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

 
 



Index of reports > Cases with Pancytopenia (15)

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

Possible Arava side effects in 70 year old female

Reported by a physician from Israel on 2012-08-13

Patient: 70 year old female

Reactions: Intestinal Perforation, Anaemia, Sepsis, Pancytopenia, Febrile Neutropenia, Platelet Count Decreased, Neutrophil Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Arava

Other drugs received by patient: Prednisone TAB; Methotrexate



Possible Arava side effects in 70 year old female

Reported by a physician from Israel on 2012-08-08

Patient: 70 year old female

Reactions: Intestinal Perforation, Anaemia, Platelet Count Decreased, Pancytopenia, Neutrophil Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Arava

Other drugs received by patient: Methotrexate; Prednisone



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 female

Reported by a physician from Spain on 2012-05-17

Patient: female, weighing 56.0 kg (123.2 pounds)

Reactions: Pancytopenia, Herpes Zoster

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra
    Dosage: starting dose: 8 mg/kg
    Start date: 2011-07-28

Arava
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2006-11-10

Actemra
    Dosage: starting dose: 8 mg/kg
    Start date: 2011-08-24

Actemra
    End date: 2011-10-26

Actemra
    Dosage: starting dose: 8 mg/kg
    Indication: Rheumatoid Arthritis
    Start date: 2011-05-31

Actemra
    Dosage: starting dose: 8 mg/kg
    Start date: 2011-09-26

Other drugs received by patient: Hydroxychloroquine Sulfate; Enalapril Maleate; Methylprednisolone; Isoniazid; Omeprazole; Hydroxychloroquine Sulfate



Possible Arava side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-14

Patient: male

Reactions: Pancytopenia, Rash, Rheumatoid Arthritis, Malaise, Acute Respiratory Distress Syndrome, Lung Infiltration, Hypertension, Renal Failure Acute, Pneumonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methotrexate Sodium
    Dosage: unk

Arava
    Dosage: unk

Catapres
    Dosage: unk

Other drugs received by patient: Protonix; Folic Acid; Prednisone; Multi-Vitamins; Levaquin; Diflucan; Metronidazole



Possible Arava side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-25

Patient: male

Reactions: Pancytopenia, Rash

Drug(s) suspected as cause:
Catapres
    Dosage: unk

Methotrexate Sodium
    Dosage: unk

Arava
    Dosage: unk



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:
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 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 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 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 70 year old female

Reported by a physician from Israel on 2012-02-10

Patient: 70 year old female

Reactions: Intestinal Perforation, Anaemia, Pancytopenia, Platelet Count Decreased, Neutrophil Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arava

Other drugs received by patient: Prednisone TAB; Methotrexate



Possible Arava side effects in 70 year old female

Reported by a physician from Israel on 2012-02-03

Patient: 70 year old female

Reactions: Intestinal Perforation, Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arava

Other drugs received by patient: Methotrexate



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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