72/100 · Elevated
Manufactured by Pfizer Laboratories Div Pfizer Inc
Somatropin Adverse Events Primarily Related to Device Issues
133,576 FDA adverse event reports analyzed
Last updated: 2026-05-12
SOMATROPIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. Based on analysis of 133,576 FDA adverse event reports, SOMATROPIN has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for SOMATROPIN include DRUG DOSE OMISSION BY DEVICE, DEVICE LEAKAGE, DEVICE BREAKAGE, DEVICE MECHANICAL ISSUE, DEVICE INFORMATION OUTPUT ISSUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SOMATROPIN.
Somatropin has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 133,576 adverse event reports for this medication, which is primarily manufactured by Pfizer Laboratories Div Pfizer Inc.
The most commonly reported adverse events include Drug Dose Omission By Device, Device Leakage, Device Breakage. Of classified reports, 26.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are related to device issues, indicating potential problems with the delivery system.
Serious adverse events account for 26.5% of the total, highlighting the need for careful monitoring. The highest number of reports involves device leakage and breakage, suggesting these are significant concerns.
Patients taking Somatropin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other drugs are not reported, but users should be cautious with device use and ensure proper technique to avoid errors. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Somatropin received a safety concern score of 72/100 (elevated concern). This is based on a 26.5% serious event ratio across 68,707 classified reports. The score accounts for 133,576 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Male: 38,295, Female: 25,229, Unknown: 65. The most frequently reported age groups are age 13 (4,640 reports), age 12 (4,302 reports), age 14 (4,253 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 68,707 classified reports for SOMATROPIN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Interactions with other drugs are not reported, but users should be cautious with device use and ensure proper technique to avoid errors.
If you are taking Somatropin, here are important things to know. The most commonly reported side effects include drug dose omission by device, device leakage, device breakage, device mechanical issue, device information output issue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always use the device as prescribed and follow the manufacturer's instructions carefully. Report any device issues or adverse reactions to the FDA's MedWatch program immediately. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with Pfizer required to address device issues and ensure patient safety.
The FDA has received approximately 133,576 adverse event reports associated with Somatropin. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Somatropin include Drug Dose Omission By Device, Device Leakage, Device Breakage, Device Mechanical Issue, Device Information Output Issue. By volume, the top reported reactions are: Drug Dose Omission By Device (16,809 reports), Device Leakage (9,680 reports), Device Breakage (8,521 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Somatropin.
Out of 68,707 classified reports, 18,181 (26.5%) were classified as serious and 50,526 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Somatropin break down by patient sex as follows: Male: 38,295, Female: 25,229, Unknown: 65. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Somatropin adverse events are: age 13: 4,640 reports, age 12: 4,302 reports, age 14: 4,253 reports, age 11: 3,656 reports, age 15: 3,300 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Somatropin adverse event reports is Pfizer Laboratories Div Pfizer Inc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Somatropin include: Device Issue, Wrong Technique In Device Usage Process, Injection Site Pain, Poor Quality Device Used, Device Use Error. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Somatropin to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Somatropin has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The majority of adverse events are related to device issues, indicating potential problems with the delivery system.
Key safety signals identified in Somatropin's adverse event data include: Device leakage and breakage are the most common issues reported.. Incorrect dose administration is a frequent problem, indicating potential user error or device malfunction.. Serious adverse events, including death and hospitalization, are reported, though less frequently.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs are not reported, but users should be cautious with device use and ensure proper technique to avoid errors. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Somatropin.
Always use the device as prescribed and follow the manufacturer's instructions carefully. Report any device issues or adverse reactions to the FDA's MedWatch program immediately.
Somatropin has 133,576 adverse event reports on file with the FDA. Serious adverse events account for 26.5% of the total, highlighting the need for careful monitoring. The volume of reports for Somatropin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with Pfizer required to address device issues and ensure patient safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Pfizer Laboratories Div Pfizer Inc and compare their safety profiles:
The following drugs share commonly reported adverse reactions with SOMATROPIN:
Drugs related to SOMATROPIN based on therapeutic use, drug class, or shared indications: