45/100 · Moderate
Manufactured by Haleon US Holdings LLC
Common Mild Reactions Dominant in Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCL Adverse Events
96,153 FDA adverse event reports analyzed
Last updated: 2026-05-12
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. Based on analysis of 96,153 FDA adverse event reports, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL has a safety score of 45 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, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL include DRUG INEFFECTIVE, FATIGUE, HEADACHE, NAUSEA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL.
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl has a safety concern score of 45 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 96,153 adverse event reports for this medication, which is primarily manufactured by Haleon Us Holdings Llc.
The most commonly reported adverse events include Drug Ineffective, Fatigue, Headache. Of classified reports, 46.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most reported reactions are mild and include fatigue, headache, and nausea.
Serious reactions, such as pneumonia and asthma, are less common but still reported. The majority of reactions are non-serious, indicating a generally safe profile. Age distribution shows a higher number of reports from individuals aged 60-72.
Patients taking Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl 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 and cardiovascular systems, should be monitored. Use with caution in patients with pre-existing conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl received a safety concern score of 45/100 (moderate concern). This is based on a 46.4% serious event ratio across 48,598 classified reports. The score accounts for 96,153 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 30,951, Male: 14,508, Unknown: 41. The most frequently reported age groups are age 60 (713 reports), age 63 (685 reports), age 65 (681 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 48,598 classified reports for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, 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 drugs, especially those affecting the respiratory and cardiovascular systems, should be monitored. Use with caution in patients with pre-existing conditions.
If you are taking Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, headache, nausea, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for any signs of serious reactions, especially respiratory and cardiovascular issues. Follow the prescribed dosage and usage instructions to avoid drug-related issues. 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 no major safety concerns identified. However, patients should report any serious adverse events immediately.
The FDA has received approximately 96,153 adverse event reports associated with Acetaminophen, Chlorpheniramine Maleate, 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 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl include Drug Ineffective, Fatigue, Headache, Nausea, Dyspnoea. By volume, the top reported reactions are: Drug Ineffective (4,248 reports), Fatigue (3,247 reports), Headache (3,059 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, Chlorpheniramine Maleate, Phenylephrine Hcl.
Out of 48,598 classified reports, 22,537 (46.4%) were classified as serious and 26,061 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, Chlorpheniramine Maleate, Phenylephrine Hcl break down by patient sex as follows: Female: 30,951, Male: 14,508, Unknown: 41. 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, Chlorpheniramine Maleate, Phenylephrine Hcl adverse events are: age 60: 713 reports, age 63: 685 reports, age 65: 681 reports, age 70: 676 reports, age 62: 667 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, Chlorpheniramine Maleate, Phenylephrine Hcl adverse event reports is Haleon Us Holdings 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, Chlorpheniramine Maleate, Phenylephrine Hcl include: Diarrhoea, Pain, Dizziness, Cough, Off Label Use. 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, Chlorpheniramine Maleate, 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.
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl has a safety concern score of 45 out of 100 (moderate 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. Most reported reactions are mild and include fatigue, headache, and nausea.
Key safety signals identified in Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl's adverse event data include: Frequent reports of respiratory issues like pneumonia and asthma.. Multiple reports of cardiovascular events, including myocardial infarction and atrial fibrillation.. Significant number of reports related to gastrointestinal issues such as nausea and abdominal pain.. 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 and cardiovascular systems, should be monitored. Use with caution in patients with pre-existing conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl.
Monitor for any signs of serious reactions, especially respiratory and cardiovascular issues. Follow the prescribed dosage and usage instructions to avoid drug-related issues.
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl has 96,153 adverse event reports on file with the FDA. Serious reactions, such as pneumonia and asthma, are less common but still reported. The volume of reports for Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with no major safety concerns identified. However, patients should report any serious adverse events immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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