DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

 
 



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 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 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 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 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 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 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



 Page 1   Next >>

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014