82/100 · Critical
Manufactured by Aurobindo Pharma Limited
Duloxetine Adverse Events: High Seriousness and Diverse Reactions
136,561 FDA adverse event reports analyzed
Last updated: 2026-05-12
DULOXETINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 136,561 FDA adverse event reports, DULOXETINE has a safety score of 82 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 include DRUG INEFFECTIVE, FATIGUE, NAUSEA, OFF LABEL USE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DULOXETINE.
Duloxetine has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 136,561 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Drug Ineffective, Fatigue, Nausea. Of classified reports, 71.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events, including death and suicide attempts, account for 71.6% of reports.
A wide range of reactions are reported, indicating diverse safety concerns. The most common reactions include fatigue, nausea, and pain, affecting a significant number of users.
Patients taking Duloxetine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Duloxetine can interact with other drugs, including monoamine oxidase inhibitors (MAOIs), leading to serotonin syndrome. It is also contraindicated in patients with uncontrolled narrow-angle glaucoma. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Duloxetine received a safety concern score of 82/100 (high concern). This is based on a 71.6% serious event ratio across 65,013 classified reports. The score accounts for 136,561 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: 41,655, Male: 17,540, Unknown: 98. The most frequently reported age groups are age 53 (1,265 reports), age 61 (1,194 reports), age 56 (1,170 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 65,013 classified reports for DULOXETINE:
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 can interact with other drugs, including monoamine oxidase inhibitors (MAOIs), leading to serotonin syndrome. It is also contraindicated in patients with uncontrolled narrow-angle glaucoma.
If you are taking Duloxetine, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, nausea, off label use, pain. 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 depression, suicidal thoughts, and respiratory issues, especially in the first few weeks of treatment. Be aware of potential drug interactions, particularly with MAOIs and other serotonergic agents. 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 duloxetine's safety, and any new or worsening symptoms should be reported to healthcare providers immediately. Regular monitoring is recommended, especially for elderly patients.
The FDA has received approximately 136,561 adverse event reports associated with Duloxetine. 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 include Drug Ineffective, Fatigue, Nausea, Off Label Use, Pain. By volume, the top reported reactions are: Drug Ineffective (5,074 reports), Fatigue (4,787 reports), Nausea (4,781 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.
Out of 65,013 classified reports, 46,544 (71.6%) were classified as serious and 18,469 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 break down by patient sex as follows: Female: 41,655, Male: 17,540, Unknown: 98. 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 adverse events are: age 53: 1,265 reports, age 61: 1,194 reports, age 56: 1,170 reports, age 64: 1,153 reports, age 57: 1,141 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 adverse event reports is Aurobindo Pharma Limited. 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 include: Headache, Diarrhoea, Dizziness, Fall, Vomiting. 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 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 has a safety concern score of 82 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. Serious adverse events, including death and suicide attempts, account for 71.6% of reports.
Key safety signals identified in Duloxetine's adverse event data include: Suicide attempts and completed suicides are reported, indicating a significant risk.. Serious respiratory issues, such as dyspnea and pneumonia, are notable.. Serotonin syndrome is reported, highlighting potential interaction risks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Duloxetine can interact with other drugs, including monoamine oxidase inhibitors (MAOIs), leading to serotonin syndrome. It is also contraindicated in patients with uncontrolled narrow-angle glaucoma. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Duloxetine.
Monitor for signs of depression, suicidal thoughts, and respiratory issues, especially in the first few weeks of treatment. Be aware of potential drug interactions, particularly with MAOIs and other serotonergic agents.
Duloxetine has 136,561 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating diverse safety concerns. The volume of reports for Duloxetine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors duloxetine's safety, and any new or worsening symptoms should be reported to healthcare providers immediately. Regular monitoring is recommended, especially for elderly patients. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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