78/100 · Elevated
Manufactured by Amgen, Inc
Denosumab Adverse Events: High Seriousness and Diverse Reactions
278,448 FDA adverse event reports analyzed
Last updated: 2026-05-12
DENOSUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen, Inc. Based on analysis of 278,448 FDA adverse event reports, DENOSUMAB has a safety score of 78 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for DENOSUMAB include OFF LABEL USE, DEATH, ARTHRALGIA, OSTEONECROSIS OF JAW, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DENOSUMAB.
Denosumab has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 278,448 adverse event reports for this medication, which is primarily manufactured by Amgen, Inc.
The most commonly reported adverse events include Off Label Use, Death, Arthralgia. Of classified reports, 53.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Denosumab has a high rate of serious adverse events, particularly related to death and osteonecrosis of the jaw.
The most common reactions include pain, fatigue, and falls, indicating a broad range of potential side effects. Serious reactions such as pneumonia and spinal fractures are also frequently reported.
Patients taking Denosumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Denosumab is contraindicated in patients with osteonecrosis of the jaw and should be used with caution in patients with a history of malignancy or bone metastases. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Denosumab received a safety concern score of 78/100 (high concern). This is based on a 53.6% serious event ratio across 196,322 classified reports. The score accounts for 278,448 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 146,088, Male: 28,090, Unknown: 668. The most frequently reported age groups are age 70 (4,359 reports), age 74 (3,998 reports), age 73 (3,904 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 196,322 classified reports for DENOSUMAB:
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 reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Denosumab is contraindicated in patients with osteonecrosis of the jaw and should be used with caution in patients with a history of malignancy or bone metastases.
If you are taking Denosumab, here are important things to know. The most commonly reported side effects include off label use, death, arthralgia, osteonecrosis of jaw, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of osteonecrosis of the jaw and other serious adverse events, especially in elderly patients. Ensure proper storage and administration to avoid medication errors. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of denosumab and has not issued any additional warnings beyond those already in place.
The FDA has received approximately 278,448 adverse event reports associated with Denosumab. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Denosumab include Off Label Use, Death, Arthralgia, Osteonecrosis Of Jaw, Fatigue. By volume, the top reported reactions are: Off Label Use (36,484 reports), Death (19,928 reports), Arthralgia (8,683 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Denosumab.
Out of 196,322 classified reports, 105,168 (53.6%) were classified as serious and 91,154 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Denosumab break down by patient sex as follows: Female: 146,088, Male: 28,090, Unknown: 668. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Denosumab adverse events are: age 70: 4,359 reports, age 74: 3,998 reports, age 73: 3,904 reports, age 75: 3,888 reports, age 71: 3,878 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Denosumab adverse event reports is Amgen, Inc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Denosumab include: Pain In Extremity, Pain, Back Pain, Nausea, Diarrhoea. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Denosumab to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Denosumab has a safety concern score of 78 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Denosumab has a high rate of serious adverse events, particularly related to death and osteonecrosis of the jaw.
Key safety signals identified in Denosumab's adverse event data include: Osteonecrosis of the jaw (8425 reports). Death (19928 reports). Serious reactions (105168 reports, 53.6% of total). These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Denosumab is contraindicated in patients with osteonecrosis of the jaw and should be used with caution in patients with a history of malignancy or bone metastases. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Denosumab.
Monitor patients for signs of osteonecrosis of the jaw and other serious adverse events, especially in elderly patients. Ensure proper storage and administration to avoid medication errors.
Denosumab has 278,448 adverse event reports on file with the FDA. The most common reactions include pain, fatigue, and falls, indicating a broad range of potential side effects. The volume of reports for Denosumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of denosumab and has not issued any additional warnings beyond those already in place. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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