65/100 · Elevated
Manufactured by WinCo Foods, LLC
Safety Profile of Dextromethorphan HBR, Guaifenesin, Phenylephrine HCl: Moderate Concern
914 FDA adverse event reports analyzed
Last updated: 2026-05-12
DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by WinCo Foods, LLC. Based on analysis of 914 FDA adverse event reports, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL 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, PHENYLEPHRINE HCL include FATIGUE, PAIN, DIARRHOEA, DYSPNOEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL.
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl 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 914 adverse event reports for this medication, which is primarily manufactured by Winco Foods, Llc.
The most commonly reported adverse events include Fatigue, Pain, Diarrhoea. Of classified reports, 60.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Falls and respiratory issues are common, indicating potential risks for older adults.
Serious adverse events, including pneumonia and death, are reported. Drug ineffectiveness and product issues are frequent, suggesting quality control concerns. A wide range of reactions, including psychological and gastrointestinal issues, are reported.
Patients taking Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other medications, particularly those affecting blood pressure and respiratory function, should be monitored. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl received a safety concern score of 65/100 (elevated concern). This is based on a 60.1% serious event ratio across 368 classified reports. The score accounts for 914 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: 209, Male: 139. The most frequently reported age groups are age 71 (13 reports), age 72 (12 reports), age 69 (10 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 368 classified reports for DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL:
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 medications, particularly those affecting blood pressure and respiratory function, should be monitored.
If you are taking Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, here are important things to know. The most commonly reported side effects include fatigue, pain, diarrhoea, dyspnoea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Use with caution, especially in older adults who may be more susceptible to falls and respiratory issues. Monitor for signs of drug ineffectiveness and address any product issues promptly. 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.
Regulatory oversight is necessary to address the reported serious adverse events and ensure product efficacy and safety.
The FDA has received approximately 914 adverse event reports associated with Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl. 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, Phenylephrine Hcl include Fatigue, Pain, Diarrhoea, Dyspnoea, Headache. By volume, the top reported reactions are: Fatigue (31 reports), Pain (25 reports), Diarrhoea (22 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, Phenylephrine Hcl.
Out of 368 classified reports, 221 (60.1%) were classified as serious and 147 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, Phenylephrine Hcl break down by patient sex as follows: Female: 209, Male: 139. 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, Phenylephrine Hcl adverse events are: age 71: 13 reports, age 72: 12 reports, age 69: 10 reports, age 70: 10 reports, age 66: 9 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, Phenylephrine Hcl adverse event reports is Winco Foods, Llc. 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, Phenylephrine Hcl include: Fall, Pneumonia, Death, Nausea, Cough. 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, Phenylephrine Hcl 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, Phenylephrine Hcl 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. Falls and respiratory issues are common, indicating potential risks for older adults.
Key safety signals identified in Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl's adverse event data include: Falls and respiratory issues are frequent, particularly in older adults.. Serious adverse events such as pneumonia and death are reported.. Drug ineffectiveness and product issues are common, indicating potential quality control problems.. A diverse range of reactions, including psychological and gastrointestinal issues, are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other medications, particularly those affecting blood pressure and respiratory function, should be monitored. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl.
Use with caution, especially in older adults who may be more susceptible to falls and respiratory issues. Monitor for signs of drug ineffectiveness and address any product issues promptly.
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl has 914 adverse event reports on file with the FDA. Serious adverse events, including pneumonia and death, are reported. The volume of reports for Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is necessary to address the reported serious adverse events and ensure product efficacy and safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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