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Arava (Leflunomide) - Disability - Suspected Cause - Side Effect Reports

 
 



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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