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Arava (Leflunomide) - Drug Ineffective - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Drug Ineffective ()

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

Possible Arava side effects in male

Reported by a physician from Australia on 2012-06-12

Patient: male

Reactions: Inappropriate Schedule of Drug Administration, Drug Ineffective, Pain, Folliculitis, Incorrect Dose Administered, Psoriasis, Post-Traumatic Stress Disorder, Malaise, Arthralgia, Mental Disorder

Drug(s) suspected as cause:
Humira
    Indication: Psoriasis

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2011-08-01

Arava
    Indication: Psoriasis

Humira
    Indication: Psoriatic Arthropathy



Possible Arava side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-05-21

Patient: female, weighing 53.0 kg (116.6 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Dyspnoea, Drug Ineffective, Drug Hypersensitivity, Pain, Abdominal Pain Upper, Weight Increased, Gastrointestinal Pain, Incorrect Drug Administration Duration, Malaise, Palpitations, Insomnia, Gait Disturbance, Breast Inflammation, Infusion Related Reaction, Inflammation

Drug(s) suspected as cause:
Arava
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-01
    End date: 2011-10-01

Remicade
    Start date: 2012-03-01

Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2006-10-01

Remicade
    Start date: 2011-01-01

Other drugs received by patient: Amytril; Prednisone; Dipyrone TAB; Omeprazole; Acetaminophen; Methotrexate



Possible Arava side effects in 54 year old male

Reported by a physician from France on 2012-02-15

Patient: 54 year old male

Reactions: Drug Ineffective, Retinal Vasculitis, Bladder Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra
    Indication: Rheumatoid Arthritis

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2004-11-01
    End date: 2004-12-01

Humira

Solu-Medrol
    Indication: Product Used FOR Unknown Indication
    Start date: 2004-12-01

Mabthera
    Indication: Rheumatoid Arthritis
    Start date: 2007-02-01
    End date: 2011-02-01

Enbrel
    Indication: Rheumatoid Arthritis
    Start date: 2004-03-01
    End date: 2004-10-01

Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2005-05-26
    End date: 2006-12-11

Arava
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-04-01
    End date: 2007-01-01

Cyclophosphamide
    Indication: Retinal Vasculitis
    Start date: 2004-12-01
    End date: 2005-05-27

Other drugs received by patient: Prednisone TAB; Methotrexate Sodium



Possible Arava side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-28

Patient: female, weighing 50.8 kg (111.9 pounds)

Reactions: Osteoarthritis, Drug Resistance, Arthralgia, Drug Ineffective

Drug(s) suspected as cause:
Arava
    Indication: Psoriatic Arthropathy

Enbrel
    Indication: Psoriatic Arthropathy
    Start date: 2010-11-01
    End date: 2011-03-01

Humira
    Indication: Psoriatic Arthropathy
    Start date: 2009-11-01
    End date: 2010-11-01

Humira
    Start date: 2011-03-01

Other drugs received by patient: Crestor; Synthroid



Possible Arava side effects in male

Reported by a physician from France on 2012-01-12

Patient: male

Reactions: Bone Density Increased, Femur Fracture, Drug Ineffective, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arava
    Dosage: from 24-jun to sep not stated and 20mg/d since sep-2008.
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2008-01-24
    End date: 2008-12-03

Tramadol HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-10-01

Actonel
    End date: 2011-07-01

Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-27

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

Pantoprazole
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-09-01

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2008-05-29
    End date: 2009-03-01

Boniva
    Administration route: Oral
    Indication: Osteoporosis Prophylaxis
    Start date: 2009-09-01
    End date: 2011-03-01

Pantoprazole Sodium
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2007-09-01

Sotalol HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-01-01

Doxazosin Mesylate
    Administration route: Oral
    Indication: Prostatic Adenoma
    Start date: 2008-10-01

Actonel
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2004-08-01
    End date: 2007-01-01

Methotrexate
    Administration route: Oral
    Start date: 2009-03-05

Humira
    Start date: 2009-03-05
    End date: 2011-01-01

Prednisone TAB
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2003-10-01
    End date: 2007-01-01

Prednisone TAB
    Administration route: Oral
    Start date: 2009-03-05

Nexium
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2006-01-01
    End date: 2007-09-01

Methotrexate
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2006-12-01
    End date: 2008-01-24

Cartrex
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-09-01

Other drugs received by patient: Calcium Carbonate



Possible Arava side effects in male

Reported by a physician from France on 2012-01-11

Patient: male

Reactions: Bone Density Increased, Femur Fracture, Drug Ineffective, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Rheumatoid Arthritis
    Start date: 2008-05-29
    End date: 2009-03-01

Actonel
    End date: 2011-07-01

Methotrexate
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2006-12-01
    End date: 2008-01-24

Methotrexate
    Administration route: Oral
    Start date: 2009-03-05

Humira
    Start date: 2009-03-05
    End date: 2011-01-01

Boniva
    Administration route: Oral
    Indication: Osteoporosis Prophylaxis
    Start date: 2009-09-01
    End date: 2011-03-01

Cartrex
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-09-01

Pantoprazole Sodium
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2007-09-01

Actonel
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2004-08-01
    End date: 2007-01-01

Nexium
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2006-01-01
    End date: 2007-09-01

Prednisone TAB
    Administration route: Oral
    Start date: 2009-03-05

Arava
    Dosage: from 24-jun to sep not stated and 20mg/d since sep-2008.
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2008-01-24
    End date: 2008-12-03

Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-27

Pantoprazole
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-09-01

Prednisone TAB
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2003-10-01
    End date: 2007-01-01

Sotalol HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-01-01

Doxazosin Mesylate
    Administration route: Oral
    Indication: Prostatic Adenoma
    Start date: 2008-10-01

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

Tramadol HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-10-01

Other drugs received by patient: Calcium Carbonate



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 female

Reported by a consumer/non-health professional from Brazil on 2011-11-14

Patient: female, weighing 66.0 kg (145.2 pounds)

Reactions: Weight Decreased, Vomiting, Drug Ineffective, Hepatitis, Hepatic Steatosis, Rheumatoid Arthritis, Hepatomegaly, Diarrhoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prednisone TAB
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Arava
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2007-01-01
    End date: 2010-12-01

Diclofenac Sodium
    Indication: Product Used FOR Unknown Indication

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