Sermorelin Side Effects: What Is Actually Documented
Sermorelin has had no FDA prescribing information since 2009, so there is no official side-effect list to quote. There is still a real evidence record, and it is more informative than the absence suggests.
- No labelNo current FDA prescribing information exists for sermorelin
- 59Adverse event reports naming sermorelin in the FDA’s reporting system
- NeoplasmsA labelled warning on the approved drug in the same class
- UnknownThat label’s word for the effects of prolonged IGF-1 elevation
The short version
Because sermorelin’s approvals were withdrawn in 2009, there is no current label carrying an adverse reactions section. Any list you find online is either copied from the discontinued 1990s labelling, inferred from the drug class, or made up. This page says which is which.
Three sources do exist and they are worth reading together: what the FDA found when it reviewed sermorelin’s post-marketing record in 2013, what the labelled warnings say on the one approved drug in the same class, and what has been reported to the FDA’s adverse event system. None is a substitute for a label, and together they are considerably better than nothing.
Why there is no official list
A prescribing label is a legal document attached to an approved product. It carries the adverse reactions section, the warnings, the contraindications, and it is maintained by the company that holds the approval. When an approval is withdrawn, the label goes with it.
We searched the FDA’s label database for sermorelin and found nothing, which is exactly what the regulatory history predicts. The approvals were withdrawn in June 2009 at the manufacturer’s request, and no generic has replaced them. What pharmacies compound today is not accompanied by an FDA-reviewed label.
Worth knowing
This is a different situation from a compound that never had a label. Sermorelin had one, for nearly two decades. It is not that nobody ever studied the safety of this molecule — it is that the document recording what they found is no longer maintained.
What the FDA found when it looked
In 2013 the agency had to decide whether sermorelin had left the market for safety reasons. Doing that meant going back through the record, and the FDA describes what it did:
What the FDA says
“We have also independently evaluated relevant literature and data for possible postmarketing adverse events for both GEREF products. We have reviewed the available evidence and determined that both GEREF products were not withdrawn from sale for reasons of safety or effectiveness.”
That is a genuine and useful finding. A regulator went looking through post-marketing adverse event data for a drug that had been on the market since 1990, and did not find a safety problem that explained its withdrawal.
It is worth being precise about the limits, though. The question the FDA was answering was narrow: was this withdrawn for safety? It was not writing a safety profile, and it was reviewing a drug used in the approved way — in children with growth failure, and as a single-administration pituitary test. It says nothing about adults taking it for years for body composition, which is what the modern market does.
The closest thing to a label: the approved drug in the same class
Tesamorelin, sold as Egrifta, is a growth hormone-releasing factor analogue — the same mechanism as sermorelin, prompting the pituitary to release growth hormone rather than supplying it. It is currently approved, which means it has a current label, and that label is the best available guide to what this class of drug is watched for.
- Increased risk of neoplasms. The label directs that “preexisting malignancy should be inactive and its treatment complete prior to starting,” and that treatment be discontinued “if there is any evidence of recurrent malignancy.”
- Elevated IGF-1. The drug “stimulates GH production and increases serum IGF-1, a growth factor.” The label then states plainly that “the effects of prolonged elevations in IGF-1 levels are unknown,” and directs that IGF-1 be monitored during therapy.
- Fluid retention. Listed as possible, and described as including oedema, joint pain and carpal tunnel syndrome.
- Glucose intolerance or diabetes. Listed as able to develop during treatment.
- Hypersensitivity and injection site reactions. Both carry their own warnings sections. The most commonly reported reactions, above 5 percent, are joint pain, injection site redness and itching, pain in the extremities, peripheral oedema and muscle pain.
How far this transfers
Tesamorelin is a different molecule from sermorelin. These are the warnings on a related drug, not sermorelin’s side-effect profile, and we are not claiming otherwise. They indicate what regulators consider worth monitoring when a drug raises growth hormone output — which is the thing both compounds do.
The cancer question, answered as precisely as we can
This is one of the most searched questions about sermorelin, and it deserves a careful answer rather than reassurance or alarm.
There is no evidence we could find that sermorelin causes cancer, and we are not suggesting it does. What exists is a mechanistic concern that regulators take seriously enough to put on a label. Drugs in this class raise growth hormone, which raises IGF-1, and IGF-1 is a growth factor — a signal that tells cells to divide. That is the reason the approved drug in the class carries a neoplasm warning and requires IGF-1 monitoring.
The sentence that matters
“The effects of prolonged elevations in IGF-1 levels are unknown.” That is the FDA-approved labelling on a currently marketed drug in this class — and prolonged elevation is precisely what long-term use for anti-ageing involves.
So the honest position has three parts. No study shows sermorelin causes cancer. The class carries a labelled malignancy warning and a monitoring requirement. And the long-term consequence of the thing these drugs are taken to do has not been established. Anyone telling you the question is settled, in either direction, is going beyond the evidence.
What has actually been reported
The FDA runs an adverse event reporting system that anyone — clinician, manufacturer or member of the public — can submit to. Searching it for sermorelin returns 59 reports in total.
The reaction terms appearing most often are itching, nausea, hypersensitivity, malaise and rash, followed by anaphylactic reaction, burning sensation, redness, sweating and injection site reactions. Each of those appears in single figures. The clustering around allergic and injection-site effects is at least consistent with the hypersensitivity and injection site warnings on the approved drug in the class.
How to read these numbers
A report is not a finding. Reporting is voluntary, nobody verifies causation, and there is no denominator — we have no idea how many people took sermorelin without reporting anything. Fifty-nine reports means fifty-nine reports. It does not mean the drug is safe, and it does not mean it caused any of them.
What compounding adds to the question
Everything above concerns sermorelin the molecule. A compounded product introduces a second set of questions that no discussion of the molecule can answer: what is in the vial, at what purity, and prepared to what standard.
There is a real distinction worth keeping hold of here. Compounded sermorelin comes from a licensed pharmacy on a clinician’s prescription, which is a materially different supply chain from the research-chemical vendors selling BPC-157 with a not-for-human-consumption label. Sermorelin is also absent from the FDA list of substances the agency says may present significant safety risks in compounding, which ipamorelin and CJC-1295 both appear on.
That is a lower-risk position, not a cleared one. Compounded products are not FDA-approved, are not reviewed for safety or efficacy before dispensing, and vary between pharmacies. If you are prescribed it, the pharmacy preparing it is a reasonable thing to ask about.
What this page will not tell you
- How much to take, or whether a smaller amount reduces any of the effects above. Sermorelin is prescription-only and that is a decision for the prescriber.
- Whether a symptom you are experiencing is caused by sermorelin. We do not employ clinicians and we have never met you.
- Which compounding pharmacy is better. We do not review them and have no basis on which to rank them.
- A confident list of sermorelin’s side effects. That document does not currently exist, and writing one from the class would mean presenting inference as fact.
Sources and method
- The absence of a label. We queried the FDA’s drug labelling database for sermorelin and it returned no matches, consistent with the withdrawal of both applications in June 2009.
- The FDA’s 2013 review. Determination That GEREF (Sermorelin Acetate) Injection … Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, Federal Register, 4 March 2013.
- The class warnings. The current FDA labelling for tesamorelin (Egrifta), BLA 022505, held by Theratechnologies. All quoted warning language is from the Warnings and Precautions and Adverse Reactions sections of that label.
- The adverse event reports. The FDA Adverse Event Reporting System, queried through openFDA for reports naming sermorelin as a medicinal product. Counts are as at 30 August 2026.
- What we could not verify. We were unable to retrieve the original GEREF prescribing information, so we do not reproduce its adverse reactions section and cannot confirm what it contained. We do not know how many people have used sermorelin, so the 59 reports have no denominator. We have not assessed whether the class warnings apply to sermorelin at the same rate, and no study we found addresses that.
- Method. Where this page uses evidence about a related drug, it says so in the same breath rather than presenting it as evidence about sermorelin. Where the record is silent, it says the record is silent.
Sermorelin overview → Regulatory tracker → How we source and verify →
FDA label, Federal Register and adverse event sources checked 30 August 2026. We recheck this page if a sermorelin product is approved.