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Generic Name: somatropin (rdna origin - refrigerated) (SOE-ma-TROE-pin)
Brand Name: Examples include Norditropin and Omnitrope

Norditropin is used for:

Treating certain children or adults whose bodies do not produce enough growth hormone. It may also be used for other conditions as determined by your doctor.

Norditropin is a growth hormone. It works by stimulating growth in patients who do not make enough natural growth hormone.

Do NOT use Norditropin if:

  • you are allergic to any ingredient in Norditropin
  • you have active or recurring cancer or brain tumor, or you currently receive treatment for cancer
  • you have severe breathing problems (eg, respiratory failure) or serious illness caused by complications from surgery or injury
  • you have a certain type of eye problem caused by diabetes (diabetic retinopathy)
  • the patient is a child who has Prader-Willi syndrome and is severely overweight or has severe breathing problems (eg, respiratory infection, history of airway blockage or sleep apnea)
  • the patient is a child who has epiphyseal closure (bone growth is complete)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Norditropin:

Some medical conditions may interact with Norditropin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are allergic to phenol
  • if you have a history of kidney or liver problems, lung or breathing problems (eg, airway blockage, respiratory infection, sleep apnea), an underactive thyroid, heart problems, high blood pressure, ear or hearing problems (eg, repeated ear infections), pancreas problems, or endocrine problems (eg, pituitary or adrenal gland problems)
  • if you have a history of diabetes or high blood sugar levels, or if a member of your family has had diabetes
  • if you have a history of leukemia, other types of cancer, or any unusual growths or tumors (especially in the brain)
  • if you have curvature of the spine (scoliosis), Prader-Willi syndrome, or a certain eye problem called papilledema (swelling of the area around your optic nerve)
  • if you are very overweight or have had recent major surgery or injury

Some MEDICINES MAY INTERACT with Norditropin. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Corticosteroids (eg, prednisone) or estrogens because they may decrease Norditropin's effectiveness
  • Anticonvulsants (eg, carbamazepine) or cyclosporine because the risk of their side effects may be increased by Norditropin
  • Insulin or other medicines for diabetes because their effectiveness may be decreased by Norditropin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Norditropin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Norditropin:

Use Norditropin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Norditropin. Talk to your pharmacist if you have questions about this information.
  • Norditropin is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Norditropin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do NOT shake Norditropin. If mixing is required, swirl gently.
  • Norditropin should be clear and colorless. Do not use Norditropin if it contains particles, is cloudy or discolored, or if the container is cracked or damaged.
  • Be sure to rotate your injection site as directed to help avoid thickening or hardening of the skin.
  • Do not share pen or cartridge devices with another person. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Norditropin, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Norditropin.

Important safety information:

  • Severe and sometimes fatal lung and breathing problems have occurred with the use of Norditropin in certain children with Prader-Willi syndrome. These children were usually either very overweight or had severe breathing problems (eg, airway blockage, sleep apnea, lung or airway infection). The risk may be greater in boys. Children with Prader-Willi syndrome should have certain breathing tests before they start Norditropin. They should be monitored for signs of lung or airway infection. They should also have an effective form of weight control. Contact the doctor at once if the patient develops irregular breathing during sleep, new or increased snoring, or symptoms of lung or airway infection (eg, fever, coughing, sore throat, shortness of breath, chest pain or discomfort).
  • Pancreas inflammation (pancreatitis) has been reported rarely in patients who take Norditropin. The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop stomach or back pain.
  • An increased risk of a second cancer has been seen in patients that had certain types of cancer as a child and received Norditropin to treat the lack of growth hormone. Discuss any questions or concerns with your doctor.
  • Rarely, children using Norditropin have experienced a slipped growth plate in the hip. Contact the doctor right away if the patient develops hip or knee pain or a limp.
  • Rarely, increased pressure in the head has been reported in patients using somatropin. The risk may be greater in patients with Turner syndrome or Prader-Willi syndrome. Symptoms usually occurred within the first 8 weeks after the start of treatment. The symptoms have gone away after the dose was lowered or treatment was stopped. Discuss any questions or concerns with your doctor. Contact your doctor right away if you develop symptoms such as vision changes or severe headache, nausea, or vomiting.
  • Norditropin may contain benzyl alcohol or phenol. Tell your doctor if you have ever had an allergic reaction to benzyl alcohol or phenol.
  • Norditropin may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Norditropin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including blood sugar levels, thyroid function, and eye exams, may be performed while you use Norditropin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Norditropin with caution in the ELDERLY; they may be more sensitive to its effects.
  • Norditropin may have benzyl alcohol in it. Do not use medicine that contains benzyl alcohol in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Norditropin while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Norditropin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Norditropin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; headache; increased sweating; mild flu-like symptoms; mild swelling (eg, of the hands or feet); muscle or joint pain; redness or itching at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast enlargement in males; burning, tingling, or numbness; change in appearance or size of a mole; chest pain or discomfort; confusion; ear pain, discharge, or discomfort; fever; hearing problems; hip or knee pain; limp; nausea or vomiting; new growth on the skin; one-sided weakness; persistent or severe cough or sore throat; severe or persistent muscle or joint pain; severe or persistent stomach or back pain; severe or persistent swelling of the hands, ankles, or feet; shortness of breath; slurred speech; snoring or irregular breathing during sleep; sudden, severe, or persistent headache or dizziness; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); thickened or hardened skin at the injection site; trouble breathing; unusual bruising; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include swelling of the hands, ankles, or feet; symptoms of high or low blood sugar (eg, dizziness; fainting; fast breathing; fast heartbeat; flushing; increased sweating; increased thirst, hunger, or urination; vision changes; unusual weakness).

Proper storage of Norditropin:

Store new (unopened) cartridges and prefilled pens in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Do not use Norditropin past the expiration date on the product label.

Store used (open) cartridges and prefilled pens as directed in the extra patient leaflet or by your health care provider. Be sure you know how long you can use your cartridge or prefilled pen after it is opened.

Contact your pharmacist if you have any questions about how to properly store Norditropin. Keep Norditropin out of the reach of children and away from pets.

General information:

  • If you have any questions about Norditropin, please talk with your doctor, pharmacist, or other health care provider.
  • Norditropin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Norditropin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Norditropin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Norditropin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Norditropin.

Issue Date: June 3, 2015