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Somatropin Side Effects

It is possible that some side effects of somatropin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to somatropin: powder for solution

As well as its needed effects, somatropin may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking somatropin, check with your doctor immediately:

More common
  • Abnormal or decreased touch sensation
  • bleeding after defecation
  • 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
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • changes in skin color
  • cold flu-like symptoms
  • cold hands and feet
  • confusion
  • constipation
  • cough or hoarseness
  • darkened urine
  • decreased urination
  • diarrhea
  • difficult urination
  • dizziness
  • dry mouth
  • fainting or loss of consciousness
  • fast heartbeat
  • fast or irregular breathing
  • feeling unusually cold
  • fever or chills
  • full or bloated feeling
  • general feeling of discomfort or illness
  • headache
  • increase in heart rate
  • itching
  • joint pain
  • light-colored stools
  • lightheadedness
  • loss of appetite
  • lower back or side pain
  • muscle aching or cramping
  • muscle pain or stiffness
  • nausea
  • pain
  • pain, redness, or swelling in the arm or leg
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pressure in the stomach
  • rapid, shallow breathing
  • rapid weight gain
  • rectal bleeding
  • runny nose
  • shivering
  • skin rash
  • sneezing
  • sore mouth or tongue
  • sore throat
  • stomach bloating, burning, cramping, or pain
  • sudden decrease in the amount of urine
  • sweating
  • swelling of the abdominal or stomach area
  • swelling of the eyes or eyelids
  • swelling or puffiness of the face
  • swollen joints
  • thirst
  • tightness in the chest and/or wheezing
  • tingling of the hands or feet
  • trouble with breathing
  • trouble with sleeping
  • uncomfortable swelling around the anus
  • unpleasant breath odor
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting
  • vomiting of blood
  • white patches in the mouth, tongue, or throat
  • wrinkled skin
  • yellow eyes or skin
Less common
  • Bone or skeletal pain
  • burning, numbness, pain, or tingling in all fingers except smallest finger
  • chest pain
  • depressed mood
  • dry skin and hair
  • feeling cold
  • hair loss
  • hoarseness or husky voice
  • slowed heartbeat
  • swelling of the ankles

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

Symptoms of Overdose
  • Anxiety
  • blurred vision
  • changes in vision
  • cold sweats
  • coma
  • cool, pale skin
  • decrease in the amount of urine
  • depression
  • excessive sweating
  • extreme weakness
  • flushed, dry skin
  • frequent urination
  • fruit-like breath odor
  • increase in hands and feet size
  • increased hunger
  • increased thirst
  • increased urination
  • increased volume of pale, diluted urine
  • nightmares
  • noisy, rattling breathing
  • pain in the arms or legs
  • seizures
  • shakiness
  • shortness of breath
  • slurred speech
  • stop in menstruation
  • swelling of the fingers or hands
  • troubled breathing at rest

Some somatropin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Body aches or pain
  • breast pain
  • change in the color, amount, or odor of vaginal discharge
  • congestion
  • discoloration of the fingernails or toenails
  • dryness or soreness of the throat
  • excess air or gas in the stomach or intestines
  • frequent urge to defecate
  • increased sweating
  • passing gas
  • rash
  • sneezing
  • straining while passing stool
  • stuffy nose
  • tender, swollen glands in neck
  • trouble with swallowing
  • voice changes
Less common
  • Discouragement
  • feeling sad or empty
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • sleeplessness
  • tiredness
  • trouble concentrating
  • unable to sleep

For Healthcare Professionals

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

General

Somatropin is generally well tolerated with minimal adverse effects.

Oncologic

Oncologic side effects have included rare reports of leukemia, however, the association with human growth hormone is uncertain.

Immunologic

Immunologic adverse reactions have included the rare development of persistent antibodies in patients treated with recombinant human growth hormone. The development of antibodies may be greater with the use of somatrem than with somatropin, although the overall incidence is very low.

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.

Nervous system

Nervous system effects have included headaches, weakness, paresthesia and hypethesia.

Musculoskeletal

Musculoskeletal side effects have included localized muscle pain, carpal tunnel syndrome, aggravation of preexisting scoliosis, jaw prominence and slipped capital femoral epiphysis. Patients with Short Stature Homeobox Containing Gene (SHOX) Deficiency have reported scoliosis and arthralgia.

Endocrine

Endocrine side effects have included mild hyperglycemia, gynecomastia, and, rarely pancreatitis. New-onset type 2 diabetes mellitus in children and adults has been reported in postmarketing experience. Elevations in IGF-1 (insulin like growth factor 1) and insulin levels have occurred consistently in adults. Alterations in thyroid hormone metabolism may occur.

Serum levels of inorganic phosphorus, alkaline phosphatase and parathyroid hormone (PTH) may increase during treatment with somatropin. The mechanism is unknown. These potential changes should be considered when evaluating patient laboratory measurements.

During postmarketing surveillance, cases of new onset glucose intolerance, diabetes mellitus and exacerbations of preexisting diabetes mellitus have been reported in patients receiving the Serostim brand of somatropin. Some patients developed ketoacidosis and diabetic coma. In some patients, these conditions improved when Serostim was discontinued but not in all patients.

Cardiovascular

Edema occurs more often in adults, appears to be dose-related, and is due to the antinatriuretic effect of growth hormone.

Cardiovascular side effects have included mild, transient, peripheral edema in up to 2.5% of patients during early treatment with somatropin. Intracranial hypertension is a rare effect that may present with papilledema, visual changes, headache, nausea and vomiting. Postmarketing reports have included hypertension.

Other

Athletes using human growth hormone for doping purposes may experience cardiac, renal, and splenic hypertrophy, cardiac myopathy, fluid retention, glucose intolerance, abnormal bone growth, and an increased risk of cancers.

Chronic use of human growth hormone by athletes can lead to toxicity seen in acromegaly.

There is no risk of acquiring Creutzfeldt-Jakob disease from recombinant human growth hormone, as with the previously marketed pituitary derived human growth hormone.

Dermatologic

Dermatologic side effects have included rash, pruritus, increased sweating and increased growth of preexisting nevi (hereditary malformation of the skin). Patients with Short Stature Homeobox Containing Gene (SHOX) Deficiency have reported excessive number of cutaneous nevi.

Metabolic

Metabolic side effects have included mild transient hyperglycemia and lipolysis in adults which resulted in a statistically significant decrease in total body fat (14% to 20%) and a significant reductions in total cholesterol and/or LDL levels. No changes in HDL have been observed. Elderly patients have exhibited triglyceride elevations. The long-term effect of recombinant human growth hormone on lipid metabolism is unknown.

Local

Local side effects have included localized injection site reactions and pain.

Other

Other side effects have included an increased incidence of otitis media and other ear disorders in Turner syndrome patients. Other side effects reported in Turner syndrome patients have included influenza-like illness, upper respiratory tract infection, eczema, excessive growth of hands and feet, and exacerbation of preexisting scoliosis.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea and vomiting.

Hypersensitivity

Hypersensitivity side effects have included allergic reactions.

Respiratory

Respiratory side effects have included rhinitis, bronchitis and upper respiratory tract infections. Postmarketing reports have included dyspnea and sleep apnea.

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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