In published studies, the most commonly reported sermorelin side effects were brief facial flushing and pain at the injection site. Long-term safety data in adults are limited, and related drugs carry warnings about blood sugar, fluid retention and active cancer.
The side effects most often reported with sermorelin in published studies are short-lived facial flushing and pain at the injection site. Those findings come mainly from studies in children and from single diagnostic doses, so they tell us less about adults using it for months. Because sermorelin raises growth hormone and IGF-1, clinicians also watch for the effects associated with that hormone system, such as changes in blood sugar and fluid retention. Compounded sermorelin is not FDA-approved, which adds product-quality questions to the picture.
A 1999 review in BioDrugs by Prakash and Goa summarized the clinical experience from when sermorelin was an approved product. It concluded that single intravenous doses and repeated nightly injections under the skin were well tolerated, and that "transient facial flushing and pain at injection site were the most commonly reported adverse events."
The product information for the diagnostic version of the brand, published by Ireland's medicines regulator, describes the same pattern: facial heat, facial flushing and injection-site pain occasionally occur and usually disappear within a few minutes.
Studies in older adults add a little more. In a 1997 placebo-controlled study by Khorram and colleagues, 19 adults aged 55 to 71 used a closely related GHRH analog nightly for 16 weeks. The only adverse effect the authors reported was a temporary rise in blood lipids that resolved by the end of the study. That is reassuring, but 19 people over 16 weeks cannot reveal uncommon or long-term effects.
The former product information listed these contraindications:
It also advised particular caution in people with diabetes or epilepsy, and noted that untreated hypothyroidism and several medicines, including glucocorticoids, insulin and anti-inflammatory drugs such as aspirin, could affect the response to sermorelin. That guidance was written for a one-time diagnostic test, but it shows which conditions regulators considered relevant. Share your full medication list with your prescriber.
Sermorelin's purpose is to increase growth hormone release, so it makes sense to look at what is known about raising growth hormone and IGF-1.
A 2018 review in Sexual Medicine Reviews by Sigalos and Pastuszak found that growth hormone secretagogues (drugs that prompt the body to release growth hormone) appear well tolerated in available studies, "with some concern for increases in blood glucose due to decreases in insulin sensitivity." Those studies were mostly small and short.
When older adults received growth hormone itself, a systematic review summarized in the 2023 Endocrine Society scientific statement found more adverse events, including soft tissue swelling, joint pain, carpal tunnel syndrome, breast tissue enlargement in men, and higher rates of diabetes and impaired fasting glucose. Sermorelin works differently, because it relies on the body's own release and feedback, but these are the effects clinicians know to look for when the growth hormone axis is pushed higher.
The Endocrine Society statement lists potential effects of growth hormone stimulation on malignancy among the concerns about growth hormone therapy in older people. The Sigalos review likewise says long-term safety evaluation, "including evaluation of cancer incidence and mortality," is still needed for secretagogues. There is no published evidence in this set of sources that sermorelin causes cancer, but there is also no long-term study ruling the question out.
Tesamorelin is a different GHRH analog that is FDA-approved for one use: reducing excess abdominal fat in adults with HIV and lipodystrophy. It is not sermorelin, and its label does not apply to sermorelin. Still, it is the closest example of how the FDA describes risks for a drug that works on the same receptor. Its label:
These points help explain why a prescriber may ask about your cancer history and blood sugar and may suggest lab work.
The sermorelin available through NewDay Wellness is compounded and not FDA-approved. The FDA explains that it does not review compounded drugs for safety, effectiveness or quality before they are marketed, and that poor-quality compounded drugs, for example contaminated products or products with too much active ingredient, can cause serious harm. Choosing a state-licensed pharmacy and following storage and injection instructions from your care team are practical safeguards. Dosing is set by your prescriber, not by this article. For background on what sermorelin is, see sermorelin explained.
In the published sermorelin literature, the most commonly reported side effects were brief facial flushing and pain at the injection site. The former product information described these as usually disappearing within a few minutes. Your experience may differ, so report anything unexpected to your provider.
It is possible. Reviews of drugs that stimulate growth hormone release note some concern for increases in blood glucose due to reduced insulin sensitivity, and the label for tesamorelin, a related approved drug, warns about glucose intolerance. If you have diabetes or prediabetes, discuss this before starting.
This is a question for your oncology team and prescriber. Reviews say long-term data on cancer incidence are lacking, and the related approved drug tesamorelin is contraindicated in active malignancy.
Seek urgent care for signs of a serious allergic reaction, such as hives, swelling of the face or throat, or trouble breathing. Call 911 in an emergency. For milder concerns, such as persistent swelling or injection-site changes, contact your provider.
A licensed provider can review your medical history, medications and goals, explain the limited long-term safety data for sermorelin, and decide whether monitoring such as IGF-1 or glucose testing is appropriate. This article is educational and does not determine eligibility for any treatment.
Written by the NewDay Wellness editorial team from the sources above and checked against them before publication, and medically reviewed by Dr. Sean Arora and Dr. Shannon Arora of Arora Health & Aesthetics; see our editorial standards. This article is educational and does not diagnose conditions, establish eligibility for any medication, or replace care from a licensed provider. Compounded medications are not FDA-approved.
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