85/100 · Critical
Manufactured by Accord Healthcare Inc.
High Serious Adverse Events with Quetiapine Fumarate
134,678 FDA adverse event reports analyzed
Last updated: 2026-05-12
QUETIAPINE FUMARATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare Inc.. Based on analysis of 134,678 FDA adverse event reports, QUETIAPINE FUMARATE 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 QUETIAPINE FUMARATE include DRUG INEFFECTIVE, OFF LABEL USE, FATIGUE, PAIN, CONDITION AGGRAVATED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for QUETIAPINE FUMARATE.
Quetiapine Fumarate 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 134,678 adverse event reports for this medication, which is primarily manufactured by Accord Healthcare Inc..
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Fatigue. Of classified reports, 87.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (87.3%)
Multiple psychiatric and neurological side effects reported Significant risk of weight gain and metabolic issues
Patients taking Quetiapine Fumarate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Quetiapine fumarate can interact with other drugs, potentially leading to adverse effects. Warnings include contraindications with certain products and potential drug interactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Quetiapine Fumarate received a safety concern score of 85/100 (high concern). This is based on a 87.3% serious event ratio across 27,725 classified reports. The score accounts for 134,678 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: 15,587, Male: 9,384, Unknown: 72. The most frequently reported age groups are age 43 (1,130 reports), age 44 (685 reports), age 54 (611 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 27,725 classified reports for QUETIAPINE FUMARATE:
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.
Quetiapine fumarate can interact with other drugs, potentially leading to adverse effects. Warnings include contraindications with certain products and potential drug interactions.
If you are taking Quetiapine Fumarate, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, fatigue, pain, condition aggravated. 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 weight changes closely. 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 adverse events for Quetiapine fumarate, and regulatory actions may be taken based on ongoing safety assessments.
The FDA has received approximately 134,678 adverse event reports associated with Quetiapine Fumarate. 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 Quetiapine Fumarate include Drug Ineffective, Off Label Use, Fatigue, Pain, Condition Aggravated. By volume, the top reported reactions are: Drug Ineffective (3,493 reports), Off Label Use (2,964 reports), Fatigue (2,565 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Quetiapine Fumarate.
Out of 27,725 classified reports, 24,194 (87.3%) were classified as serious and 3,531 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 Quetiapine Fumarate break down by patient sex as follows: Female: 15,587, Male: 9,384, Unknown: 72. 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 Quetiapine Fumarate adverse events are: age 43: 1,130 reports, age 44: 685 reports, age 54: 611 reports, age 50: 516 reports, age 36: 455 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 Quetiapine Fumarate adverse event reports is Accord Healthcare 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 Quetiapine Fumarate include: Headache, Nausea, Toxicity To Various Agents, Rheumatoid Arthritis, Weight Increased. 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 Quetiapine Fumarate 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.
Quetiapine Fumarate 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. High percentage of serious adverse events (87.3%)
Key safety signals identified in Quetiapine Fumarate's adverse event data include: High number of serious adverse events like completed suicide and liver injury. Multiple reports of psychiatric conditions including depression and anxiety. Significant risk of weight gain and increased cholesterol. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Quetiapine fumarate can interact with other drugs, potentially leading to adverse effects. Warnings include contraindications with certain products and potential drug interactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Quetiapine Fumarate.
Monitor for signs of depression, suicidal thoughts, and weight changes closely. Inform healthcare providers of all medications and supplements to avoid potential drug interactions.
Quetiapine Fumarate has 134,678 adverse event reports on file with the FDA. Multiple psychiatric and neurological side effects reported The volume of reports for Quetiapine Fumarate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors adverse events for Quetiapine fumarate, and regulatory actions may be taken based on ongoing safety assessments. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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