Human data
Small studies cannot settle safety
The FDA found no serious side effects reported in the small human studies, but said their size, length and limited monitoring could not establish safety.
Claim sourceFDA briefing document
Safety cards
The main safety fact is how much is unknown
A short report with no problems is not the same as long, careful safety testing that shows what harm a substance can do and how often.
Read time: a few calm minutes
Immune response
The FDA flags a possible immune risk
The FDA said BPC-157 given by injection or nasal spray may trigger an immune reaction.
In an immune reaction, the body treats the substance as a threat; no study has measured this risk.
Claim sourceFDA briefing document
Interactions
There is no official interaction list
Because BPC-157 has no approved label, there is no FDA-reviewed list of drug interactions or people who must avoid it.
Claim sourceFDA briefing document
Reports
A report is a signal, not proof
The FDA says a side-effect report does not prove that a product caused the event.
Claim sourceFDA notes on its side-effect report database
Reporting
Patients can report a problem
The FDA accepts patient and consumer safety reports through MedWatch.
Claim sourceFDA MedWatch
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