OBJECTIVE: To explore and evaluate the safety signal of oseltamivir after the marketing, so as to provide basis for clinical rational drug use. METHODS: Adverse drug event (ADE) reports with oseltamivir as the first suspected drugs were retrieved from the Food and Drug Administration Adverse Event Reporting System ( FAERS) database from Jan. 2004 to Sept. 2022. Reporting Odds Ratio (ROR) method and Bayesian confidence propagation neural network ( BCPNN) method were sued to detect the ADE signals, mainly included 11 key system organ classification (SOC) such as gastrointestinal, neurological, psychiatric, and hepatobiliary systems. RESULTS: Totally 794 reports of ADE (794 patients) with oseltamivir as the first suspected drug were collected, with a higher proportion of female patients ( 394 cases, 49. 62%) than male patients ( 297 cases, 37. 41%). The reported ages were all concentrated under 18 years old ( 489 cases, 61. 59%), with 232 cases of SAE ( 29. 22%). The detected ADE signals involved a total of 21 SOC. Analysis of key SOC showed that the signals of neurological system-related ADE were mainly convulsive seizures (ROR = 2. 77, IC = 1. 43), loss of consciousness (ROR = 2. 01, IC = 0. 99), and speech disorders (ROR= 2. 67, IC = 1. 37). The main manifestations of psychiatric disorders were abnormal behavior (ROR= 30. 34, IC = 4. 74), hallucination (ROR = 20. 69, IC = 4. 22), insomnia (ROR = 2. 08, IC = 1. 03). The main manifestations of oseltamivir-related gastrointestinal tract were upper abdominal pain (ROR= 2. 05, IC = 1. 01), vomiting (ROR= 6. 19, IC = 2. 48) and hemorrhagic enterocolitis (ROR = 46. 35, IC = 4. 28). Other systemic highrisk signals were mainly hepatitis fulminant (ROR = 10. 88, IC = 2. 70), acute heart failure (ROR = 5. 89, IC = 2. 17), myocarditis (ROR= 4. 49, IC = 1. 93), disseminated intravascular coagulation (ROR = 2. 60, IC = 1. 25), Stevens-Johnson syndrome (ROR = 3. 44, IC = 1. 70), and toxic epidermal necrolysis (ROR = 2. 06, IC = 0. 94). CONCLUSIONS: During the use of oseltamivir, in addition to close attention to common ADE such as convulsive seizures, abnormal behavior, hallucinations, insomnia, vomiting and epigastric pain, SAE such as hepatitis fulminant, acute heart failure,and disseminated intravascular coagulation should be monitored. [ABSTRACT FROM AUTHOR]