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Sermorelin Side Effects: What the Trials and FDA Record Report

Flushing and injection-site pain are the reported side effects. The harder truth is how small the safety record is, especially for the adults who use it today.

Article type
Safety
Sources
6
Reading
6 min
By Leah GarnerPublished

Sermorelin’s reported side effects are mild and few: flushing of the face and pain where it is injected. The catch is how little data sits behind that. Its safety record comes from children with growth hormone deficiency, and from two small, short studies in older men.

Sermorelin is a 29-amino-acid piece of growth-hormone-releasing hormone [1]. It prompts the pituitary to release growth hormone. On this site it sits under the sleep and recovery goals. Adults reading those pages are not the group most of the data comes from.

What the reported side effects are

A 1999 review pulled together the clinical record for sermorelin in children [1]. It found single intravenous doses and repeated daily injections under the skin well tolerated. The most common adverse events were transient facial flushing and pain at the injection site.

The largest single trial treated 110 prepubertal children with growth hormone deficiency for up to a year [2]. They got 30 micrograms per kilogram at bedtime. The authors saw no adverse changes in general blood chemistry or hormone tests. Fasting glucose did not change, and IGF-1 was not raised to excessive levels. The trial was open-label, with no placebo group.

What small studies in older men found

In 1992, 10 healthy older men took 0.5 mg and 1 mg of sermorelin under the skin twice daily, each dose for 14 days [3]. It did not change fasting glucose, blood pressure, or routine chemistry and blood counts. Phosphate levels rose during treatment.

In 1997, 11 healthy men aged 64 to 76 injected 2 mg every night for 6 weeks [4]. The authors report no significant adverse effects. Weight, body fat, glucose, insulin and lipids did not change either.

These are the adults most like today’s users, and there were 21 of them across the two studies. Two to six weeks is too short to show a side effect that builds slowly.

Why the approved product disappeared

Sermorelin was sold as GEREF under two FDA approvals. One, from 1990, was a diagnostic test. The other, from 1997, treated growth hormone deficiency in children [6]. The maker discontinued both in 2008, and FDA withdrew the approvals in 2009.

In 2013, FDA determined that both products were not withdrawn for reasons of safety or effectiveness. This site’s register relies on that finding when it treats sermorelin as compoundable. It is a statement about why a product left the market. It does not test sermorelin in adults. The wider rules are in are peptides legal.

What has not been measured

None of these studies ran for years in adults. None tracked cancer, heart events or diabetes as outcomes. Its better-studied cousin tesamorelin, tested in hundreds of people, carries label warnings about raised IGF-1, fluid retention and blood sugar. Whether sermorelin shares them at the doses used today has not been tested directly, and tesamorelin’s record shows what larger trials can reveal.

Doses from the trials are collected in sermorelin dosage. How it compares with a popular alternative is in sermorelin vs ipamorelin.

Frequently asked questions

What are the side effects of sermorelin?
The most common reported adverse events were transient facial flushing and pain at the injection site, according to a 1999 review of its clinical use in children.
Is sermorelin safe for adults?
The adult data is small. Two studies in 10 and 11 healthy older men, lasting 2 to 6 weeks, reported no significant adverse effects. None of the published studies summarized here is a large, long-term adult safety trial.
Does sermorelin raise blood sugar?
Fasting glucose did not change in a year-long trial of 110 children or in the two short studies in older men.
Why was sermorelin taken off the market?
The maker discontinued GEREF in 2008. In 2013 FDA determined it was not withdrawn for reasons of safety or effectiveness.

Sources

6 cited
  1. 1Prakash A, Goa KL (1999). Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency BioDrugs. PMID 18031173
  2. 2Thorner M, Rochiccioli P, Colle M, et al. (1996). Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group Journal of Clinical Endocrinology and Metabolism. PMID 8772599
  3. 3Corpas E, Harman SM, Piñeyro MA, et al. (1992). Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men Journal of Clinical Endocrinology and Metabolism. PMID 1379256
  4. 4Vittone J, Blackman MR, Busby-Whitehead J, et al. (1997). Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men Metabolism. PMID 9005976
  5. 5Khorram O, Laughlin GA, Yen SS (1997). Endocrine and metabolic effects of long-term administration of [Nle27]growth hormone-releasing hormone-(1-29)-NH2 in age-advanced men and women Journal of Clinical Endocrinology and Metabolism. PMID 9141536
  6. 6U.S. Food and Drug Administration (2013). Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Federal Register. Source

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