Tecovirimat was prescribed to more than 7100 patients in the US under the Investigational Drug Expanded Access (EA-IND) program from May 29, 2022 to July 10, 2023[1][2]. The most common reasons for prescribing were lesions in sensitive anatomical areas, such as anogenital lesions (83.5%; 5135 of 6148 patients), and pain (52.5%; 3227 of 6148 patients)[1][2]. Most patients had a low number of lesions (median 15 lesions, IQR 6 to 25) and less than 25% of the body affected by lesions[1]. Data from admission forms, outcome forms and patient diaries were analyzed, with patients with a negative orthopoxvirus PCR test excluded from the analyses[1]. A total of 223 serious adverse events (SAEs) and 40 deaths were reported, mostly in severely immunosuppressed patients, with one SAE involving double-dose hallucinations[2]. Data indicate the occurrence of life-threatening or prolonged infections in severely immunocompromised persons[1][2]. EA-IND data are not definitive and require controlled clinical trials to clarify the use of tecovirimat[2].