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Methotrexate (Methotrexate) - Diarrhoea - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Diarrhoea (136)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Methotrexate where reactions include diarrhoea. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 136   Next >>

Possible Methotrexate side effects in

Reported by a physician from United States on 2012-08-20

Patient:

Reactions: Abdominal Pain, Thrombosis, Hyperkalaemia, Hypoglycaemia, Coagulopathy, Hypokalaemia, Blood Bilirubin Abnormal, Hiccups, Pleural Effusion, Hypoxia, Hypocalcaemia, Alanine Aminotransferase Abnormal, Cough, Pneumonitis, Decreased Appetite, Pain in Extremity, Hypotension, Hyperglycaemia, Gamma-Glutamyltransferase Abnormal, Hyponatraemia, External Ear Pain, Hypercalcaemia, Haematotoxicity, Hypophosphataemia, Diarrhoea, Dehydration, Hypoalbuminaemia, Lower Gastrointestinal Haemorrhage, Hypertension, Hypofibrinogenaemia, Aspartate Aminotransferase Abnormal, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Asparaginase
    Dosage: 2500 units/m2/dose as 4 weekly doses
    Indication: Acute Lymphocytic Leukaemia

Bortezomib
    Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Dosage: on day 1 for all patients and on days 8, 15, 22 for cns invlovment
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: 10 mg/m2/day divided in to 2 doses for 14 consecutive days
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: given over 15-30 minutes on day 1
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Dosage: on days 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: 1 dose on day 15 for no cns involvement and on days 8, 15, 22 for cns involvement
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

Other drugs received by patient: Levofloxacin; Voriconazole; Posaconazole; Vancomycin



Possible Methotrexate side effects in 79 year old female

Reported by a pharmacist from United Kingdom on 2012-08-20

Patient: 79 year old female, weighing 55.4 kg (121.9 pounds)

Reactions: Pruritus, Pulmonary Embolism, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Blister, Toxic Epidermal Necrolysis, Skin Tightness, Staphylococcal Scalded Skin Syndrome, Exfoliative Rash, Vasculitis, Rash Maculo-Papular, Hypersensitivity, Skin Exfoliation, Scab, Adverse Drug Reaction, Pain, Petechiae, Skin Swelling, Stevens-Johnson Syndrome, Renal Failure Acute, Fluid Overload, Rash Generalised, Atrial Fibrillation, DRY Skin, Rash, Pulmonary Fibrosis, Skin Irritation, Mucosal Erosion, Haemoglobin Decreased, Diarrhoea, Skin Erosion

Adverse event resulted in: death

Drug(s) suspected as cause:
Amiodarone HCL
    Indication: Product Used FOR Unknown Indication

Amoxicillin
    Indication: Product Used FOR Unknown Indication

Bumetanide
    Indication: Product Used FOR Unknown Indication

Clarithromycin
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Methotrexate
    Indication: Product Used FOR Unknown Indication

Simvastatin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Dalteparin Sodium; Candesartan Cilexetil; Bisoprolol Fumarate; Bisoprolol Fumarate; Clotrimazole; Fortisip; Diclofenac Diethylammonium Salt; Adenosine; Furosemide; Acetaminophen; Tramadol HCL; Acetaminophen and Codeine Phosphate; Teicoplanin; Adcal-D3; Dioralyte; Gentamicin; Amoxicillin and Clavulanate Potassium; Heparin; Folic Acid; Omeprazole; Metoclopramide



Possible Methotrexate side effects in

Reported by a physician from United States on 2012-08-14

Patient:

Reactions: Thrombosis, Abdominal Pain, Hyperkalaemia, Hypoglycaemia, Coagulopathy, Hypoxia, Hypocalcaemia, Hiccups, Alanine Aminotransferase Abnormal, Cough, Pneumonitis, Pain in Extremity, Hyperglycaemia, Hypotension, External Ear Pain, Haematotoxicity, Dehydration, Lower Gastrointestinal Haemorrhage, Hypofibrinogenaemia, Aspartate Aminotransferase Abnormal, Hypokalaemia, Neuropathy Peripheral, Blood Bilirubin Abnormal, Pleural Effusion, Decreased Appetite, Hyponatraemia, Gamma-Glutamyltransferase Abnormal, Hypercalcaemia, Hypophosphataemia, Diarrhoea, Hypoalbuminaemia, Hypertension, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Asparaginase
    Dosage: 2500 units/m2/dose as 4 weekly doses
    Indication: Acute Lymphocytic Leukaemia

Bortezomib
    Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Dosage: on day 1 for all patients and on days 8, 15, 22 for cns invlovment
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: 10 mg/m2/day divided in to 2 doses for 14 consecutive days
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: given over 15-30 minutes on day 1
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Dosage: on days 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: 1 dose on day 15 for no cns involvement and on days 8, 15, 22 for cns involvement
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

Other drugs received by patient: Levofloxacin; Vancomycin; Posaconazole; Voriconazole



Possible Methotrexate side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14

Patient: 65 year old male, weighing 66.0 kg (145.2 pounds)

Reactions: Weight Decreased, Vomiting, Mycobacterium Chelonae Infection, Hyperkalaemia, Hypercreatininaemia, Rectal Haemorrhage, Reticulocyte Count Decreased, Diarrhoea, RED Blood Cell Count Decreased, Megakaryocytes Abnormal, Neutropenia, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin
    Dosage: 500 mg, 2x/day
    Start date: 2012-05-31
    End date: 2012-06-26

Ketoprofen
    Dosage: 100-300 mg, daily
    Administration route: Oral
    Indication: Juvenile Arthritis

Methotrexate
    Dosage: 20 mg, weekly
    Administration route: Oral
    Indication: Juvenile Arthritis

Prednisone TAB
    Dosage: 3 mg, daily
    Administration route: Oral
    Indication: Juvenile Arthritis

Zyvox
    Dosage: 7.8 mg/l, unknown
    Start date: 2012-06-28

Zyvox
    Dosage: 600 mg, 2x/day
    Start date: 2012-05-31
    End date: 2012-06-26

Other drugs received by patient: Sertraline; Bisoprolol; Metformin; Tetrazepam; Pantoprazole; Aspegic 1000



Possible Methotrexate side effects in 79 year old female

Reported by a pharmacist from United Kingdom on 2012-08-06

Patient: 79 year old female, weighing 55.4 kg (121.9 pounds)

Reactions: Pruritus, Pulmonary Embolism, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Blister, Toxic Epidermal Necrolysis, Skin Tightness, Exfoliative Rash, Staphylococcal Scalded Skin Syndrome, Vasculitis, Rash Maculo-Papular, Hypersensitivity, Skin Exfoliation, Pain, Scab, Adverse Drug Reaction, Petechiae, Skin Swelling, Stevens-Johnson Syndrome, Renal Failure Acute, Fluid Overload, Rash Generalised, Atrial Fibrillation, Rash, DRY Skin, Skin Irritation, Pulmonary Fibrosis, Haemoglobin Decreased, Mucosal Erosion, Diarrhoea, Skin Erosion

Adverse event resulted in: death

Drug(s) suspected as cause:
Amiodarone HCL
    Indication: Product Used FOR Unknown Indication

Amoxicillin
    Indication: Product Used FOR Unknown Indication

Bumetanide
    Indication: Product Used FOR Unknown Indication

Clarithromycin
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Methotrexate
    Indication: Product Used FOR Unknown Indication

Simvastatin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Candesartan Cilexetil; Clotrimazole; Gentamicin; Omeprazole; Adenosine; Fortisip; Adcal-D3; Dioralyte; Dalteparin Sodium; Bisoprolol Fumarate; Bisoprolol Fumarate; Acetaminophen and Codeine Phosphate; Diclofenac Diethylammonium Salt; Amoxicillin and Clavulanate Potassium; Heparin; Metoclopramide; Teicoplanin; Furosemide; Acetaminophen; Folic Acid; Tramadol HCL



Possible Methotrexate side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: male, weighing 119.8 kg (263.5 pounds)

Reactions: Diabetes Mellitus, Abasia, Perineal Cyst, Decreased Immune Responsiveness, Intervertebral Disc Degeneration, Abnormal Loss of Weight, Oxygen Saturation Decreased, Intervertebral Disc Protrusion, Fistula, Gout, Convulsion, Cholelithiasis, Diarrhoea, Sepsis, Heart Rate Increased, Arthritis, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Colchicine
    Administration route: Oral
    Indication: Gout
    Start date: 2012-05-01

Levemir
    Dosage: 52 units/ at night/subcutaneous
    Indication: Diabetes Mellitus

Methotrexate
    Administration route: Oral
    Indication: Intervertebral Disc Protrusion
    Start date: 2011-01-01
    End date: 2011-01-01

Novolog
    Dosage: 40 units/solution before meals
    Indication: Diabetes Mellitus
    Start date: 2011-01-01
    End date: 2011-01-01

Remicade
    Indication: Crohn's Disease
    Start date: 2004-09-09
    End date: 2010-01-01

Remicade
    Start date: 2010-01-01

Other drugs received by patient: Flomax; Dilaudid; Ambien; Valium; Hydrochlorothiazide; Cymbalta; Lyrica; Lisinopril; Simvastatin; Nexium; Humalog; Onglyza



Possible Methotrexate side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-01

Patient: female, weighing 77.0 kg (169.4 pounds)

Reactions: Vomiting, Spinal Pain, Flatulence, Neck Mass, Pyrexia, Upper Extremity Mass, Lower Extremity Mass, Malaise, Diarrhoea, Arthralgia, Swelling, Lymph Node Tuberculosis, Dysuria

Drug(s) suspected as cause:
Humira
    Indication: Rheumatoid Arthritis
    End date: 2011-11-29

Methotrexate
    Dosage: 2 tb am, 2 tb pm, on mondays
    Start date: 2010-09-01

Methotrexate
    Dosage: 4 tablets every monday, once
    Indication: Rheumatoid Arthritis

Other drugs received by patient: Meticorten; Tenoxicam; Meticorten; Losartan Potassium; Hydrochlorothiazide



Possible Methotrexate side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-27

Patient: female, weighing 56.3 kg (123.9 pounds)

Reactions: Blood Bilirubin Increased, Tachycardia, Disseminated Intravascular Coagulation, Pyrexia, Acidosis, Abdominal Tenderness, Labile Blood Pressure, Hypoxia, Unevaluable Event, Blood Creatinine Increased, Epistaxis, Mouth Haemorrhage, Hypotension, Blood Lactate Dehydrogenase Increased, Encephalopathy, Hyperammonaemia, Sinusitis Fungal, Pulseless Electrical Activity, Hepatic Function Abnormal, Skin Exfoliation, Haemorrhage, Mental Status Changes, Serum Ferritin Increased, Oral Herpes, Weight Increased, Dialysis, Tachypnoea, Dizziness, Drug Clearance Decreased, Fluid Overload, Vomiting, Febrile Neutropenia, Hepatic Enzyme Increased, Renal Impairment, Lower Respiratory Tract Infection Fungal, Diarrhoea, Respiratory Failure, Oliguria, Bradycardia, Hypertension, Cardiac Arrest, Klebsiella Test Positive, Nasal Ulcer, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methotrexate
    Dosage: 15 mg it, : 290mg x2 iv

Vincristine Sulfate
    Dosage: 4 mg iv

Other drugs received by patient: Fluconazole; Amphotericin B; Piperacillin and Tazobactam; Fligrastim; Vancomycin; Valacyclovir Hydrochloride; Dexamethasone; Etoposide



Possible Methotrexate side effects in 17 year old female

Reported by a physician from United States on 2012-07-25

Patient: 17 year old female, weighing 47.6 kg (104.7 pounds)

Reactions: Blood Bilirubin Increased, Dysphagia, Muscular Weakness, Vocal Cord Paralysis, Cerebrovascular Accident, Caecitis, Eating Disorder, Diarrhoea, Depressed Level of Consciousness, Acute Respiratory Distress Syndrome, Sinus Tachycardia, Spinal Cord Oedema, Peripheral Motor Neuropathy, Epistaxis, Neuralgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1000mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Cytarabine
    Dosage: 75mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Dalteparin Sodium
    Indication: Product Used FOR Unknown Indication

Mercaptopurine
    Dosage: 60mgm2 cyclic
    Administration route: Oral
    Indication: T-Cell Type Acute Leukaemia

Methotrexate
    Indication: T-Cell Type Acute Leukaemia

Nelarabine
    Dosage: 650mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-04-13

PEG-Asparaginase
    Indication: T-Cell Type Acute Leukaemia

Vincristine
    Dosage: 1.5mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Other drugs received by patient: Insulin Aspart; Lansoprazole; Vancomycin; Nystatin; Piperacillin and Tazobactam; Voriconazole



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 63 year old female

Reported by a consumer/non-health professional from Canada on 2012-07-20

Patient: 63 year old female

Reactions: Weight Decreased, Diarrhoea, Skin Lesion, Tooth Infection, Enteritis, Oral Herpes

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methotrexate

Orencia
    Dosage: inf:27 19oc10,08no11,10de2011,18ap12,12-14ju12.btch.1g64569.ma2014. lt#1l66305,2b69530-se14
    Indication: Rheumatoid Arthritis
    Start date: 2010-05-03

Other drugs received by patient: Diovan; Prednisone; Meloxicam; Vitamin D; Folic Acid; Tramadol Hydrochloride / Acetaminophen



Possible Methotrexate side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-19

Patient: 62 year old male, weighing 48.3 kg (106.3 pounds)

Reactions: Abdominal Pain, Diarrhoea

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Methotrexate

Other drugs received by patient: Folic Acid; Ramipril; Metformin Hydrochloride; Amlodipine; Simvastatin



Possible Methotrexate side effects in 50 year old female

Reported by a health professional (non-physician/pharmacist) from NEW Zealand on 2012-07-16

Patient: 50 year old female

Reactions: Diarrhoea, Pneumonitis, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bevacizumab
    Indication: Product Used FOR Unknown Indication

Etanercept
    Indication: Psoriatic Arthropathy
    Start date: 2011-05-04
    End date: 2011-06-07

Methotrexate
    Administration route: Oral
    Indication: Psoriatic Arthropathy
    Start date: 2010-10-07
    End date: 2011-06-07

Pegfilgrastim
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Folic Acid; Prednisolone; Acetaminophen; Cilazapril; Carbamazepine; Metformin Hydrochloride; Diclofenac Sodium; Gliclazide



Possible Methotrexate side effects in 79 year old female

Reported by a pharmacist from United Kingdom on 2012-07-16

Patient: 79 year old female, weighing 55.4 kg (121.9 pounds)

Reactions: Pruritus, Pulmonary Embolism, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Blister, Toxic Epidermal Necrolysis, Skin Tightness, Exfoliative Rash, Staphylococcal Scalded Skin Syndrome, Vasculitis, Rash Maculo-Papular, Hypersensitivity, Skin Exfoliation, Adverse Drug Reaction, Pain, Scab, Petechiae, Skin Swelling, Stevens-Johnson Syndrome, Renal Failure Acute, Fluid Overload, Rash Generalised, Atrial Fibrillation, DRY Skin, Rash, Skin Irritation, Pulmonary Fibrosis, Mucosal Erosion, Haemoglobin Decreased, Diarrhoea, Skin Erosion

Adverse event resulted in: death

Drug(s) suspected as cause:
Amiodarone HCL
    Indication: Product Used FOR Unknown Indication

Amoxicillin
    Indication: Product Used FOR Unknown Indication

Bumetanide
    Indication: Product Used FOR Unknown Indication

Clarithromycin
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Methotrexate
    Indication: Product Used FOR Unknown Indication

Simvastatin
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Candesartan; Folic Acid; Furosemide; Bisoprolol Fumarate; Heparin; Metoclopramide; Adcal-D3; Acetaminophen and Codeine Phosphate; Diclofenac Diethylammonium Salt; Dalteparin Sodium; Tramadol HCL; Acetaminophen; Fortisip; Omeprazole; Clotrimazole; Adenosine; Amoxicillin and Clavulanate Potassium; Sodium Bicarbonate; Teicoplanin; Gentamicin; Bisoprolol Fumarate



Possible Methotrexate side effects in 17 year old female

Reported by a physician from United States on 2012-07-13

Patient: 17 year old female, weighing 47.6 kg (104.7 pounds)

Reactions: Blood Bilirubin Increased, Dysphagia, Muscular Weakness, Vocal Cord Paralysis, Cerebrovascular Accident, Caecitis, Eating Disorder, Diarrhoea, Depressed Level of Consciousness, Acute Respiratory Distress Syndrome, Spinal Cord Oedema, Peripheral Motor Neuropathy, Sinus Tachycardia, Neuralgia, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1000mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Cytarabine
    Dosage: 75mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Dalteparin Sodium
    Indication: Product Used FOR Unknown Indication

Mercaptopurine
    Dosage: 60mgm2 cyclic
    Administration route: Oral
    Indication: T-Cell Type Acute Leukaemia

Methotrexate
    Indication: T-Cell Type Acute Leukaemia

Nelarabine
    Dosage: 650mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-04-13

PEG-Asparaginase
    Indication: T-Cell Type Acute Leukaemia

Vincristine
    Dosage: 1.5mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Other drugs received by patient: Insulin Aspart; Nystatin; Voriconazole; Vancomycin; Piperacillin and Tazobactam; Lansoprazole



Possible Methotrexate side effects in 17 year old female

Reported by a physician from United States on 2012-07-09

Patient: 17 year old female, weighing 47.6 kg (104.7 pounds)

Reactions: Blood Bilirubin Increased, Dysphagia, Cerebrovascular Accident, Caecitis, Eating Disorder, Dysphonia, Diarrhoea, Acute Respiratory Distress Syndrome, Depressed Level of Consciousness, Peripheral Motor Neuropathy, Sinus Tachycardia, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1000mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Cytarabine
    Dosage: 75mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Dalteparin Sodium
    Indication: Product Used FOR Unknown Indication

Mercaptopurine
    Dosage: 60mgm2 cyclic
    Administration route: Oral
    Indication: T-Cell Type Acute Leukaemia

Methotrexate
    Indication: T-Cell Type Acute Leukaemia

Nelarabine
    Dosage: 650mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-04-13

PEG-Asparaginase
    Indication: T-Cell Type Acute Leukaemia

Vincristine
    Dosage: 1.5mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Other drugs received by patient: Lansoprazole; Piperacillin and Tazobactam; Vancomycin; Voriconazole; Insulin Aspart; Nystatin



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

Reported by a physician from United States on 2012-07-05

Patient:

Reactions: Fatigue, Central Nervous System Haemorrhage, Erythema Multiforme, Dyspnoea, Stomatitis, Vomiting, Gastrointestinal Toxicity, Nausea, Condition Aggravated, Rash, Haematotoxicity, Pulmonary Haemorrhage, Tumour Lysis Syndrome, Diarrhoea, Respiratory Failure, Neurological Symptom, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: for 5 days in cycle 1
    Indication: Burkitt's Lymphoma

Cyclophosphamide
    Dosage: days 1-5 during cycle 3,5 and 7

Cyclophosphamide
    Dosage: for 5 days in cycle 1
    Indication: Burkitt's Leukaemia

Cyclophosphamide
    Dosage: days 1-5 during cycle 3,5 and 7

Cytarabine
    Dosage: on days 4 and 5 of cycle 2,4 and 6
    Indication: Burkitt's Leukaemia

Cytarabine
    Dosage: on days 4 and 5 of cycle 2,4 and 6
    Indication: Burkitt's Lymphoma

Dexamethasone Sodium Phosphate
    Dosage: on days 1-5 of cycle 2,4 and 6

Dexamethasone Sodium Phosphate
    Dosage: on days 1-5 of cycle 2,4 and 6

Dexamethasone Sodium Phosphate
    Dosage: on days 1-5 of cycle 3,5 and 7
    Indication: Burkitt's Leukaemia

Dexamethasone Sodium Phosphate
    Dosage: on days 1-5 of cycle 3,5 and 7
    Indication: Burkitt's Lymphoma

Doxorubicin HCL
    Dosage: on days 4 and 5 of cycle 3,5 and 7
    Indication: Burkitt's Lymphoma

Doxorubicin HCL
    Dosage: on days 4 and 5 of cycle 3,5 and 7
    Indication: Burkitt's Leukaemia

Etoposide
    Dosage: on days 4 and 5 of cycle 2,4 and 6
    Indication: Burkitt's Lymphoma

Etoposide
    Dosage: on days 4 and 5 of cycle 2,4 and 6
    Indication: Burkitt's Leukaemia

Ifosfamide
    Dosage: on days 1-5 in cycle 2,4 and 6
    Indication: Burkitt's Lymphoma

Ifosfamide
    Dosage: on days 1-5 in cycle 2,4 and 6
    Indication: Burkitt's Leukaemia

Methotrexate
    Dosage: on day 1 of cycle 3,5 and 7
    Indication: Burkitt's Lymphoma

Methotrexate
    Dosage: on day 1 of cycle 2,4 and 6
    Indication: Burkitt's Leukaemia

Methotrexate
    Dosage: on day 1 of cycle 3,5 and 7

Methotrexate
    Dosage: on day 1 of cycle 2,4 and 6

Prednisone
    Dosage: for 7 days in cycle 1
    Indication: Burkitt's Lymphoma

Prednisone
    Dosage: for 7 days in cycle 1
    Indication: Burkitt's Leukaemia

Rituximab
    Dosage: on day 8 from cycle 3 to 7

Rituximab
    Dosage: on day 8 from cycle 3 to 7

Rituximab
    Dosage: day 8 on cycle 2; doage increased to 375 mg/m2 on day 10 and 12
    Indication: Burkitt's Leukaemia

Rituximab
    Dosage: day 8 on cycle 2; doage increased to 375 mg/m2 on day 10 and 12
    Indication: Burkitt's Lymphoma

Vincristine
    Dosage: on day 1 of cycle 3,5 and 7
    Indication: Burkitt's Lymphoma

Vincristine
    Dosage: on day 1 of cycle 2,4 and 6

Vincristine
    Dosage: on day 1 of cycle 3,5 and 7

Vincristine
    Dosage: on day 1 of cycle 2,4 and 6
    Indication: Burkitt's Leukaemia

Other drugs received by patient: Filgrastim; Unknown Medication; Leucovorin Calcium



Possible Methotrexate side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02

Patient: female

Reactions: Diarrhoea, Toxicity To Various Agents

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: (100 mg/m2 on days 1-14 oral)
    Administration route: Oral
    Indication: Breast Cancer

Fluorouracil
    Dosage: (600 mg/m2 on days 1 and 8 intravenous (not otherwise specified))
    Indication: Breast Cancer

Methotrexate
    Dosage: (40 mg/m2 on days 1 and 8 intravenous (not otherwise specified))
    Indication: Breast Cancer



Possible Methotrexate side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02

Patient: female

Reactions: Diarrhoea, Toxicity To Various Agents

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: (100 mg/m2 oral)
    Administration route: Oral
    Indication: Breast Cancer

Fluorouracil
    Dosage: (600 mg/m2 intravenous (not otherwise specified))
    Indication: Breast Cancer

Methotrexate
    Dosage: (40 mg/m2 intravenous (not otherwise specified))
    Indication: Breast Cancer

Tamoxifen Citrate
    Dosage: (df (daily))
    Indication: Breast Cancer



Possible Methotrexate side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-02

Patient: female, weighing 16.8 kg (37.0 pounds)

Reactions: Pupillary Reflex Impaired, Vomiting, Stomatitis, Retching, Pain, Cardio-Respiratory Arrest, Diarrhoea, Choking

Drug(s) suspected as cause:
Methotrexate

Other drugs received by patient: Zosyn; Dextrose 5% Normal Saline; Zofran



Possible Methotrexate side effects in male

Reported by a individual with unspecified qualification from Norway on 2012-07-02

Patient: male

Reactions: Diarrhoea, Neutropenia

Drug(s) suspected as cause:
Mabthera
    Dosage: given after 3 months from the event

Mabthera
    Indication: Rheumatoid Arthritis
    Start date: 2008-02-01

Methotrexate
    Indication: Granuloma

Methotrexate
    Indication: Vasculitis



Possible Methotrexate side effects in 42 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-28

Patient: 42 year old female

Reactions: Abdominal Pain, Contusion, Full Blood Count Abnormal, Diarrhoea, Thrombocytopenia, Haematemesis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Gabapentin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Hydroxychloroquine Sulfate
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Methotrexate
    Administration route: Oral

Methotrexate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Omeprazole
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sulfasalazine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Venlafaxine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Miconazole; Flucloxacillin; Benzydamine; Metronidazole; Scheriproct / 00212301 /; Nystatin



Possible Methotrexate side effects in 50 year old female

Reported by a health professional (non-physician/pharmacist) from NEW Zealand on 2012-06-28

Patient: 50 year old female

Reactions: Diarrhoea, Pneumonitis, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bevacizumab
    Indication: Product Used FOR Unknown Indication

Etanercept
    Indication: Psoriatic Arthropathy
    Start date: 2011-05-04
    End date: 2011-06-07

Methotrexate
    Administration route: Oral
    Indication: Psoriatic Arthropathy
    Start date: 2010-10-07
    End date: 2011-06-07

Pegfilgrastim
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Carbamazepine; Metformin HCL; Gliclazide; Cilazapril / Hydrochlorothiazide; Folic Acid; Prednisolone; Acetaminophen; Diclofenac Sodium



Possible Methotrexate side effects in 42 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-28

Patient: 42 year old female

Reactions: Abdominal Pain, Contusion, Diarrhoea, Full Blood Count Abnormal, Thrombocytopenia, Haematemesis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Gabapentin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Hydroxychloroquine Sulfate
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Methotrexate
    Administration route: Oral

Methotrexate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Omeprazole
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sulfasalazine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Venlafaxine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Flucloxacillin; Miconazole; Scheriproct / 00212301 /; Benzydamine; Metronidazole; Nystatin



Possible Methotrexate side effects in

Reported by a physician from United States on 2012-06-28

Patient:

Reactions: Fatigue, Central Nervous System Haemorrhage, Erythema Multiforme, Vomiting, Stomatitis, Dyspnoea, Gastrointestinal Toxicity, Nausea, Condition Aggravated, Rash, Haematotoxicity, Pulmonary Haemorrhage, Tumour Lysis Syndrome, Respiratory Failure, Diarrhoea, Neurological Symptom, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: days 1-5 during cycle 3,5 and 7

Cyclophosphamide
    Dosage: days 1-5 during cycle 3,5 and 7

Cyclophosphamide
    Dosage: for 5 days in cycle 1
    Indication: Burkitt's Leukaemia

Cyclophosphamide
    Dosage: for 5 days in cycle 1
    Indication: Burkitt's Lymphoma

Cytarabine
    Dosage: on days 4 and 5 of cycle 2,4 and 6
    Indication: Burkitt's Lymphoma

Cytarabine
    Dosage: on days 4 and 5 of cycle 2,4 and 6
    Indication: Burkitt's Leukaemia

Dexamethasone
    Dosage: on days 1-5 of cycle 2,4 and 6

Dexamethasone
    Dosage: on days 1-5 of cycle 2,4 and 6

Dexamethasone
    Dosage: on days 1-5 of cycle 3,5 and 7
    Indication: Burkitt's Lymphoma

Dexamethasone
    Dosage: on days 1-5 of cycle 3,5 and 7
    Indication: Burkitt's Leukaemia

Doxorubicin HCL
    Dosage: on days 4 and 5 of cycle 3,5 and 7
    Indication: Burkitt's Lymphoma

Doxorubicin HCL
    Dosage: on days 4 and 5 of cycle 3,5 and 7
    Indication: Burkitt's Leukaemia

Etoposide
    Dosage: on days 4 and 5 of cycle 2,4 and 6
    Indication: Burkitt's Leukaemia

Etoposide
    Dosage: on days 4 and 5 of cycle 2,4 and 6
    Indication: Burkitt's Lymphoma

Ifosfamide
    Dosage: on days 1-5 in cycle 2,4 and 6
    Indication: Burkitt's Lymphoma

Ifosfamide
    Dosage: on days 1-5 in cycle 2,4 and 6
    Indication: Burkitt's Leukaemia

Methotrexate
    Dosage: on day 1 of cycle 3,5 and 7
    Indication: Burkitt's Lymphoma

Methotrexate
    Dosage: on day 1 of cycle 2,4 and 6

Methotrexate
    Dosage: on day 1 of cycle 3,5 and 7

Methotrexate
    Dosage: on day 1 of cycle 2,4 and 6
    Indication: Burkitt's Leukaemia

Prednisone TAB
    Dosage: for 7 days in cycle 1
    Indication: Burkitt's Leukaemia

Prednisone TAB
    Dosage: for 7 days in cycle 1
    Indication: Burkitt's Lymphoma

Rituximab
    Dosage: on day 8 from cycle 3 to 7

Rituximab
    Dosage: day 8 on cycle 2; doage increased to 375 mg/m2 on day 10 and 12
    Indication: Burkitt's Leukaemia

Rituximab
    Dosage: day 8 on cycle 2; doage increased to 375 mg/m2 on day 10 and 12
    Indication: Burkitt's Lymphoma

Rituximab
    Dosage: on day 8 from cycle 3 to 7

Vincristine
    Dosage: on day 1 of cycle 2,4 and 6

Vincristine
    Dosage: on day 1 of cycle 2,4 and 6
    Indication: Burkitt's Leukaemia

Vincristine
    Dosage: on day 1 of cycle 3,5 and 7

Vincristine
    Dosage: on day 1 of cycle 3,5 and 7
    Indication: Burkitt's Lymphoma

Other drugs received by patient: Unknown Medication; Leucovorin Calcium; Filgrastim



Possible Methotrexate side effects in 42 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-28

Patient: 42 year old female

Reactions: Abdominal Pain, Contusion, Diarrhoea, Full Blood Count Abnormal, Thrombocytopenia, Haematemesis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Gabapentin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Hydroxychloroquine Sulfate
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Methotrexate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Methotrexate
    Administration route: Oral

Omeprazole
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sulfasalazine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Venlafaxine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Benzydamine; Nystatin; Flucloxacillin; Scheriproct / 00212301 /; Miconazole; Metronidazole



Possible Methotrexate side effects in 42 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-28

Patient: 42 year old female

Reactions: Abdominal Pain, Contusion, Diarrhoea, Full Blood Count Abnormal, Blood Disorder, Thrombocytopenia, Haematemesis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Gabapentin
    Dosage: 600 mg, qid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Hydroxychloroquine Sulfate
    Dosage: 400 mg, daily
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Methotrexate
    Dosage: 25 mg, 1/week
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Omeprazole
    Dosage: 20 mg, bid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sulfasalazine
    Dosage: 500 mg, unknown
    Administration route: Oral
    Indication: Colitis Ulcerative

Venlafaxine Hydrochloride
    Dosage: 75 mg, bid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Nystatin; Flucloxacillin; Metronidazole; Benzydamine; Miconazole; Scheriproct / 00212301 /



Possible Methotrexate side effects in female

Reported by a physician from United States on 2012-06-28

Patient: female, weighing 44.5 kg (97.9 pounds)

Reactions: Hypotension, Pyrexia, Abdominal Pain Upper, Candida Test Positive, Simplex Virus Test Positive, Diarrhoea, Fungal Test Positive, Skin Lesion, Neutropenia, Klebsiella Test Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 70 mg

Methotrexate
    Dosage: 15 mg

Methylprednisolone
    Dosage: 813.75 mg

PEG-L-Asparaginase (K-H)
    Dosage: 3225 unit

Vincristine Sulfate
    Dosage: 3.88 mg



Possible Methotrexate side effects in 42 year old female

Reported by a health professional (non-physician/pharmacist) from Israel on 2012-06-26

Patient: 42 year old female

Reactions: Abdominal Pain, Contusion, Full Blood Count Abnormal, Diarrhoea, Blood Disorder, Thrombocytopenia, Haematemesis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Gabapentin
    Dosage: 600 mg, qid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Hydroxychloroquine Sulfate
    Dosage: 400 mg, qd
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Methotrexate
    Dosage: 25 mg, 1/week
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Omeprazole
    Dosage: 20 mg, bid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sulfasalazine
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Venlafaxine HCL
    Dosage: 75 mg, bid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Nystatin; Scheriproct; Metronidazole; Benzydamine; Flucloxacillin; Miconazole



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