Is Erythromycin ethylsuccinate approved by the US FDA?

Drugs@FDA lists 28 application product lines for Erythromycin ethylsuccinate, including E.E.S. (Prescription); ERYPED (Prescription); ERYTHROMYCIN ETHYLSUCCINATE (Prescription); ERYTHROMYCIN ETHYLSUCCINATE (Prescription); E.E.S. 400 (Prescription).

Are there safety signals or safety updates for Erythromycin ethylsuccinate?

US FDA: 2 entries (latest 2018-04-23).

Active substance

Erythromycin ethylsuccinate

US FDA 28
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
E.E.S.	EQ 200MG BASE/5ML	granule · oral	CARNEGIE	Prescription	2 Apr 1965
ERYPED	EQ 400MG BASE/5ML; EQ 200MG BASE/5ML	granule · oral	CARNEGIE	Prescription	2 Apr 1965
ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE	tablet · oral	CARNEGIE	Prescription	3 Mar 1975
ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML; EQ 400MG BASE/5ML	granule · oral	ANI PHARMS	Prescription	27 Nov 1978
E.E.S. 400	EQ 400MG BASE	tablet · oral	PHARMOBEDIENT	Prescription	12 Aug 1982
ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML; EQ 400MG BASE/5ML	granule · oral	AMNEAL PHARMS	Prescription	1 Nov 2019
ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML; EQ 400MG BASE/5ML	granule · oral	CADILA PHARMS LTD	Prescription	21 Nov 2022
E.E.S.	EQ 200MG BASE	tablet, chewable · oral	AZURITY	Discontinued	6 Aug 1970
ERYPED	EQ 200MG BASE	tablet, chewable · oral	AZURITY	Discontinued	6 Aug 1970
E.E.S. 200	EQ 200MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	suspension · oral	ARBOR PHARMS LLC	Discontinued	15 Oct 1973
E.E.S. 400	EQ 400MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	suspension · oral	ARBOR PHARMS LLC	Discontinued	15 Oct 1973
ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE	tablet · oral	BARR	Discontinued	28 Apr 1980
PEDIAMYCIN	EQ 200MG BASE/5ML	suspension · oral	ARBOR PHARMS LLC	Discontinued	18 Dec 1980
PEDIAMYCIN 400	EQ 400MG BASE/5ML	suspension · oral	ARBOR PHARMS LLC	Discontinued	18 Dec 1980
ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML; EQ 400MG BASE/5ML	suspension · oral	ALPHARMA US PHARMS	Discontinued	11 Aug 1981
E.E.S. 400	EQ 400MG BASE	tablet · oral	PHARMOBEDIENT	Discontinued	12 Aug 1982
ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE	tablet · oral	AUROBINDO PHARMA USA	Discontinued	14 Sep 1988
ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML; EQ 400MG BASE/5ML	granule · oral	PH HEALTH	Discontinued	23 Oct 2019
WYAMYCIN E	EQ 400MG BASE/5ML; EQ 200MG BASE/5ML	suspension · oral	WYETH AYERST	Discontinued
ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML; EQ 400MG BASE/5ML	suspension · oral	DISTA	Discontinued
E-MYCIN E	EQ 200MG BASE/5ML; EQ 400MG BASE/5ML	suspension · oral	PHARMACIA AND UPJOHN	Discontinued
ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML; EQ 400MG BASE/5ML	suspension · oral	PARKE DAVIS	Discontinued
PEDIAMYCIN	EQ 200MG BASE/5ML	granule · oral	ROSS LABS	Discontinued
PEDIAMYCIN	EQ 100MG BASE/2.5ML	suspension/drops · oral	ROSS LABS	Discontinued
PEDIAMYCIN	EQ 200MG BASE	tablet, chewable · oral	ROSS LABS	Discontinued

3 more — full table

Safety signals and safety-related labeling changes

US FDA 23 Apr 2018 E.E.S. — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions
US FDA 23 Apr 2018 ERYPED — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions

All safety entries for erythromycin ethylsuccinate →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.