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Arava (Leflunomide) - Death - Suspected Cause - Side Effect Reports

 
 



Index of reports > Death (28)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Arava (Leflunomide) death. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Arava side effects in 71 year old female

Reported by a consumer/non-health professional from Mexico on 2012-08-23

Patient: 71 year old female, weighing 65.0 kg (143.0 pounds)

Reactions: Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava



Possible Arava side effects in 70 year old female

Reported by a physician from Israel on 2012-08-13

Patient: 70 year old female

Reactions: Intestinal Perforation, Anaemia, Sepsis, Pancytopenia, Febrile Neutropenia, Platelet Count Decreased, Neutrophil Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Arava

Other drugs received by patient: Prednisone TAB; Methotrexate



Possible Arava side effects in 70 year old female

Reported by a physician from Israel on 2012-08-08

Patient: 70 year old female

Reactions: Intestinal Perforation, Anaemia, Platelet Count Decreased, Pancytopenia, Neutrophil Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Arava

Other drugs received by patient: Methotrexate; Prednisone



Possible Arava side effects in 73 year old female

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: 73 year old female, weighing 47.7 kg (104.9 pounds)

Reactions: Death, Weight Decreased, Abdominal Pain, Diarrhoea, Pulmonary Oedema, Asthenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-04-17

Arava
    Administration route: Oral
    Start date: 2012-04-25
    End date: 2012-05-26

Arava
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-04-17

Arava
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2012-03-22
    End date: 2012-04-01

Arava
    Administration route: Oral
    Indication: Pulmonary Fibrosis
    Start date: 2012-03-22
    End date: 2012-04-01

Arava
    Administration route: Oral
    Start date: 2012-04-25
    End date: 2012-05-26

Other drugs received by patient: Evista; Nasal Saline; Vitamin B-12; Fluticasone Propionate; Prednisone; Budesonide / Formoterol; ALL Other Therapeutic Products; Mobic; Plaquenil; Vitamin D; Hydrochlorothiazide / Losartan Potassium; ALL Other Therapeutic Products; ALL Other Therapeutic Products



Possible Arava side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from Austria on 2012-07-18

Patient: 49 year old female

Reactions: Multi-Organ Failure, Fungal Infection, Impaired Healing, Pneumonia Necrotising, Urinary Tract Infection Bacterial, Septic Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Arava

Other drugs received by patient: Prednisolone



Possible Arava side effects in 75 year old female

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

Patient: 75 year old female, weighing 62.6 kg (137.7 pounds)

Reactions: Gastrointestinal Haemorrhage, Coagulopathy, Diverticulitis, Myocardial Ischaemia, Renal Ischaemia, Abdominal Pain Upper, Haematemesis, Labile Blood Pressure, Multi-Organ Failure, Hepatotoxicity, Hepatorenal Syndrome, Hepatocellular Injury, Hepatic Ischaemia, Incision Site Haemorrhage, Hypovolaemia, Intestinal Ischaemia, Coronary Artery Disease, Duodenal Ulcer, Haemodialysis, Abdominal Rigidity, Renal Failure, Hepatic Congestion, Acute Hepatic Failure, Renal Tubular Necrosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Acetaminophen and Codeine Phosphate
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 2002-03-01

Acetylsalicylic Acid SRT
    Dosage: unk
    Indication: Pain
    Start date: 2002-03-01

Arava
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2002-03-01

Atorvastatin Calcium
    Dosage: unk
    Indication: Hypercholesterolaemia
    Start date: 1999-01-01

Budesonide
    Dosage: unk
    Indication: Asthma
    Start date: 2002-03-01

Diltiazem HCL
    Dosage: unk
    Indication: Hypertension
    Start date: 2002-03-01

Fentanyl
    Dosage: unk
    Indication: Anaesthesia
    Start date: 2002-03-01
    End date: 2002-03-01

Lansoprazole
    Dosage: unk
    Indication: Duodenal Ulcer
    Start date: 2001-03-01

Lisinopril
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension
    Start date: 2002-03-01

Midazolam
    Dosage: unk
    Indication: Anaesthesia
    Start date: 2002-03-01
    End date: 2002-03-01

Nitroglycerin
    Dosage: unk
    Administration route: Oral
    Indication: Pain
    Start date: 2002-03-01

Pancuronium Bromide
    Dosage: unk
    Indication: Muscle Relaxant Therapy
    Start date: 2002-03-01
    End date: 2002-03-01

Propofol
    Dosage: unk
    Indication: Anaesthesia
    Start date: 2002-03-01
    End date: 2002-03-01

Quinine Sulfate
    Dosage: unk
    Indication: Muscle Spasms

Other drugs received by patient: Fluticasone Propionate; Nitroglycerin



Possible Arava side effects in 53 year old male

Reported by a consumer/non-health professional from Poland on 2012-06-14

Patient: 53 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Multi-Organ Failure, Respiratory Failure, Pyrexia, Bursitis, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava

Other drugs received by patient: Methylprednisolone; Glucocorticoids



Possible Arava side effects in male

Reported by a physician from Spain on 2012-03-14

Patient: male

Reactions: Respiratory Moniliasis, Biopsy Lung Abnormal, Coagulopathy, Lung Infection, Hepatic Failure, Pyrexia, Multi-Organ Failure, Duodenitis, Hypoxia, Leukoplakia Oral, Cough, Candidiasis, Hypotension, Pancytopenia, Febrile Neutropenia, Biopsy Liver Abnormal, Renal Failure, Respiratory Failure, Oliguria, Aspergillosis, Diffuse Alveolar Damage, Septic Shock, Asthenia

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Arava
    Administration route: Oral
    Indication: Psoriatic Arthropathy
    Start date: 2011-01-07
    End date: 2011-12-03

Humira
    Indication: Psoriatic Arthropathy
    Start date: 2005-11-16
    End date: 2011-12-03

Methotrexate Sodium
    Indication: Psoriatic Arthropathy
    Start date: 1994-09-21
    End date: 2011-12-03

Other drugs received by patient: Corticosteroids; Acetaminophen; Antihypertensive Drug; Enalapril Maleate



Possible Arava side effects in male

Reported by a physician from Spain on 2012-03-13

Patient: male

Reactions: Biopsy Lung Abnormal, Respiratory Moniliasis, Coagulopathy, Lung Infection, Hepatic Failure, Pyrexia, Duodenitis, Multi-Organ Failure, Hypoxia, Leukoplakia Oral, Candidiasis, Cough, Hypotension, Pancytopenia, Biopsy Liver Abnormal, Febrile Neutropenia, Renal Failure, Respiratory Failure, Oliguria, Aspergillosis, Diffuse Alveolar Damage, Septic Shock, Asthenia

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Arava
    Administration route: Oral
    Indication: Psoriatic Arthropathy
    Start date: 2011-01-07
    End date: 2011-12-03

Humira
    Indication: Psoriatic Arthropathy
    Start date: 2005-11-16
    End date: 2011-12-03

Methotrexate Sodium
    Indication: Psoriatic Arthropathy
    Start date: 1994-09-21
    End date: 2011-12-03

Other drugs received by patient: Antihypertensive Drug; Enalapril; Corticosteroids; Acetaminophen



Possible Arava side effects in 65 year old female

Reported by a consumer/non-health professional from Brazil on 2012-03-09

Patient: 65 year old female

Reactions: Chest Pain, Hypertension, Asthenia, Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava

Etanercept
    Indication: Rheumatoid Arthritis

Prednisone

Other drugs received by patient: Losartan Potassium



Possible Arava side effects in female

Reported by a physician from Australia on 2012-02-28

Patient: female, weighing 102.0 kg (224.4 pounds)

Reactions: Anhedonia, Neutropenia, Purpura, Meningioma

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2011-07-01
    End date: 2011-08-01

Arava
    Dosage: alternate days
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2003-01-01
    End date: 2012-01-07

Methotrexate
    Dosage: dose:12.5
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2002-01-01
    End date: 2012-01-07

Other drugs received by patient: Acimax; Mobic; Slow-K; Acetaminophen; Isoptin; Prednisolone; Fosamax



Possible Arava side effects in 77 year old female

Reported by a consumer/non-health professional from Mexico on 2012-01-17

Patient: 77 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Renal Failure, Syncope, Cardiac Failure, Anaemia, Duodenal Ulcer

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Arava



Possible Arava side effects in 71 year old male

Reported by a physician from Australia on 2012-01-06

Patient: 71 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava



Possible Arava side effects in 66 year old male

Reported by a consumer/non-health professional from Mexico on 2011-12-20

Patient: 66 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Weight Decreased, Renal Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Arava
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2003-01-01
    End date: 2011-09-30

Calcort
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2003-01-01
    End date: 2011-07-01

Other drugs received by patient: Methotrexate



Possible Arava side effects in 77 year old female

Reported by a physician from Australia on 2011-12-19

Patient: 77 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava

Other drugs received by patient: Endep; Rabeprazole Sodium; ALL Other Therapeutic Products; Amitriptyline HCL; Folic Acid; Conjugated Estrogens; Oxycodone HCL; Acetaminophen; Prednisone TAB; Oxycontin; Solone



Possible Arava side effects in female

Reported by a consumer/non-health professional from Mexico on 2011-12-13

Patient: female

Reactions: Hypovolaemic Shock, Gastrointestinal Haemorrhage, Malaise, Dyspnoea, Dizziness, Decreased Appetite

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Arava



Possible Arava side effects in 57 year old female

Reported by a physician from Japan on 2011-12-05

Patient: 57 year old female

Reactions: Pancreatitis Acute, Multi-Organ Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Arava
    Administration route: Oral

Orencia
    Dosage: 13th dose on 07-oct-2011.
    Indication: Rheumatoid Arthritis
    Start date: 2010-11-26
    End date: 2011-10-07

Vildagliptin
    Administration route: Oral
    Start date: 2011-08-26

Other drugs received by patient: Forteo; Amlodipine; Evista; Prednisolone; Rabeprazole Sodium; Fluconazole; Baraclude; Loxonin; Steroids; Alendronate Sodium



Possible Arava side effects in male

Reported by a physician from Germany on 2011-11-28

Patient: male, weighing 98.0 kg (215.6 pounds)

Reactions: Hepatorenal Syndrome, Drug Interaction, Hepatic Failure, General Physical Health Deterioration, Leukopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Arava

Other drugs received by patient possibly interacting with the suspect drug:
Methotrexate
    Dosage: initially 20 mg/day orally, then up to 25 mg/day s.c., at last 10 mg/day orally
    Start date: 2006-01-01
    End date: 2011-07-01

Other drugs received by patient: Simvastatin; Prednisone; Resochin; Diclofenac Sodium; Prednisone; Ramipril; Omeprazole; Ethyl Fumarate Zinc and Dimethyl Fumarate and Ethyl Fumarate Magnesium; Prednisone; Metoprolol Tartrate; Acetylsalicylic Acid SRT; Insulin; Glimepiride; Prednisone; Sulfasalazine; Sulfasalazine



Possible Arava side effects in 57 year old female

Reported by a consumer/non-health professional from Japan on 2011-11-18

Patient: 57 year old female

Reactions: Pancreatitis Acute, Multi-Organ Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Arava
    Administration route: Oral

Orencia
    Dosage: 13th dose on 07-oct-2011.
    Indication: Rheumatoid Arthritis
    Start date: 2010-11-26
    End date: 2011-01-01

Other drugs received by patient: Baraclude; Steroids; Loxonin



Possible Arava side effects in 57 year old female

Reported by a physician from Japan on 2011-11-18

Patient: 57 year old female, weighing 42.0 kg (92.4 pounds)

Reactions: Pancreatitis Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-05-13
    End date: 2011-10-21

Prednisolone
    Dosage: 4-0-3
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Other drugs received by patient: Forteo; Rabeprazole Sodium; Evista; Amlodipine Besylate; Alendronate Sodium; Baraclude; Diflucan; Orencia; Loxonin



Possible Arava side effects in 57 year old female

Reported by a consumer/non-health professional from Japan on 2011-11-11

Patient: 57 year old female

Reactions: Pancreatitis Acute, Multi-Organ Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Arava
    Administration route: Oral

Orencia
    Dosage: 13th dose on 07-oct-2011.
    Indication: Rheumatoid Arthritis
    Start date: 2010-11-26
    End date: 2011-01-01

Other drugs received by patient: Loxonin; Baraclude; Steroids



Possible Arava side effects in 57 year old female

Reported by a physician from Japan on 2011-11-07

Patient: 57 year old female, weighing 42.0 kg (92.4 pounds)

Reactions: Pancreatitis Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-05-13
    End date: 2011-10-21

Prednisolone
    Dosage: 4-0-3
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Other drugs received by patient: Alendronate Sodium; Loxonin; Amlodipine Besylate; Rabeprazole Sodium; Evista; Baraclude



Possible Arava side effects in 61 year old female

Reported by a physician from Germany on 2011-10-18

Patient: 61 year old female

Reactions: Hepatic Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava

Other drugs received by patient: ALL Other Therapeutic Products; Methotrexate



Possible Arava side effects in 71 year old male

Reported by a consumer/non-health professional from Australia on 2011-10-14

Patient: 71 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava



Possible Arava side effects in 73 year old male

Reported by a consumer/non-health professional from Australia on 2011-10-14

Patient: 73 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava

Other drugs received by patient: Prednisone



Possible Arava side effects in 74 year old female

Reported by a consumer/non-health professional from Australia on 2011-10-13

Patient: 74 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava

Other drugs received by patient: Cyclosporine; Methotrexate; Prednisone



Possible Arava side effects in 77 year old female

Reported by a consumer/non-health professional from Australia on 2011-10-12

Patient: 77 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava

Other drugs received by patient: Folic Acid; Prednisone; Endep; ALL Other Therapeutic Products; Estrogens Conjugated; Rabeprazole Sodium; Oxycodone HCL; Solone; Oxycontin; Amitriptyline HCL; Acetaminophen



Possible Arava side effects in 75 year old male

Reported by a consumer/non-health professional from Australia on 2011-10-04

Patient: 75 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Arava

Other drugs received by patient: Avapro; Nitroglycerin; Aspirin; Prednisone

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