Safety & side effects
HGH side effects and safety data
StatusFDA approved · prescription
PeptideHound Staff · Last editorially reviewed · 25 sources
The side effects of HGH are better documented than those of almost anything else on this site, but the documentation covers a narrow group of people. In the phase 3 trials roughly four children in five recorded a mild to moderate adverse event, on daily and weekly schedules alike, and injection-site pain was named most often.
The serious events come from a registry of 83,803 treated children. Serious adverse events occurred in 3.7% of patients and death in 0.4%, and the most common were recurrence of craniopharyngioma (n = 151), neoplasm (n = 99), cancer (n = 91) and scoliosis (n = 91). No untreated comparison group sits beside those counts, so they describe how often something was recorded rather than what caused it.
Now read who that record covers. Everyone in it had a diagnosis: children short of their own growth hormone, a few adults with the same shortfall, patients fed through a vein, people wasting from HIV. Healthy adults appear nowhere, so every rate above was counted in a body already short of the hormone. Anyone using growth hormone for ageing, muscle or sport sits outside all of it.
The supply carries its own record. Eight FDA recalls sit between 2012 and 2021, covering sterility, silicone oil in a freeze-dried vial, injector pens breaking apart and a carton holding the wrong part. Every one happened inside the regulated supply. Nothing among the research behind this page measures what is in a vial that came from anywhere else.
Evidence: Registry of 83,803 treated children · phase 3 randomised trials with adverse-event tables · longest published follow-up six years · adult data limited to 20 participants with growth hormone deficiency and one case report · no adverse-event record in healthy adults · eight FDA recalls on the public record
What are the side effects of HGH?
human RCT
In the controlled trials nearly everyone recorded something, and most of it was minor. The phase 3 somatrogon study reports a similar percentage of subjects experiencing mild to moderate treatment-emergent adverse events in both groups (somatrogon: 78.9%, somatropin: 79.1%).1 That is roughly four children in five, on either schedule. The highest figure in the record comes from adults. A 2004 review reports that adverse events were reported in 100% of patients with short bowel syndrome during treatment with somatropin with or without glutamine.2 The same review supplies its own caveat at once: a high proportion of patients also reported signs and symptoms before starting therapy or adverse events after therapy.2 A 100% rate in people already severely ill measures the illness as much as the injection, rather than separating the two.
What serious events are on record?
human pilot / early trial
The largest safety record in this field is a registry rather than a trial. The Kabi/Pfizer International Growth Database (KIGS) is a large, international database (1987-2012) of children treated with recombinant human growth hormone, holding 83,803 patients.3 Across that cohort, SAEs occurred in 3.7% of patients and death in 0.4%, SAE meaning a serious adverse event that was life-threatening or worse.3 The most common SAEs were recurrence of craniopharyngioma (n = 151), neoplasm (n = 99), and cancer (n = 91); and scoliosis (n = 91).3 Craniopharyngioma is a brain tumour that grows near the pituitary gland, neoplasm means any new growth of tissue, and scoliosis is a sideways curve of the spine. Those percentages cover a shorter stretch than they look. Median rhGH treatment duration was 2.7 years and observation 3.1 years, so this is about three years each rather than a lifetime.3
Does HGH cause cancer?
human pilot / early trial
The registry counts are the only numbers available, and a count is not a cause. Among 83,803 treated children, neoplasm (n = 99), and cancer (n = 91) sit in the list of most common serious adverse events, and recurrence of craniopharyngioma (n = 151) heads that list.3 The craniopharyngioma figure is the easiest to misread, because those are recurrences in children who already had the tumour. What the record does not hold is an untreated comparison group. Nobody randomised children with growth disorders to no hormone and counted tumours in both arms, so the registry can report how often cancer was recorded rather than whether the hormone had anything to do with it. A 2025 analysis across two registries reports that incidence of adverse reactions was similar across indications, with no new safety signals.45
Does HGH affect blood sugar?
human pilot / early trial
This is the one organ question with real adult data behind it, and the data is small. It comes from one prospective, single-arm study at a single center, in 20 adults with GH deficiency and without diabetes.6 They moved from daily somatropin to a weekly version, with glucose tracked for 14 days either side. In those participants the mean sensor glucose level and net glycemic action over 24 hours were significantly increased during somapacitan treatment.6 The averages hid a pattern. In the same participants the switch resulted in increased interday glucose variability, characterized by biphasic glucose fluctuations.6 Glucose climbed and fell across the week. Longer-range blood markers did not shift at all.6 One case report shows what that can do. A 50-year-old man with hypopituitarism and T1DM moved to the weekly version, and soon thereafter, he experienced frequent hypoglycemia, which led to an emergency department visit.7
What are the side effects of HGH in men?
human pilot / early trial
No trial among the research behind this page reports an adverse-event table broken out by sex, so the answer starts there. What exists is a population that was mostly male and entirely young. The full KIGS cohort (N = 83 803 [58% male]) was treated for idiopathic GH deficiency and other growth disorders, and those are children rather than adult men.3 The only adult male record is a single case. A 50-year-old man with hypopituitarism and T1DM experienced frequent hypoglycemia after a change of preparation.7 Hypopituitarism means a pituitary gland that has stopped making its hormones. The one adult group study is small. It enrolled 20 adult GH deficiency participants without diabetes and reported its results for the group rather than by sex.6 So what is documented about men comes from children, from one man, and from twenty adults with a deficiency.
Is it safe to take HGH every day?
human RCT
Daily injection is the schedule this whole record was built on, which is a different thing from a verdict about it. In the phase 3 trials the daily arm was the comparator. One report opens by noting that treatment burden with daily somatropin injections is high, which may lead to poor adherence and suboptimal overall treatment outcomes.8 On the daily arm of the somatrogon trial, 79.1% of subjects recorded a mild to moderate treatment-emergent adverse event over twelve months.1 The six-year extension reports that adverse events were mostly mild or moderate and remained consistent with prior reports of daily somatropin.5 That is a comparison with daily use rather than with no use at all. Every daily schedule in the record belonged to a patient with a diagnosed deficiency, and daily use by anyone else has not been studied.
What are the dangers of taking more?
human pilot / early trial
Nothing among the research behind this page administered more, and that fact needs unpacking rather than repeating. Amounts in these trials were set against a diagnosis and then held to a blood target. Across the six-year extension, the mean of weekly average IGF-1 stayed within 0-2 SDS for the whole trial, and the dose held stable for the whole trial as well.5 IGF-1, short for insulin-like growth factor 1, is the blood signal that climbs when growth hormone is acting. One dose contrast does exist in the literature, where a 2025 registry analysis found that average dose of GH was higher for children with ISS vs children with GHD but mean duration of treatment was shorter4, ISS meaning idiopathic short stature. Across those same groups, incidence of adverse reactions was similar across indications, with no new safety signals.4 That is a modest gap inside a replacement range, rather than a test of what lies above it.
What happens at the injection site?
human RCT
Injection-site pain is the one everyday effect the trials actually counted. A Japanese phase 3 study reports that a similar proportion of subjects reported injection-site pain, although the somatrogon group reported more painful injections.9 The device matters more than the molecule here. Among 4,093 children in a UK database, those using ZomaJet stayed on GH therapy significantly longer than those on needle-based devices, 599 days against 535.10 A ZomaJet is a needle-free injector that pushes the dose through the skin. Devices also fail, and the enforcement record carries the proof. Two Class II recalls in 2021 cited the injector pen breaking apart and disintegrating into pieces, and two in 2012 cited complaints that the dose knob spun slowly and the injection took longer than usual.1112 A device that misdelivers is a safety problem in its own right rather than an inconvenience.
What is known about long-term use?
human pilot / early trial
Six years is the longest published follow-up, and it was an extension of a trial rather than a study built for the question. The enliGHten trial reports no evidence of accelerated skeletal maturation or safety signals associated with anti-drug antibodies in those patients.5 Anti-drug antibodies are the immune response a protein medicine can provoke against itself. The registry stretches further in calendar time but not per person. Median rhGH treatment duration was 2.7 years and observation 3.1 years across 83,803 patients.3 Most people do not stay on it. In Japanese claims data, 19% of children had stopped by 12 months and 35% by 48 months on one database, and no meaningful predictors of discontinuation were identified.13 So the long record describes a few years of exposure in children, rather than decades of it in anyone.
Who was excluded from the studies?
human RCT
The entry criteria are the most useful lines on this page, because they describe who the numbers do not cover. The heiGHt trial enrolled and dosed 161 treatment-naive, prepubertal patients with GHD.8 Treatment-naive means never previously given growth hormone. The somatrogon trial took 228 prepubertal children with GHD, impaired height and height velocity (HV), and no prior rhGH treatment.1 Adults appear only inside an illness. The glucose study enrolled 20 adult GH deficiency participants without diabetes, ruling diabetes out by design.6 The short bowel work took patients who were dependent on intravenous parenteral nutrition (IPN) [n = 41].2 So the published record covers young children with a hormone deficiency, a few adults with the same deficiency, and patients fed through a vein. Everyone else is unstudied rather than reassured.
What is documented in healthy adults?
human pilot / early trial
Nothing, and that is a statement about the whole record rather than about one missing trial. Every population behind the figures here carried a diagnosis. The registry cohort was treated for idiopathic GH deficiency (IGHD; 46.9%), organic GHD (10.0%), small for gestational age (SGA; 9.5%), Turner syndrome (TS; 9.2%), idiopathic short stature (ISS; 8.2%), and others (16.2%).3 The adult glucose work enrolled 20 adult GH deficiency participants without diabetes.6 The body composition work was done in patients where loss of body cell mass is associated with decreased survival.14 That does not mean growth hormone is harmless in a well adult. It means every rate above was counted in a body already short of the hormone, and a body making a normal amount is a different starting point. Those are different questions, and only the first has been asked.
What does HGH interact with?
human pilot / early trial
Four interactions appear in the published record. None was studied as a question in its own right. Insulin is the clearest of them. In the case described above, despite increasing the somapacitan dose, insulin titration was still required to stabilize glycemic variability in a man with type 1 diabetes.7 Glutamine was given alongside it in short bowel syndrome. Recipients of somatropin plus oral glutamine had significantly greater mean reductions from baseline in weekly total IPN volume than recipients of placebo plus glutamine.2 The two were given together rather than tested against each other. The third is not the hormone but the liquid it is mixed with, and the entry for one brand records that the manufacturer of Zomacton 5 mg recommends avoiding the use of the diluent, which contains benzyl alcohol, for lactating women.15 The fourth is the immune response, where the six-year extension found no safety signals associated with anti-drug antibodies.5
What is known about HGH and breastfeeding?
review
One version has data and three do not, which shows how thin this literature gets at the edges. For the original, limited data indicate that exogenous somatropin does not increase normal breastmilk concentrations of growth hormone.15 The same entry records that milk output increases from 19% to 36% after a 7-day course of somatropin, in small studies by one group of investigators.15 For the newer versions the entries repeat one sentence. There is no published experience with somatrem during breastfeeding, and no published experience with somatrogon during breastfeeding either.1617 Both note that the compound is poorly absorbed orally, so it is not likely to reach the bloodstream of the infant.16 For the long-acting version the note concerns the carrier: polyethylene glycol is not excreted into breastmilk.18 Three of those four entries describe an absence of data rather than a finding.
What regulatory actions are on record?
regulatory action
Eight recalls sit in the FDA enforcement record between 2012 and 2021, and they fall into three kinds. The first is sterility. A 2015 Class II recall covered Tev-Tropin (Somatropin) Injection, Rx, Western Drug Inc., and the reason given was lack of assurance of sterility.19 The second is contamination. A 2014 Class II recall was filed because a batch of Tev-Tropin may contain silicone oil due to leakage of a leaking line during the freeze-drying process.20 The rest concern devices and labels. Two 2021 recalls covered a needle-free delivery device for use with ZOMACTON (somatropin) for injection, a 2016 recall of a prefilled pen cited a low frequency assembly fault, and a Class III recall in 2013 covered cartons labelled for Needle-Free Head B that held the other head.212223 Every one happened inside the regulated supply, with a named firm and a published classification behind it.
Is HGH bought outside a pharmacy the same thing?
review
No, and the recall list is the clearest way to see why. Everything measured on this page was made by a named firm to a filed specification and tracked by batch. That is also why the failures are visible at all: one recall exists for lack of assurance of sterility, and another was filed because a vial may contain silicone oil due to leakage of a leaking line during the freeze-drying process.1920 Both were found, classified and published. The approval machinery is built around that traceability. A 2011 review notes that the European Medicines Agency (EMA) has issued guidelines that should be fulfilled in order to receive approval as biosimilar.24 No analysis among the research behind this page has measured the identity, concentration or sterility of growth hormone sold outside that supply. The checks that produced every number on this page were never run on it, so none of those numbers transfer rather than transferring in part.
Is HGH legal in the United States?
review
It is a prescription medicine, and the enforcement record says so in the plainest terms available. FDA listings describe a Norditropin FlexPro prefilled pen as Rx only, a Tev-Tropin entry carries the words Prescription Only, and a Zomacton device entry is also marked Rx only.222321 That status attaches to a named product with an approval behind it. A 2022 review records that lonapegsomatropin received its first approval in August 2021 in the USA for pediatric patients at least 1 year of age, which is the shape every one of these approvals takes: one product, one diagnosis.25 What the published record does not establish is how other routes of supply are treated in law. That belongs to a statute rather than to a trial report, and nothing cited on this page settles it. The approval, and the prescription-only status that comes with it, belong to the pharmacy injection and travel nowhere else.
What we don’t know
The gaps in the evidence matter as much as the findings.
- 01What happens in a healthy adult. Every adverse-event rate on this page was counted in someone with a diagnosis, so the risk in a body making a normal amount is unmeasured rather than low.
- 02What larger amounts do. Doses in these trials were held to a blood IGF-1 band, and nothing among the research behind this page administered more than that.
- 03Whether the registry's cancer counts mean anything causal. There is no untreated comparison group beside them.
- 04What happens past six years. The enliGHten extension is the longest published follow-up, and it ran in children.
- 05Whether the adverse-event pattern differs by sex. No trial among the research behind this page reports its table broken out that way.
- 06What happens in adults who are not deficient. The one adult group study enrolled 20 participants who all had growth hormone deficiency and no diabetes.
- 07Any interaction outside the four on record. Insulin, glutamine, a benzyl alcohol diluent and anti-drug antibodies have been described; everything else is untested rather than cleared.
- 08What is inside a vial that did not come from a pharmacy. No analysis among the research behind this page has measured its identity, concentration or sterility.
- 09How other routes of supply are treated in law. That is a question for a statute, and nothing cited on this page settles it.
Sources
- 1Efficacy and Safety of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency: A Phase 3 Study J Clin Endocrinol Metab 2022. doi:10.1210/clinem/dgac220human RCT
- 2Somatropin (Zorbtive): in short bowel syndrome Drugs 2004. doi:10.2165/00003495-200464120-00008review
- 3Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort J Clin Endocrinol Metab 2022. doi:10.1210/clinem/dgac517human pilot / early trial
- 4Comparative Outcomes of GH Treatment in Pediatric Idiopathic Short Stature and GH Deficiency J Endocr Soc 2025. doi:10.1210/jendso/bvaf133primary research
- 5Children with Growth Hormone Deficiency Treated with Lonapegsomatropin Demonstrated Sustained Height Improvements for up to 6 Years: enliGHten Trial Final Results Horm Res Paediatr 2026. doi:10.1159/000545064human pilot / early trial
- 6Distinct Glucose Profiles with Daily and Weekly Growth Hormone Therapy Revealed by Continuous Glucose Monitoring J Endocr Soc 2026. doi:10.1210/jendso/bvaf193human pilot / early trial
- 7Long-acting GH Use in Patients With Adult GH Deficiency Coexisting With Type 1 Diabetes Mellitus JCEM Case Rep 2025. doi:10.1210/jcemcr/luaf214human case report
- 8Weekly Lonapegsomatropin in Treatment-Naïve Children With Growth Hormone Deficiency: The Phase 3 heiGHt Trial J Clin Endocrinol Metab 2021. doi:10.1210/clinem/dgab529human RCT
- 9Efficacy and Safety of Once-Weekly Somatrogon Compared with Once-Daily Somatropin (Genotropin®) in Japanese Children with Pediatric Growth Hormone Deficiency: Results from a Randomized Phase 3 Study Horm Res Paediatr 2022. doi:10.1159/000524600human RCT
- 10Maintaining persistence and adherence with subcutaneous growth-hormone therapy in children: comparing jet-delivery and needle-based devices Patient Prefer Adherence 2014. doi:10.2147/PPA.S70019human pilot / early trial
- 11ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head 2021. sourceregulatory action
- 12Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01 2012. sourceregulatory action
- 13Persistence with daily growth hormone among children and adolescents with growth hormone deficiency in Japan PLoS One 2025. doi:10.1371/journal.pone.0324728primary research
- 14Mammalian cell-derived somatropin : a review of its use in the management of HIV-associated wasting Drugs 2006. doi:10.2165/00003495-200666030-00014review
- 15Somatropin 2006. PMID 30000556review
- 16Somatrem 2006. PMID 30000557review
- 17Somatrogon 2006. PMID 40864839review
- 18Lonapegsomatropin 2006. PMID 34554672review
- 19Tev-Tropin (Somatropin) Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 2015. sourceregulatory action
- 20TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 2014. sourceregulatory action
- 21ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free H 2021. sourceregulatory action
- 22Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21 2016. sourceregulatory action
- 23TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics & Specialty Products Division of Teva Pharmaceuticals USA, Sellersville, PA 18960 2013. sourceregulatory action
- 24[Biosimilars] Ther Umsch 2011. doi:10.1024/0040-5930/a000227review
- 25Lonapegsomatropin: Pediatric First Approval Paediatr Drugs 2022. doi:10.1007/s40272-021-00478-8review
