72/100 · Elevated
Manufactured by CVS Pharmacy
Moderate Safety Concerns with Dextromethorphan HBR and Doxylamine Succinate
810 FDA adverse event reports analyzed
Last updated: 2026-05-12
DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by CVS Pharmacy. Based on analysis of 810 FDA adverse event reports, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE has a safety score of 72 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 DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE include COUGH, DIARRHOEA, DYSPNOEA, NAUSEA, PNEUMONIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE.
Dextromethorphan Hbr, Doxylamine Succinate has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 810 adverse event reports for this medication, which is primarily manufactured by Cvs Pharmacy.
The most commonly reported adverse events include Cough, Diarrhoea, Dyspnoea. Of classified reports, 62.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events, including pneumonia and death, account for 62.8% of total reports.
A wide range of reactions, from cough to chest pain, indicates diverse safety issues. The drug is reported to cause drowsiness and falls, which could be particularly dangerous in the elderly. There are multiple reports of drug dose issues, suggesting potential misuse or incorrect administration.
Patients taking Dextromethorphan Hbr, Doxylamine Succinate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. The drug interactions and warnings include drowsiness and falls, which can be dangerous, especially in the elderly. Patients should be advised to avoid driving or operating heavy machinery. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dextromethorphan Hbr, Doxylamine Succinate received a safety concern score of 72/100 (elevated concern). This is based on a 62.8% serious event ratio across 309 classified reports. The score accounts for 810 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: 184, Male: 107. The most frequently reported age groups are age 73 (11 reports), age 72 (10 reports), age 66 (8 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 309 classified reports for DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE:
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.
The drug interactions and warnings include drowsiness and falls, which can be dangerous, especially in the elderly. Patients should be advised to avoid driving or operating heavy machinery.
If you are taking Dextromethorphan Hbr, Doxylamine Succinate, here are important things to know. The most commonly reported side effects include cough, diarrhoea, dyspnoea, nausea, pneumonia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow the prescribed dosage and instructions from your healthcare provider. Be aware of potential drowsiness and avoid activities that require alertness, such as driving or operating machinery. Report any unusual symptoms or side effects to your healthcare provider immediately. 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 has not issued specific warnings for this combination, but the high number of serious adverse events suggests a need for careful monitoring and adherence to prescribed dosages.
The FDA has received approximately 810 adverse event reports associated with Dextromethorphan Hbr, Doxylamine Succinate. 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 Dextromethorphan Hbr, Doxylamine Succinate include Cough, Diarrhoea, Dyspnoea, Nausea, Pneumonia. By volume, the top reported reactions are: Cough (32 reports), Diarrhoea (29 reports), Dyspnoea (29 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Dextromethorphan Hbr, Doxylamine Succinate.
Out of 309 classified reports, 194 (62.8%) were classified as serious and 115 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 Dextromethorphan Hbr, Doxylamine Succinate break down by patient sex as follows: Female: 184, Male: 107. 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 Dextromethorphan Hbr, Doxylamine Succinate adverse events are: age 73: 11 reports, age 72: 10 reports, age 66: 8 reports, age 62: 7 reports, age 64: 7 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 Dextromethorphan Hbr, Doxylamine Succinate adverse event reports is Cvs Pharmacy. 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 Dextromethorphan Hbr, Doxylamine Succinate include: Fatigue, Headache, Fall, Pain, Asthenia. 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 Dextromethorphan Hbr, Doxylamine Succinate 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.
Dextromethorphan Hbr, Doxylamine Succinate has a safety concern score of 72 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 events, including pneumonia and death, account for 62.8% of total reports.
Key safety signals identified in Dextromethorphan Hbr, Doxylamine Succinate's adverse event data include: Pneumonia and other respiratory issues are common, indicating potential respiratory risks.. Multiple reports of falls and loss of consciousness suggest the drug may cause dizziness or disorientation.. Serious adverse events like death and myocardial infarction are reported, highlighting significant risks.. Drug dose issues and ineffective drug reports suggest potential misuse or incorrect dosing.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
The drug interactions and warnings include drowsiness and falls, which can be dangerous, especially in the elderly. Patients should be advised to avoid driving or operating heavy machinery. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dextromethorphan Hbr, Doxylamine Succinate.
Always follow the prescribed dosage and instructions from your healthcare provider. Be aware of potential drowsiness and avoid activities that require alertness, such as driving or operating machinery. Report any unusual symptoms or side effects to your healthcare provider immediately.
Dextromethorphan Hbr, Doxylamine Succinate has 810 adverse event reports on file with the FDA. A wide range of reactions, from cough to chest pain, indicates diverse safety issues. The volume of reports for Dextromethorphan Hbr, Doxylamine Succinate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued specific warnings for this combination, but the high number of serious adverse events suggests a need for careful monitoring and adherence to prescribed dosages. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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