85/100 · Critical
Manufactured by Actavis Pharma, Inc.
Lactulose Adverse Events: High Seriousness and Diverse Reactions
81,371 FDA adverse event reports analyzed
Last updated: 2026-05-12
LACTULOSE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actavis Pharma, Inc.. Based on analysis of 81,371 FDA adverse event reports, LACTULOSE has a safety score of 85 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 LACTULOSE include NAUSEA, CONSTIPATION, FALL, VOMITING, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LACTULOSE.
Lactulose has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 81,371 adverse event reports for this medication, which is primarily manufactured by Actavis Pharma, Inc..
The most commonly reported adverse events include Nausea, Constipation, Fall. Of classified reports, 88.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with a high percentage of reports involving death and respiratory failure.
A wide range of reactions are reported, including gastrointestinal, neurological, and renal issues. The drug is frequently reported to cause falls and confusion, particularly in elderly patients.
Patients taking Lactulose should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lactulose can interact with other medications, potentially affecting their efficacy. It is important to inform healthcare providers of all medications being taken. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lactulose received a safety concern score of 85/100 (high concern). This is based on a 88.4% serious event ratio across 37,028 classified reports. The score accounts for 81,371 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: 17,911, Male: 16,682, Unknown: 70. The most frequently reported age groups are age 77 (1,148 reports), age 69 (781 reports), age 67 (717 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 37,028 classified reports for LACTULOSE:
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.
Lactulose can interact with other medications, potentially affecting their efficacy. It is important to inform healthcare providers of all medications being taken.
If you are taking Lactulose, here are important things to know. The most commonly reported side effects include nausea, constipation, fall, vomiting, fatigue. 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 serious adverse events such as respiratory failure, hepatic encephalopathy, and falls, especially in elderly patients. Inform healthcare providers of all medications and supplements to avoid potential drug interactions. 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 Lactulose's safety, and any new or worsening symptoms should be reported to healthcare providers promptly.
The FDA has received approximately 81,371 adverse event reports associated with Lactulose. 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 Lactulose include Nausea, Constipation, Fall, Vomiting, Fatigue. By volume, the top reported reactions are: Nausea (2,527 reports), Constipation (2,497 reports), Fall (2,242 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lactulose.
Out of 37,028 classified reports, 32,730 (88.4%) were classified as serious and 4,298 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 Lactulose break down by patient sex as follows: Female: 17,911, Male: 16,682, Unknown: 70. 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 Lactulose adverse events are: age 77: 1,148 reports, age 69: 781 reports, age 67: 717 reports, age 65: 710 reports, age 73: 704 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 Lactulose adverse event reports is Actavis Pharma, 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 Lactulose include: Death, Dyspnoea, Diarrhoea, Pain, 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 Lactulose 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.
Lactulose has a safety concern score of 85 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. The majority of adverse events are serious, with a high percentage of reports involving death and respiratory failure.
Key safety signals identified in Lactulose's adverse event data include: Death is a significant safety signal, with 1937 reports.. Respiratory failure and hepatic encephalopathy are also notable serious adverse events.. Falls and confusion are common, especially in older patients.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lactulose can interact with other medications, potentially affecting their efficacy. It is important to inform healthcare providers of all medications being taken. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lactulose.
Monitor for signs of serious adverse events such as respiratory failure, hepatic encephalopathy, and falls, especially in elderly patients. Inform healthcare providers of all medications and supplements to avoid potential drug interactions.
Lactulose has 81,371 adverse event reports on file with the FDA. A wide range of reactions are reported, including gastrointestinal, neurological, and renal issues. The volume of reports for Lactulose reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Lactulose's safety, and any new or worsening symptoms should be reported to healthcare providers promptly. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Actavis Pharma, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with LACTULOSE:
Drugs related to LACTULOSE based on therapeutic use, drug class, or shared indications: