|
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 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 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 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
|
