78/100 · Elevated
Manufactured by Atlantis Consumer Healthcare, Inc.
Docusate Sodium Adverse Events: High Fatigue and Nausea Reports
129,496 FDA adverse event reports analyzed
Last updated: 2026-05-12
DOCUSATE SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Atlantis Consumer Healthcare, Inc.. Based on analysis of 129,496 FDA adverse event reports, DOCUSATE SODIUM 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 include FATIGUE, NAUSEA, DYSPNOEA, DIARRHOEA, CONSTIPATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOCUSATE SODIUM.
Docusate Sodium 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 129,496 adverse event reports for this medication, which is primarily manufactured by Atlantis Consumer Healthcare, Inc..
The most commonly reported adverse events include Fatigue, Nausea, Dyspnoea. Of classified reports, 74.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and nausea are the most frequently reported adverse events, indicating potential gastrointestinal and general discomfort.
Serious adverse events, such as death and pneumonia, are reported but at a lower frequency compared to non-serious events. The majority of reports are from older adults, suggesting potential age-related sensitivity. Drug ineffectiveness and off-label use are also notable, indicating potential misuse or inefficacy issues.
Patients taking Docusate Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Docusate sodium may interact with other medications, particularly those affecting blood pressure and heart rate, and should be used with caution. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Docusate Sodium received a safety concern score of 78/100 (high concern). This is based on a 74.2% serious event ratio across 55,946 classified reports. The score accounts for 129,496 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: 31,152, Male: 21,982, Unknown: 69. The most frequently reported age groups are age 64 (1,078 reports), age 71 (1,023 reports), age 68 (997 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 55,946 classified reports for DOCUSATE 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.
Docusate sodium may interact with other medications, particularly those affecting blood pressure and heart rate, and should be used with caution.
If you are taking Docusate Sodium, here are important things to know. The most commonly reported side effects include fatigue, nausea, dyspnoea, diarrhoea, constipation. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of gastrointestinal issues such as fatigue and nausea, and report them to your healthcare provider. Be cautious when using docusate sodium off-label and ensure it is used as prescribed. 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 docusate sodium for safety, and any unusual symptoms should be reported to healthcare providers.
The FDA has received approximately 129,496 adverse event reports associated with Docusate 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 Docusate Sodium include Fatigue, Nausea, Dyspnoea, Diarrhoea, Constipation. By volume, the top reported reactions are: Fatigue (4,645 reports), Nausea (4,455 reports), Dyspnoea (3,477 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.
Out of 55,946 classified reports, 41,495 (74.2%) were classified as serious and 14,451 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 break down by patient sex as follows: Female: 31,152, Male: 21,982, Unknown: 69. 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 adverse events are: age 64: 1,078 reports, age 71: 1,023 reports, age 68: 997 reports, age 69: 993 reports, age 70: 966 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 adverse event reports is Atlantis Consumer Healthcare, 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 Docusate Sodium include: Pain, Death, Vomiting, Asthenia, 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 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 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. Fatigue and nausea are the most frequently reported adverse events, indicating potential gastrointestinal and general discomfort.
Key safety signals identified in Docusate Sodium's adverse event data include: Frequent reports of fatigue and nausea suggest potential gastrointestinal side effects.. High number of serious events like death and pneumonia indicate significant safety concerns.. Age distribution shows a higher number of reports from older adults, possibly due to age-related factors.. Off-label use and drug ineffectiveness are key signals indicating potential misuse or inefficacy.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Docusate sodium may interact with other medications, particularly those affecting blood pressure and heart rate, and should be used with caution. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Docusate Sodium.
Monitor for signs of gastrointestinal issues such as fatigue and nausea, and report them to your healthcare provider. Be cautious when using docusate sodium off-label and ensure it is used as prescribed.
Docusate Sodium has 129,496 adverse event reports on file with the FDA. Serious adverse events, such as death and pneumonia, are reported but at a lower frequency compared to non-serious events. The volume of reports for Docusate Sodium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor docusate sodium for safety, and any unusual symptoms should be reported to healthcare providers. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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