Overview

Pharmacovigilance intelligence

Cross-national safety signal detection across FAERS, VigiMed, CVARD, and JADER. All records mapped to OMOP CDM 5.4 for standardized analysis.

Jurisdictions

4

USA · Brazil · Canada · Japan

Safety reports

60M+

adverse event records

Data standard

5.4

OMOP CDM version

Substances tracked

4

GLP-1 receptor agonists

All pipelines operational · FAERS, VigiMed, CVARD, JADER · Last updated June 2026

Data sourced from openFDA (FAERS) · ANVISA (VigiMed) · Health Canada (CVARD) · PMDA (JADER) · OMOP CDM 5.4 · Cortexa Research Platform

Pharmacovigilance

GLP-1 — impaired gastric emptying

Proportional Reporting Ratio (PRR) for gastroparesis-related events in patients receiving GLP-1 receptor agonists, computed independently across four national pharmacovigilance databases.

Outcome: impaired gastric emptying (MedDRA PT 10021518) · Exposure: semaglutide (ozempic, wegovy, rybelsus + generic) · role_cod PS/SS only
Method: PRR = (a/n_D) / (c/(N−n_D)) · SE = √(1/a − 1/n_D + 1/c − 1/(N−n_D)) · Signal threshold: PRR ≥ 2.0, n ≥ 3 (Evans 2001)
N = 11,692,580 (FAERS 2017–2024) · n_R = 6,241 · computed from staging.faers_drug × staging.faers_reac

FAERS · USA

57.18

PRR

n (cases) 961

95% CI 53.42 – 61.20

semaglutide (all brands) · PS/SS · FAERS 2017–2024

VigiMed · Brazil

55.69

PRR

n (cases) 12

95% CI 29.80 – 104.09

semaglutide · VigiMed 2018–2026

CVARD · Canada

27.54

PRR

n (cases) 15

95% CI 16.42 – 46.20

semaglutide · CVARD 1965–2024

PRR: Proportional Reporting Ratio (Evans 2001) · signal when PRR ≥ 2.0 and n ≥ 3 · 95% CI via log-normal SE
FAERS scope: semaglutide + ozempic + wegovy + rybelsus, role_cod PS/SS, FAERS 2017–2024 (N=11,692,580) · pre-notoriety subgroup (2017–2022): PRR 9.46 (CI 6.96–12.87, n=41)
JADER (Japan): data ingested, PRR computation pending — will be added upon verification

FAERS/openFDA · VigiMed/ANVISA · CVARD/Health Canada · JADER/PMDA
Computed from staging.faers_drug, staging.vigimed_notificacoes, staging.cvard_drug · Cortexa_pharma · June 2026

Pharmacovigilance

Drug repurposing signals

Inverse PRR patterns identified during routine pharmacovigilance screening. All findings are hypothesis-generating only and require independent clinical validation before any inference.

Tesamorelin

Inverse reporting signal — gastric emptying outcomes

Pharmacovigilance screening of tesamorelin across FAERS and VigiMed reveals an inverse PRR pattern for impaired gastric emptying events: the drug appears less frequently in gastroparesis cases than the background reporting population would predict. This inverse signal was identified by contrast with GLP-1 agonist PRR values and warrants mechanistic investigation.

Hypothesis-generating, not a confirmed finding. Inverse PRR reflects absence of reporting relative to background, not an established protective effect. This observation does not constitute clinical evidence of gastroprotection. Independent prospective validation is required before any clinical inference.

Inverse PRR analysis · FAERS 2017–2024 · VigiMed 2018–2026 · Cortexa Research Platform · June 2026

Data

Pharmacovigilance sources

Four national adverse event reporting databases, standardized to OMOP CDM 5.4. Volumes are verified by direct COUNT queries — never pg_class estimates.

Source	Country	Years	Volume	Granularity
Loading verified counts...

EudraVigilance (EU) — pipeline active, ingestion in progress
Volume: COUNT(*) direct per table · 24h cache · never pg_class estimates

FAERS/openFDA · VigiMed/ANVISA · CVARD/Health Canada · JADER/PMDA
Epidemiology databases (SIH, SINAN, InfoDengue, SIM, CNES, SNGPC) are maintained separately in the epidemiology pipeline and are not shown here.

COMING SOON

Signal Explorer

Interactive PRR computation across all sources, custom drug/outcome pairs, and time-series visualization.