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Index of reports
> Disability (15)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Arava (Leflunomide) disability. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Arava side effects in female
Reported by a physician from Germany on 2012-08-01
Patient: female
Reactions: Gamma-Glutamyltransferase Increased, Alanine Aminotransferase Increased, Liver Function Test Abnormal, Aspartate Aminotransferase Increased
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
End date: 2012-06-05
Mabthera
Indication: Rheumatoid Arthritis
Start date: 2012-06-01
End date: 2012-06-15
Actonel
Administration route: Oral
Indication: Osteoporosis
Start date: 2012-05-26
End date: 2012-06-15
Other drugs received by patient: Ramipril; Doss (Germany); Nitrepress; Metoprolol Tartrate; Prednisolone; Colestyramin; Tilidine; Moxonidin; Ramipril; Levothyroxine Sodium
Possible Arava side effects in 34 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-06-28
Patient: 34 year old female
Reactions: Abnormal Product of Conception, Maternal Exposure During Pregnancy
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Hydroxychloroquine Sulfate; Levothroid
Possible Arava side effects in 59 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-08
Patient: 59 year old female, weighing 62.0 kg (136.4 pounds)
Reactions: Rheumatoid Arthritis, RED Blood Cell Sedimentation Rate Increased
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Enbrel
Dosage: unk
Indication: Rheumatoid Arthritis
Start date: 2011-04-01
Simponi
Dosage: unk
Start date: 2011-11-10
Arava
Dosage: 20 mg, unk
Start date: 2002-10-10
End date: 2012-01-01
Possible Arava side effects in 57 year old female
Reported by a consumer/non-health professional from Mexico on 2012-06-05
Patient: 57 year old female, weighing 49.0 kg (107.8 pounds)
Reactions: Patient-Device Incompatibility, Wound Dehiscence, Condition Aggravated, Transplant Rejection, Osteomyelitis
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2009-01-01
Ketoprofen
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2009-01-01
Other drugs received by patient: Antibiotics
Possible Arava side effects in 72 year old female
Reported by a physician from Germany on 2012-05-18
Patient: 72 year old female, weighing 80.0 kg (176.0 pounds)
Reactions: Enterocolitis Bacterial, Gastroenteritis Rotavirus, Pancytopenia, Bone Marrow Toxicity, Hepatic Cirrhosis
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Arava
Dosage: 10 mg, 1x/day
Administration route: Oral
Arava
Dosage: 20 mg, 3x/week
Administration route: Oral
Start date: 2011-01-03
End date: 2011-01-01
Arava
Dosage: 20 mg, 1x/day
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-08-01
End date: 2011-01-02
Etanercept
Dosage: 50 mg, qwk
Indication: Rheumatoid Arthritis
Start date: 2010-08-30
End date: 2011-06-20
Other drugs received by patient: Alendronate Sodium; Metoprolol; Levothyroxine Sodium; Dekristol; Mabthera
Possible Arava side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-04-12
Patient: 69 year old female
Reactions: Excoriation, Erythema, C-Reactive Protein Increased, Arthralgia, Skin Lesion, Oedema Peripheral, Arthritis, RED Blood Cell Sedimentation Rate Increased, Mobility Decreased, Infective Tenosynovitis
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Methotrexate
Indication: Rheumatoid Arthritis
Methotrexate
Administration route: Oral
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Other drugs received by patient: Hydroxychloroquine Sulfate
Possible Arava side effects in 53 year old female
Reported by a consumer/non-health professional from Mexico on 2012-04-11
Patient: 53 year old female, weighing 71.0 kg (156.2 pounds)
Reactions: Cataract, Anaemia, Vision Blurred
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Aralen
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
Deflazacort
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2007-01-01
Possible Arava side effects in 72 year old female
Reported by a physician from Germany on 2012-04-10
Patient: 72 year old female, weighing 80.0 kg (176.0 pounds)
Reactions: Enterocolitis Bacterial, Gastroenteritis Rotavirus, Pancytopenia, Bone Marrow Toxicity, Hepatic Cirrhosis
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Etanercept
Dosage: 50 mg, qwk
Indication: Rheumatoid Arthritis
Start date: 2010-08-30
Arava
Dosage: 20 mg, 1x/day
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-08-01
End date: 2011-01-02
Arava
Dosage: 20 mg, 3x/week
Administration route: Oral
Start date: 2011-01-03
End date: 2011-01-01
Arava
Dosage: 10 mg, 1x/day
Administration route: Oral
Other drugs received by patient: Alendronate Sodium; Mabthera; Dekristol; Levothyroxine Sodium; Metoprolol Tartrate
Possible Arava side effects in 72 year old female
Reported by a physician from Germany on 2012-04-03
Patient: 72 year old female, weighing 80.0 kg (176.0 pounds)
Reactions: Enterocolitis Bacterial, Gastroenteritis Rotavirus, Urinary Tract Infection, Pancytopenia, Bone Marrow Toxicity, Leukopenia, Hepatic Cirrhosis
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Arava
Administration route: Oral
Start date: 2011-01-01
End date: 2011-01-01
Etanercept
Indication: Rheumatoid Arthritis
Start date: 2010-08-30
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-08-01
End date: 2011-01-02
Arava
Administration route: Oral
Start date: 2011-01-03
Other drugs received by patient: Mabthera; Dekristol; Levothyroxine Sodium; Metoprolol Tartrate; Alendronate Sodium
Possible Arava side effects in 72 year old female
Reported by a physician from Germany on 2012-03-30
Patient: 72 year old female, weighing 80.0 kg (176.0 pounds)
Reactions: Enterocolitis Bacterial, Gastroenteritis Rotavirus, Pancytopenia, Bone Marrow Toxicity, Hepatic Cirrhosis
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Arava
Dosage: 20 mg, 3x/week
Administration route: Oral
Start date: 2011-01-03
End date: 2011-01-01
Arava
Dosage: 20 mg, 1x/day
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-08-01
End date: 2011-01-02
Arava
Dosage: 10 mg, 1x/day
Administration route: Oral
Etanercept
Dosage: 50 mg, qwk
Indication: Rheumatoid Arthritis
Start date: 2010-08-30
Other drugs received by patient: Alendronate Sodium; Levothyroxine Sodium; Dekristol; Metoprolol Succinate; Mabthera
Possible Arava side effects in 72 year old female
Reported by a physician from Germany on 2012-03-30
Patient: 72 year old female, weighing 80.0 kg (176.0 pounds)
Reactions: Enterocolitis Bacterial, Gastroenteritis Rotavirus, Pancytopenia, Bone Marrow Toxicity, Hepatic Cirrhosis
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Etanercept
Dosage: 50 mg, qwk
Indication: Rheumatoid Arthritis
Start date: 2010-08-30
Arava
Dosage: 20 mg, 3x/week
Administration route: Oral
Start date: 2011-01-03
End date: 2011-01-01
Arava
Dosage: 20 mg, 1x/day
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-08-01
End date: 2011-01-02
Arava
Dosage: 10 mg, 1x/day
Administration route: Oral
Other drugs received by patient: Mabthera; Levothyroxine Sodium; Metoprolol Succinate; Alendronate Sodium; Dekristol
Possible Arava side effects in 53 year old female
Reported by a consumer/non-health professional from Mexico on 2012-03-23
Patient: 53 year old female, weighing 71.0 kg (156.2 pounds)
Reactions: Cataract, Anaemia, Vision Blurred
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Deflazacort
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2007-01-01
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
Aralen
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
Possible Arava side effects in 62 year old female
Reported by a physician from Spain on 2012-03-01
Patient: 62 year old female, weighing 60.0 kg (132.0 pounds)
Reactions: Osteonecrosis, Oral Cavity Fistula
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Arava
Possible Arava side effects in 51 year old female
Reported by a consumer/non-health professional from Mexico on 2011-11-07
Patient: 51 year old female
Reactions: Arthralgia, Muscular Weakness, Dysaesthesia, Paraesthesia
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Malival Compuesto; Methotrexate; Azulfidine; Aminosalicylic Acid
Possible Arava side effects in 64 year old female
Reported by a consumer/non-health professional from Mexico on 2011-10-20
Patient: 64 year old female, weighing 65.0 kg (143.0 pounds)
Reactions: Malaise, Type 2 Diabetes Mellitus, Arthralgia, Nausea, Rash
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Arava
Administration route: Oral
Start date: 2009-01-01
Calcort
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2005-01-01
End date: 2011-04-01
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2001-01-01
End date: 2009-01-01
Other drugs received by patient: Prednisone; Methotrexate
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