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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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