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Vyleesi can cause serious side effects, including:
Temporary increase in blood pressure and decrease in heart rate: An increase in blood pressure and decrease in heart rate can happen shortly after you inject Vyleesi. These changes usually go away within 12 hours after your injection. Increases in blood pressure and an increased risk of heart (cardiovascular) problems can happen if you use Vyleesi more often than prescribed by your healthcare professional.

See How should I use Vyleesi?

Darkening of the skin on certain parts of the body (focal hyperpigmentation) including the face, gums (gingiva) and breast. The chance of darkening of the skin is increased in people with darker skin color. The chance of darkening of the skin is higher if Vyleesi is used every day. Darkening of the skin may not go away, even after you stop using Vyleesi. Tell your healthcare professional if you have any concerns about changes to your skin.

Nausea. Nausea is common and can also be severe. Nausea most commonly happens after the first Vyleesi injection but can also happen after any dose of Vyleesi. The nausea usually lasts for about 2 hours but can last longer in some people. The nausea usually goes away by itself. Tell your healthcare professional if you have nausea that is severe or does not go away. Your healthcare professional may prescribe an anti-nausea medicine for you.
The most common side effects of Vyleesi include:

These are not all the possible side effects of Vyleesi.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

For more information about using Vyleesi, please read the Vyleesi Patient Information.

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