---
title: "Teclistamab Safety Signals in FAERS: Infections, Immune Toxicities, and Sepsis Risk"
id: "pubmed-42742109"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42742109"
content_type: "clinical_feed_article"
specialty: "Critical Care"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42742109/"
doi: "10.1080/16078454.2026.2730041"
published_at: "2026-09-15T15:47:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Teclistamab Safety Signals in FAERS: Infections, Immune Toxicities, and Sepsis Risk
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42742109
- **Specialty:** [Critical Care](https://medichelpline.com/clinical-feed/critical-care.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42742109/)
- **DOI:** [10.1080/16078454.2026.2730041](https://doi.org/10.1080%2F16078454.2026.2730041)
- **Published At:** 2026-09-15T15:47:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This disproportionality study analyzed **FAERS** reports for teclistamab from 2022–2025 to characterize postmarketing adverse events and temporal patterns. - A total of 2,631 reports were identified; 85.2% described serious outcomes and 21.7% were fatal. - The most commonly reported system organ class was **infections and infestations**; key preferred-term signals included **cytokine release syndrome (CRS)**, **immune effector cell‑associated neurotoxicity syndrome (ICANS)**, infection, pneumonia, pyrexia, and **neutropenia**. - Seventy significant preferred-term signals were detected: 52 aligned with previously documented events and 18 were reported as novel signals in this dataset. - **Sepsis** emerged as the only high-priority signal; among sepsis-related reports, 58.57% had fatal outcomes. - Temporal analyses indicated immune-related and neurological events tended to occur earlier after exposure, while infectious complications generally appeared later. - Safety signal patterns were broadly similar across sex and age groups; an exception was a lower frequency of reported septic shock in females. - The overall safety profile was consistent with clinical trial observations, but the presence of novel signals and high sepsis fatality underscores the need for targeted risk mitigation and continued pharmacovigilance for severe infections and immune-related toxicities.
## Clinical Analysis & Structured Key Points
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Epub 2026 Sep 15. # Teclistamab-associated adverse events: a disproportionality analysis of the FDA adverse event reporting system [Xiaoyu He](https://pubmed.ncbi.nlm.nih.gov/?term=He+X&cauthor_id=42742109)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42742109/#full-view-affiliation-1 "Department of Hematology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, People's Republic of China."), [Gang Chen](https://pubmed.ncbi.nlm.nih.gov/?term=Chen+G&cauthor_id=42742109)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42742109/#full-view-affiliation-1 "Department of Hematology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, People's Republic of China."), [Zhengyu Zhan](https://pubmed.ncbi.nlm.nih.gov/?term=Zhan+Z&cauthor_id=42742109)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42742109/#full-view-affiliation-1 "Department of Hematology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, People's Republic of China."), [Zhenjiang Li](https://pubmed.ncbi.nlm.nih.gov/?term=Li+Z&cauthor_id=42742109)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42742109/#full-view-affiliation-1 "Department of Hematology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, People's Republic of China.") Affiliations Expand ### Affiliation * 1 Department of Hematology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, People's Republic of China. * PMID: **42742109** * DOI: [ 10.1080/16078454.2026.2730041 ](https://doi.org/10.1080/16078454.2026.2730041) Item in Clipboard # Teclistamab-associated adverse events: a disproportionality analysis of the FDA adverse event reporting system Xiaoyu He et al. Hematology. 2026. Show details Display options Display options Format Abstract PubMed PMID Hematology Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Hematology%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Hematology%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42742109/) . 2026 Dec 31;31(1):2730041. doi: 10.1080/16078454.2026.2730041. Epub 2026 Sep 15. ### Authors [Xiaoyu He](https://pubmed.ncbi.nlm.nih.gov/?term=He+X&cauthor_id=42742109)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42742109/#short-view-affiliation-1 "Department of Hematology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, People's Republic of China."), [Gang Chen](https://pubmed.ncbi.nlm.nih.gov/?term=Chen+G&cauthor_id=42742109)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42742109/#short-view-affiliation-1 "Department of Hematology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, People's Republic of China."), [Zhengyu Zhan](https://pubmed.ncbi.nlm.nih.gov/?term=Zhan+Z&cauthor_id=42742109)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42742109/#short-view-affiliation-1 "Department of Hematology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, People's Republic of China."), [Zhenjiang Li](https://pubmed.ncbi.nlm.nih.gov/?term=Li+Z&cauthor_id=42742109)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42742109/#short-view-affiliation-1 "Department of Hematology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, People's Republic of China.") ### Affiliation * 1 Department of Hematology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, People's Republic of China. * PMID: **42742109** * DOI: [ 10.1080/16078454.2026.2730041 ](https://doi.org/10.1080/16078454.2026.2730041) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Introduction:** Teclistamab, a B-cell maturation antigen (BCMA) × CD3 bispecific antibody, is effective in relapsed/refractory multiple myeloma, but its real-world post-marketing safety profile remains incompletely characterized. **Objectives:** To evaluate adverse event (AE) signals, temporal patterns, and clinical priorities associated with teclistamab using the FDA Adverse Event Reporting System (FAERS). **Methods:** We retrospectively analyzed FAERS reports from 2022 to 2025 using four disproportionality methods: reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker. Time-to-onset, Weibull, Kaplan-Meier, and semi-quantitative clinical prioritization analyses were also performed. **Results:** Among 2,631 reports, 85.2% involved serious outcomes and 21.7% fatal outcomes. The most frequently reported system organ class was infections and infestations. Seventy significant preferred-term signals were identified, including 52 previously documented and 18 novel signals. Cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, infection, pneumonia, pyrexia, and neutropenia were most frequently reported. Sepsis was the sole high-priority signal, with fatal outcomes in 58.57% of sepsis-related reports. Immune-related and neurological events occurred earlier, whereas infectious complications tended to occur later. Safety profiles were generally consistent across sex and age groups, although septic shock was less frequently reported in females. **Discussion:** The safety profile broadly aligned with clinical trial data, but novel signals and sepsis-related fatality highlighted clinically important risks. **Conclusion:** These findings support targeted risk mitigation and continued monitoring, particularly for severe infections and immune-related toxicities. **Keywords:** FAERS; Teclistamab; adverse events; bispecific antibody; disproportionality analysis; multiple myeloma; pharmacovigilance; safety signals. 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