Safety

Side effects, warnings, and how to report a problem.

Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.

These products are not FDA-approved. The safety and effectiveness of unapproved products in people have not been established. The lists below set out what has been reported and who should not use each product; they are not complete, and your provider reviews your own history before prescribing anything.

Product by product

Reported side effects and who should not use it.

Each product shows its FDA status first, then what has been reported and who should not use it.

Sermorelin

In FDA's 503B Category 1: interim enforcement discretion, not the bulks list.

Reported side effects and who should not use it

Injection-related effects can include pain, redness or swelling at the site. Allergic reactions can occur; the side-effect profile of an oral tablet cannot be inferred from an injected formulation.
Raising growth hormone and IGF-1 may not be appropriate for people with an active cancer or a history of cancer, which is why the prescriber reviews it first.
Not for anyone with a known allergy to sermorelin.
The adverse effects of the listed oral formulation have not been established. Its formulation-specific risks and absorption require review.
The safety of compounded sermorelin in adults, particularly over the long term, has not been established.
Safety in pregnancy and breastfeeding has not been established.

NAD+

In FDA's Category 1 for 503A pharmacies and 503B outsourcing facilities: interim enforcement discretion, not the bulks list.

Reported side effects and who should not use it

Subcutaneous injection can cause pain, redness, swelling or bruising at the site. Infection is possible if the product or injection technique is not sterile.
Not for anyone with a known allergy to NAD+ or to another ingredient in the preparation.
The adverse effects and longer-term safety of this nasal formulation have not been established. Injection-related experience cannot define its risks.
The safety of repeated use of either listed formulation over months has not been established.
Safety in pregnancy and breastfeeding has not been studied.

Glutathione

In FDA's Category 1 for 503A pharmacies and 503B outsourcing facilities: interim enforcement discretion, not the bulks list.

Reported side effects and who should not use it

Reported side effects include injection site pain, redness or swelling. Rash and other allergic reactions can occur. Not for anyone with a known allergy to glutathione or to another ingredient in the preparation.
Inhaled glutathione has been reported to trigger airway narrowing in some people with asthma; the risk with injection is not well characterized.
The long-term safety of injectable glutathione has not been established, and safety in pregnancy and breastfeeding has not been studied.

Methylcobalamin B12

In FDA's Category 1 for 503A pharmacies and 503B outsourcing facilities: interim enforcement discretion, not the bulks list.

Reported side effects and who should not use it

Reported side effects include injection site pain or redness, diarrhea, itching and rash.
Serious allergic reactions, including anaphylaxis, have been reported with injected vitamin B12. Not for anyone with a known allergy to cobalt or to any form of vitamin B12.
Safety data specific to injected methylcobalamin are more limited than for the more widely used forms of B12.

CJC-1295 and Ipamorelin

No compounding pathway today.

The CJC-1295 and Ipamorelin combination is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

CJC-1295 and ipamorelin are not FDA-approved, and their safety in people, alone or together, has not been established.
FDA's safety-risks page cites serious adverse events associated with CJC-1295, including increased heart rate and a systemic vasodilatory reaction, and says available clinical data are limited.
FDA's safety-risks page cites a published report of serious adverse events, including death, after ipamorelin was given intravenously, and says FDA lacks sufficient information on other injectable routes, which include subcutaneous injection.
Medicines that raise growth hormone or IGF-1 levels can cause fluid retention, joint pain, numbness or tingling in the hands, and changes in blood glucose, and these effects may occur with these peptides.
Small human studies of CJC-1295 reported flushing, headache and reactions at the injection site.
There is no FDA label, so there is no formal list of contraindications. Growth hormone and IGF-1 promote cell growth, so these peptides should not be used with active cancer, and any past cancer needs specific review by the prescriber. They should not be used during pregnancy or breastfeeding, where there are no safety data.

MOTS-c

No compounding pathway today. An FDA advisory committee recommendation is not a listing.

MOTS-c is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

Safety in people has not been established. Controlled trials of MOTS-c given to people as a medicine are lacking, so its side effects and longer-term risks are not known.
FDA says compounded MOTS-c may pose a significant risk of immunogenicity (the immune system reacting to the peptide), and that it lacks important information on whether MOTS-c would cause harm in people.
Injection under the skin can cause redness, swelling, pain or bruising at the site, and infection if the injection technique or the product is not sterile.
Not for use during pregnancy or breastfeeding, or by anyone under 18, because there is no safety information for these groups.
Stop and seek medical care for signs of an allergic reaction, such as hives, swelling of the face or throat, or difficulty breathing.

BPC-157 Injection

No compounding pathway today. An FDA advisory committee recommendation is not a listing.

BPC-157 Injection is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

Safety in people has not been established. Without controlled human trials, its side effects and longer-term risks are not known.
FDA says compounded BPC-157 may pose a risk of immunogenicity (the immune system reacting to the peptide), and that it has identified no, or only limited, safety information for the proposed routes of administration.
Injection under the skin can cause redness, swelling, pain or bruising at the site, and infection if the injection technique or the product is not sterile.
Not for use during pregnancy or breastfeeding, or by anyone under 18, because there is no safety information for these groups. People with an active cancer should not start it without discussing it with their cancer specialist.
Stop and seek medical care for signs of an allergic reaction, such as hives, swelling of the face or throat, or difficulty breathing.

Epitalon

No compounding pathway today. An FDA advisory committee recommendation is not a listing.

Epitalon is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

Safety in people has not been established. Without controlled human trials, its side effects and longer-term risks are not known.
FDA says compounded epitalon may pose a risk of immunogenicity (the immune system reacting to the peptide), and that it has not identified safety information for the proposed route of administration.
Injection under the skin can cause redness, swelling, pain or bruising at the site, and infection if the injection technique or the product is not sterile.
Not for use during pregnancy or breastfeeding, or by anyone under 18, because there is no safety information for these groups.
Stop and seek medical care for signs of an allergic reaction, such as hives, swelling of the face or throat, or difficulty breathing.

Semax

No compounding pathway today. An FDA advisory committee recommendation is not a listing.

Semax is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

Safety in people has not been established. Without large controlled human trials, its side effects and longer-term risks are not known.
FDA says compounded semax may pose a risk of immunogenicity (the immune system reacting to the peptide), and that it has no, or only limited, safety information for the proposed routes of administration.
The nasal form can irritate the lining of the nose. Injection under the skin can cause redness, swelling, pain or bruising at the site, and infection if the injection technique or the product is not sterile.
Not for use during pregnancy or breastfeeding, or by anyone under 18, because there is no safety information for these groups.
Stop and seek medical care for signs of an allergic reaction, such as hives, swelling of the face or throat, or difficulty breathing.

Selank

No compounding pathway today.

Selank is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

Selank is not FDA-approved, and its safety in people has not been established.
FDA's safety page says compounded selank acetate may pose a risk of immunogenicity, an immune reaction to the peptide, and that FDA lacks important information on its safety in people.
Side effects have not been characterized in large studies. Route-related effects are possible, such as irritation inside the nose with nasal use or reactions at the injection site.
There is no FDA label, so there is no formal list of contraindications. It should not be used during pregnancy or breastfeeding, where there are no safety data.

AOD-9604

No compounding pathway today.

AOD-9604 is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

AOD-9604 is not FDA-approved, and its safety in people has not been established.
FDA's safety page says compounded AOD-9604 may pose a significant risk of immunogenicity, an immune reaction to the peptide, and that little safety information is available.
FDA has also identified serious adverse events that may be associated with AOD-9604, although it says a causal link is not clear.
Reactions at the injection site are possible, as with any injected peptide.
There is no FDA label, so there is no formal list of contraindications. It should not be used after an allergic reaction to it, or during pregnancy or breastfeeding, where there are no safety data.

PT-141

Narrow 503A pathway as a component of an FDA-approved drug, limited by the rule on copies of approved drugs. Compounded versions are not FDA-approved.

Vyleesi is FDA-approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder. Compounded bremelanotide (PT-141) is a different product. It is not FDA-approved, it is not the same as Vyleesi, and FDA has not reviewed it.

The Vyleesi approval does not cover men or enhancing sexual performance.

Reported side effects and who should not use it

Nausea is the most commonly reported side effect on the approved label, sometimes severe enough to need anti-nausea treatment or to stop. Flushing, injection site reactions, headache and vomiting are also common.
Blood pressure rises and heart rate falls for a period after each dose, usually returning to baseline within about 12 hours. It must not be used by anyone with uncontrolled high blood pressure or known cardiovascular disease, and it is not recommended for people at high cardiovascular risk.
Darkening of the skin in patches, including on the face, gums or breasts, has been reported. It is more likely with darker skin and with more frequent use, and it did not always resolve.
It may sharply reduce the effect of oral naltrexone, so it should not be used with naltrexone taken by mouth for alcohol or opioid use disorder.
Animal studies suggest a possible risk to a developing fetus, and human pregnancy data are insufficient. The approved label advises stopping if pregnancy is suspected.
The safety of compounded bremelanotide, and of any nasal form, has not been established in clinical trials.

GHK-Cu Injection

No compounding pathway today.

GHK-Cu Injection is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

The safety of injected GHK-Cu in people has not been established. Side effects, interactions and longer-term risks are not adequately characterized.
Injection can cause pain, redness, swelling or bruising, and carries an infection risk if the product or injection technique is not sterile.
People with Wilson's disease, another disorder of copper metabolism or a known copper allergy require specific medical review before considering a copper-containing product.
Safety data are insufficient during pregnancy or breastfeeding. These groups should not use this product.
Seek urgent medical care for trouble breathing, swelling of the face or throat, or other signs of a serious allergic reaction.

BPC-157 Capsules

No compounding pathway today. An FDA advisory committee recommendation is not a listing.

BPC-157 Capsules is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

Safety in people has not been established. Side effects, interactions and longer-term risks of oral BPC-157 are not adequately characterized.
Immune or allergic reactions to a peptide or an ingredient are possible. An oral format does not remove these concerns.
How this formulation is absorbed and how food, medicines or supplements affect it have not been established.
Safety information is insufficient for use during pregnancy or breastfeeding or in people under 18. These groups should not use this product.
Seek urgent medical care for trouble breathing, swelling of the face or throat, or other signs of a serious allergic reaction.

Topical GHK-Cu

In FDA's 503A Category 1: interim enforcement discretion, not the bulks list.

Reported side effects and who should not use it

Topical use can cause skin irritation, redness or an allergic reaction. Reactions may involve GHK-Cu or another ingredient in the formulation.
Long-term safety information and interaction data for the specific formulation are limited.
People with Wilson's disease, another disorder of copper metabolism or a known copper allergy require specific medical review before considering a copper-containing product.
Safety data are insufficient during pregnancy or breastfeeding. Do not use in these circumstances without medical advice.
Stop using the product and seek medical advice if a reaction develops. Seek urgent care for trouble breathing or swelling of the face or throat.

Wolverine Stack

No compounding pathway today. An FDA advisory committee recommendation is not a listing.

The Wolverine Stack combination is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

The safety of this particular mixture in people has not been established. Combining ingredients can introduce effects and interactions that studies of one ingredient do not capture.
Immune reactions, including allergic reactions to a peptide or an impurity, are possible. The frequency and longer-term risks are not established.
Injection can cause pain, redness, swelling or bruising. Infection is possible if the product or injection technique is not sterile.
Safety information is insufficient for use during pregnancy or breastfeeding or in people under 18. These groups should not use this product.
Seek urgent medical care for trouble breathing, swelling of the face or throat, or other signs of a serious allergic reaction.

GLOW Stack

No compounding pathway today.

The GLOW Stack combination is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

The safety of this particular mixture in people has not been established. Combining ingredients can introduce effects and interactions that studies of one ingredient do not capture.
Immune reactions, including allergic reactions to a peptide or an impurity, are possible. The frequency and longer-term risks are not established.
Injection can cause pain, redness, swelling or bruising. Infection is possible if the product or injection technique is not sterile.
Safety information is insufficient for use during pregnancy or breastfeeding or in people under 18. These groups should not use this product.
Seek urgent medical care for trouble breathing, swelling of the face or throat, or other signs of a serious allergic reaction.
A copper-containing product requires specific review for anyone with Wilson's disease or another disorder of copper metabolism, or a known copper allergy.

KLOW Stack

No compounding pathway today.

The KLOW Stack combination is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

The safety of this particular mixture in people has not been established. Combining ingredients can introduce effects and interactions that studies of one ingredient do not capture.
Immune reactions, including allergic reactions to a peptide or an impurity, are possible. The frequency and longer-term risks are not established.
Injection can cause pain, redness, swelling or bruising. Infection is possible if the product or injection technique is not sterile.
Safety information is insufficient for use during pregnancy or breastfeeding or in people under 18. These groups should not use this product.
Seek urgent medical care for trouble breathing, swelling of the face or throat, or other signs of a serious allergic reaction.
A copper-containing product requires specific review for anyone with Wilson's disease or another disorder of copper metabolism, or a known copper allergy.

Semax / Selank Injection

No compounding pathway today.

The Semax / Selank Injection combination is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

The safety of semax and selank together has not been established. Side effects, interactions and longer-term risks of the mixture are not adequately characterized.
Both peptides raise concerns about immune reactions, including reactions to the peptide or impurities.
Nasal use can cause irritation inside the nose. Injectable use can cause pain, swelling or bruising and carries an infection risk if sterility fails.
Safety information is insufficient for use during pregnancy or breastfeeding or in people under 18. These groups should not use this product.
Seek urgent medical care for trouble breathing, swelling of the face or throat, or other signs of a serious allergic reaction.

Kisspeptin Injection

No compounding pathway today.

Kisspeptin Injection is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

Safety information for kisspeptin-10 is limited. Side effects and longer-term risks of this formulation have not been adequately established.
Peptide-related immune reactions and impurities are safety concerns. Prior allergic or immune reactions require review.
Injection can cause pain, redness, swelling or bruising. Infection is possible if the product or injection technique is not sterile.
Safety information is insufficient for use during pregnancy or breastfeeding or in people under 18. These groups should not use this product.
Seek urgent medical care for trouble breathing, swelling of the face or throat, or other signs of a serious allergic reaction.

DSIP Injection

No compounding pathway today.

DSIP Injection is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Reported side effects and who should not use it

Safety in people has not been established. Side effects and longer-term risks of emideltide are not adequately characterized.
Immune reactions to the peptide or impurities are a concern, and limited safety information makes the frequency of adverse effects uncertain.
Injection can cause pain, redness, swelling or bruising. Infection is possible if the product or injection technique is not sterile.
Safety information is insufficient for use during pregnancy or breastfeeding or in people under 18. These groups should not use this product.
Seek urgent medical care for trouble breathing, swelling of the face or throat, or other signs of a serious allergic reaction.

Reporting

How to report a side effect.

Tell your provider first, so they can decide what to do about your treatment.

You can also report a side effect directly to FDA through MedWatch, FDA’s safety information and adverse event reporting program, online or by phone. You do not need your provider to file it, and reports about compounded medications are accepted. Reports help FDA see problems with a product or a pharmacy that no single patient can.

It helps to have the product name, the pharmacy named on the label, the lot number, when you started, and what happened.

FDA MedWatch

FDA’s program for reporting side effects and product problems with medications, including compounded medications.

Report to MedWatch on fda.gov →

If this is a medical emergency, call 911.

FDA status tracker Questions and answers