Abstract: Background: Deliberate self-poisoning (DSP) is the globally preferred suicidal approach. Current investigations of the phenomenon involve only limited sample sizes and data reliability. Objectives: We investigate the utility of the FDA Adverse Event Reporting System (FAERS) in outlining traits and trends of DSP and estimating lethal doses (LDs). Methods: FAERS reports (January 2004-December 2021) were retrieved. Cases of “intentional overdose” and “poisoning deliberate” were selected. Temporal trends and toxidromes and case-fatality rates (CFR) were estimated for the most reported drugs. Descriptive analyses detected potential risk factors. Outcome and doses were used for a proposal of LD estimation. Results: We retrieved 42,103 DSP cases (17% fatal). Compared to FAERS reports, DSP involved younger people (p=0.003: 72% vs 32% 12-50 years old) with psychiatric conditions (p<0.001: 14% vs 6%) and alcohol consumption (p<0.001: 5% vs 0%). Multiple drug intake was recorded in >50% of reports. Fatal cases were more common in men (p<0.001: 45 vs 38%) and adults (p=0.002: 64% vs 52% 30-65 years old). Drugs implicated were mainly antidepressants (14%), analgesics (11%), and antipsychotics (10%), with paracetamol being the most reported. High CFRs were observed with oxycodone (61%) and bupropion (35%). Paracetamol doses were mostly <100g, with an estimated LD25≈150g. Conclusions: The richness, timeliness, and worldwide coverage of the FAERS, along with dose information, complement already accrued knowledge about DSP. The study of FAERS data could help design regulatory interventions and promote tailored prevention measures to address the DSP phenomenon.