Evidence map›Paper›PMID 34273099›Full record

ArticleDrug safety2021

Is There an Increased Risk of Hepatotoxicity with Metamizole? A Comparative Cohort Study in Incident Users.

Karin Hedenmalm, Alexandra Pacurariu, Jim Slattery, Xavier Kurz, Gianmario Candore, Rob Flynn

Abstract read
PubMed Publisher
In one paragraph

Article in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.6field-weighted citation impact, top 16% of its field
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

5 citing papers in PubMed, 13 citations in OpenAlex.

  1. Metamizole: Indications and Risks.Deutsches Arzteblatt international · 2026
    Review
  2. Article
  3. Drug-Induced Liver Injury Caused by Metamizole: Identification of a Characteristic Injury Pattern.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Observational
  4. Article
  5. 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

6 authors at 1 institution in 2 countries.

Karin HedenmalmData Analytics and Methods Task force, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands. karin.hedenmalm@ema.europa.eu.ORCID 0000-0002-9544-9163
Alexandra PacurariuPharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The Netherlands.
Jim SlatteryData Analytics and Methods Task force, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.
Xavier KurzData Analytics and Methods Task force, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.
Gianmario CandoreData Analytics and Methods Task force, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.
Rob FlynnData Analytics and Methods Task force, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.
European Medicines Agency · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe analgesic metamizole, which has been withdrawn from the market in several countries due to the risk of agranulocytosis but is still available on the market in Germany and some other countries, has been associated with liver injury in published case reports; however, epidemiological studies on the risk of liver injury are limited.

objectiveThe aim of this study was to compare the risk of liver injury up to 270 days after the first start of treatment with metamizole with the corresponding risk in patients starting treatment with paracetamol, using a retrospective cohort incident user design.

methodsThe first prescription for either metamizole or paracetamol in the Intercontinental Medical Statistics (IMS)

resultsMetamizole was associated with a higher risk of liver injury compared with paracetamol (adjusted hazard ratio 1.69, 95% confidence interval 1.46-1.97). Sensitivity analyses were performed to evaluate the robustness of these findings. In all the sensitivity analyses, metamizole was still associated with a higher risk of liver injury, including an analysis where naproxen was used as a comparator instead of paracetamol.

conclusionsResults from this study support previous studies suggesting that metamizole is associated with a significant risk of liver injury. Nevertheless, a possible impact of residual confounding cannot be excluded.

Indexed as

Chemical and Drug Induced Liver InjuryDrug-Related Side Effects and Adverse ReactionsAcetaminophenAnti-Inflammatory Agents, Non-SteroidalCohort StudiesDipyroneHumansRetrospective StudiesAcetaminophenAnti-Inflammatory Agents, Non-SteroidalDipyrone

Identifiers

PMID34273099
OpenAlexW3182647673

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.