Evidence map›Paper›PMID 38863974›Full record

ArticleFrontiers in pharmacology2024

Safety assessment of tranexamic acid: real-world adverse event analysis from the FAERS database.

Ningsheng Tian, Yuxin Sun, Yingying Liu, Jie Jin, Shuai Chen, Huawei Han, Ying Zhang, Zhiwei Li

Abstract read
In one paragraph

Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Tranexamic acid-induced anaphylaxis: a systematic review.European journal of clinical pharmacology · 2025
    Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Tranexamic Acid in Pediatric Care: A Comprehensive Overview.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026
    Article
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  7. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Ningsheng Tian *Department of Orthopaedics, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Yuxin Sun *Department of Orthopaedics, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Yingying Liu *Department of Orthopaedics, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Jie JinDepartment of Orthopaedics, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Shuai ChenDepartment of Orthopaedics, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Huawei HanDepartment of Orthopaedics, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Ying ZhangDepartment of Orthopaedics, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Zhiwei LiDepartment of Orthopaedics, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: In recent years, with the continuous expansion of the application scope of Tranexamic acid (TXA), its usage has surged. Despite numerous studies demonstrating its powerful efficacy, concerns regarding its adverse reactions persist, necessitating comprehensive safety assessment. This study analyzed real-world data from the U.S. Food and Drug Administration to investigate TXA-related adverse events, aiming to elucidate its safety and optimize patient treatment. Methods: The adverse drug event data concerning TXA from 2004 Q1 to 2023 Q3 were collected. Following data standardization, a variety of signal quantification techniques, including the reporting odds ratios, proportional reporting ratios, Bayesian confidence propagation neural network, and empirical Bayes geometric mean were used for analysis. Results: After analyzing 16,692,026 adverse event reports, a total of 1,574 cases of adverse events related to TXA were identified, spanning 23 system organ classes and 307 preferred terms. In addition to the common thrombosis-related Vascular disorders ( Conclusion: Our research suggests that TXA has some adverse reactions that are being overlooked. As a cornerstone medication in hemorrhage treatment, it's crucial to monitor, identify, and address these adverse reactions effectively.

Indexed as

ADEdrug discoveryFAERSpharmacovigilancetranexamic acid

Identifiers

PMID38863974
PMCPMC11165083

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.