Tarivid Otic Adverse Reactions

Out of a total 424 patients in the pre-approval survey in Japan, adverse reactions were reported in 2 patients (0.5%), including one with otalgia (2 events or 0.5%) and one with itching sensation (1 event or 0.2%). No adverse reactions were reported in children (110 cases). Audiometry was performed on 100 patients, and no cases of hearing reduction was observed. Out of a total of 3383 patients in the post-marketing surveillance (4 years in Japan), adverse reactions were reported in 15 patients (0.4%). The most frequently observed adverse reactions were 6 events (0.2%) of hearing and vestibular disturbances eg, otalgia and 4 events (0.1%) of superinfection. Adverse reactions were not reported in children (870 cases).
Hypersensitivity: Tarivid Otic solution should be discontinued when symptoms of hypersensitivity occur (frequency unknown*).
Site of Instillation: Otalgia may occur <0.1%.
Superinfection: Superinfection may occur <0.1%.
*The incidence of adverse reactions on the basis of spontaneous reports is unknown.