78/100 · Elevated
Manufactured by Accord Healthcare, Inc.
Trazodone Hydrochloride Adverse Events: High Serious Reaction Rate
32,405 FDA adverse event reports analyzed
Last updated: 2026-05-12
TRAZODONE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare, Inc.. Based on analysis of 32,405 FDA adverse event reports, TRAZODONE HYDROCHLORIDE has a safety score of 78 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 TRAZODONE HYDROCHLORIDE include DRUG INEFFECTIVE, FATIGUE, NAUSEA, HEADACHE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TRAZODONE HYDROCHLORIDE.
Trazodone Hydrochloride has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 32,405 adverse event reports for this medication, which is primarily manufactured by Accord Healthcare, Inc..
The most commonly reported adverse events include Drug Ineffective, Fatigue, Nausea. Of classified reports, 66.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High rate of serious adverse events, including death and suicide attempts.
Common side effects include fatigue, nausea, and headache. Significant number of reports involve drug interactions and overdose. Serious respiratory issues and cardiovascular events are notable.
Patients taking Trazodone Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Trazodone can interact with other drugs, leading to adverse effects. Overdose is a significant risk, and patients should be monitored closely. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Trazodone Hydrochloride received a safety concern score of 78/100 (high concern). This is based on a 66.1% serious event ratio across 15,105 classified reports. The score accounts for 32,405 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: 9,382, Male: 4,716, Unknown: 9. The most frequently reported age groups are age 56 (268 reports), age 54 (249 reports), age 66 (229 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 15,105 classified reports for TRAZODONE 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.
Trazodone can interact with other drugs, leading to adverse effects. Overdose is a significant risk, and patients should be monitored closely.
If you are taking Trazodone Hydrochloride, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, nausea, headache, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosages strictly to avoid overdose. Inform healthcare providers of all other medications to prevent 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 Trazodone's safety, and the drug carries a black box warning for suicidal ideation and behavior, especially in younger patients.
The FDA has received approximately 32,405 adverse event reports associated with Trazodone 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 Trazodone Hydrochloride include Drug Ineffective, Fatigue, Nausea, Headache, Pain. By volume, the top reported reactions are: Drug Ineffective (1,181 reports), Fatigue (1,129 reports), Nausea (1,097 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Trazodone Hydrochloride.
Out of 15,105 classified reports, 9,982 (66.1%) were classified as serious and 5,123 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 Trazodone Hydrochloride break down by patient sex as follows: Female: 9,382, Male: 4,716, Unknown: 9. 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 Trazodone Hydrochloride adverse events are: age 56: 268 reports, age 54: 249 reports, age 66: 229 reports, age 58: 223 reports, age 55: 220 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 Trazodone Hydrochloride 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 Trazodone Hydrochloride include: Diarrhoea, Off Label Use, Vomiting, Insomnia, Depression. 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 Trazodone 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.
Trazodone Hydrochloride has a safety concern score of 78 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 rate of serious adverse events, including death and suicide attempts.
Key safety signals identified in Trazodone Hydrochloride's adverse event data include: Death reports: 454. Suicide attempts: 263. Drug interactions: 407. Overdose: 231. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Trazodone can interact with other drugs, leading to adverse effects. Overdose is a significant risk, and patients should be monitored closely. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Trazodone Hydrochloride.
Follow prescribed dosages strictly to avoid overdose. Inform healthcare providers of all other medications to prevent interactions.
Trazodone Hydrochloride has 32,405 adverse event reports on file with the FDA. Common side effects include fatigue, nausea, and headache. The volume of reports for Trazodone Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Trazodone's safety, and the drug carries a black box warning for suicidal ideation and behavior, especially in younger patients. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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