Index of reports
> All Cases (82)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Renagel (Sevelamer) all cases. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 82 Next >>
Possible Renagel side effects in
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-27
Patient:
Reactions: Abdominal Pain Lower, Vomiting, Bile Duct Stone, Nausea, Cholecystitis Acute, Flatulence, Constipation, Liver Disorder, Abdominal Pain Upper, Malaise, Dyspepsia, Diarrhoea, Viral Pericarditis, Peripheral Arterial Occlusive Disease, Shunt Malfunction, Abscess, Decreased Appetite
Drug(s) suspected as cause:
Fosrenol
Dosage: 375-2250 mg, unknown
Administration route: Oral
Indication: Hyperphosphataemia
Renagel
Dosage: 750-9000 mg, unknown
Indication: Hyperphosphataemia
Other drugs received by patient: Calcium Carbonate; Vitamin D; Cinacalcet Hydrochloride
Possible Renagel side effects in
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-20
Patient:
Reactions: Aortic Valve Disease Mixed, Cardiac Failure Acute
Adverse event resulted in: death
Drug(s) suspected as cause:
Renagel
Dosage: 750-9000 mg, unknown
Administration route: Oral
Indication: Hyperphosphataemia
Fosrenol
Dosage: 375-2250 mg, unknown
Administration route: Oral
Indication: Hyperphosphataemia
Other drugs received by patient: Cinacalcet Hydrochloride; Vitamin D; Calcium Carbonate
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 75 year old male
Reported by a consumer/non-health professional from Japan on 2012-08-13
Patient: 75 year old male
Reactions: Gastrointestinal Haemorrhage
Drug(s) suspected as cause:
Renagel
Possible Renagel side effects in 81 year old male
Reported by a pharmacist from United States on 2012-08-13
Patient: 81 year old male
Reactions: Gastrostomy Tube Insertion
Drug(s) suspected as cause:
Renagel
Possible Renagel side effects in 70 year old female
Reported by a consumer/non-health professional from United States on 2012-08-09
Patient: 70 year old female, weighing 72.6 kg (159.7 pounds)
Reactions: Abdominal Discomfort, Dizziness, Product Odour Abnormal
Drug(s) suspected as cause:
Renagel
Possible Renagel side effects in 77 year old female
Reported by a consumer/non-health professional from Japan on 2012-08-07
Patient: 77 year old female
Reactions: Faeces Discoloured
Drug(s) suspected as cause:
Renagel
Possible Renagel side effects in 45 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-07
Patient: 45 year old female
Reactions: Pancreatic Disorder, Renal Failure Chronic, Constipation
Drug(s) suspected as cause:
Creon
Dosage: 8000 units per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Renagel
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Renagel side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-25
Patient: male
Reactions: Dementia Alzheimer's Type
Drug(s) suspected as cause:
Renagel
Dosage: unk
Indication: Product Used FOR Unknown Indication
Renvela
Dosage: 1.6 g, tid
Indication: Hyperphosphataemia
Start date: 2011-09-01
Renvela
Dosage: 2.4 g, unk
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Calcium Carbonate
Possible Renagel side effects in female
Reported by a pharmacist from United States on 2012-07-23
Patient: female
Reactions: Hospitalisation, Dysphagia, Unevaluable Event
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renagel
Dosage: unk
Indication: Product Used FOR Unknown Indication
Renvela
Dosage: 0.8 g, tid
Indication: Hyperphosphataemia
Start date: 2010-09-01
Possible Renagel side effects in female
Reported by a physician from United Kingdom on 2012-07-19
Patient: female
Reactions: Pancreatic Disorder, Constipation, Renal Failure Chronic
Drug(s) suspected as cause:
Renagel
Indication: Product Used FOR Unknown Indication
Creon
Dosage: 1 to 2 caps per meal (max:80,000 daily)
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Renagel side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: female
Reactions: Oral Administration Complication, Choking, Blood Parathyroid Hormone Increased
Drug(s) suspected as cause:
Renagel
Dosage: 3.6 g, qd
Indication: Product Used FOR Unknown Indication
End date: 2012-01-01
Renvela
Dosage: 4.8
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-01
Renvela
Dosage: 7.2 g, qd
Start date: 2012-01-01
Possible Renagel side effects in
Reported by a physician from Japan on 2012-07-11
Patient:
Reactions: Altered State of Consciousness
Drug(s) suspected as cause:
Renagel
Possible Renagel side effects in 84 year old male
Reported by a consumer/non-health professional from Canada on 2012-06-26
Patient: 84 year old male
Reactions: Dysphagia, Cognitive Disorder, Treatment Noncompliance, Cardiac Disorder
Drug(s) suspected as cause:
Renagel
Possible Renagel side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-19
Patient: male
Reactions: Gastrointestinal Haemorrhage, Muscular Weakness, Fall
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renagel
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 male
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-05-25
Patient: male
Reactions: Anaemia, Condition Aggravated, Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prednisone TAB
Dosage: 1 df
Administration route: Oral
Start date: 2011-05-01
Renagel
Dosage: 1 df
Administration route: Oral
Aranesp
Dosage: 0.0667 df
Calciparine
Start date: 2011-07-08
End date: 2011-08-08
Citalopram Hydrobromide
Administration route: Oral
Depakene
Dosage: 2 df
Administration route: Oral
Start date: 2011-07-16
Eupressyl
Dosage: 3 df
Administration route: Oral
Start date: 2011-05-29
Kayexalate
Dosage: 0.4286 df
Start date: 2011-06-03
Calcium Carbonate
Administration route: Oral
Other drugs received by patient: Levetiracetam
Possible Renagel side effects in
Reported by a physician from Brazil on 2012-05-24
Patient:
Reactions: Maternal Exposure During Pregnancy, Hypertension, PRE-Eclampsia
Drug(s) suspected as cause:
Renagel
Other drugs received by patient: Atenolol; Adalat; Epoetin Alfa; Vitamin B Complex CAP; Captopril; Noripurum
Possible Renagel side effects in
Reported by a consumer/non-health professional from United States on 2012-05-24
Patient:
Reactions: Cardiac Pacemaker Replacement, Coma, Cardiac Arrest
Adverse event resulted in: death
Drug(s) suspected as cause:
Renagel
Dosage: unk
Indication: Hyperphosphataemia
Renagel
Indication: Renal Failure Chronic
Renvela
Indication: Renal Failure Chronic
Renvela
Dosage: 8.8 g, qd
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2011-10-01
Possible Renagel side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-09
Patient: female, weighing 65.0 kg (143.0 pounds)
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Renagel
Dosage: unk
Amlodipine Besylate
Dosage: unk
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 female
Reported by a physician from France on 2012-04-26
Patient: female, weighing 81.0 kg (178.2 pounds)
Reactions: Impaired Healing
Drug(s) suspected as cause:
Renagel
Indication: Product Used FOR Unknown Indication
Cinacalcet Hydrochloride
Administration route: Oral
Indication: Hyperparathyroidism
Pegasys
Dosage: 135
Indication: Hepatitis C
Start date: 2011-09-21
Rebetol
Administration route: Oral
Indication: Hepatitis C
Calcium Carbonate
Administration route: Oral
Indication: Hyperparathyroidism
Incivo
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-02-07
UN Alfa
Administration route: Oral
Indication: Hyperparathyroidism
Other drugs received by patient: Rabeprazole Sodium; Aluminum Hydroxide and Magnesium Trisilicate; Kayexalate
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 72 year old male
Reported by a physician from Japan on 2012-04-18
Patient: 72 year old male
Reactions: Ischaemic Limb Pain, Gastric Ulcer
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renagel
Dosage: 1.0 g, tid
Administration route: Oral
Indication: Hyperphosphataemia
End date: 2011-10-11
Aspirin
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Acetaminophen; Loxonin
Possible Renagel side effects in
Reported by a consumer/non-health professional from United States on 2012-04-16
Patient:
Reactions: Blood Phosphorus Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renagel
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
Reported by a physician from Japan on 2012-04-10
Patient:
Reactions: Intestinal Perforation, Diverticulitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fosrenol
Dosage: 250 mg, tid
Indication: Hyperphosphataemia
Renagel
Dosage: 750 mg, tid
Administration route: Oral
Indication: Hyperphosphataemia
Cinacalcet Hydrochloride
Dosage: 100 mg, unk
Indication: Hyperparathyroidism Secondary
Other drugs received by patient: Amoban; Epinastine Hydrochloride; Famotidine; Sorbitol 50pc INJ; Pursennid; Gasmotin; 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
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