This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Arava (Leflunomide) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (474)
Death (28)
Life Threatening Events (25)
Disability (15)
Reports by Reaction Type
Maternal Exposure During Pregnancy (89),
Diarrhoea (28),
Asthenia (27),
Weight Decreased (25),
Nausea (24),
Pyrexia (20),
Anaemia (19),
Abdominal Pain (17),
Vomiting (16),
Pancytopenia (15),
Arthralgia (15),
Cough (14)
Below are a few examples of reports where side effects / adverse reactions may be related to Arava (Leflunomide). For a complete list or a specific selection of reports, please use the links above.
Possible Arava side effects in 71 year old female
Reported by a consumer/non-health professional from Mexico on 2012-08-23
Patient: 71 year old female, weighing 65.0 kg (143.0 pounds)
Reactions: Myocardial Infarction
Adverse event resulted in: death
Drug(s) suspected as cause:
Arava
Possible Arava side effects in 35 year old female
Reported by a physician from Malaysia on 2012-08-21
Patient: 35 year old female, weighing 66.0 kg (145.2 pounds)
Reactions: Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Celebrex; Lovastatin
Possible Arava side effects in 28 year old female
Reported by a physician from France on 2012-08-21
Patient: 28 year old female
Reactions: Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Arava
Other drugs received by patient: ALL Other Therapeutic Products
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 28 year old female
Reported by a physician from France on 2012-08-20
Patient: 28 year old female
Reactions: Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Arava
Other drugs received by patient: ALL Other Therapeutic Products
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 71 year old female
Reported by a consumer/non-health professional from Belgium on 2012-08-17
Patient: 71 year old female
Reactions: Retroperitoneal Abscess, Pulmonary Embolism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Possible Arava side effects in female
Reported by a physician from United Kingdom on 2012-08-14
Patient: female
Reactions: Exposure VIA Father
Drug(s) suspected as cause:
Arava
Possible Arava side effects in 62 year old female
Reported by a physician from Germany on 2012-08-14
Patient: 62 year old female, weighing 69.3 kg (152.5 pounds)
Reactions: Impaired Healing, Wound Infection, Bursitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Dosage: 10 mg, 1x/day
Administration route: Oral
Start date: 2010-05-01
End date: 2012-01-01
Arava
Dosage: 5 mg, qd
Start date: 1983-01-01
Arava
Dosage: unk
Indication: Rheumatoid Arthritis
Start date: 1999-01-01
End date: 2009-10-01
Enbrel
Dosage: 50 mg, weekly
Indication: Rheumatoid Arthritis
Start date: 2009-10-01
End date: 2012-01-01
Prednisolone
Dosage: 5 mg, 1x/day
Start date: 1983-01-01
Other drugs received by patient: Ramipril; Bisoprolol; Omeprazole
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 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 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 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 male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-10
Patient: male, weighing 69.0 kg (151.8 pounds)
Reactions: Rheumatoid Nodule, Unevaluable Event, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2007-05-01
End date: 2011-04-01
Humira
Indication: Rheumatoid Arthritis
Start date: 2010-04-29
End date: 2011-04-01
Other drugs received by patient: Prednisolone; Metoprolol Tartrate; Trospium Chloride; Fosamax; Hydrochlorothiazide; Aggrenox; Colecalciferol; Ezetimibe; Actemra; Finasterid; Calcilac KT; Tocilizumab; Metformin Hydrochloride; Prednisolone; Olmesartan Medoxomil
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 53 year old female
Reported by a physician from Australia on 2012-08-09
Patient: 53 year old female
Reactions: White Blood Cell Count Decreased, RED Blood Cell Count Decreased, Pain, Platelet Count Decreased, Pancreatitis, Lipase Increased, Influenza Like Illness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Crestor
Administration route: Oral
Levothyroxine Sodium
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 57 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-08
Patient: 57 year old female
Reactions: Ovarian Cancer
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Administration route: Oral
End date: 2012-04-01
Mabthera
Start date: 2008-03-01
End date: 2011-04-29
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 57 year old female
Reported by a physician from France on 2012-08-03
Patient: 57 year old female
Reactions: Ovarian Cancer
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2010-01-01
Mabthera
End date: 2011-04-29
Mabthera
Indication: Rheumatoid Arthritis
Start date: 2008-03-01
Other drugs received by patient: Enbrel; Humira
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
Reported by a physician from NEW Zealand on 2012-07-31
Patient:
Reactions: Cerebral Vasoconstriction, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Possible Arava side effects in 29 year old female
Reported by a consumer/non-health professional from Argentina on 2012-07-31
Patient: 29 year old female
Reactions: Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Corticosteroid NOS
Possible Arava side effects in 35 year old female
Reported by a consumer/non-health professional from Malaysia on 2012-07-31
Patient: 35 year old female, weighing 66.0 kg (145.2 pounds)
Reactions: Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Celebrex; Lovastatin
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