Sermorelin side effects are searched far more often than sermorelin itself is studied. What exists is three kinds of record: a labelled pediatric programme that ended in 2009, three small adult trials from the 1990s, and the reports that people and prescribers have sent to FDA since compounded sermorelin became common. This page reports each one, counts what is in it, and says what it cannot tell anyone. It is not reassurance and it is not a warning; where a decision is involved, the person to make it with is a clinician. How brands appear on this site is set out on our disclosure page.
The labelled programme
Sermorelin was approved in the United States as GEREF: a diagnostic ampule from 1990 and a pediatric treatment vial from 1997, both now listed as Discontinued in Drugs@FDA with FDA's determination that the withdrawal was not for safety or effectiveness reasons. The review of its labelled use summarises tolerability in one sentence: intravenous single doses and repeated once-daily subcutaneous doses "are well tolerated. Transient facial flushing and pain at injection site were the most commonly reported adverse events" (Prakash and Goa, BioDrugs 1999).
That programme was children with growth hormone deficiency, dosed by weight, under specialist supervision. It is the only regulated safety record sermorelin has.
The adult trials
| Trial | Who and what | What the abstract says about safety |
|---|---|---|
| Corpas 1992 | 10 men around 68; 0.5 mg and 1 mg twice daily, 14 days each | No effect on fasting glucose, urinary C-peptide, blood pressure, or chemistry and haematology profiles; phosphate rose |
| Vittone 1997 | 11 men aged 64 to 76; 2 mg once nightly, 6 weeks | "No significant adverse effects were observed"; no change in glucose, insulin or lipids |
| Khorram 1997 | 19 adults aged 55 to 71; nightly 10 micrograms per kilogram of a norleucine analogue, 16 weeks | "The only adverse side-effect was transient hyperlipidemia, which resolved by the end of the study" |
Forty people, in all, for between two and sixteen weeks, and one of the three compounds is an analogue rather than sermorelin itself. These trials were designed to see whether older people's growth hormone axis could be restored, not to find rare harms; a trial of eleven cannot detect an event that happens to one person in a hundred. The doses each trial used, and how they compare with what clinics state now, are on our sermorelin dosage page.
What FDA's adverse-event database holds
A query of the FDA Adverse Event Reporting System through openFDA on 2026-09-23 returned 59 reports mentioning sermorelin, 36 of them marked serious. They were received between 2009 and 2026, with a cluster of 15 in 2016 and 13 in 2025.
| Reaction term | Reports |
|---|---|
| Pruritus (itching) | 6 |
| Nausea | 5 |
| Hypersensitivity | 4 |
| Malaise | 4 |
| Rash | 4 |
| Anaphylactic reaction | 3 |
| Burning sensation | 3 |
| Erythema | 3 |
| Injection-site pruritus | 3 |
| Injection-site urticaria | 3 |
| Wrong product administered | 3 |
One report records a death, and it was opened rather than counted. Its suspect drug is a compounded testosterone cypionate; sermorelin is listed as a concomitant product, alongside vitamins, insulin, fish oil, bacteriostatic water and a hormone blend. The report does not establish what caused the death, and it does not name sermorelin as the suspect. A tally that read "sermorelin: one death" would be true of the database and false about the drug.
For scale, the same database holds 1,586 reports for tesamorelin, the GHRH analogue with a current label and a drug company obliged to forward reports. A small count for a compounded product reflects who reports as much as what happens. How to read this database in general, and why a low number is not a clean record, is set out on our peptide side effects page.
What is plausible from the mechanism, and what is only that
Sermorelin works by making the pituitary release growth hormone, which raises IGF-1. A current somatropin label — GENOTROPIN's, effective 2026-08-04 — lists edema and arthralgia among adverse reactions and warns that impaired glucose tolerance may be unmasked, and some of those terms appear in the sermorelin reports: fluid retention, arthralgia and "weight increased" twice each. That overlap is a reason the question is worth asking, not an answer to it; the adult trials measured glucose and found no change over weeks. Whether years of compounded use carry the risks of long-term growth hormone exposure is not in any record.
Where it differs from its neighbours
Tesamorelin, the 44-residue GHRH analogue, has a current label with an adverse-reaction table and a trial programme of hundreds of patients; its dose record is on our tesamorelin dosage page. Ipamorelin, often paired with sermorelin, reaches growth hormone through a different receptor and has its own, differently shaped record; the two are compared on our ipamorelin vs sermorelin page. Sermorelin is also prohibited at all times under the World Anti-Doping Agency's list, as a GHRH analogue, which matters to anyone tested in sport. Its longer-acting relative CJC-1295 has a fuller adverse-event record, drawn from FDA's own reading of the trials, on our page on CJC-1295's recorded side effects.
What the record does not contain
Any adverse-event data from adults under 55; any study longer than 16 weeks in adults; any comparison of compounded sermorelin's impurity profile with the labelled product's; and any systematic follow-up of the pediatric programme into adulthood that appears in an indexed abstract. A person weighing sermorelin, or deciding whether a symptom is related to it, should take that question to a clinician who can see their history and their other medicines.
Sources and dates
Read 2026-09-23: the GENOTROPIN (somatropin) label via openFDA; Drugs@FDA records for NDA 019863 and NDA 020443 via openFDA; FAERS via the openFDA drug event endpoint (reports mentioning sermorelin in any role, reaction-term counts, seriousness, received date, and the one death-flagged report opened in full; tesamorelin total); PubMed abstracts for Prakash and Goa 1999 (PMID 18031173), Corpas 1992 (PMID 1379256), Vittone 1997 (PMID 9005976) and Khorram 1997 (PMID 9141536). Corrections go to the contact page.