A Gram Research analysis of over 10,000 adverse event reports found that children taking growth hormones experience 361 different safety signals, with muscle and bone problems (13.47% of reports) and nervous system issues (13.06%) being most common. While known side effects like injection site reactions remain frequent, researchers identified five previously unreported risks including sleep apnea, low vitamin D, and vision problems that warrant closer medical monitoring.
Researchers analyzed over 10,000 reports of side effects from growth hormone treatments in children to understand what problems occur most often. According to Gram Research analysis, they found 361 different safety signals across 20 body systems, with muscle and bone issues being the most commonly reported. While most side effects were already known, the study uncovered some unexpected risks not listed on medication labels, including sleep problems and vision issues. The findings highlight the importance of careful monitoring when children receive growth hormone therapy.
Key Statistics
A 2026 analysis of 10,559 adverse event reports from the FDA database found that muscle and bone disorders accounted for 13.47% of all reported side effects in children receiving growth hormone therapy between 2004 and 2024.
According to research reviewed by Gram, five previously unreported safety signals emerged in children on growth hormones: elevated kidney markers, increased bone density, decreased vitamin D, sleep apnea syndrome, and papilloedema, none of which were listed on original medication labels.
A retrospective study of 10,559 growth hormone adverse event reports identified 361 distinct safety signals across 20 organ systems, with general side effects and injection site conditions representing 33.4% of all reported problems in children under 18.
Research analyzing FDA adverse event data found that nervous system disorders accounted for 13.06% of reported side effects in children using growth hormones, highlighting the need for enhanced neurological monitoring during treatment.
The Quick Take
- What they studied: What side effects happen most often when children take growth hormone medications, and whether there are any unexpected problems doctors should watch for
- Who participated: 10,559 reports of adverse events in children under 18 years old who received growth hormone treatment, collected from the FDA’s adverse event database between 2004 and 2024
- Key finding: Researchers identified 361 different safety signals, with muscle and bone problems being the most common (13.47% of reports), followed by nervous system issues (13.06%), and general side effects like injection site reactions (33.4%)
- What it means for you: If your child takes growth hormone, doctors should monitor them closely for muscle pain, bone changes, sleep problems, and vision issues. Most side effects are manageable, but some risks aren’t yet listed on medication labels, so ongoing communication with your doctor is essential
The Research Details
This study looked backward at real-world reports of side effects from growth hormone use in children. Researchers used a tool called OpenVigil 2.1 to search through the FDA’s adverse event reporting system (FAERS), which is like a giant database where doctors and patients report problems with medications. They collected all reports from 2004 through early 2024 for children under 18 years old.
The researchers then used a statistical method called reporting odds ratio to identify which side effects happened more often than expected. This helps them spot patterns and warning signals that might need more attention. They organized all the reported problems by which body systems were affected—like the nervous system, muscles and bones, metabolism, and others.
This approach is important because it uses real-world data from actual patients and doctors, not just controlled laboratory studies. When millions of people use a medication, rare side effects sometimes show up that weren’t caught in smaller clinical trials. By analyzing thousands of reports, researchers can spot patterns and trends that help doctors provide safer care. This type of study is especially valuable for identifying unexpected problems that might not be listed on medication labels yet.
The study’s strength is its large sample size of over 10,000 reports spanning 20 years, which provides a comprehensive picture of growth hormone side effects in real-world use. However, the study has important limitations: it relies on voluntary reporting, meaning some side effects may be underreported or overreported depending on how likely people are to report them. The reports come mostly from the United States, so the findings may not apply equally to other countries. Most importantly, this type of database analysis can identify patterns but cannot prove that growth hormone directly caused a specific side effect—it can only show that the side effect was reported more often than expected
What the Results Show
The study found 361 different safety signals across 20 different body systems in children taking growth hormones. The most commonly reported problems were general side effects and injection site conditions (33.4% of all reports), followed by abnormal test results (19.97%), muscle and bone disorders (13.47%), and nervous system problems (13.06%).
The researchers also identified five unexpected side effects that weren’t previously listed on growth hormone medication labels: elevated kidney function markers (blood urea nitrogen/creatinine ratio), increased bone density, low vitamin D levels, sleep apnea (breathing problems during sleep), and papilloedema (swelling of the optic nerve). While some of these like increased bone density might seem positive, they still require medical monitoring.
The study confirmed that known side effects like injection site reactions and headaches remain the most frequently reported problems. However, the high number of reports for muscle, bone, and nervous system issues suggests these areas need closer monitoring than current medical guidelines may recommend.
The study noted that tumor-related reports made up 3.28% of all adverse events. However, the researchers emphasized that existing scientific evidence does not support a causal link between growth hormone use and cancer development in children. This highlights an important limitation of adverse event databases: they can show what problems people reported, but they cannot prove that one thing caused another. Some reports may reflect coincidental timing rather than actual drug effects.
The findings align with previously known side effects of growth hormone therapy in children, such as injection site reactions and headaches, which confirms the database’s reliability. However, the study reveals several previously unreported or under-recognized risks, particularly in the areas of kidney function, vitamin D metabolism, sleep disorders, and vision problems. This suggests that current medication labels may not fully capture all the side effects that occur in real-world use, and that ongoing surveillance is necessary to update safety information as new patterns emerge.
The study has several important limitations that affect how we interpret the results. First, FAERS relies on voluntary reporting, meaning doctors and patients must actively report side effects—many problems may go unreported, while others might be reported more frequently due to media attention or lawsuits. Second, the database is heavily skewed toward reports from the United States, so the findings may not represent children in other countries who might have different genetics, healthcare practices, or reporting patterns. Third, and most importantly, this type of analysis can only show that side effects were reported together with growth hormone use; it cannot prove that the growth hormone actually caused those side effects. A child might develop a problem for an entirely different reason that happens to coincide with starting growth hormone therapy. Finally, the study cannot determine how common these side effects actually are in the general population of children using growth hormones, only that they were reported more often than statistically expected
The Bottom Line
Children receiving growth hormone therapy should have regular medical check-ups that specifically monitor for muscle pain, bone changes, sleep disturbances, vision problems, and kidney function (through blood tests). Parents should report any new symptoms to their doctor promptly. The benefits of growth hormone therapy for children with growth disorders generally outweigh the risks when prescribed appropriately, but informed monitoring is essential. Confidence level: High for known side effects; Moderate for newly identified signals requiring further study.
This research is most relevant for children with growth hormone deficiency or other conditions where growth hormone therapy is medically necessary, their parents, and their doctors. Children with normal growth patterns should not receive growth hormone therapy. Healthcare providers should use these findings to enhance their monitoring protocols and patient education. Researchers and pharmaceutical companies should use this data to update medication labels and safety information.
Most common side effects like injection site reactions appear within days to weeks of starting treatment. Muscle and bone changes typically develop over weeks to months. Sleep problems and vision issues may emerge at any point during treatment. Kidney function changes can be detected through regular blood tests. Long-term monitoring throughout the entire duration of therapy is recommended, as some effects may take months or years to become apparent
Frequently Asked Questions
What are the most common side effects of growth hormone in children?
General side effects and injection site reactions (redness, swelling, pain) are most common at 33.4% of reports, followed by muscle and bone problems at 13.47% and nervous system issues at 13.06%. Most are manageable with proper medical monitoring.
Are there any side effects of growth hormone that doctors don’t know about yet?
Yes, this study identified five previously unreported risks: elevated kidney markers, increased bone density, low vitamin D, sleep apnea, and vision problems (papilloedema). These weren’t listed on medication labels but appeared in real-world reports, suggesting ongoing monitoring is needed.
Does growth hormone cause cancer in children?
While 3.28% of adverse event reports mentioned tumors, existing scientific evidence does not support a causal link between growth hormone therapy and cancer development. The database can show reported problems but cannot prove one caused the other.
How often should my child be monitored while taking growth hormone?
Regular medical check-ups should specifically monitor for muscle pain, bone changes, sleep disturbances, vision problems, and kidney function through blood tests. Monthly discussions with your doctor about any new symptoms are recommended throughout treatment.
Is growth hormone therapy safe for children with growth disorders?
Growth hormone therapy is generally safe and beneficial for children with growth hormone deficiency when prescribed appropriately, but requires careful medical oversight. Benefits typically outweigh risks when monitored closely for known and emerging side effects.
Want to Apply This Research?
- Log weekly reports of injection site reactions (redness, swelling, pain), muscle or joint aches, sleep quality (hours slept, sleep disturbances), and any vision changes or headaches. Rate each symptom on a 1-10 scale to track patterns over time
- Set reminders for monthly check-ins with your child’s doctor to discuss any new symptoms. Create a symptom diary in the app to record when problems occur and what they were doing when symptoms started, helping identify patterns and triggers
- Use the app to track trends across multiple body systems over 3-6 month periods. Share monthly summaries with your child’s healthcare provider to support informed decision-making about continuing or adjusting growth hormone therapy. Flag any new or worsening symptoms for immediate medical attention
This research analyzes reported adverse events but cannot establish direct causation between growth hormone use and specific side effects. Growth hormone therapy is an important treatment for children with growth disorders and should only be prescribed and monitored by qualified healthcare providers. Parents should not stop or change their child’s growth hormone therapy based on this information alone. All concerns about side effects should be discussed with your child’s endocrinologist or pediatrician. This article is for educational purposes and does not constitute medical advice. Individual responses to growth hormone therapy vary, and medical decisions should be based on your child’s specific medical history and needs.
This research translation is published by Gram Research, the science division of Gram, an AI-powered nutrition tracking app.