ROMOSOZUMAB AQQG

N/A

Manufactured by Amgen, Inc

15,195 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ROMOSOZUMAB AQQG

ROMOSOZUMAB AQQG is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen, Inc. The most commonly reported adverse reactions for ROMOSOZUMAB AQQG include FALL, FRACTURE, ARTHRALGIA, INJECTION SITE PAIN, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ROMOSOZUMAB AQQG.

Top Adverse Reactions

FALL699 reports
FRACTURE635 reports
ARTHRALGIA561 reports
INJECTION SITE PAIN519 reports
OFF LABEL USE460 reports
BONE DENSITY ABNORMAL456 reports
HOSPITALISATION411 reports
HEADACHE401 reports
PRODUCT STORAGE ERROR352 reports
PAIN IN EXTREMITY277 reports
SPINAL FRACTURE275 reports
DEATH272 reports
INJECTION SITE SWELLING271 reports
PAIN266 reports
INJECTION SITE ERYTHEMA259 reports
FEMUR FRACTURE254 reports
FATIGUE244 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR224 reports
DIZZINESS213 reports
BONE PAIN201 reports
CARDIAC FAILURE197 reports
NAUSEA184 reports
BACK PAIN183 reports
RASH180 reports
MYALGIA179 reports
SPINAL COMPRESSION FRACTURE166 reports
DRUG INEFFECTIVE160 reports
MYOCARDIAL INFARCTION157 reports
BONE DENSITY DECREASED150 reports
PNEUMONIA150 reports
COMPRESSION FRACTURE148 reports
RENAL IMPAIRMENT147 reports
CEREBROVASCULAR ACCIDENT137 reports
MUSCLE SPASMS129 reports
DYSPNOEA128 reports
ILL DEFINED DISORDER125 reports
UNEVALUABLE EVENT124 reports
PRURITUS117 reports
TRANSIENT ISCHAEMIC ATTACK117 reports
INTERCEPTED PRODUCT ADMINISTRATION ERROR115 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS115 reports
ADVERSE EVENT112 reports
FEMORAL NECK FRACTURE111 reports
MALAISE111 reports
CHEST PAIN110 reports
PERIPHERAL SWELLING110 reports
URTICARIA108 reports
ATRIAL FIBRILLATION107 reports
PARAESTHESIA104 reports
THERAPY INTERRUPTED103 reports
HYPERTENSION101 reports
PAIN IN JAW101 reports
THERAPY NON RESPONDER101 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION100 reports
FEELING ABNORMAL99 reports
INSOMNIA98 reports
INJECTION SITE PRURITUS95 reports
INJECTION SITE REACTION95 reports
TOOTH DISORDER95 reports
ALOPECIA94 reports
DIARRHOEA93 reports
PYREXIA93 reports
INJECTION SITE MASS92 reports
ARRHYTHMIA91 reports
ASTHENIA89 reports
CEREBRAL INFARCTION89 reports
HYPOCALCAEMIA86 reports
HYPOAESTHESIA85 reports
LOSS OF CONSCIOUSNESS85 reports
PALPITATIONS85 reports
GAIT DISTURBANCE84 reports
PRODUCT DOSE OMISSION ISSUE83 reports
COVID 1981 reports
BLOOD PRESSURE INCREASED80 reports
HIP FRACTURE80 reports
ANGINA PECTORIS79 reports
BLOOD ALKALINE PHOSPHATASE INCREASED73 reports
OSTEOPOROSIS73 reports
OSTEONECROSIS OF JAW72 reports
BLOOD CALCIUM DECREASED68 reports
LUMBAR VERTEBRAL FRACTURE68 reports
VOMITING68 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE66 reports
URINARY TRACT INFECTION65 reports
INJECTION SITE WARMTH64 reports
WEIGHT DECREASED64 reports
DECREASED APPETITE63 reports
THORACIC VERTEBRAL FRACTURE63 reports
INJECTION SITE URTICARIA62 reports
ILLNESS61 reports
SURGERY61 reports
DEMENTIA59 reports
NECK PAIN59 reports
INJURY ASSOCIATED WITH DEVICE58 reports
RADIUS FRACTURE58 reports
ACUTE MYOCARDIAL INFARCTION57 reports
CHEST DISCOMFORT57 reports
WEIGHT INCREASED57 reports
ACCIDENTAL EXPOSURE TO PRODUCT56 reports
MOBILITY DECREASED55 reports

Report Outcomes

Out of 12,137 classified reports for ROMOSOZUMAB AQQG:

Serious 56.6%Non-Serious 43.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female8,625 (92.9%)
Male659 (7.1%)
Unknown3 (0.0%)

Reports by Age

Age 78200 reports
Age 75196 reports
Age 77191 reports
Age 80188 reports
Age 70182 reports
Age 72175 reports
Age 76174 reports
Age 73173 reports
Age 68172 reports
Age 82171 reports
Age 66168 reports
Age 79166 reports
Age 74165 reports
Age 81155 reports
Age 83155 reports
Age 84153 reports
Age 71152 reports
Age 85151 reports
Age 86146 reports
Age 69142 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ROMOSOZUMAB AQQG?

This profile reflects 15,195 FDA FAERS reports that mention ROMOSOZUMAB AQQG. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ROMOSOZUMAB AQQG?

Frequently reported terms in FAERS include FALL, FRACTURE, ARTHRALGIA, INJECTION SITE PAIN, OFF LABEL USE, BONE DENSITY ABNORMAL. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ROMOSOZUMAB AQQG?

Labeling and FAERS entries often list Amgen, Inc in connection with ROMOSOZUMAB AQQG. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.