72/100 · Elevated
Manufactured by Allergan, Inc.
High Incidence of Pain and Gastrointestinal Issues with Risedronate Sodium
143,309 FDA adverse event reports analyzed
Last updated: 2026-05-12
RISEDRONATE SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. Based on analysis of 143,309 FDA adverse event reports, RISEDRONATE SODIUM has a safety score of 72 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 RISEDRONATE SODIUM include ARTHRALGIA, DRUG INEFFECTIVE, PAIN, NAUSEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RISEDRONATE SODIUM.
Risedronate Sodium has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 143,309 adverse event reports for this medication, which is primarily manufactured by Allergan, Inc..
The most commonly reported adverse events include Arthralgia, Drug Ineffective, Pain. Of classified reports, 82.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Pain and gastrointestinal issues are the most common adverse reactions, with over 10,000 reports each.
Serious adverse events, such as pneumonia and femur fracture, account for 82.8% of all reports. The majority of reports are from females, with a significant number of adverse events reported in the 65-75 age range.
Patients taking Risedronate Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions are not commonly reported, but patients should be warned about potential risks of falls and musculoskeletal issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Risedronate Sodium received a safety concern score of 72/100 (elevated concern). This is based on a 82.8% serious event ratio across 30,096 classified reports. The score accounts for 143,309 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 23,735, Male: 3,960, Unknown: 74. The most frequently reported age groups are age 65 (1,201 reports), age 43 (937 reports), age 76 (650 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 30,096 classified reports for RISEDRONATE 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.
Drug interactions are not commonly reported, but patients should be warned about potential risks of falls and musculoskeletal issues.
If you are taking Risedronate Sodium, here are important things to know. The most commonly reported side effects include arthralgia, drug ineffective, pain, nausea, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any unusual symptoms to their healthcare provider immediately. Follow prescribed dosing instructions and do not exceed recommended doses. 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 Risedronate Sodium, and updates will be provided as necessary.
The FDA has received approximately 143,309 adverse event reports associated with Risedronate 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 Risedronate Sodium include Arthralgia, Drug Ineffective, Pain, Nausea, Fatigue. By volume, the top reported reactions are: Arthralgia (3,731 reports), Drug Ineffective (3,620 reports), Pain (3,613 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Risedronate Sodium.
Out of 30,096 classified reports, 24,907 (82.8%) were classified as serious and 5,189 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 Risedronate Sodium break down by patient sex as follows: Female: 23,735, Male: 3,960, Unknown: 74. 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 Risedronate Sodium adverse events are: age 65: 1,201 reports, age 43: 937 reports, age 76: 650 reports, age 64: 638 reports, age 78: 585 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 Risedronate Sodium adverse event reports is Allergan, 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 Risedronate Sodium include: Off Label Use, Dyspnoea, Vomiting, Diarrhoea, Pneumonia. 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 Risedronate 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.
Risedronate Sodium has a safety concern score of 72 out of 100 (elevated 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. Pain and gastrointestinal issues are the most common adverse reactions, with over 10,000 reports each.
Key safety signals identified in Risedronate Sodium's adverse event data include: Pain (arthralgia, joint swelling, musculoskeletal stiffness) is a key safety signal.. Gastrointestinal issues (nausea, vomiting, diarrhea) are also a significant safety concern.. Serious adverse events like pneumonia and femur fracture are notable.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions are not commonly reported, but patients should be warned about potential risks of falls and musculoskeletal issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Risedronate Sodium.
Patients should report any unusual symptoms to their healthcare provider immediately. Follow prescribed dosing instructions and do not exceed recommended doses.
Risedronate Sodium has 143,309 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and femur fracture, account for 82.8% of all reports. The volume of reports for Risedronate Sodium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Risedronate Sodium, and updates will be provided as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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