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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ROMOSOZUMAB-AQQG: 11,361 Adverse Event Reports & Safety Profile

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11,361
Total FAERS Reports
633 (5.6%)
Deaths Reported
2,717
Hospitalizations
11,361
As Primary/Secondary Suspect
170
Life-Threatening
139
Disabilities
Prescription
Status

FDA Application: 761062 ·

First Report: 20080307 · Latest Report: 20250924

What Are the Most Common ROMOSOZUMAB-AQQG Side Effects?

#1 Most Reported
Fall
646 reports (5.7%)
#2 Most Reported
Fracture
612 reports (5.4%)
#3 Most Reported
Arthralgia
517 reports (4.6%)

All ROMOSOZUMAB-AQQG Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fall 646 5.7% 35 360
Fracture 612 5.4% 5 135
Arthralgia 517 4.6% 0 41
Injection site pain 490 4.3% 2 15
Bone density abnormal 454 4.0% 0 1
Off label use 419 3.7% 9 73
Hospitalisation 381 3.4% 7 376
Headache 360 3.2% 1 32
Product storage error 348 3.1% 0 2
Death 263 2.3% 258 19
Spinal fracture 256 2.3% 2 52
Pain in extremity 255 2.2% 0 27
Injection site swelling 254 2.2% 0 8
Injection site erythema 247 2.2% 0 8
Pain 235 2.1% 3 32
Femur fracture 231 2.0% 11 136
Circumstance or information capable of leading to medication error 222 2.0% 0 1
Fatigue 203 1.8% 0 22
Cardiac failure 193 1.7% 34 102
Bone pain 189 1.7% 1 16

Who Reports ROMOSOZUMAB-AQQG Side Effects? Age & Gender Data

Gender: 92.9% female, 7.1% male. Average age: 74.7 years. Most reports from: US. View detailed demographics →

Is ROMOSOZUMAB-AQQG Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 1 0 0
2012 1 0 0
2014 3 0 1
2015 5 1 1
2016 5 0 0
2017 10 0 1
2018 8 0 0
2019 926 98 378
2020 688 70 231
2021 763 62 261
2022 876 44 225
2023 911 30 225
2024 935 25 232
2025 483 14 139

View full timeline →

What Is ROMOSOZUMAB-AQQG Used For?

IndicationReports
Product used for unknown indication 5,202
Osteoporosis 4,398
Osteoporosis postmenopausal 1,401
Off label use 123
Osteoporotic fracture 68
Spinal fracture 50
Senile osteoporosis 42
Osteoporosis prophylaxis 40
Osteopenia 33
Fracture 26

ROMOSOZUMAB-AQQG vs Alternatives: Which Is Safer?

ROMOSOZUMAB-AQQG vs ROPEGINTERFERON ALFA-2B-NJFT ROMOSOZUMAB-AQQG vs ROPINIROLE ROMOSOZUMAB-AQQG vs ROPIVACAINE ROMOSOZUMAB-AQQG vs ROSIGLITAZONE ROMOSOZUMAB-AQQG vs ROSUVASTATIN ROMOSOZUMAB-AQQG vs ROSUVASTATIN\ROSUVASTATIN ROMOSOZUMAB-AQQG vs ROTIGOTINE ROMOSOZUMAB-AQQG vs ROXADUSTAT ROMOSOZUMAB-AQQG vs ROXICODONE ROMOSOZUMAB-AQQG vs ROXITHROMYCIN

Official FDA Label for ROMOSOZUMAB-AQQG

Official prescribing information from the FDA-approved drug label.