Straight talk about safety.
For parents, and for Novo Nordisk, safety is always a top priority. We’ve spelled out some key facts about the safety and side effects of Norditropin® to help you and your doctor make the right decision about growth hormone therapy.
We’ve studied it extensively.
The safety of growth hormone treatment, and the safety profile of Norditropin®, have been established in many clinical studies. In fact, one of our studies followed pediatric patients for up to 13 years. We don’t stop there; following US Food and Drug Administration (FDA) approval, we continue to review new data as it arises, including analyzing studies done in other countries.
Some people should not use Norditropin®.
It’s important to realize that Norditropin® is not for everyone. You should not use Norditropin® if:
- you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems
- you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea
- you have cancer or other tumors
- you are allergic to somatropin or any of the ingredients in Norditropin® (see the Prescribing Information for a complete list of ingredients in Norditropin®)
- your health care provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy)
- you are a child with closed bone growth plates (epiphyses)
See the complete list of side effects and contraindications in the Prescribing Information.
For more information, talk to your health care provider or pharmacist.
Common side effects.
Knowing what to look for will help you identify growth hormone side effects if they should arise. The most common side effects of Norditropin® include:
- Injection site reactions and rashes
Serious side effects.
Norditropin® may cause serious side effects, including:
- high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems
- high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
- increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your or your child’s health care provider will need to monitor you or your child for a return of cancer or a tumor. Contact the health care provider if you or your child starts to have headaches, or have changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of your skin.
- new or worsening high blood sugar (hyperglycemia) or diabetes. Your or your child’s blood sugar may need to be monitored during treatment with Norditropin®.
- increase in pressure in the skull (intracranial hypertension). If you or your child has headaches, eye problems, nausea or vomiting, contact the health care provider.
- serious allergic reactions. Get medical help right away if you or your child has the following symptoms:
- swelling of your face, lips, mouth, or tongue
- trouble breathing
- severe itching
- skin rashes, redness, or swelling
- dizziness or fainting
- fast heartbeat or pounding in your chest
- your body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Fluid retention can happen in adults during treatment with Norditropin®. Tell your health care provider if you have any of these signs or symptoms of fluid retention.
- decrease in a hormone called cortisol. The health care provider will do blood tests to check your or your child’s cortisol levels. Tell your or your child’s health care provider if you or your child has darkening of the skin, severe fatigue, dizziness, weakness, or weight loss.
- decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well Norditropin® works. The health care provider will do blood tests to check your or your child’s thyroid hormone levels.
- hip and knee pain or a limp in children (slipped capital femoral epiphysis)
- worsening of curvature of the spine (scoliosis)
- severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child’s health care provider if you or your child has any new abdominal pain.
- loss of fat and tissue weakness in the area of skin you inject. Talk to your health care provider about rotating the areas where you inject Norditropin®.
- increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your or your child’s health care provider will do blood tests to check this.
There are other possible side effects, too. See the complete list in the Prescribing Information. For more information, talk to your health care provider or pharmacist.
Side Effects: You may report side effects to the FDA at 1-800-332-1088. You may also report side effects to Novo Nordisk at 1-888-NOVO-444 (1-888-668-6444).
What to tell your doctor.
Before taking Norditropin®, tell your healthcare provider about all of your medical conditions, including if you:
- have had heart or stomach surgery, trauma or serious breathing (respiratory) problems.
- have had a history of problems breathing while you sleep (sleep apnea).
- have or have had cancer or any tumor.
- have diabetes.
- are pregnant or plan to become pregnant. It is not known if Norditropin® will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if Norditropin® passes into your breast milk. You and your healthcare provider should decide if you will take Norditropin® while you breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Norditropin® may affect how other medicines work, and other medicines may affect how Norditropin® works.
Read about all of the risk factors in the Prescribing Information, and talk with your health care provider about these or any other concerns you may have. Be sure to tell your doctor if your child has any serious medical conditions or is taking any other medications.