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Prescription medicine

Mecasermin Brand names: Increlex

Mecasermin (Increlex) is a prescription medicine. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the mecasermin FDA label on DailyMed (effective August 5, 2025); every mecasermin label on DailyMed.

Highlights of the record

FDA label of August 5, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

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.

Forms and strengths

  • 40 mg/4ml

Injection (solution); injection.

On the market

Generic approvals
No generic approved
Labelers listed (NDC)
2 of which 0 under generic applications, 2 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
809 through July 30, 2026

What is mecasermin used for?

From the label: indications and usage

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. Severe Primary IGF-1 Deficiency (Primary IGFD) INCRELEX is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with: severe primary IGF-1 deficiency or growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. […]

Source: FDA drug label (Increlex), Ipsen Biopharmaceuticals, Inc., effective August 5, 2025 (SPL set a8b27a1b-a611-4f91-ad22-76d4b390c3ae), via openFDA; the full label on DailyMed

Is there a generic for mecasermin (Increlex)?

No generic mecasermin is approved (Drugs@FDA, October 8, 2026).

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for mecasermin?

The FDA Adverse Event Reporting System holds 809 reports that list mecasermin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 24 are coded as a death and 219 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Off Label Use (a use or a product term, not a reaction)132
  • Headache (named in the label)68
  • Hypoglycaemia (named in the label)62
  • Vomiting (named in the label)44
  • Injection Site Pain41
  • Drug Dose Omission (a use or a product term, not a reaction)40
  • Blood Glucose Decreased36
  • Pyrexia36

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Mecasermin side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other