Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Omnitrope (Somatropin). If you are concerned about side effects, discuss the risks and benefits of Omnitrope (Somatropin) with your doctor.

The following side effects have been reported by at least 1% of people taking Omnitrope (Somatropin). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Carpal Tunnel Syndrome
• headache
• joint pain
• muscle pain
• pain and swelling at site of injection
• swelling of hands, feet, or lower legs
• unusual tiredness or weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• a limp
• numbness, tingling or pain in the arms, legs or face
• pain in hip or knee
• signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of Hypothyroidism (e.g., Constipation, dry skin, cold intolerance, weight gain)
• skin rash or itching
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• vision problems

Stop taking the medication and seek immediate medical attention if any of the following occur:

• severe or frequent Headaches with nausea and vomiting or vision problems
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, Fever, chills, rapid heartbeat, swollen abdomen)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Omnitrope (Somatropin).

Vial

Each vial of sterile lyophilized powder for reconstitution contains 5.8 mg of Omnitrope (Somatropin). Nonmedicinal ingredients: glycine, disodium hydrogen phosphate heptahydrate and sodium dihydrogen phosphate dehydrate. Diluent contains bacteriostatic water for injection, benzyl alcohol (as preservative).

Pen cartridge

5 mg/1.5 mL
Each 1.5 mL pen cartridge contains 5 mg of Omnitrope (Somatropin) (15 IU/1.5 mL). Nonmedicinal ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, poloxamer 188, benzyl alcohol, mannitol, and water for injection. Phosphoric acid and/or sodium hydroxide may have been used to adjust pH.

10 mg/1.5 mL
Each 1.5 mL pen cartridge contains 10 mg of Omnitrope (Somatropin) (30 IU/1.5 mL). Nonmedicinal ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, poloxamer 188, phenol, glycine, and water for injection. Phosphoric acid and/or sodium hydroxide may have been used to adjust pH.

15 mg/1.5 mL
Each 1.5 mL pen cartridge contains 15 mg of Omnitrope (Somatropin) (45 IU/1.5 mL). Nonmedicinal ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, poloxamer 188, phenol, glycine, and water for injection. Phosphoric acid and/or sodium hydroxide may have been used to adjust pH.

Do not use Omnitrope (Somatropin) if you:

• are allergic to Omnitrope (Somatropin) or any ingredients of Omnitrope (Somatropin)
• have active cancer
• have an active brain tumour
• have an acute illness due to complications of surgery, have respiratory (breathing) failure, or have just had a serious accident
• have Prader-Willi syndrome and are severely obese or have severe breathing problems
• have had a kidney transplant
• have vision problems due to long-term effects of Diabetes
• are a child with closed epiphyses (growth plates)

Do not give Omnitrope (Somatropin) to children with closed epiphyses (bone growth plates).

There may be an interaction between Omnitrope (Somatropin) and any of the following:

• corticosteroids (e.g., cortisone, Prednisone)
• diabetes medications (e.g., Glyburide, insulin, Metformin, Sitagliptin)
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Omnitrope (Somatropin). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Omnitrope (Somatropin).

Cancer: There is an increased risk of tumour growth, both cancerous and non-cancerous, when growth hormone is used by survivors of childhood cancer. Discuss any concerns you may have with your doctor.

Diabetes: Omnitrope (Somatropin) may cause an increase in blood sugar levels and glucose tolerance may change. If you have diabetes, you may find it necessary to monitor your blood sugar more frequently while using Omnitrope (Somatropin).

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Omnitrope (Somatropin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Omnitrope (Somatropin), and whether any special monitoring is needed.

Hypothyroidism (low level of Thyroid hormone): If you have uncontrolled hypothyroidism, treatment with Omnitrope (Somatropin) may not work as well as it could. Discuss with your doctor how Omnitrope (Somatropin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Omnitrope (Somatropin), and whether any special monitoring is needed. Treatment with Omnitrope (Somatropin) may trigger hypothyroidism. If you experience unexplained weight gain, muscle aches or stiffness, constipation, dry skin or fatigue, this may be a result of too little thyroid hormone and you should contact your doctor as soon as possible.

Pancreatitis: Somatotropin can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Omnitrope (Somatropin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Omnitrope (Somatropin), and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Scoliosis: People with scoliosis are at risk of their condition worsening while taking Omnitrope (Somatropin). If you have scoliosis, discuss with your doctor how Omnitrope (Somatropin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Omnitrope (Somatropin), and whether any special monitoring is needed.

Turner Syndrome: When Omnitrope (Somatropin) is used to encourage growth in children with Turner Syndrome, there may be an increased risk of certain side effects. These children may be at increased risk of developing increased blood pressure in the brain. Because they are at an increased risk of ear and hearing disorders, the doctor should thoroughly review the child's medical history. If you or your child has ear or hearing problems, discuss with your doctor how Omnitrope (Somatropin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Omnitrope (Somatropin), and whether any special monitoring is needed.

Pregnancy: Omnitrope (Somatropin) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Omnitrope (Somatropin), contact your doctor immediately.

Breast-feeding: It is not known if Omnitrope (Somatropin) passes into breast milk. If you are a breast-feeding mother and are taking Omnitrope (Somatropin), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Some formulations of Omnitrope (Somatropin) contain the preservative benzyl alcohol. Be careful about giving these formulations to children under the age of 3 years.

Seniors: The safety and effectiveness of using Omnitrope (Somatropin) have not been established for adults over 65 years of age.