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EudraVigilance
Data by European Medicines Agency
Search EudraVigilance substances and retrieve aggregate counts of suspected adverse drug reactions reported in the EEA — by age group, sex, geographic origin, reporter type, and by MedDRA reaction group (System Organ Class) — sourced from the EMA public adrreports.eu portal.
pharmacovigilance, adverse-reactions, pharma, ema, healthcare, regulatory
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Tools (7)
- getSubstanceAdverseReactionAggregatesSuspected adverse reaction counts from EudraVigilance (EMA, EEA) for one substance or one commercial product: total individual cases, and breakdowns by sex, age group, reporter group, geographic origin and reporting country. Pair with searchSubstances or searchProducts to resolve the code.Free
- searchSubstancesSearch EudraVigilance substances by name and get their Substance High Level Code. Use the returned substanceHighLevelCodes with getSubstanceAdverseReactionAggregates to fetch suspected adverse reaction breakdowns for a substance.Free
- getSubstanceReactionDetailEudraVigilance reactions for one substance or one commercial product at MedDRA preferred-term level, with their outcome, ICH seriousness, CTCAE severity range, the indication each case reported, the medicines taken alongside, and the official case form for fatal ones. Reads a window of months, and counts each term against the window before it. Use for what was reported and how it ended; use getSubstanceReactionDisproportionality for whether a group is over-reported.Free
- getSubstanceCaseAccrualHow fast one substance or one commercial product is accruing new EudraVigilance case reports month over month, and which MedDRA reaction groups the new cases fall into. Use for reporting momentum; use getSubstanceReactionBreakdown for the standing totals.Free
- getSubstanceReactionDisproportionalityDisproportionality screen (ROR, PRR) over EudraVigilance for one substance or one commercial product, by MedDRA reaction group. EU counterpart of the FAERS screen, computed only against EudraVigilance denominators.Free
- searchProductsSearch EudraVigilance commercial products (brand names) for their Product High Level Code, to read the cases of one product rather than of its molecule. Centrally authorised products only. Pair with searchSubstances, which answers on molecules.Free
- getSubstanceReactionBreakdownSuspected adverse reaction case counts for one substance or one commercial product, broken down by MedDRA reaction group (System Organ Class), from EudraVigilance (EMA, EEA). Pair with searchSubstances or searchProducts to resolve the code.Free