Index of reports
> Serious Reactions (209)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Arava (Leflunomide) serious reactions. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 209 Next >>
Possible Arava side effects in female
Reported by a physician from Brazil on 2012-08-21
Patient: female
Reactions: Hepatotoxicity
Drug(s) suspected as cause:
Arava
Indication: Rheumatoid Arthritis
Methotrexate
Indication: Rheumatoid Arthritis
Possible Arava side effects in 72 year old female
Reported by a physician from Canada on 2012-08-21
Patient: 72 year old female
Reactions: Abdominal Pain, Weight Decreased, Tinnitus, Onychoclasis, Vomiting, Nausea, Urinary Tract Infection, Bursitis, Intestinal Obstruction, Wound Complication, Haemoglobin Decreased, Diarrhoea, Visual Impairment, Sleep Apnoea Syndrome, Asthenia, Inflammation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Cymbalta
Dilaudid
Lyrica
Dosage: also taken 150mg
Orencia
Dosage: lastdose20oct11,15dec11,16dec11,7feb12,6mar12,13jul12 inf:11,57-500mg-q4wk,exp:ma2014,sep14
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
Prednisone TAB
Dosage: also taken 15 mg
Other drugs received by patient: Nexium; Hydromorphone Hydrochloride; Alendronate Sodium; Pramipexole Dihydrochloride; Calcium; Atenolol; Acetaminophen; Oxybutynin; Amiloride Hydrochloride; Calcitonin Salmon; Naproxen
Possible Arava side effects in 55 year old female
Reported by a physician from Germany on 2012-08-20
Patient: 55 year old female
Reactions: Rheumatoid Arthritis, Dyshidrosis, Fatigue, Chills, Empyema, Rash, Synovial Cyst
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Dosage: daily
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2006-10-01
End date: 2011-01-01
Humira
Indication: Rheumatoid Arthritis
Start date: 2011-02-01
End date: 2011-04-17
Tocilizumab
Dosage: total 636mg
Indication: Rheumatoid Arthritis
Other drugs received by patient: Tocilizumab; Pantoprazole; Leflunomide; Pantoprazole; Arcoxia; Novalgin; Prednisolone
Possible Arava side effects in 33 year old female
Reported by a physician from Turkey on 2012-08-17
Patient: 33 year old female, weighing 70.0 kg (154.0 pounds)
Reactions: Foetal Death
Drug(s) suspected as cause:
Arava
Possible Arava side effects in 76 year old female
Reported by a consumer/non-health professional from NEW Zealand on 2012-08-13
Patient: 76 year old female
Reactions: Transient Ischaemic Attack
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Prednisone TAB; Methotrexate; Ondansetron; Folic Acid
Possible Arava side effects in 64 year old female
Reported by a consumer/non-health professional from Australia on 2012-08-13
Patient: 64 year old female
Reactions: Breast Cancer, Breast Cancer Female
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Magnesium; Mobic; Calcium Carbonate; ALL Other Therapeutic Products; ALL Other Therapeutic Products; Pantoprazole
Possible Arava side effects in 13 year old female
Reported by a consumer/non-health professional from Brazil on 2012-08-13
Patient: 13 year old female, weighing 45.0 kg (99.0 pounds)
Reactions: Drug-Induced Liver Injury
Drug(s) suspected as cause:
Arava
Possible Arava side effects in 33 year old female
Reported by a physician from Turkey on 2012-08-13
Patient: 33 year old female, weighing 70.0 kg (154.0 pounds)
Reactions: Death Neonatal
Drug(s) suspected as cause:
Arava
Possible Arava side effects in 64 year old female
Reported by a consumer/non-health professional from Mexico on 2012-08-13
Patient: 64 year old female
Reactions: Hypercholesterolaemia, Inappropriate Schedule of Drug Administration, Calcium Metabolism Disorder, Surgery, Wound Dehiscence, Hyperglycaemia, Hypertension
Drug(s) suspected as cause:
Arava
Administration route: Oral
Start date: 2012-02-01
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2002-01-01
End date: 2012-02-01
Other drugs received by patient: Methotrexate; Celebrex
Possible Arava side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-10
Patient: 72 year old female
Reactions: Abdominal Pain, Weight Decreased, Vomiting, Tinnitus, Nausea, Urinary Tract Infection, Bursitis, Wound Complication, Haemoglobin Decreased, Diarrhoea, Visual Impairment, Onychoclasis, Sleep Apnoea Syndrome, Asthenia, Inflammation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Cymbalta
Dilaudid
Lyrica
Dosage: also taken 150mg
Orencia
Dosage: last dose20oct11,15dec11,16dec11,7feb12,6mar12,13jul12 inf:11,57-500mg-also every 4 week,exp:ma2014
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
Prednisone TAB
Dosage: also taken 15 mg
Other drugs received by patient: Nexium; Calcium; Amiloride Hydrochloride; Calcitonin Salmon; Hydromorphone Hydrochloride; Acetaminophen; Oxybutynin Chloride; Atenolol; Alendronate Sodium; Naproxen; Pramipexole Dihydrochloride
Possible Arava side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-09
Patient: female, weighing 66.2 kg (145.7 pounds)
Reactions: Photosensitivity Reaction, Incisional Drainage, Nightmare, Drug Effect Decreased, Nausea, Implant Site Pain, Meningitis Chemical, Incision Site Haemorrhage, Scar
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-04-01
End date: 2012-06-01
Medrol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-01
Remicade
Start date: 2012-07-01
Remicade
Dosage: once a month
Indication: Rheumatoid Arthritis
Start date: 2011-04-01
Possible Arava side effects in 13 year old female
Reported by a consumer/non-health professional from Brazil on 2012-08-08
Patient: 13 year old female, weighing 45.0 kg (99.0 pounds)
Reactions: Drug-Induced Liver Injury
Drug(s) suspected as cause:
Arava
Dosage: unk
Enbrel
Dosage: 25 mg, 2x/week
Indication: Juvenile Arthritis
End date: 2012-07-01
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:
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2011-11-01
End date: 2012-05-22
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1996-11-20
End date: 2012-05-07
Other drugs received by patient: Folic Acid; Acetylsalicylic Acid SRT; Calcium Carbonate; Eprosartan Mesilate / Hydrochlorothiazide
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:
Actonel
Administration route: Oral
Indication: Osteoporosis
Start date: 2012-05-26
End date: 2012-06-15
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
Other drugs received by patient: Ramipril; Doss (Germany); Nitrepress; Metoprolol Tartrate; Prednisolone; Colestyramin; Tilidine; Moxonidin; Ramipril; Levothyroxine Sodium
Possible Arava side effects in 66 year old female
Reported by a physician from Australia on 2012-07-31
Patient: 66 year old female
Reactions: Haemoglobin Decreased, Gastric Ulcer, Gastric Haemorrhage, Large Intestinal Haemorrhage
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Aspirin
Possible Arava side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: female, weighing 109.0 kg (239.7 pounds)
Reactions: Pneumonia, Tachycardia, Dehydration, Vertigo, Bronchitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Indication: Rheumatoid Arthritis
Start date: 2011-11-01
End date: 2011-12-01
Humira
Indication: Rheumatoid Arthritis
Start date: 2010-11-01
End date: 2011-11-01
Other drugs received by patient: Celebrex; Enbrel; Flexeril; Multiple Vitamin; Methotrexate; Tramadol Hydrochloride; Diltiazem; Aspirin; Spiriva; Elavil
Possible Arava side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: female, weighing 66.2 kg (145.7 pounds)
Reactions: Photosensitivity Reaction, Nightmare, Drug Effect Decreased, Incisional Drainage, Nausea, Implant Site Pain, Meningitis Chemical, Incision Site Haemorrhage, Scar
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-04-01
End date: 2012-06-01
Medrol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-01
Remicade
Start date: 2012-07-01
Remicade
Dosage: once a month
Start date: 2011-04-01
Remicade
Indication: Rheumatoid Arthritis
Start date: 2011-04-01
Possible Arava side effects in 73 year old female
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: 73 year old female, weighing 47.7 kg (104.9 pounds)
Reactions: Death, Weight Decreased, Abdominal Pain, Diarrhoea, Pulmonary Oedema, Asthenia
Adverse event resulted in: death
Drug(s) suspected as cause:
Arava
Administration route: Oral
Start date: 2012-04-01
End date: 2012-04-17
Arava
Administration route: Oral
Start date: 2012-04-25
End date: 2012-05-26
Arava
Administration route: Oral
Start date: 2012-04-01
End date: 2012-04-17
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2012-03-22
End date: 2012-04-01
Arava
Administration route: Oral
Indication: Pulmonary Fibrosis
Start date: 2012-03-22
End date: 2012-04-01
Arava
Administration route: Oral
Start date: 2012-04-25
End date: 2012-05-26
Other drugs received by patient: Evista; Nasal Saline; Vitamin B-12; Fluticasone Propionate; Prednisone; Budesonide / Formoterol; ALL Other Therapeutic Products; Mobic; Plaquenil; Vitamin D; Hydrochlorothiazide / Losartan Potassium; ALL Other Therapeutic Products; ALL Other Therapeutic Products
Possible Arava side effects in 56 year old
Reported by a physician from Australia on 2012-07-25
Patient: 56 year old
Reactions: Gastric Ulcer, Gastric Haemorrhage
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Aspirin
Possible Arava side effects in 90 year old male
Reported by a consumer/non-health professional from Germany on 2012-07-24
Patient: 90 year old male
Reactions: Lung Disorder, Dysphonia, Cough
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Metoprolol Succinate; Tamsulosin HCL; Clopidogrel; Methotrexate; Finasteride
Possible Arava side effects in 72 year old female
Reported by a physician from Canada on 2012-07-24
Patient: 72 year old female
Reactions: Abdominal Pain, Weight Decreased, Vomiting, Tinnitus, Nausea, Urinary Tract Infection, Bursitis, Wound Complication, Haemoglobin Decreased, Diarrhoea, Visual Impairment, Onychoclasis, Sleep Apnoea Syndrome, Asthenia, Inflammation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Cymbalta
Dilaudid
Lyrica
Dosage: also taken 150mg
Orencia
Dosage: last dose20oct11,15dec11,16dec11,7feb12,6mar12,13jul12 inf:11,57-500mg-also every 4 week,exp:ma2014
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
Prednisone
Dosage: also taken 15 mg
Other drugs received by patient: Nexium; Pramipexole Dihydrochloride; Amiloride Hydrochloride; Alendronate Sodium; Oxybutynin; Naproxen; Atenolol; Acetaminophen; Calcium; Calcitonin Salmon; Hydromorphone HCL
Possible Arava side effects in female
Reported by a physician from United States on 2012-07-20
Patient: female
Reactions: Diarrhoea Haemorrhagic
Drug(s) suspected as cause:
Arava
Indication: Ankylosing Spondylitis
Methotrexate Sodium
Indication: Ankylosing Spondylitis
Possible Arava side effects in 48 year old female
Reported by a physician from Germany on 2012-07-19
Patient: 48 year old female, weighing 75.0 kg (165.0 pounds)
Reactions: Subcutaneous Abscess, Fungal Infection, Hypertensive Crisis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Administration route: Oral
Start date: 2011-05-12
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2009-05-19
End date: 2010-11-22
Etanercept
Indication: Rheumatoid Arthritis
Start date: 2010-11-26
Other drugs received by patient: Tilidine; Methotrexate; Sulfasalazine; Tramadol Hydrochloride; Sympal; Hydroxychloroquine Sulfate; Folic Acid
Possible Arava side effects in 65 year old female
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: 65 year old female, weighing 78.0 kg (171.6 pounds)
Reactions: White Blood Cell Count Decreased, Weight Increased, Cellulitis, Escherichia Test Positive, Pulmonary Oedema, Cardiac Failure Congestive
Drug(s) suspected as cause:
Arava
Dosage: one tablet once daily po
Administration route: Oral
Indication: Arthralgia
Start date: 2012-03-05
End date: 2012-05-14
Azathioprine
Dosage: one tablet twice daily po
Administration route: Oral
Indication: Arthralgia
Start date: 2012-03-05
End date: 2012-05-14
Possible Arava side effects in 75 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-16
Patient: 75 year old female, weighing 62.6 kg (137.7 pounds)
Reactions: Gastrointestinal Haemorrhage, Coagulopathy, Diverticulitis, Myocardial Ischaemia, Renal Ischaemia, Abdominal Pain Upper, Haematemesis, Labile Blood Pressure, Multi-Organ Failure, Hepatotoxicity, Hepatorenal Syndrome, Hepatocellular Injury, Hepatic Ischaemia, Incision Site Haemorrhage, Hypovolaemia, Intestinal Ischaemia, Coronary Artery Disease, Duodenal Ulcer, Haemodialysis, Abdominal Rigidity, Renal Failure, Hepatic Congestion, Acute Hepatic Failure, Renal Tubular Necrosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Acetaminophen and Codeine Phosphate
Dosage: unk
Indication: Rheumatoid Arthritis
Start date: 2002-03-01
Acetylsalicylic Acid SRT
Dosage: unk
Indication: Pain
Start date: 2002-03-01
Arava
Dosage: 20 mg, 1x/day
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2002-03-01
Atorvastatin Calcium
Dosage: unk
Indication: Hypercholesterolaemia
Start date: 1999-01-01
Budesonide
Dosage: unk
Indication: Asthma
Start date: 2002-03-01
Diltiazem HCL
Dosage: unk
Indication: Hypertension
Start date: 2002-03-01
Fentanyl
Dosage: unk
Indication: Anaesthesia
Start date: 2002-03-01
End date: 2002-03-01
Lansoprazole
Dosage: unk
Indication: Duodenal Ulcer
Start date: 2001-03-01
Lisinopril
Dosage: unk
Administration route: Oral
Indication: Hypertension
Start date: 2002-03-01
Midazolam
Dosage: unk
Indication: Anaesthesia
Start date: 2002-03-01
End date: 2002-03-01
Nitroglycerin
Dosage: unk
Administration route: Oral
Indication: Pain
Start date: 2002-03-01
Pancuronium Bromide
Dosage: unk
Indication: Muscle Relaxant Therapy
Start date: 2002-03-01
End date: 2002-03-01
Propofol
Dosage: unk
Indication: Anaesthesia
Start date: 2002-03-01
End date: 2002-03-01
Quinine Sulfate
Dosage: unk
Indication: Muscle Spasms
Other drugs received by patient: Fluticasone Propionate; Nitroglycerin
Possible Arava side effects in
Reported by a consumer/non-health professional from United States on 2012-07-13
Patient:
Reactions: Systemic Lupus Erythematosus
Drug(s) suspected as cause:
Arava
Possible Arava side effects in 68 year old female
Reported by a consumer/non-health professional from Greece on 2012-07-13
Patient: 68 year old female
Reactions: Hypogammaglobulinaemia
Drug(s) suspected as cause:
Arava
Dosage: unk
Methotrexate
Dosage: unk
Prolia
Dosage: 60 mg, q6mo
Indication: Osteoporosis
Start date: 2011-01-01
Other drugs received by patient: Immunosuppressants
Possible Arava side effects in 54 year old female
Reported by a physician from Italy on 2012-07-05
Patient: 54 year old female
Reactions: Oral Lichen Planus
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Lisinopril and Hydrochlorothiazide; Vitamin D; Humira
Possible Arava side effects in 55 year old female
Reported by a physician from Germany on 2012-06-29
Patient: 55 year old female
Reactions: Dyshidrosis, Rheumatoid Arthritis, Fatigue, Chills, Empyema, Rash, Synovial Cyst
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Dosage: daily
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2006-10-01
End date: 2011-01-01
Humira
Indication: Rheumatoid Arthritis
Start date: 2011-02-01
End date: 2011-04-17
Tocilizumab
Dosage: total 636mg
Indication: Rheumatoid Arthritis
Other drugs received by patient: Pantoprazole; Arcoxia; Novalgin; Prednisolone; Pantoprazole; Leflunomide; Tocilizumab
Possible Arava side effects in 24 year old female
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-06-28
Patient: 24 year old female
Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous
Drug(s) suspected as cause:
Arava
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