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Tigecycline

Also known as: Tygacil · Tigecycline Accord

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In short

In the European Union, tigecycline is indicated in adults and in children from the age of eight years for the treatment of complicated skin and soft tissue infections, excluding diabetic foot infections, and complicated intra-abdominal infections. In the European Union, it should be used only in situations where other alternative antibiotics are not suitable. In the United States, tigecycline is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia. In the United States, it is not indicated for the treatment of diabetic foot infections or hospital-acquired pneumonia, including ventilator-associated pneumonia.

From: Source: European Medicines Agency (EMA), Tygacil — EPAR, 22/10/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
384455 tigecycline
EMA
EMEA/H/C/000644, EMEA/H/C/005114

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

FDA (USA) Tigecycline

1 INDICATIONS AND USAGE Tigecycline for Injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for: Complicated skin and skin structure infections ( 1.1 ) Complicated intra-abdominal infections ( 1.2 ) Community-acquired bacterial pneumonia ( 1.3 ) Limitations of Use : Tigecycline for Injection is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia. ( 1.4 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tigecycline for Injection and other antibacterial drugs, Tigecycline for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.5 ) 1.1 Complicated Skin and Skin Structure Infections Tigecycline for Injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus ), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis. 1.2 Complicated Intra-abdominal Infections Tigecycline for Injection is indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections caused by susceptible isolates of Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus ), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros. 1.3 Community-Acquired Bacterial Pneumonia Tigecycline for Injection is indicated in patients 18 years of age and older for the treatment of community-acquired bacterial pneumonia caused by susceptible isolates of Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae , and Legionella pneumophila . 1.4 Limitations of Use Tigecycline for Injection is not indicated for the treatment of diabetic foot infections. A clinical trial failed to demonstrate non-inferiority of Tigecycline for Injection for treatment of diabetic foot infections. Tigecycline for Injection is not indicated for the treatment of hospital-acquired or ventilator-associated pneumonia. In a comparative clinical trial, greater mortality and decreased efficacy were reported in Tigecycline for Injection-treated patients [see Warnings and Precautions ( 5.2 )]. 1.5 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tigecycline for Injection and other antibacterial drugs, Tigecycline for Injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to tigecycline. Tigecycline for Injection may be initiated as empiric monotherapy before results of these tests are known.

Data provided by the U.S. Food and Drug Administration.

Document date: 20260217 · Official document →

EMA (EU) Tygacil

Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections Complicated intra-abdominal infections (cIAI) Tygacil should be used only in situations where other alternative antibiotics are not suitable. Consideration should be given to official guidance on the appropriate use of antibacterial agents. appropriate use of antibacterial agents.

Source: European Medicines Agency (EMA), Tygacil — EPAR, 22/10/2025. © European Medicines Agency.

Document date: 22/10/2025 · Official document →

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Questions

What is Tigecycline approved for in the European Union?

Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections Complicated intra-abdominal infections (cIAI) Tygacil should be used only in situations where other alternative antibiotics are not suitable. Consideration should be given to official guidance on the appropriate use of antibacterial agents. appropriate use of antibacterial agents. (Source: European Medicines Agency (EMA), Tygacil — EPAR, 22/10/2025. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Tygacil — EPAR, 22/10/2025. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →