Hair Dye-Induced Periorbital Oedema: A Retrospective Pharmacovigilance Data Analysis

Introduction:: Paraphenylenediamine (PPD) in permanent hair dyes is a common sen-sitiser. This pharmacovigilance study analyses reported cases of periorbital oedema associated with hair dye use. Methods:: We conducted a retrospective pharmacovigilance analysis of Individual Case Safety Reports (ICSRs) for hair dye-induced periorbital oedema in the WHO VigiLyze database (Indian data, 2015-2024). We analysed demographics, time-to-onset, and causality and performed dis-proportionality analysis using the Information Component (IC), Proportional Reporting Ratio (PRR), and Reporting Odds Ratio (ROR). Results:: Six ICSRs were identified. Patients were predominantly female (67%), with a mean age of 49 years. The reaction often had an immediate onset (mean 0.2 days), with a positive de-chal-lenge in 83% of cases and a 'Probable/Likely' causality assessment. Co-reported terms included urticaria and pruritus. Disproportionality analysis revealed a significant signal: IC=2.0, PRR=21.9, ROR=22.0 (lower 95% CI >1). Conclusion:: This analysis confirms a significant pharmacovigilance signal linking hair dye to periorbital oedema, supported by strong disproportionality metrics and clinical consistency. A skin patch test prior to use is strongly recommended to prevent this adverse reaction. Discussion:: There were several reports on hair dye-associated toxicities, and the present study reinforces the same. However, as part of passive pharmacovigilance, a strong conclusion can be made only after a strong chemical and mechanistic study with different epidemiological or clini-cal settings.