OpenClaim

Denosumab Side Effects

The most commonly reported side effects of denosumab include off label use, death, and arthralgia, based on 196,839 FDA adverse event reports from 2007 to 2025.

Denosumab side effects

Percentages show how often each reaction appears relative to total reports for denosumab.

1
Off Label Use18.5%36,497
2
Death10.1%19,832
3
Arthralgia4.3%8,381
4
Osteonecrosis Of Jaw4.2%8,274
5
Fatigue3.7%7,363
6
Pain3.3%6,524
7
Pain In Extremity3.3%6,523
8
Back Pain3.2%6,372
9
Nausea2.6%5,162
10
Diarrhoea2.5%5,004
11
Fall2.5%4,912
12
Rash2.0%3,963
13
Myalgia2.0%3,945
14
Asthenia1.9%3,830
15
Bone Pain1.9%3,723

These are voluntary reports and do not establish that denosumab caused these reactions.

Report severity

53.6%Serious105,565 reports
15.4%Hospitalizations30,363 reports
12.8%Fatal25,141 reports

Seriousness is determined by the reporter, not by OpenClaim.

Denosumab drug interactions

Other drugs that appear in adverse event reports alongside denosumab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Palbociclib2.3%4,540
2
Lenalidomide1.6%3,126
3
Letrozole1.5%2,924
4
Trastuzumab1.2%2,382
5
Enzalutamide1.1%2,232
6
Fulvestrant1.0%2,015
7
Docetaxel0.9%1,840
8
Pertuzumab0.8%1,515
9
Capecitabine0.8%1,512
10
Zoledronic-acid0.8%1,478
11
Paclitaxel0.7%1,474
12
Ribociclib0.7%1,415
13
Abiraterone-acetate0.5%1,081
14
Everolimus0.5%1,056
15
Prednisone0.5%1,050

Taken alongside

1
Ergocalciferol8.9%17,444
2
Calcium8.2%16,121
3
Acetaminophen4.4%8,706
4
Aspirin4.1%8,155
5
Levothyroxine-sodium4.0%7,803
6
Omeprazole2.9%5,744
7
Prednisone2.7%5,293
8
Atorvastatin-calcium2.7%5,255
9
Amlodipine2.6%5,102
10
Dexamethasone2.3%4,520
11
Pantoprazole-sodium2.2%4,416
12
Metoprolol2.2%4,287
13
Furosemide2.1%4,145
14
Gabapentin1.9%3,793
15
Ondansetron1.9%3,779

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports denosumab side effects

74.4% of denosumab adverse event reports involve female patients and 14.3% involve male patients. The largest age group is elderly at 72%. These figures reflect who reports side effects, not underlying risk.

Sex

Female74.4%
Male14.3%
Unknown11.3%

Age group

< 2<0.1%
2–11<0.1%
12–170.1%
18–6427.3%
65+72.5%

What is denosumab used for

Conditions and purposes for which patients were taking denosumab when the adverse event was reported.

Abdominal DiscomfortAbdominal PainAbdominal Pain UpperAccidental PoisoningAcetabulum FractureAchlorhydriaAcoustic NeuromaAcromegalyActivated Protein C ResistanceAcute Febrile Neutrophilic DermatosisAcute Kidney InjuryAcute Myeloid LeukaemiaAcute Myocardial InfarctionAcute SinusitisAddison^s Disease

Showing 15 of 1,513 indications

Denosumab brand names and reporting trend

Denosumab is sold under the brand name Xgeva.

Brand names

Xgeva18,975

Quarterly reports (20072025)

20072010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking denosumab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.