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 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 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 2012-08-20
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 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 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
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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