Evidence map›Paper›PMID 40710914›Full record

ArticleNeurology international2025

Selective Serotonin Reuptake Inhibitor-Associated Intracranial Hemorrhage: Drug-Specific Risk Patterns and Patient-Level Modifiers.

Josef Yayan, Kurt Rasche

Abstract read
In one paragraph

Article in Neurology international, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
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1 · What the graph read from it

What it found

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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

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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

2 citing papers in PubMed.

  1. Review
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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

2 authors.

Josef YayanDepartment of Internal Medicine, Division of Pulmonary, Allergy and Sleep Medicine, HELIOS Clinic Wuppertal, Witten/Herdecke University, Heusnerstr. 40, 42283 Wuppertal, Germany.ORCID 0000-0002-8363-621X
Kurt RascheDepartment of Internal Medicine, Division of Pulmonary, Allergy and Sleep Medicine, HELIOS Clinic Wuppertal, Witten/Herdecke University, Heusnerstr. 40, 42283 Wuppertal, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSelective serotonin reuptake inhibitors (SSRIs) are among the most commonly prescribed antidepressants and are generally considered safe. However, emerging data suggest a potential association with intracranial hemorrhage (ICH), especially among elderly patients and those on anticoagulation.

methodsWe conducted a retrospective pharmacovigilance analysis using data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS). Reports up to May 2025 listing an SSRI (sertraline, fluoxetine, paroxetine, escitalopram, citalopram, or fluvoxamine) as a suspect or interacting drug and involving an ICH event were included. Disproportionality was assessed using reporting odds ratios (RORs) with 95% confidence intervals.

resultsAmong 226 eligible ICH cases, sertraline (30.5%), paroxetine (28.8%), and fluoxetine (27.9%) were most frequently implicated. Sertraline showed a strong signal for cerebral hemorrhage (ROR = 4.97), while fluoxetine was associated with subarachnoid hemorrhage (ROR = 4.51). Sertraline had a pronounced signal among patients aged >60 years (ROR = 7.92) and in combination with anticoagulants (ROR = 9.56). Fluoxetine was underrepresented in elderly cases. Given the very small number of fluvoxamine-related cases (n = 2), interpretation should be cautious due to limited statistical power. Gender-stratified analyses showed female predominance in sertraline-related ICH and male predominance for paroxetine. Citalopram demonstrated a potentially protective profile with inverse association with cerebral hemorrhage.

conclusionsThis study highlights significant differences in ICH reporting patterns across SSRIs, modified by patient age, gender, and co-medication. These findings underscore the need for individualized SSRI prescribing, particularly in patients receiving anticoagulant therapy particularly in elderly patients and those receiving anticoagulant therapy, where sertraline and fluoxetine may pose increased risk.

Indexed as

anticoagulationdrug safetyFAERSintracranial hemorrhagepharmacovigilanceselective serotonin reuptake inhibitors

Identifiers

PMID40710914
PMCPMC12299848

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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.