65/100 · Elevated
Manufactured by CVS Pharmacy
Moderate Safety Concerns with Dextromethorphan HBR, Guaifenesin
2,122 FDA adverse event reports analyzed
Last updated: 2026-05-12
DEXTROMETHORPHAN HBR, GUAIFENESIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by CVS Pharmacy. Based on analysis of 2,122 FDA adverse event reports, DEXTROMETHORPHAN HBR, GUAIFENESIN has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for DEXTROMETHORPHAN HBR, GUAIFENESIN include DYSPNOEA, COUGH, DIARRHOEA, FATIGUE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DEXTROMETHORPHAN HBR, GUAIFENESIN.
Dextromethorphan Hbr, Guaifenesin has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 2,122 adverse event reports for this medication, which is primarily manufactured by Cvs Pharmacy.
The most commonly reported adverse events include Dyspnoea, Cough, Diarrhoea. Of classified reports, 62.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Dyspnea and pneumonia are among the most serious adverse reactions reported.
Fatigue, nausea, and cough are common, but not necessarily serious, side effects. The drug has been reported to be ineffective in some cases, indicating potential issues with efficacy. There is a notable number of serious reactions, particularly respiratory issues and falls. The diversity of reactions suggests a complex safety profile.
Patients taking Dextromethorphan Hbr, Guaifenesin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other respiratory medications and potential for respiratory depression are warnings to consider. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dextromethorphan Hbr, Guaifenesin received a safety concern score of 65/100 (elevated concern). This is based on a 62.1% serious event ratio across 939 classified reports. The score accounts for 2,122 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: 532, Male: 336, Unknown: 2. The most frequently reported age groups are age 71 (27 reports), age 72 (24 reports), age 66 (20 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 939 classified reports for DEXTROMETHORPHAN HBR, GUAIFENESIN:
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.
Interactions with other respiratory medications and potential for respiratory depression are warnings to consider.
If you are taking Dextromethorphan Hbr, Guaifenesin, here are important things to know. The most commonly reported side effects include dyspnoea, cough, diarrhoea, fatigue, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosing instructions carefully to avoid adverse reactions. Inform your healthcare provider about any pre-existing respiratory conditions or other medications you are taking. Monitor for signs of respiratory distress or other serious reactions and seek medical attention if they occur. 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 this drug for safety concerns, particularly in older adults and those with pre-existing respiratory conditions.
The FDA has received approximately 2,122 adverse event reports associated with Dextromethorphan Hbr, Guaifenesin. 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, Guaifenesin include Dyspnoea, Cough, Diarrhoea, Fatigue, Nausea. By volume, the top reported reactions are: Dyspnoea (73 reports), Cough (68 reports), Diarrhoea (65 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, Guaifenesin.
Out of 939 classified reports, 583 (62.1%) were classified as serious and 356 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, Guaifenesin break down by patient sex as follows: Female: 532, Male: 336, Unknown: 2. 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, Guaifenesin adverse events are: age 71: 27 reports, age 72: 24 reports, age 66: 20 reports, age 75: 19 reports, age 63: 16 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, Guaifenesin 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, Guaifenesin include: Drug Ineffective, Pneumonia, Headache, Fall, 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, Guaifenesin 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, Guaifenesin has a safety concern score of 65 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. Dyspnea and pneumonia are among the most serious adverse reactions reported.
Key safety signals identified in Dextromethorphan Hbr, Guaifenesin's adverse event data include: Respiratory issues like dyspnea and pneumonia are frequent and serious.. Falls and dizziness are common, indicating potential risks for older adults.. Drug ineffectiveness and product dose omission issues highlight concerns with dosing and efficacy.. A wide range of reactions, including neurological and gastrointestinal symptoms, suggests a complex safety profile.. Serious reactions, particularly respiratory and cardiovascular issues, are a significant concern.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other respiratory medications and potential for respiratory depression are warnings to consider. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dextromethorphan Hbr, Guaifenesin.
Follow prescribed dosing instructions carefully to avoid adverse reactions. Inform your healthcare provider about any pre-existing respiratory conditions or other medications you are taking. Monitor for signs of respiratory distress or other serious reactions and seek medical attention if they occur.
Dextromethorphan Hbr, Guaifenesin has 2,122 adverse event reports on file with the FDA. Fatigue, nausea, and cough are common, but not necessarily serious, side effects. The volume of reports for Dextromethorphan Hbr, Guaifenesin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor this drug for safety concerns, particularly in older adults and those with pre-existing respiratory conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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