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Analyses of Ocular Adverse Reactions Associated With Anticancer Drugs Based on the Japanese Pharmacovigilance
Junko Tanaka1, Takenao Koseki2, Masashi Kondo3
1Department of Clinical Pharmacy, Fujita Health University School of Medicine, Toyoake, Japan.
Background/Aim:
The systemic administration of anticancer drugs may cause ocular adverse reactions (OARs). However, such adverse events are generally rare and occur with an unknown frequency. This study aimed to investigate the tendency of occurrence of OARs induced by systemic anticancer drugs using a large spontaneous pharmacovigilance database in Japan.
Patients And Methods:
The safety signals for eight OARs (periorbital and eyelid, conjunctival, corneal, scleral, lacrimal, lens, retinal, and optic nerve disorders) and their associations with anticancer drugs were evaluated by analyzing reporting odds ratios (RORs) and information components (ICs) based on data from the Japanese Adverse Drug Event Report (JADER).
Results:
Safety signals associated with anticancer drugs were detected for periorbital and eyelid disorders (imatinib), conjunctival disorders (imatinib and lapatinib), corneal disorders (S-1, erlotinib, capecitabine, cetuximab, gefitinib, vandetanib, trastuzumab emtansine, lapatinib), lacrimal disorders (S-1, pembrolizumab), lens disorders (lenalidomide, pomalidomide, elotuzumab, tamoxifen, bexarotene, venetoclax), retinal disorders (encorafenib, binimetinib, tamoxifen, nab-paclitaxel, trametinib, dabrafenib), and optic nerve disorders (tamoxifen and blinatumomab). Some anticancer drugs showed differences in safety signals based on sex and age.
Conclusion:
Safety signals indicative of the risk of occurrence of OARs were observed for several anticancer drugs, and several hitherto unreported ocular adverse events requiring caution were also detected. Our results will help predict the occurrence of OARs by oncologists, ophthalmologists, pharmacists, and other healthcare professionals.
Insights
Systemic anticancer drugs can cause ocular adverse reactions (OARs), though their frequency is often unknown. This study identified safety signals for various OARs linked to specific anticancer drugs using a Japanese pharmacovigilance database.
Area of Science:
- Ophthalmology
- Pharmacovigilance
- Oncology
Background:
- Systemic anticancer drugs can lead to ocular adverse reactions (OARs).
- The frequency and specific drug associations of these OARs are not well-established.
- A comprehensive analysis of OARs associated with anticancer drugs is needed.
Purpose of the Study:
- To investigate the occurrence of OARs induced by systemic anticancer drugs.
- To identify specific anticancer drugs associated with various OARs.
- To utilize a large spontaneous pharmacovigilance database for signal detection.
Main Methods:
- Analysis of the Japanese Adverse Drug Event Report (JADER) database.
- Evaluation of safety signals for eight types of OARs.
- Calculation of reporting odds ratios (RORs) and information components (ICs) to assess drug-event associations.
Main Results:
- Safety signals were detected for multiple OARs linked to specific anticancer drugs, including imatinib, lapatinib, S-1, erlotinib, capecitabine, cetuximab, gefitinib, vandetanib, trastuzumab emtansine, pembrolizumab, lenalidomide, pomalidomide, elotuzumab, tamoxifen, bexarotene, venetoclax, encorafenib, binimetinib, nab-paclitaxel, trametinib, dabrafenib, and blinatumomab.
- Specific associations included corneal disorders with several drugs, lens disorders with lenalidomide and others, and retinal disorders with tamoxifen and others.
- Differences in safety signals were observed based on patient sex and age for some drug-OAR combinations.
Conclusions:
- Several anticancer drugs show safety signals for OARs, including previously unreported events.
- These findings aid oncologists, ophthalmologists, and pharmacists in predicting and managing OARs.
- Enhanced awareness of these drug-induced OARs is crucial for patient safety.
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