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Renvela (Sevelamer) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Renvela (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 (67)
Death (16)
Life Threatening Events (4)
Disability (3)

Reports by Reaction Type

Death (6)Nausea (5)Diarrhoea (5)Fall (4)Abdominal Pain Upper (4)Malaise (4)Intestinal Obstruction (4)Pyrexia (3)Muscle Rupture (3)Klebsiella Infection (3)Fatigue (3)Hospitalisation (3)

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

Possible Renvela side effects in 58 year old female

Reported by a consumer/non-health professional from Israel on 2012-08-21

Patient: 58 year old female

Reactions: Faeces Pale, Diarrhoea, Faeces Discoloured

Drug(s) suspected as cause:
Renvela
    Dosage: 2 packets a day, unk
    Start date: 2012-01-01
    End date: 2012-01-01

Renvela
    Dosage: 3 packets a day, unk
    Start date: 2012-08-01

Renvela
    Dosage: 3 packets a day, unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-01
    End date: 2012-01-01

Other drugs received by patient: Folic Acid; Norvasc; Vaben; Levothyroxine Sodium; Furosemide; Furosemide; Tribemin; Tegretol; Simvastatin; Bisoprolol Fumarate; Taroctyl



Possible Renvela side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Renvela



Possible Renvela side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Back Pain, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Renvela

Other drugs received by patient: Insulin; Synthroid; Metoprolol Tartrate; Hydralazine HCL; Metolazone; Vitamin D; Protonix; Paxil; Vitamin D12; Benicar; Lasix



Possible Renvela side effects in 58 year old female

Reported by a consumer/non-health professional from Israel on 2012-08-14

Patient: 58 year old female

Reactions: Faeces Pale, Diarrhoea, Faeces Discoloured

Drug(s) suspected as cause:
Renvela
    Dosage: 3 packets a day, unk
    Start date: 2012-08-01

Renvela
    Dosage: 3 packets a day, unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-01
    End date: 2012-01-01

Renvela
    Dosage: 2 packets a day, unk
    Start date: 2012-01-01
    End date: 2012-01-01

Other drugs received by patient: Furosemide; Vaben; Bisoprolol Fumarate; Tegretol; Tribemin; Folic Acid; Norvasc; Furosemide; Taroctyl; Levothyroxine Sodium; Simvastatin



Possible Renvela side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: female

Reactions: Diarrhoea, Parenteral Nutrition

Drug(s) suspected as cause:
Renvela



Possible Renvela 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 Renvela side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: male

Reactions: Vomiting, Diarrhoea, Chills, Streptococcus Test Positive, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Renvela

Other drugs received by patient: Imdur; Diphenhydramine HCL; Acetaminophen; Colace; Tricor; Niacin; Zemplar; Actos; Oxycodone HCL; Nicoderm; Tramadol Hydrochloride; Metoprolol Succinate; Nexium; Lisinopril; Ergocalciferol; Ambien; Senna-Mint WAF; Nephrocaps; Plavix; Actos



Possible Renvela 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 Renvela side effects in male

Reported by a pharmacist from United States on 2012-07-23

Patient: male

Reactions: Decreased Appetite

Drug(s) suspected as cause:
Renvela



Possible Renvela side effects in 80 year old female

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: 80 year old female

Reactions: Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Renvela



Possible Renvela side effects in

Reported by a physician from United States on 2012-07-20

Patient:

Reactions: Alkalosis

Drug(s) suspected as cause:
Renvela



Possible Renvela side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient: male

Reactions: Drug Interaction, Hypertension

Drug(s) suspected as cause:
Renvela

Other drugs received by patient: Labetalol HCL



Possible Renvela 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 Renvela side effects in 42 year old male

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: 42 year old male

Reactions: Streptococcus Test Positive, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Renvela



Possible Renvela side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: male

Reactions: Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Renvela



Possible Renvela side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-25

Patient: female, weighing 77.6 kg (170.6 pounds)

Reactions: Dizziness, Adhesion, Intestinal Obstruction, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Renvela

Other drugs received by patient: Nifedipine; Atorvastatin Calcium; Labetalol HCL; Novolog; Esomeprazole; Aspirin; Niacin; Clopidogrel Bisulfate



Possible Renvela side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-19

Patient: female

Reactions: Foreign Body Aspiration

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Renvela



Possible Renvela side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Renvela
    Dosage: 2 tablet, tid, with meals
    Administration route: Oral
    Start date: 2011-09-08
    End date: 2012-02-04

Renvela
    Dosage: 800 mg, tid
    Administration route: Oral
    Indication: Hyperphosphataemia
    Start date: 2008-06-21
    End date: 2011-09-08

Hectorol
    Dosage: 2 mcg, 3x/w
    Indication: Hyperparathyroidism Secondary
    Start date: 2012-02-23

Other drugs received by patient: Epogen; Iron; Venofer; Clonidine; Sensipar; Epogen; Epogen; Epogen; Epogen; Epogen; Epogen; Folbee Plus; Doxazosin Mesylate; Nifedipine; Epogen; Venofer; Folbee Plus; Clonidine; Clonidine; Labetalol Hydrochloride; Epogen; Epogen; Epogen; Epogen; Iron; Calcitriol; Venofer; Folbee Plus; Sensipar; Epogen; Epogen; Calcitriol; Folic Acid; Acetaminophen; Metoprolol Succinate; Aciphex; Methyldopa; Epogen; Epogen; Epogen; Epogen; Epogen; Venofer; Vitamin D; Aciphex; Epogen; Venofer; Clonidine; Lisinopril; Epogen; Epogen; Iron; Iron; Calcitriol; Venofer; Topzol



Possible Renvela 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 Renvela side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-11

Patient: female

Reactions: Dizziness, Adhesion, Intestinal Obstruction, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Renvela



Possible Renvela side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female

Reactions: Maternal Exposure During Pregnancy, Foetal Death

Drug(s) suspected as cause:
Hectorol
    Dosage: 2 mcg, 3x/w
    Indication: Hyperparathyroidism Secondary
    Start date: 2012-02-23

Renvela
    Dosage: 2 tablet, tid, with meals
    Administration route: Oral
    Start date: 2011-09-08
    End date: 2012-02-04

Renvela
    Dosage: 800 mg, tid
    Administration route: Oral
    Indication: Hyperphosphataemia
    Start date: 2008-06-21
    End date: 2011-09-08

Other drugs received by patient: Epogen; Epogen; Calcitriol; Venofer; Clonidine; Clonidine; Metoprolol; Epogen; Folbee Plus; Topzol; Epogen; Epogen; Epogen; Iron; Venofer; Folbee Plus; Folbee Plus; Clonidine; Vitamin D; Sensipar; Aciphex; Epogen; Epogen; Epogen; Venofer; Venofer; Labetalol Hydrochloride; Lisinopril; Epogen; Epogen; Epogen; Epogen; Epogen; Epogen; Calcitriol; Doxazosin Mesylate; Methyldopa; Epogen; Iron; Iron; Venofer; Aciphex; Nifedipine; Epogen; Epogen; Epogen; Epogen; Venofer; Folic Acid; Sensipar; Epogen; Epogen; Iron; Calcitriol; Acetaminophen; Clonidine



Possible Renvela side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-05

Patient: female

Reactions: Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Renvela



Possible Renvela 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 Renvela side effects in

Reported by a physician from France on 2012-05-21

Patient:

Reactions: Drug Ineffective, Cholecystitis Infective, Noninfectious Peritonitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Renvela
    Dosage: 2.4 g, tid
    Administration route: Oral

Renvela
    Dosage: 2.4 g, tid
    Administration route: Oral
    Indication: Hyperphosphataemia

Renvela
    Dosage: 2.4 g, qd
    Administration route: Oral

Other drugs received by patient: Aspirin; Lasix



Possible Renvela side effects in

Reported by a consumer/non-health professional from Argentina on 2012-05-14

Patient:

Reactions: Ligament Rupture, Tendon Rupture, Condition Aggravated, Fall, Muscle Rupture, Malaise, Fatigue, Asthenia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Hectorol
    Dosage: 7.5 mg, 3x/w
    Administration route: Oral
    Indication: Hyperparathyroidism Secondary
    Start date: 2011-09-01
    End date: 2011-10-01

Renvela
    Dosage: 1.6 g, 3x/w
    Administration route: Oral
    Indication: Hyperphosphataemia
    Start date: 2011-09-01
    End date: 2011-10-01

Other drugs received by patient: Carvedilol; Alprazolam; Enalapril Maleate



Possible Renvela side effects in

Reported by a physician from United States on 2012-05-11

Patient:

Reactions: Chest Pain, Dizziness, Adhesion, Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Renvela



Possible Renvela side effects in

Reported by a consumer/non-health professional from Argentina on 2012-04-27

Patient:

Reactions: Ligament Rupture, Tendon Rupture, Condition Aggravated, Fall, Muscle Rupture, Fatigue, Malaise, Asthenia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Renvela
    Dosage: 1.6 g, 3x/w
    Administration route: Oral
    Indication: Hyperphosphataemia
    Start date: 2011-09-01
    End date: 2011-10-01

Hectorol
    Dosage: 7.5 mg, 3x/w
    Administration route: Oral
    Indication: Hyperparathyroidism Secondary
    Start date: 2011-09-01
    End date: 2011-10-01

Other drugs received by patient: Enalapril Maleate; Carvedilol; Alprazolam



Possible Renvela side effects in male

Reported by a pharmacist from United States on 2012-04-16

Patient: male

Reactions: Dysarthria, Muscle Spasms

Drug(s) suspected as cause:
Micardis

Acthar
    Dosage: 80un biw sq
    Indication: Nephrotic Syndrome
    Start date: 2012-03-01

Renvela

Other drugs received by patient: Amlodipine; Citalopram; Prilosec; Simvastatin



Possible Renvela 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 Renvela 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

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