Eravacycline: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 22, 2026🚩 Report this page

Eravacycline

Tetracyclines

Sold as Xerava

GB MHRAEU EMA

Drug class: Tetracyclines
Availability: See label
Markets covered: 2
Products on record: 5

J01AATetracyclines

Overview

Eravacycline is an active pharmaceutical ingredient in the Tetracyclines group (J01AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	4	May 22, 2026
EU European Union	EMA	1	March 13, 2026

GBUnited Kingdom· MHRA

4 products

Uses

GBOfficial regulatory label· revised September 6, 2024[1]

1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

How to take

GB

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised March 13, 2026[2]

1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

How to take

EU

Drug interactions

Known interactions involving Eravacycline. Select one for details. This list is informational and not a complete interaction checker.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB246260006 · revised September 6, 2024
[2]European Medicines Agency · EMEA/H/C/004237 · revised March 13, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised September 6, 2024[1]

3%), which were generally mild or moderate in severity. Tabulated list of adverse reactions The adverse reactions identified with eravacycline are presented in Table 1. Adverse reactions are classified according to MedDRA system organ classification and frequency.
Frequency categories are derived according to the following conventions: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1 Tabulated list of adverse reactions to eravacycline in clinical trials System Organ Class Common Uncommon Blood and lymphatic system disorders Hypofibrinogenaemia Increased international normalised ratio (INR) Prolonged activated partial thromboplastin time (aPTT) Prolonged prothrombin time (PT) Immune system disorders Hypersensitivity Nervous system disorders Dizziness Headache Vascular disorders Thrombophlebitisa Phlebitisb Gastrointestinal disorders Nausea Vomiting Pancreatitis Diarrhoea Hepatobiliary disorders Aspartate aminotransferase (AST) increased Alanine aminotransferase (ALT) increased Hyperbilirubinaemia Skin and subcutaneous tissue disorders Rash Hyperhidrosis General disorders and administration site conditions Infusion site reactionsc a.
Thrombophlebitis includes the preferred terms thrombophlebitis and infusion site thrombosis b. Phlebitis includes the preferred terms phlebitis, infusion site phlebitis, superficial phlebitis and injection site phlebitis c. Infusion site reaction includes the preferred terms injection site erythema, infusion site hypoaesthesia, vessel puncture site erythema and vessel puncture site pain Description of selected adverse reactions Infusion site reactions Mild to moderate infusion site reactions, including pain or discomfort, erythema and swelling or inflammation at the injection site as well as superficial thrombophlebitis and/or phlebitis have been reported in patients treated with eravacycline.
Infusion site reactions can be mitigated by reducing the eravacycline infusion concentration or the infusion rate. Tetracycline class effects Tetracycline class adverse reactions include photosensitivity, pseudotumor cerebri, and anti-anabolic action which have led to increased blood urea nitrogen, azotaemia, acidosis, and hyperphosphataemia.
4). 7% of patients; all cases were mild in severity. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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GBOfficial regulatory label· Warnings and precautions· revised September 6, 2024[1]

3). In case of hypersensitivity reactions, treatment with eravacycline must be discontinued immediately and appropriate emergency measures must be initiated. Clostridioides difficile-associated diarrhoea Antibiotic-associated colitis and pseudomembranous colitis have been reported with the use of nearly all antibiotics and may range in severity from mild to life- threatening.
8). In such circumstances, the discontinuation of eravacycline and the use of supportive measures together with the administration of specific treatment for Clostridioides difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Infusion-site reactions Eravacycline is administered via intravenous infusion, using an infusion time of approximately 1 hour to minimise the risk of infusion-site reactions. 8). In case of serious reactions, eravacycline should be discontinued until a new intravenous access site is established.
Additional measures to reduce the occurrence and severity of infusion site reactions include decreasing the eravacycline infusion rate and/or concentration. Non-susceptible micro-organisms Prolonged use may result in the overgrowth of non-susceptible micro-organisms, including fungi.
If superinfection occurs during therapy, it may require interruption of treatment. Other appropriate measures should be taken and alternative antimicrobial treatment should be considered in accordance with existing therapeutic guidelines.
8). If pancreatitis is suspected, eravacycline should be discontinued. 6). Concomitant use of strong CYP3A4 inducers Medicines that induce CYP3A4 are expected to increase the rate and extent of metabolism of eravacycline. CYP3A4 inducers exert their effect in a time-dependent manner, and may take at least 2 weeks to reach maximal effect after introduction.
Conversely, on discontinuation, CYP3A4 induction may take at least 2 weeks to decline. Co-administration of a strong CYP3A4 inducer (such as phenobarbital, rifampicin, carbamazepine, phenytoin, St. 5). Patients with severe hepatic impairment Exposure may be increased in patients with severe hepatic impairment (Child-Pugh Class C).
2). In these cases, no recommendation on a posology can be made. 4% of the patients had concurrent bacteraemia at baseline; 34% of the patients had complicated appendicitis. Coagulopathy Eravacycline may prolong both prothrombin time (PT) and activated partial thromboplastin time (aPTT).

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised March 13, 2026[2]

3%), which were generally mild or moderate in severity. Tabulated list of adverse reactions The adverse reactions identified with eravacycline are presented in Table 1. Adverse reactions are classified according to MedDRA system organ classification and frequency.
Frequency categories are derived according to the following conventions: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1 Tabulated list of adverse reactions to eravacycline in clinical trials System Organ Class Common Uncommon Blood and lymphatic system disorders Hypofibrinogenaemia Increased international normalised ratio (INR) Prolonged activated partial thromboplastin time (aPTT) Prolonged prothrombin time (PT) Immune system disorders Hypersensitivity Nervous system disorders Dizziness Headache Vascular disorders Thrombophlebitisa Phlebitisb Gastrointestinal disorders Nausea Vomiting Pancreatitis Diarrhoea Hepatobiliary disorders Aspartate aminotransferase (AST) increased Alanine aminotransferase (ALT) increased Hyperbilirubinaemia Skin and subcutaneous tissue disorders Rash Hyperhidrosis General disorders and administration site conditions Infusion site reactionc a.
Thrombophlebitis includes the preferred terms thrombophlebitis and infusion site thrombosis b. Phlebitis includes the preferred terms phlebitis, infusion site phlebitis, superficial phlebitis and injection site phlebitis c. Infusion site reaction includes the preferred terms injection site erythema, infusion site hypoaesthesia, vessel puncture site erythema and vessel puncture site pain Description of selected adverse reactions Infusion site reactions Mild to moderate infusion site reactions, including pain or discomfort, erythema and swelling or inflammation at the injection site as well as superficial thrombophlebitis and/or phlebitis have been reported in patients treated with eravacycline.
Infusion site reactions can be mitigated by reducing the eravacycline infusion concentration or the infusion rate. Tetracycline class effects Tetracycline class adverse reactions include photosensitivity, pseudotumor cerebri, and anti-anabolic action which have led to increased blood urea nitrogen , azotaemia, acidosis, and hyperphosphataemia.
4). 7% of patients; all cases were mild in severity. 5%). In general, adverse reactions were mild or moderate in severity and similar to the adverse reactions observed in adults. Two events were assessed as severe including one event of anaphylactic reaction and one event of pleural effusion, which was also assessed as serious.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised March 13, 2026[2]

3). In case of hypersensitivity reactions, treatment with eravacycline must be discontinued immediately and appropriate emergency measures must be initiated. Clostridioides difficile-associated diarrhoea Antibiotic-associated colitis and pseudomembranous colitis have been reported with the use of nearly all antibiotics and may range in severity from mild to life-threatening.
8). In such circumstances, the discontinuation of eravacycline and the use of supportive measures together with the administration of specific treatment for Clostridioides difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Infusion-site reactions Eravacycline is administered via intravenous infusion, using an infusion time of approximately 1 hour to minimise the risk of infusion-site reactions. 8). In case of serious reactions, eravacycline should be discontinued until a new intravenous access site is established.
Additional measures to reduce the occurrence and severity of infusion site reactions include decreasing the eravacycline infusion rate and/or concentration. Non-susceptible micro-organisms Prolonged use may result in the overgrowth of non-susceptible micro-organisms, including fungi.
If superinfection occurs during therapy, it may require interruption of treatment. Other appropriate measures should be taken and alternative antimicrobial treatment should be considered in accordance with existing therapeutic guidelines.
8). If pancreatitis is suspected, eravacycline should be discontinued. 6). Concomitant use of strong CYP3A4 inducers Medicines that induce CYP3A4 are expected to increase the rate and extent of metabolism of eravacycline. CYP3A4 inducers exert their effect in a time-dependent manner, and may take at least 2 weeks to reach maximal effect after introduction.
Conversely, on discontinuation, CYP3A4 induction may take at least 2 weeks to decline. Co-administration of a strong CYP3A4 inducer (such as phenobarbital, rifampicin, carbamazepine, phenytoin, St. 5). Patients with severe hepatic impairment Exposure may be increased in patients with severe hepatic impairment (Child-Pugh Class C).
2). In these cases, no recommendation on a posology can be made. 4% of the patients had concurrent bacteraemia at baseline; 34% of the patients had complicated appendicitis. Coagulopathy Eravacycline may prolong both prothrombin time (PT) and activated partial thromboplastin time (aPTT).

This is not medical advice. Consult a qualified healthcare professional.