Are Compounded GLP-1s Safe? What the Data Shows

"Is it safe?" It's the first question most people ask about compounded GLP-1 medications—and rightfully so. You're putting something in your body, and you want to know the risks. In this article, we'll give you an honest, balanced assessment based on available data.

The Honest Answer

Let's start with the straightforward truth: millions of people have used compounded GLP-1 medications without serious problems. At the same time, compounded medications carry different considerations than FDA-approved drugs.

There are two separate safety questions to consider:

1. Is semaglutide (the molecule) safe? – This is well-studied.
2. Is the compounding process safe? – This depends on the pharmacy.

Understanding the difference helps you make an informed decision.

Semaglutide Safety: What We Know About the Molecule

Semaglutide itself has been extensively studied. Novo Nordisk's clinical trials for Ozempic and Wegovy involved tens of thousands of patients, and the medication has now been used by millions worldwide.

What the research shows:

Common side effects (similar for brand-name and compounded):

• Nausea: Very common, especially when starting or increasing dose (usually improves over time)
• Vomiting and diarrhea: Common, typically mild to moderate
• Constipation: Common
• Fatigue: Some patients report this, especially early on
• Injection site reactions: Mild redness or irritation

Rare but serious side effects (applies to all semaglutide products):

• Pancreatitis: Rare, but seek immediate care if you have severe abdominal pain
• Gallbladder problems: Increased risk, especially with rapid weight loss
• Thyroid tumors: Seen in rodent studies; avoid if you have personal/family history of certain thyroid cancers

The key point: these side effects are associated with semaglutide itself, regardless of whether it's brand-name or compounded. The molecule is the same.

Compounding-Specific Safety Concerns

When it comes to compounded medications specifically, the concerns are different. They're not about the molecule—they're about how the medication is prepared.

1. Quality and Consistency

FDA-approved drugs are manufactured under strict conditions with rigorous testing of every batch. Compounded medications don't go through the same federal approval process, though reputable compounding pharmacies do test their products.

The FDA has tested some compounded semaglutide products and found variation in potency—some samples contained less semaglutide than labeled, while others contained more. This is why choosing a pharmacy with robust testing protocols matters.

2. Sterility

Injectable medications must be sterile. Contamination during compounding is rare but can be serious. This risk is why 503B outsourcing facilities—which are FDA-registered and must follow Current Good Manufacturing Practices—provide an extra layer of assurance.

3. Dosing Accuracy

Brand-name Ozempic and Wegovy come in pre-filled pens that deliver exact doses. Compounded semaglutide often comes in multi-dose vials, requiring patients to draw their own doses using a syringe. This creates room for error.

If you're using vials, it's important to understand how to calculate and measure your dose correctly. Many providers offer training and support to help with this.

What About FDA Warnings?

You may have seen news about FDA warning letters to compounding pharmacies and telehealth companies. Let's put this in context:

In September 2025, the FDA issued warning letters to various telehealth platforms and pharmacies. The warnings were primarily about marketing claims, not necessarily product safety. Companies were cited for things like:

• Implying compounded products are FDA-approved
• Claiming products are "the same as" brand-name drugs
• Making unsubstantiated efficacy claims

These are important regulatory issues, but they're primarily about marketing, not necessarily about the safety of the products themselves. The FDA's stance is that compounded medications have their place but shouldn't be marketed as equivalent to FDA-approved drugs.

How to Minimize Risk

If you decide compounded semaglutide is right for you, here's how to make the safest choice:

The Bottom Line

Here's our balanced assessment:

Semaglutide is a well-studied medication with a strong safety profile. The side effects are well-known, and millions of people use it safely for weight loss and diabetes management.

Compounding adds some variables related to how the medication is prepared. These can be managed by choosing reputable providers who partner with certified, tested compounding pharmacies.

Many people use compounded GLP-1s successfully. The lower cost has made weight loss treatment accessible to people who otherwise couldn't afford it. When sourced from quality pharmacies and used properly, compounded semaglutide can be a reasonable option.

But it's not risk-free. No medication is. By choosing your provider carefully, asking the right questions, and using your medication correctly, you can minimize the additional considerations that come with compounded medications.

Ultimately, this is a decision to make with full information. We believe in transparent advocacy—giving you the facts so you can make the choice that's right for you.