78/100 · Elevated
Manufactured by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
Erythromycin Ethylsuccinate Adverse Events Show High Serious Reaction Rate
1,062 FDA adverse event reports analyzed
Last updated: 2026-05-12
ERYTHROMYCIN ETHYLSUCCINATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals). Based on analysis of 1,062 FDA adverse event reports, ERYTHROMYCIN ETHYLSUCCINATE has a safety score of 78 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 ETHYLSUCCINATE include DRUG HYPERSENSITIVITY, VOMITING, NAUSEA, DIARRHOEA, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ERYTHROMYCIN ETHYLSUCCINATE.
Erythromycin Ethylsuccinate has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 1,062 adverse event reports for this medication, which is primarily manufactured by Azurity Pharmaceuticals, Inc. (Formerly Arbor Pharmaceuticals).
The most commonly reported adverse events include Drug Hypersensitivity, Vomiting, Nausea. Of classified reports, 59.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High rate of serious reactions (59.2%) including pneumonia, respiratory distress, and sepsis.
A wide variety of reactions reported, indicating potential for multiple side effects. Significant number of gastrointestinal issues reported, including diarrhea and nausea.
Patients taking Erythromycin Ethylsuccinate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Erythromycin Ethylsuccinate can cause drug interactions, and patients should be warned about potential liver and kidney toxicity. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Erythromycin Ethylsuccinate received a safety concern score of 78/100 (high concern). This is based on a 59.2% serious event ratio across 595 classified reports. The score accounts for 1,062 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 350, Male: 154, Unknown: 3. The most frequently reported age groups are age 1 (25 reports), age 6 (14 reports), age 2 (13 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 595 classified reports for ERYTHROMYCIN ETHYLSUCCINATE:
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 Ethylsuccinate can cause drug interactions, and patients should be warned about potential liver and kidney toxicity.
If you are taking Erythromycin Ethylsuccinate, here are important things to know. The most commonly reported side effects include drug hypersensitivity, vomiting, nausea, diarrhoea, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be informed about the potential for serious side effects and should seek medical attention if they experience any concerning symptoms. Follow prescribed dosing instructions and report any missed doses to a healthcare provider. 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 Erythromycin Ethylsuccinate, and healthcare providers should report any adverse events.
The FDA has received approximately 1,062 adverse event reports associated with Erythromycin Ethylsuccinate. 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 Ethylsuccinate include Drug Hypersensitivity, Vomiting, Nausea, Diarrhoea, Off Label Use. By volume, the top reported reactions are: Drug Hypersensitivity (72 reports), Vomiting (45 reports), Nausea (40 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 Ethylsuccinate.
Out of 595 classified reports, 352 (59.2%) were classified as serious and 243 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 Ethylsuccinate break down by patient sex as follows: Female: 350, Male: 154, Unknown: 3. 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 Ethylsuccinate adverse events are: age 1: 25 reports, age 6: 14 reports, age 2: 13 reports, age 3: 12 reports, age 23: 12 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 Ethylsuccinate adverse event reports is Azurity Pharmaceuticals, Inc. (Formerly Arbor Pharmaceuticals). 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 Ethylsuccinate include: Dyspnoea, Rash, Hypersensitivity, Abdominal Pain, Product Use In Unapproved Indication. 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 Ethylsuccinate 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 Ethylsuccinate has a safety concern score of 78 out of 100 (high 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. High rate of serious reactions (59.2%) including pneumonia, respiratory distress, and sepsis.
Key safety signals identified in Erythromycin Ethylsuccinate's adverse event data include: High number of serious reactions (352 out of 595, 59.2%). Multiple gastrointestinal issues reported (diarrhea, nausea, vomiting). Drug hypersensitivity and rash are common, with 72 and 23 reports respectively. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Erythromycin Ethylsuccinate can cause drug interactions, and patients should be warned about potential liver and kidney toxicity. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Erythromycin Ethylsuccinate.
Patients should be informed about the potential for serious side effects and should seek medical attention if they experience any concerning symptoms. Follow prescribed dosing instructions and report any missed doses to a healthcare provider.
Erythromycin Ethylsuccinate has 1,062 adverse event reports on file with the FDA. A wide variety of reactions reported, indicating potential for multiple side effects. The volume of reports for Erythromycin Ethylsuccinate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Erythromycin Ethylsuccinate, and healthcare providers should report any adverse events. 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 ERYTHROMYCIN ETHYLSUCCINATE:
Drugs related to ERYTHROMYCIN ETHYLSUCCINATE based on therapeutic use, drug class, or shared indications: