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. 2025 Jan 10:15:1517546.
doi: 10.3389/fphar.2024.1517546. eCollection 2024.

Overweight and glucose/lipid metabolism abnormality associated with SSRIs: a pharmacovigilance study based on the FDA adverse event reporting system

Jinming Cao  1 , Zhicong Chen  1 , Yan Wang  2 , Yunpeng Ma  2 , Zhen Yang  2 , Jian Cai  3 , Zhijun Xiao  2 , Feng Xu  1
Affiliations

Overweight and glucose/lipid metabolism abnormality associated with SSRIs: a pharmacovigilance study based on the FDA adverse event reporting system

Jinming Cao et al. Front Pharmacol. .

Abstract

Background: In the past few decades, selective serotonin reuptake inhibitors (SSRIs) became widely used antidepressants worldwide. Therefore, the adverse reactions of patients after SSRI administration became a public and clinical concern. In this study, we conducted a pharmacovigilance study using the Adverse Event Reporting System (FAERS) database of the US Food and Drug Administration. Our main goal was to evaluate adverse events related to SSRIs, with a particular focus on abnormal weight gain and glucose/lipid metabolism disorders.

Method: The adverse event data for representative SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) was extracted from the FAERS database from 2004Q1 to 2023Q4. The reporting odds ratio and proportional reporting ratio were employed to explore relevant adverse event reports (ADEs) signals. Univariate logistic regression analysis was utilized to explore factors associated with glucose/lipid metabolism abnormality following SSRIs treatment.

Results: We identified 143,744 ADE reports associated with SSRIs and revealed significant abnormal signals related to weight gain and glucose/lipid metabolism in depressed patients. Variations were observed among different SSRIs medications. Specifically, citalopram was associated with abnormal weight gain (ROR: 4, 95% CI: 3.1-5.2) and hepatic steatosis (ROR: 2.8, 95% CI: 2.1-3.6); escitalopram was correlated with gestational diabetes (ROR: 9.1, 95% CI: 6.6-12.4) and cholestasis (ROR: 2.4, 95% CI: 1.75-3.38); fluoxetine was associated with obesity (ROR: 2.8, 95% CI: 2.08-3.78); fluvoxamine was linked to arteriospasm coronary (ROR: 13.87, 95% CI: 4.47-43.1); and sertraline was implicated in neonatal jaundice (ROR: 16.1, 95% CI: 12.6-20.6). Females and younger age are important risk factors for the development of associated adverse effects.

Conclusion: Our study screened for adverse effects associated with abnormal glucose/lipid metabolism, such as abnormal body weight and fatty liver, in depressed patients taking selective serotonin reuptake inhibitors by utilizing FAERS database. This provides valuable insights for healthcare professionals in accepting and managing patients treated with SSRIs.

Keywords: ADEs; FAERS; glucose/lipid metabolism disorders; overweight; selective serotonin reuptake inhibitors.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.

Figures

FIGURE 1
FIGURE 1
The flowchart for screening signals of overweight and glucose/lipid metabolism disorders associated with SSRIs.
FIGURE 2
FIGURE 2
Statistics of reported diseases associated with abnormalities of glycolipid metabolism caused by treatment with SSRIs with and without SSRIs in FAERS between 2004 and 2023. (A) Annual ADE reports on SSRIs. (B) Total number of cases of adverse reactions after taking SSRIs and number of cases of adverse reactions related to disorders of glucolipid metabolism. (C) The proportions of reports with and without diseases associated with abnormalities of glycolipid metabolism for different SSRIs.
FIGURE 3
FIGURE 3
The overall signals of disorders associated with SSRIs. Adverse reactions related to citalopram (A), escitalopram (B), fluoxetine (C), fluvoxamine (D), paroxetine (E), sertraline (F) and occurring in the top 10 numbers.
FIGURE 4
FIGURE 4
The signals of overweight and glucose/lipid metabolism disorders associated with SSRIs. Adverse reactions related to citalopram (A), escitalopram (B), fluoxetine (C), fluvoxamine (D), paroxetine (E), sertraline (F) caused by abnormalities in glucolipid metabolism.
FIGURE 5
FIGURE 5
Differences in adverse reactions triggered by abnormalities in glucolipid metabolism in men and women after taking SSRIs. (A) Citalopram. (B) Escitalopram. (C) Fluvoxamine. (D) Fluoxetine. (E) Paroxetine. (F) Sertraline. The numerical values in the heatmap represent the number of specific PTs occurrences in males and females, respectively.
FIGURE 6
FIGURE 6
Forest plots showing the results of univariate logistic regression analyses regarding demographic factors affecting diseases caused by SSRIs-associated disorders of glucolipid metabolism.
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