Your safety is our first priority. Learn more about key medication details, possible side effects, warnings, and other important information about semaglutide sublingual treatment below.
Prescribing Information
Semaglutide sublingual is a compounded medication option that may be prescribed when clinically appropriate through a licensed provider and pharmacy partner. Semaglutide sublingual is not an FDA-approved finished drug product and is not the same as FDA-approved semaglutide injection or Wegovy® tablets.
Because compounded medications are not FDA-approved, the FDA does not review them for safety, effectiveness, or quality before they are dispensed.
Black Box Warning
There is no FDA-approved prescribing label specific to compounded semaglutide sublingual. However, FDA-approved semaglutide products include a boxed warning for risk of thyroid C-cell tumors.
Do not use semaglutide if you or your family have a history of medullary thyroid carcinoma, or MTC, or if you have Multiple Endocrine Neoplasia syndrome type 2, or MEN 2.
Common Side Effects
Possible side effects may include:
Nausea
Vomiting
Diarrhea
Constipation
Abdominal discomfort
Decreased appetite
Headache
Fatigue
Dizziness
Mouth or throat irritation
Important Safety Information
Do not use semaglutide if you have a known allergy to semaglutide or any ingredient in the medication, have a personal or family history of MTC, or have MEN 2.
Tell your provider if you have or have had pancreatitis, gallbladder disease, kidney disease, diabetes, diabetic retinopathy, stomach-emptying problems, severe gastrointestinal disease, depression, suicidal thoughts, or are pregnant, planning to become pregnant, or breastfeeding.
Semaglutide may increase the risk of pancreatitis, gallbladder problems, dehydration, kidney injury, severe gastrointestinal symptoms, low blood sugar when used with certain diabetes medications, allergic reactions, increased heart rate, and worsening diabetic retinopathy in certain patients.
Because this is a compounded sublingual formulation, dosing, absorption, and response may differ from FDA-approved semaglutide products.
Seek urgent medical help if you experience severe abdominal pain, swelling of the face or throat, trouble breathing, severe vomiting, symptoms of dehydration, fainting, or signs of an allergic reaction.
To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
