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Increlex Side Effects

Generic Name: mecasermin

Note: This page contains information about the side effects of mecasermin. Some of the dosage forms included on this document may not apply to the brand name Increlex.

Not all side effects for Increlex may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to mecasermin: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by mecasermin (the active ingredient contained in Increlex). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking mecasermin:

More common
  • Anxiety
  • bluish skin color of the fingertips
  • blurred vision
  • breathlessness
  • chest pain
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • depression
  • dizziness
  • fast heartbeat
  • headache
  • increased hunger
  • loss of hearing
  • nausea
  • nervousness
  • nightmares
  • rapid growth of normal cells of the thymus (no symptoms)
  • seizures
  • shakiness
  • slurred speech
  • thickening of the skin
  • unusual tiredness or weakness
Incidence not known
  • Change in the ability to see colors, especially blue or yellow
  • cough
  • difficult or labored breathing
  • difficulty with swallowing
  • hives or welts
  • itching
  • itching or hives at the injection site
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • limp
  • pain in the hip or knee
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • shortness of breath
  • skin rash
  • tightness in the chest
  • vomiting
  • wheezing

If any of the following symptoms of overdose occur while taking mecasermin, get emergency help immediately:

Symptoms of overdose
  • Anxiety
  • arm or leg pain
  • backache
  • changes in vision
  • excessive sweating
  • extreme weakness
  • frequent urination
  • increase in hands and feet size
  • increased thirst
  • increased volume of pale, diluted urine
  • joint pain
  • stop in menstruation

Some of the side effects that can occur with mecasermin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abnormal response of the tympanic membrane to air pressure
  • difficulty with moving
  • difficulty with swallowing
  • ear pain
  • earache
  • large, flat, blue or purplish patches in the skin
  • muffled hearing
  • muscle pain or stiffness
  • redness or swelling in the ear
  • sense of fullness in the ear
  • snoring
  • sore throat
  • voice changing

For Healthcare Professionals

Applies to mecasermin: subcutaneous solution


The most common adverse events were hypoglycemia, injection site hypertrophy, snoring, hypoacusis, headache, and tonsillar hypertrophy.[Ref]


Very common (10% or more): Hypoglycemia (47%)
Common (1% to 10%): Hypoglycemic seizure, hyperglycemia, hyperlipidemia, obesity, increased weight[Ref]


Very common (10% or more): Injection site hypertrophy (32%)
Common (1% to 10%): Injection site pain, injection site bruising, injection site fibrosis, injection site reaction, injection site swelling, injection site induration, injection site pigmentation changes
Postmarketing reports: Pruritus, urticaria, injection site reactions (e.g. erythema, pain, hematoma, hemorrhage, induration, rash, swelling)[Ref]


Very common (10% or more): Hypoacusis (20%), febrile infection, otitis media, serous otitis media, chronic otitis media serous, otitis externa, ear infection
Common (1% to 10%): Fluid in middle ear, ear pain, abnormal tympanometry, ear tube insertion, otorrhea, ear disorder, middle ear disorder, tympanic membrane disorder, ear congestion, Mucosal membrane hyperplasia, hypertrophy, mucosal edema, asthenia, chest discomfort, abnormal tympanometry, adenotonsillectomy, adenoidectomy, ear tube insertion
Frequency not reported: Elevations in cholesterol, elevations in triglycerides[Ref]


Very common (10% or more): Snoring (22%), tonsillar hypertrophy (16%), upper respiratory tract infection, pharyngitis, tonsillitis
Common (1% to 10%): Tonsillectomy/adenoidectomy, obstructive sleep apnea, adenoidal hypertrophy, nasal turbinate hypertrophy, dyspnea, nasal mucosal disorder, obstructive airway disorder, abnormal respiration, nasal congestion, mouth breathing[Ref]

Nervous system

Very common (10% or more): Headache (18%)
Common (1% to 10%): Intracranial hypertension, dizziness, convulsions, febrile convulsion, benign intracranial hypertension, loss of consciousness, sleep apnea syndrome, dizziness, tremor, restless leg syndrome, lethargy[Ref]


Very common (10% or more): Anti-IGF-1 antibodies (up to 61%), thymus hypertrophy[Ref]


Common (1% to 10%): Cardiac murmur, cardiomegaly, ventricular hypertrophy, atrial hypertrophy, tachycardia, tachycardia paroxysmal, mitral valve incompetence, tricuspid valve incompetence, abnormal echocardiogram
Frequency not reported: Cardiomegaly/valvulopathy[Ref]


Tonsillar hypertrophy appears to occur more frequently in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years.[Ref]

Very common (10% or more): Oral candidiasis
Common (1% to 10%): Vomiting, retching, abdominal pain, upper abdominal pain, abdominal distension, dysphagia[Ref]


Common (1% to 10%): Lipohypertrophy, bruising, skin hypertrophy, acrochordons, abnormal hair texture, pigmented nevus
Frequency not reported: Thickening of the soft tissues of the face
Postmarketing reports: Alopecia, hair texture abnormal[Ref]


Common (1% to 10%): Increased alanine aminotransferase, increased aspartate aminotransferase
Frequency not reported: Elevated AST, elevated LDH, elevated ALT[Ref]


Common (1% to 10%): Local and/or systemic hypersensitivity
Postmarketing reports: Anaphylaxis, local allergic reactions, generalized urticaria, angioedema, dyspnea[Ref]


Common (1% to 10%): Lymphadenopathy[Ref]


Common (1% to 10%): Arthralgia, pain in extremity, myalgia, scoliosis, spinal deformity, soft tissue disorder, muscle cramp, flank pain, musculoskeletal stiffness, congenital jaw malformation
Postmarketing reports: Osteonecrosis/avascular necrosis (occasionally associated with slipped capital femoral epiphysis)[Ref]


Common (1% to 10%): Nephrolithiasis, hydronephrosis, renal colic
Frequency not reported: Renal and splenic length increased rapidly[Ref]


Common (1% to 10%): Papilledema, reduced visual acuity, myopia[Ref]


Common (1% to 10%): Gynecomastia, ovarian cyst[Ref]


Common (1% to 10%): Depression, sleep terror, nervousness, abnormal behavior, disorientation[Ref]


1. "Product Information. Increlex (mecasermin)." Tercica Inc, Brisbane, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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