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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

SOMATROGON-GHLA: 1,057 Adverse Event Reports & Safety Profile

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1,057
Total FAERS Reports
2 (0.2%)
Deaths Reported
36
Hospitalizations
1,057
As Primary/Secondary Suspect
5
Life-Threatening
4
Disabilities
Prescription
Status

FDA Application: 761184 ·

First Report: 20220101 · Latest Report: 20250925

What Are the Most Common SOMATROGON-GHLA Side Effects?

#1 Most Reported
Injection site pain
738 reports (69.8%)
#2 Most Reported
Wrong technique in device usage process
43 reports (4.1%)
#3 Most Reported
Injection site erythema
42 reports (4.0%)

All SOMATROGON-GHLA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Injection site pain 738 69.8% 0 2
Wrong technique in device usage process 43 4.1% 0 0
Injection site erythema 42 4.0% 0 0
Incorrect dose administered by device 41 3.9% 0 0
Injection site swelling 38 3.6% 0 0
Off label use 29 2.7% 0 3
Patient-device incompatibility 29 2.7% 0 0
Headache 27 2.6% 0 3
Needle issue 27 2.6% 0 0
Device mechanical issue 24 2.3% 0 0
Device delivery system issue 23 2.2% 0 0
Incorrect dose administered 22 2.1% 0 0
Drug dose omission by device 21 2.0% 0 0
Injection site mass 21 2.0% 0 0
Device leakage 19 1.8% 0 0
Crying 18 1.7% 0 0
Product communication issue 18 1.7% 0 0
Device issue 17 1.6% 0 0
Injection site bruising 17 1.6% 0 1
Injection site pruritus 17 1.6% 0 0

Who Reports SOMATROGON-GHLA Side Effects? Age & Gender Data

Gender: 36.4% female, 63.6% male. Average age: 10.3 years. Most reports from: JP. View detailed demographics →

Is SOMATROGON-GHLA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2022 9 0 0
2023 206 0 8
2024 161 1 12
2025 73 0 5

View full timeline →

What Is SOMATROGON-GHLA Used For?

IndicationReports
Growth hormone deficiency 373
Dwarfism 110
Hypopituitarism 38
Short stature 31
Blood growth hormone 5
Blood growth hormone decreased 5

SOMATROGON-GHLA vs Alternatives: Which Is Safer?

SOMATROGON-GHLA vs SOMATROPIN SOMATROGON-GHLA vs SPIRAMYCIN SOMATROGON-GHLA vs SUFENTANIL SOMATROGON-GHLA vs SULBACTAM SOMATROGON-GHLA vs SULFAMETHOXAZOLE\TRIMETHOPRIM SOMATROGON-GHLA vs SYNTHROID SOMATROGON-GHLA vs TAZOBACTAM SOMATROGON-GHLA vs TEDIZOLID SOMATROGON-GHLA vs TEDUGLUTIDE SOMATROGON-GHLA vs TEICOPLANIN

Official FDA Label for SOMATROGON-GHLA

Official prescribing information from the FDA-approved drug label.