85/100 · Critical
Manufactured by Alembic Pharmaceuticals Inc.
Fluoxetine Adverse Events: High Seriousness and Diverse Reactions
120,799 FDA adverse event reports analyzed
Last updated: 2026-05-12
FLUOXETINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alembic Pharmaceuticals Inc.. Based on analysis of 120,799 FDA adverse event reports, FLUOXETINE 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 FLUOXETINE include DRUG INEFFECTIVE, DRUG INTERACTION, TOXICITY TO VARIOUS AGENTS, NAUSEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUOXETINE.
Fluoxetine 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 120,799 adverse event reports for this medication, which is primarily manufactured by Alembic Pharmaceuticals Inc..
The most commonly reported adverse events include Drug Ineffective, Drug Interaction, Toxicity To Various Agents. Of classified reports, 79.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fluoxetine reports show a high percentage of serious adverse events, particularly related to suicide and overdose.
The drug is associated with a wide range of reactions, including neurological, gastrointestinal, and cardiovascular issues. Fluoxetine has a significant number of reports related to psychiatric symptoms such as depression, anxiety, and suicidal ideation.
Patients taking Fluoxetine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Fluoxetine can interact with other drugs, including monoamine oxidase inhibitors (MAOIs), leading to serotonin syndrome. It is also contraindicated with certain drugs like meperidine. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Fluoxetine received a safety concern score of 85/100 (high concern). This is based on a 79.9% serious event ratio across 64,103 classified reports. The score accounts for 120,799 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: 40,256, Male: 18,186, Unknown: 220. The most frequently reported age groups are age 52 (950 reports), age 53 (949 reports), age 61 (940 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 64,103 classified reports for FLUOXETINE:
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.
Fluoxetine can interact with other drugs, including monoamine oxidase inhibitors (MAOIs), leading to serotonin syndrome. It is also contraindicated with certain drugs like meperidine.
If you are taking Fluoxetine, here are important things to know. The most commonly reported side effects include drug ineffective, drug interaction, toxicity to various agents, nausea, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before starting fluoxetine and discuss any other medications you are taking. Monitor for signs of suicidal thoughts or behaviors, especially during the first few months of treatment. 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 fluoxetine due to its high risk of serious adverse events, particularly suicide and overdose. Patients should not stop taking the medication abruptly without consulting a healthcare provider.
The FDA has received approximately 120,799 adverse event reports associated with Fluoxetine. 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 Fluoxetine include Drug Ineffective, Drug Interaction, Toxicity To Various Agents, Nausea, Fatigue. By volume, the top reported reactions are: Drug Ineffective (3,636 reports), Drug Interaction (3,336 reports), Toxicity To Various Agents (3,316 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Fluoxetine.
Out of 64,103 classified reports, 51,198 (79.9%) were classified as serious and 12,905 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 Fluoxetine break down by patient sex as follows: Female: 40,256, Male: 18,186, Unknown: 220. 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 Fluoxetine adverse events are: age 52: 950 reports, age 53: 949 reports, age 61: 940 reports, age 57: 930 reports, age 55: 924 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 Fluoxetine adverse event reports is Alembic Pharmaceuticals 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 Fluoxetine include: Completed Suicide, Headache, Off Label Use, Anxiety, Diarrhoea. 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 Fluoxetine 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.
Fluoxetine 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. Fluoxetine reports show a high percentage of serious adverse events, particularly related to suicide and overdose.
Key safety signals identified in Fluoxetine's adverse event data include: High percentage of serious adverse events (79.9%). Multiple reports of completed suicide and suicide attempts. Significant number of drug interaction reports. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Fluoxetine can interact with other drugs, including monoamine oxidase inhibitors (MAOIs), leading to serotonin syndrome. It is also contraindicated with certain drugs like meperidine. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Fluoxetine.
Consult a healthcare provider before starting fluoxetine and discuss any other medications you are taking. Monitor for signs of suicidal thoughts or behaviors, especially during the first few months of treatment.
Fluoxetine has 120,799 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, including neurological, gastrointestinal, and cardiovascular issues. The volume of reports for Fluoxetine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors fluoxetine due to its high risk of serious adverse events, particularly suicide and overdose. Patients should not stop taking the medication abruptly without consulting a healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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