Safety assessment of temozolomidee: real-world adverse event analysis from the FAERS database
BackgroundTemozolomidee (TMZ) is an alkylating antitumor drug used in the treatment of glioblastoma and anaplastic astrocytoma. It is often combined with radiotherapy and has cytotoxic effects on tumor cells. Although temozolomidee has a certain efficacy in the treatment of brain malignancies, its n...
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Frontiers Media S.A.
2025-08-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2025.1578406/full |
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| author | Yu Liu Lan Ma Lan Ma Xiaojia Fu Xiaojia Fu Yi Zhang Yi Zhang Jinyu Zheng Zhongjun Chen |
| author_facet | Yu Liu Lan Ma Lan Ma Xiaojia Fu Xiaojia Fu Yi Zhang Yi Zhang Jinyu Zheng Zhongjun Chen |
| author_sort | Yu Liu |
| collection | DOAJ |
| description | BackgroundTemozolomidee (TMZ) is an alkylating antitumor drug used in the treatment of glioblastoma and anaplastic astrocytoma. It is often combined with radiotherapy and has cytotoxic effects on tumor cells. Although temozolomidee has a certain efficacy in the treatment of brain malignancies, its numerous adverse effects (AEs) suggest that its safety needs to be thoroughly evaluated.MethodsBased on data from the FDA Adverse Event Reporting System (FAERS) database, a retrospective pharmacovigilance study was conducted to evaluate temozolomide-related adverse events. Methods for identifying temozolomide-related AEs signals include taking a case/non-case approach. Specific detection algorithms also include report Odds ratio (ROR), Proportional Report ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item Gamma-Poisson constrictor (MGPS).ResultsAmong 48,766,547 FAERS reports, 13,608 TMZ-related AEs were identified. Males (53.66%) and patients aged ≥45 years predominated. The most frequent outcomes were hospitalization (35.76%), death (22.79%), and serious AEs (34.24%). Hematologic toxicities dominated, with “blood and lymphatic system disorders” showing the strongest signal (ROR 5.94, 95% CI: 5.73–6.15; PRR 5.48). Notable PTs included *petechiae* (ROR 9.87), *hemiparesis* (ROR 9.36), and *platelet count decreased* (ROR 8.61). Unexpected AEs, such as *pulmonary embolism* (ROR 4.96) and *Pneumocystis jirovecii pneumonia* (ROR 7.09), were identified. Renal/metabolic disorders (e.g., hypernatremia) and neurotoxic events (e.g., seizures, ROR 6.19) also demonstrated significant signals.ConclusionThis large-scale analysis highlights TMZ’s association with severe hematologic, thromboembolic, and opportunistic infection-related AEs in real-world settings. While expected toxicities (e.g., myelosuppression) were confirmed, novel signals like pulmonary embolism and neurotoxicity warrant further investigation. Clinicians should prioritize hematologic monitoring, thromboprophylaxis in high-risk patients, and *Pneumocystis* prophylaxis during corticosteroid co-administration. Future studies should validate these signals through prospective trials and mechanistic research to optimize TMZ’s risk-benefit profile in glioma therapy. |
| format | Article |
| id | doaj-art-081e0eeb2e054ab692615cf4cd07d0d3 |
| institution | Kabale University |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Frontiers Media S.A. |
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| spelling | doaj-art-081e0eeb2e054ab692615cf4cd07d0d32025-08-20T04:02:01ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-08-011610.3389/fphar.2025.15784061578406Safety assessment of temozolomidee: real-world adverse event analysis from the FAERS databaseYu Liu0Lan Ma1Lan Ma2Xiaojia Fu3Xiaojia Fu4Yi Zhang5Yi Zhang6Jinyu Zheng7Zhongjun Chen8Department of Neurosurgery, Affiliated Huaian Hospital of Xuzhou Medical University, Huaian, ChinaDepartment of Neurosurgery, Affiliated Huaian Hospital of Xuzhou Medical University, Huaian, ChinaDepartment of Neurosurgery of Xuzhou Medical University, Xuzhou, ChinaDepartment of Neurosurgery, Affiliated Huaian Hospital of Xuzhou Medical University, Huaian, ChinaDepartment of Neurosurgery of Xuzhou Medical University, Xuzhou, ChinaDepartment of Neurosurgery, Affiliated Huaian Hospital of Xuzhou Medical University, Huaian, ChinaDepartment of Neurosurgery of Xuzhou Medical University, Xuzhou, ChinaDepartment of Neurosurgery, Affiliated Huaian Hospital of Xuzhou Medical University, Huaian, ChinaDepartment of Neurosurgery, Affiliated Huaian Hospital of Xuzhou Medical University, Huaian, ChinaBackgroundTemozolomidee (TMZ) is an alkylating antitumor drug used in the treatment of glioblastoma and anaplastic astrocytoma. It is often combined with radiotherapy and has cytotoxic effects on tumor cells. Although temozolomidee has a certain efficacy in the treatment of brain malignancies, its numerous adverse effects (AEs) suggest that its safety needs to be thoroughly evaluated.MethodsBased on data from the FDA Adverse Event Reporting System (FAERS) database, a retrospective pharmacovigilance study was conducted to evaluate temozolomide-related adverse events. Methods for identifying temozolomide-related AEs signals include taking a case/non-case approach. Specific detection algorithms also include report Odds ratio (ROR), Proportional Report ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item Gamma-Poisson constrictor (MGPS).ResultsAmong 48,766,547 FAERS reports, 13,608 TMZ-related AEs were identified. Males (53.66%) and patients aged ≥45 years predominated. The most frequent outcomes were hospitalization (35.76%), death (22.79%), and serious AEs (34.24%). Hematologic toxicities dominated, with “blood and lymphatic system disorders” showing the strongest signal (ROR 5.94, 95% CI: 5.73–6.15; PRR 5.48). Notable PTs included *petechiae* (ROR 9.87), *hemiparesis* (ROR 9.36), and *platelet count decreased* (ROR 8.61). Unexpected AEs, such as *pulmonary embolism* (ROR 4.96) and *Pneumocystis jirovecii pneumonia* (ROR 7.09), were identified. Renal/metabolic disorders (e.g., hypernatremia) and neurotoxic events (e.g., seizures, ROR 6.19) also demonstrated significant signals.ConclusionThis large-scale analysis highlights TMZ’s association with severe hematologic, thromboembolic, and opportunistic infection-related AEs in real-world settings. While expected toxicities (e.g., myelosuppression) were confirmed, novel signals like pulmonary embolism and neurotoxicity warrant further investigation. Clinicians should prioritize hematologic monitoring, thromboprophylaxis in high-risk patients, and *Pneumocystis* prophylaxis during corticosteroid co-administration. Future studies should validate these signals through prospective trials and mechanistic research to optimize TMZ’s risk-benefit profile in glioma therapy.https://www.frontiersin.org/articles/10.3389/fphar.2025.1578406/fulladverse eventFAERS databasegliomachemotherapeuticstemozolomidee |
| spellingShingle | Yu Liu Lan Ma Lan Ma Xiaojia Fu Xiaojia Fu Yi Zhang Yi Zhang Jinyu Zheng Zhongjun Chen Safety assessment of temozolomidee: real-world adverse event analysis from the FAERS database Frontiers in Pharmacology adverse event FAERS database glioma chemotherapeutics temozolomidee |
| title | Safety assessment of temozolomidee: real-world adverse event analysis from the FAERS database |
| title_full | Safety assessment of temozolomidee: real-world adverse event analysis from the FAERS database |
| title_fullStr | Safety assessment of temozolomidee: real-world adverse event analysis from the FAERS database |
| title_full_unstemmed | Safety assessment of temozolomidee: real-world adverse event analysis from the FAERS database |
| title_short | Safety assessment of temozolomidee: real-world adverse event analysis from the FAERS database |
| title_sort | safety assessment of temozolomidee real world adverse event analysis from the faers database |
| topic | adverse event FAERS database glioma chemotherapeutics temozolomidee |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1578406/full |
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