Index of reports
> Hospitalization (199)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Arava (Leflunomide) hospitalization. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 199 Next >>
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 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 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 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 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 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
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 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 40 year old female
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-07-24
Patient: 40 year old female
Reactions: Hemiparesis, Transient Ischaemic Attack, Cerebral Ischaemia, Viith Nerve Paralysis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Prednisone TAB; Acetaminophen; Calcimagon; Rabeprazole Sodium; Atorvastatin; Xanax; Budesonide / Formoterol
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 49 year old female
Reported by a health professional (non-physician/pharmacist) from Austria on 2012-07-18
Patient: 49 year old female
Reactions: Multi-Organ Failure, Fungal Infection, Impaired Healing, Pneumonia Necrotising, Urinary Tract Infection Bacterial, Septic Shock
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Prednisolone
Possible Arava side effects in female
Reported by a physician from Sweden on 2012-07-18
Patient: female
Reactions: Tubulointerstitial Nephritis, Rash
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-01
End date: 2012-01-01
Arava
Cimzia
Dosage: 200 mg cyclic
Indication: Rheumatoid Arthritis
Start date: 2012-01-12
End date: 2012-02-07
Enbrel
Indication: Rheumatoid Arthritis
Start date: 2012-04-23
End date: 2012-05-15
Humira
Dosage: 40 mg cyclic
Indication: Rheumatoid Arthritis
Start date: 2012-02-07
End date: 2012-04-02
Methotrexate
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
End date: 2012-05-15
Methotrexate
Administration route: Oral
Start date: 2011-05-01
Other drugs received by patient: Spironolactone; Enalapril Comp Sandoz
Possible Arava side effects in 46 year old female
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: 46 year old female
Reactions: Pain in Extremity, Joint Swelling, Arthralgia, Alopecia, Oedema Peripheral, Mobility Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Dosage: 10 mg, unk
End date: 2007-06-11
Enbrel
Dosage: 25 mg, 2 times/wk
Start date: 2000-10-06
End date: 2003-08-07
Enbrel
Dosage: 50 mg, qwk
Start date: 1998-11-01
End date: 2011-05-07
Enbrel
Dosage: 50 mg, qwk
Indication: Rheumatoid Arthritis
Start date: 2004-03-17
End date: 2011-05-09
Other drugs received by patient: Remicade; Azulfidine; Prednisone; Methotrexate; Plaquenil
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 53 year old female
Reported by a pharmacist from Australia on 2012-07-11
Patient: 53 year old female
Reactions: Pain, 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 64 year old female
Reported by a pharmacist from Germany on 2012-07-09
Patient: 64 year old female
Reactions: Abdominal Pain, Histamine Intolerance, Flatulence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Pantoprazole; Prednisolone; Metoprolol
Possible Arava side effects in 61 year old male
Reported by a physician from France on 2012-07-05
Patient: 61 year old male, weighing 98.0 kg (215.6 pounds)
Reactions: Oral Herpes
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Administration route: Oral
Cimzia
Indication: Rheumatoid Arthritis
Start date: 2012-02-01
End date: 2012-01-01
Prednisone TAB
Administration route: Oral
Possible Arava side effects in 38 year old female
Reported by a physician from France on 2012-07-05
Patient: 38 year old female
Reactions: Subarachnoid Haemorrhage, Cerebral Arteritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-09-01
Humira
Indication: Rheumatoid Arthritis
Start date: 2009-08-29
End date: 2011-06-24
Possible Arava side effects in 38 year old female
Reported by a physician from France on 2012-07-03
Patient: 38 year old female
Reactions: Subarachnoid Haemorrhage, Cerebral Arteritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Start date: 2008-09-01
Humira
Start date: 2009-08-01
Possible Arava side effects in 64 year old male
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-07-03
Patient: 64 year old male, weighing 67.0 kg (147.4 pounds)
Reactions: Pleural Effusion, Pericardial Effusion, Eosinophilia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Administration route: Oral
End date: 2011-10-01
Arava
Administration route: Oral
Start date: 2006-09-18
Other drugs received by patient: DE-Ursil; Prednisone TAB; Candesartan Cilexetil and Hydrochlorothiazide; Mabthera; Pantoprazole; Zolpidem
Page 1 Next >>
|