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Please review the following safety information regarding the use of this medication carefully. Contact your healthcare provider if you have any concerns or questions.

• Increased Mortality Risk in Critical Illness: Avoid using somatropin injections like Omnitrope in individuals with severe illnesses following open heart or abdominal surgery, serious injuries, or severe respiratory issues, as it may increase the risk of death.

• Risk of Sudden Death in Prader-Willi Syndrome: Somatropin should not be used in children with Prader-Willi syndrome who are obese, have obstructed airways, or suffer from undiagnosed respiratory infections, as it may lead to sudden death. Children without these risk factors may use the medication under close supervision to maintain weight control and monitor for respiratory symptoms.

• Severe Allergic Reactions: Somatropin injections can cause severe allergic reactions, including anaphylaxis. Seek immediate medical attention if you experience dizziness, choking, breathing difficulties, nausea, or swelling around the face.

• Cancer Considerations: Those with active tumors or cancer should not use somatropin. If you have a cancer history, your healthcare provider may monitor you closely, as the medication can potentially increase the risk of new or worsening cancers.

• Blood Sugar Levels: Somatropin may elevate blood sugar levels, increasing the risk of diabetes, especially in individuals who are obese, have Turner syndrome, or a family history of diabetes. Regular monitoring of blood sugar levels is recommended.

• Intracranial Hypertension: Some patients may experience increased brain pressure, leading to vision changes, headaches, and nausea. These symptoms typically resolve upon stopping or reducing the medication dose. Regular check-ups are advised.

• Fluid Retention: The medication can cause swelling due to fluid retention, leading to muscle pain or carpal tunnel syndrome. Notify your provider if symptoms occur.

• Low Cortisol Levels: Somatropin may reduce cortisol levels, with the risk heightened in those taking certain steroid medications. Monitor for signs of low hormone levels.

• Bone Issues in Children: The medication may cause a condition where the thigh bone slips out of position, particularly in rapidly growing children. Report any knee or hip pain or limping to a healthcare provider.

• Pancreatitis: Rarely, somatropin can lead to pancreatitis, characterized by severe abdominal and back pain. Discontinue use immediately and seek medical help if these symptoms occur.

Contraindications: Do not use this medication if you have:

• A critical illness following surgery, injury, or severe breathing problems.
• Active cancer.
• Severe diabetic eye damage.
• Prader-Willi syndrome with severe obesity or breathing issues.
• Closed growth plates in children.

Always consult your healthcare provider before starting or stopping any medication.

When taking this medication, some individuals may experience common side effects such as headache, bruising, leg pain, nausea, vomiting, tiredness, and muscle pain. While these are typically mild, it's important to consult your healthcare provider if they persist or worsen. Other side effects that some users have reported include swelling in the arms and legs, joint pain, upper respiratory infections, and pain in the arms and legs. These may vary in intensity, so reaching out for medical advice is advisable if they become bothersome.

Serious side effects, although rare, necessitate immediate medical attention. These include persistent nausea or vomiting, severe stomach or back pain, fatigue, muscle pain, tingling sensations, stiffness in the arms and legs, ear infections, and any significant changes in vision or hearing. If you experience any of these symptoms, seek urgent care.

In children with Prader-Willi syndrome, there is a risk of severe, potentially fatal lung or breathing problems, especially in those who are male, severely overweight, or have pre-existing lung conditions like sleep apnea. Signs such as heavy snoring or irregular breathing during sleep require prompt medical evaluation. Additionally, there is a potential increased risk of tumor or cancer development associated with this medication, so discussing these risks with your healthcare provider is crucial.

Although very rare, severe allergic reactions may occur. Symptoms like rash, severe itching or swelling, dizziness, and difficulty breathing require immediate medical intervention. This summary does not encompass all possible side effects, so if you notice any other unusual symptoms, consult with your healthcare provider promptly.