BPC-157 — safety
Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.
§4Safety
§4.1Adverse events reported in controlled trials
Table 4. Adverse events for BPC-157 as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.
| Event | Active, % | Comparator, % | Difference, pp | Source |
|---|---|---|---|---|
| Injection-site reaction | — | — | — | Reported anecdotally; no controlled safety dataset exists |
| No dose-limiting toxicity in rodent studies | — | — | — | Preclinical studies report a wide therapeutic index; this does not establish human safety |
| Angiogenic mechanism | — | — | — | If the proposed angiogenic mechanism is real, its consequences in the presence of occult neoplasia have not been studied at all |
| A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here. | ||||
§4.2Contraindications
- Not established — no marketing authorisation in any jurisdiction
§4.3Warnings and precautions
- No human pharmacokinetic, safety or efficacy dataset of adequate quality exists
- The proposed mechanism is angiogenic; the implications for undiagnosed malignancy are entirely unstudied
- Prohibited in competitive sport: BPC-157 was added to the World Anti-Doping Agency Prohibited List under section S0 (non-approved substances) with effect from 2022
§4.4What this section does not establish
Related assessments: tolerability of incretin receptor agonists · acute pancreatitis · the rodent thyroid C-cell signal.[1,2]
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Sikiric P, Seiwerth S, Rucman R, Turkovic B, Rokotov DS, Brcic L, Sever M, Klicek R, Radic B, Drmic D, Ilic S, Kolenc D, Aralica G, Stupnisek M, Suran J, Barisic I, Dzidic S, Prkacin I. Stable gastric pentadecapeptide BPC 157: novel therapy in gastrointestinal tract. Current Pharmaceutical Design 2011;17(16):1612–1632. doi:10.2174/138161211796196954 · PMID 21548867
- Bhattacharyya S, Wang J, Kaplan RM. Quality of peptide products obtained from unregulated online suppliers: an analytical survey. Journal of Pharmaceutical Sciences 2024;113(4):1102–1110. doi:10.1016/j.xphs.2023.11.021 Cited by the Institute as an indicative analytical survey; sample frame was not random.
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.