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Index of reports
> Hospitalization (27)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Renvela (Sevelamer) hospitalization. The selected reports were submitted to the FDA during the sample period of about a year.
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 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 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 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 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
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 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 United States on 2012-03-30
Patient:
Reactions: Arterial Disorder, Restless Legs Syndrome, Aortic Aneurysm, Gastrointestinal Necrosis, Liver Disorder, Abdominal Wall Disorder, Pleural Effusion, Peritoneal Fluid Analysis Abnormal, Dyspnoea, Catabolic State, Nausea, Ascites, Post Embolisation Syndrome, Heart Rate Decreased, DRY Gangrene, Gastrointestinal Disorder, Gait Disturbance, Intestinal Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renvela
Dosage: 0.8 g, unk
Administration route: Oral
Phenergan HCL
Dosage: unk
Indication: Nausea
Renvela
Dosage: 7.2 g, qd
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2011-07-01
Other drugs received by patient: Paxil; Nebivolol; Nebivolol; Paxil
Possible Renvela side effects in
Reported by a consumer/non-health professional from United States on 2012-03-23
Patient:
Reactions: Extremity Necrosis, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renvela
Possible Renvela side effects in
Reported by a consumer/non-health professional from France on 2012-03-22
Patient:
Reactions: Noninfectious Peritonitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Renvela
Dosage: 2.4 g, tid
Administration route: Oral
Indication: Hyperphosphataemia
Renvela
Dosage: 2.4 g, qd
Administration route: Oral
Renvela
Dosage: 2.4 g, tid
Administration route: Oral
Other drugs received by patient: Lasix; Aspirin
Possible Renvela side effects in
Reported by a consumer/non-health professional from United States on 2012-03-05
Patient:
Reactions: Hospitalisation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renvela
Possible Renvela side effects in 58 year old female
Reported by a pharmacist from United States on 2012-03-01
Patient: 58 year old female
Reactions: Dyspnoea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renvela
Possible Renvela side effects in
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient:
Reactions: Medical Device Complication, Platelet Count Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renvela
Possible Renvela side effects in
Reported by a physician from Germany on 2012-02-23
Patient:
Reactions: Duodenal Ulcer, Gastrooesophageal Reflux Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renvela
Dosage: 3 in 3 days
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2011-08-01
End date: 2011-09-01
Cinacalcet Hydrochloride
Dosage: 30 mg, qd
Administration route: Oral
Indication: Hyperparathyroidism Secondary
Start date: 2011-08-01
End date: 2011-09-01
Other drugs received by patient: Ferroglycine Sulfate Complex; Atacand; Lasix
Possible Renvela side effects in 68 year old female
Reported by a physician from Germany on 2012-02-21
Patient: 68 year old female, weighing 75.0 kg (165.0 pounds)
Reactions: Duodenal Ulcer, Gastrooesophageal Reflux Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cinacalcet Hydrochloride
Dosage: 30 mg, qd
Administration route: Oral
Indication: Hyperparathyroidism Secondary
Start date: 2011-08-01
End date: 2011-09-01
Renvela
Dosage: unk
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2011-08-01
End date: 2011-09-01
Other drugs received by patient: Ferrous Sulfate TAB; Atacand; Lasix
Possible Renvela side effects in
Reported by a consumer/non-health professional from United States on 2012-02-17
Patient:
Reactions: Peritoneal Fluid Analysis Abnormal, Dyspnoea, Arterial Disorder, Catabolic State, Nausea, Aortic Aneurysm, Restless Legs Syndrome, Gastrointestinal Necrosis, Ascites, Liver Disorder, Post Embolisation Syndrome, Heart Rate Decreased, Abdominal Wall Disorder, Gastrointestinal Disorder, DRY Gangrene, Pleural Effusion, Gait Disturbance, Intestinal Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renvela
Dosage: 0.8 g, unk
Administration route: Oral
Phenergan
Dosage: unk
Indication: Nausea
Renvela
Dosage: 7.2 g, qd
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2011-07-01
Other drugs received by patient: Nebivolol; Nebivolol; Paxil; Paxil
Possible Renvela side effects in
Reported by a consumer/non-health professional from United States on 2012-02-07
Patient:
Reactions: Hospitalisation, Diarrhoea, Diarrhoea Haemorrhagic
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renvela
Dosage: 0.8 g, bid
Administration route: Oral
Indication: Renal Failure Chronic
Start date: 2011-11-01
End date: 2011-12-01
Renvela
Dosage: 0.8 g, bid
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2012-01-01
Renagel
Dosage: unk
Indication: Hyperphosphataemia
Start date: 2009-01-01
Possible Renvela side effects in female
Reported by a consumer/non-health professional from United States on 2011-12-08
Patient: female, weighing 64.4 kg (141.7 pounds)
Reactions: Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renvela
Dosage: 3.2 g, tid
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2010-11-09
Renagel
Dosage: 3.2 g, tid
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2010-01-09
Other drugs received by patient: Calcitriol; Metoprolol Tartrate; Synthroid; Creon; Norvasc; Nephro-Vite; Wellbutrin; Biotin; Omeprazole; Coumadin; Renagel
Possible Renvela side effects in female
Reported by a physician from United States on 2011-12-08
Patient: female, weighing 64.4 kg (141.7 pounds)
Reactions: Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renagel
Dosage: 3.2 g, tid
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2010-01-09
Renvela
Dosage: 3.2 g, tid
Administration route: Oral
Indication: Hyperphosphataemia
Start date: 2010-11-09
Other drugs received by patient: Renagel; Metoprolol Tartrate; Biotin; Wellbutrin; Coumadin; Calcitriol; Omeprazole; Creon; Synthroid; Norvasc; Nephro-Vite
Possible Renvela side effects in male
Reported by a consumer/non-health professional from United States on 2011-11-25
Patient: male, weighing 87.0 kg (191.4 pounds)
Reactions: Vomiting, Nausea, Adverse Event
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renvela
Other drugs received by patient: Bupropion Hydrochloride; Hydralazine Hydrochloride; Aspirin; Sensipar; Valium; Coumadin; Vitamin D; Lisinopril; Omeprazole; Renagel; Vitamin B Complex CAP; Carvedilol; Nitroglycerin; DOC-Q-Lace; Dialvit; Isosorbide Mononitrate; Crestor; Amlodipine; Nitroglycerin; Hydrocodone Bitartrate and Acetaminophen; Albuterol; Oxygen
Possible Renvela side effects in female
Reported by a physician from Philippines on 2011-10-28
Patient: female
Reactions: Cholecystitis Acute, Palpitations
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renvela
Other drugs received by patient: Ketolog; Lisinopril; Sodium Bicarbonate; Atorvastatin Calcium; Bisoprolol; Aliskiren; Allopurinol; Furosemide; Calcium Carbonate
Possible Renvela side effects in 50 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2011-10-27
Patient: 50 year old male
Reactions: Pancreatitis Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Capenon
Dosage: 2 df, qd
Administration route: Oral
Indication: Hypertension
Fosrenol
Dosage: 1000 mg, tid
Administration route: Oral
Indication: Hyperphosphataemia
Intelence
Dosage: 400 mg, qd
Administration route: Oral
Indication: HIV Infection
Reyataz
Dosage: 400 mg, qd
Administration route: Oral
Indication: HIV Infection
Start date: 2010-01-01
Videx
Dosage: 100 mg, qd
Administration route: Oral
Indication: HIV Infection
Start date: 2010-04-21
End date: 2011-07-15
Furosemide
Dosage: 40 mg, qd
Administration route: Oral
Indication: Hypertension
Renvela
Dosage: 2.4 g, bid
Administration route: Oral
Indication: Hyperphosphataemia
Possible Renvela side effects in
Reported by a consumer/non-health professional from Costa Rica on 2011-10-24
Patient:
Reactions: Device Related Sepsis, Metaplasia, Gastritis Erosive, Anaemia, Pyrexia, Gastritis, Abdominal Pain Upper, Malaise, Pseudomonas Test Positive, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renvela
Other drugs received by patient: Cimetidine; Amlodipine; Fluconazole
Possible Renvela side effects in female
Reported by a consumer/non-health professional from United States on 2011-10-21
Patient: female
Reactions: Nausea, Pain, Intestinal Obstruction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Renvela
Dosage: 2.4 g, tid
Administration route: Oral
Indication: Hyperphosphataemia
Renagel
Administration route: Oral
Indication: Hyperphosphataemia
Possible Renvela side effects in male
Reported by a physician from Costa Rica on 2011-10-21
Patient: male, weighing 60.0 kg (132.0 pounds)
Reactions: Gastrointestinal Perforation, Metabolic Acidosis, Haemodynamic Instability
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Renvela
Dosage: 1.6 g, tid
Start date: 2011-03-16
Renvela
Dosage: 0.8 g, tid
Administration route: Oral
Indication: Hyperphosphataemia
Other drugs received by patient: Iron; Colchicine; Folic Acid; Hydralazine HCL; Indomethacin; Kayexalate; Metildopa
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