Evidence map›Paper›PMID 40892374›Full record

ArticleDrug safety2026

Leveraging Large Language Models in Extracting Drug Safety Information from Prescription Drug Labels.

Undina Gisladottir, Michael Zietz, Sophia Kivelson, Yutaro Tanaka, Gaurav Sirdeshmukh, Kathleen LaRow Brown, Nicholas P Tatonetti

Abstract read
In one paragraph

Article in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Undina GisladottirDepartment of Biomedical Informatics, Columbia University, New York, NY, USA.
Michael ZietzDepartment of Biomedical Informatics, Columbia University, New York, NY, USA.
Sophia KivelsonDepartment of Computational Biomedicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Yutaro TanakaDepartment of Biomedical Informatics, Columbia University, New York, NY, USA.
Gaurav SirdeshmukhCedars-Sinai Cancer, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Kathleen LaRow BrownDepartment of Biomedical Informatics, Columbia University, New York, NY, USA.
Nicholas P TatonettiDepartment of Biomedical Informatics, Columbia University, New York, NY, USA. Nicholas.Tatonetti@cshs.org.ORCID 0000-0002-2700-2597

Funding

Training in Biomedical Informatics at Columbia UniversityT15LM007079 · NLM · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI NOEMIE ELHADAD, GEORGE M HRIPCSAK · 1992 to 2026
$28.9M
Precision Pharmacology and Pharmacovigilance: Leveraging AI to address drug safety knowledge gapsR35GM131905 · NIGMS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI Nicholas P Tatonetti · 2019 to 2026
$3.3M
NIGMS NIH HHS R35 GM131905NIGMS NIH HHS R35GM131905NLM NIH HHS T15 LM007079U.S. National Library of Medicine T15-LM007079
6 · The paper itself

Abstract

introductionAdverse drug reactions (ADRs), including those resulting from drug interactions, remain a leading cause of morbidity and mortality. Structured product labels (SPLs) serve as a primary source for drug safety information. Having machine-readable product labels, including adverse reactions (ARs) and drug interactions, readily available would allow researchers to streamline medication safety studies. However, extracting this information is complex and requires the use of natural language processing (NLP) methods.

objectiveIn this study, we explored the application of generative language models in the extraction of drug safety information from SPLs.

methodsWe compared multiple generative LLMs (GPT, Llama, and Mixtral) to two baseline methods in the task of extracting adverse reactions (ARs) from SPLs. We explored various factors, such as prompting strategies and term complexity, that impact the performance of these models in the extraction of ARs. Finally, we explored the generative models' capacity to extract drug interactions from a separate section of SPLs without additional fine-tuning or training, demonstrating their flexibility and adaptability for information retrieval.

resultsWe found that generative language models, specifically GPT-4, are able to match or exceed the performance of previous state-of-the-art models without additional training or fine-tuning. Additionally, we found that the specific SPL section, surrounding context, and complexity of the AR term impacted the extraction performance. Finally, we demonstrated the generalizability of these models by applying them to a separate task of extracting drug names from the drug interaction section where curated training data are not available.

conclusionGenerative language models demonstrate significant potential for automating drug safety information extraction from SPLs, offering a promising avenue for improving post-market surveillance and reducing ADRs. Future work should focus on refining prompting strategies and expanding the models' capabilities to handle increasingly complex and nuanced drug safety information.

Indexed as

Drug LabelingDrug-Related Side Effects and Adverse ReactionsNatural Language ProcessingPrescription DrugsDrug InteractionsHumansLarge Language ModelsPrescription Drugs

Identifiers

PMID40892374
PMCPMC12860809

What Socratic holds

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LicenceCC BY-NC
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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 Socratic graph.