85/100 · Critical
Manufactured by Organon LLC
High Seriousness in Adverse Reactions for ALENDRONATE SODIUM
542,544 FDA adverse event reports analyzed
Last updated: 2026-05-12
ALENDRONATE SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Organon LLC. Based on analysis of 542,544 FDA adverse event reports, ALENDRONATE SODIUM has a safety score of 85 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 ALENDRONATE SODIUM include PAIN, FATIGUE, DRUG INEFFECTIVE, FEMUR FRACTURE, ARTHRALGIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALENDRONATE SODIUM.
Alendronate Sodium has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 542,544 adverse event reports for this medication, which is primarily manufactured by Organon Llc.
The most commonly reported adverse events include Pain, Fatigue, Drug Ineffective. Of classified reports, 78.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Femur fractures and falls are significant safety concerns, especially in older adults.
Rheumatoid arthritis and arthropathy are common musculoskeletal issues. Drug intolerance and ineffectiveness are frequent, indicating potential treatment challenges.
Patients taking Alendronate Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Avoid concurrent use with bisphosphonates and corticosteroids, as these can increase the risk of osteonecrosis and other bone-related issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Alendronate Sodium received a safety concern score of 85/100 (high concern). This is based on a 78.6% serious event ratio across 98,013 classified reports. The score accounts for 542,544 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: 76,863, Male: 12,152, Unknown: 411. The most frequently reported age groups are age 44 (2,296 reports), age 43 (2,272 reports), age 65 (1,749 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 98,013 classified reports for ALENDRONATE SODIUM:
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.
Avoid concurrent use with bisphosphonates and corticosteroids, as these can increase the risk of osteonecrosis and other bone-related issues.
If you are taking Alendronate Sodium, here are important things to know. The most commonly reported side effects include pain, fatigue, drug ineffective, femur fracture, arthralgia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosing instructions carefully to minimize the risk of adverse reactions. Report any unusual symptoms to your healthcare provider promptly. 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 ALENDRONATE SODIUM for safety, and updates will be issued as necessary.
The FDA has received approximately 542,544 adverse event reports associated with Alendronate Sodium. 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 Alendronate Sodium include Pain, Fatigue, Drug Ineffective, Femur Fracture, Arthralgia. By volume, the top reported reactions are: Pain (13,520 reports), Fatigue (12,771 reports), Drug Ineffective (12,333 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Alendronate Sodium.
Out of 98,013 classified reports, 77,019 (78.6%) were classified as serious and 20,994 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 Alendronate Sodium break down by patient sex as follows: Female: 76,863, Male: 12,152, Unknown: 411. 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 Alendronate Sodium adverse events are: age 44: 2,296 reports, age 43: 2,272 reports, age 65: 1,749 reports, age 59: 1,704 reports, age 68: 1,700 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 Alendronate Sodium adverse event reports is Organon Llc. 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 Alendronate Sodium include: Rheumatoid Arthritis, Alopecia, Abdominal Discomfort, Systemic Lupus Erythematosus, Rash. 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 Alendronate Sodium 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.
Alendronate Sodium has a safety concern score of 85 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. Femur fractures and falls are significant safety concerns, especially in older adults.
Key safety signals identified in Alendronate Sodium's adverse event data include: Femur fractures and falls. Rheumatoid arthritis and arthropathy. Drug intolerance and ineffectiveness. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Avoid concurrent use with bisphosphonates and corticosteroids, as these can increase the risk of osteonecrosis and other bone-related issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Alendronate Sodium.
Follow prescribed dosing instructions carefully to minimize the risk of adverse reactions. Report any unusual symptoms to your healthcare provider promptly.
Alendronate Sodium has 542,544 adverse event reports on file with the FDA. Rheumatoid arthritis and arthropathy are common musculoskeletal issues. The volume of reports for Alendronate Sodium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor ALENDRONATE SODIUM for safety, and updates will be issued as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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