Important Safety Information for Semaglutide

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Medications, such as semaglutide, may be prescribed by your healthcare provider but are not regulated by the FDA for safety, efficacy, or quality. FDA-approved versions of semaglutide are available.

WARNING

It is imperative to seek immediate medical attention if you experience any of the following serious side effects:

• Severe nausea or vomiting leading to dehydration: Maintaining proper hydration is critical during treatment with semaglutide.
• Kidney dysfunction or failure: Nausea, vomiting, and diarrhea can result in dehydration, which may worsen pre-existing kidney conditions and, in some cases, necessitate dialysis.
• Thyroid C-Cell Tumors: Symptoms such as difficulty swallowing, hoarseness, a lump or swelling in the neck, or shortness of breath should be reported to your physician immediately (see Black Box Warning below).
• Pancreatitis: Severe and persistent abdominal or back pain may indicate pancreatitis and requires immediate evaluation.
• Acute gallbladder disease: Symptoms such as pain in the upper right or middle abdomen, fever, yellowing of the skin or eyes, nausea, or vomiting may indicate gallbladder issues, warranting further diagnostic evaluation.
• Liver complications (hepatitis, elevated liver enzymes, jaundice).
• Worsening diabetic retinopathy: Changes in vision, particularly in patients with pre-existing diabetic retinopathy, should be closely monitored.
• Gastrointestinal disorders: This medication is contraindicated in patients with a history of severe gastrointestinal diseases.
• Symptoms of hypoglycemia: Although uncommon with GLP-1 receptor agonists, hypoglycemia may occur. Signs include dizziness, shaking, sweating, and confusion. In such cases, consuming foods or beverages containing sugar can help restore normal blood sugar levels. Patients on insulin or sulfonylureas (e.g., glipizide, glimepiride, glyburide) should consult their physician about potential dose adjustments to avoid hypoglycemia.
• Elevated heart rate.
• Worsening depression or suicidal ideation.

Do not share your semaglutide prescription with others.

Drug Interactions

Semaglutide may interact with alcohol, prescription and non-prescription medications, and herbal supplements. The risk of hypoglycemia increases when used in conjunction with insulin or insulin-stimulating medications (e.g., sulfonylureas). Additionally, semaglutide can slow gastric emptying, affecting the absorption of oral medications. Patients on thyroid medication should consult with their healthcare provider to discuss potential adjustments to their dosing schedule. For medications with narrow therapeutic windows, such as warfarin, close monitoring is essential.

For a comprehensive list of potential side effects, drug interactions, and precautions, please refer to the official pharmaceutical documentation.

To report adverse reactions, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. In the event of a medical emergency, dial 911 or visit the nearest emergency facility.

Note: These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.

Black Box Warning

GLP-1 receptor agonists, including semaglutide, are contraindicated in individuals with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2). Animal studies have demonstrated an increased risk of thyroid tumors, including cancer, although it is uncertain whether these findings apply to humans. Notify your healthcare provider immediately if you develop symptoms such as difficulty swallowing, hoarseness, a lump in your neck, or shortness of breath.

Additional Precautions

• Alcohol use: Avoid alcohol consumption while using this medication.
• Contraception: Use appropriate birth control while taking semaglutide. If pregnant, breastfeeding, or planning to conceive, discuss discontinuation of the medication with your healthcare provider at least two months prior to conception, as it may cause harm to the fetus.
• Medical history: Inform your healthcare provider if you have any history of liver, kidney, or pancreatic conditions.
• Allergic reactions: If you experience any signs of a severe allergic reaction, such as swelling of the face, lips, tongue, or throat, difficulty breathing, or a rapid heartbeat, seek medical attention immediately. Severe hypersensitivity reactions, including anaphylaxis, have been reported, and the medication should be discontinued if this occurs.

Ensure that you communicate your full medical history with your healthcare provider before initiating treatment with semaglutide.