 38 Male 4/12/2010 Other Health Professional United States
Primary
Concomitant
Condition Aggravated Female 4/12/2010 Consumer United States
Primary
Concomitant
Serum Ferritin Increased 1/1/2010 75 Male 178 lb 4/12/2010 Other Health Professional United States
Primary
Concomitant
Headache 2/1/2010 29 Male 4/12/2010 Consumer United States
Primary
Concomitant
Serum Ferritin Increased 3/11/2010 30 Male 4/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Gait Disturbance 1/1/2010 75 Male 4/12/2010 Consumer United States
Primary
Concomitant
Weight Decreased 9/1/2009 43 Female 4/12/2010 Consumer United States
Primary
Concomitant
Viral Infection Hospitalization 12/1/2009 38 Male 4/12/2010 Other Health Professional United States
Primary
Concomitant
Vomiting Other Serious 5/3/2010 23 Female 5/19/2010 Consumer United States
Primary
Concomitant
Somnolence Other Serious 6/1/2010 69 Female 100 lb 6/30/2010 Physician United States
Primary
Secondary
Concomitant
Somnolence Other Serious 6/1/2010 69 Female 100 lb 7/12/2010 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 1/1/2010 86 Male 7/13/2010 United States
Primary
Concomitant
Thrombocytopenia Hospitalization 1/1/2010 86 Male 8/2/2010 United States
Primary
Concomitant
Pneumonia Hospitalization 9/27/2010 70 Female 10/27/2010 Consumer United States
Primary
Concomitant
Vomiting Hospitalization Female 10/28/2010 Physician United States
Primary
Concomitant
Gastrointestinal Ulcer Other Serious 10/1/2010 51 Female 11/9/2010 United States
Primary
Concomitant
Pancytopenia Other Serious 1/1/2010 51 Female 11/16/2010 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 11/1/2010 82 Male 11/24/2010 Consumer United States
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 1/1/2010 55 Female 11/24/2010 Consumer United States
Primary
Concomitant
Gastrointestinal Pain Other Serious 11/27/2010 Consumer United States
Primary
Concomitant
Renal Failure Acute Other Serious 1/1/2010 55 Female 11/30/2010 Consumer United States
Primary
Concomitant
Pancytopenia Other Serious 1/1/2010 51 Female 12/1/2010 Physician United States
Primary
Concomitant
Uterine Leiomyoma Other Serious Female 11/16/2010 Consumer Canada
Primary
Concomitant
Pancytopenia Other Serious 1/1/2010 51 Female 12/7/2010 Physician United States
Primary
Concomitant
Cholecystitis Hospitalization 11/20/2010 67 Male 150 lb 12/13/2010 Physician United States
Primary
Secondary
Concomitant
Pancytopenia Other Serious 1/1/2010 51 Female 12/13/2010 Physician United States
Primary
Concomitant
Paraesthesia Other Serious 12/16/2010 12/28/2010 Canada
Primary
Concomitant
Back Pain Other Serious 8/1/2010 61 Male 1/11/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Back Pain Other Serious 8/1/2010 1/20/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Dysphagia Other Serious Female 1/21/2011 Consumer Canada
Primary
Concomitant
Feeling Abnormal Other Serious 1/24/2011 54 Female 2/4/2011 Consumer United States
Primary
Concomitant
Cholecystitis Hospitalization 11/20/2010 67 Male 150 lb 2/7/2011 Physician United States
Primary
Secondary
Concomitant
Fatigue Other Serious 8/13/2003 43 Female 2/11/2011 Physician United States
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 1/24/2011 54 Female 2/15/2011 Other Health Professional United States
Primary
Concomitant
Hypocalcaemia Other Serious 12/9/2010 Male 3/8/2011 Physician United States
Primary
Concomitant
Anaemia Other Serious 11/1/2010 78 Female 3/28/2011 Pharmacist United States
Primary
Concomitant
Hypophosphataemia Other Serious 4/8/2011 Physician Canada
Primary
Concomitant
Weight Increased Hospitalization 8/13/2003 43 Female 4/12/2011 Physician United States
Primary
Secondary
Concomitant
Cystitis Hospitalization 2/1/2011 35 Female 4/28/2011 United States
Primary
Concomitant
Body Temperature Increased 1/1/2010 70 Male 161 lb 2/7/2011 Consumer United States
Primary
Concomitant
Atrophy Other Serious Female 4/21/2011 Consumer Canada
Primary
Concomitant
Haemoglobin Decreased 3/1/2010 65 Male 5/9/2011 Other Health Professional United States
Primary
Concomitant
Fatigue 4/2/2010 63 Male 5/9/2011 Consumer United States
Primary
Concomitant
Headache 4/27/2010 43 Female 5/9/2011 United States
Primary
Concomitant
Diarrhoea 4/3/2010 86 Male 5/9/2011 Consumer United States
Primary
Concomitant
Tooth Impacted 4/7/2010 75 Male 5/9/2011 Consumer United States
Primary
Concomitant
Fatigue Female 5/9/2011 Consumer United States
Primary
Concomitant
Headache 3/1/2010 5/9/2011 Other Health Professional United States
Primary
Concomitant
Sinusitis 3/26/2010 29 Female 124 lb 5/9/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Asthenia 2/1/2010 75 Male 5/9/2011 Other Health Professional United States
Primary
Concomitant
Anaemia Hospitalization 5/12/2010 65 Male 5/9/2011 United States
Primary
Concomitant
Upper Respiratory Tract Infection 1/1/2010 51 Female 5/9/2011 Consumer United States
Primary
Concomitant
Nasopharyngitis 3/1/2010 49 Male 5/9/2011 United States
Primary
Concomitant
Chromaturia 5/25/2010 44 Female 189 lb 5/9/2011 United States
Primary
Concomitant
Oesophageal Spasm Male 5/9/2011 United States
Primary
Concomitant
Fatigue Female 5/9/2011 Pharmacist United States
Primary
Concomitant
Haemoglobin Decreased 7/19/2010 87 Male 5/9/2011 Consumer United States
Primary
Concomitant
Eye Irritation Male 5/9/2011 Other Health Professional United States
Primary
Concomitant
Urine Colour Abnormal 7/19/2010 65 Female 5/9/2011 United States
Primary
Concomitant
Pyrexia 1/1/2010 43 Female 5/9/2011 United States
Primary
Concomitant
Ocular Hyperaemia Male 5/9/2011 United States
Primary
Concomitant
Nausea 8/22/2010 5/9/2011 United States
Primary
Concomitant
Malaise 7/1/2010 49 Male 5/9/2011 Consumer United States
Primary
Concomitant
Haemolysis 8/24/2010 44 Female 180 lb 5/9/2011 Physician United States
Primary
Concomitant
Chest Pain 1/1/2010 43 Female 5/9/2011 Consumer United States
Primary
Concomitant
Cough 9/7/2010 80 Female 5/9/2011 Consumer United States
Primary
Secondary
Concomitant
Rhinitis Seasonal 9/19/2010 56 Female 5/9/2011 Consumer United States
Primary
Concomitant
Chromaturia Male 5/9/2011 United States
Primary
Concomitant
Haemoglobin Decreased 1/1/2010 43 Female 5/9/2011 Consumer United States
Primary
Concomitant
Open Wound 1/1/2010 55 Female 5/9/2011 Consumer United States
Primary
Concomitant
Drug Hypersensitivity Other Serious 1/1/2011 65 Female 198 lb 4/29/2011 Consumer United States
Primary
Concomitant
Off Label Use Death 54 Female 5/17/2011 Consumer Venezuela
Primary
Concomitant
Anaemia Hospitalization 4/14/2011 90 Male 125 lb 5/20/2011 Other Health Professional United States
Primary
Concomitant
Labyrinthitis 3/28/2011 59 Female 205 lb 5/11/2011 Consumer United States
Primary
Concomitant
Nasopharyngitis 2/2/2011 42 Female 145 lb 5/11/2011 Consumer United States
Primary
Concomitant
Fatigue 1/1/2011 68 Female 93 lb 5/11/2011 Consumer United States
Primary
Concomitant
Hypothermia Other Serious 4/25/2011 84 Male 148 lb 6/28/2011 Physician United States
Primary
Secondary
Concomitant
Influenza Like Illness 5/1/2011 69 Female 9/6/2011 Consumer United States
Primary
Concomitant
Exostosis Other Serious 12/19/2009 65 Male 156 lb 9/27/2011 Physician United States
Primary
Secondary
Concomitant
Paraesthesia Other Serious 12/16/2010 59 Female 165 lb 9/30/2011 Consumer Canada
Primary
Concomitant
Musculoskeletal Stiffness 9/13/2010 49 Female 10/27/2011 Consumer United States
Primary
Concomitant
Drug Ineffective 64 Female 10/30/2011 Consumer United States
Primary
Concomitant
Fungal Infection 4/19/2011 68 Female 95 lb 10/30/2011 Consumer United States
Primary
Concomitant
Thrombocytopenia Other Serious Female 10/31/2011 Physician United States
Primary
Concomitant
Asthma 6/27/2011 87 Female 11/2/2011 Other Health Professional United States
Primary
Secondary
Concomitant

Drug Data