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Prolia (Denosumab) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (21)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Prolia (Denosumab) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Prolia side effects in 71 year old female

Reported by a physician from United Kingdom on 2012-08-22

Patient: 71 year old female

Reactions: Colon Cancer, Metastases To Liver

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 88 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-17

Patient: 88 year old female, weighing 47.6 kg (104.8 pounds)

Reactions: Cellulitis, Haematoma

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Vitamin D / 00318501 /; Arimidex; Bisoprolol Fumarate; Diovan; Aspirin; Plavix



Possible Prolia side effects in 76 year old female

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

Patient: 76 year old female

Reactions: Motor Dysfunction, Coma, Thrombotic Thrombocytopenic Purpura, Amnesia, Epilepsy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Aspirin; Nolpaza; Calcium; Vitamin D; Micardis; Bisoprolol Fumarate



Possible Prolia side effects in 82 year old female

Reported by a consumer/non-health professional from Greece on 2012-07-17

Patient: 82 year old female

Reactions: Chronic Respiratory Failure, Hypocalcaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 80 year old female

Reported by a physician from Greece on 2012-07-17

Patient: 80 year old female

Reactions: Hypocalcaemia, Chronic Respiratory Failure

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 75 year old female

Reported by a physician from Greece on 2012-05-15

Patient: 75 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Hypocalcaemia, Hypoaesthesia, Asthenia, Decreased Appetite

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Kayexalate; Lacitens; Medrol; Renvela; Aranesp; Calcioral D3; Ferrous Sulfate TAB; Soluric



Possible Prolia side effects in 75 year old female

Reported by a consumer/non-health professional from Greece on 2012-04-30

Patient: 75 year old female

Reactions: Stomatitis, Skin Exfoliation, Pain, Bone Pain, Skin Disorder, Dermatitis, Respiratory Failure, Hypocalcaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Calcium



Possible Prolia side effects in 75 year old female

Reported by a consumer/non-health professional from Greece on 2012-04-30

Patient: 75 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Hypocalcaemia, Hypoaesthesia, Asthenia, Decreased Appetite

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Kayexalate; Soluric; Aranesp; Medrol; Calcioral D3; Ferrous Sulfate TAB; Lacitens; Renvela



Possible Prolia side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-04-16

Patient: 65 year old female

Reactions: Back Pain, Headache, Abdominal Pain Upper, Dysstasia, Cardio-Respiratory Arrest, Pneumothorax, Abdominal Adhesions, Influenza Like Illness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia
    Dosage: 60 mg, q6mo
    Indication: Osteoporosis Postmenopausal
    Start date: 2011-09-13

Prolia
    Dosage: 60mg, q6mo
    Start date: 2011-01-01



Possible Prolia side effects in 50 year old female

Reported by a physician from Netherlands on 2012-02-27

Patient: 50 year old female

Reactions: Tetany, Hypocalcaemia, Muscle Spasms

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Ranitidine



Possible Prolia side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-27

Patient: female, weighing 52.2 kg (114.8 pounds)

Reactions: Arthropathy, Vomiting, Nausea, Pain in Extremity, Diarrhoea, Muscular Weakness, Muscle Spasms

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Calcium 750 MG + VIT D 500 IU, + K 40 MG
    Dosage: cal + d + k only had take 1 pill 2 days oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2012-01-16
    End date: 2012-01-17

Prolia
    Dosage: subderm
    Indication: Osteoporosis
    Start date: 2012-01-04



Possible Prolia side effects in 54 year old female

Reported by a physician from Germany on 2012-02-24

Patient: 54 year old female, weighing 66.0 kg (145.2 pounds)

Reactions: Ventricular Arrhythmia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Vagantin; Metoprolol Tartrate



Possible Prolia side effects in 82 year old female

Reported by a consumer/non-health professional from Greece on 2012-02-02

Patient: 82 year old female

Reactions: Hypocalcaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 67 year old female

Reported by a physician from Canada on 2012-02-02

Patient: 67 year old female

Reactions: Cerebrovascular Accident, Cardiac Arrest

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Coumadin; Voltaren; Pantoprazole Sodium; Digoxin; Naproxin; Diovan; Synthroid; Toloxin



Possible Prolia side effects in 41 year old male

Reported by a pharmacist from United States on 2012-01-24

Patient: 41 year old male, weighing 65.0 kg (143.0 pounds)

Reactions: Hypocalcaemia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Aranesp -Albumin Free Soln -Darbepoetin Alfa-Polysorbate Soln; Zocor; Hectorol Soln -Doxercalciferol Soln; Prilosec; NA Ferric Gluc Cplx IN Sucrose; Nulecit 12.5 MG / ML Soln; Nephplex-RX; Levocarnitine; Hydrocortisone 0.5 % Crea; Phoslo 667 MG Caps; Captopril



Possible Prolia side effects in female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-01-04

Patient: female

Reactions: Death, Terminal State

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

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in female

Reported by a health professional (non-physician/pharmacist) from Germany on 2011-12-20

Patient: female

Reactions: Death, Terminal State

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

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 73 year old female

Reported by a physician from Netherlands on 2011-12-15

Patient: 73 year old female

Reactions: Pain, Hypocalcaemia, Atrial Fibrillation, Myocardial Infarction, Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Novorapid; Multivitamines and Minerals; Lidocaine W / Prilocaine; Tramadol HCL; Diazepam; Polyethylene Glycol; Calcium Carbonate; Acetylsalicylic Acid SRT; Colecalciferol; Prednisolone; Colchicine; Ferrofumaraat; Calcium; Omeprazole; Novolog MIX 70 / 30; Nadroparin / 01437702 /; Digoxin; Furosemide; Lipitor; Leflunomide; Sevelamer Carbonate; Vitamin D; Alfacalcidol; Lisinopril; Amlodipine; Nitrazepam; Calcium; Aranesp; Prednisolone; Oxycodone HCL; Allopurinol; Temazepam; Citalopram; Prednisone; Ascal Cardio; Metoprolol Tartrate; Paracetamol; Natrium Bicarbonat



Possible Prolia side effects in 73 year old female

Reported by a physician from Netherlands on 2011-12-01

Patient: 73 year old female

Reactions: Pain, Hypocalcaemia, Myocardial Infarction, Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Polyethylene Glycol; Citalopram; Novolog MIX 70 / 30; Darbepoetin Alfa; Acetaminophen; Temazepam; Novorapid; Colecalciferol; Digoxin; Furosemide; Metoprolol Tartrate; Sevelamer Carbonate; Alfacalcidol; Nadroparin / 01437702 /; Lidocaine W / Prilocaine; Prednisolone; Omeprazole; Acetylsalicylic Acid SRT; Prednisolone; Leflunomide; Oxycodone HCL; Multivitamines and Minerals; Calcium Carbonate; Atorvastatin Calcium



Possible Prolia side effects in

Reported by a physician from United States on 2011-11-18

Patient:

Reactions: Pulmonary Embolism

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 81 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-27

Patient: 81 year old female

Reactions: Haemoglobin Decreased, Colonic Haematoma, Hernia Obstructive, Gastrointestinal Obstruction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Omeprazole; Cyclizine; Sodium Cromoglicate; Amlodipine; Domperidone; Omeprazole; Acetaminophen; Symbicort

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