72/100 · Elevated
Manufactured by Amneal Pharmaceuticals NY LLC
Erythromycin Adverse Events Show High Seriousness and Diverse Reactions
48,243 FDA adverse event reports analyzed
Last updated: 2026-05-12
ERYTHROMYCIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. Based on analysis of 48,243 FDA adverse event reports, ERYTHROMYCIN 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 ERYTHROMYCIN include DRUG HYPERSENSITIVITY, NAUSEA, VOMITING, DIARRHOEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ERYTHROMYCIN.
Erythromycin 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 48,243 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Ny Llc.
The most commonly reported adverse events include Drug Hypersensitivity, Nausea, Vomiting. Of classified reports, 61.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Erythromycin reports show a high percentage of serious adverse events (61.9%).
The most common reactions include drug hypersensitivity, nausea, and vomiting. A wide range of reactions are reported, indicating diverse safety concerns.
Patients taking Erythromycin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Erythromycin can cause drug interactions, and patients should be warned about potential interactions with other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Erythromycin received a safety concern score of 72/100 (elevated concern). This is based on a 61.9% serious event ratio across 18,229 classified reports. The score accounts for 48,243 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: 11,426, Male: 4,849, Unknown: 73. The most frequently reported age groups are age 44 (454 reports), age 60 (299 reports), age 65 (265 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 18,229 classified reports for ERYTHROMYCIN:
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.
Erythromycin can cause drug interactions, and patients should be warned about potential interactions with other medications.
If you are taking Erythromycin, here are important things to know. The most commonly reported side effects include drug hypersensitivity, nausea, vomiting, diarrhoea, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before starting erythromycin, especially if you have a history of allergies or other health conditions. Report any side effects to your healthcare provider promptly. 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 serious adverse events and drug interactions.
The FDA has received approximately 48,243 adverse event reports associated with Erythromycin. 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 Erythromycin include Drug Hypersensitivity, Nausea, Vomiting, Diarrhoea, Drug Ineffective. By volume, the top reported reactions are: Drug Hypersensitivity (4,088 reports), Nausea (1,270 reports), Vomiting (1,122 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Erythromycin.
Out of 18,229 classified reports, 11,276 (61.9%) were classified as serious and 6,953 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 Erythromycin break down by patient sex as follows: Female: 11,426, Male: 4,849, Unknown: 73. 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 Erythromycin adverse events are: age 44: 454 reports, age 60: 299 reports, age 65: 265 reports, age 67: 237 reports, age 70: 234 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 Erythromycin adverse event reports is Amneal Pharmaceuticals Ny 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 Erythromycin include: Dyspnoea, Fatigue, Rash, Off Label Use, Headache. 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 Erythromycin 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.
Erythromycin 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. Erythromycin reports show a high percentage of serious adverse events (61.9%).
Key safety signals identified in Erythromycin's adverse event data include: Drug hypersensitivity reactions are frequent and serious.. Respiratory issues like pneumonia and dyspnoea are notable.. Kidney-related issues, including chronic kidney disease and acute kidney injury, are significant.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Erythromycin can cause drug interactions, and patients should be warned about potential interactions with other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Erythromycin.
Consult a healthcare provider before starting erythromycin, especially if you have a history of allergies or other health conditions. Report any side effects to your healthcare provider promptly.
Erythromycin has 48,243 adverse event reports on file with the FDA. The most common reactions include drug hypersensitivity, nausea, and vomiting. The volume of reports for Erythromycin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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