72/100 · Elevated
Manufactured by American Health Packaging
Amoxicillin Adverse Events: Chronic Kidney Disease and Acute Kidney Injury Most Common
142,723 FDA adverse event reports analyzed
Last updated: 2026-05-12
AMOXICILLIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by American Health Packaging. Based on analysis of 142,723 FDA adverse event reports, AMOXICILLIN 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 AMOXICILLIN include CHRONIC KIDNEY DISEASE, ACUTE KIDNEY INJURY, DIARRHOEA, DRUG HYPERSENSITIVITY, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMOXICILLIN.
Amoxicillin 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 142,723 adverse event reports for this medication, which is primarily manufactured by American Health Packaging.
The most commonly reported adverse events include Chronic Kidney Disease, Acute Kidney Injury, Diarrhoea. Of classified reports, 80.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Chronic kidney disease and acute kidney injury are the most frequently reported serious adverse events.
Diarrhea and nausea are among the most common non-serious adverse events. Drug hypersensitivity reactions are also a significant concern, with a high number of reports.
Patients taking Amoxicillin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Amoxicillin can cause kidney-related adverse events, including chronic and acute kidney disease, and renal failure. Patients with pre-existing kidney conditions should be monitored closely. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Amoxicillin received a safety concern score of 72/100 (elevated concern). This is based on a 80.4% serious event ratio across 73,383 classified reports. The score accounts for 142,723 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: 40,254, Male: 26,755, Unknown: 195. The most frequently reported age groups are age 67 (1,036 reports), age 71 (1,031 reports), age 66 (1,020 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 73,383 classified reports for AMOXICILLIN:
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.
Amoxicillin can cause kidney-related adverse events, including chronic and acute kidney disease, and renal failure. Patients with pre-existing kidney conditions should be monitored closely.
If you are taking Amoxicillin, here are important things to know. The most commonly reported side effects include chronic kidney disease, acute kidney injury, diarrhoea, drug hypersensitivity, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any signs of kidney problems, such as decreased urination or swelling, to their healthcare provider. Follow prescribed dosages and do not exceed recommended usage to minimize the risk of adverse reactions. 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 the safety of amoxicillin, and regulatory actions may be taken if new safety concerns arise.
The FDA has received approximately 142,723 adverse event reports associated with Amoxicillin. 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 Amoxicillin include Chronic Kidney Disease, Acute Kidney Injury, Diarrhoea, Drug Hypersensitivity, Nausea. By volume, the top reported reactions are: Chronic Kidney Disease (4,661 reports), Acute Kidney Injury (4,200 reports), Diarrhoea (4,082 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Amoxicillin.
Out of 73,383 classified reports, 59,004 (80.4%) were classified as serious and 14,379 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 Amoxicillin break down by patient sex as follows: Female: 40,254, Male: 26,755, Unknown: 195. 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 Amoxicillin adverse events are: age 67: 1,036 reports, age 71: 1,031 reports, age 66: 1,020 reports, age 62: 1,002 reports, age 60: 999 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 Amoxicillin adverse event reports is American Health Packaging. 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 Amoxicillin include: Dyspnoea, Pain, Rash, Fatigue, Renal Failure. 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 Amoxicillin 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.
Amoxicillin 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. Chronic kidney disease and acute kidney injury are the most frequently reported serious adverse events.
Key safety signals identified in Amoxicillin's adverse event data include: Chronic kidney disease and acute kidney injury. Drug hypersensitivity reactions. Renal failure and renal impairment. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Amoxicillin can cause kidney-related adverse events, including chronic and acute kidney disease, and renal failure. Patients with pre-existing kidney conditions should be monitored closely. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Amoxicillin.
Patients should report any signs of kidney problems, such as decreased urination or swelling, to their healthcare provider. Follow prescribed dosages and do not exceed recommended usage to minimize the risk of adverse reactions.
Amoxicillin has 142,723 adverse event reports on file with the FDA. Diarrhea and nausea are among the most common non-serious adverse events. The volume of reports for Amoxicillin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of amoxicillin, and regulatory actions may be taken if new safety concerns arise. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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