Mecasermin side effects: what 806 FDA adverse event reports show

Mecasermin · Increlex · 26 reaction terms · 387 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Increlex

openFDA label

Who reports

806 reports · 53% serious · 24 with death outcome · 34% female

openFDA FAERS counts, all years, deduplication not applied

Used for

INCRELEX (mecasermin) injection is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with severe primary IGF-1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. ( 1 ) Limitations of use: INCRELEX is not a substitute to GH for approved GH indications.

FDA label, Indications and Usage

What it is

Mecasermin is a human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology. IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 Da. The amino acid sequence of the product is identical to that of endogenous human IGF-1.

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 19 strongest signals

Labeled adverse reaction 2Labeled (related wording) 9Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 5

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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 7 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
Hypoglycaemia (low blood sugar)	62	33.1 26.1–42.1ROR 35.8 · χ² 1,903 / p <1e-300	32.8 EB05 26.5 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 32.5 · 96% clinician	no trial data cached
Injection site urticaria	21	22.5 14.7–34.3ROR 23.0 · χ² 409 / p 2e-91	22.0 EB05 15.1 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious n=4	no trial data cached
Pharyngitis streptococcal	9	21.6 11.3–41.3ROR 21.8 · χ² 156 / p 3e-36	20.1 EB05 10.4 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Hair texture abnormal	11	21.1 11.8–38.0ROR 21.4 · χ² 191 / p 8e-44	20.1 EB05 11.4 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Blood glucose decreased	36	19.4 14.1–26.7ROR 20.2 · χ² 610 / p 6e-135	19.2 EB05 14.4 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.4	no trial data cached
Increased appetite	9	12.4 6.5–23.8ROR 12.5 · χ² 83 / p 3e-20	10.1 EB05 4.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 3.9	no trial data cached
Injection site induration	6	12.0 5.4–26.6ROR 12.1 · χ² 50 / p 8e-13	8.5 EB05 3.5 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious n=5	no trial data cached
Eyelid oedema	5	11.1 4.6–26.5ROR 11.1 · χ² 36 / p 8e-10	7.1 EB05 2.9 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Injection site pruritus	25	9.7 6.6–14.3ROR 10.0 · χ² 188 / p 4e-43	8.9 EB05 6.1 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 20.8	no trial data cached
Hunger	5	9.6 4.0–23.1ROR 9.7 · χ² 31 / p 2e-8	6.1 EB05 2.6 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Crying	11	7.8 4.3–14.1ROR 7.9 · χ² 59 / p 8e-15	6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 1.3	no trial data cached
Blood glucose abnormal	5	7.0 2.9–16.8ROR 7.0 · χ² 20 / p 4e-6	4.6 EB05 2.1 · IC025 +0.6 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Injection site mass	9	6.3 3.3–12.1ROR 6.4 · χ² 35 / p 1e-9	4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.1	no trial data cached
Drug dose omission	40	6.2 4.6–8.4ROR 6.5 · χ² 170 / p 4e-39	5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 13.7	no trial data cached
Injection site bruising	16	5.3 3.2–8.5ROR 5.3 · χ² 51 / p 4e-13	4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.8	no trial data cached
Injection site erythema (redness where injected)	24	5.0 3.4–7.5ROR 5.2 · χ² 74 / p 4e-18	4.6 EB05 3.3 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.7	no trial data cached
Inappropriate schedule of drug administration	14	5.0 3.0–8.5ROR 5.1 · χ² 41 / p 6e-11	4.4 EB05 2.8 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.1	no trial data cached
Injection site swelling	14	4.8 2.8–8.1ROR 4.9 · χ² 38 / p 3e-10	4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.8	no trial data cached
Injection site pain (pain where injected)	41	3.5 2.6–4.7ROR 3.6 · χ² 72 / p 1e-17	3.4 EB05 2.6 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 1.2	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
Hypoglycaemia (low blood sugar)	62	33.1 26.1–42.1ROR 35.8 · χ² 1,903 / p <1e-300	32.8 EB05 26.5 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 32.5 · 96% clinician	no trial data cached
Injection site pain (pain where injected)	41	3.5 2.6–4.7ROR 3.6 · χ² 72 / p 1e-17	3.4 EB05 2.6 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 1.2	no trial data cached
Drug dose omission	40	6.2 4.6–8.4ROR 6.5 · χ² 170 / p 4e-39	5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 13.7	no trial data cached
Blood glucose decreased	36	19.4 14.1–26.7ROR 20.2 · χ² 610 / p 6e-135	19.2 EB05 14.4 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.4	no trial data cached
Injection site pruritus	25	9.7 6.6–14.3ROR 10.0 · χ² 188 / p 4e-43	8.9 EB05 6.1 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 20.8	no trial data cached
Injection site erythema (redness where injected)	24	5.0 3.4–7.5ROR 5.2 · χ² 74 / p 4e-18	4.6 EB05 3.3 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.7	no trial data cached
Injection site urticaria	21	22.5 14.7–34.3ROR 23.0 · χ² 409 / p 2e-91	22.0 EB05 15.1 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious n=4	no trial data cached
Injection site bruising	16	5.3 3.2–8.5ROR 5.3 · χ² 51 / p 4e-13	4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.8	no trial data cached
Injection site swelling	14	4.8 2.8–8.1ROR 4.9 · χ² 38 / p 3e-10	4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.8	no trial data cached
Inappropriate schedule of drug administration	14	5.0 3.0–8.5ROR 5.1 · χ² 41 / p 6e-11	4.4 EB05 2.8 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.1	no trial data cached
Crying	11	7.8 4.3–14.1ROR 7.9 · χ² 59 / p 8e-15	6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 1.3	no trial data cached
Hair texture abnormal	11	21.1 11.8–38.0ROR 21.4 · χ² 191 / p 8e-44	20.1 EB05 11.4 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Injection site mass	9	6.3 3.3–12.1ROR 6.4 · χ² 35 / p 1e-9	4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.1	no trial data cached
Increased appetite	9	12.4 6.5–23.8ROR 12.5 · χ² 83 / p 3e-20	10.1 EB05 4.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 3.9	no trial data cached
Pharyngitis streptococcal	9	21.6 11.3–41.3ROR 21.8 · χ² 156 / p 3e-36	20.1 EB05 10.4 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Mecasermin?

In FDA FAERS, the most frequently co-reported reaction terms for Mecasermin are hypoglycaemia, injection site pain, blood glucose decreased, injection site pruritus, injection site erythema, injection site urticaria. 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 Mecasermin have an FDA boxed warning?

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

Do FAERS signals prove that Mecasermin 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 a8b27a1b-a611-4f91-ad22-76d4b390c3ae, effective 20250805; matched on openfda.generic_name.exact:"MECASERMIN")
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, 26 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.