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Index of reports
> Cases with Renal Failure Acute (26)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Naproxen where reactions include renal failure acute. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Naproxen side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-13
Patient: 75 year old male
Reactions: Blood Creatinine Increased, Renal Failure Acute, Anuria
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Finasteride; Simvastatin; Warfarin Sodium; Alfuzosin; Metformin Hydrochloride; Omeprazole
Possible Naproxen side effects in 75 year old male
Reported by a pharmacist on 2012-08-09
Patient: 75 year old male
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Metfformin Hydrochloride; Warfarin Sodium; Omeprazole; Finasteride; Alfuzosin HCL; Simvastatin
Possible Naproxen side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-31
Patient: 75 year old male
Reactions: Blood Creatinine Increased, Anuria, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Finasteride; Alfuzosin; Metformin Hydrochloride; Simvastatin; Omeprazole; Warfarin Sodium
Possible Naproxen side effects in 74 year old female
Reported by a physician from United States on 2012-07-30
Patient: 74 year old female, weighing 74.4 kg (163.7 pounds)
Reactions: Pulmonary Hypertension, Dilatation Ventricular, Myocardial Ischaemia, Blood Albumin Decreased, Mental Status Changes, Tricuspid Valve Incompetence, Neuropathy Peripheral, Hypoxia, Cholecystitis, Thrombocytopenia, Renal Failure Acute, Neutrophil Percentage Increased, Vomiting, Blood Chloride Decreased, Nausea, Diastolic Dysfunction, Left Ventricular Hypertrophy, Toxicity To Various Agents, Tremor, Haemodialysis, Cholelithiasis, Syncope, Dilatation Atrial, Diarrhoea, Dehydration, Drug-Induced Liver Injury, Renal Tubular Necrosis, Normochromic Normocytic Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Dosage: three times a day, oral
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-12-17
End date: 2009-09-03
Naproxen
Dosage: three times a day, oral
Administration route: Oral
Indication: Osteoarthritis
Start date: 2008-12-17
End date: 2009-09-03
Celecoxib; Ibuprofen; Placebo
Dosage: three times a day, oral
Administration route: Oral
Indication: Osteoarthritis
Start date: 2008-12-17
End date: 2009-09-03
Celecoxib; Ibuprofen; Placebo
Dosage: three times a day, oral
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-12-17
End date: 2009-09-03
Other drugs received by patient: Fexofenadine HCL; Lovastatin; Methotrexate; Zolpidem Tartrate; Diltiazem HCL; Calcium Carbonate; Multi-Vitamins
Possible Naproxen side effects in female
Reported by a physician from United States on 2012-07-16
Patient: female, weighing 58.5 kg (128.7 pounds)
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Blinded NO Subject Drug
Dosage: high dose, 3x/day
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-01-10
End date: 2011-09-14
Ibuprofen
Celecoxib
Dosage: high dose, 3x/day
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-01-10
End date: 2011-09-14
Placebo
Dosage: high dose, 3x/day
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-01-10
End date: 2011-09-14
Celecoxib
Indication: Rheumatoid Arthritis
Ibuprofen
Dosage: high dose, 3x/day
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-01-10
End date: 2011-09-14
Naproxen
Dosage: high dose, 3x/day
Administration route: Oral
Start date: 2011-01-10
End date: 2011-09-14
Blinded NO Subject Drug
Indication: Rheumatoid Arthritis
Ativan
Dosage: unk
Oxycontin
Dosage: 80 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2011-01-26
End date: 2011-09-14
Naproxen
Dosage: high dose, 3x/day
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-01-10
End date: 2011-09-14
Naproxen
Indication: Rheumatoid Arthritis
Ibuprofen
Dosage: high dose, 3x/day
Administration route: Oral
Start date: 2011-01-10
End date: 2011-09-14
Ibuprofen
Indication: Rheumatoid Arthritis
Naproxen
Oxycodone HCL
Dosage: 30 mg, 3x/day
Administration route: Oral
Indication: Pain
Start date: 2011-01-26
End date: 2011-09-14
Placebo
Indication: Rheumatoid Arthritis
Other drugs received by patient: Flonase; Onglyza; Bystolic; Potassium Chloride; Singulair; Fluoxetine; Levothyroxine; Glimepiride; Zocor; Prempro; Seroquel; Ropinirole Hydrochloride; Savella; Soma; Tiotropium; Acetaminophen; Lasix; Nexium; Symbicort
Possible Naproxen side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-06-26
Patient: 61 year old female
Reactions: Rhabdomyolysis, Respiratory Failure, Disseminated Intravascular Coagulation, Hepatic Failure, Toxic Epidermal Necrolysis, Bradycardia, Renal Tubular Necrosis, Cardiac Arrest, Renal Failure Acute
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Naproxen
Administration route: Oral
Indication: Arthritis
Naproxen
Atorvastatin
Administration route: Oral
Indication: Hypercholesterolaemia
Other drugs received by patient: Ranitidine; Tramadol HCL; Metformin HCL; Lisinopril; Allopurinol; Quinine Sulfate
Possible Naproxen side effects in 61 year old female
Reported by a physician from Belgium on 2012-06-08
Patient: 61 year old female
Reactions: Multi-Organ Failure, Muscle Necrosis, Rhabdomyolysis, Respiratory Failure, Hepatic Failure, Toxic Epidermal Necrolysis, Cardiac Arrest, Renal Failure Acute
Adverse event resulted in: death
Drug(s) suspected as cause:
Atorvastatin
Dosage: 10 mg, daily
Indication: Hypercholesterolaemia
Naproxen
Indication: Chest Pain
Naproxen
Dosage: 500 mg, tid
Indication: Arthritis
Possible Naproxen side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-06-06
Patient: 61 year old female
Reactions: Rhabdomyolysis, Respiratory Failure, Disseminated Intravascular Coagulation, Hepatic Failure, Toxic Epidermal Necrolysis, Bradycardia, Renal Tubular Necrosis, Cardiac Arrest, Renal Failure Acute
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Naproxen
Naproxen
Administration route: Oral
Indication: Arthritis
Atorvastatin Calcium
Administration route: Oral
Indication: Hypercholesterolaemia
Other drugs received by patient: Ranitidine; Metformin HCL; Tramadol HCL; Allopurinol; Quinine Sulfate; Lisinopril
Possible Naproxen side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from Israel on 2012-05-30
Patient: 75 year old male
Reactions: Blood Creatinine Increased, Renal Failure Acute, Anuria
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Finasteride; Omeprazole; Alfuzosin HCL; Warfarin Sodium; Metformin HCL; Simvastatin
Possible Naproxen side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) on 2012-05-30
Patient: 75 year old male
Reactions: Haemodialysis, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Simvastatin; Omeprazole; Warfarin Sodium; Alfuzosin (Alfuzosin); Finasteride; Metfformin Hydrochloride
Possible Naproxen side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-05-25
Patient: 61 year old female
Reactions: Pco2 Decreased, Blood Creatine Phosphokinase Increased, Rhabdomyolysis, Renal Infarct, Disseminated Intravascular Coagulation, Blood PH Decreased, Continuous Haemodiafiltration, Hepatic Failure, Hyperuricaemia, Multi-Organ Failure, Renal Failure Acute, Hypotension, Toxic Epidermal Necrolysis, Lymphocyte Stimulation Test Positive, Blood Lactic Acid, Blood Bicarbonate Decreased, Toxicity To Various Agents, Muscle Necrosis, Sepsis Syndrome, Respiratory Failure, Blood Potassium Decreased, Dehydration, PO2 Increased, Renal Tubular Necrosis, Bradycardia, Base Excess Decreased, Sinus Tachycardia, Cardiac Arrest
Adverse event resulted in: death
Drug(s) suspected as cause:
Atorvastatin Calcium
Dosage: 10 mg, 1x/day
Naproxen
Dosage: 500 mg, three times a day and as needed
Indication: Arthritis
Other drugs received by patient: Metformin; Tramadol; Lisinopril and Hydrochlorothiazide; Ranitidine; Allopurinol; Quinine Sulfate
Possible Naproxen side effects in 74 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-23
Patient: 74 year old female, weighing 74.4 kg (163.7 pounds)
Reactions: Pulmonary Hypertension, Myocardial Ischaemia, Tricuspid Valve Incompetence, Right Ventricular Hypertrophy, Loss of Consciousness, Neuropathy Peripheral, RED Blood Cell Count Decreased, Hypoxia, Thrombocytopenia, Renal Failure Acute, Neutrophil Percentage Increased, Vomiting, Nausea, Diastolic Dysfunction, Left Ventricular Hypertrophy, Tremor, Haemodialysis, Syncope, Renal Failure, Dilatation Atrial, Drug-Induced Liver Injury, Dehydration, Renal Tubular Necrosis, Normochromic Normocytic Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Dosage: three times a day, oral
Administration route: Oral
Indication: Osteoarthritis
Start date: 2008-12-17
End date: 2009-09-03
Naproxen
Dosage: three times a day, oral
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-12-17
End date: 2009-09-03
Celecoxib; Ibuprofen; Placebo
Dosage: three times a day, oral
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-12-17
End date: 2009-09-03
Celecoxib; Ibuprofen; Placebo
Dosage: three times a day, oral
Administration route: Oral
Indication: Osteoarthritis
Start date: 2008-12-17
End date: 2009-09-03
Other drugs received by patient: Lovastatin; Venlafaxine Hydrochloride; Multi-Vitamins; Fexofenadine Hydrochloride; Calcium Carbonate; Esomeprazole Capsule; Zolpidem Tartrate; Methotrexate; Folic Acid; Diltiazem HCL
Possible Naproxen side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-21
Patient: 75 year old male
Reactions: Blood Creatinine Increased, Renal Failure Acute, Anuria
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Warfarin Sodium; Alfuzosin HCL; Simvastatin; Omeprazole; Finasteride; Metformin HCL
Possible Naproxen side effects in 77 year old male
Reported by a pharmacist from United States on 2012-05-18
Patient: 77 year old male, weighing 104.3 kg (229.5 pounds)
Reactions: Hyperkalaemia, Renal Failure Acute
Drug(s) suspected as cause:
Lisinopril
Dosage: 2.5mg every day po
Administration route: Oral
Start date: 2011-09-21
End date: 2012-04-19
Naproxen
Dosage: 500 mg bid po
Administration route: Oral
Start date: 2011-09-21
Possible Naproxen side effects in 64 year old male
Reported by a pharmacist from United States on 2012-05-17
Patient: 64 year old male
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Possible Naproxen side effects in 36 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-04-27
Patient: 36 year old female
Reactions: Tubulointerstitial Nephritis, Drug Interaction, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diclofenac Epolamine
Indication: Pain
Start date: 2010-12-21
End date: 2011-08-31
Ibuprofen
Administration route: Oral
Indication: Pain
Start date: 2010-08-03
End date: 2011-08-30
Janumet
Administration route: Oral
Indication: Diabetes Mellitus
Start date: 2010-10-04
End date: 2011-08-30
Naproxen
Administration route: Oral
Indication: Pain
Start date: 2011-05-25
End date: 2011-08-31
Possible Naproxen 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 Naproxen 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 Naproxen side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-03-13
Patient: 75 year old male
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Amlodipine; Irbesartan; Simvastatin; Allopurinol; MST Continious; Oramorph SR; Doxazosin Mesylate; Diazepam; Codeine Sulfate; Metformin HCL; Acetaminophen
Possible Naproxen side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-13
Patient: 75 year old male
Reactions: Glomerular Filtration Rate Decreased, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Amlodipine; Metformin HCL; Oramorph SR; Codeine Sulfate; Irbesartan; MS Contin; Simvastatin; Diazepam; Doxazosin Mesylate; Acetaminophen; Allopurinol
Possible Naproxen side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-06
Patient: 75 year old male
Reactions: Glomerular Filtration Rate Decreased, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Doxazosin Mesylate; MS Contin; Simvastatin; Allopurinol; Amlodipine; Codeine Sulfate; Irbesartan; Oramorph SR; Acetaminophen; Diazepam; Metformin HCL
Possible Naproxen side effects in 46 year old male
Reported by a physician from France on 2011-12-23
Patient: 46 year old male
Reactions: Renal Failure Acute, Anuria
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Naproxen
Administration route: Oral
Indication: Neck Pain
Start date: 2011-09-06
End date: 2011-09-11
Abilify
Administration route: Oral
End date: 2011-09-11
Zestoretic
Dosage: 20 mg/12.5 mg,1 df : 1tab,scored tablet
Administration route: Oral
End date: 2011-09-11
Acetaminophen and Tramadol HCL
Administration route: Oral
Indication: Neck Pain
Start date: 2011-09-06
End date: 2011-09-11
Bisoprolol Fumarate
Dosage: film-coated scored tablet
Administration route: Oral
End date: 2011-09-11
Aspirin
Dosage: powder for oral solution in packets
Administration route: Oral
End date: 2011-09-11
Atarax
Administration route: Oral
End date: 2011-09-11
Other drugs received by patient: Neurontin; Oxazepam; Creon; Atorvastatin Calcium; Omeprazole
Possible Naproxen side effects in 75 year old male
Reported by a physician from United States on 2011-11-16
Patient: 75 year old male, weighing 93.9 kg (206.6 pounds)
Reactions: Atrial Flutter, Chest Pain, Cardiac Failure Congestive, Renal Failure Acute, Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Placebo
Indication: Osteoarthritis
Start date: 2011-04-14
End date: 2011-05-05
Ibuprofen
Start date: 2011-04-14
End date: 2011-05-05
Furosemide
Administration route: Oral
Start date: 2011-06-02
Celecoxib
Indication: Osteoarthritis
Start date: 2011-04-14
End date: 2011-05-05
Naproxen
Indication: Osteoarthritis
Start date: 2011-04-14
End date: 2011-05-05
Other drugs received by patient: Insulin; Esomeprazole; Acetylsalicylic Acid SRT; Fish OIL; Simvastatin; Insulin Detemir; Metoprolol Succinate; Coumadin; Gemfibrozil; Amlodipine; Carvedilol; Tocopherol Concentrate CAP; Ubidecarenone; Amiodarone HCL; Metformin HCL; Protonix; Insulin Isophane Bovine / Insulin Isophane Porcine; Humulin R; ALL Other Therapeutic Products; Atenolol; Folic Acid; Vitamin E
Possible Naproxen side effects in
Reported by a health professional (non-physician/pharmacist) from Israel on 2011-11-02
Patient:
Reactions: Glomerular Filtration Rate Decreased, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Bisoprolol; Aspirin; Ropinirole; Furosemide; Rosuvastatin; Oxybutynin; Levothyroxine Sodium; Ferrous Fumarate
Possible Naproxen side effects in 74 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-31
Patient: 74 year old female, weighing 79.0 kg (173.8 pounds)
Reactions: Glomerular Filtration Rate Decreased, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Oxybutynin; Furosemide; Levothyroxine Sodium; Rosuvastatin; Ferrous Fumarate; Aspirin; Bisoprolol; Ropinirole
Possible Naproxen side effects in 74 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-10-31
Patient: 74 year old female
Reactions: Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Bisoprolol; Ferrous Fumarate; Levothyroxine Sodium; Ropinirole; Rosuvastatin; Oxybutynin; Furosemide; Aspirin
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