This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Prolia (Denosumab) 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 (3624)
Death (161)
Life Threatening Events (21)
Disability (39)
Reports by Reaction Type
Pain in Extremity (348),
Back Pain (330),
Arthralgia (289),
Rash (223),
Pain (212),
Myalgia (197),
Osteonecrosis of JAW (169),
Bone Pain (161),
Pruritus (160),
Hypocalcaemia (146),
Pain in JAW (140),
Headache (135)
Below are a few examples of reports where side effects / adverse reactions may be related to Prolia (Denosumab). For a complete list or a specific selection of reports, please use the links above.
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 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 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 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 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 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 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 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 45 year old female
Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-21
Patient: 45 year old female
Reactions: Ear Pain, Muscular Weakness, Local Swelling, Headache, Sense of Oppression, Pain in JAW
Drug(s) suspected as cause:
Neulasta
Dosage: 6 mg, q3wk
Indication: Chemotherapy
Start date: 2012-07-25
Prolia
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Metoclopramide; Ciprofloxacin; Diclofenac; Aprepitant; Metamucil / 00029101 /; Dexamethasone; Pantoprazole; Calci Chew D3; Antineoplastic Agents
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
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