{"meta":{"dataset":"drug-events","title":"Serious drug adverse event reports by active ingredient (openFDA FAERS)","version":"1.0.0","doi":"10.5281/zenodo.23752994","doiUrl":"https://doi.org/10.5281/zenodo.23752994","conceptDoi":"10.5281/zenodo.23752993","license":"CC BY 4.0","licenseUrl":"https://creativecommons.org/licenses/by/4.0/","attribution":"Source: Probative, Serious drug adverse event reports by active ingredient (openFDA FAERS), version 1.0.0, https://doi.org/10.5281/zenodo.23752994, licensed CC BY 4.0.","citation":"Probative. (2026). Serious drug adverse event reports by active ingredient (openFDA FAERS) (Version 1.0.0) [Data set]. Zenodo. https://doi.org/10.5281/zenodo.23752994","disclaimer":"Not legal advice. This is not medical advice either. A report in the FDA Adverse Event Reporting System is not proof that a drug caused an event; reports come from patients, clinicians and manufacturers, can be duplicated and are not verified. Questions about a medicine are for a health professional, and questions about an injury are for a licensed attorney.","notice":"Probative is a marketing firm, not a law firm; not legal advice.","lastChecked":"2026-10-29","url":"https://probativegrowth.com/data/v1/drug-events/ingredients/-ALPHA--TOCOPHEROL-ACETATE-DL-.json","humanUrl":"https://probativegrowth.com/data/drug-events/","statusCodes":{"P":"primary source","S":"secondary source","D":"ABA model default","U":"open question"}},"key":"-ALPHA--TOCOPHEROL-ACETATE-DL-","records":[{"id":"drug-events:alpha-tocopherol-acetate-dl","dataset":"drug-events","jurisdiction":"US","ingredient":".ALPHA.-TOCOPHEROL ACETATE, DL-","level":"ingredient","rank":56,"quarters":"2024Q3,2024Q4,2025Q1,2025Q2,2025Q3,2025Q4,2026Q1,2026Q2","status":"P","text":".ALPHA.-TOCOPHEROL ACETATE, DL-: 27,334 FAERS reports listing this ingredient were received 2024Q3 to 2026Q2; 22,338 were serious (81.7%) and 5,120 reported a death outcome (18.7%). Most reported reactions: OFF LABEL USE (3,834); FATIGUE (3,148); PAIN (2,915); ARTHRALGIA (2,583); DRUG INEFFECTIVE (2,542). A report does not show that the drug caused the event.","value":27334,"unit":"FAERS reports received in the window","reports":27334,"serious":22338,"deaths":5120,"serious_pct":81.7,"death_pct":18.7,"reports_q1":3581,"reports_q2":3888,"reports_q3":3509,"reports_q4":3478,"reports_q5":3630,"reports_q6":3227,"reports_q7":3044,"reports_q8":2977,"serious_q1":2995,"serious_q2":3209,"serious_q3":2927,"serious_q4":2833,"serious_q5":3007,"serious_q6":2690,"serious_q7":2417,"serious_q8":2260,"topReactions":"OFF LABEL USE (3,834); FATIGUE (3,148); PAIN (2,915); ARTHRALGIA (2,583); DRUG INEFFECTIVE (2,542)","mdl":null,"effectiveFrom":"2024-07-01","effectiveTo":"2026-06-30","sources":[{"label":"FDA openFDA drug adverse event API (FAERS)","url":"https://open.fda.gov/apis/drug/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA licence (CC0 1.0) and terms","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, FAERS)","url":"https://open.fda.gov/apis/drug/event/","table":"drug/event: count on patient.drug.openfda.substance_name.exact by receivedate","release":"openFDA last updated 2026-07-30; reports received 2024-07-01 to 2026-06-30","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"}]}