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Romosozumab Side Effects

The most commonly reported side effects of romosozumab include fall, fracture, and arthralgia, based on 12,662 FDA adverse event reports from 2019 to 2025.

Romosozumab side effects

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

1
Fall5.7%727
2
Fracture5.2%661
3
Arthralgia4.6%577
4
Injection Site Pain4.3%542
5
Off Label Use3.9%489
6
Bone Density Abnormal3.6%457
7
Headache3.3%419
8
Hospitalisation3.2%411
9
Product Storage Error2.8%353
10
Spinal Fracture2.6%324
11
Death2.4%305
12
Injection Site Swelling2.2%284
13
Pain In Extremity2.2%283
14
Pain2.2%274
15
Injection Site Erythema2.1%269

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

Report severity

57.9%Serious7,337 reports
23.7%Hospitalizations2,995 reports
5.7%Fatal728 reports

Seriousness is determined by the reporter, not by OpenClaim.

Romosozumab drug interactions

Other drugs that appear in adverse event reports alongside romosozumab. 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
Denosumab7.9%999
2
Dupilumab0.2%28
3
Zoledronic-acid0.2%28
4
Prednisone0.2%27
5
Etanercept0.2%27
6
Teriparatide0.2%22
7
Alendronate-sodium0.2%21
8
Evolocumab0.2%21
9
Celecoxib0.2%20
10
Abaloparatide0.2%19
11
Adalimumab0.2%19
12
Upadacitinib0.1%18
13
Darbepoetin-alfa0.1%16
14
Rituximab0.1%16
15
Methotrexate0.1%15

Taken alongside

1
Ergocalciferol3.4%432
2
Calcium2.9%370
3
Amlodipine1.7%216
4
Levothyroxine-sodium1.7%211
5
Aspirin1.5%190
6
Acetaminophen1.4%178
7
Atorvastatin-calcium1.2%157
8
Rosuvastatin1.0%129
9
Prednisone1.0%125
10
Omeprazole0.9%120
11
Pregabalin0.9%118
12
Furosemide0.8%98
13
Celecoxib0.7%94
14
Metoprolol0.7%93
15
Magnesium-oxide0.7%91

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 romosozumab side effects

70.9% of romosozumab adverse event reports involve female patients and 5.3% involve male patients. The largest age group is elderly at 81%. These figures reflect who reports side effects, not underlying risk.

Sex

Female70.9%
Male5.3%
Unknown23.8%

Age group

< 20.0%
2–11<0.1%
12–170.0%
18–6419.1%
65+80.9%

What is romosozumab used for

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

Ankle FractureAdverse Drug ReactionArthralgiaArthritisArtificial MenopauseAtypical Femur FractureAtypical FractureBack PainBone Density AbnormalBone Density DecreasedBone DisorderBack DisorderBack PainBlood Cadmium DecreasedBlood Parathyroid Hormone Increased

Showing 15 of 107 indications

Romosozumab brand names and reporting trend

Romosozumab is sold under the brand name Evenity.

Brand names

Evenity593

Quarterly reports (20192025)

20192020202220242025

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

Taking romosozumab with another medication?

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