78/100 · Elevated
Manufactured by Allegiant Health
High Nausea and Fatigue Reports for DocuSate Sodium 100mg
54,665 FDA adverse event reports analyzed
Last updated: 2026-05-12
DOCUSATE SODIUM 100MG is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allegiant Health. Based on analysis of 54,665 FDA adverse event reports, DOCUSATE SODIUM 100MG 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 DOCUSATE SODIUM 100MG include NAUSEA, FATIGUE, DYSPNOEA, CONSTIPATION, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOCUSATE SODIUM 100MG.
Docusate Sodium 100mg 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 54,665 adverse event reports for this medication, which is primarily manufactured by Allegiant Health.
The most commonly reported adverse events include Nausea, Fatigue, Dyspnoea. Of classified reports, 76.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea and fatigue are the most common adverse reactions reported.
Serious adverse events, such as death and pneumonia, are also frequently reported. A wide range of reactions, including cardiovascular and respiratory issues, are noted.
Patients taking Docusate Sodium 100mg should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions are reported, and patients should be cautious when using DocuSate Sodium 100mg with other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Docusate Sodium 100mg received a safety concern score of 78/100 (high concern). This is based on a 76.6% serious event ratio across 23,006 classified reports. The score accounts for 54,665 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: 12,528, Male: 9,171, Unknown: 30. The most frequently reported age groups are age 64 (565 reports), age 71 (430 reports), age 69 (421 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 23,006 classified reports for DOCUSATE SODIUM 100MG:
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 reported, and patients should be cautious when using DocuSate Sodium 100mg with other medications.
If you are taking Docusate Sodium 100mg, here are important things to know. The most commonly reported side effects include nausea, fatigue, dyspnoea, constipation, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider if you experience severe or persistent side effects. Do not stop taking the medication without consulting your doctor. 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 closely monitors these reports and may require additional safety studies or label changes based on ongoing data.
The FDA has received approximately 54,665 adverse event reports associated with Docusate Sodium 100mg. 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 Docusate Sodium 100mg include Nausea, Fatigue, Dyspnoea, Constipation, Diarrhoea. By volume, the top reported reactions are: Nausea (1,848 reports), Fatigue (1,783 reports), Dyspnoea (1,514 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Docusate Sodium 100mg.
Out of 23,006 classified reports, 17,612 (76.6%) were classified as serious and 5,394 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 Docusate Sodium 100mg break down by patient sex as follows: Female: 12,528, Male: 9,171, Unknown: 30. 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 Docusate Sodium 100mg adverse events are: age 64: 565 reports, age 71: 430 reports, age 69: 421 reports, age 68: 416 reports, age 75: 414 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 Docusate Sodium 100mg adverse event reports is Allegiant Health. 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 Docusate Sodium 100mg include: Pain, Vomiting, Death, Off Label Use, Fall. 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 Docusate Sodium 100mg 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.
Docusate Sodium 100mg 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. Nausea and fatigue are the most common adverse reactions reported.
Key safety signals identified in Docusate Sodium 100mg's adverse event data include: Death and pneumonia are among the most serious reactions reported.. A significant number of reports involve drug ineffectiveness and fall incidents.. There are multiple reports of cardiovascular issues, including atrial fibrillation and myocardial infarction.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions are reported, and patients should be cautious when using DocuSate Sodium 100mg with other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Docusate Sodium 100mg.
Consult a healthcare provider if you experience severe or persistent side effects. Do not stop taking the medication without consulting your doctor.
Docusate Sodium 100mg has 54,665 adverse event reports on file with the FDA. Serious adverse events, such as death and pneumonia, are also frequently reported. The volume of reports for Docusate Sodium 100mg reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors these reports and may require additional safety studies or label changes based on ongoing data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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