65/100 · Elevated
Manufactured by Kenvue Brands LLC
Moderate Safety Concerns with Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
444,449 FDA adverse event reports analyzed
Last updated: 2026-05-12
ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kenvue Brands LLC. Based on analysis of 444,449 FDA adverse event reports, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE 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 ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE include DRUG INEFFECTIVE, FATIGUE, HEADACHE, PAIN, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE.
Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride 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 444,449 adverse event reports for this medication, which is primarily manufactured by Kenvue Brands Llc.
The most commonly reported adverse events include Drug Ineffective, Fatigue, Headache. Of classified reports, 59.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reported reactions are non-serious, but the high volume of reports indicates a significant safety concern.
Fatigue, headache, and pain are the most commonly reported symptoms, suggesting these may be the primary side effects. Serious reactions, including death and pneumonia, are reported, indicating potential severe adverse effects. The drug is often used off-label, which may contribute to the high number of adverse events reported. There is a notable age distribution, with the majority of reports coming from individuals aged 65 and older.
Patients taking Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions are a concern, especially with off-label use, and patients should be advised to consult a healthcare provider before use. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride received a safety concern score of 65/100 (elevated concern). This is based on a 59.5% serious event ratio across 152,871 classified reports. The score accounts for 444,449 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: 91,899, Male: 41,899, Unknown: 140. The most frequently reported age groups are age 65 (2,106 reports), age 61 (2,099 reports), age 70 (2,038 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 152,871 classified reports for ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE:
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.
Drug interactions are a concern, especially with off-label use, and patients should be advised to consult a healthcare provider before use.
If you are taking Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, headache, pain, nausea. 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 use as directed by a healthcare provider. Report any unusual symptoms or side effects to your healthcare provider immediately. Do not use the drug for off-label purposes without consulting a healthcare professional. 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 these adverse events and may require additional safety studies or label changes based on ongoing data.
The FDA has received approximately 444,449 adverse event reports associated with Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride. 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 Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride include Drug Ineffective, Fatigue, Headache, Pain, Nausea. By volume, the top reported reactions are: Drug Ineffective (16,740 reports), Fatigue (16,054 reports), Headache (12,972 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride.
Out of 152,871 classified reports, 91,028 (59.5%) were classified as serious and 61,843 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 Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride break down by patient sex as follows: Female: 91,899, Male: 41,899, Unknown: 140. 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 Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride adverse events are: age 65: 2,106 reports, age 61: 2,099 reports, age 70: 2,038 reports, age 64: 2,015 reports, age 62: 2,011 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 Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride adverse event reports is Kenvue Brands 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 Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride include: Off Label Use, Diarrhoea, Arthralgia, Dyspnoea, Vomiting. 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 Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride 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.
Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride 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 majority of reported reactions are non-serious, but the high volume of reports indicates a significant safety concern.
Key safety signals identified in Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride's adverse event data include: Death and pneumonia are among the most serious reactions reported.. Off-label use is a key safety signal, as the drug is frequently used for unapproved indications.. There is a high volume of reports for gastrointestinal disorders, which may indicate a common side effect.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions are a concern, especially with off-label use, and patients should be advised to consult a healthcare provider before use. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride.
Always follow the prescribed dosage and use as directed by a healthcare provider. Report any unusual symptoms or side effects to your healthcare provider immediately. Do not use the drug for off-label purposes without consulting a healthcare professional.
Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride has 444,449 adverse event reports on file with the FDA. Fatigue, headache, and pain are the most commonly reported symptoms, suggesting these may be the primary side effects. The volume of reports for Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor these adverse events and may require additional safety studies or label changes based on ongoing data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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