72/100 · Elevated
Manufactured by SpecGx LLC
Lubiprostone Adverse Events: High Nausea and Diarrhea Rates, with Serious Reactions
19,293 FDA adverse event reports analyzed
Last updated: 2026-05-12
LUBIPROSTONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by SpecGx LLC. Based on analysis of 19,293 FDA adverse event reports, LUBIPROSTONE 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 LUBIPROSTONE include NAUSEA, DYSPNOEA, DIARRHOEA, CONSTIPATION, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LUBIPROSTONE.
Lubiprostone 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 19,293 adverse event reports for this medication, which is primarily manufactured by Specgx Llc.
The most commonly reported adverse events include Nausea, Dyspnoea, Diarrhoea. Of classified reports, 67.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea and diarrhea are the most common adverse reactions, with over 700 reports each.
Serious adverse events, including chronic kidney disease and renal failure, account for 67.2% of all reports. The majority of reports are from females, with a significant number of elderly patients (65+ years).
Patients taking Lubiprostone should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lubiprostone is contraindicated in patients with chronic kidney disease and renal failure. It should be used with caution in patients with a history of gastrointestinal disorders, as it may exacerbate symptoms. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lubiprostone received a safety concern score of 72/100 (elevated concern). This is based on a 67.2% serious event ratio across 9,104 classified reports. The score accounts for 19,293 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: 5,915, Male: 2,538, Unknown: 35. The most frequently reported age groups are age 68 (156 reports), age 69 (140 reports), age 70 (140 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 9,104 classified reports for LUBIPROSTONE:
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.
Lubiprostone is contraindicated in patients with chronic kidney disease and renal failure. It should be used with caution in patients with a history of gastrointestinal disorders, as it may exacerbate symptoms.
If you are taking Lubiprostone, here are important things to know. The most commonly reported side effects include nausea, dyspnoea, diarrhoea, constipation, drug ineffective. 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 gastrointestinal symptoms, especially nausea and diarrhea, to their healthcare provider. Avoid off-label use and follow prescribed dosing instructions to minimize the risk of adverse events. 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 lubiprostone. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 19,293 adverse event reports associated with Lubiprostone. 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 Lubiprostone include Nausea, Dyspnoea, Diarrhoea, Constipation, Drug Ineffective. By volume, the top reported reactions are: Nausea (765 reports), Dyspnoea (621 reports), Diarrhoea (581 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lubiprostone.
Out of 9,104 classified reports, 6,120 (67.2%) were classified as serious and 2,984 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 Lubiprostone break down by patient sex as follows: Female: 5,915, Male: 2,538, Unknown: 35. 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 Lubiprostone adverse events are: age 68: 156 reports, age 69: 140 reports, age 70: 140 reports, age 71: 140 reports, age 76: 136 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 Lubiprostone adverse event reports is Specgx 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 Lubiprostone include: Fatigue, Headache, Pain, Dizziness, 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 Lubiprostone 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.
Lubiprostone 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. Nausea and diarrhea are the most common adverse reactions, with over 700 reports each.
Key safety signals identified in Lubiprostone's adverse event data include: Chronic kidney disease and renal failure are key safety signals, with 334 and 259 reports respectively.. There are multiple reports of serious infections, including pneumonia and sepsis.. Off-label use is a notable safety signal, with 318 reports indicating potential misuse.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lubiprostone is contraindicated in patients with chronic kidney disease and renal failure. It should be used with caution in patients with a history of gastrointestinal disorders, as it may exacerbate symptoms. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lubiprostone.
Patients should report any gastrointestinal symptoms, especially nausea and diarrhea, to their healthcare provider. Avoid off-label use and follow prescribed dosing instructions to minimize the risk of adverse events.
Lubiprostone has 19,293 adverse event reports on file with the FDA. Serious adverse events, including chronic kidney disease and renal failure, account for 67.2% of all reports. The volume of reports for Lubiprostone reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of lubiprostone. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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