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Important Safety Information
Sermorelin injections
Read this before starting treatment. It is a summary of the most important safety information, not a complete list.
Last updated 13 August 2026
Off-label use notice
Sermorelin was previously FDA-approved for the diagnosis and treatment of growth hormone deficiency in children; that product was withdrawn from the US market in 2008 for commercial reasons. There is no FDA-approved sermorelin product for adults. Its use for healthy aging, sleep, recovery, energy or body composition is off-label — the FDA has not evaluated the evidence for that use, and no outcome is promised or guaranteed. Sermorelin is not an anabolic steroid and is not prescribed for athletic performance.
About compounded medication. The medication described here is prepared for an individual patient by a state-licensed compounding pharmacy. It is not FDA-approved for safety and effectiveness, and the FDA does not review compounded preparations for quality, strength or purity before they are dispensed. The safety information below is drawn from the historical FDA labelling for sermorelin acetate and from what is known about growth-hormone-releasing hormone analogues.
What this is
Sermorelin is a synthetic fragment of growth-hormone-releasing hormone (GHRH) — the signal your hypothalamus sends to your pituitary. It does not supply growth hormone; it prompts your own pituitary to release it, so your body's normal feedback loops still govern how much is produced. It is dosed at night to match your natural overnight release. DonoMed prescribes it as a subcutaneous injection on a protocol set by a licensed provider after reviewing your health history.
Do not use if you
- Have an active malignancy, or are being evaluated for one. Growth hormone signalling can promote cell growth.
- Are pregnant, breastfeeding, or trying to conceive.
- Have had an allergic reaction to sermorelin or any component of the preparation.
Tell your provider before starting if you
- Have a personal or family history of cancer.
- Have diabetes or impaired glucose tolerance — growth hormone can raise blood sugar and reduce insulin sensitivity.
- Have untreated or suspected sleep apnoea.
- Have thyroid disease, or take thyroid medication — hypothyroidism blunts the response.
- Take corticosteroids (including inhaled or high-dose steroids), which suppress the response.
- Have carpal tunnel syndrome, joint problems, or a history of intracranial hypertension.
- Take any other prescription medication or supplement.
Common side effects
Injection-site redness, swelling, pain or itching — the most frequently reported effect. Flushing, headache, dizziness, nausea, drowsiness, or a metallic taste. Mild fluid retention, joint aching, or transient changes in blood sugar.
Serious side effects — stop and seek care
- Serious allergic reaction. Swelling of the face, lips, tongue or throat, difficulty breathing, or widespread rash. Call 911.
- Persistent swelling of the hands or feet, or significant weight gain from fluid.
- New or worsening numbness, tingling or weakness in the hands — possible carpal tunnel syndrome.
- Severe or persistent headache with vision changes or vomiting.
- Symptoms of high blood sugar: unusual thirst, frequent urination, or blurred vision.
- Signs of injection-site infection. Spreading redness, warmth, pus, or fever.
An important caution
Sermorelin is a long-horizon therapy, not a same-week one, and it is not a substitute for sleep, training or nutrition. Because growth hormone signalling affects cell growth and glucose handling, it should be prescribed and reviewed by a provider rather than continued indefinitely without check-ins. Tell your provider promptly about any new lump, unexplained weight loss, or other symptom that concerns you.
Storage and handling
Store as instructed on your label — sermorelin is typically refrigerated after reconstitution and protected from light — and keep it out of reach of children. Do not use after the beyond-use date. Never share your medication, needles or syringes. Dispose of used needles in an approved sharps container.
This summary is not complete
The information above is a summary and does not list every possible risk, interaction or side effect. Discuss your full health history and all medications and supplements you take with your provider before starting treatment.
Reporting a problem
Tell your provider about any side effect. You can also report side effects directly to the FDA at fda.gov/medwatch or by calling 1-800-FDA-1088. If you think you are having a medical emergency, call 911.