Somatrogon-Ghla side effects: what 1,211 FDA adverse event reports show

Somatrogon-Ghla · Ngenla · 36 reaction terms · 1,403 drug–reaction co-reports · data 2026-09-14

Drug class

Human growth hormone analog

FDA label, Indications wording

Brand names

Ngenla

openFDA label

Who reports

1,211 reports · 16% serious · 3 with death outcome · 36% female

openFDA FAERS counts, all years, deduplication not applied

Used for

NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone ( 1 ).

FDA label, Indications and Usage

What it is

Somatrogon-ghla, a human growth hormone analog, is a fusion protein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. It is comprised of the amino acid sequence of h.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 22 strongest signals

Labeled adverse reaction 5Labeled (related wording) 4Reporting / coding artifact 9Not in label — unassessed 4

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 14 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Device mechanical issue	36	48.4 35.1–66.8ROR 49.9 · χ² 1,622 / p <1e-300	47.2 EB05 35.6 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Injection site pain (pain where injected)	789	45.1 43.3–47.0ROR 127.6 · χ² 34,409 / p <1e-300	45.0 EB05 42.4 · IC025 +5.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 31.3	no trial data cached
Incorrect dose administered by device	46	31.4 23.7–41.7ROR 32.6 · χ² 1,324 / p 4e-290	31.0 EB05 24.2 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious n=7	no trial data cached
Injection site discomfort	14	23.5 14.0–39.6ROR 23.8 · χ² 279 / p 5e-63	22.7 EB05 14.2 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Needle issue	34	20.6 14.8–28.7ROR 21.2 · χ² 615 / p 5e-136	20.4 EB05 15.2 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Device delivery system issue	30	19.9 14.0–28.3ROR 20.4 · χ² 520 / p 2e-115	19.6 EB05 14.4 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious n=6	no trial data cached
Wrong technique in device usage process	47	17.8 13.5–23.6ROR 18.5 · χ² 730 / p 4e-161	17.7 EB05 13.8 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Injection site mass	26	12.2 8.4–17.9ROR 12.5 · χ² 257 / p 4e-58	11.6 EB05 8.0 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.8	no trial data cached
Injury associated with device	13	11.2 6.5–19.2ROR 11.3 · χ² 111 / p 3e-26	9.6 EB05 5.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Device leakage	27	11.0 7.6–16.0ROR 11.3 · χ² 237 / p 8e-54	10.4 EB05 7.2 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious n=2 · 70% consumer	no trial data cached
Exposure via skin contact	12	9.2 5.2–16.1ROR 9.3 · χ² 80 / p 2e-19	7.5 EB05 4.3 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Injection site swelling	40	9.1 6.7–12.4ROR 9.4 · χ² 283 / p 8e-64	8.6 EB05 6.5 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 26.3 · ♀ 57% (drug 36%)	no trial data cached
Crying	18	8.5 5.4–13.5ROR 8.7 · χ² 113 / p 1e-26	7.4 EB05 4.8 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 2.9	no trial data cached
Drug dose omission by device	37	8.4 6.1–11.5ROR 8.6 · χ² 233 / p 5e-53	7.8 EB05 5.8 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Injection site erythema (redness where injected)	47	6.6 5.0–8.7ROR 6.8 · χ² 219 / p 9e-50	6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.3	no trial data cached
Injection site rash	10	5.7 3.1–10.6ROR 5.7 · χ² 34 / p 2e-9	4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Injection site pruritus	21	5.5 3.6–8.4ROR 5.5 · χ² 72 / p 9e-18	4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.5	no trial data cached
Device breakage	11	4.8 2.7–8.7ROR 4.9 · χ² 30 / p 2e-8	4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injection site haemorrhage	20	4.4 2.8–6.7ROR 4.4 · χ² 49 / p 1e-12	4.0 EB05 2.7 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.6 · 70% consumer	no trial data cached
Injection site bruising	19	4.2 2.7–6.5ROR 4.2 · χ² 43 / p 3e-11	3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.5	no trial data cached
Device difficult to use	15	3.9 2.4–6.5ROR 4.0 · χ² 30 / p 2e-8	3.6 EB05 2.3 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 7.5	no trial data cached
Device issue	19	3.8 2.4–5.9ROR 3.8 · χ² 36 / p 9e-10	3.5 EB05 2.4 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 6.7	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Injection site pain (pain where injected)	789	45.1 43.3–47.0ROR 127.6 · χ² 34,409 / p <1e-300	45.0 EB05 42.4 · IC025 +5.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 31.3	no trial data cached
Injection site erythema (redness where injected)	47	6.6 5.0–8.7ROR 6.8 · χ² 219 / p 9e-50	6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.3	no trial data cached
Wrong technique in device usage process	47	17.8 13.5–23.6ROR 18.5 · χ² 730 / p 4e-161	17.7 EB05 13.8 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Incorrect dose administered by device	46	31.4 23.7–41.7ROR 32.6 · χ² 1,324 / p 4e-290	31.0 EB05 24.2 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious n=7	no trial data cached
Injection site swelling	40	9.1 6.7–12.4ROR 9.4 · χ² 283 / p 8e-64	8.6 EB05 6.5 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 26.3 · ♀ 57% (drug 36%)	no trial data cached
Drug dose omission by device	37	8.4 6.1–11.5ROR 8.6 · χ² 233 / p 5e-53	7.8 EB05 5.8 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Device mechanical issue	36	48.4 35.1–66.8ROR 49.9 · χ² 1,622 / p <1e-300	47.2 EB05 35.6 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Needle issue	34	20.6 14.8–28.7ROR 21.2 · χ² 615 / p 5e-136	20.4 EB05 15.2 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Device delivery system issue	30	19.9 14.0–28.3ROR 20.4 · χ² 520 / p 2e-115	19.6 EB05 14.4 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious n=6	no trial data cached
Device leakage	27	11.0 7.6–16.0ROR 11.3 · χ² 237 / p 8e-54	10.4 EB05 7.2 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious n=2 · 70% consumer	no trial data cached
Injection site mass	26	12.2 8.4–17.9ROR 12.5 · χ² 257 / p 4e-58	11.6 EB05 8.0 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.8	no trial data cached
Injection site pruritus	21	5.5 3.6–8.4ROR 5.5 · χ² 72 / p 9e-18	4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.5	no trial data cached
Injection site haemorrhage	20	4.4 2.8–6.7ROR 4.4 · χ² 49 / p 1e-12	4.0 EB05 2.7 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.6 · 70% consumer	no trial data cached
Device issue	19	3.8 2.4–5.9ROR 3.8 · χ² 36 / p 9e-10	3.5 EB05 2.4 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 6.7	no trial data cached
Injection site bruising	19	4.2 2.7–6.5ROR 4.2 · χ² 43 / p 3e-11	3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.5	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Needle issue — n=34, PRR 20.6
Drug dose omission by device — n=37, PRR 8.4

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Somatrogon-Ghla?

In FDA FAERS, the most frequently co-reported reaction terms for Somatrogon-Ghla are injection site pain, injection site erythema, injection site swelling, drug dose omission by device, needle issue, injection site mass. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Somatrogon-Ghla have an FDA boxed warning?

No. The FDA label retrieved for Somatrogon-Ghla has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Somatrogon-Ghla causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 06dce529-b741-4a1b-8842-3ad77be6e308, effective 20260814; matched on openfda.generic_name.exact:"SOMATROGON-GHLA")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 36 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.