72/100 · Elevated
Manufactured by Discount Drug Mart
Moderate Safety Concerns for Dextromethorphan Hydrobromide and Guaifenesin
1,653 FDA adverse event reports analyzed
Last updated: 2026-05-12
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Discount Drug Mart. Based on analysis of 1,653 FDA adverse event reports, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN 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 HYDROBROMIDE, GUAIFENESIN include DYSPNOEA, COUGH, NAUSEA, DIARRHOEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN.
Dextromethorphan Hydrobromide, Guaifenesin 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 1,653 adverse event reports for this medication, which is primarily manufactured by Discount Drug Mart.
The most commonly reported adverse events include Dyspnoea, Cough, Nausea. Of classified reports, 62.9% 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 62.9% of total reports.
A wide range of reactions, from cough to severe conditions like heart failure, are reported. The majority of reports are from older adults, with 75 being the most common age reported. Drug ineffectiveness and product dose issues are common, indicating potential misuse or quality concerns.
Patients taking Dextromethorphan Hydrobromide, Guaifenesin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Warnings include potential misuse due to drug ineffectiveness and dose issues, and quality concerns related to product dose and administration. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dextromethorphan Hydrobromide, Guaifenesin received a safety concern score of 72/100 (elevated concern). This is based on a 62.9% serious event ratio across 688 classified reports. The score accounts for 1,653 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: 398, Male: 251. The most frequently reported age groups are age 75 (18 reports), age 72 (17 reports), age 73 (15 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 688 classified reports for DEXTROMETHORPHAN HYDROBROMIDE, 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.
Warnings include potential misuse due to drug ineffectiveness and dose issues, and quality concerns related to product dose and administration.
If you are taking Dextromethorphan Hydrobromide, Guaifenesin, here are important things to know. The most commonly reported side effects include dyspnoea, cough, nausea, diarrhoea, drug ineffective. 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 for use. Report any severe or unusual 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 is monitoring these reports and may require additional safety studies or label changes to address the identified safety signals.
The FDA has received approximately 1,653 adverse event reports associated with Dextromethorphan Hydrobromide, 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 Hydrobromide, Guaifenesin include Dyspnoea, Cough, Nausea, Diarrhoea, Drug Ineffective. By volume, the top reported reactions are: Dyspnoea (63 reports), Cough (62 reports), Nausea (56 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 Hydrobromide, Guaifenesin.
Out of 688 classified reports, 433 (62.9%) were classified as serious and 255 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 Hydrobromide, Guaifenesin break down by patient sex as follows: Female: 398, Male: 251. 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 Hydrobromide, Guaifenesin adverse events are: age 75: 18 reports, age 72: 17 reports, age 73: 15 reports, age 74: 14 reports, age 64: 12 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 Hydrobromide, Guaifenesin adverse event reports is Discount Drug Mart. 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 Hydrobromide, Guaifenesin include: Headache, Pneumonia, Fatigue, Dizziness, Fall. 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 Hydrobromide, 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 Hydrobromide, Guaifenesin 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 62.9% of total reports.
Key safety signals identified in Dextromethorphan Hydrobromide, Guaifenesin's adverse event data include: Pneumonia and death are among the most serious reactions reported.. A high number of reports involve drug ineffectiveness and dose issues.. Heart-related issues, such as atrial fibrillation and congestive heart failure, are notable.. A wide variety of reactions, including neurological 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.
Warnings include potential misuse due to drug ineffectiveness and dose issues, and quality concerns related to product dose and administration. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dextromethorphan Hydrobromide, Guaifenesin.
Always follow the prescribed dosage and instructions for use. Report any severe or unusual side effects to your healthcare provider immediately.
Dextromethorphan Hydrobromide, Guaifenesin has 1,653 adverse event reports on file with the FDA. A wide range of reactions, from cough to severe conditions like heart failure, are reported. The volume of reports for Dextromethorphan Hydrobromide, Guaifenesin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA is monitoring these reports and may require additional safety studies or label changes to address the identified safety signals. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN:
Drugs related to DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN based on therapeutic use, drug class, or shared indications: