Semaglutide is approved by the FDA, but compounded semaglutide isn’t.
Understanding the differences between FDA-approved and compounded semaglutide is essential for making proper decisions
The risks can vary since the FDA hasn’t approved compounded semaglutide, but it's still available for purchase. Compounded semaglutide may be prescribed by a licensed provider, but its safety and effectiveness have not been evaluated by the FDA.
Aside from that, several other factors keep compounded semaglutide and semaglutide distinct from one another.
Understanding Semaglutide
What is Semaglutide?
Semaglutide works as an anti diabetic medication. They replicate themselves as natural GLP-1 hormones in the body. What it does is:
- Lower blood sugar levels
- Alow gastric emptying
- Reduce appetite
- Treat type 2 diabetes
- Weight loss
Semaglutide is FDA-approved for type 2 diabetes, while compounded versions lack standardized clinical trials. Patients who have renal or hepatic disorders don’t even need dose modifications.
Therefore, semagultide is all about:
Semaglutide has been approved by the FDA for the following medical purposes:
- Semaglutide improves blood sugar control in adults with type 2 diabetes.
- Insulin is released due to high blood sugar.
- Lowering glucagon reduces blood glucose.
- Help with at least one weight-related condition
- Reduces appetite and calorie intake for weight loss.
What is Compounded Semaglutide?
Compound semaglutide is a custom-made medication. It isn’t the same as semaglutide.
Licensed compounding pharmacies mix, alter, or combine ingredients to create a compounded formulation. Unlike semaglutide, it aligns with patients' requirements.
This practice is used when a patient:
- Needs a different dosage strength
- Has allergies to certain ingredients in standard formulations
- Needs a different delivery method
Compounded Semaglutide Explained
Compounded semaglutide refers to a non-commercially manufactured version of semaglutide. A compounding pharmacist makes this medication.
The brand name semaglutide already has patents and FDA approval. However, compounded semagultuide do not have that. They don’t use the same raw ingredients used in FDA-approved medications.
Instead, they may use:
- Semaglutide Base: The active ingredient used in FDA-approved formulations.
- Semaglutide Sodium: A chemically modified version not found in FDA-approved medications.
As compounding pharmacies create their own formulations, the potency, purity, and safety may vary.
Potential Variations in Ingredients and Concentrations
- Contain different active ingredient forms
- Customize the formulation
- Have variable concentrations of semaglutide
- Differences in efficacy, purity, potency, and safety
- Add extra ingredients that are not present in FDA-approved versions.
Common Additives: Compounded Semaglutide with B12
Some compounding pharmacies provide semaglutide along with vitamin B12. The reasoning for this combination includes:
- Potential energy-boosting effects from B12.
- Reduced nausea is a common side effect of semaglutide.
- Fight with fatigue
- Enhance metabolic rate
However, limited clinical research exists on the effectiveness or safety of compounded semaglutide with B12. The FDA did not approve this formulation/combination. So, its safety and efficacy remain uncertain.
Key Considerations for Compounded Semaglutide
- ⚠️ Does not undergo FDA testing for safety and efficacy
- ⚠️ Differences in formulation, potency, and purity
- ⚠️ Some compounding pharmacies operate within gray areas of regulation
- ⚠️ Not all sources of compounded semaglutide are reputable
Key Differences Between Standard and Compounded Semaglutide
Here is a detailed rundown of the major differences between the two.
Regulatory Approval and Oversight
Safety and Efficacy
Cost and Accessibility
Safety Considerations
Safety comes first. No matter which medication you choose, there should be at least minimal safety measures to follow. We have a couple of important points regarding safety for both semaglutide and compounded semaglutide.
Common Side Effects of Standard Semaglutide
Semaglutide is like other GLP-1 receptor agonists. It affects the digestive system and metabolism. This is why you can experience both mild and severe side effects.
1. Gastrointestinal Issues (Most Common)
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Abdominal pain
- Bloating
- Excess gas
- Heartburn
- Fatigue
2. Metabolic Effects
- Decreased appetite
- Weight loss
3. Serious Side Effects (Less Common but Severe)
- Pancreatitis (inflammation of the pancreas)
- Gallbladder problems (gallstones)
- Kidney injury (due to dehydration from severe vomiting or diarrhea)
- Thyroid tumors (found in animal studies but unclear risk in humans)
- Hypoglycemia (low blood sugar)
Additional Risks with Compounded Semaglutide
Since compounded semaglutide lacks FDA approval and its formulation can vary, it may carry extra risks, including:
- A dose may be stronger or weaker than expected
- Affecting blood sugar control and weight loss.
- Some formulations mix semaglutide with B12 or other elements untested clinically.
- Compounded versions may introduce harmful bacteria if not prepared sterilely.
Is Compounded Semaglutide Safe?
The FDA has issued warnings regarding compounded semaglutide due to:
- Some compounding pharmacies use semaglutide sodium, a form not approved for human injection.
- Some patients using compounded versions have experienced:
- Unexpected gastrointestinal distress
- Severe nausea and vomiting
- Signs of allergic reactions or infections
- Compounded medications lack FDA review, risking their safety, efficacy, and sterility.
FDA Recommendations
- ⚠️ Patients should only use FDA-approved versions of semaglutide.
- ⚠️ Ensure the pharmacy is licensed before using compounded semaglutide.
- ⚠️Consult a healthcare provider before using non-standard formulations.
Dosing and Administration
Administering a medication requires proper medical supervision. With Semaglutide, you must make gradual dose increases to minimize side effects.
Improper self-medication increases risks like:
- Too much semaglutide can cause severe nausea, vomiting, and dangerously low blood sugar.
- Poor mixing or administration can cause pain, irritation, or infection at the injection site.
- Compounded versions may fail, hindering diabetes and weight management.
Potential Issues with Dosing Errors in Compounded Products
- Compounded versions may lack consistent concentration per injection without FDA regulation.
- Some patients may receive higher or lower doses than prescribed.
- Improper handling can reduce the medication's effectiveness or cause degradation.
So, what we get to learn about the safety of semaglutide and compounded semaglutide are:
Frequently Asked Questions
Is Compounded Semaglutide Less Effective?
Since the FDA didn’t approve compounded semaglutide, there are still questions about its effectiveness. Some patients have seen better results, but the clinical trials are still ongoing.
Can You Lose Weight on Compounded Semaglutide?
Compounded semaglutide is not FDA-approved for weight management. Patients should consult a healthcare provider for guidance.
