65/100 · Elevated
Manufactured by RB Health (US) LLC
Guaifenesin Adverse Events: Moderate Safety Concerns
61,553 FDA adverse event reports analyzed
Last updated: 2026-05-12
GUAIFENESIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by RB Health (US) LLC. Based on analysis of 61,553 FDA adverse event reports, 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 GUAIFENESIN include DRUG INEFFECTIVE, DYSPNOEA, FATIGUE, NAUSEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GUAIFENESIN.
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 61,553 adverse event reports for this medication, which is primarily manufactured by Rb Health (Us) Llc.
The most commonly reported adverse events include Drug Ineffective, Dyspnoea, Fatigue. Of classified reports, 49.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common adverse reactions include dyspnea, fatigue, and nausea, indicating potential respiratory and gastrointestinal effects.
Serious adverse events, such as pneumonia and death, are reported but at a lower frequency compared to non-serious events. A significant number of reports involve off-label use and incorrect administration, suggesting potential misuse. The majority of adverse events are non-serious, but the high volume of reports indicates a need for continued monitoring.
Patients taking Guaifenesin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Guaifenesin may interact with other respiratory medications, and incorrect administration can lead to serious adverse events such as pneumonia and respiratory failure. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Guaifenesin received a safety concern score of 65/100 (elevated concern). This is based on a 49.6% serious event ratio across 29,377 classified reports. The score accounts for 61,553 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: 17,339, Male: 10,060, Unknown: 22. The most frequently reported age groups are age 71 (486 reports), age 68 (476 reports), age 73 (461 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 29,377 classified reports for 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.
Guaifenesin may interact with other respiratory medications, and incorrect administration can lead to serious adverse events such as pneumonia and respiratory failure.
If you are taking Guaifenesin, here are important things to know. The most commonly reported side effects include drug ineffective, dyspnoea, fatigue, nausea, diarrhoea. 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 adverse reactions to the FDA's MedWatch program for further evaluation. Avoid using Guaifenesin for off-label purposes unless directed by a healthcare provider. 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 ongoing, with a focus on monitoring misuse and ensuring correct administration to minimize risks.
The FDA has received approximately 61,553 adverse event reports associated with 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 Guaifenesin include Drug Ineffective, Dyspnoea, Fatigue, Nausea, Diarrhoea. By volume, the top reported reactions are: Drug Ineffective (2,450 reports), Dyspnoea (2,179 reports), Fatigue (1,782 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Guaifenesin.
Out of 29,377 classified reports, 14,577 (49.6%) were classified as serious and 14,800 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 Guaifenesin break down by patient sex as follows: Female: 17,339, Male: 10,060, Unknown: 22. 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 Guaifenesin adverse events are: age 71: 486 reports, age 68: 476 reports, age 73: 461 reports, age 65: 459 reports, age 70: 457 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 Guaifenesin adverse event reports is Rb Health (Us) 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 Guaifenesin include: Pneumonia, Cough, Headache, Dizziness, Pain. 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 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.
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. The most common adverse reactions include dyspnea, fatigue, and nausea, indicating potential respiratory and gastrointestinal effects.
Key safety signals identified in Guaifenesin's adverse event data include: Pneumonia and death are key safety signals, indicating potential respiratory risks.. Off-label use and incorrect administration are frequent, highlighting misuse concerns.. A high volume of reports for dyspnea and fatigue suggests respiratory and general fatigue issues.. Serious adverse events, though less frequent, are notable, including respiratory failure and sepsis.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Guaifenesin may interact with other respiratory medications, and incorrect administration can lead to serious adverse events such as pneumonia and respiratory failure. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Guaifenesin.
Always follow the prescribed dosage and instructions for use. Report any adverse reactions to the FDA's MedWatch program for further evaluation. Avoid using Guaifenesin for off-label purposes unless directed by a healthcare provider.
Guaifenesin has 61,553 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and death, are reported but at a lower frequency compared to non-serious events. The volume of reports for Guaifenesin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring misuse and ensuring correct administration to minimize risks. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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