SoftMaxx AI sells no peptides and takes no vendor money.
Health Canada advises anyone who feels unwell after an unauthorized peptide to talk to a healthcare professional right away, and the GLP-1 drug labels name the symptoms that mean stopping the medicine and getting help, such as severe stomach pain that will not go away or swelling of the face and throat.[1][2][3]
Warning signs named in the sources
| Sign | Reported with | What the source says | Source |
|---|---|---|---|
| Severe stomach pain that will not go away, sometimes felt through to the back, with or without vomiting | GLP-1 drugs | Possible pancreatitis: stop the medicine and call your healthcare provider right away | [2][3] |
| Upper stomach pain, yellow skin or eyes, fever, clay-colored stools | GLP-1 drugs | Possible gallbladder problems: call your healthcare provider | [2][3] |
| Swelling of the face, lips, tongue or throat; trouble breathing or swallowing; fainting | GLP-1 drugs | Possible serious allergic reaction: stop and get medical help right away | [2][3][4] |
| A lump or swelling in the neck, hoarseness, trouble swallowing | Wegovy | Tell your healthcare provider; possible thyroid tumor symptoms | [2] |
| Sudden loss of vision or rapidly worsening eyesight | Semaglutide | Contact your doctor without delay | [5] |
| Redness, swelling, pain or a red lump where a product went in | A fraudulent compounded tirzepatide product; unauthorized peptides | FDA received such a report; Health Canada warns unauthorized products can lead to infections | [6][1] |
| Nausea, vomiting, diarrhea, stomach pain or constipation | Compounded semaglutide or tirzepatide prescribed at doses beyond the approved label | FDA reports that may be related to those doses; some were serious | [6] |
| Feeling unwell after a dose you measured yourself | Compounded injectable semaglutide | FDA reports, some needing hospital care, that may be related to dosing errors | [6] |
| Darkening of the skin and gums | A product containing BPC-157 and TB-500 | One FDA adverse-event report; it came back when the product was used again | [7] |
| New moles, or existing moles that darken | Melanotan injections (one report names Melanotan II) | Case reports, one within 24 hours of a single Melanotan II injection | [8][9] |
| A suspicious dark skin lesion, or a growth inside the mouth | Melanotan II | Melanoma case reports; cause not established | [10][11] |
| An erection that will not go down (priapism) | Melanotan II | Case report; surgery was needed | [12] |
| Racing heart, sweating, body aches and anxiety within hours | Melanotan II | One case of muscle breakdown and kidney dysfunction needing intensive care | [13] |
The table is not a complete list of what can go wrong.
BPC-157 and TB-500: what FDA's adverse-event search found
FDA searched its adverse-event database for BPC-157 for its July 2026 advisory committee briefing [7]. FDA notes that a report does not prove the product caused the event, and that it may not hear about problems with compounded products unless someone reports them [7].
- Case report FDA found three reports for BPC-157 through December 4, 2025, all with injected products. In one, a 40-year-old woman using a product that contained both BPC-157 and TB-500 developed diffuse darkening of the skin and gums within a week; it came back when she used the product again and did not recur after she stopped. FDA says it is not possible to tell which peptide was responsible.[7]
- Case report The other two reports were 9 days of redness and swelling around the injection site in a woman also using injected thymosin, and shortness of breath leading to an emergency room visit, with no further detail.[7]
- Regulator document FDA's compounding safety page says compounded BPC-157 and TB-500 may pose a risk of immune reactions (immunogenicity) for certain routes of administration, flags peptide-related impurities for both, and says FDA has not identified any human exposure data for TB-500.[14]
Melanotan II: moles, melanoma and other case reports
Melanotan II is an unlicensed peptide used to darken the skin [10]. FDA's compounding safety page says published case reports discuss serious adverse events including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism [14].
Case reports describe what happened to individual people. They cannot show how often it happens, or that the drug was the cause.
- Case report Two case reports describe new moles after melanotan injections, one with darkening of existing moles 24 hours after a single injection. PubMed lists no abstract for either, so we cite them for what their titles state.[8][9]
- Case report A 20-year-old woman was diagnosed with melanoma three months after a 3- to 4-week course of Melanotan II self-injections, used alongside sunbeds. The authors write that the extent and types of the drug's adverse effects are unknown.[10]
- Case report A 22-year-old woman developed melanoma in the upper jaw, inside the mouth, after using a Melanotan II nasal spray for tanning; the report's title asks whether the spray is a possible risk factor.[11]
- Case report Two further reports, titled "Melanotan-associated melanoma" and one describing five melanomas in situ in a person who had also used tanning beds and anabolic hormones, have no PubMed abstract; we cite their titles only.[15][16]
- Case report A case report describes ischemic priapism after a Melanotan II injection that needed surgery; the authors say it had been reported only twice before.[12]
- Case report A 39-year-old man had a racing heart, sweating, body aches and anxiety within two hours of a Melanotan II injection, then muscle breakdown (rhabdomyolysis) and kidney dysfunction, and spent 3 days in intensive care.[13]
GLP-1 drugs: label warnings to act on
Semaglutide, tirzepatide and orforglipron are approved prescription drugs, and their labels say which symptoms mean calling a prescriber [2] [3] [4]. The wording below follows the Wegovy, Zepbound and Foundayo labels [2] [3] [4].
- Drug label Pancreatitis: the Wegovy and Zepbound labels say to stop the medicine and call your healthcare provider right away for severe stomach pain that will not go away, with or without nausea or vomiting, sometimes felt through to the back.[2][3]
- Drug label Gallbladder problems, including gallstones: the labels list upper stomach pain, yellowing of the skin or eyes, fever and clay-colored stools as reasons to call your healthcare provider. In weight trials of Wegovy injection, gallstones (cholelithiasis) were reported in 1.6% of adults on the drug and 0.7% on placebo.[2][3]
- Expert review A 2022 meta-analysis of 76 randomized trials found a higher risk of gallbladder or biliary disease with GLP-1 drugs, more so at higher doses, with longer use, and in weight-loss trials.[17]
- Drug label Serious allergic reactions: all three labels say to stop the medicine and get medical help right away for swelling of the face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, or fainting or feeling dizzy.[2][3][4]
- Drug label Thyroid: the Wegovy label asks you to tell your healthcare provider about a lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath, and notes that in rodent studies Wegovy and similar medicines caused thyroid tumors.[2]
- Regulator document Vision: EMA's safety committee concluded that NAION, an eye condition that may cause loss of vision, is a very rare side effect of semaglutide (up to 1 in 10,000 people), and says anyone with sudden vision loss or rapidly worsening eyesight should contact their doctor without delay. The US Wegovy label we read does not name NAION; it tells people with type 2 diabetes to report changes in vision.[5][2]
- Regulator document As of May 31, 2026, FDA had received 990 adverse-event reports for compounded semaglutide and more than 730 for compounded tirzepatide. FDA says some reports, including some that needed hospitalization, may be related to dosing errors with compounded injectable semaglutide, when patients measured and gave themselves the wrong amount. Other reports may be related to compounded semaglutide or tirzepatide prescribed at doses beyond the approved label; symptoms included nausea, vomiting, diarrhea, abdominal pain and constipation.[6]
Products with unknown contents
See how to read a certificate of analysis for what product testing can and cannot show, and how long reconstituted peptides last for what the labels say about storage.
- Regulator document Health Canada warns that unauthorized peptide drugs may lead to infections, allergic reactions and other serious complications; may contain too much, too little or none of the active ingredient; may contain contaminants such as particles, bacteria, fungi or endotoxins; and may be poorly labelled or improperly stored.[1]
- Expert review Two 2026 reviews describe gray-market peptides as products of uncertain identity, purity, potency and sterility, with risks that include contamination, manufacturing impurities and inaccurate dosing.[18][19]
What to tell a clinician
FDA said its interpretation of several of the reports above was limited because they lacked detail, or because the person used more than one product at once; in the skin-darkening case, the reaction returning on re-use is what made FDA judge the product the likely cause [7]. So the more of this you can give a clinician, the better:
- every product you used, with its name exactly as printed on the packaging, including blends
- every other medicine, supplement and skin product you use
- when you started each one, and when the symptom began
- how you took it (by mouth, on the skin, as a nasal spray or by injection), how much and how often
- whether the symptom eased when you stopped, or came back when you restarted
- whether it was prescribed and dispensed by a pharmacy
Health Canada's advice is to contact a physician, nurse practitioner or pharmacist if you feel unwell or have concerns after using an unauthorized injectable peptide [1].
Report it
In the US, report side effects or quality problems to FDA MedWatch; in Canada, to Canada Vigilance. FDA notes that pharmacies compounding under section 503A generally do not report adverse events to it, so it may not know about a problem unless someone reports it [7]. Health Canada asks people to report side effects and complaints about health products [1].
Regulatory status (checked 2026-09-30)
- United States (FDA)We found no FDA-approved product containing BPC-157 in Drugs@FDA (searched 2026-10-01). (FDA:
Drugs@FDA search: bpc-157 — no approved product found
) FDA removed BPC-157 from 503A Category 2 on 2026-04-22 after the nominations were withdrawn; FDA’s safety page still lists it under “Bulk drug substances nominated but withdrawn”. (FDA:Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act
; FDA:Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
) We found no FDA-approved product containing TB-500 in Drugs@FDA (searched 2026-10-01). (FDA:Drugs@FDA search: tb-500 — no approved product found
) FDA removed Thymosin beta-4 fragment (LKKTETQ), 'TB-500' from 503A Category 2 on 2026-04-22 after the nominations were withdrawn; FDA’s safety page still lists it under “Bulk drug substances nominated but withdrawn”. (FDA:Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act
; FDA:Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
) We found no FDA-approved product containing Melanotan II in Drugs@FDA (searched 2026-10-01). (FDA:Drugs@FDA search: melanotan-ii — no approved product found
) FDA removed Melanotan II from 503A Category 2 on 2026-04-22 after the nominations were withdrawn; FDA’s safety page still lists it under “Bulk drug substances nominated but withdrawn”. (FDA:Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act
; FDA:Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
) Semaglutide is FDA-approved as Ozempic and Wegovy (prescription drugs). (DailyMed:OZEMPIC (semaglutide) injection — Prescribing Information
; DailyMed:WEGOVY (semaglutide) injection; WEGOVY (semaglutide) tablets — Prescribing Information
) Tirzepatide is FDA-approved as Mounjaro and Zepbound (prescription drugs). (DailyMed:MOUNJARO (tirzepatide) injection — Prescribing Information
; DailyMed:ZEPBOUND (tirzepatide) injection — Prescribing Information
) Orforglipron is FDA-approved as Foundayo (prescription drug). (DailyMed:FOUNDAYO (orforglipron) tablets — Prescribing Information
) - CanadaWe found no product containing BPC-157 in Health Canada’s Drug Product Database (searched 2026-10-01). (Health Canada:
Health Canada Drug Product Database search: bpc-157 — no product found
) Health Canada named BPC-157 in “Think twice before injecting peptides bought online: unauthorized products can seriously harm you”. (Health Canada:Think twice before injecting peptides bought online: unauthorized products can seriously harm you
) We found no product containing TB-500 in Health Canada’s Drug Product Database (searched 2026-10-01). (Health Canada:Health Canada Drug Product Database search: tb-500 — no product found
) Health Canada named TB-500 in “Think twice before injecting peptides bought online: unauthorized products can seriously harm you”. (Health Canada:Think twice before injecting peptides bought online: unauthorized products can seriously harm you
) We found no product containing Melanotan II in Health Canada’s Drug Product Database (searched 2026-10-01). (Health Canada:Health Canada Drug Product Database search: melanotan-ii — no product found
) Health Canada named Melanotan II in “Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks”. (Health Canada document) Ozempic and Wegovy (semaglutide) have Drug Identification Numbers in Health Canada’s Drug Product Database. (Health Canada:Health Canada Drug Product Database: OZEMPIC (semaglutide) — Drug Identification Numbers listed
; Health Canada:Health Canada Drug Product Database: WEGOVY (semaglutide) — Drug Identification Numbers listed
) Mounjaro and Zepbound (tirzepatide) have Drug Identification Numbers in Health Canada’s Drug Product Database. (Health Canada:Health Canada Drug Product Database: MOUNJARO (tirzepatide) — Drug Identification Numbers listed
; Health Canada document) - Sport (WADA)BPC-157 is named on the 2026 WADA Prohibited List (S0). (WADA:
World Anti-Doping Code International Standard Prohibited List 2026
) TB-500 is named on the 2026 WADA Prohibited List (S2.3). (WADA:World Anti-Doping Code International Standard Prohibited List 2026
) Melanotan II is not named on the 2026 WADA Prohibited List; by our reading it falls under S0, non-approved substances. (WADA:World Anti-Doping Code International Standard Prohibited List 2026
) Semaglutide is not on the 2026 WADA Prohibited List. (WADA:World Anti-Doping Code International Standard Prohibited List 2026
) Tirzepatide is not on the 2026 WADA Prohibited List. (WADA:World Anti-Doping Code International Standard Prohibited List 2026
) Orforglipron is not on the 2026 WADA Prohibited List. (WADA:World Anti-Doping Code International Standard Prohibited List 2026
)
Official sources: FDA: July 23-24, 2026, Meeting of the Pharmacy Compounding Advisory Committee – FDA Briefing Document for BPC-157-Related Bulk Drug Substances (BPC-157 (free base) and BPC-157 acetate)
· FDA: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
· Health Canada: Think twice before injecting peptides bought online: unauthorized products can seriously harm you
· WADA: World Anti-Doping Code International Standard Prohibited List 2026
· FDA document 1 · FDA document 2 · FDA document 3
Report a side effect
If something went wrong after using any product, tell a clinician and report it. Reports are how regulators find contaminated or mislabeled products.
- FDA MedWatch (United States)
- Canada Vigilance Program (Canada)
Questions to ask your doctor
SoftMaxx AI gives no doses or prescriptions; take these to a clinician.
- Could this symptom be related to the product I used, or to something else?
- Should I stop the product now, and what should I watch for after stopping?
- Which symptoms mean I should go to an emergency department rather than wait?
- Do I need any tests, and what would the results change?
- Could the product interact with my other medicines or supplements?
- Will you report this to FDA MedWatch or Canada Vigilance, or should I?
- When should I follow up with you?
Common questions
What are the warning signs after a peptide injection?
The sources we found name redness, swelling, pain or a lump where the product went in, and infections with unauthorized products. The GLP-1 drug labels add signs of a serious allergic reaction, such as swelling of the face, lips, tongue or throat or trouble breathing. Health Canada advises anyone who feels unwell after an unauthorized peptide to talk to a healthcare professional right away.[6][1][2]
When is a symptom an emergency?
The GLP-1 drug labels say to stop the medicine and get medical help right away for signs of a serious allergic reaction, and EMA says sudden vision loss on semaglutide needs a doctor without delay. For anything else that worries you, the labels and Health Canada point you to a healthcare professional.[2][3][4][5][1]
Can BPC-157 cause skin darkening?
Case report One FDA adverse-event report describes diffuse darkening of the skin and gums in a woman using a product with both BPC-157 and TB-500; it came back when she used the product again. FDA says it cannot tell which peptide was responsible.[7]
Can Melanotan II cause melanoma?
Case report Case reports describe melanoma in people who used Melanotan II, some alongside sunbeds or tanning beds, and FDA's compounding safety page lists melanoma among the serious adverse events in published case reports. Case reports cannot show that the drug caused it.[10][11][16][14]
Do GLP-1 drugs cause vision problems?
Regulator document EMA's safety committee concluded that NAION, an eye condition that may cause loss of vision, is a very rare side effect of semaglutide, affecting up to 1 in 10,000 people. The US Wegovy label we read does not name NAION; it tells people with type 2 diabetes to report changes in vision.[5][2]
How do I report a side effect?
Regulator document In the US, use FDA MedWatch, which FDA asks patients to use for adverse events and quality problems. In Canada, use Canada Vigilance; Health Canada asks people to report side effects and complaints about health products.[6][1] Source: FDA document; Health Canada document
References
Every reference below was matched to its PubMed or DOI record (title checked) before publication. "Verified" means the paper exists and is the one named; what it supports is stated next to each claim.
Think twice before injecting peptides bought online: unauthorized products can seriously harm you (Health Canada advisory; lists KPV)
SourceWEGOVY (semaglutide) injection; WEGOVY (semaglutide) tablets — Prescribing Information
SourceZEPBOUND (tirzepatide) injection — Prescribing Information
SourceFOUNDAYO (orforglipron) tablets — Prescribing Information
SourcePRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy
SourceFDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
SourceJuly 23-24, 2026, Meeting of the Pharmacy Compounding Advisory Committee – FDA Briefing Document for BPC-157-Related Bulk Drug Substances (BPC-157 (free base) and BPC-157 acetate)
SourceEruptive naevi and darkening of pre-existing naevi 24 h after a single mono-dose injection of melanotan II.
PubMed 24334249 DOIEruptive melanocytic naevi following melanotan injection.
PubMed 19575725 DOIMelanoma associated with the use of melanotan-II.
PubMed 24355990 DOIMelanotan II nasal spray: a possible risk factor for oral mucosal malignant melanoma?
PubMed 40210573 DOIMelanotan Tanning Injection: A Rare Cause of Priapism.
PubMed 33460908 DOIMelanotan II injection resulting in systemic toxicity and rhabdomyolysis.
PubMed 23121206 DOICertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
SourceMelanotan-associated melanoma.
PubMed 21564053 DOIFive primary melanomas in situ in a patient with recent tanning bed use, melanotan exposure, and anabolic hormone use.
PubMed 42328529 DOIAssociation of Glucagon-Like Peptide-1 Receptor Agonist Use With Risk of Gallbladder and Biliary Diseases: A Systematic Review and Meta-analysis of Randomized Clinical Trials.
PubMed 35344001 DOIUnregulated Peptide Use in the Age of Biohacking: Digital Promotion, Gray-Market Access, and Emerging Public Health Risks.
PubMed 42437212 DOIDangers of Injectable Peptides and Other Unregulated "Biohacking" Drugs.
PubMed 42757290
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