Taurolidine
Antiinfectives
Sold as DEFENCATH
- Drug class
- Antiinfectives
- Availability
- Prescription only
- Routes
- Intraluminal
- Markets covered
- 1
- Products on record
- 1
- FDA reports (12 mo)
- 7
Overview
Plain-language summary, compiled from the cited regulatory records
Taurolidine is an anti-infective agent [1]. It is approved to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure who are receiving chronic hemodialysis through a central venous catheter (CVC) [1]. This indication is for a limited and specific patient population [1].
Taurolidine is available under the brand name DEFENCATH [1]. In the past 12 months, there have been 7 adverse event reports associated with taurolidine [2]. The most frequent reactions reported were "Drug Ineffective," "Device Malfunction," "Drug Hypersensitivity," "Complication Associated With Device," and "Device Occlusion" [2]. The safety and effectiveness of taurolidine have not been established for use in populations other than adult patients with kidney failure on chronic hemodialysis [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 1 | September 29, 2025 |
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE LIMITED POPULATION: DEFENCATH ® is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC).
This drug is indicated for use in a limited and specific population of patients [see Clinical Studies (14) ]. Limitations of Use The safety and effectiveness of DEFENCATH have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC.
LIMITED POPULATION:
DEFENCATH is a combination of taurolidine, a thiadiazinane antimicrobial, and heparin, an anti-coagulant, indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC).
Sources & citations
- [1]FDA DailyMed · 13b3a61e-5a4b-4a… · revised September 29, 2025 [PDF]
- [2]OpenFDA adverse-event reports (US), 12 months ending June 4, 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.