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Zemplar (Paricalcitol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zemplar (Paricalcitol) 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 (353)
Death (102)
Life Threatening Events (14)
Disability (5)

Reports by Reaction Type

Dyspnoea (26)Death (17)Cardiac Failure (16)Diarrhoea (16)Renal Failure Chronic (15)Fatigue (14)Dizziness (14)Myocardial Infarction (14)Nausea (13)Cardiac Arrest (13)General Physical Health Deterioration (12)Renal Failure (12)

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

Possible Zemplar side effects in 75 year old female

Reported by a physician from Germany on 2012-08-23

Patient: 75 year old female, weighing 77.0 kg (169.4 pounds)

Reactions: Spinal Fracture, Gastroenteritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Aranesp



Possible Zemplar side effects in female

Reported by a physician from Germany on 2012-08-23

Patient: female, weighing 64.0 kg (140.8 pounds)

Reactions: Metabolic Acidosis, Hyperkalaemia, Iron Deficiency Anaemia, Bile Duct Stone, Tooth Extraction, Phosphorus Metabolism Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemplar
    Indication: Renal Failure Chronic
    Start date: 2010-12-10

Zemplar
    Indication: Hyperparathyroidism Secondary

Other drugs received by patient: Carbabeta; Renagel; Iron(ii)succinate (Ferrlecit); Colecalciferole (Dekristol); Aranesp; Aranesp; Acetylsalicylic Acid SRT; Methimazole; Citalopram Hydrobromide; Amlodipine; Omeprazole; Nephrotrans; Methimazole; Losartan (Lorzaar); Aranesp; Benazepril Hydrochloride



Possible Zemplar side effects in 61 year old male

Reported by a physician from Germany on 2012-08-22

Patient: 61 year old male, weighing 123.0 kg (270.6 pounds)

Reactions: Hospitalisation, Diabetic Retinopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemplar



Possible Zemplar side effects in female

Reported by a physician from Romania on 2012-08-21

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Renal Hypertension, Oedematous Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Spironolactone; Furosemide; Allopurinol; Sodium Bicarbonate; Cozaar; Atorvastatin; Diltiazem



Possible Zemplar side effects in male

Reported by a physician from Germany on 2012-08-20

Patient: male, weighing 81.5 kg (179.3 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Silapo; Torsemide; Bimatoprost and Timolol Maleate; Humalog; Dreisavit N; Propranolol; Huminsulin Basal; Iron (Ferrlecit); Calcium, Magnesium (Osvaren); Pantoprazole; Calcitriol; Diclofenac; Silapo; Allopurinol; Vitamin B-12



Possible Zemplar side effects in 64 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-14

Patient: 64 year old female, weighing 70.3 kg (154.7 pounds)

Reactions: Vomiting, Diarrhoea, Nausea, Hypotension, Rhinorrhoea, Heart Rate Irregular, Decreased Appetite

Drug(s) suspected as cause:
Zemplar



Possible Zemplar side effects in male

Reported by a physician from Austria on 2012-08-14

Patient: male, weighing 50.0 kg (110.0 pounds)

Reactions: Emphysema, Hyperphosphataemia, Wheezing, General Physical Health Deterioration, Arrhythmia, Dyspnoea Exertional, Diarrhoea, Breath Sounds Abnormal, Hypocalcaemia, Urinary Retention, Splenic Calcification, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sevelamer Hydrochloride
    Administration route: Oral
    Indication: Hyperphosphataemia
    Start date: 2011-03-07
    End date: 2012-06-07

Zemplar
    Dosage: 2 x 2 cps per week
    Indication: Hyperparathyroidism
    Start date: 2012-02-06
    End date: 2012-04-23

Zemplar
    Dosage: 3 x 4 caps/week (monday, wednesday,friday)
    Start date: 2012-04-23
    End date: 2012-07-04

Other drugs received by patient: Aeromuc; Carvedilol; Trospium Chloride; Rocaltrol; Ferrlecit; Lasix; Calc Acet; Erypo; Carvedilol; Folsan; Maxi Kalz; CPS



Possible Zemplar side effects in male

Reported by a physician from United States on 2012-08-14

Patient: male, weighing 70.8 kg (155.8 pounds)

Reactions: Death, Cellulitis, Oedema Peripheral

Adverse event resulted in: death

Drug(s) suspected as cause:
Zemplar
    Indication: Hyperparathyroidism Secondary

Zemplar
    Indication: Renal Failure Chronic
    Start date: 2010-09-01
    End date: 2011-10-21

Other drugs received by patient: Clindamycin HCL; Acetaminophen; Triamcinolone Acetonide; NU-Iron; Imdur; Imdur; Metoprolol; Potassium Chloride; Nitroglycerin; Tamsulosin HCL; Bumex; Proscar; Levothyroxine Sodium; Warfarin Sodium; Multi-Vitamin; Warfarin Sodium; Paricalcitol; Metolazone; Digoxin



Possible Zemplar side effects in male

Reported by a physician from Austria on 2012-08-10

Patient: male, weighing 50.0 kg (110.0 pounds)

Reactions: Emphysema, Hyperphosphataemia, Wheezing, General Physical Health Deterioration, Arrhythmia, Dyspnoea Exertional, Breath Sounds Abnormal, Diarrhoea, Hypocalcaemia, Urinary Retention, Splenic Calcification, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sevelamer Hydrochloride
    Administration route: Oral
    Indication: Hyperphosphataemia
    Start date: 2011-03-07
    End date: 2012-06-07

Zemplar
    Dosage: 2 x 2 cps per week
    Indication: Hyperparathyroidism
    Start date: 2012-02-06
    End date: 2012-04-23

Zemplar
    Dosage: 3 x 4 caps/week (monday, wednesday,friday)
    Start date: 2012-04-23
    End date: 2012-07-04

Other drugs received by patient: Rocaltrol; Ferrlecit; Folsan; Lasix; Aeromuc; Carvedilol; CPS; Trospium Chloride; Maxi Kalz; Erypo; Calc Acet; Carvedilol



Possible Zemplar side effects in male

Reported by a physician from United States on 2012-08-09

Patient: male, weighing 69.5 kg (152.8 pounds)

Reactions: Chest Pain, Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Unknown Beta Blockers; Metoprolol Tartrate; Several Other Medications



Possible Zemplar side effects in male

Reported by a physician from United States on 2012-08-08

Patient: male, weighing 69.5 kg (152.8 pounds)

Reactions: Chest Pain, Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Metoprolol Tartrate; Unknown Beta Blockers; Several Other Medications



Possible Zemplar side effects in male

Reported by a physician from Austria on 2012-08-07

Patient: male, weighing 50.0 kg (110.0 pounds)

Reactions: Emphysema, Hyperphosphataemia, Wheezing, General Physical Health Deterioration, Arrhythmia, Dyspnoea Exertional, Diarrhoea, Breath Sounds Abnormal, Hypocalcaemia, Urinary Retention, Splenic Calcification, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sevelamer Hydrochloride
    Administration route: Oral
    Indication: Hyperphosphataemia
    Start date: 2011-03-07
    End date: 2012-06-07

Zemplar
    Dosage: 3 x 4 caps/week (monday, wednesday,friday)
    Start date: 2012-04-23
    End date: 2012-07-04

Zemplar
    Dosage: 2 x 2 cps per week
    Indication: Hyperparathyroidism
    Start date: 2012-02-06
    End date: 2012-04-23

Other drugs received by patient: Trospium Chloride; Rocaltrol; Calc Acet; Aeromuc; Renvela; CPS; Lasix; Maxi Kalz; Ferrlecit; Carvedilol; Carvedilol; Folsan; Erypo



Possible Zemplar side effects in male

Reported by a physician from Greece on 2012-08-06

Patient: male, weighing 55.0 kg (121.0 pounds)

Reactions: Bone Neoplasm Malignant, Dysphagia

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Calcium Carbonate; Amlodipine; Epoeitin-Alpha; Sevelamer; Atorvastatin; Amlodipine



Possible Zemplar side effects in male

Reported by a physician from Greece on 2012-08-04

Patient: male, weighing 68.0 kg (149.6 pounds)

Reactions: Angina Pectoris, Coronary Artery Occlusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Ezetimibe; Tamsulosin HCL; Manyper; Hytrin; Allopurinol; Eprex; Imdur; Catapres; Plavix; Indapamide



Possible Zemplar side effects in 48 year old male

Reported by a physician from Germany on 2012-08-02

Patient: 48 year old male, weighing 113.0 kg (248.6 pounds)

Reactions: Parathyroidectomy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemplar



Possible Zemplar side effects in 40 year old male

Reported by a physician from Germany on 2012-08-02

Patient: 40 year old male

Reactions: Renal Transplant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemplar



Possible Zemplar side effects in 77 year old female

Reported by a physician from Germany on 2012-08-01

Patient: 77 year old female, weighing 59.5 kg (130.9 pounds)

Reactions: Femur Fracture, Fluid Retention

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Aranesp; Dekristol; Berodual; Calcet; Magnesium; Dreisavit; Metamizol; Heparin; Repaglinide; Fluticasone Propionate / Salmeterol; Torsemide; Spiriva; Spironolactone; Falithrom; Fluvastatin Sodium; Lyrica



Possible Zemplar side effects in 84 year old

Reported by a physician from Germany on 2012-08-01

Patient: 84 year old

Reactions: Dyspnoea Exertional, General Physical Health Deterioration, Coronary Artery Disease, Fall, Myocardial Infarction, Asthenia

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Erypo; Simvastatin; Frrlecit; Creon; Aspirin; Pantoprazole; Fosrenol



Possible Zemplar side effects in 47 year old male

Reported by a physician from Germany on 2012-08-01

Patient: 47 year old male, weighing 113.0 kg (248.6 pounds)

Reactions: Catheterisation Cardiac, Thyroid Neoplasm

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemplar



Possible Zemplar side effects in 47 year old male

Reported by a physician from Germany on 2012-08-01

Patient: 47 year old male, weighing 113.0 kg (248.6 pounds)

Reactions: Restless Legs Syndrome, Central Nervous System Lesion, Toxicity To Various Agents, Cerebellar Syndrome

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Dekristol



Possible Zemplar side effects in 82 year old female

Reported by a physician from Greece on 2012-08-01

Patient: 82 year old female

Reactions: Acute Pulmonary Oedema, Cardiac Failure, Renal Failure Chronic, Respiratory Tract Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Plavix; Allopurinol; Adalat CC; Lipitor; Aranesp



Possible Zemplar side effects in male

Reported by a physician from Germany on 2012-07-31

Patient: male, weighing 81.0 kg (178.2 pounds)

Reactions: Metastases To Central Nervous System, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Ramipril; Epoetin Alfa; Ferrlecit; Metamizole; Metoprolol Tartrate; Omeprazole; Simvastatin



Possible Zemplar side effects in male

Reported by a physician from Austria on 2012-07-25

Patient: male, weighing 50.0 kg (110.0 pounds)

Reactions: Emphysema, Hyperphosphataemia, Wheezing, General Physical Health Deterioration, Arrhythmia, Dyspnoea Exertional, Breath Sounds Abnormal, Diarrhoea, Hypocalcaemia, Urinary Retention, Splenic Calcification, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sevelamer
    Administration route: Oral
    Indication: Hyperphosphataemia
    Start date: 2011-03-07
    End date: 2012-06-07

Zemplar
    Dosage: 3 x 4 caps/week (monday, wednesday,friday)
    Start date: 2012-04-23
    End date: 2012-07-04

Zemplar
    Dosage: 2 x 2 cps per week
    Indication: Hyperparathyroidism
    Start date: 2012-02-06
    End date: 2012-04-23

Other drugs received by patient: Lasix; Carvedilol; Maxi Kalz; Aeromuc; Carvedilol; Calc Acet; Calcitriol; CPS; Renvela; Erypo; Folsan; Rocaltrol; Spasmolyt Dragees; Ferrlecit



Possible Zemplar side effects in male

Reported by a physician from Greece on 2012-07-25

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Vertigo, Arteriovenous Fistula Thrombosis, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bicalutamide
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2012-05-02

Zemplar
    Indication: Hyperparathyroidism Secondary
    Start date: 2012-01-04

Other drugs received by patient: Erythropoetin; Iron; Sevelamer; Triptorelin; L-Carnitine; Lantus; Calcium Carbonate



Possible Zemplar side effects in female

Reported by a physician from Germany on 2012-07-24

Patient: female, weighing 57.0 kg (125.4 pounds)

Reactions: Uterine Leiomyoma, Menorrhagia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemplar



Possible Zemplar side effects in 73 year old female

Reported by a physician from Austria on 2012-07-23

Patient: 73 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Zemplar
    Dosage: 15mcg/week
    Indication: Hyperparathyroidism Secondary
    Start date: 2012-01-06
    End date: 2012-02-29

Zemplar
    Dosage: 10mcg/week
    Start date: 2012-02-29

Other drugs received by patient: Nexium



Possible Zemplar side effects in 76 year old male

Reported by a physician from Germany on 2012-07-23

Patient: 76 year old male, weighing 96.0 kg (211.2 pounds)

Reactions: Diabetic Foot, Coronary Artery Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Carenal; Aspirin; Xipamid; Torsemide; Nephrotrans; Ramipril



Possible Zemplar side effects in 71 year old male

Reported by a physician from Germany on 2012-07-23

Patient: 71 year old male

Reactions: Lymphostasis, Restless Legs Syndrome, Benign Prostatic Hyperplasia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Isotret; Calciumacetat; Ferlecit; Torsemide



Possible Zemplar side effects in male

Reported by a physician from Germany on 2012-07-20

Patient: male, weighing 98.5 kg (216.7 pounds)

Reactions: Weight Decreased, Vomiting, Nausea, Intervertebral Discitis, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine
    Dosage: 52 mcg per hour
    Indication: Back Pain
    Start date: 2011-12-23

Zemplar
    Dosage: 5mcg on monday and friday after dialysis
    Indication: Mesangioproliferative Glomerulonephritis
    Start date: 2011-12-02
    End date: 2012-01-23

Other drugs received by patient: Diclofenac; Concor; Pantoprazole; Abstral; Duragesic-100; Ferrlecit; Clindamycin; Aquaphor; Dekristol; Lercanidipine; Cefazolin; Carenal; Duragesic-100; Torsemide; Metoclopramide; Vergentan; Insuman; Allopurinol



Possible Zemplar side effects in female

Reported by a physician from Romania on 2012-07-19

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Renal Hypertension, Oedematous Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemplar

Other drugs received by patient: Spironolactone; Sodium Bicarbonate; Esomeprazole Magnesium; Furosemide; Esomeprazole Magnesium; Triferment; Allopurinol; Cozaar; Atorvastatin; Diltiazem; Triferment

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