75/100 · Elevated
Manufactured by Aurobindo Pharma Limited
Serious Adverse Reactions Common with Fluoxetine Hydrochloride
241,604 FDA adverse event reports analyzed
Last updated: 2026-05-12
FLUOXETINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 241,604 FDA adverse event reports, FLUOXETINE HYDROCHLORIDE has a safety score of 75 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 HYDROCHLORIDE include DRUG INEFFECTIVE, NAUSEA, FATIGUE, HEADACHE, DEPRESSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUOXETINE HYDROCHLORIDE.
Fluoxetine Hydrochloride has a safety concern score of 75 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 241,604 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Drug Ineffective, Nausea, Fatigue. Of classified reports, 71.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse reactions, particularly suicidal ideation and attempts, are common.
A wide range of reactions, including cardiovascular and neurological issues, are reported. Weight changes and gastrointestinal issues are frequently reported side effects. Drug interactions and overdose are significant concerns.
Patients taking Fluoxetine Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Fluoxetine Hydrochloride can interact with other drugs, potentially leading to adverse effects. Overdose is a significant risk and should be avoided. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Fluoxetine Hydrochloride received a safety concern score of 75/100 (elevated concern). This is based on a 71.6% serious event ratio across 122,995 classified reports. The score accounts for 241,604 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: 80,642, Male: 32,078, Unknown: 495. The most frequently reported age groups are age 53 (1,754 reports), age 55 (1,717 reports), age 57 (1,716 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 122,995 classified reports for FLUOXETINE 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.
Fluoxetine Hydrochloride can interact with other drugs, potentially leading to adverse effects. Overdose is a significant risk and should be avoided.
If you are taking Fluoxetine Hydrochloride, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, fatigue, headache, depression. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Inform your healthcare provider about all medications you are taking to avoid potential drug interactions. Do not stop taking Fluoxetine Hydrochloride abruptly without consulting your doctor to prevent withdrawal symptoms. 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 Hydrochloride due to its high rate of serious adverse events. Patients should be closely monitored, especially for suicidal ideation and cardiovascular issues.
The FDA has received approximately 241,604 adverse event reports associated with Fluoxetine 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 Fluoxetine Hydrochloride include Drug Ineffective, Nausea, Fatigue, Headache, Depression. By volume, the top reported reactions are: Drug Ineffective (7,928 reports), Nausea (7,226 reports), Fatigue (7,176 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 Hydrochloride.
Out of 122,995 classified reports, 88,120 (71.6%) were classified as serious and 34,875 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 Hydrochloride break down by patient sex as follows: Female: 80,642, Male: 32,078, Unknown: 495. 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 Hydrochloride adverse events are: age 53: 1,754 reports, age 55: 1,717 reports, age 57: 1,716 reports, age 58: 1,707 reports, age 60: 1,705 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 Hydrochloride 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 Fluoxetine Hydrochloride include: Anxiety, Dizziness, Diarrhoea, Pain, Off Label Use. 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 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.
Fluoxetine Hydrochloride has a safety concern score of 75 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. Serious adverse reactions, particularly suicidal ideation and attempts, are common.
Key safety signals identified in Fluoxetine Hydrochloride's adverse event data include: Suicidal ideation and attempts are reported in 3.6% of cases.. Cardiovascular issues, including QT prolongation and arrhythmias, are noted.. Neurological symptoms such as confusion and hallucinations are frequent.. Serious reactions like death and renal failure are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Fluoxetine Hydrochloride can interact with other drugs, potentially leading to adverse effects. Overdose is a significant risk and should be avoided. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Fluoxetine Hydrochloride.
Inform your healthcare provider about all medications you are taking to avoid potential drug interactions. Do not stop taking Fluoxetine Hydrochloride abruptly without consulting your doctor to prevent withdrawal symptoms.
Fluoxetine Hydrochloride has 241,604 adverse event reports on file with the FDA. A wide range of reactions, including cardiovascular and neurological issues, are reported. The volume of reports for Fluoxetine Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Fluoxetine Hydrochloride due to its high rate of serious adverse events. Patients should be closely monitored, especially for suicidal ideation and cardiovascular issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Aurobindo Pharma Limited and compare their safety profiles:
The following drugs share commonly reported adverse reactions with FLUOXETINE HYDROCHLORIDE:
Drugs related to FLUOXETINE HYDROCHLORIDE based on therapeutic use, drug class, or shared indications: