Index of reports
> Life Threatening Events (354)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Methotrexate life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 354 Next >>
Possible Methotrexate side effects in 13 year old female
Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-27
Patient: 13 year old female
Reactions: Intra-Abdominal Haemorrhage, Pruritus, Febrile Neutropenia, Hyperaemia, Thoracic Haemorrhage, Mucosal Inflammation, Haemoglobin Decreased, Tumour Lysis Syndrome, Fungal Oesophagitis, Abdominal Distension, Pulmonary Oedema, Tachypnoea, Platelet Count Decreased, Renal Failure Acute, Blister
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Methotrexate
Other drugs received by patient: Etoposide; Cytarabine; Leucovorin Calcium
Possible Methotrexate side effects in female
Reported by a physician from United Kingdom on 2012-08-22
Patient: female, weighing 67.5 kg (148.5 pounds)
Reactions: Small Intestinal Obstruction, Abdominal Adhesions
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Dosage: wk 52 only
Indication: Rheumatoid Arthritis
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2010-06-30
Placebo
Indication: Rheumatoid Arthritis
Other drugs received by patient: Alendronate Sodium; Symbicort; Prednisolone; Tiotropium; Lansoprazole; Prednisolone; Celecoxib; Albuterol Sulate; Theophylline; Simvastatin
Possible Methotrexate side effects in female
Reported by a physician from United States on 2012-08-20
Patient: female, weighing 70.8 kg (155.8 pounds)
Reactions: Abdominal Pain, Hyperpyrexia, Anaphylactic Reaction, Chills, Pain, Hepatic Failure, Transaminases Increased, Splenic Infarction, Loss of Consciousness, Aortic Thrombosis, Off Label Use, Malaise, C-Reactive Protein Increased, Myositis, Dyspnoea, Hypotension, Arrhythmia, Lung Consolidation, Hypophosphataemia, Zygomycosis, Bacteraemia, Ventricular Tachycardia, Hyperammonaemia, Neutropenia, Hepatic Infarction, Shock, Infusion Related Reaction
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Cytarabine
Dosage: day 1,8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Start date: 2007-10-23
Decadron Phosphate
Dosage: day 1
Indication: Acute Lymphocytic Leukaemia
Start date: 2007-10-23
Doxil
Dosage: day 1
Indication: Acute Lymphocytic Leukaemia
Start date: 2007-10-23
End date: 2007-10-23
Methotrexate
Dosage: day 1
Indication: Acute Lymphocytic Leukaemia
Start date: 2005-01-01
End date: 2007-01-01
PEG-Asparaginase
Dosage: day 2, 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Start date: 2007-10-25
End date: 2007-10-25
Velcade
Dosage: day 1, 4, 8 and 11
Indication: Acute Lymphocytic Leukaemia
Start date: 2007-10-23
End date: 2007-10-23
Vincristine
Dosage: day 1,8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Start date: 2007-10-23
End date: 2007-10-23
Possible Methotrexate side effects in 72 year old male
Reported by a consumer/non-health professional from Canada on 2012-08-17
Patient: 72 year old male
Reactions: Colon Cancer, Septic Shock, Immobile
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Orencia
Indication: Rheumatoid Arthritis
Start date: 2010-01-01
End date: 2012-04-02
Prednisone TAB
Other drugs received by patient: Metformin HCL; Folic Acid; Verapamil; Glyburide; Vitamin B-12; Rivasa; Avalide; Coumadin; Lipitor
Possible Methotrexate side effects in male
Reported by a physician from Japan on 2012-08-17
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Pneumocystis Jiroveci Pneumonia, Arthralgia, Joint Swelling, Decreased Appetite
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Adalimumab
Indication: Rheumatoid Arthritis
Start date: 2010-07-13
End date: 2011-01-12
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2009-07-01
End date: 2011-01-21
Other drugs received by patient: Prednisolone; Amlodipine Besylate; Methotrexate; Diclofenac Sodium
Possible Methotrexate side effects in female
Reported by a physician from Netherlands on 2012-08-16
Patient: female, weighing 7.4 kg (16.3 pounds)
Reactions: Capillary Leak Syndrome, Hepatic Function Abnormal, Respiratory Failure, Disease Progression, Ascites
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Clofarabine
Dosage: 11 mg (40 mg/m2), qdx5
Indication: Acute Lymphocytic Leukaemia
Start date: 2010-07-23
End date: 2010-07-27
Cyclophosphamide
Dosage: 80 mg, qd
Indication: Acute Lymphocytic Leukaemia
Start date: 2010-07-23
End date: 2010-07-27
Cytarabine
Dosage: 15 mg, od
Indication: Acute Lymphocytic Leukaemia
Start date: 2010-07-28
End date: 2010-07-28
Cytarabine
Indication: Chemotherapy
Etoposide
Dosage: 28 mg, qd
Indication: Acute Lymphocytic Leukaemia
Start date: 2010-07-23
End date: 2010-07-27
Methotrexate
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: 6 mgr, od
Indication: Chemotherapy
Start date: 2010-07-28
End date: 2010-07-28
Prednisolone
Indication: Chemotherapy
Prednisolone
Dosage: 6 mgr, od
Indication: Acute Lymphocytic Leukaemia
Start date: 2010-07-28
End date: 2010-07-28
Other drugs received by patient: Itraconazole; Vancomycin; Dexamethasone; Filgrastim; Teicoplanin; Ciprofloxacin HCL; Ciprofloxacin HCL; Tramadol HCL; Vancomycin; Ceftazidime; Zofran; Vancomycin; Furosemide; Cotrim; Vancomycin; Vitamin K TAB; Cotrim; Itraconazole; Vancomycin; Vancomycin; Omeprazole; Acetaminophen; Ciprofloxacin; Furosemide; Ceftazidime; Furosemide; Omeprazole
Possible Methotrexate side effects in female
Reported by a physician from Germany on 2012-08-10
Patient: female
Reactions: Cellulitis, C-Reactive Protein Increased, Necrosis, Lymphangitis, Aplastic Anaemia, Skin Necrosis, Empyema, Thermal Burn, White Blood Cell Count Increased
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2005-12-01
End date: 2006-12-01
Hydrocortisone
Indication: Rheumatoid Arthritis
Methotrexate
Administration route: Oral
Start date: 2007-06-19
Methotrexate
Indication: Rheumatoid Arthritis
Start date: 2005-12-01
End date: 2006-12-01
Other drugs received by patient: Prednisolone; Etanercept
Possible Methotrexate side effects in 22 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: 22 year old male, weighing 93.1 kg (204.8 pounds)
Reactions: Abdominal Pain, Vomiting, Nausea, Pain, Hyperglycaemia, Unresponsive To Stimuli, Pancytopenia, Disorientation, Pyrexia, Toxicity To Various Agents, Convulsion, Myalgia, Arthralgia, Chest Pain
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Possible Methotrexate side effects in 65 year old male
Reported by a pharmacist from United States on 2012-08-09
Patient: 65 year old male
Reactions: Neoplasm Malignant, Pancytopenia, Toxicity To Various Agents, Acute Myocardial Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Possible Methotrexate side effects in male
Reported by a physician from Japan on 2012-08-06
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Pneumocystis Jiroveci Pneumonia, Arthralgia, Joint Swelling, Decreased Appetite
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2010-07-13
End date: 2011-01-12
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2009-07-01
End date: 2011-01-21
Other drugs received by patient: Amlodipine Besylate; Prednisolone; Methotrexate; Diclofenac Sodium
Possible Methotrexate side effects in 74 year old male
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: 74 year old male
Reactions: Blood Bilirubin Increased, Pneumonia, Atrial Fibrillation, Hepatic Enzyme Increased, Death, Enterococcal Sepsis, Fluid Retention, Cardiac Failure Congestive
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Daunorubicin HCL
Dosage: on days 1,8,15,22
Indication: Acute Lymphocytic Leukaemia
Elspar
Methotrexate
Dosage: day15
Indication: Acute Lymphocytic Leukaemia
Prednisone
Indication: Acute Lymphocytic Leukaemia
Sprycel
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-05-22
Vincristine
Dosage: on days 1,8,15,22
Indication: Acute Lymphocytic Leukaemia
Possible Methotrexate side effects in female
Reported by a physician from France on 2012-08-01
Patient: female, weighing 54.0 kg (118.8 pounds)
Reactions: Diverticulitis, Lymphopenia, Pulmonary Embolism, Cytomegalovirus Colitis, Peritonitis, Intestinal Perforation, Diffuse Large B-Cell Lymphoma, Lymphoma
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Etanercept
Indication: Rheumatoid Arthritis
Mabthera
Indication: Rheumatoid Arthritis
Methotrexate
Indication: Rheumatoid Arthritis
Piroxicam
Indication: Rheumatoid Arthritis
Other drugs received by patient: Omeprazole; Ferrous Sulfate TAB; Vitamin D; Indapamide; Protelos; Aluminum Hydroxide and Magnesium Trisilicate; Calcium Carbonate; Prednisone TAB; Imodium; Folic Acid; Arixtra; Acetaminophen
Possible Methotrexate side effects in male
Reported by a consumer/non-health professional from Australia on 2012-08-01
Patient: male
Reactions: Pneumonia Legionella, Cardiac Arrest, Septic Shock, Renal Failure Acute
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Humira
Indication: Product Used FOR Unknown Indication
Start date: 2011-05-15
End date: 2011-07-15
Methotrexate
Indication: Product Used FOR Unknown Indication
End date: 2011-07-15
Other drugs received by patient: Cartia XT; Lipitor; Metoprolol Succinate
Possible Methotrexate side effects in male
Reported by a physician from Hungary on 2012-07-30
Patient: male, weighing 85.0 kg (187.0 pounds)
Reactions: Abdominal Strangulated Hernia, Peritonitis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Start date: 2011-05-18
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2007-01-01
Other drugs received by patient: Silymarin; Methylprednisolone; Allopurinol; Metoprolol Tartrate; Betahistine; Amlodipine Besilate / Lisinopril; Famotidine; Infliximab
Possible Methotrexate side effects in female
Reported by a physician from Netherlands on 2012-07-26
Patient: female, weighing 62.0 kg (136.4 pounds)
Reactions: Swelling, Ovarian Cancer
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2008-11-01
End date: 2012-03-05
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1999-01-01
Other drugs received by patient: Synapause; Methotrexate; Calcium D3; Acenocoumarol; Folic Acid; Sotalol Hydrochloride
Possible Methotrexate side effects in female
Reported by a physician from Netherlands on 2012-07-23
Patient: female, weighing 62.0 kg (136.4 pounds)
Reactions: Swelling, Ovarian Cancer
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2008-11-01
End date: 2012-03-05
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1999-01-01
Other drugs received by patient: F2 NOS; Acenocoumarol; Soltatol; Calcium D3; Synapause
Possible Methotrexate side effects in 53 year old female
Reported by a consumer/non-health professional from Ecuador on 2012-07-20
Patient: 53 year old female
Reactions: Abdominal Pain, Vomiting, Diarrhoea, Dehydration
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Indication: Rheumatoid Arthritis
Rituximab
Dosage: 2 cycles
Start date: 2011-10-17
End date: 2011-10-31
Rituximab
Dosage: 2 cycles
Indication: Rheumatoid Arthritis
Start date: 2009-01-01
Other drugs received by patient: Vitamin B Complex CAP; Naproxen; Prednisone; Gemfibrozil
Possible Methotrexate side effects in female
Reported by a physician from Switzerland on 2012-07-19
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Alveolitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Indication: Temporal Arteritis
Start date: 2012-06-01
End date: 2012-06-01
Methotrexate
Administration route: Oral
Methotrexate
Indication: Temporal Arteritis
Start date: 2012-01-03
End date: 2012-05-29
Methotrexate
Prednisone
Prednisone
Administration route: Oral
Indication: Temporal Arteritis
Start date: 2011-09-01
Prednisone
Possible Methotrexate side effects in 75 year old female
Reported by a consumer/non-health professional from Japan on 2012-07-19
Patient: 75 year old female
Reactions: Duodenal Ulcer Perforation, RED Blood Cell Count Decreased, Interstitial Lung Disease, Post Procedural Complication, Post Procedural Infection, Peritonitis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Methotrexate
Dosage: 10 mg, qw
Indication: Rheumatoid Arthritis
Start date: 2000-04-01
End date: 2011-04-05
Methotrexate
Dosage: 4 mg, qw
Start date: 2011-07-15
End date: 2011-08-08
Methotrexate
Dosage: 4 mg, qw
Start date: 2011-11-26
End date: 2012-02-08
Methotrexate
Dosage: 6 mg/ week
Start date: 2012-02-08
End date: 2012-05-09
Methotrexate
Dosage: 6 mg, qw
Start date: 2011-08-08
End date: 2011-11-26
Orencia
Dosage: 500 mg, unk
Indication: Rheumatoid Arthritis
Start date: 2011-01-07
Orencia
Dosage: 500 mg, unk
Start date: 2011-02-03
Orencia
Dosage: 500 mg, unk
Start date: 2011-03-04
Orencia
Dosage: 500 mg, unk
Start date: 2011-05-14
Voltaren
Indication: Rheumatoid Arthritis
Other drugs received by patient: Fosamax; Prednisolone; Warfarin Potassium; Mucosta; Betamethasone; Sulfamethoxazole and Trimethoprim
Possible Methotrexate side effects in 61 year old male
Reported by a consumer/non-health professional from United States on 2012-07-14
Patient: 61 year old male
Reactions: Bladder Cancer
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Enbrel
Indication: Arthritis
Enbrel
Dosage: 50 mg, qw
Indication: Psoriasis
Start date: 2010-03-01
End date: 2012-04-01
Methotrexate
Dosage: 15 mg, qw
Administration route: Oral
Indication: Psoriasis
Start date: 2005-06-01
End date: 2005-12-01
Methotrexate
Indication: Arthritis
Sandimmune
Indication: Arthritis
Sandimmune
Dosage: 300 mg, per day
Administration route: Oral
Indication: Psoriasis
Start date: 2008-01-01
End date: 2008-06-01
Possible Methotrexate side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-13
Patient:
Reactions: Toxicity To Various Agents
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Dosage: 10 mg, q1week
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Possible Methotrexate side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-07-13
Patient: 50 year old female, weighing 97.5 kg (214.6 pounds)
Reactions: Multi-Organ Failure, Haematochezia, Alopecia, Pollakiuria, Mucous Membrane Disorder, Full Blood Count Decreased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Possible Methotrexate side effects in 54 year old female
Reported by a physician from France on 2012-07-13
Patient: 54 year old female
Reactions: Leukaemia, Leukaemia Plasmacytic
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Doxorubicin HCL
Dosage: cumulative total dose of doxorubicine of 504 mg (300 mg/m2)
Indication: non-Hodgkin's Lymphoma
Start date: 2010-05-10
End date: 2010-08-16
Etoposide
Dosage: (500 mg)
Indication: non-Hodgkin's Lymphoma
Start date: 2010-01-01
End date: 2011-01-01
Ifosfamide
Dosage: 2480 mg
Indication: non-Hodgkin's Lymphoma
Start date: 2010-01-01
End date: 2011-01-01
Mabthera
Dosage: 650 mg
Indication: non-Hodgkin's Lymphoma
Start date: 2010-05-10
End date: 2010-08-16
Methotrexate
Dosage: (4500 mg)
Start date: 2012-05-14
Methotrexate
Indication: non-Hodgkin's Lymphoma
Start date: 2010-09-13
End date: 2010-09-28
Methylprednisolone
Indication: non-Hodgkin's Lymphoma
Start date: 2010-05-10
End date: 2010-08-16
Prednisone
Indication: non-Hodgkin's Lymphoma
Start date: 2010-05-10
End date: 2010-08-16
Vincristine
Indication: non-Hodgkin's Lymphoma
Start date: 2010-05-10
End date: 2010-08-16
Possible Methotrexate side effects in 51 year old male
Reported by a physician from United Kingdom on 2012-07-12
Patient: 51 year old male, weighing 110.0 kg (242.0 pounds)
Reactions: Liver Injury
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Cimzia
Indication: Rheumatoid Arthritis
Start date: 2011-03-15
End date: 2012-06-18
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1998-01-01
End date: 2012-06-18
Other drugs received by patient: Acetaminophen and Codeine Phosphate
Possible Methotrexate side effects in 79 year old female
Reported by a pharmacist from United States on 2012-07-10
Patient: 79 year old female
Reactions: Subdural Haematoma, International Normalised Ratio Increased, Intracranial Pressure Increased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Methotrexate
Dosage: 17.5mg once weekly po
Administration route: Oral
Indication: Rheumatoid Arthritis
Warfarin Sodium
Dosage: 2.5mg daily -5mg on m/th- daily except m/th po
Administration route: Oral
Indication: Atrial Fibrillation
Other drugs received by patient: Omeprazole -Prilosec 20mg DR CAP Take 1 CAP BY Mouth Daily. FOR Sympt
Possible Methotrexate side effects in 62 year old male
Reported by a physician from Japan on 2012-07-09
Patient: 62 year old male
Reactions: Spinal Compression Fracture, Interstitial Lung Disease, Staphylococcal Bacteraemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Dosage: restarted from 15sep
Orencia
Indication: Rheumatoid Arthritis
Start date: 2010-12-21
Prednisolone
Dosage: also 15mg dose increased to 40mg/d on 14jan11 dose reduced to 30mg/d on 21jan11
Indication: Rheumatoid Vasculitis
Other drugs received by patient: Bactrim; Imuran; Kenalog; Onealfa; Tacrolimus
Possible Methotrexate side effects in 55 year old female
Reported by a physician from United Kingdom on 2012-07-06
Patient: 55 year old female
Reactions: Pancytopenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Other drugs received by patient: Etoposide; Daunorubicin HCL; Cytarabine; Vincristine; Mercaptopurine
Possible Methotrexate side effects in female
Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-07-06
Patient: female
Reactions: Vomiting, Arachnoiditis, Respiratory Failure, Mental Status Changes, Headache, Progressive Multifocal Leukoencephalopathy
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Methotrexate
Possible Methotrexate side effects in female
Reported by a individual with unspecified qualification from Japan on 2012-07-06
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Pneumocystis Jiroveci Pneumonia, Diarrhoea, Interstitial Lung Disease, Pneumonia Pneumococcal
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Start date: 2009-11-20
End date: 2011-02-07
Actemra
Start date: 2011-06-01
End date: 2011-06-01
Actemra
Indication: Rheumatoid Arthritis
Start date: 2009-07-21
End date: 2009-07-21
Actemra
Start date: 2011-04-15
End date: 2011-04-15
Methotrexate
Dosage: form: peroral agent
Administration route: Oral
Start date: 2008-03-14
End date: 2008-05-15
Methotrexate
Dosage: form: peroral agent
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2007-01-01
End date: 2008-03-14
Methotrexate
Dosage: form: peroral agent
Administration route: Oral
Prednisolone
Administration route: Oral
Indication: Rheumatoid Arthritis
Other drugs received by patient: Loxonin; Mucosta; Omeprazole; Risedronate Sodium
Possible Methotrexate side effects in 10 year old female
Reported by a physician from Korea, Democratic People's Republic of on 2012-07-06
Patient: 10 year old female
Reactions: Vomiting, Wernicke's Encephalopathy, Nausea, Malnutrition, Mental Status Changes, Convulsion
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Methotrexate
Other drugs received by patient: Cisplatin; Adriamycin PFS
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