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Arava (Leflunomide) - Side Effect Reports to FDA

 
 



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 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 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 2012-08-20

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 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 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 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 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 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 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 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 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 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



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 33 year old female

Reported by a physician from Turkey on 2012-07-31

Patient: 33 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Arava

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