Is Eravacycline approved by the US FDA?

Drugs@FDA lists 1 application product line for Eravacycline, including XERAVA (Prescription).

Is Eravacycline authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Eravacycline: Xerava.

Are there safety signals or safety updates for Eravacycline?

US FDA: 1 entry (latest 2025-03-31).

Active substance

Eravacycline

US FDA 1
EMA 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
XERAVA	EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL	powder · intravenous	TETRAPHASE PHARMS	Prescription	27 Aug 2018

EMA European Union — centrally authorised medicines

Xerava PAION Pharma GmbH · Authorised · authorised 20 Sep 2018 · ATC J01AA13

Therapeutic indication (EMA)

Xerava is indicated in adolescents from the age of 12 years weighing at least 50 kg, and in adults, for the treatment of complicated intra-abdominal infections (cIAI). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Safety signals and safety-related labeling changes

US FDA 31 Mar 2025 XERAVA — safety-related labeling change
Labeling sections changed: Warnings and Precautions

All safety entries for eravacycline →

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.