BPC-157 Side Effects: Withdrawal and Discontinuation Syndrome

At a glance

  • Human evidence base / Meeting abstracts, a 17-patient chart review, a 12-woman pilot and a 2-person pilot [1]
  • Orthopaedic review, 2026 / 3 studies, 30 patients, very low certainty [2]
  • Human pharmacokinetics / None for oral, subcutaneous, nasal or skin use; mostly not detectable in blood after rectal enemas [1]
  • Reported adverse events / 3 reports through December 4, 2025, all injectable [1]
  • Approval status / Not FDA-approved; no approved product found in any country FDA searched [1]

Does BPC-157 cause withdrawal when you stop it?

The human studies FDA reviewed and those in the 2026 systematic review did not report symptoms after BPC-157 was stopped, but they were not designed to test for withdrawal [1][2]. The systematic review searched to June 1, 2026 and found three human studies with 30 patients total: a knee-pain chart review, an interstitial cystitis pilot and a two-person intravenous safety pilot. All were of poor methodological quality, and certainty of evidence was rated very low [2]. FDA's own review also covered small enema studies, including a trial in 53 people with mild to moderate ulcerative colitis (BPC-157 enema 80 mg or placebo daily for 2 weeks) that exists only as a meeting abstract [1].

What the human studies measured

Knee pain. A retrospective chart review at one Florida clinic covered 17 patients, 16 of whom were reached by phone; 11 of the 12 given BPC-157 alone into the knee reported significant improvement. There was no control group, no validated outcome tool, results were recalled, and no adverse events were noted [3].

Interstitial cystitis. Twelve women who had not responded to pentosan polysulfate received a total of 10 mg injected around the bladder wall in one procedure; 10 of 12 reported complete symptom resolution and 2 of 12 about 80%. Single arm, no placebo, patient-rated, no adverse events reported [4].

Intravenous safety. Two adults received 10 mg on day 1 and 20 mg on day 2, with no measurable change in the tested heart, liver, kidney, thyroid or glucose markers and no side effects reported. With two people, the study cannot establish safety [5].

Pharmacokinetics and dosing

FDA found no human pharmacokinetic data for BPC-157 taken by mouth, injected under the skin, used as a nasal spray or applied to the skin. After rectal enemas in two early studies, BPC-157 was mostly not detectable in blood, so FDA judged it appears not to be absorbed systemically by that route [1].

There is also no approved dose. Doses in the small human reports (80 mg daily by enema for two weeks in ulcerative colitis, 2 to 4 mg injected into the knee, 10 mg into the bladder wall) are study doses, not recommended ones [1].

What has been reported with BPC-157

FDA's search of its adverse-event database through December 4, 2025 found three reports, all injectable BPC-157: injection-site redness and swelling lasting nine days in a patient who also used a compounded thymosin; shortness of breath leading to an emergency room visit; and widespread skin and gum darkening that recurred when the person was re-exposed to a BPC-157 plus TB-500 research product. FDA said it cannot tell whether BPC-157 caused these events [1].

In the small human studies FDA reviewed, no serious adverse events were reported, but the studies were short, small and gave limited safety information. In the healthy-volunteer enema studies (meeting abstracts), the most frequent events were headache and flatulence [1].

Frequently asked questions

How many people have been studied with BPC-157?
Very few. FDA identified five small human studies: meeting abstracts, a retrospective chart review, a single-arm pilot and a 2-person pilot. A 2026 systematic review of orthopaedic and regenerative use found 3 studies with 30 patients, with very low certainty of evidence [1][2].
Is there a standard BPC-157 dose?
No. There is no FDA-approved product, so there is no approved dose, and the doses in the small human reports are study doses, not recommended ones [1].
Is BPC-157 FDA-approved?
No. No FDA-approved drug contains BPC-157, there is no US Pharmacopeia or National Formulary monograph for it, and FDA's July 2026 review found no approved product containing it in any country it searched [1].
What side effects have been reported with BPC-157?
FDA's adverse-event database search through December 4, 2025 found three reports, all injectable: injection-site redness and swelling for nine days, shortness of breath leading to an emergency room visit, and widespread skin and gum darkening that recurred on re-exposure to a BPC-157 plus TB-500 product. FDA said it cannot tell whether BPC-157 caused them [1].

References

  1. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  2. Poolton JT, Minett J, Kazmi A. Human evidence for BPC-157 in orthopaedic and regenerative medicine: a systematic review of efficacy and safety. Acta Orthop Belg. 2026;92(3). Human evidence for BPC-157 in orthopaedic and regenerative medicine: a systematic review of efficacy and safety
  3. Lee E, Padgett B. Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain. Altern Ther Health Med. 2021;27(4):8-13. Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain
  4. Lee E, Walker C, Ayadi B. Effect of BPC-157 on Symptoms in Patients with Interstitial Cystitis: A Pilot Study. Altern Ther Health Med. 2024;30(10):12-17. Effect of BPC-157 on Symptoms in Patients with Interstitial Cystitis: A Pilot Study
  5. Lee E, Burgess K. Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study. Altern Ther Health Med. 2025;31(5):20-24. Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study
Evidence overview for BPC-157 Side Effects: Withdrawal and Discontinuation Syndrome