PT-141 Side Effects: Nausea, Blood Pressure and Skin

Key facts

• Compounded PT-141 is not FDA-approved and has no label, so this page draws on the label for Vyleesi®, an injection, and on published studies.
• Nausea is the most common side effect on the Vyleesi® label, and it was most common after the first dose.
• The Vyleesi® label warns of a temporary rise in blood pressure, and says the injection should not be used with uncontrolled high blood pressure or known cardiovascular disease.
• PT-141 is not a tanning product. The Vyleesi® label describes patches of darker skin that may not fade.
• CHROMA X Max tablets also hold tadalafil. An erection lasting longer than 4 hours is a medical emergency.

What are the side effects of PT-141?

Compounded PT-141 has no FDA label, so it has no official side effect list. The Vyleesi® label covers that injection only, but it is the only FDA label for this medicine. The injection was studied in premenopausal women. The most common side effects on that label are:

• Nausea
• Flushing
• Reactions at the injection site
• Headache

The same label also lists vomiting, cough, fatigue, hot flush, tingling, dizziness and a stuffy nose. It says most events were mild to moderate and passed, and that far more people stopped because of side effects on Vyleesi® than on placebo.

Those facts belong to that injection. Other forms may behave differently, and this comparison explains how absorption varies by route.

Does PT-141 cause nausea?

Nausea is the most common side effect on the Vyleesi® label. In the phase 3 trials it was far more common than with placebo. It usually began within an hour of a dose and lasted about two hours. It was most common after the first dose, and the label says it improves for most patients with the second.

Some patients needed anti-nausea medicine, and nausea was the most common side effect that led people to stop. The label also says that taking ondansetron beforehand did not reduce nausea in a study, so talk to your provider rather than trying something yourself. Report nausea that is severe or does not go away.

Does PT-141 raise blood pressure?

The Vyleesi® label says the injection raises blood pressure and lowers heart rate for a short time after each dose. The changes in its trials were temporary, but those trials studied premenopausal women, not men with ED, and none tested it with tadalafil. They are still the reason the label says it should not be used by people with uncontrolled high blood pressure or known cardiovascular disease, and does not recommend it for people at high risk of cardiovascular disease.

A published study notes that earlier research on a nasal form suggested it could raise blood pressure in both men and women, and that its absorption was less predictable than an injection.

Does PT-141 make you tan?

PT-141 is not a tanning product, though the question has a basis. Bremelanotide binds a receptor on the cells that make pigment. The Vyleesi® label says this can cause focal hyperpigmentation, which means patches of darker skin, including on the face, gums and breasts. That is not an even tan.

In the main trials a small share of patients had it. It was far more common in a study of daily use, and people with dark skin were more likely to get it. The FDA's approval announcement said it did not go away in about half of the patients who had it, even after they stopped, and the label limits how often Vyleesi® can be used partly for this reason. Tell your provider about any change in your skin.

Melanotan II, the peptide sold online for tanning, is a different substance. The comparison page covers it.

What are the side effects of PT-141 in men?

No FDA label covers PT-141 in men, so there is no official list. Use in men is outside the FDA-approved indication, and the evidence is limited. In early studies of nasal PT-141 in men, flushing and nausea were the most common side effects. A larger nasal trial reported more side effects than placebo, and that paper now carries an expression of concern.

CHROMA X Max tablets also hold tadalafil and oxytocin, and that mix has no FDA label either. These pages list no side effects for oxytocin, so ask your provider. For tadalafil on its own, the Cialis® label lists headache, indigestion, back pain, muscle aches, a stuffy nose, flushing and pain in a limb as the most common side effects. It says to stop and seek medical care for a sudden loss of vision or hearing, and to seek immediate medical attention for chest pain after taking it. Tell emergency staff you took tadalafil, because nitrates given for chest pain can be dangerous with it.

An erection lasting longer than 4 hours is a medical emergency. Go to an emergency department. The Cialis® label warns that priapism, if not treated promptly, can cause irreversible damage. Tell the staff what you took and name the medicines in it.

Who should not use PT-141?

Tell your provider about every medicine and condition before you start. The Vyleesi® label names these for that injection:

• Uncontrolled high blood pressure or known cardiovascular disease: it should not be used
• High risk of cardiovascular disease: it is not recommended
• Naltrexone taken by mouth for alcohol or opioid addiction: avoid, because it may lower naltrexone levels and treatment could fail
• Pregnancy: use effective contraception, and stop if pregnancy is suspected
• Oral medicines that need a certain level in the blood to work, such as some antibiotics: avoid, because it may slow their absorption
• Severe kidney or liver impairment: use with caution

The label also reports one case of acute hepatitis in a long-term study, and says the role of Vyleesi® could not be ruled out. Report any new symptom to your provider.

The safety information for CHROMA X Max adds nitrates, guanylate cyclase stimulators, other PDE5 medicines and cardiac medicines that lower blood pressure, because of the tadalafil. The Cialis® label also warns that alpha-blockers, blood pressure medicines or large amounts of alcohol taken with tadalafil may lower blood pressure. Your cardiovascular health is assessed before prescribing.

Frequently asked questions

About CHROMA23®

CHROMA23® brings weight loss, longevity, sexual health, hair, and skincare into one place. Every prescription decision is made by an independent provider licensed in the patient's state, where available, and every medication is dispensed by a state-licensed pharmacy. The assessment is free. One clear price per plan, shown in full before you pay. The medicine is real. The provider is real.

Sources

1. Vyleesi® (bremelanotide injection) full prescribing information, revised October 2026
2. MedlinePlus: bremelanotide injection
3. FDA: approval announcement for Vyleesi®, June 21, 2019 (archived copy)
4. White et al.: ambulatory blood pressure monitoring with bremelanotide (Journal of Hypertension, 2017)
5. Cialis® (tadalafil) full prescribing information
6. Diamond et al.: intranasal PT-141 in healthy men and men with erectile dysfunction (International Journal of Impotence Research, 2004)
7. Safarinejad and Hosseini: intranasal bremelanotide after sildenafil failure (Journal of Urology, 2008)
8. Journal of Urology: expression of concern on Safarinejad and Hosseini, 2023
9. Böhm et al.: benefits and risks of chronic melanocortin 1 receptor activation (Journal of the European Academy of Dermatology and Venereology, 2024)
10. FDA: compounding and the FDA, questions and answers

Keep reading