About compounded medications and pharmacies Individual compounded formulations of semaglutide aren’t monitored, approved, or evaluated for safety, efficacy, or quality by the FDA.

The practices (but not the medications produced) of some compounding pharmacies, known as outsourcing facilities and termed 503B compounding pharmacies, are monitored by the FDA and subject to current good manufacturing practice (CGMP) requirements. CGMP requirements are the same standards that pharmaceutical manufacturers, like Novo Nordisk that makes Wegovy and Ozempic, follow. 503B pharmacies can make large batches of medication and typically supply hospitals and clinics, but not individuals.

Other compounding pharmacies’ practices, known as 503A pharmacies, are regulated by state boards of pharmacy. They don’t have to follow CGMP requirements and can only make small batches of medication, for example, a 30-day supply.

All pharmacies, including 503B, and 503A compounding pharmacies, have to comply with United States Pharmacopeia (USP) Standards for medication strength, quality, and purity.

About potential side effects from semaglutide
Individual compounded medications aren’t regulated by the FDA and don’t go through clinical trials. The side effects shared here are for Wegovy, which uses the same active ingredient as compounded semaglutide. Any side effects you experience on compounded semaglutide may be similar. However, you may also experience other side effects since compounded semaglutide may not be identical to Wegovy and may include ingredients not found in Wegovy.

Common Wegovy side effects
The list below is for common side effects experienced by participants in clinical trials for Wegovy.
● Nausea
● Diarrhea
● Vomiting
● Constipation
● Abdominal pain
● Abdominal distension (swelling)
● Abdominal pain
● Belching
● Dizziness
● Dysesthesia (abnormal sensation)
● Dyspepsia
● Headache
● Fatigue
● Flatulence
● Gastritis (inflammation of the stomach)
● Gastroenteritis (inflammation of the digestive tract)
● Gastroesophageal reflux disease (GERD)
● Hair loss
● Hypoglycemia (low blood sugar)
● Nasopharyngitis (inflammation of the nose and throat)

More rare, but serious side effects of Wegovy
Wegovy has an FDA boxed warning (the most serious warning the FDA issues for a medication) for the risk of thyroid C-cell tumors. It’s not known if Wegovy causes thyroid tumors, such as medullary thyroid carcinoma (MTC), in people, but it has in animal studies. It’s recommended that anyone with a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) avoid semaglutide or take it only with strict monitoring from their provider for potential signs of thyroid tumors.

Other serious side effects can occur when taking Wegovy. Serious side effects experienced in clinical trials include:

● Serious allergic reactions, such as swelling of your face, lips, tongue or throat, trouble breathing or swallowing, rapid heart rate, a severe rash, itching, fainting, feeling faint, dizziness or a very rapid heartbeat. Don’t take semaglutide if you’ve had a previous reaction to it.
● Low blood sugar, especially if you have type 2 diabetes. Symptoms include light-headedness, sweating, dizziness, giddiness, feeling confused or drowsy, headache, blurry vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood changes, hunger, weakness, or feeling jittery. Kidney damage, including acute kidney injury or kidney failure.
● Gallbladder problems, including acute gallbladder disease and gallstones. Symptoms include pain in your upper abdomen, fever, yellowing of your skin or eyes, or clay-colored stools.
● Pancreatitis (inflammation of the pancreas), characterized by persistent pain in your upper abdomen, especially stomach pain that radiates toward your back. Pancreatitis can occur with or without vomiting.
● Rapid heartbeat, greater than 100 beats per minute.
● Vision changes and/or diabetic retinopathy, if you have type 2 diabetes.
● Depression or suicidal thoughts, including low mood and associated changes in behavior.
● Ileus, or inability of the intestines to contract normally, can prevent your body from properly emptying food waste.

Other rare side effects seen in clinical trials are:
● Reactions at the injection site such as swelling, pain, and redness
● Persistent foul, rancid, metallic taste in the mouth
● Fractures which are more common in older adults taking Wegovy
● Low blood pressure and fainting
● Hiccups
● Hemorrhoids
● Appendicitis
● Inflammation of the nose and throat

Additionally, don’t use semaglutide if you use insulin or an insulin secretagogue, such as sulfonylurea without your provider’s supervision due to the risk of reduced blood sugar levels.

Don’t combine compounded semaglutide with another compounded semaglutide product or a prescription GLP-1 medication.

Because semaglutide may slow how quickly food leaves your stomach, it may affect how your body absorbs medication. Tell your provider about all medications you take so they can monitor you.