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Index of reports
> Life Threatening Events (15)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Renagel (Sevelamer) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Renagel side effects in female
Reported by a consumer/non-health professional from Japan on 2012-08-17
Patient: female, weighing 49.8 kg (109.6 pounds)
Reactions: Intestinal Perforation, Disseminated Intravascular Coagulation, Diverticular Perforation, Peritonitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Renagel
Dosage: 250 mg, bid
Administration route: Oral
Indication: Hyperphosphataemia
End date: 2012-07-23
Renagel
Dosage: 125 mg, qd
Administration route: Oral
End date: 2012-07-23
Other drugs received by patient: Espo; Promac; Amlodipine; Iron Sucrose; Heparin; Propafenone Hydrochloride; Allopurinol; Clonazepam; Micardis; Rocaltrol; Levothyroxine Sodium; Calcium Carbonate; Cinacalcet Hydrochloride
Possible Renagel side effects in male
Reported by a physician from Japan on 2012-08-13
Patient: male, weighing 62.0 kg (136.4 pounds)
Reactions: Anaphylactic Reaction
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Renagel
Dosage: 0.8 g, tid
Administration route: Oral
Start date: 2011-06-06
End date: 2011-06-11
Renagel
Dosage: 0.75 g, tid
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2009-02-09
End date: 2011-06-05
Other drugs received by patient: Dorner; Amlodipine; Allopurinol; Rocaltrol; Enalapril Maleate; Calcium Carbonate; Omeprazole; Isosorbide Dinitrate; Ticlopidine HCL; Carvedilol; Brotizolam; Lasix; Aspirin
Possible Renagel side effects in 68 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-15
Patient: 68 year old male
Reactions: Klebsiella Infection, Sepsis, Varicose Ulceration, Neutropenia, TOE Amputation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Pantoprazole Sodium
Dosage: 40 mg, daily
Administration route: Oral
Start date: 2007-08-02
Renagel
Dosage: 800 mg, 3x/day
Administration route: Oral
Start date: 2010-12-01
End date: 2011-11-25
Renvela
Dosage: 800 mg, 3x/day
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2010-10-11
End date: 2010-11-29
Renagel
Dosage: 800 mg, 3x/day
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2007-08-02
End date: 2010-10-11
Plavix
Dosage: 75 mg, unk
Administration route: Oral
Indication: Myocardial Ischaemia
Start date: 2005-01-01
End date: 2011-01-01
Irbesartan
Dosage: 300mg, then 150mg, then 75mg
Administration route: Oral
Indication: Myocardial Ischaemia
Start date: 2007-08-02
End date: 2011-11-25
Other drugs received by patient: Tramadol HCL; Rocephin; Tenormin; Lyrica; Paracetamol; Iron; Kayexalate; Orbenin CAP; Gentamicin; Claritin; Aspirin; Iron; Lidocaine; Rocephin; Novolog MIX 70 / 30; Calcium Carbonate; Folic Acid; Pravastatin
Possible Renagel side effects in
Reported by a consumer/non-health professional from Japan on 2012-05-01
Patient:
Reactions: Gastrointestinal Perforation, Diverticulitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Renagel
Dosage: 1 g, tid
Administration route: Oral
Start date: 2004-11-25
End date: 2011-05-24
Renagel
Dosage: 1 g, tid
Administration route: Oral
Start date: 2011-09-09
Renagel
Dosage: 750 mg, tid
Administration route: Oral
Indication: Hyperphosphataemia
Fosrenol
Dosage: 250 mg, tid
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2010-02-02
Other drugs received by patient: Gasmotin; Epinastine Hydrochloride; Oxarol; Sorbitol 50pc INJ; Famotidine; Pursennid; Cinacalcet Hydrochloride; Amoban; Alosenn
Possible Renagel side effects in 73 year old male
Reported by a physician from Japan on 2012-04-26
Patient: 73 year old male
Reactions: Gastrointestinal Perforation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Renagel
Dosage: unk, unknown
Administration route: Oral
Start date: 2011-09-09
Renagel
Dosage: unk, unknown
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2004-11-25
End date: 2011-05-24
Fosrenol
Dosage: 750 mg, unknown
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2010-02-02
Other drugs received by patient: Alosenn / 00476901 /; Sorbitol 50pc INJ; Oxarol; Gaster / 00661201 /; Epinastine Hydrochloride; Cinacalcet Hydrochloride; Amoban; Gasmotin; Pursennid / 00142207 /
Possible Renagel side effects in
Reported by a consumer/non-health professional from Japan on 2012-04-18
Patient:
Reactions: Gastrointestinal Perforation, Diverticulitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Renagel
Dosage: 750 mg, tid
Administration route: Oral
Indication: Hyperphosphataemia
Renagel
Dosage: 1 g, tid
Administration route: Oral
Start date: 2004-11-25
End date: 2011-05-24
Renagel
Dosage: 1 g, tid
Administration route: Oral
Start date: 2011-09-09
Fosrenol
Dosage: 250 mg, tid
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2010-02-02
Other drugs received by patient: Epinastine Hydrochloride; Famotidine; Gasmotin; Sorbitol 50pc INJ; Pursennid; Oxarol; Amoban; Cinacalcet Hydrochloride; Alosenn
Possible Renagel side effects in 68 year old male
Reported by a physician from France on 2012-04-10
Patient: 68 year old male
Reactions: Klebsiella Infection, Skin Ulcer, Neutropenia, Staphylococcal Sepsis, TOE Amputation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Plavix
Administration route: Oral
Indication: Cardiac Disorder
Start date: 2005-01-01
End date: 2011-01-01
Pantoprazole Sodium
Administration route: Oral
Start date: 2007-08-02
Irbesartan
Administration route: Oral
Indication: Cardiac Disorder
Start date: 2007-08-02
End date: 2011-11-25
Renagel
Dosage: 2aug07-11oct10 3years,50 days from 11oct10-29nov10
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2007-08-02
Other drugs received by patient: Acetaminophen; Tenormin; Iron; Calcium Carbonate; Pravastatin; Tramadol HCL; Lyrica; Kayexalate; Lidocaine; Claritin
Possible Renagel side effects in
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-10
Patient:
Reactions: Klebsiella Infection, Skin Ulcer, Neutropenia, Staphylococcal Sepsis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Irbesartan
Dosage: 300 mg, qd, then 150 mg/d, then 75 mg/d
Administration route: Oral
Indication: Coronary Artery Disease
Start date: 2007-08-02
End date: 2011-11-25
Renagel
Dosage: 800 mg, tid
Administration route: Oral
Indication: Renal Failure Chronic
Start date: 2010-12-01
End date: 2011-11-25
Irbesartan
Dosage: 150 mg, qd
Administration route: Oral
Irbesartan
Dosage: 75 mg, qd
Administration route: Oral
Renagel
Dosage: 800 mg, tid
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2007-08-02
End date: 2010-10-11
Renvela
Dosage: 800 mg, tid
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2010-10-11
End date: 2010-11-29
Lyrica
Dosage: unk
Administration route: Oral
Indication: Diabetic Neuropathy
Start date: 2007-11-22
End date: 2011-09-05
Plavix
Dosage: 75 mg, qd
Administration route: Oral
Indication: Coronary Artery Disease
Start date: 2005-01-01
End date: 2011-01-01
Pantoprazole Sodium
Dosage: 40 mg, qd
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2007-08-02
Other drugs received by patient: Pravastatin; Calcium Carbonate; Lidocaine; Acetaminophen; Aspirin; Aspirin; Kayexalate; Tenormin; Novomix; Folic Acid; Tenormin; Iron; Claritin; Tramadol HCL
Possible Renagel side effects in 68 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-06
Patient: 68 year old male
Reactions: Klebsiella Infection, Sepsis, Varicose Ulceration, Neutropenia, TOE Amputation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Renagel
Dosage: 800 mg, 3x/day
Administration route: Oral
Start date: 2010-12-01
End date: 2011-11-25
Renagel
Dosage: 800 mg, 3x/day
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2007-08-02
End date: 2010-10-11
Renvela
Dosage: 800 mg, 3x/day
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2010-10-11
End date: 2010-11-29
Pantoprazole Sodium
Dosage: 40 mg, daily
Administration route: Oral
Start date: 2007-08-02
Plavix
Dosage: 75 mg, unk
Administration route: Oral
Indication: Myocardial Ischaemia
Start date: 2005-01-01
End date: 2011-01-01
Irbesartan
Dosage: 300gm then 150gm then 75mg
Administration route: Oral
Indication: Myocardial Ischaemia
Start date: 2007-08-02
End date: 2011-11-25
Other drugs received by patient: Lyrica; Paracetamol; Claritin; Calcium Carbonate; Folic Acid; Novomix; Kayexalate; Tenormin; Lidocaine; Aspirin; Pravastatin; Tramadol HCL; Iron
Possible Renagel side effects in
Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-03-06
Patient:
Reactions: Helicobacter Infection, Melaena, Gastric Haemorrhage, Gastroduodenitis, Gastritis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Renagel
Indication: Renal Failure Chronic
Renagel
Dosage: 0.8 g, bid
Indication: Hyperphosphataemia
Start date: 2011-10-22
End date: 2011-10-27
Possible Renagel side effects in
Reported by a physician from Romania on 2012-03-05
Patient:
Reactions: Cardio-Respiratory Arrest, Respiratory Failure, Bronchopneumonia, Gastric Ulcer Haemorrhage, Abdominal Pain Upper
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Renagel
Other drugs received by patient: Aulin; Vitamin B6; Aminoplasma; Vitamin B1 TAB; Ketoprofen
Possible Renagel side effects in
Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-02-17
Patient:
Reactions: Helicobacter Infection, Melaena, Gastric Haemorrhage, Gastroduodenitis, Gastritis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Renagel
Dosage: 0.8 g, bid
Indication: Hyperphosphataemia
Start date: 2011-10-22
End date: 2011-10-27
Renagel
Indication: Renal Failure Chronic
Possible Renagel side effects in
Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-02-07
Patient:
Reactions: Melaena, Gastric Haemorrhage, Gastroduodenitis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Renagel
Dosage: 0.8 g, bid
Indication: Hyperphosphataemia
Start date: 2011-10-22
End date: 2011-10-27
Renagel
Indication: Renal Failure Chronic
Other drugs received by patient: Pantoprazole; Ortanol
Possible Renagel side effects in male
Reported by a physician from Romania on 2012-01-23
Patient: male, weighing 81.0 kg (178.2 pounds)
Reactions: Cardio-Respiratory Arrest, Bronchopneumonia, Respiratory Failure, Gastric Ulcer Haemorrhage, Abdominal Pain Upper
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Renagel
Other drugs received by patient: Ketoprofen; Aulin; Vitamin B6; Vitamin B1 TAB; Aminoplasma
Possible Renagel side effects in male
Reported by a physician from Italy on 2011-11-23
Patient: male, weighing 81.0 kg (178.2 pounds)
Reactions: Cardio-Respiratory Arrest, Bronchopneumonia, Respiratory Failure, Gastric Ulcer Haemorrhage, Abdominal Pain Upper
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Renagel
Other drugs received by patient: Aminoplasma; Vitamin B1 TAB; Ketoprofen; Vitamin B6; Aulin
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