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MedDRA specifications


Unique identifier OMICS_06244
Name MedDRA
Restrictions to use None
Maintained Yes


  • Primates
    • Homo sapiens


  • person_outline MedDRA Team

Publication for MedDRA

MedDRA citations


ImmPort, toward repurposing of open access immunological assay data for translational and clinical research

Sci Data
PMCID: 5827693
PMID: 29485622
DOI: 10.1038/sdata.2018.15

[…] terms from several ontologies including Cell Ontology, Disease Ontology (, Ontology for Biomedical Investigations (OBI;, Protein Ontology, and Vaccine Ontology. MedDRA ( is used for adverse event terms and the NCI Thesaurus supplies terms from a variety of sources (e.g., CDISC). The Antibody Ontology (AntiO) is a new resource developed from dat […]


Introduction and Goals for the National Children’s Study

PMCID: 5827357
PMID: 29520353
DOI: 10.3389/fped.2017.00240

[…] saurus. The terminology is currently available for public access through the NCI Term Browser and the NCI ftp site. Through direct collaboration with the Medical Dictionary for Regulatory Activities (MedDRA), many of the terms have also been incorporated into MedDRA.The NCS co-sponsored an international conference on terminology harmonization to receive input and also increase awareness of the val […]


Is fasting safe? A chart review of adverse events during medically supervised, water only fasting

BMC Complement Altern Med
PMCID: 5819235
PMID: 29458369
DOI: 10.1186/s12906-018-2136-6
call_split See protocol

[…] tistics of the study population at the patient and visit levels were tabulated. Chief complaints were categorized by SOC when possible. For each visit, the highest grade AE (HGAE) experienced (of any MedDRA term) and the total AEs were calculated for the fasting, refeeding, and entire protocol periods. Tallies and percentages of HGAE within each of these periods were computed in total and by the f […]


The eXtensible ontology development (XOD) principles and tool implementation to support ontology interoperability

J Biomed Semantics
PMCID: 5765662
PMID: 29329592
DOI: 10.1186/s13326-017-0169-2

[…] ntiates VO vaccination (i.e., administering a vaccine to in vivo) from immunization (i.e., to make one immune to something). In comparison, vaccination is considered as the synonym of immunization in MedDRA, a controlled terminology system commonly used for representation of regulatory activities [].In many cases, we can generate a number of new terms simultaneously by developing and following spe […]


Safety of intravenously applied mistletoe extract – results from a phase I dose escalation study in patients with advanced cancer

BMC Complement Altern Med
PMCID: 5604151
PMID: 28923036
DOI: 10.1186/s12906-017-1971-1

[…] t masks reflecting content and layout of the CRF forms. Independent double data entry with third party reconciliation was used; data were validated according to a validation plan. Medical coding used MedDRA for concurrent diseases and adverse events, and WHO-DD for therapies and concomitant medications. Sample size of this dose finding phase I study was planned according to three scenarios which s […]


Medication related visits in a pediatric emergency department: an 8 years retrospective analysis

PMCID: 5470287
PMID: 28610634
DOI: 10.1186/s13052-017-0375-7

[…] d ED visits that were made by the same patient.Narrative summaries, clinical testing, and physician’s diagnoses from MRVs reports were coded according to Medical Dictionary for regulatory Activities (MedDRA) terminology and System Organ Class (SOC) list [].Medication involved in each event was classified according to anatomical therapeutic classification code (ATC).The study was performed on the b […]


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MedDRA institution(s)
Medicines Control Agency, London, UK

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