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® (somatropin [rDNA origin] injection) 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
- your health care provider tells you that you have certain types of eye problems caused by diabetes
- you are a child with closed bone growth plates (epiphyses)
- you are allergic to Norditropin® or any of the ingredients in Norditropin® (see the Prescribing Information for a complete list of ingredients in Norditropin®)
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:
- Muscle pain
- Joint stiffness
- High blood sugar (called hyperglycemia)
- Sugar in the urine (called glucosuria)
Serious side effects.
Norditropin® can 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 death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
- return of tumor or cancerous growths
- high blood sugar (hyperglycemia)
- increase in pressure in the skull (intracranial hypertension). If you have headaches, eye problems, nausea or vomiting, swollen hands and feet due to fluid retention contact your health care provider right away.
- serious allergic reactions. Get medical help right away if you have the following symptoms: swelling of your face, lips, mouth or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness or swelling, dizziness or fainting, fast heartbeat or pounding in your chest, or sweating
- decrease in a hormone called cortisol.
- decrease in thyroid hormone levels. Your health care provider will do blood tests to check your thyroid hormone levels.
- hip and knee pain or a limp in children (slipped capital femoral epiphysis)
- worsening of curvature of the spine (scoliosis)
- middle ear infection, hearing problems, or ear problems in people with Turner syndrome
- redness, itching, and tissue weakness in the area of skin you inject
- increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood. Your health care provider may 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.
What should I tell my health care provider before I start Norditropin®? Before you take Norditropin®, tell your health care provider if you:
- have diabetes
- had cancer or any tumor
- have any other medical condition
- are pregnant or plan to become pregnant. It is not known if Norditropin® will harm your unborn baby. Talk to your doctor 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 health care provider should decide if you will take Norditropin® while you breastfeed.
Tell your health care provider about all the medicines you take, including prescription and non-prescription 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.