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Index of reports
> Cases with Osteonecrosis of JAW (169)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Prolia (Denosumab) where reactions include osteonecrosis of jaw. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 169 Next >>
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 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 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 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 2012-08-17
Patient: 85 year old female
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Other drugs received by patient: Norvasc; Calcium Plus Vitamin D; Iron; Lisinopril; Levothyroxine Sodium; Aspirin
Possible Prolia side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13
Patient: 69 year old female, weighing 53.1 kg (116.7 pounds)
Reactions: Blood Calcium Decreased, Tooth Fracture, Osteonecrosis of JAW, Loose Tooth
Drug(s) suspected as cause:
Prolia
Dosage: 60 mg, q6mo
Indication: Osteoporosis Postmenopausal
Start date: 2010-10-07
End date: 2011-11-07
Prolia
Prolia
Other drugs received by patient: Simvastatin; Calcium; Toprol-XL; Diovan
Possible Prolia side effects in 80 year old female
Reported by a physician from United States on 2012-08-10
Patient: 80 year old female
Reactions: Death, Osteonecrosis of JAW, Osteomyelitis, Pathological Fracture
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Prolia
Other drugs received by patient: Simvastatin; Aspirin; Colace; Hydrochlorothiazide; Benadryl; Lisinopril; Loratadine; Synthroid; Ambien CR; Cyclobenzaprine; Crestor; Atenolol; Caltrate / 00751519 /; Centrum Silver / 01292501 /; Boniva
Possible Prolia side effects in female
Reported by a physician from United States on 2012-08-10
Patient: female
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Possible Prolia side effects in 72 year old female
Reported by a physician from Germany on 2012-08-09
Patient: 72 year old female, weighing 71.0 kg (156.2 pounds)
Reactions: Gingivitis, Gingival Recession, Exposed Bone in JAW, Osteonecrosis of JAW, Bone Disorder, Gingival Atrophy
Drug(s) suspected as cause:
Prolia
Other drugs received by patient: Vitamin D
Possible Prolia side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-08
Patient: female, weighing 47.6 kg (104.8 pounds)
Reactions: Device Failure, Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Other drugs received by patient: Coumadin; Ramipril; Norvasc
Possible Prolia side effects in 78 year old female
Reported by a physician from Czech Republic on 2012-08-08
Patient: 78 year old female
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Possible Prolia side effects in 70 year old male
Reported by a physician from Germany on 2012-08-03
Patient: 70 year old male, weighing 83.0 kg (182.6 pounds)
Reactions: Osteonecrosis of JAW, Tooth Extraction
Drug(s) suspected as cause:
Prolia
Other drugs received by patient: Leflunomide; Methotrexate; Aspirin; Bonviva / 01304701 /; Prednisolone; Pantoprazole
Possible Prolia side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02
Patient: female
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Possible Prolia side effects in 63 year old female
Reported by a physician from United States on 2012-08-02
Patient: 63 year old female, weighing 83.9 kg (184.6 pounds)
Reactions: Osteonecrosis of JAW, Pain, Infection
Drug(s) suspected as cause:
Prolia
Possible Prolia side effects in 86 year old female
Reported by a consumer/non-health professional from Germany on 2012-07-27
Patient: 86 year old female, weighing 45.0 kg (99.0 pounds)
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prednisolone
Dosage: 5 mg, qd
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2004-12-01
Prolia
Dosage: 60 mg, q6mo
Indication: Osteoporosis Postmenopausal
Start date: 2011-02-01
End date: 2012-02-01
Possible Prolia side effects in 70 year old female
Reported by a consumer/non-health professional from Spain on 2012-07-25
Patient: 70 year old female
Reactions: Osteonecrosis of JAW, Impaired Healing
Drug(s) suspected as cause:
Prolia
Possible Prolia side effects in 63 year old female
Reported by a consumer/non-health professional from Switzerland on 2012-07-23
Patient: 63 year old female, weighing 35.0 kg (77.0 pounds)
Reactions: Osteonecrosis of JAW
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prolia
Other drugs received by patient: Calcimagon D3; Magnesiocard; Dihydergot / 00017802 /
Possible Prolia side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-23
Patient: female
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Possible Prolia side effects in female
Reported by a physician from United States on 2012-07-23
Patient: female
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Possible Prolia side effects in 84 year old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-23
Patient: 84 year old male, weighing 66.0 kg (145.2 pounds)
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Possible Prolia side effects in female
Reported by a physician from United States on 2012-07-23
Patient: female
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Possible Prolia side effects in 70 year old male
Reported by a physician from Germany on 2012-07-19
Patient: 70 year old male, weighing 83.0 kg (182.6 pounds)
Reactions: Osteonecrosis of JAW, Tooth Extraction
Drug(s) suspected as cause:
Prolia
Other drugs received by patient: Methotrexate; Pantoprazole; Prednisolone; Leflunomide; Aspirin; Bonviva / 01304701 /
Possible Prolia side effects in 72 year old female
Reported by a physician from Germany on 2012-07-18
Patient: 72 year old female, weighing 71.0 kg (156.2 pounds)
Reactions: Gingival Recession, Gingivitis, Osteonecrosis of JAW, Exposed Bone in JAW, Bone Disorder, Gingival Atrophy
Drug(s) suspected as cause:
Prolia
Other drugs received by patient: Vitamin D
Possible Prolia side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-17
Patient: female
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Possible Prolia side effects in 63 year old female
Reported by a consumer/non-health professional from Switzerland on 2012-07-15
Patient: 63 year old female, weighing 35.0 kg (77.0 pounds)
Reactions: Osteonecrosis of JAW
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prolia
Other drugs received by patient: Calcimagon D3; Dihydergot / 00017802 /; Magnesiocard
Possible Prolia side effects in 70 year old female
Reported by a physician from Greece on 2012-07-13
Patient: 70 year old female
Reactions: Osteonecrosis of JAW, Toothache
Drug(s) suspected as cause:
Prolia
Other drugs received by patient: Antipsychotics
Possible Prolia side effects in female
Reported by a consumer/non-health professional from Luxembourg on 2012-07-13
Patient: female
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Possible Prolia side effects in female
Reported by a physician from Germany on 2012-07-13
Patient: female
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Possible Prolia side effects in 70 year old female
Reported by a physician from Germany on 2012-07-12
Patient: 70 year old female
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Other drugs received by patient: Cortisone Acetate
Possible Prolia side effects in 65 year old female
Reported by a consumer/non-health professional from United States on 2012-07-12
Patient: 65 year old female, weighing 52.2 kg (114.7 pounds)
Reactions: Osteonecrosis of JAW
Drug(s) suspected as cause:
Prolia
Prolia
Dosage: 60 mg, q6mo
Indication: Osteoporosis Postmenopausal
Start date: 2011-07-07
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