Vraylar's Potential Effects: Regular, Mild, and Severe
Vraylar, the branded capsule for certain mental health issues like depression, comes with its own set of side effects. Similar to other drugs, it can induce side effects such as vomiting, insomnia, and uncontrollable body movements.
Vraylar features a 'boxed warning,' the most severe warning from the Food and Drug Administration (FDA). To understand this better, check out the "Side effect specifics" section.
More frequent side effects of Vraylar
Several side effects have been reported by users of Vraylar, some of which are more prevalent than others. These side effects are often temporary, lasting for a few days or weeks. However, if they persist, worsen, or become severe, consult your healthcare provider or pharmacist.
Some of the more common side effects observed in Vraylar users during clinical trials include:
- Difficulty moving or sluggish movements
- Shaking (tremors)
- Agitation
- Sleepiness
- Uncontrolled body movements*
* Please refer to the “Side effect specifics” section for additional details.
Mild side effects of Vraylar
Mild side effects can present themselves during Vraylar treatment. The following list does not cover all possible mild side effects of the drug. For more information, consult Vraylar's prescribing information.
Mild side effects reported by Vraylar users include:
- Difficulty moving or sluggish movements
- Shaking (tremors)
- Agitation
- Stomach upset
- Vomiting
- Constipation
- Fatigue
- Nausea*
- Sleeplessness*
- Weight gain†
These side effects are often temporary and may last for a few days or weeks. Should they persist or worsen, consult your healthcare provider or pharmacist.
* For further details, see the “Side effect specifics” section.† Refer to the “Vraylar weight gain” section for more information.
Serious side effects of Vraylar
Vraylar may lead to serious side effects. This list may not include all potential serious side effects of the drug. For additional information, consult Vraylar's prescribing information.
If you develop serious side effects while using Vraylar, contact your doctor immediately. If the side effects appear life-threatening or you suspect a medical emergency, dial 911 or your local emergency number without delay.
Serious side effects and their signs that users of Vraylar have reported include:
- Neuroleptic malignant syndrome (a critical reaction to specific drugs demanding immediate medical attention). Symptoms may include:
- Changes in your breathing, heart rate, or blood pressure
- Confusion
- Fever higher than 106°F (41.1°C)
- Muscle rigidity
- Sweating
- Type 2 diabetes and high blood sugar. Symptoms include:
- Strong thirst
- Intense hunger
- Weakness, confusion, or exhaustion
- Frequent urination
- Orthostatic hypotension (drop in blood pressure upon standing or sitting up). Symptoms may include:
- Falling
- Dizziness
- Blurred vision
- Seizure. Symptoms may include:
- Uncontrollable muscle spasms
- Falling
- Loss of consciousness followed by confusion
- Leukopenia (decreased white blood cell levels). Symptoms may include:
- Mouth sores
- Sore throat, mouth, and gums
- Fever
- Trouble swallowing, which could potentially result in aspiration (inhalation of food or liquid).
- Difficulty regulating body temperature, particularly during exercise or in hot weather. Symptoms may include:
- Heatstroke
- Hot, dry skin
- Lack of perspiration when you're hot
- Increased triglycerides and cholesterol levels in your blood, generally without causing noticeable symptoms other than abnormal lab test results.
- Uncontrolled body movements.*
- Enhanced risk of death when used to treat psychosis related to dementia in older adults.†
- Risk of suicidal thoughts and behaviors.†
Note: After a drug is approved by the FDA, they track its side effects. If you experience a side effect while using Vraylar and wish to report it to the FDA, visit MedWatch.
* For additional details, refer to the “Side effect specifics” section.† Vraylar has a boxed warning for this side effect. This is a serious warning from the FDA. For more information, see the “Side effect specifics” section.
Allergic reaction
Some individuals might experience an allergic reaction to Vraylar.
However, the frequency of this side effect in the drug's studies remains unclear.
In general, allergic reaction symptoms can range from mild to severe.
Managing your symptoms
For mild allergic reaction symptoms, such as a minor rash, consult your doctor promptly. They may suggest treatments to help manage your symptoms and decide if you should continue using the medication.
For severe allergic reactions, such as swelling or difficulty breathing, immediately contact 911 or your local emergency number. These symptoms necessitate immediate medical attention due to their potential to become life-threatening. If you've experienced a severe allergic reaction to Vraylar, your doctor might suggest switching to a different medication.
Weight gain is a potential side effect of atypical antipsychotics, including Vraylar. This is because Vraylar can stimulate your appetite, which could lead to overeating and subsequently, weight gain. Furthermore, antipsychotic medications like Vraylar can elevate cholesterol and triglyceride levels, also contributing to weight gain. However, significant weight gain wasn't commonly observed in Vraylar's clinical trials, and it usually presented as a mild symptom.
Doctors typically assess body weight before initiating Vraylar treatment and monitor weight during the course of therapy. If Vraylar is determined to be causing weight gain, your doctor might recommend switching to an alternative medication.
If you have concerns about weight gain while using Vraylar, consult your doctor for advice on maintaining a healthy weight.
Vraylar may induce several side effects. Here are some frequently asked questions about the drug's side effects and their answers:
Can one experience withdrawal symptoms by stopping Vraylar treatment?
There are typically no specific withdrawal symptoms reported when stopping Vraylar treatment. However, if you cease Vraylar use, symptoms of your condition might reoccur. Therefore, it's crucial to consult your doctor before stopping any medication, as they can determine if it's safe to do so and recommend alternative treatments if necessary.
Do Vraylar side effects last indefinitely? Are there any long-term side effects?
Most Vraylar side effects subside within a few days or upon cessation of the drug. However, certain side effects may be long-lasting. For instance, uncontrolled body movements caused by Vraylar may persist after stopping the medication, known as tardive dyskinesia. Additionally, Vraylar may induce type 2 diabetes, which could also persist post-discontinuation.
Are sexual side effects associated with Vraylar use?
People participating in Vraylar clinical trials did not report sexual side effects. While certain antipsychotic drugs can cause sexual issues such as changes in libido, Vraylar is not known for this side effect.
If you have sexual concerns, discuss them with your doctor.
Are Vraylar side effects influenced by its strengths?
Vraylar's different strengths don't appear to cause distinct side effects. The drug is available in 1.5 milligrams (mg), 3 mg, 4.5 mg, and 6 mg strengths.
Although certain side effects may present more or less frequently with specific dosages in clinical trials, the rates of side effects might vary depending on your Vraylar dose.
For clarification on the various strengths of Vraylar and potential side effects, consult your doctor or pharmacist.
Vraylar may affect your health by causing several side effects, including boxed warnings.
Is there an elevated risk of death in older adults with dementia-related psychosis when taking Vraylar?
Vraylar carries a boxed warning for increased mortality risk in adults aged 65 and older with dementia-related psychosis. The warning alerts patients and healthcare providers about potentially harmful drug effects. Psychosis in dementia patients refers to a distorted perception of reality, while dementia is associated with memory, thinking, and communication issues.
Older adults with psychosis related to dementia have a heightened risk of mortality when treated with antipsychotic medications, including Vraylar.
What can be done
Vraylar is not authorized for dementia-related psychosis treatment in older adults. If an elderly individual exhibits psychosis associated with dementia and you're considering treatment options, consult their doctor.
Is there a risk of suicidal thoughts and behaviors with Vraylar use in children and young adults under 25?
Vraylar carries a boxed warning for the potential of suicidal thoughts and behaviors in children and young adults under 25. Antidepressant medications may increase the risk of suicidal thoughts and behaviors in the aforementioned age group. Vraylar is a type of antipsychotic drug and could have similar effects when used to treat bipolar depression or major depressive disorder (MDD), as it is typically prescribed in conjunction with an antidepressant for MDD treatment.
Vraylar is not approved for use in individuals younger than 18 years. However, regardless of age, healthcare providers will often monitor patients while they're taking medications such as Vraylar, watching for changes in thinking, including suicidal thoughts or behaviors.
What can be done
During your Vraylar therapy, keep an eye out for shifts in your thoughts and actions. It could be beneficial to get your friends and relatives to monitor your symptoms, particularly when you first start using the medication or when your dosage is adjusted.
If you or someone else observes any changes, promptly contact your physician or seek immediate medical assistance.
Nausea
Nausea is a mild, potential side effect of Vraylar. While it was a common side effect reported in clinical trials, the majority of users did not experience it.
For most individuals, this side effect tends to subside on its own after a few days.
What you can do
Should you continue to feel nauseous even after several days of using Vraylar, reach out to your doctor. They'll likely want to schedule an appointment to determine if something else might be causing your nausea. If they diagnose nausea as a side effect of Vraylar, they may suggest strategies to alleviate it. However, if the nausea disrupts your daily routine, your doctor might propose a different medication for your condition.
Insomnia
Insomnia is a potential side effect of taking Vraylar. It is characterized by difficulty in falling asleep or staying asleep. People using Vraylar reported symptoms such as:
- trouble falling asleep or staying asleep
- difficulty returning to sleep after waking up in the middle of the night or early morning
What you can do
If you develop insomnia while taking Vraylar, consult your doctor. They might suggest coping mechanisms to manage this side effect, such as administering a sleep aid. Your doctor might also recommend improvements in sleep hygiene, like avoiding electronic devices before bed, or suggest switching to a different drug for your condition.
Uncontrolled body movements
Although rare, Vraylar can lead to a severe side effect known as tardive dyskinesia. This condition is characterized by repetitive, involuntary body movements.
Symptoms of tardive dyskinesia can include recurrent:
- jaw movements
- jerking movements of your limbs, torso, or face
- lip smacking
- puffing air into your cheeks
- tongue twisting
Tardive dyskinesia symptoms may dissipate after stopping Vraylar. However, this side effect can sometimes be permanent.
It's impossible to predict who will develop tardive dyskinesia with Vraylar. However, older adults, particularly older females, are believed to be at a higher risk. The risk of developing tardive dyskinesia and its permanence increases the longer you take Vraylar.
Higher dosages can also increase the risk, although tardive dyskinesia has occurred in people taking low doses, albeit rarely. Additionally, tardive dyskinesia can develop after stopping Vraylar therapy because the drug remains in your body for an extended period.
What you can do
Your doctor will keep a close watch on you while you're using Vraylar to assess its effectiveness and any side effects. They'll endeavor to prescribe the lowest effective dosage for you.
While taking Vraylar, be vigilant for signs of tardive dyskinesia and share any you observe with your doctor. They will likely want to discuss with you the pros and cons of continuing to use the drug. Some individuals may find Vraylar to be the best long-term treatment for their condition, even when tardive dyskinesia occurs. For others, tardive dyskinesia may be a reason to discontinue Vraylar and switch to a different medication.
Suicide prevention
Should you know someone in immediate danger of self-harm, attempting suicide, or hurting another person:
- Ask the challenging question: “Are you considering suicide?”
- Listen to them without judgment.
- Contact 911 or your local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
- Stay with them until professional help arrives.
- If it's safe to do so, remove any lethal objects, medications, or tools.
If you or someone you know is grappling with suicidal thoughts, a prevention hotline can provide assistance. The 988 Suicide and Crisis Lifeline is accessible 24/7 at 988. During a crisis, individuals who are hard of hearing can use their preferred relay service or dial 711 then 988.
Find more links and local resources.
Cautions for Vraylar
Before starting Vraylar, share your health history with your doctor. Vraylar might not be suitable for those with certain medical conditions or other health issues. Make sure to discuss any of the following with your doctor:
- type 2 diabetes
- high or low blood pressure
- high cholesterol
- liver or kidney problems
- low white blood cell count
- seizure disorder
- previous adverse reaction to this or a similar drug
- pregnancy
- breastfeeding
- alcohol consumption
Warning: Medical News Today has taken every measure to ensure that all information provided is accurate, all-encompassing, and current. Nevertheless, this content should not serve as a substitute for the guidance and expertise of a certified medical practitioner. It's crucial to seek advice from your doctor or another healthcare specialist prior to taking any medication. The drug details that appear in this article are subject to alteration and are not intended to cover all possible applications, instructions, precautions, warnings, drug interactions, allergic reactions, or side effects. The omission of warnings or other information regarding a specific drug does not imply that the drug, or the pairing of drugs, is safe, effective, or suitable for all individuals or specific uses.
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Vraylar's "Side effect specifics" section provides more information about the drug's frequent side effects, such as stomach upset and sleeplessness.
The more common side effects of Vraylar, including stomach upset and vomiting, can often be temporary and improve over time.
