Arava (Leflunomide) - Serious Events - Suspected Cause - Side Effect Reports

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 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 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 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 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 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

Reported by a physician from NEW Zealand on 2012-07-25

Patient:

Reactions: Cerebral Vasoconstriction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arava

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