Safety, in plain words.
Updated October 28, 2026. Safety information for every RULE Longevity program. Read it before your online visit, and ask your licensed provider about anything that is unclear.
Prescription only. A licensed provider reviews your health history in an online visit and decides whether this program is appropriate for you. Tell your provider about every medication, supplement, allergy and condition, and whether you are pregnant, trying to conceive or breastfeeding. If you have a severe reaction, trouble breathing, chest pain or swelling of the face or throat, call 911.
Compounded medications
Compounded medications are prepared by a licensed US pharmacy for an individual patient. They are not FDA-approved, and the FDA does not verify their safety, effectiveness or quality before they are dispensed. RULE Longevity semaglutide, tirzepatide, sermorelin, NAD+, glutathione, PT-141 and GHK-Cu cream are compounded.
Report a side effect
Message your care team through your account. You can also report to the FDA MedWatch program at fda.gov/medwatch. In an emergency, call 911.
Semaglutide Weight Program
- The most common effects are nausea, vomiting, diarrhea, constipation and stomach pain, especially when the dose goes up.
- Brand semaglutide carries a boxed warning about thyroid C-cell tumors seen in rodents. Do not use it if you or your family have had medullary thyroid cancer or MEN 2.
- Get care right away for severe stomach pain that does not go away (possible pancreatitis), pain in the upper right belly or yellow skin (possible gallbladder problems), or signs of an allergic reaction.
- Low blood sugar is more likely if you also take insulin or a sulfonylurea. Tell your provider about every diabetes medicine.
- Brand semaglutide (Wegovy, Ozempic) is FDA-approved. The FDA declared the semaglutide shortage over in February 2025 and has raised concerns about compounded versions.
Not for:
- A personal or family history of medullary thyroid cancer or MEN 2
- Pregnancy, trying to conceive or breastfeeding
- A history of pancreatitis, unless your provider approves
- Type 1 diabetes
Compounded medications are prepared by a licensed US pharmacy for an individual patient. They are not FDA-approved, and the FDA does not verify their safety, effectiveness or quality before they are dispensed.
Sources: FDA label via DailyMed, Wegovy (semaglutide) prescribing information, MedlinePlus, Semaglutide Injection, FDA, FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, NIDDK, Prescription Medications to Treat Overweight and Obesity. Program page.
Tirzepatide Weight Program
- Nausea, diarrhea, vomiting, constipation and reduced appetite are common, mostly as the dose increases.
- Brand tirzepatide carries a boxed warning about thyroid C-cell tumors seen in rodents. Do not use it if you or your family have had medullary thyroid cancer or MEN 2.
- Get care right away for severe ongoing stomach pain, gallbladder symptoms, signs of dehydration or an allergic reaction.
- Tirzepatide can make birth control pills less effective after starting and after each dose increase. Ask your provider about a backup method.
- Brand tirzepatide (Zepbound, Mounjaro) is FDA-approved. The FDA ended the tirzepatide shortage in December 2024 and has raised concerns about compounded versions.
Not for:
- A personal or family history of medullary thyroid cancer or MEN 2
- Pregnancy, trying to conceive or breastfeeding
- A history of pancreatitis, unless your provider approves
- Type 1 diabetes
Compounded medications are prepared by a licensed US pharmacy for an individual patient. They are not FDA-approved, and the FDA does not verify their safety, effectiveness or quality before they are dispensed.
Sources: FDA label via DailyMed, Zepbound (tirzepatide) prescribing information, MedlinePlus, Tirzepatide Injection, FDA, FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, NIDDK, Prescription Medications to Treat Overweight and Obesity. Program page.
Sermorelin
- Common effects include redness, swelling or pain where you inject, flushing, headache and trouble sleeping.
- Injections go under the skin with a small needle, following the written directions that come with your prescription. Redness, stinging or a small bump where you inject are common. Never share or reuse needles, and use a sharps container.
- Growth hormone affects blood sugar and other hormones, so your provider may ask about diabetes, thyroid conditions and medicines first.
- Sermorelin may be prohibited in tested sport. Check your sport's anti-doping rules before starting.
Not for:
- Active cancer or a history of cancer unless your provider approves
- Pregnancy or breastfeeding
- Anyone under 18
- Untreated thyroid problems
Compounded medications are prepared by a licensed US pharmacy for an individual patient. They are not FDA-approved, and the FDA does not verify their safety, effectiveness or quality before they are dispensed.
Sources: Federal Register, Determination That Geref (sermorelin acetate) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (2013), Walker RF, Sermorelin: a better approach to management of adult-onset growth hormone insufficiency? Clin Interv Aging 2006, Khorram O et al., Endocrine and metabolic effects of long-term administration of a GHRH-(1-29) analog in age-advanced men and women, 1997, FDA, Compounding and the FDA: Questions and Answers. Program page.
NAD+ Injection
- Commonly reported effects include flushing, nausea, headache, stinging where you inject and a feeling of chest tightness, especially if injected quickly.
- Injections go under the skin with a small needle, following the written directions that come with your prescription. Redness, stinging or a small bump where you inject are common. Never share or reuse needles, and use a sharps container.
- Prescriptions are filled only by licensed US pharmacies, because injectables made with unsuitable ingredients have caused reactions.
Not for:
- Pregnancy or breastfeeding
- Anyone who has reacted badly to NAD+ before
- Anyone under 18
Compounded medications are prepared by a licensed US pharmacy for an individual patient. They are not FDA-approved, and the FDA does not verify their safety, effectiveness or quality before they are dispensed.
Sources: Radenkovic D, Reason, Verdin E, Clinical Evidence for Targeting NAD Therapeutically, Pharmaceuticals 2020, Grant R et al., Changes in the human plasma and urine NAD+ metabolome during a 6 hour intravenous infusion of NAD+, 2019, FDA, Compounding and the FDA: Questions and Answers. Program page.
Glutathione Injection
- Possible effects include pain or redness where you inject, stomach upset and allergic reactions.
- Injections go under the skin with a small needle, following the written directions that come with your prescription. Redness, stinging or a small bump where you inject are common. Never share or reuse needles, and use a sharps container.
- In 2026 the FDA warned compounders not to use dietary supplement grade glutathione for injections after patient reactions. RULE Longevity prescriptions are filled only by licensed US pharmacies.
Not for:
- Pregnancy or breastfeeding
- Asthma, unless your provider approves
- Anyone under 18
- Anyone seeking skin lightening, which is not what this program is for
Compounded medications are prepared by a licensed US pharmacy for an individual patient. They are not FDA-approved, and the FDA does not verify their safety, effectiveness or quality before they are dispensed.
Sources: FDA, FDA reminds compounders not to use dietary supplement grade glutathione for injectables (2026), Dilokthornsakul W et al., The clinical effect of glutathione on skin color and other related skin conditions: a systematic review, FDA, Compounding and the FDA: Questions and Answers. Program page.
PT-141
- Nausea is the most common side effect; in the brand product's trials about 40% of women had nausea.
- It can raise blood pressure and lower heart rate for several hours after a dose.
- Darkening of the gums and skin on the face or breasts has been reported and may not fully fade.
- Injections go under the skin with a small needle, following the written directions that come with your prescription. Redness, stinging or a small bump where you inject are common. Never share or reuse needles, and use a sharps container.
Not for:
- Uncontrolled high blood pressure or known heart disease
- Pregnancy
- Anyone taking oral naltrexone without provider review
Compounded medications are prepared by a licensed US pharmacy for an individual patient. They are not FDA-approved, and the FDA does not verify their safety, effectiveness or quality before they are dispensed.
Sources: FDA label via DailyMed, Vyleesi (bremelanotide injection) prescribing information, MedlinePlus, Bremelanotide Injection, Diamond LE et al., Double-blind, placebo-controlled evaluation of intranasal PT-141 in healthy males and men with mild to moderate erectile dysfunction, 2004, FDA, Compounding and the FDA: Questions and Answers. Program page.
Tadalafil
- Common effects include headache, indigestion, back pain, muscle aches, flushing and a stuffy nose.
- Never take it with nitrates or riociguat: the combination can drop blood pressure dangerously.
- Get emergency care for an erection lasting more than 4 hours, sudden vision loss or sudden hearing loss.
- Alpha blockers and large amounts of alcohol can add to blood pressure drops.
Not for:
- Anyone who takes nitrates (such as nitroglycerin) or riociguat
- Men told to avoid sexual activity for heart reasons
- Severe liver or kidney disease, unless your provider approves
Sources: FDA label, Cialis (tadalafil) tablets prescribing information, MedlinePlus, Tadalafil, American Urological Association, Erectile Dysfunction (ED) Guideline. Program page.
Sildenafil
- Common effects include headache, flushing, upset stomach, stuffy nose and changes in color vision.
- Never take it with nitrates or riociguat: the combination can drop blood pressure dangerously.
- Get emergency care for an erection lasting more than 4 hours, sudden vision loss or sudden hearing loss.
- A heavy, high-fat meal can delay how fast it works.
Not for:
- Anyone who takes nitrates (such as nitroglycerin) or riociguat
- Men told to avoid sexual activity for heart reasons
- Recent stroke or heart attack, unless your provider approves
Sources: FDA label, Viagra (sildenafil citrate) tablets prescribing information, MedlinePlus, Sildenafil, American Urological Association, Erectile Dysfunction (ED) Guideline. Program page.
Finasteride for Hair
- Sexual side effects, such as lower libido, erection problems and less ejaculate, are reported in a small share of men, and some reports describe them continuing after stopping.
- Depression and suicidal thoughts have been reported; the label added suicidal ideation in 2022. Tell your provider about mood changes right away. If you have thoughts of harming yourself, call or text 988.
- Women who are or may become pregnant should not handle crushed or broken tablets, because finasteride can harm a male fetus.
- Finasteride lowers PSA test results. Tell anyone checking your PSA that you take it.
- RULE Longevity offers oral tablets only. A 2025 FDA alert concerned compounded topical finasteride products.
Not for:
- Women, especially anyone who is or may become pregnant
- Anyone under 18
- Men with liver disease, unless their provider approves
Sources: FDA label, Propecia (finasteride) tablets prescribing information, 2022, MedlinePlus, Finasteride, FDA, Potential risks associated with compounded topical finasteride products (2025). Program page.
GHK-Cu 2% Copper Peptide Cream
- Stop using it and contact your care team if you develop redness, stinging, itching, swelling or a rash.
- Patch test on a small area first if your skin is reactive.
- For external use only. Avoid eyes and mucous membranes.
Not for:
- A known copper allergy or allergy to an ingredient
- Broken, infected or freshly treated skin, unless your provider says otherwise
- Pregnancy or breastfeeding, where there is not enough data
Compounded medications are prepared by a licensed US pharmacy for an individual patient. They are not FDA-approved, and the FDA does not verify their safety, effectiveness or quality before they are dispensed.
Sources: Pickart L, Margolina A, Regenerative and Protective Actions of the GHK-Cu Peptide in the Light of the New Gene Data, 2018, Pickart L et al., GHK Peptide as a Natural Modulator of Multiple Cellular Pathways in Skin Regeneration, 2015, FDA, Compounding and the FDA: Questions and Answers. Program page.
Progesterone
- Drowsiness and dizziness are common, so it is usually taken at bedtime. Do not drive if it makes you sleepy.
- Other effects can include breast tenderness, headache, mood changes and spotting.
- Report chest pain, sudden leg swelling, sudden vision changes, stroke symptoms or unusual bleeding right away.
Not for:
- A history of breast cancer, blood clots, stroke or heart attack
- Unexplained vaginal bleeding
- Liver disease
- Allergy to peanuts, since capsules may contain peanut oil
Sources: FDA label, Prometrium (progesterone) capsules prescribing information, 2026, The North American Menopause Society, The 2022 hormone therapy position statement, Menopause 2022, FDA, FDA approves labeling changes to menopausal hormone therapy products (February 2026). Program page.
Estradiol Patch
- Common effects include skin irritation where the patch sits, breast tenderness, headache and spotting.
- If you have a uterus, estrogen without a progestogen raises the risk of endometrial cancer; that warning stays on estrogen-alone products.
- In 2025 and 2026 the FDA began updating menopause hormone therapy labels and removing some boxed warning language. Your provider weighs your age, timing and history.
- Report chest pain, sudden leg swelling, stroke symptoms or any bleeding after menopause right away.
Not for:
- A history of breast or uterine cancer, blood clots, stroke or heart attack
- Active liver disease or unexplained vaginal bleeding
- Pregnancy
Sources: FDA label via DailyMed, Climara (estradiol transdermal system) prescribing information, MedlinePlus, Estradiol Transdermal Patch, The North American Menopause Society, The 2022 hormone therapy position statement, Menopause 2022, FDA, FDA approves labeling changes to menopausal hormone therapy products (February 2026), HHS fact sheet, FDA initiates removal of boxed warnings from menopausal hormone therapy products (November 2025). Program page.
Testosterone Therapy (TRT)
- Testosterone is a controlled substance with extra federal and state rules for prescribing.
- Testosterone therapy needs lab monitoring, including blood counts and PSA, and can affect fertility.
- This page is for the waitlist only. No testosterone is prescribed through RULE Longevity today.
Not for:
- Anyone trying to conceive soon, since testosterone can lower sperm production
- Men with untreated prostate or breast cancer
- Anyone under 18
Sources: Cappola AR et al., Hormones and Aging: An Endocrine Society Scientific Statement, 2023. Program page.
Safety questions
Are compounded medications safe?
Compounded medications are not FDA-approved, which means the FDA has not reviewed them for safety, effectiveness or quality before they are sold. RULE Longevity works only with licensed US pharmacies, and a licensed provider decides whether a compounded medication is appropriate for you. Talk with your provider about the risks and benefits.
What is a 503A compounding pharmacy?
A 503A pharmacy is a state-licensed pharmacy that compounds medication for an individual patient based on a valid prescription. It is regulated mainly by state boards of pharmacy, and the medications it compounds are not FDA-approved. When a brand drug is not in shortage, a 503A pharmacy may compound it only for a patient with a documented clinical need.
Is it safe to buy peptides online without a prescription?
No. Products sold online as research chemicals or not for human use skip provider review and licensed pharmacy standards. At RULE Longevity, every medication requires an online visit, a licensed provider decision and a licensed US pharmacy.
What should I do if I have a side effect?
Message your provider through your account and describe what you are feeling, and your provider will advise next steps. For severe symptoms such as trouble breathing, chest pain, severe stomach pain or fainting, call 911 or go to the nearest emergency room. Do not change your dose on your own.
