Vol.74 No.2 March 2026

Long-term safety of tedizolid in children

Tomohito Wakabayashi^{1, 2)}, Ichiro Nakakura¹⁾, Kota Sakakura^{1, 2)}, Ayako Takahashi^{2, 3)}, Kaori Imanishi¹⁾, Kaori Yamanishi¹⁾, Makoto Sata^{2, 3)}, Kenichi Kurosaki⁴⁾ and Yoshiko Une¹⁾

¹⁾Department of Pharmacy, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shinmachi, Suita, Osaka, Japan
²⁾Division of Infection Control, National Cerebral and Cardiovascular Center
³⁾Division of Pulmonology, National Cerebral and Cardiovascular Center
⁴⁾Department of Pediatric Cardiology, National Cerebral and Cardiovascular Center

Abstract

Tedizolid (TZD) is a new oxazolidinone antibacterial agent with demonstrated activity against methicillin-resistant Staphylococcus aureus that has been reported as having fewer adverse effects than linezolid (LZD). While LZD is currently in use for pediatric patients, no clinical trials of TZD for pediatric patients have been conducted yet in Japan. In this study, we report on the safety of long-term TZD used based on a study conducted in pediatric patients at our hospital. Between September 2019 and September 2024, a total of 110 patients received treatment with TZD at our hospital. Of these, 6 patients under 15 years of age were treated with TZD for more than 14 days. The median (min-max) age of the pediatric patients was 12.5 years (2-13 years) and the median weight was 32.2 kg (8.6-48.2 kg). The median (min-max) number of days, daily dose, and dose per kg body weight were 39 days (15-95 days), 150 mg (32-200 mg), and 4.25 mg/kg/day (3.7-4.8 mg/kg/day), respectively. Changes in laboratory values after TZD administration were evaluated using the Common Terminology Criteria for Adverse Events Version 5.0. Grade 1 increase of the serum ALT and serum sodium was observed in one patient each. Although the number of patients was limited, our results suggest the safety of long-term administration (>14 days) of TZD in Japanese pediatric patients. Even pediatric patients with LZD-induced thrombocytopenia whose treatment was switched to TZD showed good tolerability of long-term TZD use. However, as the study sample was small, further study is needed to confirm the safety of TZD in Japanese pediatric patients.

Key word

antimicrobial, tedizolid, long-term therapy, pediatrics

Received

June 12, 2025

Accepted

December 4, 2025

Jpn. J. Chemother. 74 (2): 163-169, 2026