85/100 · Critical
Manufactured by Aurobindo Pharma Limited
High Safety Concerns with Doxepin Hydrochloride, Particularly for Serious Reactions
28,719 FDA adverse event reports analyzed
Last updated: 2026-05-12
DOXEPIN HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 28,719 FDA adverse event reports, DOXEPIN HYDROCHLORIDE 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 DOXEPIN HYDROCHLORIDE include TOXICITY TO VARIOUS AGENTS, DRUG INEFFECTIVE, COMPLETED SUICIDE, FATIGUE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOXEPIN HYDROCHLORIDE.
Doxepin Hydrochloride 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 28,719 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Toxicity To Various Agents, Drug Ineffective, Completed Suicide. Of classified reports, 69.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events, including completed suicide and death, are common.
Fatigue, pain, and nausea are frequently reported non-serious side effects. Drug interactions and overuse are significant safety signals.
Patients taking Doxepin Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Doxepin Hydrochloride can interact with other medications, and its use should be carefully monitored, especially with drugs that affect the central nervous system. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Doxepin Hydrochloride received a safety concern score of 85/100 (high concern). This is based on a 69.6% serious event ratio across 12,089 classified reports. The score accounts for 28,719 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: 7,517, Male: 3,461, Unknown: 42. The most frequently reported age groups are age 58 (228 reports), age 52 (223 reports), age 53 (204 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 12,089 classified reports for DOXEPIN 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.
Doxepin Hydrochloride can interact with other medications, and its use should be carefully monitored, especially with drugs that affect the central nervous system.
If you are taking Doxepin Hydrochloride, here are important things to know. The most commonly reported side effects include toxicity to various agents, drug ineffective, completed suicide, fatigue, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow prescribed dosages and do not exceed the recommended amount. Inform your healthcare provider about all other medications you are taking to avoid potential 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 Doxepin Hydrochloride due to its high incidence of serious adverse events, particularly related to mental health and respiratory issues.
The FDA has received approximately 28,719 adverse event reports associated with Doxepin 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 Doxepin Hydrochloride include Toxicity To Various Agents, Drug Ineffective, Completed Suicide, Fatigue, Pain. By volume, the top reported reactions are: Toxicity To Various Agents (958 reports), Drug Ineffective (951 reports), Completed Suicide (796 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Doxepin Hydrochloride.
Out of 12,089 classified reports, 8,419 (69.6%) were classified as serious and 3,670 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 Doxepin Hydrochloride break down by patient sex as follows: Female: 7,517, Male: 3,461, Unknown: 42. 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 Doxepin Hydrochloride adverse events are: age 58: 228 reports, age 52: 223 reports, age 53: 204 reports, age 47: 202 reports, age 63: 201 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 Doxepin 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 Doxepin Hydrochloride include: Nausea, Headache, Insomnia, Dizziness, Pruritus. 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 Doxepin 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.
Doxepin Hydrochloride 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. Serious adverse events, including completed suicide and death, are common.
Key safety signals identified in Doxepin Hydrochloride's adverse event data include: Completed suicide and death are among the most serious reactions.. Over 6,000 reports of serious adverse events, comprising 69.6% of total reports.. Drug ineffectiveness and off-label use are also notable signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Doxepin Hydrochloride can interact with other medications, and its use should be carefully monitored, especially with drugs that affect the central nervous system. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Doxepin Hydrochloride.
Always follow prescribed dosages and do not exceed the recommended amount. Inform your healthcare provider about all other medications you are taking to avoid potential interactions.
Doxepin Hydrochloride has 28,719 adverse event reports on file with the FDA. Fatigue, pain, and nausea are frequently reported non-serious side effects. The volume of reports for Doxepin Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Doxepin Hydrochloride due to its high incidence of serious adverse events, particularly related to mental health and respiratory 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 DOXEPIN HYDROCHLORIDE:
Drugs related to DOXEPIN HYDROCHLORIDE based on therapeutic use, drug class, or shared indications: