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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 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 hands and feet size
  • increased volume of pale, diluted urine
  • pain in extremities
  • 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. Zorbtive (somatropin)." Serono Laboratories Inc, Rockland, MA.

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

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

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

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

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

Some side effects of somatropin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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