[Analysis of reports of otoxicity, with symptoms of tinnitus, in the database of the Spanish Pharmacovigilance System for medicinal products for human use.].

Objective: One of the adverse drug reactions (ADR) can be the Ototoxicity, either in a cochlear level or in a vestibular one. This may cause an incapacitating symptomatology due to a hearing impairment or deafness, tinnitus, or a vertiginous syndrome. The objective of this work was to analyze the notifications of ototoxic ADRs registered in the FEDRA database of the Spanish Pharmacovigilance System for Medicinal products for Human Use (SEFV-H), manifested as tinnitus, describing epidemiological and prognostic factors, as well as active principles and associated therapeutic groups.