# FAERS review: 451 adverse event reports for 10 U.S. PET radiopharmaceuticals in 2012–2024

- Published: 2026-11-11 15:09 UTC
- Section: Life & Health › Medicine
- Tags: PET radiopharmaceuticals safety, FAERS analysis, adverse events PET, 21 CFR 212, PET drug manufacturing GMP, adverse drug reactions, PET scans United States, pharmacovigilance
- URL: https://realtech.media/news/rt-7bea4c6949539ab6b7ac8524_faers_review_451/

**A retrospective study of FDA reports found adverse reactions in 237 cases, two-thirds non-serious. Authors estimate 4.3 events per 100,000 scans in 2024.**

![FAERS review: 451 adverse event reports for 10 U.S. PET radiopharmaceuticals in 2012–2024](https://realtech.media/media/2026/11/5baabdacdb92c5b5.jpg)
*Agentschap Zorg en Gezondheid, Wikimedia Commons, CC BY 3.0*

A retrospective analysis published in EJNMMI Radiopharmacy and Chemistry reviewed adverse event reports for PET radiopharmaceuticals in the FDA Adverse Events Reporting System (FAERS). The data were collected in December 2025 and cover reports received between 2012 and 2024, the period since the PET good manufacturing practice rules in 21 CFR 212 came into force [1].

The authors focused on 10 PET radiopharmaceuticals manufactured under 21 CFR 212. For them, 451 cases were recorded. At least one adverse reaction to the drug was reported in 237 cases, and 157 of these (66.2%) were characterized as non-serious; 80 were serious [1].

## What the reports contained

For all FDA-approved PET radiopharmaceuticals, 1,090 reports were submitted in 2012–2024. After removal of seven duplicates, 1,083 remained, or 0.0045% of the more than 23.9 million adverse event reports for all drugs in that period. The most common reactions were flushing, nausea, dyspnoea, hyperhidrosis, dizziness and back pain. Fifteen cases listed death as the event or outcome; in several of them other suspected drugs or missing information complicated attribution to the radiopharmaceutical.

The remaining cases were classified by the authors as efficacy-related (119, all non-serious, abnormal scan in 80), administration errors (25) and manufacturing errors (36). Only three manufacturing errors involved sterility, and none of the manufacturing error cases reported an adverse drug reaction [1].

## Rate per administration

The number of PET scans in the U.S. has doubled over 12 years to almost three million in 2024, according to recent reports cited in the study. The authors estimated fewer than 7.0 adverse events per 100,000 administrations for all PET drugs in 2024, and 4.3 per 100,000 for drugs made under 21 CFR 212. Earlier literature reported 1.2 to 3.4 per 100,000 for all diagnostic radiopharmaceuticals.

The number of reports has grown, which the authors attribute to the increase in administered doses and to the rise in FDA adverse event reports overall, from about 930,000 in 2012 to more than 2,000,000 in 2024. They conclude that the lack of correlation between manufacturing issues and safety events supports a low risk profile, and that the data do not appear to justify more stringent regulation of PET drug manufacture.

The authors note limitations: FAERS reporting is voluntary and may understate the true frequency, event categories are assigned by the reporting party, and the FDA does not independently verify the information [1].

## Sources

1. [EJNMMI Radiopharmacy and Chemistry](https://doi.org/10.1186/s41181-026-00482-8)
2. [bioengineer.org](https://bioengineer.org/u-s-pet-drug-adverse-events-remain-rare-study-finds)

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Source: RealTech, realtech.media — https://realtech.media/news/rt-7bea4c6949539ab6b7ac8524_faers_review_451/