Brazil’s VigiMed database reveals radiopharmaceutical safety reporting patterns

Radiopharmaceuticals are expanding rapidly as diagnostic, therapeutic and theranostic agents, yet national post-marketing safety evidence remains limited in many health systems. A new retrospective cross-sectional study has now examined spontaneous adverse event reports involving radiopharmaceuticals in Brazil’s VigiMed system, the national implementation of VigiFlow that has been in operation since December 2018 and makes part of the country’s pharmacovigilance database publicly available.

The researchers analyzed reports available in VigiMed from 10 December 2018 to 26 May 2026. Radiopharmaceuticals were identified through ATC codes V09 and V10, explicit radionuclide or vector terminology, and commercial product names, followed by manual exclusion of false positives. Reports were described at three levels: the report level, the medicinal-product level and the MedDRA-coded event level. Because of small numbers, lack of exposure denominators and sparse event categories, two products—radium-223 dichloride (Xofigo) and lutetium-177 vipivotide tetraxetan (Pluvicto)—were compared only descriptively.

Among 333,622 unique medication-linked reports in the database, the team identified 191 radiopharmaceutical drug entries in 126 unique reports, comprising 483 MedDRA-coded events. Xofigo and Pluvicto together accounted for 132 of the 191 entries, or 69.1 percent. Demographic coverage was available for 54 reports, or 42.9 percent, and within that subset male sex accounted for 77.8 percent of reports, São Paulo was the reporting state in 70.4 percent, and industry E2B submissions made up 64.8 percent.

The seriousness profile was substantial. Overall, 188 events, or 38.9 percent, were classified as serious, and 29 events, or 6.0 percent, carried a fatal outcome code. The authors emphasized that fatal reports were concentrated in advanced prostate cancer and were not interpreted as evidence of treatment-related mortality—a caution that reflects the inherent difficulty of attributing outcomes in spontaneous reporting systems where patients often have advanced underlying disease.

The two flagship products showed qualitatively distinct reporting patterns. Pluvicto reports, by contrast, included more general disorders, investigations, hematologic terms, dysgeusia and systemic symptoms—features consistent with the known tolerability profile of PSMA-targeted radioligand therapy.

To explore potential safety signals, the researchers applied disproportionality analysis using the proportional reporting ratio, the reporting odds ratio and Yates-corrected chi-square statistics. Twenty-five Preferred Terms met Evans PRR criteria. After separating indication-confounded terms—those likely driven by the underlying disease rather than the drug—the interpretable signals included myelosuppression, increased blood alkaline phosphatase, bone pain, extravasation, administration-site extravasation, decreased hemoglobin, decreased platelet count, thrombocytopenia, anemia, dysgeusia, fatigue and pain in extremity.

International evidence was used only for contextual interpretation, and the authors concluded that the Brazilian VigiMed reports capture radiopharmaceutical safety and reporting patterns broadly coherent with established international findings. They highlighted the principal contribution of this Latin American dataset as the characterization of the national reporting profile and of actionable radiopharmacy-related issues, particularly hematologic monitoring, salivary and taste symptoms associated with PSMA-targeted therapy, and radiopharmaceutical extravasation during administration.

The researchers stressed that the findings are signal-generating and should not be interpreted as incidence, comparative-risk or causal estimates. Spontaneous pharmacovigilance data lack exposure denominators and are subject to reporting biases, so the study’s value lies in mapping what is being reported in Brazil and flagging issues—such as extravasation and hematologic toxicity—that warrant attention in radiopharmacy practice, rather than in quantifying risk.

Subject of Research: Pharmacovigilance analysis of adverse event reports for radiopharmaceuticals in Brazil's VigiMed database

Article Title: Adverse event reporting for radiopharmaceuticals in Brazil: a vigimed pharmacovigilance study with disproportionality and international safety intercomparison

Article References: Santos-Oliveira, R., Moriel, P., Fidelis, G. F. S., Martins, P. G., & Portilho, F. L. (2026). Adverse event reporting for radiopharmaceuticals in Brazil: a vigimed pharmacovigilance study with disproportionality and international safety intercomparison. EJNMMI Radiopharmacy and Chemistry. https://doi.org/10.1186/s41181-026-00511-6

Image Credits: AI Generated

DOI: 10.1186/s41181-026-00511-6

Keywords: radiopharmaceuticals, pharmacovigilance, VigiMed, Brazil, adverse event reporting, disproportionality analysis, Xofigo, Pluvicto, myelosuppression, extravasation, PSMA-targeted therapy, EJNMMI Radiopharmacy and Chemistry