What is Bipolar l Disorder? - VRAYLAR® (cariprazine) Skip to Main Content For adults in the treatment of bipolar I depression and for the short-term treatment of manic or mixed episodes of bipolar I disorder. For adults in the treatment of bipolar I depression and for the short-term treatment of manic or mixed episodes of bipolar I disorder. For adults in the treatment of bipolar I depression and for the short-term treatment of manic or mixed episodes of bipolar I disorder. SELECT CONDITION Major Depressive Disorder Bipolar I Disorder Other Condition Important Safety Information Prescribing Information Medication Guide Cost & Savings Healthcare Professional Site Sign up for support See savings* Why VRAYLAR? Is VRAYLAR right for you? How does VRAYLAR work? Who is VRAYLAR for? How do I take VRAYLAR? What side effects are possible? Bipolar I basics What is bipolar I disorder? What are the symptoms? What can trigger episodes? How is it diagnosed? How is it treated? Support & resources Track your mood & symptoms Watch real bipolar I stories Tips from a healthcare provider Sign up for helpful resources Find a support group Tools for friends and family FAQs Resources for starting VRAYLAR Save on VRAYLAR Connect with a healthcare provider Sign up for support social fb insta youtube Healthcare Professional site En Español Bipolar I Basics What is bipolar I disorder? Bipolar I disorder is a condition that causes periods of severe changes in your mood, activity levels, energy, and ability to carry out everyday tasks. These changes are commonly called “mood episodes.” Although you may feel alone, ~3 million Americans are affected by bipolar I disorder each year While anyone can develop bipolar I disorder, it often starts in the late teen or early adult years and it lasts a lifetime Medical researchers believe that it can result from many factors, including an imbalance of certain chemicals in the brain called neurotransmitters, which may be too high or too low Did you know? Bipolar I disorder often runs in families. If you have a family history of bipolar I disorder, be sure to let your healthcare provider know. Have you taken any medication(s) for your bipolar I? Select an answer below to learn how VRAYLAR may work to treat your bipolar I. Yes, I have taken multiple medications to help treat my bipolar I. Yes, I have taken one medication to treat my bipolar I. No, but I would like to learn more about managing bipolar I. Yes, I have taken multiple medications to help treat my bipolar I. Can VRAYLAR treat the highs AND lows? There are many ways to manage your bipolar I. Learn how VRAYLAR can help treat depressive, acute manic and acute mixed episodes of bipolar I. Get to know VRAYLAR Yes, I have taken one medication to treat my bipolar I. How can I treat the highs AND lows? You may experience bipolar I depressive, acute mixed and acute manic episodes. It is important to treat all parts of bipolar I. Learn how VRAYLAR can help by treating both the highs and lows. See VRAYLAR in action No, but I would like to learn more about managing bipolar I. How can I learn more about managing the highs and lows? Learn more about treating the highs and lows and hear real stories from people living with bipolar I. Get more information Reset What are the symptoms of bipolar I? Bipolar I disorder can cause unpredictable high and low mood swings, also known as manic and depressive episodes. Bex and Heidi, two individuals living with bipolar I, shed light on depressive and manic aspects of bipolar I. The people featured in these videos are sharing their individual experiences with bipolar I. Individual experiences with the condition and treatment will vary. Not all of those featured are currently taking VRAYLAR. These videos are brought to you by AbbVie. Transcript Bex's experience with bipolar I depression View transcript Transcript Heidi's experience with bipolar I mania View transcript Symptoms to consider talking to your healthcare provider about Select a mood state below to see common symptoms. Not all of these symptoms may be indicative of bipolar I . Depressive symptoms Depressive symptoms Mixed episodes Mixed episodes Manic symptoms Manic symptoms Commonly referred to as the “lows,” depressive symptoms include at least five of the following, lasting for at least two weeks: Having trouble concentrating Forgetting things a lot Thinking about death or suicide Having trouble sleeping Feeling like you can’t enjoy anything Feeling very down or sad Feeling worried and empty Sleeping too much or too little Changes in appetite or weight Having little to no interest or pleasure in your hobbies Mixed episodes occur when highs and lows are experienced at the same time. For example, you may be having a mixed episode if you’re: Having trouble concentrating Forgetting things a lot Thinking about death or suicide Having trouble sleeping Feeling like you can’t enjoy anything Feeling exhausted but overly wired Having too much energy while feeling very sad Being talkative while pessimistic Behaving impulsively while feeling exhausted Behaving impulsively Feeling jumpy or wired Feeling like your thoughts are coming very fast Becoming more active than usual Having higher than usual energy levels Commonly referred to as the “highs,” manic symptoms include at least three of the following (four if the mood is only irritable), lasting for at least one week: Behaving impulsively Feeling jumpy or wired Feeling like your thoughts are coming very fast Becoming more active than usual Having higher than usual energy levels Being agitated, irritable, or touchy Not feeling tired or needing little sleep Talking really fast about a lot of different things Thinking you can do a lot of things at once Feeling overconfident in your abilities Do these symptoms sound familiar? Answer some questions that could help your healthcare provider determine whether you may have bipolar I disorder. Take quiz What can trigger bipolar I episodes? Depressive and manic episodes are often triggered by something. Being aware of your triggers or warning signs can help you in managing your mood episodes. Common triggers for bipolar I disorder may include: Sleep deprivation Medications Seasonal changes Substance abuse Some triggers you can control or manage, while others you may not. Be sure to discuss your triggers with your doctor. Use this mood tracker to record your symptoms each day and help your healthcare provider spot warning signs of bipolar I disorder. Track your mood Watch Now Tips on ways you can manage bipolar I disorder View Transcript How is bipolar I disorder diagnosed? Bipolar I disorder can go unrecognized for years by not only those who suffer with it, but by family, friends, and even healthcare providers. Manic symptoms are reported less often than depressive ones for most people with bipolar I , so healthcare providers may only see, and therefore treat, symptoms of depression instead of bipolar I disorder. The first step: If you think you may have bipolar I disorder , talk with a doctor. They can complete a physical exam to rule out other conditions. Why this matters: People with bipolar disorder often have other health problems including substance abuse, anxiety disorders, thyroid disease, heart disease, and obesity. These conditions can have similar symptoms to bipolar I disorder, which can complicate the diagnosis of bipolar I disorder. Bipolar I depression is different Bipolar refers to the opposite ends (the poles) of the emotional spectrum—lows (depression) and the highs (mania). In addition to the deep, unshakeable sadness or emptiness felt by patients with major depressive disorder (MDD), patients with bipolar I also experience manic episodes. Treatments for MDD may not be effective for patients with bipolar I disorder, so it’s important to get the right diagnosis. Learn about VRAYLAR How is bipolar I treated? An effective treatment plan for bipolar I often includes a combination of: Medication Talk therapy Support groups Improving overall health and wellness However, the cornerstone of every treatment plan is medication, and finding the right one for you could take some time. Your healthcare provider will start the process by evaluating your symptoms and treatments. So it’s critical to share all the symptoms you’re experiencing now or have experienced in the past, as well as the medications you’re taking now or have taken in the past. Make the most out of your appointment Help your provider understand how you’re feeling. Complete this simple quiz about your symptoms to create a personalized discussion guide for your next appointment. Take quiz Additional resources Tips for managing bipolar I Discover tips that may help manage your bipolar I disorder. Download brochure Bipolar I quiz Answer questions that could help your healthcare provider determine whether you may have bipolar I disorder. Take quiz Bipolar I support Sign up for wellness support sent directly to your inbox. Get updates *Terms and conditions apply. Available to commercially insured patients only. See Terms and Conditions for full details. INDICATIONS AND USAGE VRAYLAR is approved in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) and for the short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder. IMPORTANT SAFETY INFORMATION What is the most important information I should know about VRAYLAR? Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like VRAYLAR are at an increased risk of death. VRAYLAR is not approved for treating patients with dementia-related psychosis. VRAYLAR and antidepressants increase the risk of suicidal thoughts or actions in people 24 years of age and younger especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when VRAYLAR or the antidepressant is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. VRAYLAR may cause serious side effects, including: Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death Neuroleptic malignant syndrome (NMS): Call your healthcare provider or go to the nearest hospital emergency room right away if you have high fever, stiff muscles, confusion, increased sweating, or changes in breathing, heart rate, and blood pressure. These can be symptoms of a rare but potentially fatal side effect called NMS. VRAYLAR should be stopped if you have NMS. Uncontrolled body movements (tardive dyskinesia or TD): VRAYLAR may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking VRAYLAR. Tardive dyskinesia may also start after you stop taking VRAYLAR. Late-occurring side effects: VRAYLAR stays in your body for a long time. Some side effects may not happen right away and can start a few weeks after starting VRAYLAR, or if your dose increases. Your healthcare provider should monitor you for side effects for several weeks after starting or increasing dose of VRAYLAR. Problems with your metabolism, such as: High blood sugar and diabetes: Increases in blood sugar can happen in some people who take VRAYLAR. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before or soon after starting VRAYLAR and regularly during treatment. Tell your healthcare provider if you have symptoms such as feeling very thirsty, very hungry, or sick to your stomach, urinating more than usual, feeling weak, tired, confused, or your breath smells fruity. Increased fat levels (cholesterol and triglycerides) in your blood: Your healthcare provider should check fat levels in your blood before or soon after starting VRAYLAR and during treatment. Weight gain: Weight gain has been reported with VRAYLAR. You and your healthcare provider should check your weight before and regularly during treatment. Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs, including VRAYLAR. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics. Your healthcare provider may do blood tests during the first few months of treatment with VRAYLAR. Decreased blood pressure (orthostatic hypotension): You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Falls: VRAYLAR may make you sleepy or dizzy, may cause a decrease in blood pressure when changing position (orthostatic hypotension), and can slow thinking and motor skills, which may lead to falls that can cause fractures or other injuries. Seizures (convulsions) Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities: Do NOT drive, operate machinery, or do other dangerous activities until you know how VRAYLAR affects you. VRAYLAR may make you drowsy. Increased body temperature: Do not become too hot or dehydrated during VRAYLAR treatment. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water. Difficulty swallowing that can cause food or liquid to get into your lungs Who should not take VRAYLAR? Do not take VRAYLAR if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, rash, itching, hives, swelling of the tongue, lip, face or throat). What should I tell my healthcare provider before taking VRAYLAR? Tell your healthcare provider about any medical conditions and if you: have or had heart problems or a stroke have or had low or high blood pressure have or had diabetes or high blood sugar in you or your family have or had high levels of total cholesterol, LDL-cholesterol, or triglycerides; or low levels of HDL-cholesterol have or had seizures (convulsions) have or had kidney or liver problems have or had low white blood cell count are pregnant or plan to become pregnant. VRAYLAR may harm your unborn baby. Taking VRAYLAR during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take VRAYLAR during pregnancy. There is a pregnancy exposure registry for women who are exposed to VRAYLAR during pregnancy. If you become pregnant or think you are pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or http://www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . are breastfeeding or plan to breastfeed. It is not known if VRAYLAR passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with VRAYLAR. Tell your healthcare provider about all medicines that you take, including prescriptions, over-the-counter medicines, vitamins, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works. Do not start or stop any medicines while taking VRAYLAR without talking to your healthcare provider. What are the most common side effects of VRAYLAR? The most common side effects include difficulty moving or slow movements, tremors, uncontrolled body movements, restlessness and feeling like you need to move around, sleepiness, nausea, vomiting, indigestion, constipation, feeling tired, trouble sleeping, increased appetite, and dizziness. These are not all the possible side effects of VRAYLAR. VRAYLAR is available in 0.5 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, and 6 mg capsules. INDICATIONS AND USAGE VRAYLAR is a prescription medicine used: along with antidepressant medicines to treat major depressive disorder (MDD) in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) in adults to treat short-term (acute) manic or mixed episodes that happen with bipolar I disorder in adults and children ages 10 years and older Please see the full Prescribing Information , including Boxed Warnings, and Medication Guide . US-VRAA-250457 You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more. HOME ABOUT ABBVIE PRESCRIBING INFORMATION SITEMAP ACCESSIBILITY STATEMENT CONTACT US TERMS OF USE PRIVACY NOTICE COOKIES SETTINGS YOUR PRIVACY CHOICES THIS SITE IS INTENDED FOR U.S. CONSUMERS ONLY. LICENSED FROM GEDEON RICHTER PLC. © 2025 ABBVIE. ALL RIGHTS RESERVED. VRAYLAR ® AND ITS DESIGN ARE TRADEMARKS OF ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED, AN ABBVIE COMPANY. VRAYPAY SM IS A SERVICE MARK OF ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED, AN ABBVIE COMPANY. IF YOU ARE A PATIENT, AND HAVE ANY QUESTIONS, PLEASE DISCUSS THEM WITH YOUR DOCTOR OR HEALTHCARE PROVIDER. FOR ADDITIONAL INFORMATION ABOUT VRAYLAR ® , CALL ABBVIE MEDICAL INFORMATION TOLL-FREE AT 1.800.678.1605. US-VRA-240147 Journey to a bipolar I diagnosis Transcript View transcript Tips about living with bipolar I Transcript View transcript What bipolar I and mania symptoms may feel like Transcript View transcript Terms and Conditions AbbVie Inc. is providing this information to help patients find healthcare professionals in their area who have experience with therapies such as VRAYLAR ® (cariprazine). No fees have been received by AbbVie Inc. or paid to healthcare professionals for their inclusion in this locator directory. Inclusion of a healthcare professional in this directory neither represents an endorsement by or a recommendation from AbbVie Inc. regarding the qualifications of or medical care provided by the healthcare professional, nor implies that the healthcare professionals on the list will determine that any therapy such as VRAYLAR is right for you. The selection of a healthcare provider is an important decision that should not be based solely on the inclusion in this healthcare provider locator tool. AbbVie Inc. is the maker and marketer of VRAYLAR. CLOSE US-VRA-230116 Transcript View transcript You are now leaving VRAYLAR.com Links to other websites are provided as a service to you. By clicking “YES,” you acknowledge and agree that AbbVie makes no guarantees that using any such support groups will result in your desired outcome. AbbVie accepts no responsibility for the content of other sites. Would you like to continue? YES NO US-VRA-220161 You are now leaving VRAYLAR.com Links to other websites are provided as a service to you. By clicking “YES,” you acknowledge and agree that AbbVie makes no guarantees that using any such support groups will result in your desired outcome. AbbVie accepts no responsibility for the content of other sites. Would you like to continue? YES NO US-VRA-220161 You are now being redirected to the VRAYLAR Savings Card activation website, where patients can activate and print a Savings Card. YES NO US-VRA-220161 You are now leaving VRAYLAR.com You are leaving the VRAYLAR (cariprazine) site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site, and AbbVie makes no guarantee that any such support groups will result in your desired outcome. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility. Conversely, the presence of this link does not imply the linked site's endorsement of VRAYLAR.com or AbbVie. Do you wish to leave this site? YES NO US-VRA-230116test For Healthcare Professionals The information provided in this website is intended for U.S. healthcare professionals only. I certify that I am a U.S. healthcare professional. If you choose “NO,” you will remain on the patient website. YES NO US-VRA-220161 You are now leaving VRAYLAR.com Links to other websites are provided as a service to you. AbbVie accepts no responsibility for the content of other sites. Would you like to continue? YES NO US-VRA-220161 You are now leaving VRAYLAR.com Links to other websites are provided as a service to you. AbbVie accepts no responsibility for the content of other sites. Would you like to continue? YES NO US-VRA-220161 Real People, Real Stories Transcript View transcript Terms and Conditions AbbVie Inc. is providing this information to help patients find healthcare professionals in their area who have experience with therapies such as VRAYLAR ® (cariprazine). No fees have been received by AbbVie Inc. or paid to healthcare professionals for their inclusion in this locator directory. Inclusion of a healthcare professional in this directory neither represents an endorsement by or a recommendation from AbbVie Inc. regarding the qualifications of or medical care provided by the healthcare professional, nor implies that the healthcare professionals on the list will determine that any therapy such as VRAYLAR is right for you. The selection of a healthcare provider is an important decision that should not be based solely on the inclusion in this healthcare provider locator tool. AbbVie Inc. is the maker and marketer of VRAYLAR. CLOSE US-VRA-230116 For Healthcare Professionals The information provided in this website is intended for U.S. healthcare professionals only. I certify that I am a U.S. healthcare professional. If you choose “NO,” you will remain on the patient website. YES NO US-VRA-230180 For residents of Puerto Rico By selecting ‘continue’ you will enter the VRAYLAR Puerto Rico website, which includes key information presented in Spanish. Cost & Savings information on this site is intended for Puerto Rico residents only. If you are a U.S. resident looking for cost information, please select ‘Back’ and visit the Cost & Savings page. Continue Back US-VRAA-240126 US-VRA-240106 For residents of Puerto Rico By selecting ‘continue’ you will enter the VRAYLAR Puerto Rico website, which includes key information presented in Spanish. Cost & Savings information on this site is intended for Puerto Rico residents only. If you are a U.S. resident looking for cost information, please select ‘Back’ and visit the Cost & Savings page. Continue Back US-VRA-240106 You are now leaving VRAYLAR.com You are leaving the VRAYLAR (cariprazine) site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility. Conversely, the presence of this link does not imply the linked site's endorsement of VRAYLAR.com or AbbVie. Do you wish to leave this site? YES NO US-VRA-230180 You are now leaving VRAYLAR.com Links to other websites are provided as a service to you. AbbVie accepts no responsibility for the content of other sites. Would you like to continue? YES NO US-VRAA-220054 For Healthcare Professionals The information provided in this website is intended for U.S. healthcare professionals only. I certify that I am a U.S. healthcare professional. If you choose “NO,” you will remain on the patient website. YES NO US-VRA-230180 You are now leaving VRAYLAR.com You are leaving the VRAYLAR (cariprazine) site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility. Conversely, the presence of this link does not imply the linked site's endorsement of VRAYLAR.com or AbbVie. Do you wish to leave this site? Yes No US-VRA-230180 For residents of Puerto Rico By selecting ‘continue’ you will enter the VRAYLAR Puerto Rico website, which includes key information presented in Spanish. Cost & Savings information on this site is intended for Puerto Rico residents only. If you are a U.S. resident looking for cost information, please select ‘Back’ and visit the Cost & Savings page. Continue Back US-VRAA-240126 US-VRA-240106 INDICATIONS AND USAGE VRAYLAR is a prescription medicine used in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) and for the short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder. IMPORTANT SAFETY INFORMATION What is the most important information I should know about VRAYLAR? Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like VRAYLAR are at an increased risk of death. VRAYLAR is not approved for treating patients with dementia-related psychosis. IMPORTANT SAFETY INFORMATION Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like INDICATIONS AND USAGE VRAYLAR is a prescription medicine used in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) and for the short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder. IMPORTANT SAFETY INFORMATION What is the most important information I should know about VRAYLAR? Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like VRAYLAR are at an increased risk of death. VRAYLAR is not approved for treating patients with dementia-related psychosis. IMPORTANT SAFETY INFORMATION Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like INDICATIONS AND USAGE VRAYLAR is approved in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) and for the short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder. IMPORTANT SAFETY INFORMATION What is the most important information I should know about VRAYLAR? Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like VRAYLAR are at an increased risk of death. VRAYLAR is not approved for treating patients with dementia-related psychosis. VRAYLAR and antidepressants increase the risk of suicidal thoughts or actions in people 24 years of age and younger especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when VRAYLAR or the antidepressant is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. VRAYLAR may cause serious side effects, including: Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death Neuroleptic malignant syndrome (NMS): Call your healthcare provider or go to the nearest hospital emergency room right away if you have high fever, stiff muscles, confusion, increased sweating, or changes in breathing, heart rate, and blood pressure. These can be symptoms of a rare but potentially fatal side effect called NMS. VRAYLAR should be stopped if you have NMS. Uncontrolled body movements (tardive dyskinesia or TD): VRAYLAR may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking VRAYLAR. Tardive dyskinesia may also start after you stop taking VRAYLAR. Late-occurring side effects: VRAYLAR stays in your body for a long time. Some side effects may not happen right away and can start a few weeks after starting VRAYLAR, or if your dose increases. Your healthcare provider should monitor you for side effects for several weeks after starting or increasing dose of VRAYLAR. Problems with your metabolism, such as: High blood sugar and diabetes: Increases in blood sugar can happen in some people who take VRAYLAR. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before or soon after starting VRAYLAR and regularly during treatment. Tell your healthcare provider if you have symptoms such as feeling very thirsty, very hungry, or sick to your stomach, urinating more than usual, feeling weak, tired, confused, or your breath smells fruity. Increased fat levels (cholesterol and triglycerides) in your blood: Your healthcare provider should check fat levels in your blood before or soon after starting VRAYLAR and during treatment. Weight gain: Weight gain has been reported with VRAYLAR. You and your healthcare provider should check your weight before and regularly during treatment. Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs, including VRAYLAR. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics. Your healthcare provider may do blood tests during the first few months of treatment with VRAYLAR. Decreased blood pressure (orthostatic hypotension): You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Falls: VRAYLAR may make you sleepy or dizzy, may cause a decrease in blood pressure when changing position (orthostatic hypotension), and can slow thinking and motor skills, which may lead to falls that can cause fractures or other injuries. Seizures (convulsions) Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities: Do NOT drive, operate machinery, or do other dangerous activities until you know how VRAYLAR affects you. VRAYLAR may make you drowsy. Increased body temperature: Do not become too hot or dehydrated during VRAYLAR treatment. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water. Difficulty swallowing that can cause food or liquid to get into your lungs Who should not take VRAYLAR? Do not take VRAYLAR if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, rash, itching, hives, swelling of the tongue, lip, face or throat). What should I tell my healthcare provider before taking VRAYLAR? Tell your healthcare provider about any medical conditions and if you: have or had heart problems or a stroke have or had low or high blood pressure have or had diabetes or high blood sugar in you or your family have or had high levels of total cholesterol, LDL-cholesterol, or triglycerides; or low levels of HDL-cholesterol have or had seizures (convulsions) have or had kidney or liver problems have or had low white blood cell count are pregnant or plan to become pregnant. VRAYLAR may harm your unborn baby. Taking VRAYLAR during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take VRAYLAR during pregnancy. There is a pregnancy exposure registry for women who are exposed to VRAYLAR during pregnancy. If you become pregnant or think you are pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or http://www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . are breastfeeding or plan to breastfeed. It is not known if VRAYLAR passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with VRAYLAR. Tell your healthcare provider about all medicines that you take, including prescriptions, over-the-counter medicines, vitamins, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works. Do not start or stop any medicines while taking VRAYLAR without talking to your healthcare provider. What are the most common side effects of VRAYLAR? The most common side effects include difficulty moving or slow movements, tremors, uncontrolled body movements, restlessness and feeling like you need to move around, sleepiness, nausea, vomiting, indigestion, constipation, feeling tired, trouble sleeping, increased appetite, and dizziness. These are not all the possible side effects of VRAYLAR. VRAYLAR is available in 0.5 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, and 6 mg capsules. INDICATIONS AND USAGE VRAYLAR is a prescription medicine used: along with antidepressant medicines to treat major depressive disorder (MDD) in adults to treat depressive episodes that happen with bipolar I disorder (bipolar depression) in adults to treat short-term (acute) manic or mixed episodes that happen with bipolar I disorder in adults and children ages 10 years and older Please see the full Prescribing Information , including Boxed Warnings, and Medication Guide . US-VRAA-250457