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Important Safety Information: Compounded Semaglutide

Please read this before starting treatment, and talk with your licensed provider about any questions.

About Compounded Semaglutide

Federal law allows compounded medications to be prescribed, but they are not FDA-approved, and the FDA does not review them for safety, effectiveness, or manufacturing quality. Compounded semaglutide is a different product from brand-name Wegovy® or Ozempic®. Whether it’s right for you, and at what dose, is decided by your licensed provider through Only Human RX after a medical evaluation.

Boxed Warning: Thyroid Tumor Risk

Semaglutide led to thyroid tumors, including cancerous ones, in rodent studies. Researchers do not yet know whether it has the same effect in humans, including a thyroid cancer known as medullary thyroid carcinoma (MTC). MTC has been reported in some people after liraglutide, a similar medication, became available. Contact your provider promptly if you develop swelling or a lump in your neck, a hoarse voice, difficulty swallowing, or shortness of breath.

Who Should Not Take Semaglutide

Semaglutide is not right for you if:

  • You have a personal or family history of medullary thyroid carcinoma (MTC)

  • You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

  • You’ve had a severe allergic reaction to semaglutide in the past

  • You have type 1 diabetes

  • You’re already using another semaglutide product or GLP-1 medication, such as Wegovy®, Ozempic®, Saxenda®, Victoza®, Trulicity®, Byetta®, or Bydureon®

Share Your Full Health Picture

Being open and accurate on your intake helps your provider keep you safe. Leaving out or misstating health details to qualify for treatment can result in serious harm, and in rare cases, death. Be sure to let your provider know about:

Conditions, current or past:

  • Diabetes (type 1 or type 2) or diabetic eye disease (retinopathy)

  • Thyroid cancer

  • Pancreatitis

  • Kidney disease

  • Ileus (slowed or blocked bowel movement)

  • Depression, suicidal thoughts, or suicidal behavior

Everything you take:

  • All prescriptions, over-the-counter medicines, vitamins, and supplements

  • Diabetes medicines such as insulin or sulfonylureas (for example, glimepiride or glipizide), which raise the chance of low blood sugar

  • Other weight loss products, including supplements

  • Oral medications in general, because semaglutide slows digestion and can change how well other pills are absorbed. Your provider can help you time your doses.

Pregnancy, Family Planning, and Nursing

Semaglutide should not be taken while pregnant. Animal research points to possible risks for a developing baby, and losing weight during pregnancy offers no benefit. Because semaglutide stays in your system for an extended time, stop taking it at least 2 months before trying to conceive. If you’re breastfeeding, talk with your provider before starting, as semaglutide has been detected in the milk of nursing rats.

Using Your Medication

Semaglutide is a once-weekly injection given just beneath the skin of the abdomen, thigh, or upper arm. Pick one day each week and stay consistent; it can be taken with or without a meal. Your provider will explain your dosing plan, which often starts low and increases gradually. Check with your provider before changing your dose or stopping treatment. Use each needle only once and never share needles or syringes, which can transmit infections.

Serious Side Effects to Watch For

If you have a medical emergency, call 911 right away. Stay especially alert early in treatment and after any dose change.

  • Pancreas inflammation (pancreatitis): Ongoing, severe pain in your stomach area that may reach your back, with or without vomiting.

  • Gallbladder issues: Gallstones and other gallbladder problems can occur, and some need surgery. Report upper stomach pain, fever, yellow-tinged skin or eyes, or pale, clay-colored stool.

  • Low blood sugar (hypoglycemia): Most likely in people with type 2 diabetes using other blood sugar medicines. Watch for dizziness, blurry vision, sudden mood shifts, sweating, or a pounding heartbeat.

  • Kidney strain: Fluid loss from nausea, vomiting, or diarrhea can worsen kidney function. Stay well hydrated.

  • Severe allergic reaction: Stop your medication and seek help immediately if you have swelling of the face, lips, tongue, or throat, intense itching or rash, a racing heart, trouble breathing or swallowing, fainting, or dizziness.

  • Eye changes in type 2 diabetes: Report any change in your vision right away.

  • Elevated resting heart rate: Let your provider know if your heart races while you’re resting.

  • Changes in mental health: Pay attention to sudden shifts in mood, behavior, or thinking, and reach out to your provider right away about anything new, worsening, or concerning.

  • Surgery or sedation: Before any procedure, let every member of your care team know you take semaglutide, as it may raise the risk of inhaling food or fluid into your lungs.

More Common Side Effects

Many people experience mild to moderate side effects, most often digestive. These include nausea, diarrhea, vomiting, constipation, stomach pain, indigestion, bloating, burping, gas, acid reflux, and stomach flu. Headache, tiredness, and dizziness can also occur, as can low blood sugar in people with type 2 diabetes.

Reporting Side Effects

Please tell your provider about any side effects. You can also report them directly to the FDA’s MedWatch program at 1-800-FDA-1088 or www.fda.gov/medwatch.

Questions about safety?

Your licensed provider will review your health history and talk through risks and benefits before prescribing. For a medical emergency, call 911.

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