Experiencing Side Effects with Caplyta and Potential Solutions

Experiencing Side Effects with Caplyta and Potential Solutions

Caplyta, sold under the brand name, is an oral capsule used to treat schizophrenia and bipolar depression in adults. Like other medications, Caplyta can lead to side effects such as drowsiness and dry mouth.

Caplyta carries boxed warnings, which is the most severe warning issued by the Food and Drug Administration (FDA). To learn about these warnings, please check out the "Side effect specifics" section.

More prevalent side effects of Caplyta

Caplyta may produce side effects in some individuals, some of which are more common than others. These side effects might be temporary, lasting a few days to weeks. However, if the side effects persist, worsen, or become severe, reach out to your doctor or pharmacist for advice.

The list below showcases some of the more common side effects experienced by people participating in clinical trials taking Caplyta. The specific side effects can vary based on the condition being treated.

More prevalent side effects in individuals using Caplyta for schizophrenia include:

  • drowsiness
  • nausea or vomiting
  • abnormal lab test results, such as elevated liver enzyme levels
  • fatigue
  • reduced appetite
  • dry mouth*
  • dizziness*

More prevalent side effects in individuals using Caplyta for bipolar depression include:

  • headache
  • drowsiness
  • nausea or vomiting
  • diarrhea
  • dry mouth
  • abdominal pain
  • upper respiratory infection, such as the common cold
  • dizziness*
  • blurred vision†
  • increased prolactin level (a hormone produced by the pituitary gland)†

* For details about this side effect, see “Side effect specifics” below.† This side effect emerged when Caplyta was used in conjunction with lithium or valproate.

Mild side effects of Caplyta

Mild side effects may occur while using Caplyta. This list isn't exhaustive as it does not cover all possible mild side effects of the drug. To learn more, check Caplyta's prescribing information.

Mild side effects reported with Caplyta for schizophrenia include:

  • drowsiness
  • nausea and vomiting
  • dry mouth
  • fatigue
  • reduced appetite
  • abnormal lab test results, such as elevated liver enzyme levels
  • weight gain*
  • dizziness*

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects reported with Caplyta for bipolar depression include:

  • headache
  • drowsiness
  • nausea or vomiting
  • diarrhea
  • dry mouth
  • abdominal pain
  • upper respiratory infection, such as the common cold
  • weight gain*
  • dizziness*
  • blurred vision†
  • increased prolactin level (a hormone produced by the pituitary gland)†

These side effects can be temporary, lasting a few days to weeks. However, if the side effects persist, worsen, or become severe, consult your doctor or pharmacist.

Please note: After Caplyta receives FDA approval, the regulatory body keeps track of the drug's side effects. If you notice any side effects while using Caplyta and wish to share this information with the FDA, visit the MedWatch website.

* For more information about this side effect, see “Side effect specifics” below.† This side effect emerged when Caplyta was used in conjunction with lithium or valproate.

  • Tardive dyskinesia. Manifestations may encompass uncontrollable twitching in the face, neck, limbs, and torso.
  • Neuroleptic malignant syndrome. Symptoms can include:
    • fever
    • muscle rigidness
    • cognitive impairment
    • issues with the autonomic nervous system of the body
    • rhabdomyolysis (breakdown of muscle tissue that releases proteins into the blood)
    • abrupt (sudden) kidney failure
  • Metabolic alterations, such as high blood sugar levels and diabetes. Symptoms can include:
    • weight loss
    • blurry vision
    • enhanced urination
    • fruity-smelling breath
    • elevated cholesterol and triglyceride levels (usually detected in blood tests)
    • weight gain
  • Decreased white blood cells (usually detected in blood tests). Symptoms can include:
    • infection
    • weakness
    • fever
  • Orthostatic hypotension and syncope. Symptoms can include:
    • feeling dizzy upon standing up
    • falling
    • fainting
  • Seizures. Symptoms can include
    • involuntary shaking or uncontrollable body movements
    • losing consciousness
    • falling
  • Difficulty regulating body temperature. Symptoms can include:
    • feeling excessively heated
    • not sweating while hot or exerting oneself
    • feeling overwhelmed by heat
  • Difficulty swallowing. Symptoms can include
    • coughing or choking while eating
    • inhaling saliva or food into the lungs
  • Extrapyramidal side effects (uncontrollable movements)
  • Allergic reaction.*†
  • Increased risk of death in elderly individuals with psychosis due to dementia.***
  • Risk of suicidal thoughts and behaviors.***

* To acquire further information, refer to the “Side effect specifics” section below.† An allergic reaction is conceivable after administering Caplyta. However, this side effect wasn’t reported in clinical trials. Caplyta carries a boxed warning* for this side effect. This is the most serious warning from the Food and Drug Administration (FDA).

Frequently Asked Questions about the side effects of Caplyta

Caplyta may induce several side effects. Here are some frequently asked questions regarding the drug’s side effects and their answers.

Does Caplyta cause any cardiac side effects?

It's plausible. Caplyta can cause orthostatic hypotension (a decrease in blood pressure when transitioning from a sitting to a standing position). Symptoms include dizziness, fainting, and falling. Take your time moving between positions to help mitigate this potential side effect of Caplyta.

Caplyta also carries a boxed warning for an increased risk of death in the elderly with psychosis due to dementia. In clinical trials, causes of death included heart failure and stroke. For further details, see the “Side effect specifics” section below.

If you have concerns about cardiac side effects and Caplyta, consult your doctor.

Are there any side effects of ceasing Caplyta treatment?

No, there weren’t any side effects associated with ceasing Caplyta treatment in clinical trials. Withdrawal symptoms (side effects that may manifest upon cessation of a drug the body has grown dependent on) weren’t reported in adults who took the drug in clinical trials.

However, stopping treatment with Caplyta may cause symptoms of schizophrenia or bipolar depression to resurface. (These are conditions that Caplyta is approved to treat.)

If you have questions about Caplyta’s side effects, consult your doctor. Remember, you should not alter your dose of Caplyta or cease taking it without consulting your doctor.

Can Caplyta be employed to treat bipolar disorder?

No, Caplyta is not approved to treat bipolar disorder. Caplyta is only approved to treat bipolar depression and schizophrenia in adults.

If you have questions about treating bipolar disorder or whether Caplyta is suitable for you, consult your doctor.

Is Caplyta a mood stabilizer or an antipsychotic?

Caplyta belongs to the atypical antipsychotics drug class. These are also called second-generation antipsychotics, and they usually cause fewer and milder side effects than first-generation antipsychotics.

Caplyta may be prescribed in conjunction with a mood stabilizer such as lithium or valproate to treat depressive episodes resulting from bipolar I or bipolar II disorder. Doctors may also prescribe Caplyta on its own for this purpose.

If you take Caplyta with a mood stabilizer, you may experience different side effects than individuals taking Caplyta alone. Speak with your doctor if you have questions about side effects of Caplyta or other drugs.

Something to Keep in Mind Before Using Caplyta

Prior to starting Caplyta, you might want to jot down your weight. You can keep tabs on your weight throughout the treatment process. In case you experience weight gain during Caplyta treatment, chat with your physician. They can provide suggestions to help maintain a healthy weight for you.

Is Caplyta Likely to Make You Feel Dizzy?

Caplyta might cause dizziness. In clinical trials, this side effect was quite common.

Caplyta can also lead to orthostatic hypotension, especially at the beginning of treatment. With orthostatic hypotension, your blood pressure can drop significantly when transitioning from a sitting to a standing position. Symptoms may include fainting, dizziness, and even loss of balance.

Dizziness may be more prevalent if you have a past history of heart issues, such as heart attacks, strokes, or heart rhythm problems.

What Can Be Done

To reduce the likelihood of dizziness while taking Caplyta, proceed with caution when moving from one body position to another. If you're concerned about dizziness during Caplyta treatment, share your concerns with your doctor. Make sure to discuss all the medications you're currently taking and any previous heart issues you've had.

Caplyta and Dry Mouth

Dry mouth was a common side effect seen in clinical trials for Caplyta treatment. This side effect is usually mild.

What Can Be Done

Speak with your doctor if you suffer from dry mouth while using Caplyta. They can offer tips to help manage this side effect.

Caplyta and Allergic Reactions

While rare, Caplyta can cause allergic reactions in some individuals. However, this side effect was not reported in clinical trials.

Symptoms can range from mild to severe and may include:

  • Rash
  • Itching
  • Flushing
  • Swelling beneath the skin around the lips, eyelids, feet, or hands
  • Swelling of the mouth, tongue, or throat, making swallowing difficult

What Can Be Done

For mild allergy symptoms, contact your doctor promptly. They may suggest methods to alleviate your symptoms and assess whether Caplyta should continue to be used. However, if your symptoms are severe and you believe you're experiencing a medical emergency, immediately call 911 or your local emergency number.

Risk of Death in Older Adults with Psychosis due to Dementia

Caplyta carries a boxed warning regarding the increased risk of death in older adults with psychosis due to dementia. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). Due to this risk, Caplyta is not approved for use in older adults with dementia-related psychosis.

In clinical trials, the causes of death in older adults included heart failure, stroke, and pneumonia.

What Can Be Done

If you're a healthcare professional for an older adult with dementia-related psychosis, ensure their doctor knows about all the medications they're taking.

Enhanced Risk of Suicidal Thoughts and Behaviors

Caplyta increases the risk of suicidal thoughts and behaviors. Caplyta carries a boxed warning about this side effect.

In clinical trials, this side effect was more common in children and people aged 24 years or younger. This risk of suicidal thoughts and behaviors can occur when a person starts taking Caplyta or when their doctor increases the dosage.

What Can Be Done

While using Caplyta, contact your doctor right away if you experience:

  • Sudden changes in mood, behavior, feelings, or thoughts
  • Suicidal thoughts or intentions to harm yourself
  • New or worsening depression
  • New or worsening anxiety
  • Agitation or restlessness
  • Panic attacks
  • Feelings of anger or violence
  • Impulsive behavior

Suicide Prevention

If you or someone you know is experiencing suicidal thoughts, reach out to a suicide prevention hotline. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Precautions for Caplyta

There are several precautions to consider before taking Caplyta. These include two boxed warnings.

Boxed Warnings

Caplyta has boxed warnings for an increased risk of death in older adults with psychosis due to dementia and a risk of suicidal thoughts and behaviors. These are serious warnings from the Food and Drug Administration (FDA). For more information, refer to the "Side effect specifics" section above.

Other Precautions

Discuss your health history with your doctor before starting Caplyta. Caplyta may not be suitable for individuals with certain medical conditions or other factors that could impact their health. The conditions and factors to consider include:

  • History of epilepsy or seizures: Share your history of epilepsy or seizures with your doctor. Caplyta may increase your risk of seizures if you have epilepsy or a history of seizures. Your doctor can help determine if Caplyta is suitable for you.

Low blood pressure risk: Caplyta might enhance your likelihood of experiencing orthostatic hypotension, a type of low blood pressure. This risk is more substantial if you already have low blood pressure, use blood pressure medication, or have cardiovascular disease. Consult your physician if you have low blood pressure. They may monitor your blood pressure while you're on Caplyta treatment.

Low white blood cell count: Taking Caplyta may decrease your white blood cell count, including neutrophils. Your doctor might monitor your white blood cell levels through blood tests throughout your Caplyta treatment.

Overheating or dehydration: Caplyta can impact how your body controls its temperature, potentially causing overheating or dehydration. To prevent overheating, avoid doing intense exercise, using a sauna, or spending prolonged periods in hot weather while taking Caplyta. Stay hydrated, and contact your doctor about the risks of overheating and dehydration with Caplyta.

Liver disease: If you have moderate to severe liver disease, you should not take Caplyta. Inform your doctor if you've had any liver issues in the past.

Allergic reaction: If you've had an allergic reaction to Caplyta or any of its substances, your doctor is unlikely to prescribe Caplyta. Discuss alternative medications with your doctor.

Alcohol and Caplyta

There aren’t any recognized interactions between Caplyta and alcohol.

However, alcohol may exacerbate specific Caplyta side effects, such as fatigue, dizziness, nausea, and vomiting.

Alcohol can also worsen mental health conditions, like schizophrenia and bipolar depression. (Caplyta is approved to treat schizophrenia and bipolar depression.)

If you consume alcohol, discuss safe alcohol limits with your doctor during Caplyta treatment.

Pregnancy and breastfeeding while taking Caplyta

It's unknown if it's safe to take Caplyta during pregnancy. Newborns who were exposed to Caplyta during the third trimester have experienced withdrawal symptoms and abnormal muscle movements after birth.

You should not take Caplyta if you're breastfeeding. Exposure to antipsychotic medications, including Caplyta, through breastfeeding has resulted in atypical muscle movements and excessive sleepiness in clinical trials.

If you have questions regarding pregnancy or breastfeeding options while taking Caplyta, consult your doctor.

When to speak with your doctor

Caplyta treatment may cause both mild and severe side effects. Most side effects are mild and usually subside after a few days to weeks. However, Caplyta can cause serious side effects infrequently. Discuss any persistent, bothersome, or severe side effects with your doctor.

If you'd like to learn more about Caplyta, speak with your doctor or pharmacist. They can provide answers to any questions you have about Caplyta side effects.

In addition to speaking with your doctor, performing independent research can be helpful. These sources may aid you:

  • More information about Caplyta: Gain further insights about Caplyta from this article.
  • Dosage: Learn more about Caplyta's dosage by visiting this article.
  • Interactions: Discover Caplyta's interactions by referring to this article.
  • A look at your condition: Gather details about your condition from our mental health hub. You can also consult our lists of schizophrenia and bipolar disorder articles.

Disclaimer: Medical News Today has made every effort to ensure all information is accurate, comprehensive, and up-to-date. Nevertheless, this article should not replace professional medical advice. Always consult your doctor or another healthcare professional before using any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, precautions, warnings, drug-drug interactions, allergic reactions, or side effects. The absence of warnings or additional information for a given drug does not imply that the drug or drug combination is safe, effective, or appropriate for all patients or for all specific uses.

Caplyta's boxed warnings may include information about potentially serious side effects, such as an increased risk of death in older adults with psychosis due to dementia.

The "Side effect specifics" section cites dry mouth as a common side effect of Caplyta, which could be managed by contacting a doctor.

Read also: