Important Safety Information for

Oral Semaglutide

Oral Semaglutide GLP-1

*Compounded medications may be prescribed by physicians but have not been FDA regulated for safety, effectiveness, or quality. FDA-approved medicines containing semaglutide are available.

WARNING

Please contact your doctor ASAP and seek in-person care immediately if a side effect becomes problematic or you experience:

  • Severe nausea and/or vomiting resulting in dehydration -  it is important to stay well hydrated and drink plenty of fluids while on this medication.
  • Kidney problems/kidney failure - vomiting, nausea, diarrhea can cause dehydration and kidney issues and make kidney problems worse in individuals who have pre-existing kidney conditions; may sometimes lead to the need for hemodialysis.
  • Thyroid C-Cell Tumor: Trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath (see black box warning below).
  • Pancreatitis: Severe pain in your abdomen or back that will not go away.
  • Acute gallbladder disease - Pain in the middle or right upper stomach, fever, white parts of your eyes turn yellow or skin turns yellow, nausea/vomiting. If gallstones or inflammation of the gallbladder is suspected further studies are needed.
  • Hepatitis/Elevated liver enzymes/Jaundice
  • Diabetic retinopathy problems: Changes in vision in those with type II diabetes, particularly vision problems may worsen in those with a history of diabetic retinopathy.
  • Severe gastrointestinal disease - may cause gastrointestinal disease; do not use if you have a history of severe gastrointestinal disease
  • Signs of low blood sugar (for example, dizziness, weakness, shakiness, jitteriness, headache, anxiety/mood changes, rapid heartbeat, confusion, slurred speech, sweating, or lightheadedness). While this is rare with GLP-1s, if it occurs, please seek in-person care immediately. If you have these symptoms, try having liquid or food containing sugar (around 15-20 grams) —drinking juice, having regular soda, or eating some hard candies right away, as this will help raise your blood sugar quickly. If taken with insulin or an insulin secretagogue (i.e. sulfonylurea such as Glipizide, glimepiride, and glyburide) it is best to talk to your healthcare provider about possibly lowering the dose of these medications to lower the risk of hypoglycemia.
  • Increasing heart rate
  • Worsening depression, behavior changes, or suicidality
  • Never share the semaglutide with other people

Drug Interactions

As with other medications, oral semaglutide can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Oral semaglutide delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting oral semaglutide, please review the timing of taking your thyroid hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (ie warfarin) should be monitored closely while on oral semaglutide.

Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.

To report suspected adverse reactions to o semaglutide, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In case of emergencies, please call 911 or go to the nearest emergency room.

Note: The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.