75/100 · Elevated
Manufactured by Atlantis Consumer Healthcare, Inc.
Significant Adverse Reactions with DocuSate Sodium - Sennosides
73,666 FDA adverse event reports analyzed
Last updated: 2026-05-12
DOCUSATE SODIUM SENNOSIDES is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Atlantis Consumer Healthcare, Inc.. Based on analysis of 73,666 FDA adverse event reports, DOCUSATE SODIUM SENNOSIDES has a safety score of 75 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 SENNOSIDES include FATIGUE, NAUSEA, DIARRHOEA, DYSPNOEA, CONSTIPATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOCUSATE SODIUM SENNOSIDES.
Docusate Sodium - Sennosides has a safety concern score of 75 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 73,666 adverse event reports for this medication, which is primarily manufactured by Atlantis Consumer Healthcare, Inc..
The most commonly reported adverse events include Fatigue, Nausea, Diarrhoea. Of classified reports, 73.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include fatigue, nausea, and diarrhea, indicating gastrointestinal side effects are prevalent.
Serious adverse events, such as death, pneumonia, and renal failure, are concerning and occur frequently. A wide range of reactions, including neurological and cardiovascular issues, suggests a diverse safety profile.
Patients taking Docusate Sodium - Sennosides should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. DocuSate Sodium - Sennosides may interact with other medications, potentially exacerbating gastrointestinal side effects or affecting electrolyte balance. Warnings include the risk of dehydration and electrolyte imbalances, especially in elderly pati This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Docusate Sodium - Sennosides received a safety concern score of 75/100 (elevated concern). This is based on a 73.2% serious event ratio across 31,389 classified reports. The score accounts for 73,666 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: 17,715, Male: 12,229, Unknown: 37. The most frequently reported age groups are age 71 (564 reports), age 68 (561 reports), age 70 (549 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 31,389 classified reports for DOCUSATE SODIUM SENNOSIDES:
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 - Sennosides may interact with other medications, potentially exacerbating gastrointestinal side effects or affecting electrolyte balance. Warnings include the risk of dehydration and electrolyte imbalances, especially in elderly pati
If you are taking Docusate Sodium - Sennosides, here are important things to know. The most commonly reported side effects include fatigue, nausea, diarrhoea, dyspnoea, constipation. 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 new or worsening symptoms to their healthcare provider immediately. Follow the prescribed dosage and do not exceed the recommended dose. 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. Healthcare providers should be vigilant about patient monitoring and consider alternative treatments for patients with a history of serious adverse eve
The FDA has received approximately 73,666 adverse event reports associated with Docusate Sodium - Sennosides. 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 - Sennosides include Fatigue, Nausea, Diarrhoea, Dyspnoea, Constipation. By volume, the top reported reactions are: Fatigue (2,785 reports), Nausea (2,539 reports), Diarrhoea (1,948 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 - Sennosides.
Out of 31,389 classified reports, 22,981 (73.2%) were classified as serious and 8,408 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 - Sennosides break down by patient sex as follows: Female: 17,715, Male: 12,229, Unknown: 37. 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 - Sennosides adverse events are: age 71: 564 reports, age 68: 561 reports, age 70: 549 reports, age 69: 545 reports, age 66: 535 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 - Sennosides 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 - Sennosides include: Death, Pain, Asthenia, Fall, 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 Docusate Sodium - Sennosides 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 - Sennosides has a safety concern score of 75 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. The most common reactions include fatigue, nausea, and diarrhea, indicating gastrointestinal side effects are prevalent.
Key safety signals identified in Docusate Sodium - Sennosides's adverse event data include: Death reports are a significant concern, with 1772 cases reported.. Renal failure and acute kidney injury are notable serious adverse events.. Cardiac issues, including atrial fibrillation and congestive heart failure, are also reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
DocuSate Sodium - Sennosides may interact with other medications, potentially exacerbating gastrointestinal side effects or affecting electrolyte balance. Warnings include the risk of dehydration and electrolyte imbalances, especially in elderly pati Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Docusate Sodium - Sennosides.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow the prescribed dosage and do not exceed the recommended dose.
Docusate Sodium - Sennosides has 73,666 adverse event reports on file with the FDA. Serious adverse events, such as death, pneumonia, and renal failure, are concerning and occur frequently. The volume of reports for Docusate Sodium - Sennosides 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. Healthcare providers should be vigilant about patient monitoring and consider alternative treatments for patients with a history of serious adverse eve For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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