MedDRA

Medical Dictionary for Regulatory Activities. The international standard for coding adverse events in clinical trials and pharmacovigilance

Medical Dictionary for Regulatory Activities (MedDRA) is maintained by the ICH (International Council for Harmonisation). It is the international standard for coding adverse events, medical history, and indications in clinical trials and post-marketing surveillance. MedDRA is organized in a five-level hierarchy: System Organ Class (SOC), High Level Group Term (HLGT), High Level Term (HLT), Preferred Term (PT), and Lowest Level Term (LLT).

Quick start

System identifiers: meddra-en · meddra-de · meddra-es · meddra-fr · meddra-no · meddra-se · meddra-it

JavaScript

const codes = await client.codes.predict({
  system: ["meddra-en"],
  context: [
    {
      type: "text",
      text: "Patient developed severe nausea and vomiting three days after starting metformin. Reported feeling dizzy and fatigued.",
    },
  ],
});

API reference →

Language support

MedDRA prediction is available in seven languages, each with its own system identifier:

Language	System identifier
English	meddra-en
German	meddra-de
Spanish	meddra-es
French	meddra-fr
Norwegian	meddra-no
Swedish	meddra-se
Italian	meddra-it

MedDRA is in Beta because we do not have real-world benchmark datasets for it. The model has only been evaluated on synthetic data, and performance may not reflect real-world clinical trial or pharmacovigilance workflows. We encourage you to evaluate it against your own data and use case. If you notice anything that doesn’t look right, please let us know so we can improve it.