Omnitrope Side Effects
Generic Name: somatropin
Note: This document contains side effect information about somatropin. Some of the dosage forms listed on this page may not apply to the brand name Omnitrope.
Some side effects of Omnitrope may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to somatropin: powder for solution
Other dosage forms:
Along with its needed effects, somatropin (the active ingredient contained in Omnitrope) 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
- 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
- cough or hoarseness
- darkened urine
- decreased urination
- difficult urination
- 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
- increase in heart rate
- joint pain
- light-colored stools
- loss of appetite
- lower back or side pain
- muscle aching or cramping
- muscle pain or stiffness
- 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
- skin rash
- sore mouth or tongue
- sore throat
- stomach bloating, burning, cramping, or pain
- sudden decrease in the amount of urine
- swelling of the abdominal or stomach area
- swelling of the eyes or eyelids
- swelling or puffiness of the face
- swollen joints
- 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 of blood
- white patches in the mouth, tongue, or throat
- wrinkled skin
- yellow eyes or skin
- 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
Get emergency help immediately if any of the following symptoms of overdose occur while taking somatropin:Symptoms of Overdose
- blurred vision
- changes in vision
- cold sweats
- cool, pale skin
- decrease in the amount of urine
- 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
- noisy, rattling breathing
- pain in the arms or legs
- shortness of breath
- slurred speech
- stop in menstruation
- swelling of the fingers or hands
- troubled breathing at rest
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
- Body aches or pain
- breast pain
- change in the color, amount, or odor of vaginal discharge
- 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
- straining while passing stool
- stuffy nose
- tender, swollen glands in neck
- trouble with swallowing
- voice changes
- feeling sad or empty
- lack of appetite
- loss of interest or pleasure
- 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
Somatropin (the active ingredient contained in Omnitrope) is generally well tolerated with minimal adverse effects.
Oncologic side effects have included rare reports of leukemia, however, the association with human growth hormone is uncertain.
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 (the active ingredient contained in Omnitrope) 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 effects have included headaches, weakness, paresthesia and hypethesia.
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 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.
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.
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 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 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 side effects have included localized injection site reactions and pain.
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 side effects have included diarrhea, nausea and vomiting.
Hypersensitivity side effects have included allergic reactions.
Respiratory side effects have included rhinitis, bronchitis and upper respiratory tract infections. Postmarketing reports have included dyspnea and sleep apnea.
More about Omnitrope (somatropin)
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