What are 6 Vraylar side effects you need to be aware of?

Key Points

• Vraylar (cariprazine) is a once-daily oral medication that may be used to treat bipolar disorder, depression, or schizophrenia. Vraylar is not approved for use in older adults with dementia-related psychosis.
• Common side effects of Vraylar include movement disorders (extrapyramidal symptoms); stomach problems (such as indigestion, nausea, vomiting, or constipation); sleep problems such as drowsiness, dizziness, feeling sleepy all the time, fatigue, or trouble sleeping; and increased appetite and weight gain. For most people, these side effects lessen or go away after a few weeks of treatment.
• More serious side effects with Vraylar are less common or rare, but include a risk that Vraylar may disrupt your body’s core temperature, which may cause you to overheat or become dehydrated more easily, and an increased risk of suicidal thoughts and actions, particularly in young adults.

What is Vraylar used to treat?

Vraylar (cariprazine) is an atypical antipsychotic that may be used to treat certain types of bipolar I disorder, major depressive disorder (MDD), and schizophrenia. Vraylar comes as a capsule that is taken once a day.

6 side effects of Vraylar and how to manage them

Let’s look at 6 side effects* of Vraylar (cariprazine) that you need to be aware of. Some are common and others are rare. Most common side effects are short-term and only last a few days or weeks. We’ll offer tips on how you can recognize and manage these side effects so you can stay on treatment and live your life.

1. Movement problems (extrapyramidal symptoms)

Movement problems with atypical antipsychotics, such as Vraylar are common, even though traditional antipsychotics, such as haloperidol, have a higher risk of causing them. Movement problems are also called extrapyramidal symptoms and you might find yourself walking slower, have a shuffling gait, or have difficulty getting out of a chair. Tremors and other involuntary muscle contractions or spasms can also occur and your muscles might feel rigid or your face may develop a mask-like appearance.

Other common movement problems reported with Vraylar include akathisia (the inability to remain still), restlessness (needing to move around), and tardive dyskinesia (uncontrollable, jerky movements of the face or body such as tongue, thrusting, rapid blinking, or arm waving). Some of these movement disorders may be irreversible or may occur after stopping treatment.
Up to 29% of people taking Vraylar report uncontrolled or changed body movements.

Tips for managing movement disorders

Tell your healthcare provider right away if you develop any movements that you cannot control in your face, tongue, or other parts of your body. Some of these may occur after several weeks of treatment or after stopping treatment. Certain types of movement disorders experienced with Vraylar may not go away even if you stop treatment.

Sometimes adjusting the dose of medication, adding in another type of medication, or switching to another antipsychotic can help.

2. Stomach problems

Stomach (abdominal) side effects with antipsychotics, such as Vraylar are common and well-known, but are usually mild and clear up in a few weeks. They occur because Vraylar affects neurotransmitters in the gastrointestinal tract as well as in the brain. The most common stomach-related side effect with Vraylar is nausea and constipation and these occur in up to 13% of people. Others include indigestion (9%), vomiting (8%), abdominal pain (8%), diarrhea (6%), toothache (3%) and dry mouth (2%).

Stomach side effects tend to occur at the beginning of treatment and when your dose is increased too quickly. Because of this, your healthcare provider will slowly increase your dose, until you reach your normal dose. You can take Vraylar with or without food.

The good news is that for most people these side effects are mild, temporary, and will not interfere with long-term treatment. They typically subside within a few weeks of starting treatment.

Tips for managing stomach side effects

Taking Vraylar with food can often help with nausea or vomiting, as can ginger or peppermint teas. Other tips that may help manage nausea, vomiting, or diarrhea include:

• Eating more slowly
• Consuming smaller meals
• Selecting more bland, low-fat foods (like crackers, pasta, bread, toast and rice)
• Avoiding greasy, fried, or spicy foods
• Drinking plenty of fluids, including water, electrolytes, or tea
• Eating foods that contain water (like soup or gelatin)
• Not lying down after eating
• Going outside for fresh air or doing some exercise soon after eating.

If you get constipated, eat more vegetables and whole grains to get more fiber into your diet, and drink plenty of water. Regular exercise also helps.

If Vraylar gives you a dry mouth, chew sugar-free gum or suck on sugar-free sweets and brush your teeth twice a day to prevent tooth decay. Ask your pharmacist for a dry mouth gel and use a lip balm if your lips are dry.

If none of this advice helps, talk with your healthcare provider.

3. Sleep problems

It is common for antipsychotics, such as Vraylar, to cause sleep problems. Up to 10% of people feel sleepy all day long, and regularly nod off during the day, whereas 16% find it difficult to sleep at all when taking Vraylar and impossible to get to sleep at night. 5% just feel physically exhausted or fatigued all the time. Both extremes – feeling sleepy all day or not sleeping at all can affect your mood and make it difficult to function.

Tips for managing sleep problems

Tiredness, fatigue, and sleepiness caused by Vraylar will often go away or get better once you have been taking the medication for a while. If you feel sleepy during the day while taking Vraylar:

• Take your dose at night
• Do not drive, ride a bike, make important decisions, or use tools or machinery if Vraylar makes you feel tired or sleepy during the day
• Do not drink alcohol or take other medications that have drowsiness as a side effect (such as allergy medications) as these will only make you feel more tired
• Tell your healthcare provider if Vraylar is still making you feel sleepy after a few weeks.

If you have difficulty falling asleep while taking Vraylar:

• Avoid nicotine and caffeine several hours before bed
• Practice relaxation techniques
• Avoid stimulating activities, such as electronic games at least two hours before bed.

Talk to your Healthcare provider if you are still having difficulty falling asleep after a few weeks.

4. Increased appetite and weight gain

Vraylar may boost appetite, and make you hungry even if you have just eaten because it can change the way your brain and hormones work together. This increased hunger can make you overeat and put on weight, and on average, people taking Vraylar gained an average of 3.7 pounds (1.7kg).

Vraylar may also increase your blood sugar levels as well as levels of cholesterol or other fats in your blood. You will be monitored for these but you should call your healthcare provider if you start feeling very thirsty or hungry; have severe nausea; need to urinate more than usual; or feel confused, or your breath smells fruity.

The good news is that Vraylar is less likely to cause weight gain than many other antipsychotics such as clozapine and olanzapine, Any initial weight gain is generally easy to lose if you watch what you eat and exercise.

Tips for managing weight gain

Ask your healthcare provider to weigh you before you start Vraylar and monitor your weight regularly. You should also:

• Schedule one 30-minute walk daily or split it into two or three shorter 15-minute walks. Park farther from the store than you need to or get off the bus one stop earlier
• Water naturally suppresses appetite, so try to consume between 30 to 70 ounces (1 to 2 liters) of water daily
• Cook your food and aim to make half your plate vegetables or fruit and a quarter protein and the rest whole grains. Watch serving sizes and condiments and sauces as many of these are calorie-rich
• Weigh yourself daily or at least every second day in the morning before breakfast. Being aware of small weight changes is the best reminder to eat healthy and get your workout in
• Aim for 7 to 8 hours sleep per night. Increased stress and inadequate sleep can elevate cortisol levels and disrupt hunger hormones, potentially leading to weight gain. Furthermore, our bodies may misinterpret feeling tired from hunger.

5. Risk of overheating or dehydration

Vraylar, like other antipsychotics, can disrupt your body’s ability to regulate heat and reduce core body temperature. Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications (such as benztropine) may cause an increase in body temperature.

Symptoms of overheating include a really high body temperature. Unfortunately, another rare but very serious condition called Neuroleptic Malignant Syndrome (NMS), which can lead to death, can have similar symptoms, including a very high temperature. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following symptoms of NMS: high fever, confusion, or changes in your breathing, heart rate, or blood pressure.

Tips for managing overheating and dehydration

Try not to become too hot or dehydrated while you are taking Vraylar.

• Avoid over-exercising
• In hot weather, stay inside in a cool place if possible
• Stay out of the sun
• If you have to go outside, wear a wide-brimmed hat and apply sunscreen. Try not to stay in the sun for too long
• Do not wear too much clothing or heavy clothing
• Drink plenty of water and other fluids.

6. Increased risk of suicidal thoughts and actions, particularly in young people

Vraylar and other medications used to treat mood can rarely sometimes appear to worsen depression and cause suicidal thoughts and behaviors to develop. This is because of their effect on chemicals in the brain, including dopamine (dopamine, along with serotonin, are mood-enhancing chemicals and are associated with feelings of pleasure, and motivation).

Research has shown that this is more likely to happen in young people, with studies showing an extra 5 to 14 patients out of every 1000 children and young adults under the age of 24 treated with antidepressants and medications such as Vraylar experienced an increased risk of suicidal thoughts and behaviors. The risk is higher during the first few months of treatment or when the dose is changed.

Tips for managing somebody at risk of developing suicidal thoughts

If you or someone you care for is taking Vraylar, be aware of any sudden changes in mood, behavior, thoughts, or feelings, particularly when starting or adjusting the dose. Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• Thoughts about suicide or dying or attempts to commit suicide
• New or worse depression
• Feeling very agitated, irritated, or restless
• Acting aggressively, being angry, or violent
• Trouble sleeping (insomnia)
• An extreme increase in activity and talking
• New or worse anxiety or panic attacks
• Acting on dangerous impulses
• Other unusual changes in behavior or mood.

Report any changes to your healthcare provider immediately. Keep all your scheduled follow-up appointments and contact your healthcare provider between visits if you have any concerns.

* This is not a complete list of side effects. See here for more information.