Skip to Content

Somatropin Side Effects

For the Consumer

Applies to somatropin: powder for solution, solution

Other dosage forms:

Along with its needed effects, somatropin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking somatropin:

More Common

  • Bleeding gums
  • bloating or swelling of the face, arms, hands, ankles, lower legs, or feet
  • burning, numbness, pain, or tingling in all fingers except the smallest finger
  • coughing up blood
  • difficulty with breathing or swallowing
  • difficulty with moving
  • dizziness
  • increased menstrual flow or vaginal bleeding
  • muscle pain or stiffness
  • nosebleeds
  • not able to move
  • pain, swelling, or redness in the joints
  • prolonged bleeding from cuts
  • rapid weight gain
  • red or black, tarry stools
  • red or dark brown urine
  • tingling of the hands or feet
  • unusual weight gain or loss

Rare

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • blurred vision
  • bone pain
  • change in personality
  • change in the ability to see colors, especially blue or yellow
  • changes in vision
  • chills
  • confusion
  • constipation
  • curved spine
  • darkened urine
  • dry mouth
  • fast heartbeat
  • fever
  • flushed, dry skin
  • fracture
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • limp pain in the hip or knee
  • loss of appetite
  • loss of consciousness
  • nausea
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • problems with walking or talking
  • seizures
  • stomachache
  • sweating
  • troubled breathing
  • tumor
  • unusual tiredness or weakness
  • vomiting
  • weakness
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking somatropin:

Symptoms of Overdose

  • Backache
  • excessive sweating
  • extreme weakness
  • increase in hand and foot size
  • increased volume of pale, diluted urine
  • pain in the arms or legs
  • stop in menstruation

Some side effects of somatropin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Large, flat, blue, or purplish patches in the skin
  • unusually warm skin

Rare

  • Increased growth of skin lesions
  • swelling of the breasts or breast soreness in both females and males

For Healthcare Professionals

Applies to somatropin: injectable kit, injectable powder for injection, subcutaneous kit, subcutaneous powder for injection, subcutaneous solution

General

The most common adverse events were glucose intolerance, fluid retention, injection site reactions, and unmasking of latent central hypothyroidism.[Ref]

Other

Very common (10% or more): Otitis media (up to 86.4%), surgical procedure (44.6%), peripheral edema (45.4%), edema (25%), flu syndrome (22.9%), ear disorders (17.6%), peripheral swelling (17.5%), leg edema (15%), pain in extremities (19.3%), pain (13.5%), headache (11.4%)

Common (1% to 10%): Hematoma, fatigue, flu-like symptoms, asthenia, fatigue, generalized edema

Uncommon (0.1% to 1%): Weakness

Frequency not reported: Sudden death, pyrexia, ear infection, influenza-like illness, otitis externa,

Postmarketing reports: Increased blood alkaline phosphatase level[Ref]

Endocrine

Very common (10% or more): IGF-1 scores above 2 standard deviations (38%), hypothyroidism (16%)

Common (1% to 10%): Hypothyroidism

Uncommon (0.1% to 1%): Central precocious puberty

Frequency not reported: Unmasking of latent central hypothyroidism

Postmarketing reports: Decrease in serum thyroxin levels[Ref]

Musculoskeletal

Scoliosis was reported as an adverse event in 5 out of 21 children with Noonan Syndrome who were followed for 11 years.[Ref]

Very common (10% or more): Arthralgia (37.1%), myalgia (30.4%), scoliosis (23.8%), skeletal pain (11%), back pain (10.9%), arthrosis (10.7%)

Common (1% to 10%): Musculoskeletal stiffness, stiffness of extremities, joint stiffness, joint swelling, joint disorder, leg pain, hip pain, progression of preexisting scoliosis,

Uncommon (0.1% to 1%): Localized muscle pain, jaw prominence, slipped capital femoral epiphysis

Frequency not reported: fracture, joint pain, growth attenuation, interference with growth response, excessive growth of hands or feet, exacerbation of preexisting scoliosis, disproportionate growth of the lower jaw, fracture

Postmarketing reports: Legg-Calvé-Perthes disease[Ref]

Metabolic

Very common (10% or more): Impaired fasting glucose (22%), elevated HbA1c (14%), blood glucose increased (13.8%)

Common (1% to 10%): Hyperglycemia, hyperlipidemia, glucose tolerance abnormal, fluid retention, hypertriglyceridemia, overt type II diabetes mellitus

Uncommon (0.1% to 1%): Diabetes mellitus, abnormalities of carbohydrate metabolism (glucose intolerance and high serum HbA1c)

Frequency not reported: Glucose intolerance including impaired glucose tolerance/impaired fasting glucose, increased appetite, transient episodes of fasting blood sugars between 100 and 126 mg/dL, transient episodes of fasting blood sugars exceeding 126 mg/dL, increased fasting blood glucose levels, increases in insulin levels, insulin resistance

Postmarketing reports: Exacerbation of preexisting diabetes mellitus, diabetic ketoacidosis, diabetic coma[Ref]

Nervous system

Intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients.[Ref]

Very common (10% or more): Paresthesia (17.3%), hypoesthesia (15%)

Common (1% to 10%): Hypesthesia, fatigue, carpal tunnel syndrome, Tinel's sign

Uncommon (0.1% to 1%): Benign intracranial hypertension, motor problem, seizure[Ref]

Gastrointestinal

Very common (10% or more): Pharyngitis (14.3%),

Common (1% to 10%): Nausea, gastroenteritis, gastritis

Frequency not reported: Abdominal pain, increased appetite

Postmarketing reports: Pancreatitis[Ref]

Hepatic

Very common (10% or more): AST increased (12.5%)

Common (1% to 10%): ALT increased[Ref]

Hematologic

Very common (10% or more): Eosinophilia (12%)[Ref]

Ocular

Very common (10% or more): Periorbital edema

Frequency not reported: Diabetic retinopathy[Ref]

Respiratory

Very common (10% or more): Upper respiratory infection (15.9%), rhinitis (13.5%)

Common (1% to 10%): Bronchitis, cough increased, laryngitis, respiratory disorder, dyspnea, sleep apnea

Frequency not reported: Influenza, tonsillitis, nasopharyngitis, sinusitis, bronchitis[Ref]

Immunologic

Very common (10% or more): Anti-rhGH antibodies (24%), infection (non-viral) (13%)

Frequency not reported: Antibody formation, anti-periplasmic Escherichia coli peptides (PECP) antibodies[Ref]

An IgG antibody has been identified. No antibodies to the IgE class have been detected. Growth hormone antibody binding capacities less than 2 mg/L have not led to growth attenuation. Testing for antibodies should be carried out in any patient failing to respond to treatment.

Primate studies have failed to reveal evidence of histopathological changes due to immune complex formation.[Ref]

Local

Common (1% to 10%): Injection site pain

Frequency not reported: Injection site reactions/rashes, lipoatrophy, nodules, rash, inflammation, pigmentation, bleeding[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity to solvent (m-cresol/glycerol)

Rare (less than 0.1%): Generalized hypersensitivity reactions

Postmarketing reports: Hypersensitivity[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Frequency not reported: Cardiac disorders[Ref]

Dermatologic

Common (1% to 10%): Increased sweating, excessive number of cutaneous nevi, acne

Uncommon (0.1% to 1%): Pruritus

Rare (less than 0.1%): Rash

Frequency not reported: Hair loss, progression of pigmented nevi, eczema[Ref]

Genitourinary

Common (1% to 10%): Gynecomastia, breast-related adverse reactions (e.g. nipple pain,

gynecomastia, breast pain/mass/tenderness/swelling/edema/hypertrophy)

Frequency not reported: Urinary tract infection[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Frequency not reported: Aggressiveness, altered mood[Ref]

Renal

Uncommon (0.1% to 1%): Glucosuria

Frequency not reported: Hematuria[Ref]

Oncologic

Very rare (less than 0.01%): Leukemia

Frequency not reported: Intracranial tumors including meningiomas, melanocytic nevus[Ref]

References

1. "Product Information. Nutropin (somatropin)." Genentech, South San Francisco, CA.

2. "Product Information. Humatrope (somatropin)." Lilly, Eli and Company, Indianapolis, IN.

3. "Product Information. Serostim (somatropin)." Serono Laboratories Inc, Rockland, MA.

4. "Product Information. Genotropin (somatropin)." Pharmacia and Upjohn, Kalamazoo, MI.

5. "Product Information. Zorbtive (somatropin)." Serono Laboratories Inc, Rockland, MA.

6. "Product Information. Norditropin Cartridge (somatropin)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

7. Cerner Multum, Inc. "Australian Product Information." O 0

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Hide