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Index of reports
> Cases with Pyrexia (20)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Arava (Leflunomide) where reactions include pyrexia. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Arava side effects in 73 year old male
Reported by a physician from Finland on 2012-08-06
Patient: 73 year old male
Reactions: Lymphocytosis, Interstitial Lung Disease, Pulmonary Eosinophilia, Pyrexia, Cough
Drug(s) suspected as cause:
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1996-11-20
End date: 2012-05-07
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2011-11-01
End date: 2012-05-22
Other drugs received by patient: Folic Acid; Acetylsalicylic Acid SRT; Calcium Carbonate; Eprosartan Mesilate / Hydrochlorothiazide
Possible Arava side effects in 53 year old male
Reported by a consumer/non-health professional from Poland on 2012-06-14
Patient: 53 year old male, weighing 70.0 kg (154.0 pounds)
Reactions: Multi-Organ Failure, Respiratory Failure, Pyrexia, Bursitis, Infection
Adverse event resulted in: death
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Methylprednisolone; Glucocorticoids
Possible Arava side effects in 72 year old female
Reported by a physician from Turkey on 2012-05-25
Patient: 72 year old female, weighing 40.0 kg (88.0 pounds)
Reactions: Incorrect Dose Administered, Pharyngeal Ulceration, Depressed Level of Consciousness, Neutropenia, Pyrexia, Toxicity To Various Agents, Thrombocytopenia, Leukopenia, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Dosage: drug taken from: arava treatment started 3-4 yrs ago therefore captured as unknown.
Administration route: Oral
Indication: Rheumatoid Arthritis
Arava
Dosage: dose: patient sometimes took the drug two times in a day.
Administration route: Oral
End date: 2012-01-01
Possible Arava side effects in 65 year old female
Reported by a physician from Turkey on 2012-05-11
Patient: 65 year old female, weighing 40.0 kg (88.0 pounds)
Reactions: Incorrect Dose Administered, Depressed Level of Consciousness, Pharyngeal Ulceration, Neutropenia, Toxicity To Various Agents, Pyrexia, Thrombocytopenia, Leukopenia, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Dosage: drug taken from: arava treatment started 3-4 yrs ago therefore captured as unknown.
Administration route: Oral
Indication: Rheumatoid Arthritis
Arava
Dosage: dose: patient sometimes took the drug two times in a day.
Administration route: Oral
Possible Arava side effects in male
Reported by a physician from Brazil on 2012-05-02
Patient: male
Reactions: Abdominal Pain, Dyspnoea, Ultrasound Liver Abnormal, Pyrexia, Staphylococcal Sepsis, Diverticulum Intestinal, Ascites, Liver Disorder, Fatigue, Gallbladder Disorder, Proteus Infection, Decreased Appetite, Cough, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Indication: Product Used FOR Unknown Indication
End date: 2011-11-01
Methotrexate
Dosage: 20 mg per week
Indication: Product Used FOR Unknown Indication
Humira
Indication: Rheumatoid Arthritis
Start date: 2011-03-26
End date: 2011-11-01
Possible Arava side effects in 63 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-04-26
Patient: 63 year old male, weighing 95.0 kg (209.0 pounds)
Reactions: Malaise, Induration, Pyrexia, Necrotising Fasciitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2009-06-01
End date: 2011-06-23
Etanercept
Indication: Rheumatoid Arthritis
Start date: 2009-06-01
End date: 2011-06-23
Other drugs received by patient: Valsartan and Hydrochlorothiazide; Omeprazole; Calcium Carbonate
Possible Arava side effects in 30 year old female
Reported by a physician from France on 2012-04-13
Patient: 30 year old female, weighing 59.0 kg (129.8 pounds)
Reactions: Abdominal Pain, Diarrhoea, Crohn's Disease, Condition Aggravated, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Prednisone TAB; Diclofenac Sodium
Possible Arava side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-11
Patient: male
Reactions: Fatigue, Diarrhoea, Dehydration, Pyrexia, Asthenia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Dosage: 20 mg, unk
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2002-01-01
End date: 2011-01-01
Naproxen Sodium
Dosage: 20 mg, unk
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2006-01-01
End date: 2011-01-01
Possible Arava side effects in male
Reported by a physician from Germany on 2012-04-11
Patient: male
Reactions: Fatigue, Diarrhoea, Dehydration, Pyrexia, Asthenia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2002-01-01
End date: 2011-01-01
Naproxen
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2006-01-01
End date: 2011-01-01
Possible Arava side effects in male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-04
Patient: male
Reactions: Fatigue, Diarrhoea, Dehydration, Pyrexia, Asthenia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Dosage: daily dose: 20 mg millgram(s) every days
Administration route: Oral
Start date: 2006-01-01
End date: 2011-01-01
Arava
Dosage: daily dose: 20 mg millgram(s) every days
Administration route: Oral
Start date: 2006-01-01
End date: 2011-01-01
Possible Arava side effects in male
Reported by a consumer/non-health professional from Germany on 2012-04-03
Patient: male
Reactions: Fatigue, Diarrhoea, Dehydration, Pyrexia, Asthenia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen Sodium
Dosage: 20 mg, qd
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2006-01-01
End date: 2011-01-01
Arava
Dosage: 20 mg, qd
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2006-01-01
End date: 2011-01-01
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 female
Reported by a pharmacist from Brazil on 2012-03-10
Patient: female, weighing 61.0 kg (134.2 pounds)
Reactions: Weight Decreased, Respiratory Disorder, Pyrexia, X-RAY Abnormal, Arthropathy, Asthenia, Decreased Appetite, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2012-01-09
Arava
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Acetaminophen; Methotrexate; Prednisone; Methotrexate; Alginac
Possible Arava side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-02-22
Patient: female, weighing 61.0 kg (134.2 pounds)
Reactions: Weight Decreased, Respiratory Disorder, Pyrexia, Asthenia, Decreased Appetite, Cough, X-RAY Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2012-01-09
Arava
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Alginac; Methotrexate; Methotrexate; Acetaminophen; Prednisone
Possible Arava side effects in 75 year old male
Reported by a pharmacist from France on 2012-01-13
Patient: 75 year old male, weighing 80.0 kg (176.0 pounds)
Reactions: Weight Decreased, Chills, Anaemia, General Physical Health Deterioration, Purpura, Pyrexia, non-Hodgkin's Lymphoma, Sinusitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Indapamide; Acetaminophen; Tadenan; Ibuprofen; Perindopril; Nebivolol HCL; Chondrosulf; Levothyroxine Sodium; Vastarel ^biopharma^; Miorel
Possible Arava side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-01-03
Patient: female, weighing 64.0 kg (140.8 pounds)
Reactions: Injection Site Discolouration, Weight Decreased, Urticaria, Tachycardia, Wound, Vulvovaginal Erythema, Pyrexia, Photopsia, Vulvovaginal Pruritus, Perianal Erythema, Vomiting, Stomatitis, Dyspnoea, Nausea, Injection Site Pain, Haematochezia, Diarrhoea, Vulvovaginal Swelling, Rectal Discharge
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2011-11-28
Arava
Indication: Arthritis
End date: 2011-11-28
Other drugs received by patient: Cinnarizine; Hydrochlorothiazide; Omeprazole; Hydrochlorothiazide; Enalapril Maleate; Fluticasone Propionate / Salmeterol; Amitriptyline HCL; Acetylsalicylic Acid SRT; Insulin; Nimesilide; Methotrexate; Digoxin
Possible Arava side effects in female
Reported by a consumer/non-health professional from Brazil on 2011-12-21
Patient: female, weighing 64.0 kg (140.8 pounds)
Reactions: Weight Decreased, Injection Site Discolouration, Vomiting, Stomatitis, Dyspnoea, Nausea, Wound, Tachycardia, Injection Site Pain, Pyrexia, Vulvovaginal Erythema, Haematochezia, Diarrhoea, Vulvovaginal Swelling, Vulvovaginal Pruritus
Drug(s) suspected as cause:
Arava
Indication: Arthritis
End date: 2011-11-28
Humira
Indication: Rheumatoid Arthritis
Start date: 2011-11-28
Other drugs received by patient: Omeprazole; Methotrexate; Nimesilide; Acetylsalicylic Acid SRT; Digoxin; Enalapril Maleate; Insulin; Amitriptyline HCL; Hydrochlorothiazide; Cinnarizine; Fluticasone Propionate / Salmeterol; Hydrochlorothiazide
Possible Arava side effects in female
Reported by a physician from South Africa on 2011-12-05
Patient: female
Reactions: Arthralgia, Pyrexia, Headache, Oropharyngeal Pain, Tendonitis, Erythema, Infusion Related Reaction
Drug(s) suspected as cause:
Revellex
Dosage: patient's first infusion and the infusion rate was 40ml/hr
Indication: Juvenile Arthritis
Start date: 2011-11-16
Arava
Indication: Product Used FOR Unknown Indication
Cortisone Acetate
Indication: Product Used FOR Unknown Indication
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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