INLYTA® What are the possible side effects of INLYTA?

(axitinib)

What are the possible side effects of INLYTA?

INLYTA may cause serious side effects, including:
•
High blood pressure (hypertension). High blood pressure is common with INLYTA and may sometimes be severe. Your healthcare provider should check your blood pressure regularly during treatment with INLYTA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA.
•
Blood clots in your veins or arteries. INLYTA can cause blood clots which can be serious, and sometimes lead to death. Get emergency help and call your healthcare provider if you get any of the following symptoms:
o
chest pain or pressure
o
pain in your arms, back, neck or jaw
o
shortness of breath
o
numbness or weakness on one side of your body
o
trouble talking
o
headache
o
vision changes
•
Bleeding. INLYTA can cause bleeding which can be serious, and sometimes lead to death. Call your healthcare provider right away or get medical help if you develop any of the following signs or symptoms:
o
unexpected bleeding or bleeding that lasts a long time, such as:
•
unusual bleeding from the gums
•
menstrual bleeding or vaginal bleeding that is heavier than normal
•
bleeding that is severe or you cannot control
•
pink or brown urine
•
red or black stools (looks like tar)
•
bruises that happen without a known cause or get larger
•
cough up blood or blood clots
•
vomit blood or your vomit looks like "coffee grounds"
o
unexpected pain, swelling, or joint pain
o
headaches, feeling dizzy or weak
•
Heart failure. Your healthcare provider should check you for signs or symptoms of heart failure regularly during treatment with INLYTA. Heart failure can be serious and can sometimes lead to death. Tell your healthcare provider if you have any of the following symptoms during your treatment with INLYTA:
o
tiredness
o
swelling of your stomach-area (abdomen), legs or ankles
o
shortness of breath
o
protruding neck veins
•
Tear in your stomach or intestinal wall (perforation). A tear in your stomach or intestinal wall can be serious and can sometimes lead to death. Get medical help right away if you get the following symptoms:
o
severe stomach-area (abdominal) pain or stomach-area pain that does not go away
o
vomit blood
o
red or black stools
•
Thyroid gland problems. Your healthcare provider should do blood tests to check your thyroid gland function before and during your treatment with INLYTA. Tell your healthcare provider if you have any of the following symptoms during your treatment with INLYTA:
o
tiredness that worsens or that does not go away
o
feeling hot or cold
o
your voice deepens
o
weight gain or weight loss
o
hair loss
o
muscle cramps and aches
•
Risk of wound healing problems. Wounds may not heal properly during INLYTA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with INLYTA.
o
You should stop taking INLYTA at least 2 days before planned surgery.
o
Your healthcare provider should tell you when you may start taking INLYTA again after surgery.
•
Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen during treatment with INLYTA. Call your healthcare provider right away if you get:
o
headache
o
seizures
o
weakness
o
confusion
o
high blood pressure
o
blindness or change in vision
o
problems thinking
•
Protein in your urine. Your healthcare provider should check your urine for protein before and during your treatment with INLYTA. If you develop protein in your urine, your healthcare provider may decrease your dose of INLYTA or stop your treatment.
•
Liver problems. Your healthcare provider will do blood tests before and during your treatment with INLYTA. Your healthcare provider may delay or stop your treatment with INLYTA if you develop severe liver problems.
Tell your healthcare provider right way if you have any of the following symptoms:
o
yellowing of your skin or the whites of your eyes
o
severe nausea or vomiting
o
pain on the right side of your stomach area (abdomen)
o
dark urine (tea colored)
o
bleeding or bruising more easily than normal
•
Heart problems. When INLYTA is used with the medicine avelumab, severe heart problems can happen and can lead to death. Your healthcare provider will check you for heart problems during your treatment with INLYTA. Tell your healthcare provider right away or get medical help if you have any of the following symptoms:
o
swelling of your stomach-area, legs, hands feet or ankles
o
shortness of breath
o
nausea or vomiting
o
new or worsening chest discomfort, including pain or pressure
o
weight gain
o
pain or discomfort in your arms, back, neck, or jaw
o
breaking out in a cold sweat
o
feeling lightheaded or dizzy

The most common side effects of INLYTA with avelumab include:

o
diarrhea
o
feeling tired
o
high blood pressure
o
muscle and bone pain
o
nausea
o
mouth sores
o
rash, redness, itching, or peeling of your skin on your hands and feet
o
hoarseness
o
decreased appetite
o
low levels of thyroid hormone
o
rash
o
liver problems
o
cough
o
shortness of breath
o
stomach-area (abdomen) pain
o
headache

The most common side effects of INLYTA with pembrolizumab include:

o
diarrhea
o
feeling tired or weak
o
high blood pressure
o
liver problems
o
low levels of thyroid hormone
o
decreased appetite
o
rash, redness, itching or peeling of your skin on your hands and feet
o
nausea
o
mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina
o
hoarseness
o
rash
o
cough
o
constipation

The most common side effects of INLYTA when used alone include:

o
diarrhea
o
high blood pressure
o
feeling tired or weak
o
decreased appetite
o
nausea
o
hoarseness
o
rash, redness, itching or peeling of your skin on your hands and feet
o
decreased weight
o
vomiting
o
constipation

INLYTA may cause fertility problems in males and females, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of INLYTA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Find INLYTA® medical information:

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Health Professional Information

What are the possible side effects of INLYTA?

What are the possible side effects of INLYTA?

INLYTA may cause serious side effects, including:
•
High blood pressure (hypertension). High blood pressure is common with INLYTA and may sometimes be severe. Your healthcare provider should check your blood pressure regularly during treatment with INLYTA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA.
•
Blood clots in your veins or arteries. INLYTA can cause blood clots which can be serious, and sometimes lead to death. Get emergency help and call your healthcare provider if you get any of the following symptoms:
o
chest pain or pressure
o
pain in your arms, back, neck or jaw
o
shortness of breath
o
numbness or weakness on one side of your body
o
trouble talking
o
headache
o
vision changes
•
Bleeding. INLYTA can cause bleeding which can be serious, and sometimes lead to death. Call your healthcare provider right away or get medical help if you develop any of the following signs or symptoms:
o
unexpected bleeding or bleeding that lasts a long time, such as:
•
unusual bleeding from the gums
•
menstrual bleeding or vaginal bleeding that is heavier than normal
•
bleeding that is severe or you cannot control
•
pink or brown urine
•
red or black stools (looks like tar)
•
bruises that happen without a known cause or get larger
•
cough up blood or blood clots
•
vomit blood or your vomit looks like "coffee grounds"
o
unexpected pain, swelling, or joint pain
o
headaches, feeling dizzy or weak
•
Heart failure. Your healthcare provider should check you for signs or symptoms of heart failure regularly during treatment with INLYTA. Heart failure can be serious and can sometimes lead to death. Tell your healthcare provider if you have any of the following symptoms during your treatment with INLYTA:
o
tiredness
o
swelling of your stomach-area (abdomen), legs or ankles
o
shortness of breath
o
protruding neck veins
•
Tear in your stomach or intestinal wall (perforation). A tear in your stomach or intestinal wall can be serious and can sometimes lead to death. Get medical help right away if you get the following symptoms:
o
severe stomach-area (abdominal) pain or stomach-area pain that does not go away
o
vomit blood
o
red or black stools
•
Thyroid gland problems. Your healthcare provider should do blood tests to check your thyroid gland function before and during your treatment with INLYTA. Tell your healthcare provider if you have any of the following symptoms during your treatment with INLYTA:
o
tiredness that worsens or that does not go away
o
feeling hot or cold
o
your voice deepens
o
weight gain or weight loss
o
hair loss
o
muscle cramps and aches
•
Risk of wound healing problems. Wounds may not heal properly during INLYTA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with INLYTA.
o
You should stop taking INLYTA at least 2 days before planned surgery.
o
Your healthcare provider should tell you when you may start taking INLYTA again after surgery.
•
Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen during treatment with INLYTA. Call your healthcare provider right away if you get:
o
headache
o
seizures
o
weakness
o
confusion
o
high blood pressure
o
blindness or change in vision
o
problems thinking
•
Protein in your urine. Your healthcare provider should check your urine for protein before and during your treatment with INLYTA. If you develop protein in your urine, your healthcare provider may decrease your dose of INLYTA or stop your treatment.
•
Liver problems. Your healthcare provider will do blood tests before and during your treatment with INLYTA. Your healthcare provider may delay or stop your treatment with INLYTA if you develop severe liver problems.
Tell your healthcare provider right way if you have any of the following symptoms:
o
yellowing of your skin or the whites of your eyes
o
severe nausea or vomiting
o
pain on the right side of your stomach area (abdomen)
o
dark urine (tea colored)
o
bleeding or bruising more easily than normal
•
Heart problems. When INLYTA is used with the medicine avelumab, severe heart problems can happen and can lead to death. Your healthcare provider will check you for heart problems during your treatment with INLYTA. Tell your healthcare provider right away or get medical help if you have any of the following symptoms:
o
swelling of your stomach-area, legs, hands feet or ankles
o
shortness of breath
o
nausea or vomiting
o
new or worsening chest discomfort, including pain or pressure
o
weight gain
o
pain or discomfort in your arms, back, neck, or jaw
o
breaking out in a cold sweat
o
feeling lightheaded or dizzy

The most common side effects of INLYTA with avelumab include:

o
diarrhea
o
feeling tired
o
high blood pressure
o
muscle and bone pain
o
nausea
o
mouth sores
o
rash, redness, itching, or peeling of your skin on your hands and feet
o
hoarseness
o
decreased appetite
o
low levels of thyroid hormone
o
rash
o
liver problems
o
cough
o
shortness of breath
o
stomach-area (abdomen) pain
o
headache

The most common side effects of INLYTA with pembrolizumab include:

o
diarrhea
o
feeling tired or weak
o
high blood pressure
o
liver problems
o
low levels of thyroid hormone
o
decreased appetite
o
rash, redness, itching or peeling of your skin on your hands and feet
o
nausea
o
mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina
o
hoarseness
o
rash
o
cough
o
constipation

The most common side effects of INLYTA when used alone include:

o
diarrhea
o
high blood pressure
o
feeling tired or weak
o
decreased appetite
o
nausea
o
hoarseness
o
rash, redness, itching or peeling of your skin on your hands and feet
o
decreased weight
o
vomiting
o
constipation

INLYTA may cause fertility problems in males and females, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of INLYTA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Prescribing Information
Download Prescribing Information

Health Professional Information

What are the possible side effects of INLYTA?

What are the possible side effects of INLYTA?

INLYTA may cause serious side effects, including:
•
High blood pressure (hypertension). High blood pressure is common with INLYTA and may sometimes be severe. Your healthcare provider should check your blood pressure regularly during treatment with INLYTA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA.
•
Blood clots in your veins or arteries. INLYTA can cause blood clots which can be serious, and sometimes lead to death. Get emergency help and call your healthcare provider if you get any of the following symptoms:
o
chest pain or pressure
o
pain in your arms, back, neck or jaw
o
shortness of breath
o
numbness or weakness on one side of your body
o
trouble talking
o
headache
o
vision changes
•
Bleeding. INLYTA can cause bleeding which can be serious, and sometimes lead to death. Call your healthcare provider right away or get medical help if you develop any of the following signs or symptoms:
o
unexpected bleeding or bleeding that lasts a long time, such as:
•
unusual bleeding from the gums
•
menstrual bleeding or vaginal bleeding that is heavier than normal
•
bleeding that is severe or you cannot control
•
pink or brown urine
•
red or black stools (looks like tar)
•
bruises that happen without a known cause or get larger
•
cough up blood or blood clots
•
vomit blood or your vomit looks like "coffee grounds"
o
unexpected pain, swelling, or joint pain
o
headaches, feeling dizzy or weak
•
Heart failure. Your healthcare provider should check you for signs or symptoms of heart failure regularly during treatment with INLYTA. Heart failure can be serious and can sometimes lead to death. Tell your healthcare provider if you have any of the following symptoms during your treatment with INLYTA:
o
tiredness
o
swelling of your stomach-area (abdomen), legs or ankles
o
shortness of breath
o
protruding neck veins
•
Tear in your stomach or intestinal wall (perforation). A tear in your stomach or intestinal wall can be serious and can sometimes lead to death. Get medical help right away if you get the following symptoms:
o
severe stomach-area (abdominal) pain or stomach-area pain that does not go away
o
vomit blood
o
red or black stools
•
Thyroid gland problems. Your healthcare provider should do blood tests to check your thyroid gland function before and during your treatment with INLYTA. Tell your healthcare provider if you have any of the following symptoms during your treatment with INLYTA:
o
tiredness that worsens or that does not go away
o
feeling hot or cold
o
your voice deepens
o
weight gain or weight loss
o
hair loss
o
muscle cramps and aches
•
Risk of wound healing problems. Wounds may not heal properly during INLYTA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with INLYTA.
o
You should stop taking INLYTA at least 2 days before planned surgery.
o
Your healthcare provider should tell you when you may start taking INLYTA again after surgery.
•
Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen during treatment with INLYTA. Call your healthcare provider right away if you get:
o
headache
o
seizures
o
weakness
o
confusion
o
high blood pressure
o
blindness or change in vision
o
problems thinking
•
Protein in your urine. Your healthcare provider should check your urine for protein before and during your treatment with INLYTA. If you develop protein in your urine, your healthcare provider may decrease your dose of INLYTA or stop your treatment.
•
Liver problems. Your healthcare provider will do blood tests before and during your treatment with INLYTA. Your healthcare provider may delay or stop your treatment with INLYTA if you develop severe liver problems.
Tell your healthcare provider right way if you have any of the following symptoms:
o
yellowing of your skin or the whites of your eyes
o
severe nausea or vomiting
o
pain on the right side of your stomach area (abdomen)
o
dark urine (tea colored)
o
bleeding or bruising more easily than normal
•
Heart problems. When INLYTA is used with the medicine avelumab, severe heart problems can happen and can lead to death. Your healthcare provider will check you for heart problems during your treatment with INLYTA. Tell your healthcare provider right away or get medical help if you have any of the following symptoms:
o
swelling of your stomach-area, legs, hands feet or ankles
o
shortness of breath
o
nausea or vomiting
o
new or worsening chest discomfort, including pain or pressure
o
weight gain
o
pain or discomfort in your arms, back, neck, or jaw
o
breaking out in a cold sweat
o
feeling lightheaded or dizzy

The most common side effects of INLYTA with avelumab include:

o
diarrhea
o
feeling tired
o
high blood pressure
o
muscle and bone pain
o
nausea
o
mouth sores
o
rash, redness, itching, or peeling of your skin on your hands and feet
o
hoarseness
o
decreased appetite
o
low levels of thyroid hormone
o
rash
o
liver problems
o
cough
o
shortness of breath
o
stomach-area (abdomen) pain
o
headache

The most common side effects of INLYTA with pembrolizumab include:

o
diarrhea
o
feeling tired or weak
o
high blood pressure
o
liver problems
o
low levels of thyroid hormone
o
decreased appetite
o
rash, redness, itching or peeling of your skin on your hands and feet
o
nausea
o
mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina
o
hoarseness
o
rash
o
cough
o
constipation

The most common side effects of INLYTA when used alone include:

o
diarrhea
o
high blood pressure
o
feeling tired or weak
o
decreased appetite
o
nausea
o
hoarseness
o
rash, redness, itching or peeling of your skin on your hands and feet
o
decreased weight
o
vomiting
o
constipation

INLYTA may cause fertility problems in males and females, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of INLYTA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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