Evidence map›Paper›PMID 40752738›Full record

ArticleThe journal of allergy and clinical immunology. In practice2025

Anaphylaxis to Penicillin: Harvesting Insights From the Food and Drug Administration's Adverse Event Reporting System.

Ami P Belmont, Samantha Novotny, Eric Milan Mukherjee, Dodie Park, Katelyn H Wong, Michelle D Martin-Pozo, Elizabeth J Phillips, Cosby A Stone

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Article in The journal of allergy and clinical immunology. In practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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.

Ami P BelmontSection of Rheumatology, Allergy and Immunology, Department of Internal Medicine, Yale School of Medicine, New Haven, Conn. Electronic address: ami.belmont@yale.edu.
Samantha NovotnySection of Rheumatology, Allergy and Immunology, Department of Internal Medicine, Yale School of Medicine, New Haven, Conn.
Eric Milan MukherjeeDepartment of Dermatology, Vanderbilt University Medical Center, Nashville, Tenn; Center for Drug Safety and Immunology, Vanderbilt University Medical Center, Nashville, Tenn.
Dodie ParkCenter for Drug Safety and Immunology, Vanderbilt University Medical Center, Nashville, Tenn.
Katelyn H WongSection of Rheumatology, Allergy and Immunology, Department of Internal Medicine, Yale School of Medicine, New Haven, Conn; Section of Pediatric Pulmonology, Allergy, Immunology and Sleep Medicine, Department of Pediatrics, Yale School of Medicine, New Haven, Conn.
Michelle D Martin-PozoCenter for Drug Safety and Immunology, Vanderbilt University Medical Center, Nashville, Tenn; Department of Medicine, Vanderbilt University Medical Center, Nashville, Tenn.
Elizabeth J PhillipsDepartment of Medicine, Vanderbilt University Medical Center, Nashville, Tenn; Institute for Immunology and Infectious Diseases, Murdoch University, Murdoch, Western Australia, Australia.
Cosby A StoneDepartment of Medicine, Vanderbilt University Medical Center, Nashville, Tenn.

Funding

AHRQ HHS R01 HS030234
6 · The paper itself

Abstract

backgroundThere is a gap in knowledge regarding the contemporary epidemiology of penicillin-associated anaphylaxis.

objectiveTo assess whether penicillin antibiotics (PAs) had higher reporting odds of anaphylaxis compared with other medications, patterns of anaphylaxis reports attributed to specific PAs, and the frequency of reported mortality associated with anaphylaxis using pharmacovigilance methods using the Food and Drug Administration Adverse Event Reporting System database.

methodsWe included patients in the Food and Drug Administration Adverse Event Reporting System with reported anaphylaxis to PAs from 2013 to 2023 in this cross-sectional study. Reporting odds ratios and proportional reporting ratios were used to determine whether specific PAs had higher reporting odds of anaphylaxis.

resultsAmong a total of 20,815,425 adverse events and 48,637 reports of anaphylaxis, there were 3,176 reports of anaphylaxis to PAs. Compared with other medications, all PAs had higher reporting odds of anaphylaxis. Compared with all other PAs, there were disproportionality signals for reported anaphylaxis to amoxicillin-containing medications (reporting odds ratio, 1.97; 95% CI, 1.82-2.14) and "unspecified" PAs (reporting odds ratio, 1.77; 95% CI, 1.44-2.19). We observed a higher proportion of anaphylaxis reports to all PAs (4.5%) from reports outside the United States (US) compared with reports from the US (2.3%, P < .0001). US reports demonstrated higher reporting odds for anaphylaxis to nonaminopenicillins and piperacillin-tazobactam, whereas non-US reports demonstrated higher reporting odds for amoxicillin-containing medications. There were 139 reports of anaphylaxis to PAs associated with death.

conclusionsPAs had higher reporting odds of anaphylaxis compared with all other medications in the Food and Drug Administration Adverse Event Reporting System database. We observed regional differences in reporting odds to specific PAs when comparing US and non-US reports. Fatalities reported following anaphylaxis were rare.

Indexed as

Adverse Drug Reaction Reporting SystemsAnaphylaxisAnti-Bacterial AgentsDrug HypersensitivityPenicillinsAdolescentAdultAgedChildChild, PreschoolCross-Sectional StudiesDatabases, FactualFemaleHumansInfantMaleAnti-Bacterial AgentsPenicillinsAdverse drug reactionsAnaphylaxisBeta-lactam allergyDrug allergyPenicillin allergyPharmacovigilance

Identifiers

PMID40752738
PMCPMC12926993

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.