72/100 · Elevated
Manufactured by Advance Pharmaceutical Inc.
Guaifenesin 400 mg Adverse Events Show Serious Health Concerns
682 FDA adverse event reports analyzed
Last updated: 2026-05-12
GUAIFENESIN 400 MG is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Advance Pharmaceutical Inc.. Based on analysis of 682 FDA adverse event reports, GUAIFENESIN 400 MG 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 GUAIFENESIN 400 MG include FATIGUE, PNEUMONIA, FALL, PAIN, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GUAIFENESIN 400 MG.
Guaifenesin 400 Mg 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 682 adverse event reports for this medication, which is primarily manufactured by Advance Pharmaceutical Inc..
The most commonly reported adverse events include Fatigue, Pneumonia, Fall. Of classified reports, 59.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Falls and pneumonia are among the most serious adverse events reported.
A wide range of reactions indicates potential for diverse side effects. Serious adverse events account for nearly 60% of total reports.
Patients taking Guaifenesin 400 Mg should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other drugs, especially those affecting the respiratory system, should be monitored. Dose omission issues may lead to ineffective treatment. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Guaifenesin 400 Mg received a safety concern score of 72/100 (elevated concern). This is based on a 59.9% serious event ratio across 284 classified reports. The score accounts for 682 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: 156, Male: 111. The most frequently reported age groups are age 71 (13 reports), age 72 (11 reports), age 76 (9 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 284 classified reports for GUAIFENESIN 400 MG:
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 drugs, especially those affecting the respiratory system, should be monitored. Dose omission issues may lead to ineffective treatment.
If you are taking Guaifenesin 400 Mg, here are important things to know. The most commonly reported side effects include fatigue, pneumonia, fall, pain, 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. Be cautious of potential respiratory issues and falls, especially in older adults. 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 closely monitoring these adverse events. Healthcare providers should report any serious adverse events to the FDA's MedWatch program.
The FDA has received approximately 682 adverse event reports associated with Guaifenesin 400 Mg. 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 400 Mg include Fatigue, Pneumonia, Fall, Pain, Diarrhoea. By volume, the top reported reactions are: Fatigue (23 reports), Pneumonia (19 reports), Fall (17 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 400 Mg.
Out of 284 classified reports, 170 (59.9%) were classified as serious and 114 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 400 Mg break down by patient sex as follows: Female: 156, Male: 111. 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 400 Mg adverse events are: age 71: 13 reports, age 72: 11 reports, age 76: 9 reports, age 63: 8 reports, age 69: 8 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 400 Mg adverse event reports is Advance Pharmaceutical Inc.. 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 400 Mg include: Dyspnoea, Product Dose Omission Issue, Covid-19, Nausea, Asthma. 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 400 Mg 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 400 Mg 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. Falls and pneumonia are among the most serious adverse events reported.
Key safety signals identified in Guaifenesin 400 Mg's adverse event data include: Falls and pneumonia are key safety signals, indicating potential respiratory and fall risks.. Death and acute kidney injury are also significant safety signals.. Drug dose omission issues are frequently reported, suggesting potential misuse.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs, especially those affecting the respiratory system, should be monitored. Dose omission issues may lead to ineffective treatment. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Guaifenesin 400 Mg.
Always follow the prescribed dosage and instructions for use. Be cautious of potential respiratory issues and falls, especially in older adults.
Guaifenesin 400 Mg has 682 adverse event reports on file with the FDA. A wide range of reactions indicates potential for diverse side effects. The volume of reports for Guaifenesin 400 Mg reflects both the drug's usage level and the vigilance of the reporting community.
The FDA is closely monitoring these adverse events. Healthcare providers should report any serious adverse events to the FDA's MedWatch program. 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 GUAIFENESIN 400 MG:
Drugs related to GUAIFENESIN 400 MG based on therapeutic use, drug class, or shared indications: