72/100 · Elevated
Manufactured by Eli Lilly and Company
Duloxetine Hydrochloride Adverse Events: Significant Gastrointestinal and Psychiatric Concerns
434,529 FDA adverse event reports analyzed
Last updated: 2026-05-12
DULOXETINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Eli Lilly and Company. Based on analysis of 434,529 FDA adverse event reports, DULOXETINE HYDROCHLORIDE 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 DULOXETINE HYDROCHLORIDE include NAUSEA, FATIGUE, DRUG INEFFECTIVE, HEADACHE, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DULOXETINE HYDROCHLORIDE.
Duloxetine Hydrochloride 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 434,529 adverse event reports for this medication, which is primarily manufactured by Eli Lilly And Company.
The most commonly reported adverse events include Nausea, Fatigue, Drug Ineffective. Of classified reports, 61.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Gastrointestinal issues like nausea and diarrhea are common, with a high frequency of serious reports.
Psychiatric symptoms such as depression, anxiety, and suicidal ideation are prevalent and serious. Drug interactions and withdrawal syndrome are reported, requiring careful monitoring.
Patients taking Duloxetine Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Duloxetine may interact with other medications, and patients should be monitored for withdrawal symptoms when discontinuing the drug. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Duloxetine Hydrochloride received a safety concern score of 72/100 (elevated concern). This is based on a 61.4% serious event ratio across 181,563 classified reports. The score accounts for 434,529 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: 126,365, Male: 43,830, Unknown: 342. The most frequently reported age groups are age 55 (3,174 reports), age 53 (3,114 reports), age 60 (3,008 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 181,563 classified reports for DULOXETINE HYDROCHLORIDE:
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.
Duloxetine may interact with other medications, and patients should be monitored for withdrawal symptoms when discontinuing the drug.
If you are taking Duloxetine Hydrochloride, here are important things to know. The most commonly reported side effects include nausea, fatigue, drug ineffective, headache, dizziness. 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 prescribed dosing instructions and do not alter the dose without medical advice. 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 adverse events and may require additional safety measures or labeling changes based on ongoing data.
The FDA has received approximately 434,529 adverse event reports associated with Duloxetine Hydrochloride. 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 Duloxetine Hydrochloride include Nausea, Fatigue, Drug Ineffective, Headache, Dizziness. By volume, the top reported reactions are: Nausea (17,479 reports), Fatigue (15,603 reports), Drug Ineffective (13,692 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Duloxetine Hydrochloride.
Out of 181,563 classified reports, 111,560 (61.4%) were classified as serious and 70,003 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 Duloxetine Hydrochloride break down by patient sex as follows: Female: 126,365, Male: 43,830, Unknown: 342. 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 Duloxetine Hydrochloride adverse events are: age 55: 3,174 reports, age 53: 3,114 reports, age 60: 3,008 reports, age 50: 2,952 reports, age 57: 2,922 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 Duloxetine Hydrochloride adverse event reports is Eli Lilly And Company. 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 Duloxetine Hydrochloride include: Pain, Diarrhoea, Insomnia, Off Label Use, Anxiety. 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 Duloxetine Hydrochloride 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.
Duloxetine Hydrochloride 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. Gastrointestinal issues like nausea and diarrhea are common, with a high frequency of serious reports.
Key safety signals identified in Duloxetine Hydrochloride's adverse event data include: High incidence of serious gastrointestinal reactions (e.g., nausea, diarrhea, vomiting).. Psychiatric symptoms including depression, anxiety, and suicidal ideation are frequent and serious.. Reports of drug interactions and withdrawal syndrome highlight the need for caution.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Duloxetine may interact with other medications, and patients should be monitored for withdrawal symptoms when discontinuing the drug. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Duloxetine Hydrochloride.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions and do not alter the dose without medical advice.
Duloxetine Hydrochloride has 434,529 adverse event reports on file with the FDA. Psychiatric symptoms such as depression, anxiety, and suicidal ideation are prevalent and serious. The volume of reports for Duloxetine Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors adverse events and may require additional safety measures or labeling 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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