Comparative safety signals of carboplatin and cisplatin in lung cancer: a pharmacovigilance study based on FAERS

Platinum-based chemotherapy remains a key component of lung cancer treatment. Although carboplatin and cisplatin are widely used, their real-world adverse-event reporting profiles may differ. This study compared carboplatin- and cisplatin-associated safety signals in lung cancer using the FDA Adverse Event Reporting System (FAERS), with emphasis on organ-specific signals, demographic heterogeneity, and time-to-onset...

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Audiologists monitoring patients on platinum-based chemotherapy should note that cisplatin carries a stronger ototoxicity signal than carboplatin per this database study, reinforcing existing monitoring guidelines — no immediate practice change beyond current ASHA/AAA ototoxicity monitoring protocols.

Pharmacovigilance data from large real-world databases can quantify the comparative ototoxicity risk between platinum agents, potentially informing oncology-audiology collaboration and risk-based monitoring intensity.

1. 01FAERS (FDA Adverse Event Reporting System) data were used to compare safety profiles of carboplatin vs. cisplatin in lung cancer.
2. 02Ototoxicity (hearing damage from medication) is a known risk of platinum-based chemotherapy, especially cisplatin.
3. 03Real-world pharmacovigilance studies complement clinical trials by capturing broader, longer-term adverse events.
4. 04Retrospective database study design limits causal inference.
5. 05Findings are broadly consistent with established knowledge that cisplatin is more ototoxic than carboplatin.

PMID

42558823

DOI

10.3389/fmed.2026.1846025.

Journal

Frontiers in Medicine

Publication type

research_article

Evidence level

3

Population

Lung cancer patients with adverse event reports in the FDA FAERS database

Intervention

Carboplatin (platinum-based chemotherapy)

Comparator

Cisplatin