82/100 · Critical
Manufactured by Actavis Pharma, Inc.
Doxepin Adverse Events: High Concern for Suicide and Toxicity
22,514 FDA adverse event reports analyzed
Last updated: 2026-05-12
DOXEPIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actavis Pharma, Inc.. Based on analysis of 22,514 FDA adverse event reports, DOXEPIN has a safety score of 82 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 include TOXICITY TO VARIOUS AGENTS, DRUG INEFFECTIVE, COMPLETED SUICIDE, FATIGUE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOXEPIN.
Doxepin has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 22,514 adverse event reports for this medication, which is primarily manufactured by Actavis Pharma, Inc..
The most commonly reported adverse events include Toxicity To Various Agents, Drug Ineffective, Completed Suicide. Of classified reports, 71.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events, particularly suicide and toxicity, are prevalent.
A high number of reports involve drug ineffectiveness and various physical symptoms. The data shows a significant number of serious events, including death and respiratory depression.
Patients taking Doxepin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Doxepin can interact with other drugs, potentially leading to adverse effects. Patients should avoid alcohol and other CNS depressants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Doxepin received a safety concern score of 82/100 (high concern). This is based on a 71.3% serious event ratio across 9,777 classified reports. The score accounts for 22,514 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: 6,137, Male: 2,822, Unknown: 38. The most frequently reported age groups are age 53 (170 reports), age 59 (169 reports), age 58 (167 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 9,777 classified reports for DOXEPIN:
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 can interact with other drugs, potentially leading to adverse effects. Patients should avoid alcohol and other CNS depressants.
If you are taking Doxepin, here are important things to know. The most commonly reported side effects include toxicity to various agents, drug ineffective, completed suicide, fatigue, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult your healthcare provider if you experience any unusual symptoms or side effects. Do not stop taking doxepin abruptly without consulting your doctor. 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 continues to monitor doxepin for safety. Patients should report any adverse events to their healthcare provider.
The FDA has received approximately 22,514 adverse event reports associated with Doxepin. 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 include Toxicity To Various Agents, Drug Ineffective, Completed Suicide, Fatigue, Nausea. By volume, the top reported reactions are: Toxicity To Various Agents (801 reports), Drug Ineffective (707 reports), Completed Suicide (613 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.
Out of 9,777 classified reports, 6,967 (71.3%) were classified as serious and 2,810 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 break down by patient sex as follows: Female: 6,137, Male: 2,822, Unknown: 38. 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 adverse events are: age 53: 170 reports, age 59: 169 reports, age 58: 167 reports, age 52: 160 reports, age 63: 159 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 adverse event reports is Actavis Pharma, 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 Doxepin include: Pain, Headache, Pruritus, Off Label Use, 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 Doxepin 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 has a safety concern score of 82 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, particularly suicide and toxicity, are prevalent.
Key safety signals identified in Doxepin's adverse event data include: Multiple reports of completed suicide and suicidal ideation.. High incidence of toxicity and drug ineffectiveness.. Significant number of serious events, including death and respiratory depression.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Doxepin can interact with other drugs, potentially leading to adverse effects. Patients should avoid alcohol and other CNS depressants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Doxepin.
Consult your healthcare provider if you experience any unusual symptoms or side effects. Do not stop taking doxepin abruptly without consulting your doctor.
Doxepin has 22,514 adverse event reports on file with the FDA. A high number of reports involve drug ineffectiveness and various physical symptoms. The volume of reports for Doxepin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor doxepin for safety. Patients should report any adverse events to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Actavis Pharma, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with DOXEPIN:
Drugs related to DOXEPIN based on therapeutic use, drug class, or shared indications: