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Arava (Leflunomide) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (25)

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

Possible Arava side effects in 64 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-25

Patient: 64 year old male

Reactions: Prostate Cancer

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2010-05-11
    End date: 2012-03-14

Arava
    Indication: Rheumatoid Arthritis
    Start date: 2004-04-01
    End date: 2012-03-14

Other drugs received by patient: Zoledronoc Acid; Cacit D3; Prednisone TAB; Fosamax; Pantoprazole Sodium



Possible Arava side effects in 64 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-20

Patient: 64 year old male

Reactions: Prostate Cancer

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Arava
    Dosage: strength; 20 mg
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2004-04-01
    End date: 2012-03-14

Remicade
    Dosage: freq; every 8 week, strength; 100 mg
    Indication: Rheumatoid Arthritis
    Start date: 2010-05-11
    End date: 2012-03-14

Other drugs received by patient: Fosamax; Cacit D3; Prednisone TAB; Zoledronic Acid; Pantoprazole Sodium



Possible Arava side effects in 63 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-04-26

Patient: 63 year old male, weighing 95.0 kg (209.0 pounds)

Reactions: Malaise, Induration, Pyrexia, Necrotising Fasciitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arava
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2009-06-01
    End date: 2011-06-23

Etanercept
    Indication: Rheumatoid Arthritis
    Start date: 2009-06-01
    End date: 2011-06-23

Other drugs received by patient: Valsartan and Hydrochlorothiazide; Omeprazole; Calcium Carbonate



Possible Arava side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-30

Patient: 73 year old female

Reactions: Septic Shock, Clostridium Difficile Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prednisone TAB
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1985-01-01

Arava
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2003-09-01
    End date: 2011-01-01

Pantoprazole Sodium
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2000-01-01

Other drugs received by patient: Zestoretic; Lekovit CA; Ezetimibe; Spiriva; Plavix; Enbrel; Atorvastatin; Metformin; Fluticasone; Humalog



Possible Arava side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-28

Patient: 73 year old female

Reactions: Septic Shock, Clostridium Difficile Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arava
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2003-09-01
    End date: 2011-01-01

Pantoprazole Sodium
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2000-01-01

Prednisone TAB
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1985-01-01

Other drugs received by patient: Atorvastatin; Fluticasone; Lekovit CA; Spiriva; Enbrel; Ezetimibe; Metformin; Zestoretic; Plavix



Possible Arava side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-16

Patient: 73 year old female

Reactions: Septic Shock, Clostridium Difficile Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pantoprazole Sodium
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2000-01-01

Prednisone TAB
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1985-01-01

Etanercept
    Dosage: 50 mg, 1 in 1 wk
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-06
    End date: 2011-03-01

Arava
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2003-09-01
    End date: 2011-01-01

Other drugs received by patient: Spiriva; Atorvastatin; Lekovit CA; Zestoretic; Fluticasone; Metformin; Plavix; Ezetimibe



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 73 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-14

Patient: 73 year old female

Reactions: Septic Shock, Clostridium Difficile Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arava
    Dosage: 10 mg, unk
    Indication: Rheumatoid Arthritis
    Start date: 2003-09-01
    End date: 2011-01-01

Prednisone TAB
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1985-01-01

Pantoprazole Sodium
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2000-01-01

Etanercept
    Dosage: 50 mg, 1 in 1 wk
    Indication: Rheumatoid Arthritis
    Start date: 2012-01-06
    End date: 2012-01-01

Other drugs received by patient: Metformin; Lekovit CA; Atorvastatin; Fluticasone; Spiriva; Zestoretic; Plavix; Ezetimibe



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

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

Arava
    Administration route: Oral
    Indication: Psoriatic Arthropathy
    Start date: 2011-01-07
    End date: 2011-12-03

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



Possible Arava side effects in 61 year old male

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

Patient: 61 year old male, weighing 100.0 kg (220.0 pounds)

Reactions: Hyperthermia, Pain, Weight Increased, Syncope, Cardiac Failure, Ventricular Tachycardia, Amyloidosis, Ventricular Fibrillation, Cardiac Arrest, Altered State of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Enbrel
    Indication: Rheumatoid Arthritis
    Start date: 2010-11-22
    End date: 2011-01-21

Methotrexate
    Indication: Rheumatoid Arthritis
    Start date: 2010-04-01
    End date: 2010-04-01

Prednisone TAB
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2010-10-15
    End date: 2010-11-28

Prednisone TAB
    Administration route: Oral
    Start date: 2010-11-29
    End date: 2010-12-30

Methotrexate
    Administration route: Oral
    Start date: 2010-07-16
    End date: 2010-09-22

Novalgin
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-14
    End date: 2011-01-17

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-21
    End date: 2011-01-21

Methotrexate
    Administration route: Oral
    Start date: 2010-04-28
    End date: 2010-07-15

Arava
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2010-09-22
    End date: 2010-11-22

Other drugs received by patient: Furosemide; Aldactone



Possible Arava side effects in 62 year old male

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

Patient: 62 year old male, weighing 100.0 kg (220.0 pounds)

Reactions: Hyperthermia, Pain, Bundle Branch Block Left, Weight Increased, Syncope, Cardiac Failure, Ventricular Tachycardia, Amyloidosis, Ventricular Fibrillation, Cardiac Arrest, Altered State of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Novalgin
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-14
    End date: 2011-01-17

Methotrexate
    Start date: 2010-07-16
    End date: 2010-09-22

Enbrel
    Indication: Rheumatoid Arthritis
    Start date: 2010-11-22
    End date: 2011-01-21

Methotrexate
    Administration route: Oral
    Start date: 2010-04-28
    End date: 2010-07-15

Prednisone TAB
    Start date: 2010-11-29
    End date: 2010-12-30

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-21
    End date: 2011-01-21

Arava
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2010-09-22
    End date: 2010-11-22

Prednisone TAB
    Indication: Rheumatoid Arthritis
    Start date: 2010-10-15
    End date: 2010-11-28

Methotrexate
    Indication: Rheumatoid Arthritis
    Start date: 2010-04-01
    End date: 2010-04-01

Other drugs received by patient: Spironolactone; Furosemide



Possible Arava side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-12

Patient: 73 year old female

Reactions: Septic Shock, Clostridium Difficile Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arava
    Dosage: 10 mg, unk
    Indication: Rheumatoid Arthritis
    Start date: 2003-09-01
    End date: 2011-01-01

Etanercept
    Dosage: 50 mg, 1 in 1 wk
    Start date: 2012-01-06
    End date: 2012-01-01

Prednisone TAB
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1985-01-01

Pantoprazole Sodium
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2000-01-01

Other drugs received by patient: Spiriva; Ezetimibe; Metformin; Atorvastatin; Plavix; Zestoretic; Fluticasone; Lekovit CA



Possible Arava side effects in 56 year old female

Reported by a physician from Norway on 2012-03-08

Patient: 56 year old female

Reactions: Angioedema, Type I Hypersensitivity

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arava
    Dosage: 20 mg, 1x/day
    Indication: Rheumatoid Arthritis
    Start date: 2010-11-01
    End date: 2011-01-01

Orencia
    Dosage: 40 mg,
    Indication: Rheumatoid Arthritis
    Start date: 2008-05-01
    End date: 2010-08-01

Enbrel
    Dosage: 50 mg, weekly
    Indication: Rheumatoid Arthritis
    Start date: 2005-05-01
    End date: 2005-12-01

Other drugs received by patient: Lipitor; Inderal Retard; Calcigran Forte; Imovane; Imovane; Lipitor; Prednisolone; Inderal Retard; Inderal Retard; Aspirin



Possible Arava side effects in 56 year old female

Reported by a health professional (non-physician/pharmacist) from Norway on 2012-03-01

Patient: 56 year old female

Reactions: Rheumatoid Arthritis, Angioedema, Urticaria, Type I Hypersensitivity

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arava
    Dosage: 20 mg, 1x/day
    Indication: Rheumatoid Arthritis
    Start date: 2010-11-01
    End date: 2011-01-01

Orencia
    Dosage: 40 mg,
    Indication: Rheumatoid Arthritis
    Start date: 2008-05-01
    End date: 2010-08-01

Enbrel
    Dosage: 50 mg, weekly
    Indication: Rheumatoid Arthritis
    Start date: 2003-04-01
    End date: 2005-12-01

Other drugs received by patient: Inderal Retard; Prednisolone; Aspirin; Lipitor; Imovane; Prednisolone; Lipitor; Calcigran / 00434901 /; Imovane; Inderal Retard; Calcigran Forte



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

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

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

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



Possible Arava side effects in 56 year old female

Reported by a health professional (non-physician/pharmacist) from Norway on 2012-02-10

Patient: 56 year old female

Reactions: Rheumatoid Arthritis, Angioedema, Urticaria, Type I Hypersensitivity

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Orencia
    Dosage: 40 mg, unk
    Indication: Rheumatoid Arthritis
    Start date: 2008-05-01
    End date: 2010-08-01

Enbrel
    Dosage: 50 mg, qwk
    Indication: Rheumatoid Arthritis
    Start date: 2003-04-01

Arava
    Dosage: 20 mg, 1x/day
    Indication: Rheumatoid Arthritis
    Start date: 2010-11-01
    End date: 2011-01-01

Enbrel
    Dosage: 50 mg, qwk
    Start date: 2005-05-01
    End date: 2005-12-01

Other drugs received by patient: Lipitor; Aspirin; Imovane; Inderal Retard; Prednisolone; Calcigran / 00434901 /



Possible Arava side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-08

Patient: 68 year old female

Reactions: Peritoneal Abscess, Impaired Healing, Malnutrition, Diverticulitis, Infectious Peritonitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arava
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2008-01-01
    End date: 2011-09-25

Enbrel
    Dosage: 1 df, weekly
    Indication: Rheumatoid Arthritis
    Start date: 2008-01-01
    End date: 2011-09-27

Prednisone TAB
    Dosage: 13 mg, 1x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2008-01-01
    End date: 2011-09-27

Duoplavin
    Dosage: unk

Other drugs received by patient: Bisoprolol Biogaran; Lasix; Levothyroxine Sodium; Tramadol Biogaran; Ezetimibe



Possible Arava side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-03

Patient: 68 year old female

Reactions: Peritoneal Abscess, Impaired Healing, Diverticulitis, Malnutrition, Infectious Peritonitis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Arava
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2008-01-01
    End date: 2011-09-01

Etanercept
    Indication: Rheumatoid Arthritis
    Start date: 2008-01-01
    End date: 2011-09-27

Duoplavin

Ezetimibe

Prednisone TAB
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2008-01-01
    End date: 2011-09-27

Other drugs received by patient: Tramadol HCL; Lasix; Bisoprolol; Levothyroxine Sodium



Possible Arava side effects in 81 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-29

Patient: 81 year old female

Reactions: Ovarian Epithelial Cancer

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Methotrexate
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2003-01-01
    End date: 2009-01-01

Arava
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2009-04-01
    End date: 2010-10-01

Sulfasalazine
    Indication: Rheumatoid Arthritis



Possible Arava side effects in 81 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-22

Patient: 81 year old female

Reactions: Drug Ineffective, Drug Intolerance, Ovarian Epithelial Cancer

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Arava
    Dosage: unk
    Indication: Rheumatoid Arthritis

Sulfasalazine
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 1991-01-01

Humira
    Dosage: 40 mg, every 15 days
    Indication: Rheumatoid Arthritis
    Start date: 2009-04-01
    End date: 2010-10-01

Methotrexate Sodium
    Dosage: unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2003-01-01
    End date: 2009-01-01



Possible Arava side effects in 63 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2011-12-02

Patient: 63 year old male

Reactions: Cardiovascular Disorder, Respiratory Distress, Infusion Related Reaction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Methotrexate
    Start date: 1989-10-01

Abatacept
    Start date: 2010-12-01
    End date: 2010-12-01

Arava



Possible Arava side effects in 43 year old female

Reported by a physician from Germany on 2011-12-01

Patient: 43 year old female, weighing 76.0 kg (167.2 pounds)

Reactions: Multi-Organ Failure, Breast Abscess, Streptococcal Sepsis, Toxic Shock Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arava
    Dosage: 20 mg, qd
    Indication: Rheumatoid Arthritis
    End date: 2011-05-01

Enbrel
    Dosage: 50 mg, unk
    Indication: Rheumatoid Arthritis
    Start date: 2011-02-14
    End date: 2011-05-01



Possible Arava side effects in 57 year old female

Reported by a physician from Japan on 2011-11-09

Patient: 57 year old female

Reactions: Pancreatitis Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Orencia
    Dosage: 13th dose on 07-oct-2011.
    Indication: Rheumatoid Arthritis
    Start date: 2010-11-26
    End date: 2011-01-01

Arava
    Administration route: Oral

Other drugs received by patient: Baraclude; Steroids; Loxonin



Possible Arava side effects in 57 year old female

Reported by a consumer/non-health professional from Japan on 2011-11-01

Patient: 57 year old female

Reactions: Pancreatitis Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Orencia
    Dosage: 13th dose on 07-oct-2011.
    Indication: Rheumatoid Arthritis
    End date: 2011-01-01

Arava
    Administration route: Oral

Other drugs received by patient: Steroids; Loxonin; Baraclude



Possible Arava side effects in 32 year old female

Reported by a physician from Germany on 2011-10-21

Patient: 32 year old female

Reactions: Pneumonia Fungal, Subcutaneous Abscess, Pain, Chills, Pancytopenia, Osteomyelitis, Tonsillitis, Oropharyngeal Pain, Pyrexia, Tooth Infection, Diarrhoea, Haematoma Infection, Bone Marrow Failure, Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arava

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