Related Experiment Video

Updated: May 20, 2026

A Semi-Quantitative Drug Affinity Responsive Target Stability (DARTS) assay for studying Rapamycin/mTOR interaction
05:28

A Semi-Quantitative Drug Affinity Responsive Target Stability (DARTS) assay for studying Rapamycin/mTOR interaction

Published on: August 27, 2019

Descriptive Analysis of Adverse Drug Events of Three mTOR Inhibitors Using WHO-VigiAccess

Prerna Bhati1, Prakash Haloi1, Havagiray R Chitme1

  • 1Amity Institute of Pharmacy, Amity University, Noida, 201303, Uttar Pradesh, India.

Current Drug Safety
|May 19, 2026
PubMed
Abstract

Insights

Mechanistic target of rapamycin (mTOR) inhibitors like Sirolimus and Temsirolimus carry significant risks, including gastrointestinal bleeding, lung disease, and infections. Careful monitoring is crucial for patient safety.

Area of Science:

  • Pharmacology
  • Oncology
  • Immunology

Background:

  • The mechanistic target of rapamycin (mTOR) pathway is crucial for cell growth, metabolism, and survival, with its dysregulation implicated in various diseases including cancer and aging.
  • mTOR inhibitors (e.g., Sirolimus, Everolimus, Temsirolimus) are valuable therapeutics but are associated with significant adverse drug reactions (ADRs).

Purpose of the Study:

  • To investigate the adverse events (AEs) and ADRs linked to mTOR inhibitors.
  • Utilized the World Health Organization's VigiAccess database for comprehensive data analysis.

Main Methods:

  • Conducted a retrospective descriptive analysis of ADR reports from the WHO VigiAccess database (2000 onwards).
  • Analyzed patient demographics and geographic distribution of reported ADRs.
  • Employed statistical measures like odds ratios and relative risks to quantify the risks associated with mTOR inhibitors.

Main Results:

  • Sirolimus demonstrated a 132% increased risk of gastrointestinal hemorrhage and was linked to oral ulceration, interstitial lung disease (67% higher risk), and ascites (63% increased likelihood).
  • Temsirolimus was associated with a 40% higher risk of pneumonia and a 36% increased risk of sepsis, indicating potential immunosuppressive effects.

Conclusions:

  • mTOR inhibitors are associated with a wide spectrum of serious ADRs, including gastrointestinal and pulmonary complications, as well as an increased risk of infections.
  • Clinical use necessitates careful patient monitoring and a thorough risk-benefit assessment to optimize therapeutic outcomes and patient safety.
Keywords:
Temsirolimusdrug safety.everolimuspharmacovigilancesirolimus

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