Risk Information

If something is going wrong right now

This page is not for emergencies. If you are having a severe allergic reaction, chest pain, difficulty breathing, sudden vision or hearing loss, or an erection lasting more than four hours, stop and seek emergency medical care or call 911. Do not wait to message your provider.

Reporting a side effect

Tell your provider about any side effect through your account messaging. You can also report adverse events directly to FDA through MedWatch at fda.gov/safety/medwatch or by calling 1-800-FDA-1088. Reporting to us does not replace reporting to FDA, and it does not replace getting care.

Compounded GLP-1 medications (semaglutide, tirzepatide)

Semaglutide and tirzepatide are the active ingredients in FDA-approved products manufactured by Novo Nordisk and Eli Lilly. What we dispense is a compounded preparation containing those ingredients, prepared for an individual patient by a state board-licensed 503A compounding pharmacy under a prescription from a licensed provider. Compounded medications are not FDA-approved and are not generic equivalents of any approved drug. FDA does not review them for safety, effectiveness, or quality.

• The FDA-approved products in this class carry a boxed warning regarding thyroid C-cell tumours observed in rodents. They are contraindicated in anyone with a personal or family history of medullary thyroid carcinoma, or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Your provider screens for this before prescribing.
• Common adverse effects include nausea, vomiting, diarrhoea, constipation and abdominal pain, and are typically most pronounced when a dose increases.
• Serious reported risks include pancreatitis, gallbladder disease, kidney injury from dehydration, and diabetic retinopathy complications.
• Not appropriate in pregnancy, or where a provider identifies another contraindication.
• Tell your provider about every medication you take, including insulin and sulfonylureas, which change the risk picture.

Testosterone and hormone therapy

Testosterone is a Schedule III controlled substance. Prescribing it is subject to DEA telemedicine rules and state controlled-substance requirements in addition to ordinary standards of care. Testosterone cypionate is dispensed as the FDA-approved commercial vial; testosterone cream is compounded. Compounded hormone preparations, including compounded testosterone, Biest, progesterone and thyroid preparations, are not FDA-approved drug products. Estriol is not a component of any FDA-approved drug.

• Testosterone therapy requires baseline and ongoing laboratory monitoring. Your provider determines what testing is required and when.
• Reported risks include erythrocytosis, effects on fertility and spermatogenesis, worsening of sleep apnoea, acne, and cardiovascular considerations your provider will review against your history.
• Not appropriate in pregnancy, in anyone who is or may become pregnant, or where a provider identifies a contraindication such as active prostate or breast malignancy.
• FDA has raised concerns specifically about marketing compounded hormone preparations as safer or more natural than approved products. We do not make that claim and you should be sceptical of anyone who does.

Peptide protocols (sermorelin, tesamorelin)

These are prescription compounds, not supplements. Each requires a clinical evaluation before a prescription can be written. Sermorelin acetate was formerly approved in the United States as Geref, discontinued in 2008; there is no FDA-approved sermorelin product today. Use for body composition, sleep, recovery or anti-aging is off-label. Ingredient-level research on any of these compounds is separate from what the finished compounded products have been individually studied for.

• Growth hormone and IGF-1 are mitogenic. These protocols are not appropriate in active malignancy, in disruption of the hypothalamic-pituitary axis, or in pregnancy.
• Growth hormone induces insulin resistance, which matters if you are diabetic or pre-diabetic.
• These therapies are not FDA-approved for anti-aging or longevity purposes.

Sexual health (sildenafil, tadalafil, bremelanotide)

Sildenafil and tadalafil tablets are dispensed as FDA-approved generic medications. The combination preparations (the sildenafil/tadalafil/bremelanotide ODT, Fem Max and Olympus Male) are compounded, prepared for an individual patient by a state board-licensed 503A pharmacy under a prescription written for that patient. A compounded preparation is not an FDA-approved drug product, is not a generic equivalent of any approved drug, and FDA does not review it for safety, effectiveness or quality. Bremelanotide is FDA-approved as Vyleesi for acquired, generalised hypoactive sexual desire disorder in premenopausal women; any other use is off-label, and compounded bremelanotide is not an FDA-approved drug product.

• PDE5 inhibitors must not be combined with nitrates in any form. This combination can cause a life-threatening drop in blood pressure. Tell your provider about every medication you take.
• Use caution with alpha-blockers and with certain cardiovascular conditions. Your provider reviews your cardiac history before prescribing.
• Seek immediate medical attention for an erection lasting more than four hours, or for sudden vision or hearing loss.
• Bremelanotide commonly causes nausea, and can raise blood pressure and lower heart rate transiently after a dose.

Longevity and wellness injections (NAD+, glutathione, B12)

Compounded NAD+, glutathione and B12 preparations are not FDA-approved drug products. They are prepared for an individual patient by a state board-licensed 503A compounding pharmacy under a valid prescription. Use for energy, longevity, detoxification, recovery or cellular health is not an FDA-approved indication. These are prescription compounds, not supplements.

• Injection-site reactions are the most commonly reported effect.
• Rapid administration of NAD+ is associated with flushing, nausea and chest tightness. These are dispensed for subcutaneous self-administration; we do not provide IV infusion.
• Not appropriate in pregnancy or where a provider identifies a contraindication.
• No NAD+ therapy has been shown to slow or reverse aging in humans.

Hair loss (finasteride, minoxidil)

Finasteride is FDA-approved for androgenetic alopecia in men, and we dispense the approved generic. Oral minoxidil is FDA-approved as Loniten for hypertension; low-dose use for hair loss is off-label. A compounded finasteride/minoxidil topical has no approved equivalent and is not an FDA-approved drug product.

• Finasteride is contraindicated in pregnancy and must not be handled by anyone who is or may become pregnant.
• Reported risks of finasteride include sexual adverse effects, some of which have been reported to persist after stopping, and mood changes. Raise any history of depression with your provider.
• Oral minoxidil affects blood pressure and fluid balance, and can cause tachycardia and pericardial effects. Your provider reviews your cardiovascular history before prescribing it.

Weight-management adjuncts (MIC-B12, low-dose naltrexone, ondansetron)

These are compounded or off-label prescriptions used alongside a weight-management protocol where a provider determines they are appropriate. Low-dose naltrexone is a strength that is not commercially manufactured — the approved product is 50mg — which is a legitimate reason to compound and is documented as such.

• Naltrexone must not be taken with opioid medication and will precipitate withdrawal in anyone who is opioid-dependent. Tell your provider about every medication you take.
• Ondansetron can affect cardiac conduction. Your provider reviews your history and other medications before prescribing it.
• Lipotropic injections are not FDA-approved for weight loss and we make no weight-loss efficacy claim for them.

This list is not exhaustive

No web page can substitute for the approved prescribing information for a medication or for a conversation with the clinician who has read your history. Where an FDA-approved product exists, read its labelling. Where one does not, understand that the compounded preparation has not been evaluated by FDA at all, and ask your provider what that means for you.