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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:
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 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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