Vraylar Long-Term Effects and Health Risks

Last Updated on September 19, 2026 by Carol Gillette

Alternative to Meds Editorial Team
Medically Reviewed by ATMC Clinical Review Team

Vraylar Long-Term Effects — What is Known?

Vraylar has a 10-year history of post-marketing information from which we can find out about the long-term effects and benefits of this drug. Like most drugs on the market today, a poverty of clinical research and a handful of short-term clinical trials preceded its approval.⁹

Clinical research has helped inform us on the subject, despite this being marketed for a relatively short period of time. You may notice that Vraylar long-term effects are quite similar to a great many other, if not all, antipsychotic medications. Below is a brief summary of the long-term effects (in trials, longer than 3 weeks is considered “long-term”) that are currently known about cariprazine. Some adverse effects can occur early on, and some are late-developing. Some may be mild, and yet some may be fatal. Anyone taking Vraylar should be informed and aware of the potential adverse effects that may occur in both short- and long-term use.^1-4 

Vraylar long-term effects can include:

• Increased cerebrovascular events and mortality in elderly dementia patients
• NMS (neuroleptic malignant syndrome, described below)
• Tardive dyskinesia (see details below)
• Akathisia
• Seizures
• Tremors
• Involuntary muscle movements
• Stiffness
• Weight gain
• Diabetes
• High or dysregulated blood sugar levels
• Orthostatic hypotension-related side effects, i.e., dizziness, fainting, sudden drop in blood pressure when standing up)
• Elevated hemoglobin levels over time
• Somnolence, leading to increased risks of falling and injuries
• Dysphagia – inability to swallow, or pain while swallowing. Over time dysphagia can lead to potential fatalities such as respiration being blocked by inhaling food/liquid, starvation, pneumonia, especially in the elderly or bed-ridden.
• Drooling can also result from dysphagia.
• Elevated or dysregulated body temperature
• Leukopenia, neutropenia (see section on immune system below) ¹⁷

The above side effects have been observed after long-term use of Vraylar. However, some side effects can occur within hours, days, or weeks of taking a drug. As mentioned above, some Vraylar side effects can be mild and transitory, and yet others can persist and worsen over time. Working with a trusted caregiver is highly recommended so these changes can be monitored and the numerous factors affecting your health are protected and cared for over the long term.^2-6,9,12

Vraylar side effects that were observed within 3 week trials included:

• Sleepiness
• Vomiting
• Diarrhea
• Abdominal pain
• Agitation
• Insomnia
• Restlessness
• Anxiety
• Akathisia
• Rash
• Cough
• Extrapyramidal symptoms such as muscle stiffness, tremors, involuntary movements or postures
• Seizures
• Impaired cognitive skills including judgement, thinking, reaction time
• Motor impairment (FDA recommends not operating heavy machinery or driving when starting Vraylar)
• Dysphagia

NOTE:  One should expect his or her prescriber to monitor when adverse effects begin, or change, and especially if they persist or worsen and could become long-term effects of Vraylar without intervention. Whether your diagnosis was for bipolar mania, schizophrenia, psychosis, or other reasons, never stop taking antipsychotic medication abruptly or cold turkey. The results could be devastating. Seek help that you trust to assist in the process so it is done safely.^3.6-8

How to Report Adverse and Long-term Effects of Vraylar or Any Drug?

You may have experienced some of the above Vraylar side effects, and you may have experienced other long-term effects after taking Vraylar that you don’t see on the list. If so, you may be helping others by reporting your experiences to the FDA’s adverse event reporting platform. If you are too ill or unable to make the report yourself, ask your prescriber or other trusted person to do it on your behalf.¹⁶

Notes on Akathisia

Symptoms of akathisia can include:

• Inability to be still or rest, must be in constant motion, rocking, pacing, swinging the arms, etc.
• Inner sensation of extreme restlessness and distress
• Acute agitation
• High anxiety, sense of dread
• Erratic behavior, anger
• Insomnia
• Can be so severe as to lead to suicidality

It should be noted that akathisia is associated with both taking antipsychotics, and also coming off an antipsychotic medication too quickly. This can include missing a dose, or abruptly stopping. Never abruptly stop taking antipsychotic medication. The safer route is to put a gradual tapering plan in place that is monitored by a physician who is familiar with antipsychotic medication withdrawal.

What is NMS – Neuroleptic Malignant Syndrome?

Neuroleptic means any drug that affects neurons and neurology. Malignant means harmful, destructive, negative. Syndrome is a set of symptoms that are seen to occur together.

Vraylar’s drug insert mentions NMS as a possibly fatal adverse effect that can occur both after a short time or as a result of more long-term Vraylar treatment. The usual medical interventions, if done early enough, can save the person’s life.

If NMS occurred because of a drug reaction, stopping the medication immediately may reverse these symptoms, and there are other medications that can potentially bring the person back to normal status.

However, it is important to note that NMS can also manifest as a result of abrupt withdrawal of a neuroleptic medication. If NMS occurred as a consequence of withdrawal of a neuroleptic drug, then reinstating that drug is the accepted medical intervention along with certain drugs to help revert the condition.^13,14

Symptoms of NMS can include:

• Changes in mental status, i.e., confusion, delirium, loss of consciousness, coma
• Fever, hydrothermia
• Lead-pipe stiffness in the muscles
• Autonomic instability, meaning irregular or elevated heartbeat, changes to blood pressure, dysregulated breathing, digestion, perspiration, body temperature fluctuations

Tardive Dyskinesia and Long-Term Antipsychotics

Tardive means “developing slowly” and dyskinesia means “uncontrollable muscle or body movements.” Tardive dyskinesia is a term that encompasses many different types of movement disorders.

TD is associated with antipsychotic medications taken long-term like Vraylar and many others. It is thought that drugs which dysregulate the dopamine receptors can cause this condition.

Sometimes TD can be reversed by stopping the offending drug. There is incomplete understanding of how the condition develops, and beyond stopping the offending drug, there is no known “cure.” Sometimes the condition is irreversible and can manifest even after the drug is withdrawn.¹⁵

Manifestations of TD syndromes can include these involuntary, repetitive movements:

• Lip-smacking
• Grimacing
• Frowning
• Tongue protrusion, tongue rolling
• Puffing out the cheeks
• Rapid blinking
• Finger motions, leg motions, arm, and hand motions
• Jerking of the neck and shoulders, twisting of the spine
• Abnormal postures, dystonia
• Buccolingual stereotypy (facial muscle movements) – can impact all of the mouth muscles including the jaw, forehead, eyes, etc.
• Chorea, meaning “dance-like” involuntary movements
• Tics, involving sounds and motions
• Akathisia

These types of involuntary muscle movements can be quite mild and hardly noticeable at first, and even before reaching a debilitating state, can be a crushing source of distress and embarrassment.

In olden times, these motions were considered part of being “mentally ill” but now these are fully recognized as the long-term effects of Vraylar and other drugs.

Long-term Effects of Vraylar on the Immune System

The Vraylar package insert also mentions that the white blood cells (leukocytes) that are the engines and armies of the immune system may become decreased over time in some persons. When leukocytes are deficient, a certain kind of white blood cell called neutrophils also become deficient. These conditions are called leukopenia and neutropenia.

This means our natural immunity to infections, microorganisms, bacteria, pathogens, etc. would be weakened. Some functions that may be compromised are tissue repair, the ability to fight inflammation, and opens the gates for infections or certain diseases to proliferate without the body’s natural ability to fight back.¹⁷

The Natural Alternatives to Chemical Treatments

Symptoms of schizophrenia and manic episodes of bipolar conditions can be ruinous. Perhaps in a time of crisis, a chemical treatment like Vraylar may be appropriate. However, after the crisis has passed, it may be prudent to consider reduction or withdrawal of the chemical/drug to avoid long-term effects.

A strong support system can be put in place that involves proper nutrition, checking for neurotoxins in the body and cleansing, professional counseling, therapies for comfort and stress-relief, revamping one’s sleep hygiene, and many other ways to assist authentic recovery of mental wellness. While drugs can at times provide a welcome buffer or numbing effect, there are superior ways to approach real healing for long-term health without depending on prescription medication alone.

If your prescriber has recommended Vraylar as a first-line treatment, but you want to explore non-drug alternatives, there are options that may be healthier, especially over long-term Vraylar or other type of antipsychotic medication.

You can find out much more about natural alternative treatments and strong supportive therapeutics for mental health issues on our website. To get a better understanding of ATMC protocols used inpatient, you can visit antipsychotic alternatives, as well as antipsychotic medication withdrawal.

Find Out More about Safe, Proven ATMC Treatment Protocols

Please call us or visit our services overview pages to learn much more about the ways that ATMC has found highly successful in making improvements in mental health without taking the risk of compromising your overall health. We are a leader in alternative treatments for mental wellness and successful recovery after long-term Vraylar or other types of treatment may have disappointed your treatment goals.

We have helped literally thousands of clients to reach their mental wellness goals through medication reduction or withdrawal, and every person we treat receives a highly individualized treatment program under medical supervision. Our staff are passionate about your recovery, many of whom suffered and recovered in similar ways to what is offered at Alternative to Meds Center. You don’t have to further compromise your health — there are other treatment choices available at ATMC.

We understand that not everyone is a candidate for inpatient treatment, and in this case, we recommend you contact the following resources for help in your immediate area.

Be well, stay well, and please take time to review the many other informative articles that may interest you on our website.

Here are some additional resources you may find helpful:

IMMH.org

AACAM.org 

for Help with Vraylar Long-Term Effects

Sources:

1. Chokhawala K. Stevens L, Antipsychotics Medications Stat Pearls published online Feb 26, 2023 [cited 2025 Oct 7]

2. Oldak S, et al, A Brief Review of Cariprazine American Journal of Psychiatry Residents’ Journal Volume 19 Number 3, 1 March 2024 [cited 2025 Oct 7]

3. Cariprazine (Vraylar): CADTH Reimbursement Review: Therapeutic area: Schizophrenia [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2022 Oct. Clinical Review. Available from: https://www.ncbi.nlm.nih.gov/books/NBK602653/ [cited 2025 Oct 7]

4. Cariprazine.pdf published by NAMI 2023  [cited 2025 Oct 7]

5. Campbell RH, Diduch M, Gardner KN, Thomas C. Review of cariprazine in management of psychiatric illness. Ment Health Clin. 2018 Mar 23;7(5):221-229. doi: 10.9740/mhc.2017.09.221. PMID: 29955527; PMCID: PMC6007710. [cited 2025 Oct 7]

6. Durgam S, Earley W, Li R, Li D, Lu K, Laszlovszky I, Fleischhacker WW, Nasrallah HA. Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial. Schizophr Res. 2016 Oct;176(2-3):264-271. doi: 10.1016/j.schres.2016.06.030. Epub 2016 Jul 15. Erratum in: Schizophr Res. 2018 Feb;192:493. doi: 10.1016/j.schres.2017.04.020. PMID: 27427558. [cited 2025 Oct 7]

7. Moncrieffe J, et al Antipsychotic Dose Reduction…Radar Trial ..The Lancet Psychiatry Vol 10, Issue 11, p848-859 November 2023 [cited 2025 Oct 7]

8. Riccobene T, Riesenberg R, Yeung PP, Earley WR, Hankinson AL. Pharmacokinetics, Safety, and Tolerability of Cariprazine in Pediatric Patients with Bipolar I Disorder or Schizophrenia. J Child Adolesc Psychopharmacol. 2022 Oct;32(8):434-443. doi: 10.1089/cap.2021.0139. PMID: 36282772.  [cited 2025 Oct 7]

9. FDA label Vraylar (cariprazine) capsules for oral use approved 2015 [cited 2025 Oct 7]

10. Patel J, Marwaha R. Akathisia. [Updated 2023 Jul 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/sites/books/NBK519543/ [cited 2025 Oct 7]

11. Akagi H, Kumar TM. Lesson of the week: Akathisia: overlooked at a cost. BMJ. 2002 Jun 22;324(7352):1506-7. doi: 10.1136/bmj.324.7352.1506. PMID: 12077042; PMCID: PMC1123446. [cited 2025 Oct 7]

12. Jiménez-Jiménez FJ, García-Ruiz PJ, Molina JA. Drug-induced movement disorders. Drug Saf. 1997 Mar;16(3):180-204. doi: 10.2165/00002018-199716030-00004. PMID: 9098656. [cited 2025 Oct 7]

13. Tan CM, Kumachev A. Neuroleptic malignant syndrome. CMAJ. 2023 Nov 6;195(43):E1481. doi: 10.1503/cmaj.221763. PMID: 37931952; PMCID: PMC10627565. [cited 2025 Oct 7]

14. Simon LV, Hashmi MF, Callahan AL. Neuroleptic Malignant Syndrome. 2023 Apr 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan–. PMID: 29489248. [cited 2025 Oct 7]

15. Vasan S, Padhy RK. Tardive Dyskinesia. 2023 Apr 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan–. PMID: 28846278.  [cited 2025 Oct 7]

16. FDA publication: Report a Problem to the FDA (online) [cited 2025 Oct 7]

17. Ing VW. The etiology and management of leukopenia. Can Fam Physician. 1984 Sep;30:1835-9. PMID: 21279100; PMCID: PMC2154209. [cited 2025 Oct 7]

Originally Published October 8, 2025 by Diane Ridaeus

This content has been reviewed and approved by:

ATMC Clinical Review Team

The ATMC Clinical Review Team includes licensed physicians and experienced healthcare professionals dedicated to ensuring the accuracy, quality, and integrity of our medical content. The team reviews articles for clinical accuracy, evidence-based guidance, and relevance while supporting Alternative to Meds Center’s whole-person approach to mental health, recovery, and long-term wellness.

Diane Ridaeus

Diane is an avid supporter and researcher of natural mental health strategies. Diane received her medical writing and science communication certification through Stanford University and has published over 3 million words on the topics of holistic health, addiction, recovery, and alternative medicine. She has proudly worked with the Alternative to Meds Center since its inception and is grateful for the opportunity to help the founding members develop this world-class center that has helped so many thousands regain natural mental health.