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Index of reports
> Cases with Diarrhoea (28)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Arava (Leflunomide) where reactions include diarrhoea. The selected reports were submitted to the FDA during the sample period of about a year.
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:
Lyrica
Dosage: also taken 150mg
Prednisone TAB
Dosage: also taken 15 mg
Arava
Orencia
Dosage: lastdose20oct11,15dec11,16dec11,7feb12,6mar12,13jul12 inf:11,57-500mg-q4wk,exp:ma2014,sep14
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
Cymbalta
Dilaudid
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 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:
Prednisone TAB
Dosage: also taken 15 mg
Lyrica
Dosage: also taken 150mg
Cymbalta
Dilaudid
Arava
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
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 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 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:
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
Arava
Prednisone
Dosage: also taken 15 mg
Cymbalta
Dilaudid
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 Germany on 2012-06-25
Patient: female
Reactions: Body Temperature Increased, Diarrhoea, Anaemia, Transaminases Increased, Asthenia
Drug(s) suspected as cause:
Arava
Possible Arava side effects in 73 year old female
Reported by a consumer/non-health professional from United States on 2012-06-04
Patient: 73 year old female
Reactions: Weight Decreased, Abdominal Pain, Diarrhoea, Pulmonary Oedema, Asthenia
Drug(s) suspected as cause:
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2012-03-22
End date: 2012-04-01
Arava
Administration route: Oral
Start date: 2012-04-01
End date: 2012-04-16
Arava
Administration route: Oral
Start date: 2012-04-22
End date: 2012-05-01
Other drugs received by patient: Plaquenil
Possible Arava side effects in 59 year old female
Reported by a consumer/non-health professional from Mexico on 2012-05-25
Patient: 59 year old female, weighing 52.0 kg (114.4 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Diarrhoea, Nausea, Dehydration, Alopecia, Joint Stiffness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Dosage: strength- 100mg tablet
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2010-01-01
End date: 2010-01-01
Arava
Dosage: strength- 20 mg tablet
Administration route: Oral
Start date: 2010-01-01
Other drugs received by patient: Methotrexate; Gabapentin; Nexium; Trimebutine Maleate
Possible Arava side effects in 72 year old female
Reported by a consumer/non-health professional from Canada on 2012-05-10
Patient: 72 year old female
Reactions: Weight Decreased, Abdominal Pain, Vomiting, 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:
Lyrica
Cymbalta
Arava
Dilaudid
Orencia
Dosage: last dose on 20oct11,15dec11,16dec11,7feb12,06mar12 no of inf:8, also every 4 week,exp:ma2014
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
Prednisone TAB
Other drugs received by patient: Amiloride Hydrochloride; Calcium; Hydromorphone HCL; Alendronate Sodium; Acetaminophen; Naproxen; Nexium; Oxybutynin; Pramipexole Dihydrochloride; Atenolol; Calcitonin Salmon
Possible Arava side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-26
Patient: 72 year old female
Reactions: Abdominal Pain, Weight Decreased, Vomiting, Nausea, Urinary Tract Infection, Bursitis, Wound Complication, Haemoglobin Decreased, Diarrhoea, Visual Impairment, Sleep Apnoea Syndrome, Asthenia, Inflammation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orencia
Dosage: every two weeks
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
Lyrica
Dilaudid
Prednisone TAB
Cymbalta
Arava
Administration route: Oral
Other drugs received by patient: Acetaminophen; Pramipexole Dihydrochloride; Calcium; Levothyroxine Sodium; Calcitonin Salmon; Alendronate Sodium; Atenolol; Oxybutynin; Esomeprazole Magnesium; Hydromorphone HCL; Naproxen; Amiloride Hydrochloride
Possible Arava side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-23
Patient: 72 year old female
Reactions: Abdominal Pain, Weight Decreased, Vomiting, Nausea, Urinary Tract Infection, Bursitis, Wound Complication, Haemoglobin Decreased, Intervertebral Disc Disorder, Diarrhoea, Visual Impairment, Clostridial Infection, Sleep Apnoea Syndrome, Asthenia, Inflammation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prednisone
Dosage: 5 mg, 1x/day
Cymbalta
Dosage: 60 mg, 1x/day
Orencia
Dosage: 750 mg, 1/2 week
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
Arava
Dosage: 10 mg, 1x/day
Dilaudid
Dosage: unk
Lyrica
Dosage: 200 mg, 1x/day
Other drugs received by patient: Oxybutynin; Nexium; Pramipexole; Calcium; Hydromorphone; Amiloride; Calcitonin; Alendronate Sodium; Naproxen; Acetaminophen; Atenolol
Possible Arava side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-20
Patient: female
Reactions: Abdominal Pain, Weight Decreased, Vomiting, Nausea, Urinary Tract Infection, Bursitis, Wound Complication, Haemoglobin Decreased, Diarrhoea, Visual Impairment, Asthenia, Sleep Apnoea Syndrome, Inflammation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Dosage: 60 mg, daily
Indication: Product Used FOR Unknown Indication
Lyrica
Dosage: 200 mg, daily
Indication: Product Used FOR Unknown Indication
Hydromorphone HCL
Indication: Product Used FOR Unknown Indication
Arava
Dosage: 10 mg, daily
Indication: Product Used FOR Unknown Indication
Prednisone TAB
Dosage: 5 mg, daily
Indication: Product Used FOR Unknown Indication
Dilaudid
Indication: Product Used FOR Unknown Indication
Orencia
Dosage: 750 mg, see text
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
Other drugs received by patient: Oxybutynin Chloride; Calcium; Calcitonin Salmon; Pramipexole Dihydrochloride; Nexium; Acetaminophen; Alendronate Sodium; Atenolol; Amiloride Hydrochloride; Naproxen; Levothyroxine Sodium
Possible Arava side effects in 59 year old female
Reported by a consumer/non-health professional from France on 2012-04-19
Patient: 59 year old female
Reactions: Abdominal Pain, Pneumonia Haemophilus, Diarrhoea, Sigmoiditis, Influenza
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Augmentin '125'
Dosage: 3 g, 1x/day
Start date: 2012-03-01
Arava
Dosage: unk
Start date: 2011-10-22
End date: 2012-03-01
Enbrel
Dosage: unk
Start date: 2011-10-22
End date: 2012-03-01
Enbrel
Dosage: 50 mg, weekly
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
End date: 2011-09-01
Arava
Dosage: unk
Start date: 2011-05-01
End date: 2011-09-01
Prednisone TAB
Dosage: 40 to 50 mg daily
Possible Arava side effects in 30 year old female
Reported by a physician from France on 2012-04-13
Patient: 30 year old female, weighing 59.0 kg (129.8 pounds)
Reactions: Abdominal Pain, Diarrhoea, Crohn's Disease, Condition Aggravated, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Prednisone TAB; Diclofenac Sodium
Possible Arava side effects in male
Reported by a physician from Germany on 2012-04-11
Patient: male
Reactions: Fatigue, Diarrhoea, Dehydration, Pyrexia, Asthenia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2002-01-01
End date: 2011-01-01
Naproxen
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2006-01-01
End date: 2011-01-01
Possible Arava side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-11
Patient: male
Reactions: Fatigue, Diarrhoea, Dehydration, Pyrexia, Asthenia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Dosage: 20 mg, unk
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2002-01-01
End date: 2011-01-01
Naproxen Sodium
Dosage: 20 mg, unk
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2006-01-01
End date: 2011-01-01
Possible Arava side effects in male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-04
Patient: male
Reactions: Fatigue, Diarrhoea, Dehydration, Pyrexia, Asthenia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Dosage: daily dose: 20 mg millgram(s) every days
Administration route: Oral
Start date: 2006-01-01
End date: 2011-01-01
Arava
Dosage: daily dose: 20 mg millgram(s) every days
Administration route: Oral
Start date: 2006-01-01
End date: 2011-01-01
Possible Arava side effects in male
Reported by a consumer/non-health professional from Germany on 2012-04-03
Patient: male
Reactions: Fatigue, Diarrhoea, Dehydration, Pyrexia, Asthenia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen Sodium
Dosage: 20 mg, qd
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2006-01-01
End date: 2011-01-01
Arava
Dosage: 20 mg, qd
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2006-01-01
End date: 2011-01-01
Possible Arava side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-30
Patient: female
Reactions: Weight Decreased, Abdominal Pain, Vomiting, Nausea, Urinary Tract Infection, Bursitis, Wound Complication, Haemoglobin Decreased, Diarrhoea, Visual Impairment, Sleep Apnoea Syndrome, Asthenia, Inflammation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Dilaudid
Indication: Product Used FOR Unknown Indication
Cymbalta
Dosage: 60 mg, daily
Indication: Product Used FOR Unknown Indication
Prednisone TAB
Dosage: 5 mg, daily
Indication: Product Used FOR Unknown Indication
Hydromorphone HCL
Indication: Product Used FOR Unknown Indication
Lyrica
Dosage: 200 mg, daily
Indication: Product Used FOR Unknown Indication
Arava
Dosage: 10 mg, daily
Indication: Product Used FOR Unknown Indication
Orencia
Dosage: 750 mg, see text
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
Other drugs received by patient: Alendronate Sodium; Atenolol; Pramipexole Dihydrochloride; Naproxen; Calcium Carbonate; Oxybutynin Chloride; Acetaminophen; Nexium; Amiloride Hydrochloride; Levothyroxine Sodium; Calcitonin Salmon
Possible Arava side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-03-23
Patient: 72 year old female
Reactions: Abdominal Pain, Weight Decreased, Vomiting, Nausea, Urinary Tract Infection, Bursitis, Wound Complication, Haemoglobin Decreased, Diarrhoea, Visual Impairment, Asthenia, Sleep Apnoea Syndrome, Inflammation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lyrica
Arava
Administration route: Oral
Prednisone
Dilaudid
Orencia
Dosage: every two weeks
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
Cymbalta
Other drugs received by patient: Alendronate Sodium; Esomeprazole Sodium; Hydromorphone HCL; Oxybutynin; Atenolol; Amiloride Hydrochloride; Calcium Carbonate; Acetaminophen; Pramipexole Dihydrochloride; Calcitonin Salmon; Levothyroxine Sodium; Naproxen
Possible Arava side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-20
Patient: 72 year old female
Reactions: Abdominal Pain, Weight Decreased, Vomiting, Nausea, Urinary Tract Infection, Bursitis, Wound Complication, Haemoglobin Decreased, Diarrhoea, Intervertebral Disc Disorder, Visual Impairment, Clostridial Infection, Asthenia, Sleep Apnoea Syndrome, Inflammation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Dosage: 60 mg, 1x/day
Lyrica
Dosage: 200 mg, 1x/day
Dilaudid
Dosage: unk
Prednisone TAB
Dosage: 5 mg, 1x/day
Orencia
Dosage: 750 mg, 1/2 week
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
Arava
Dosage: 10 mg, 1x/day
Other drugs received by patient: Alendronate Sodium; Calcitonin; Oxybutynin; Pramipexole; Calcium; Hydromorphone; Naproxen; Atenolol; Acetaminophen; Amiloride; Nexium
Possible Arava side effects in female
Reported by a consumer/non-health professional from Mexico on 2012-02-08
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Weight Decreased, Pneumonia, Nausea, Oropharyngeal Pain, Rectal Tenesmus, Abdominal Pain Upper, Dyspepsia, Diarrhoea, Chest Pain, Gastroenteritis, Gastrooesophageal Reflux Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Hydrochlorothiazide; Caltrate; Cyclosporine; Omeprazole; Risedronate Sodium; Refresh; Enalapril Maleate
Possible Arava side effects in 51 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-06
Patient: 51 year old female
Reactions: Back Pain, Dermatosis, Weight Decreased, Diarrhoea, Lupus-Like Syndrome, General Physical Health Deterioration, Musculoskeletal Chest Pain, Asthenia, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Crestor; Levothyroxine Sodium; Prednisone TAB; Rabeprazole Sodium; Spiriva; Cymbalta; Abilify
Possible Arava side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-01-03
Patient: female, weighing 64.0 kg (140.8 pounds)
Reactions: Injection Site Discolouration, Weight Decreased, Urticaria, Tachycardia, Wound, Vulvovaginal Erythema, Pyrexia, Photopsia, Vulvovaginal Pruritus, Perianal Erythema, Vomiting, Stomatitis, Dyspnoea, Nausea, Injection Site Pain, Haematochezia, Diarrhoea, Vulvovaginal Swelling, Rectal Discharge
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2011-11-28
Arava
Indication: Arthritis
End date: 2011-11-28
Other drugs received by patient: Cinnarizine; Hydrochlorothiazide; Omeprazole; Hydrochlorothiazide; Enalapril Maleate; Fluticasone Propionate / Salmeterol; Amitriptyline HCL; Acetylsalicylic Acid SRT; Insulin; Nimesilide; Methotrexate; Digoxin
Possible Arava side effects in female
Reported by a consumer/non-health professional from Brazil on 2011-12-21
Patient: female, weighing 64.0 kg (140.8 pounds)
Reactions: Weight Decreased, Injection Site Discolouration, Vomiting, Stomatitis, Dyspnoea, Nausea, Wound, Tachycardia, Injection Site Pain, Pyrexia, Vulvovaginal Erythema, Haematochezia, Diarrhoea, Vulvovaginal Swelling, Vulvovaginal Pruritus
Drug(s) suspected as cause:
Arava
Indication: Arthritis
End date: 2011-11-28
Humira
Indication: Rheumatoid Arthritis
Start date: 2011-11-28
Other drugs received by patient: Omeprazole; Methotrexate; Nimesilide; Acetylsalicylic Acid SRT; Digoxin; Enalapril Maleate; Insulin; Amitriptyline HCL; Hydrochlorothiazide; Cinnarizine; Fluticasone Propionate / Salmeterol; Hydrochlorothiazide
Possible Arava side effects in female
Reported by a pharmacist from United States on 2011-12-13
Patient: female
Reactions: Therapeutic Response Decreased, Arthralgia, Diarrhoea, Pain in Extremity, Joint Swelling, Oedema Peripheral, Joint Stiffness
Drug(s) suspected as cause:
Arava
Enbrel
Dosage: 50 mg, qwk
Indication: Rheumatoid Arthritis
Methotrexate
Other drugs received by patient: Norvasc; Sulfasalazine; Nexium
Possible Arava side effects in female
Reported by a consumer/non-health professional from Brazil on 2011-11-14
Patient: female, weighing 66.0 kg (145.2 pounds)
Reactions: Weight Decreased, Vomiting, Drug Ineffective, Hepatitis, Hepatic Steatosis, Rheumatoid Arthritis, Hepatomegaly, Diarrhoea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prednisone TAB
Administration route: Oral
Indication: Rheumatoid Arthritis
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Humira
Indication: Rheumatoid Arthritis
Start date: 2007-01-01
End date: 2010-12-01
Diclofenac Sodium
Indication: Product Used FOR Unknown Indication
Possible Arava side effects in 69 year old female
Reported by a consumer/non-health professional from Mexico on 2011-11-07
Patient: 69 year old female, weighing 48.0 kg (105.6 pounds)
Reactions: Weight Decreased, Nausea, Diarrhoea, Vision Blurred, Visual Acuity Reduced, Cervix Carcinoma, Vaginal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Other drugs received by patient: Chloroquine Diphosphate; Sulindac
Possible Arava side effects in 32 year old female
Reported by a physician from Germany on 2011-10-21
Patient: 32 year old female
Reactions: Pneumonia Fungal, Subcutaneous Abscess, Pain, Chills, Pancytopenia, Osteomyelitis, Tonsillitis, Oropharyngeal Pain, Pyrexia, Tooth Infection, Diarrhoea, Haematoma Infection, Bone Marrow Failure, Infection
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Arava
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