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Renagel (Sevelamer) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Renagel (Sevelamer) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (82)
Death (12)
Life Threatening Events (15)

Reports by Reaction Type

Thrombocytopenia (12)Anaemia (12)Abdominal Pain Upper (6)Constipation (5)Gastric Ulcer (5)Liver Disorder (5)Large Intestine Perforation (5)Renal Impairment (5)Klebsiella Infection (4)Melaena (4)Maternal Exposure During Pregnancy (4)Condition Aggravated (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Renagel (Sevelamer). For a complete list or a specific selection of reports, please use the links above.

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 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 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 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 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 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

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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