What the label lists and what reports show
Mecasermin side effects
Mecasermin's FDA label lists its adverse reactions in its own words. FAERS holds 809 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (68 reports).
- No generic listed
Check it at the source: the mecasermin FDA label on DailyMed (effective August 5, 2025); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of INCRELEX?INCRELEX may cause serious side effects, including: Low blood sugar (hypoglycemia). INCRELEX may lower blood sugar levels. It is important to only give your child INCRELEX 20 minutes before or 20 minutes after a meal or snack to reduce the chances of low blood sugar. Do not give your child INCRELEX if your child cannot eat. Signs of low blood sugar include: dizziness tiredness restlessness hunger irritability trouble concentrating sweating nausea fast or irregular heartbeat Severe hypoglycemia may cause unconsciousness, seizures, or death. If your child receives INCRELEX, they should avoid participating in high risk activities (e.g. driving, exercise, etc.) within 2 to 3 hours after the INCRELEX injection, especially at the beginning of INCRELEX treatment. Before beginning treatment with INCRELEX your child's doctor or nurse will explain to you how to treat hypoglycemia. […]
Source: FDA drug label, Ipsen Biopharmaceuticals, Inc., effective August 5, 2025 (SPL set a8b27a1b-a611-4f91-ad22-76d4b390c3ae), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following serious adverse reactions are described below and elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions (5.1) ]. Hypersensitivity and Allergic Reactions, including Anaphylaxis [see Warnings and Precautions (5.2) ] Intracranial hypertension (IH) [see Warnings and Precautions (5.3) ] Tonsillar and Adenoidal Hypertrophy and related complications [see Warnings and Precautions (5.4) ] Slipped Capital Femoral Epiphysis [see Warnings and Precautions (5.5) ] Progression of Preexisting Scoliosis [see Warnings and Precautions (5.6) ] Malignant Neoplasia [see Warnings and Precautions (5.7) ] Benzyl Alcohol [see Warnings and Precautions (5.8) ] Common INCRELEX-related adverse reactions in clinical trials include: hypoglycemia, local and systemic hypersensitivity, tonsillar hypertrophy ( 6.1 ). …
Source: FDA drug label, Ipsen Biopharmaceuticals, Inc., effective August 5, 2025 (SPL set a8b27a1b-a611-4f91-ad22-76d4b390c3ae), via openFDA; the full label on DailyMed
What do FAERS reports show?
809 reports list mecasermin among the medicines taken, 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. Of the 19 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Mecasermin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions