VELSIPITY™ What are the possible side effects of VELSIPITY?

(etrasimod)

What are the possible side effects of VELSIPITY?

VELSIPITY can cause serious side effects, including:
See "What is the most important information I should know about VELSIPITY?"

Liver problems. VELSIPITY may cause liver problems. Your healthcare provider will do blood tests to check your liver before you start taking VELSIPITY. Call your healthcare provider right away if you have any of the following symptoms:
unexplained nausea
vomiting
stomach area (abdominal pain)
tiredness
loss of appetite
yellowing of the whites of your eyes or skin
dark colored urine
 
If you develop any of these symptoms, your healthcare provider will do blood tests to check your liver and may stop your treatment with VELSIPITY.

Increased blood pressure. Your healthcare provider should check your blood pressure during treatment with VELSIPITY and treat you as needed.

A problem with your vision called macular edema. Your healthcare provider should test your vision around the time you start taking VELSIPITY or at any time you notice vision changes during your treatment with VELSIPITY. Call your healthcare provider right away if you have any of the following symptoms:
blurriness or shadows in the center of your vision
sensitivity to light
a blind spot in the center of your vision
unusually colored vision
Types of skin cancer. Certain types of skin cancer have happened with medicines in the same class as VELSIPITY. Limit the amount of time you spend in sunlight and ultraviolet (UV) light while taking VELSIPITY. Wear protective clothing and use a sunscreen with a high sun protection factor. Tell your healthcare provider if you have any changes in the appearance of your skin.

Swelling and narrowing of the blood vessels in your brain. A condition called Posterior Reversible Encephalopathy Syndrome (PRES) has happened with drugs in the same class. Symptoms of PRES usually get better when you discontinue treatment. If not treated, PRES may cause a stroke. Call your healthcare provider right away if you have any of the following symptoms:
o
sudden severe headache
o
sudden confusion
o
sudden loss of vision or other changes in your vision
o
seizure
o
If you develop any of these symptoms, your healthcare provider will stop treatment with VELSIPITY.
Breathing problems. Some people who take medicines in the same class as VELSIPITY may experience shortness of breath. Your healthcare provider may do tests to check your breathing during treatment with VELSIPITY. Call your healthcare provider right away if you have new or worsening breathing problems.

The most common side effects of VELSIPITY include headache, elevated liver tests, and dizziness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of VELSIPITY.

For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Pfizer at 1-800-438-1985.

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What are the possible side effects of VELSIPITY?

What are the possible side effects of VELSIPITY?

VELSIPITY can cause serious side effects, including:
See "What is the most important information I should know about VELSIPITY?"

Liver problems. VELSIPITY may cause liver problems. Your healthcare provider will do blood tests to check your liver before you start taking VELSIPITY. Call your healthcare provider right away if you have any of the following symptoms:
unexplained nausea
vomiting
stomach area (abdominal pain)
tiredness
loss of appetite
yellowing of the whites of your eyes or skin
dark colored urine
 
If you develop any of these symptoms, your healthcare provider will do blood tests to check your liver and may stop your treatment with VELSIPITY.

Increased blood pressure. Your healthcare provider should check your blood pressure during treatment with VELSIPITY and treat you as needed.

A problem with your vision called macular edema. Your healthcare provider should test your vision around the time you start taking VELSIPITY or at any time you notice vision changes during your treatment with VELSIPITY. Call your healthcare provider right away if you have any of the following symptoms:
blurriness or shadows in the center of your vision
sensitivity to light
a blind spot in the center of your vision
unusually colored vision
Types of skin cancer. Certain types of skin cancer have happened with medicines in the same class as VELSIPITY. Limit the amount of time you spend in sunlight and ultraviolet (UV) light while taking VELSIPITY. Wear protective clothing and use a sunscreen with a high sun protection factor. Tell your healthcare provider if you have any changes in the appearance of your skin.

Swelling and narrowing of the blood vessels in your brain. A condition called Posterior Reversible Encephalopathy Syndrome (PRES) has happened with drugs in the same class. Symptoms of PRES usually get better when you discontinue treatment. If not treated, PRES may cause a stroke. Call your healthcare provider right away if you have any of the following symptoms:
o
sudden severe headache
o
sudden confusion
o
sudden loss of vision or other changes in your vision
o
seizure
o
If you develop any of these symptoms, your healthcare provider will stop treatment with VELSIPITY.
Breathing problems. Some people who take medicines in the same class as VELSIPITY may experience shortness of breath. Your healthcare provider may do tests to check your breathing during treatment with VELSIPITY. Call your healthcare provider right away if you have new or worsening breathing problems.

The most common side effects of VELSIPITY include headache, elevated liver tests, and dizziness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of VELSIPITY.

For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Pfizer at 1-800-438-1985.

Prescribing Information
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Health Professional Information

What are the possible side effects of VELSIPITY?

What are the possible side effects of VELSIPITY?

VELSIPITY can cause serious side effects, including:
See "What is the most important information I should know about VELSIPITY?"

Liver problems. VELSIPITY may cause liver problems. Your healthcare provider will do blood tests to check your liver before you start taking VELSIPITY. Call your healthcare provider right away if you have any of the following symptoms:
unexplained nausea
vomiting
stomach area (abdominal pain)
tiredness
loss of appetite
yellowing of the whites of your eyes or skin
dark colored urine
 
If you develop any of these symptoms, your healthcare provider will do blood tests to check your liver and may stop your treatment with VELSIPITY.

Increased blood pressure. Your healthcare provider should check your blood pressure during treatment with VELSIPITY and treat you as needed.

A problem with your vision called macular edema. Your healthcare provider should test your vision around the time you start taking VELSIPITY or at any time you notice vision changes during your treatment with VELSIPITY. Call your healthcare provider right away if you have any of the following symptoms:
blurriness or shadows in the center of your vision
sensitivity to light
a blind spot in the center of your vision
unusually colored vision
Types of skin cancer. Certain types of skin cancer have happened with medicines in the same class as VELSIPITY. Limit the amount of time you spend in sunlight and ultraviolet (UV) light while taking VELSIPITY. Wear protective clothing and use a sunscreen with a high sun protection factor. Tell your healthcare provider if you have any changes in the appearance of your skin.

Swelling and narrowing of the blood vessels in your brain. A condition called Posterior Reversible Encephalopathy Syndrome (PRES) has happened with drugs in the same class. Symptoms of PRES usually get better when you discontinue treatment. If not treated, PRES may cause a stroke. Call your healthcare provider right away if you have any of the following symptoms:
o
sudden severe headache
o
sudden confusion
o
sudden loss of vision or other changes in your vision
o
seizure
o
If you develop any of these symptoms, your healthcare provider will stop treatment with VELSIPITY.
Breathing problems. Some people who take medicines in the same class as VELSIPITY may experience shortness of breath. Your healthcare provider may do tests to check your breathing during treatment with VELSIPITY. Call your healthcare provider right away if you have new or worsening breathing problems.

The most common side effects of VELSIPITY include headache, elevated liver tests, and dizziness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of VELSIPITY.

For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Pfizer at 1-800-438-1985.

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If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.