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Prolia (Denosumab) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (3624)

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

 Reports 1 - 30 of 3624   Next >>

Possible Prolia side effects in 60 year old female

Reported by a physician from United States on 2012-08-27

Patient: 60 year old female, weighing 55.3 kg (121.7 pounds)

Reactions: Arthralgia, Sciatica, Abasia, Alopecia, Osteopenia

Drug(s) suspected as cause:
Prolia
    Dosage: 60 mg, q6mo
    Indication: Osteoporosis Postmenopausal
    Start date: 2011-04-21

Prolia

Other drugs received by patient: Ibuprofen (Advil)



Possible Prolia side effects in

Reported by a consumer/non-health professional from Slovenia on 2012-08-27

Patient:

Reactions: Osteonecrosis of JAW

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 81 year old female

Reported by a consumer/non-health professional from Canada on 2012-08-27

Patient: 81 year old female, weighing 50.0 kg (110.0 pounds)

Reactions: Pelvic Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 73 year old male

Reported by a consumer/non-health professional from Canada on 2012-08-27

Patient: 73 year old male, weighing 84.1 kg (185.0 pounds)

Reactions: Coma, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in female

Reported by a physician from United States on 2012-08-26

Patient: female

Reactions: Insomnia, Vertigo, Mood Swings, Depression

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Effexor XR; Antidepressants; Antipsychotics



Possible Prolia side effects in 56 year old female

Reported by a consumer/non-health professional from Greece on 2012-08-26

Patient: 56 year old female

Reactions: Panic Attack, Fatigue, Musculoskeletal Pain, Chest Pain, Muscular Weakness, Atrial Fibrillation, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Lepur; Thyro; Carvedilol



Possible Prolia side effects in 69 year old female

Reported by a physician from Sweden on 2012-08-24

Patient: 69 year old female, weighing 59.7 kg (131.3 pounds)

Reactions: Pneumonia, Urinary Tract Infection, Sinusitis, Spondylitis, Pain in JAW

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Tegretol; Kalcipos-D



Possible Prolia side effects in 91 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 91 year old female

Reactions: HIP Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 85 year old female

Reported by a pharmacist from Spain on 2012-08-24

Patient: 85 year old female

Reactions: Hypocalcaemia, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Osteonecrosis of JAW

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 30 year old female

Reported by a physician from Puerto Rico on 2012-08-24

Patient: 30 year old female, weighing 46.7 kg (102.8 pounds)

Reactions: Vertigo, Dizziness, Ear Infection, Cystitis, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Provera; Premarin



Possible Prolia side effects in 81 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 81 year old female

Reactions: Myalgia, Pain in Extremity, Arthralgia, Cerebrovascular Accident

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Levothyroxine Sodium; Lisinopril; Metoprolol Tartrate



Possible Prolia side effects in female

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

Patient: female

Reactions: Urinary Tract Disorder, Urinary Tract Infection, Hyponatraemia, Urosepsis, Asthenia, Sarcopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in male

Reported by a consumer/non-health professional from Germany on 2012-08-23

Patient: male

Reactions: Drug Administration Error

Drug(s) suspected as cause:
Prolia
    Dosage: unk
    Indication: Prostate Cancer Metastatic

Prolia
    Indication: Metastases To Bone



Possible Prolia side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female, weighing 51.7 kg (113.8 pounds)

Reactions: Arthralgia, Balance Disorder, Tenderness, Muscle Rupture, Inflammation

Drug(s) suspected as cause:
Prolia
    Dosage: 60 mg, 1 injection
    Indication: Osteoporosis
    Start date: 2011-08-01

Prolia



Possible Prolia side effects in 79 year old female

Reported by a physician from United States on 2012-08-23

Patient: 79 year old female, weighing 64.9 kg (142.7 pounds)

Reactions: Tooth Loss, Tooth Fracture, Adverse Event

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 78 year old female

Reported by a physician from Czech Republic on 2012-08-23

Patient: 78 year old female

Reactions: Osteonecrosis of JAW, Tooth Extraction

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 85 year old female

Reported by a physician from United States on 2012-08-23

Patient: 85 year old female

Reactions: Cellulitis

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 81 year old female

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

Patient: 81 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Osteonecrosis of JAW, Neck Pain, Pain in JAW

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 44 year old female

Reported by a physician from Slovakia (Slovak Republic) on 2012-08-23

Patient: 44 year old female, weighing 71.0 kg (156.2 pounds)

Reactions: Tetany, Hypocalcaemia, Muscle Spasms

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Vigantol / 00318501 /; Calcium; Vitacalcin; Vitamin D / 00318501 /; Rocaltrol; Calcium Gluconate; Alfa-D3



Possible Prolia side effects in 63 year old female

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

Patient: 63 year old female, weighing 43.0 kg (94.6 pounds)

Reactions: Cellulitis, Dermatitis, Joint Effusion, Constipation, Inflammation

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Prednisolone; Femsept; Azathioprine; Mestinon; Valsartan



Possible Prolia side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Arthralgia, Abasia, Sciatica, Alopecia, Osteopenia

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Ibuprofen (Advil)



Possible Prolia side effects in female

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

Patient: female, weighing 51.7 kg (113.8 pounds)

Reactions: Arthralgia, Balance Disorder, Tenderness, Muscle Rupture, Inflammation

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 58 year old female

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

Patient: 58 year old female, weighing 111.6 kg (245.5 pounds)

Reactions: Pulmonary Hypertension, Dyspnoea, Chest Discomfort, Acrochordon, Nausea, Tachycardia, Skin Disorder, Headache, Diarrhoea, Chest Pain, Hypertension

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Metoprolol Succinate; Metformin Hydrochloride; Cozaar; Lasix; Lipitor; Allegra; Flonase; Glyburide; Vitamin D; Centrum Silver / 01292501 /; Multivitamin / 00097801 /



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 female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 65 year old female

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

Patient: 65 year old female

Reactions: Tooth Loss, Exposed Bone in JAW, Tooth Extraction

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Tramadol HCL; Zofran; Nystatin; Viactiv / 00751501 /; Meclizine; Aspirin; Amlodipine; Ambien; Prednisone; Omeprazole; Oxycontin; Flexeril; Imitrex; Clotrimazole AF; Pepcid; Potassium Chloride; Voltaren; Pramipexole Dihychloride; Vitamin D; Tofranil; Klonopin



Possible Prolia side effects in female

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

Patient: female

Reactions: Sepsis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolia



Possible Prolia side effects in 80 year old female

Reported by a physician from United States on 2012-08-21

Patient: 80 year old female

Reactions: Impaired Healing, Skin Ulcer, Wound Complication

Drug(s) suspected as cause:
Prolia

Other drugs received by patient: Nexium; Tylenol Arthritis; Morphine; Glycolax; Coumadin; Calcium; Vitamin D; Mobic



Possible Prolia side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: female

Reactions: Chest Pain, Hypoaesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolia



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