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Index of reports
> Cases with Nausea (24)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Arava (Leflunomide) where reactions include nausea. 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 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
Remicade
Start date: 2012-07-01
Medrol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-01
Remicade
Dosage: once a month
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 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:
Remicade
Start date: 2012-07-01
Arava
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-04-01
End date: 2012-06-01
Remicade
Dosage: once a month
Start date: 2011-04-01
Remicade
Indication: Rheumatoid Arthritis
Start date: 2011-04-01
Medrol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-01
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 60 year old male
Reported by a consumer/non-health professional from United States on 2012-06-20
Patient: 60 year old male, weighing 129.0 kg (283.8 pounds)
Reactions: Myalgia, Arthropathy, Arthralgia, Nausea, Tendon Disorder, Headache, Joint Stiffness, Infection, Influenza Like Illness
Drug(s) suspected as cause:
Orencia
Dosage: restarted on 4may12. recent inf 1jun12
Indication: Rheumatoid Arthritis
Arava
Possible Arava side effects in 72 year old female
Reported by a consumer/non-health professional from Brazil on 2012-05-31
Patient: 72 year old female, weighing 66.0 kg (145.2 pounds)
Reactions: Pruritus, Nausea, Pain, Wound, Sensation of Heaviness, Headache, Fall, Loss of Consciousness, Abdominal Pain Upper, Fatigue, Syncope, Balance Disorder, Oedema Peripheral, Gait Disturbance, Decreased Appetite
Drug(s) suspected as cause:
Arava
Dosage: start-feb-20121 tab after breakfast
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2012-01-01
End date: 2012-01-01
Arava
Dosage: 1 tab after breakfast
Administration route: Oral
Start date: 2012-01-01
End date: 2012-05-01
Arava
Dosage: 1 tab after lunch
Administration route: Oral
Start date: 2012-01-01
End date: 2012-01-01
Other drugs received by patient: Calcium; Alendronate Sodium; Methotrexate
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 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 Brazil on 2012-02-24
Patient: female, weighing 47.0 kg (103.4 pounds)
Reactions: Nasopharyngitis, Nausea, Wound, Somnolence, Malaise, Arthropathy, Muscle Fatigue, Dizziness, Blood Cholesterol Increased, Asthenia
Drug(s) suspected as cause:
Nimesulide
Administration route: Oral
Indication: Inflammation
Humira
End date: 2010-10-20
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Humira
Indication: Rheumatoid Arthritis
End date: 2010-07-04
Other drugs received by patient: Sodium Chloride; Synthroid; Risedronate Sodium; Calcium Phosphate W / Colecalciferol; Deflazacort; Calcium Phosphate W / Colecalciferol; Deflazacort; Omeprazole
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 53 year old female
Reported by a consumer/non-health professional from United States on 2012-01-28
Patient: 53 year old female
Reactions: Nasopharyngitis, Injection Site Haematoma, Nausea, Insomnia, Rhinorrhoea, Energy Increased, Cough
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2011-02-01
Arava
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Nabumetone; Flexeril; Tegretol; Amitriptyline HCL; Cymbalta; Folic Acid; Senokot; Vicodin; Fenofibrate; Fentanyl; Lorazepam; Zantac; Zocor
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 33 year old female
Reported by a consumer/non-health professional from United States on 2011-11-29
Patient: 33 year old female
Reactions: Vomiting, Nausea, Crohn's Disease, Injection Site Pain, Injection Site Erythema, Malaise, Diarrhoea Haemorrhagic, Alopecia, Clostridial Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Methotrexate
Indication: Rheumatoid Arthritis
Arava
Indication: Product Used FOR Unknown Indication
Humira
Indication: Rheumatoid Arthritis
Start date: 2011-08-11
Plaquenil
Indication: Rheumatoid Arthritis
Methotrexate
Indication: Crohn's Disease
Other drugs received by patient: Tramadol HCL; Oxycodone HCL; Probiotic; Compazine; Levsin; Ambien; Synthroid; Vivelle; Ativan; Bytrens Patch
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 48 year old female
Reported by a physician from United States on 2011-10-28
Patient: 48 year old female
Reactions: Renal Failure, Nausea, Mouth Ulceration, Anaemia, Squamous Cell Carcinoma of Skin, Neutropenia, Rash, Accidental Exposure
Drug(s) suspected as cause:
Dapsone
Dosage: titrated up to 100 mg twice daily, titrated up to 50 mg daily
Indication: Behcet's Syndrome
Arava
Dosage: 20 mg daily
Indication: Behcet's Syndrome
Imuran
Dosage: titrated up to 150 mg daily
Indication: Behcet's Syndrome
Plaquenil
Dosage: 300 mg daily, 200 mg daily, 200 mg twice daily, oral
Administration route: Oral
Indication: Behcet's Syndrome
Enbrel
Dosage: 25 mg twice weekly
Indication: Behcet's Syndrome
Methotrexate
Dosage: 7.5 mg per week, titrated up to 20 mg per week
Indication: Behcet's Syndrome
Cytoxan
Dosage: 250 mg, 250 mg, 500 mg, 750 mg, 1000 mg, 1250 mg, intravenous
Indication: Behcet's Syndrome
Cyclosporine
Indication: Behcet's Syndrome
End date: 2001-01-06
Remicade
Dosage: 200 mg, 300 mg, 400 mg, intravenous
Indication: Behcet's Syndrome
Leukeran
Dosage: titrated up to 4 mg daily, 3 mg daily, 3 mg daily
Indication: Behcet's Syndrome
Colchicine
Dosage: 6 mg twice daily, 6 mg twice daily
Indication: Behcet's Syndrome
Cellcept
Dosage: 1000 mg twice daily
Indication: Behcet's Syndrome
Rituxan
Dosage: 1000 mg, 1000 mg, intravenous
Indication: Behcet's Syndrome
End date: 2006-07-05
Prednisone
Dosage: 10 mg daily
Indication: Behcet's Syndrome
Other drugs received by patient: Terbutaline Sulfate; (Esomeprazole); Pregabalin; Acyclovir; (Fentanyl); Erythromycin; Sertraline Hydrochloride; Theophylline; Pentoxifylline; Furosemide; Folic Acid; Fluticasone Propionate / Salmeterol; Ipratropium Bromide and Albuterol Sulfate
Possible Arava side effects in 64 year old female
Reported by a consumer/non-health professional from Mexico on 2011-10-20
Patient: 64 year old female, weighing 65.0 kg (143.0 pounds)
Reactions: Malaise, Type 2 Diabetes Mellitus, Arthralgia, Nausea, Rash
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Arava
Administration route: Oral
Start date: 2009-01-01
Calcort
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2005-01-01
End date: 2011-04-01
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2001-01-01
End date: 2009-01-01
Other drugs received by patient: Prednisone; Methotrexate
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