Understanding the Potential Side Effects of Spravato and Strategies for Coping
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ESketamine, marketed under the brand name Spravato, is a nasal spray used to treat specific types of depression in adults. Like other medications, Spravato can trigger side effects, such as nausea and an elevation in blood pressure.
More typical side effects of Spravato
Spravato can induce various side effects, with some being more common than others. These side effects can differ based on the condition it's prescribed for. These side effects may be transient, lasting a few days to weeks. However, if the side effects persist beyond that, cause discomfort, or worsen, consult your doctor or pharmacist.
Spravato is usually prescribed alongside an oral antidepressant, like Zoloft (sertraline) or Prozac (fluoxetine). Remember that some side effects might be attributable to the oral antidepressant rather than Spravato.
Listed below are just a few of the more typical side effects reported from individuals who used Spravato in clinical trials:
- lightheadedness
- vertigo (feeling of dizziness and spinning)
- nausea*
- numbness in a body part*
- dissociation*†
- drowsiness*†
* For more information about this side effect, see “Side effect specifics” below.† Spravato has a boxed warning for this side effect. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).
Mild side effects of Spravato
Mild side effects can sometimes appear when using Spravato. These side effects can differ based on the condition it's prescribed for. This list doesn't include all potential mild side effects of the drug. For additional information, check Spravato’s prescribing information.
Spravato is usually prescribed alongside an oral antidepressant. Keep in mind that some side effects might be due to the oral antidepressant rather than Spravato.
Mild side effects reported with Spravato include:
- lightheadedness
- vertigo (feeling of dizziness and spinning)
- anxiety
- lethargy (feeling sluggish and unmotivated)
- feeling intoxicated
- irritation or discomfort in the throat or nose
- headache
- feeling overly joyful or excited
- insomnia
- diarrhea
- nausea and vomiting*
- numbness in a body part*
- mild drowsiness*†
- mild allergic reaction*
These side effects may be transient, lasting a few days to weeks. However, if the side effects persist beyond that, cause discomfort, or worsen, consult your doctor or pharmacist.
Note: The Food and Drug Administration (FDA) tracks side effects of approved drugs. If you experience a side effect with Spravato and want to report it to the FDA, visit MedWatch.
* For more information about this side effect, see “Side effect specifics” below. † Drowsiness is a common side effect with Spravato. This symptom can be mild. However, it can also be severe. In fact, Spravato has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA.
Serious side effects of Spravato
Spravato may cause severe side effects, which can vary based on the condition it's prescribed for. The following list may not include all possible severe side effects of the drug. For more details, check Spravato’s prescribing information.
Spravato is usually prescribed alongside an oral antidepressant. Keep in mind that some side effects might be due to the oral antidepressant rather than Spravato.
If you experience severe side effects with Spravato, contact your doctor immediately. If the side effects seem life-threatening or you think you're having a medical emergency, immediately call 911 or your local emergency number.
Severe side effects reported and their symptoms include:
- Issues with thinking, learning, and remembering. Symptoms can include:
- trouble making decisions
- trouble remembering things
- reduced concentration span
- Elevated blood pressure.*
- Serious bladder problems.*
- Severe allergic reaction.*†
- Risk of misuse.*‡
- Risk of respiratory depression.*‡
- Risk of dissociation.*‡
- Risk of sedation.*‡
- Risk of suicidal thoughts and behaviors.*‡
* For more information about this side effect, see “Side effect specifics” below. † An allergic reaction is possible with Spravato. However, this side effect wasn’t reported in clinical trials. ‡ Spravato has a boxed warning for this side effect. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).
FAQ about the side effects of Spravato
Spravato may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
Should I anticipate cardiovascular side effects with Spravato?
Spravato may induce side effects leading to cardiovascular problems. (Cardiovascular refers to the heart and blood vessels.)
Spravato might elevate your heart rate. This was a regular occurrence during the clinical trials of Spravato. If your heart rate soars excessively, it could lead to a severe condition like a heart attack. A heart attack is characterized by the blockage or rupture of a blood vessel that supplies blood to the heart.
To further explore the relationship between heart rate and Spravato, check out the "Side effect specifics" section below.
Is Spravato associated with weight gain?
No, weight gain is not a known side effect of Spravato. Weight gain was not reported during the clinical trials of the medication.
On the contrary, specific medications used to treat depression, like Loxitane (haloperidol) and Seroquel (quetiapine), can induce weight gain.
If you have concerns about potential weight gain, discuss it with your doctor. They can provide guidance on managing your weight.
Could Spravato alleviate pain like ketamine does?
Spravato is not approved for pain management. A medication similar to Spravato called Maraton (ketamine) is sometimes used to alleviate pain resulting from certain injuries due to its anesthetic properties. While Spravato and ketamine share similar chemical structures, they affect the body differently.
Instead, Spravato has been approved by the Food and Drug Administration (FDA) for the following conditions under specific circumstances:
- major depressive disorder in adults with thoughts of self-harm
- treatment-resistant depression in adults
Spravato is prescribed in conjunction with an oral antidepressant.
If you are experiencing pain, consult your doctor about potential treatment options.
Are hallucinations a side effect of Spravato?
Yes, some users have reported experiencing hallucinations after taking Spravato. Hallucinations refer to sensory experiences that are not real, such as seeing, hearing, or feeling things that do not exist. Due to the risk of hallucinations, a healthcare professional will monitor you following the administration of the drug.
If you have concerns about hallucinations and Spravato, speak with your doctor.
Side effect specifics
Gain more insights into some of the side effects that Spravato might induce. For information on how frequently side effects occurred during clinical trials, consult the "prescribing information" for Spravato.
Nausea and vomiting
Spravato can cause feelings of nausea and vomiting. In clinical trials, these symptoms were common. They usually manifest the day you receive the dose and do not typically persist longer than 1 hour. The nausea and vomiting should gradually subside with subsequent doses.
What can you do?
To minimize nausea and vomiting, avoid eating for 2 hours before your Spravato dose. Also, try to refrain from drinking liquids for about 30 minutes prior to your dose.
If you have questions about nausea and vomiting with Spravato, consult your doctor.
Elevated heart rate
Spravato can lead to an increased pulse rate. The increase typically starts around 40 minutes after the dose and lasts around 4 hours. In clinical trials, increased heart rate was a common side effect.
In rare instances, Spravato might result in a heart attack. Symptoms might include chest pain and difficulty breathing.
Spravato may also cause a condition called hypertensive encephalopathy. It occurs when blood pressure significantly increases and affects the brain. Symptoms include:
- sudden, severe headache
- problems with vision
- seizures
- loss of consciousness
- symptoms affecting the central nervous system, including the nerves, brain, and spine
Heart attack and hypertensive encephalopathy are medical emergencies.
What can you do?
Following your Spravato dose, a healthcare professional will monitor your heart rate for at least 2 hours to ensure it's not increasing too rapidly. If you have a history of heart attack or hypertensive encephalopathy, they may monitor you more closely than usual, looking for signs of increased heart rate and other symptoms.
If Spravato causes an elevated heart rate, you may receive medication to help bring it down.
Loss of sensation in various body parts
During clinical trials, individuals receiving Spravato commonly reported losing feeling in various body parts. This included losing feeling in the mouth, throat, nose, and teeth. The duration of these symptoms is unclear as they have not been fully studied. However, these are generally mild side effects that typically resolve within a few days.
What can you do?
If symptoms persist beyond a few days, consult your doctor. They can help determine whether Spravato is the cause and if the medication is appropriate for you. Be sure to inform your doctor if you have experienced loss of sensation in body parts in the past.
Serious bladder issues
Spravato might induce bladder issues such as:
- pain while urinating
- increased frequency of urination during the day and at night
- nighttime urination
- urinary tract infection
These bladder issues are usually mild. They should improve after a few days or with brief treatment from your doctor.
There have been reports of a bladder condition called interstitial cystitis in individuals who misused Maraton (ketamine), a medication similar to Spravato. There have not been any reported cases of interstitial cystitis with Spravato. Misuse refers to using a medication in a manner other than how your doctor prescribed.
What can you do?
Discuss any bladder issues you develop during Spravato treatment with your doctor. They can help determine if you need treatment.
Sensitivity Reactions
Like many medications, Spravato can trigger a sensitivity reaction in certain individuals. However, this side effect wasn't noticeable during clinical trials.
Symptoms can manifest as mild or severe, and they can include:
- rash on the skin
- skin itching
- skin flushing
- swelling beneath the skin, typically in areas like the lips, eyelids, feet, or hands
- swelling of the mouth, tongue, or throat, which might make it difficult to breathe
Steps to Take
For less severe signs of a sensitivity reaction, contact your healthcare provider right away. They may suggest ways to alleviate your symptoms and decide if Spravato should continue to be administered. If your symptoms are severe and you believe you're experiencing a medical emergency, immediately contact 911 or your local emergency number.
Cautionary Labels
Spravato has several cautionary labels due to various risks. These labels are the most severe warnings provided by the Food and Drug Administration (FDA). Spravato's cautionary labels pertain to risks of misuse, respiratory depression, dissociation, sedation, and suicidal thoughts and behaviors.
Since the potential risks associated with these cautionary labels are significant, Spravato is only distributed through a restricted program called Spravato Risk Evaluation and Mitigation Strategy (REMS). This program requires that the administering doctor's office and pharmacy are participating members. Additionally, patients enroll as well, with the goal of ensuring Spravato is administered safely. More information about Spravato REMS can be found on the program's website or by calling them directly.
Risk of Misuse. Spravato holds the potential for misuse, which is defined as using the drug in a manner not prescribed by your doctor. Misuse was not a common side effect in clinical trials.
Risk of Respiratory Depression. Spravato has a cautionary label regarding the risk of respiratory depression, which refers to a slow, shallow breathing rate. This side effect wasn't reported in clinical trials, but it has arisen since the drug was authorized.
Risk of Dissociation. Spravato may cause dissociation, which means feeling detached from your mind, your body, time, or space. You may perceive or experience things that are not real, or feel as though your mind and body are not connected. Dissociation was a very common side effect in clinical trials.
Risk of Sedation. Spravato may cause sedation, which means the drug can make you significantly tired. This was a very common side effect in clinical trials. In rare instances, individuals have become so sedated that they lost consciousness.
Risk of Suicidal Thoughts and Behaviors. Spravato, like other antidepressants, has a cautionary label regarding an increased risk of suicidal thoughts and behaviors. This side effect has been observed in adults aged 24 years and younger, as well as in children (Spravato is not approved for use in children).
Antidepressants are typically used to treat depression. However, they can also induce changes in mood and other unwanted effects that might contribute to an increased risk of suicidal thoughts and behaviors.
Steps to Take
Here are some steps that can be taken to help mitigate the risks associated with cautionary labels.
What You Can Do to Reduce the Risk of Misuse. During Spravato treatment, your doctor will monitor you for signs of misuse. Your risk of misuse may be increased if you have a history of drug or alcohol misuse. It is crucial to discuss any history of substance misuse with your doctor to learn more. See "Spravato and Misuse" below for more information.
What You Can Do to Reduce the Risk of Respiratory Depression. After administering a dose of Spravato, a healthcare professional will monitor you for at least 2 hours. This will include checking your blood oxygen levels. They will also conduct an assessment to ensure you are alert and it is safe for you to leave. Make sure to inform the healthcare professional if you experience any symptoms of respiratory depression, which can include:
- shortness of breath
- frequent yawning
- confusion
What You Can Do to Reduce the Risk of Dissociation. After administering a dose of Spravato, a healthcare professional will monitor you for at least 2 hours. They will conduct an assessment to ensure you are alert and it is safe for you to leave. It is essential to inform them if your perception of time or space changes. You should also let them know if you see, hear, or feel things that are not real.
Before starting Spravato treatment, it is important to tell your doctor if you have had psychosis in the past. (Psychosis is a mental disorder that involves a loss of touch with reality.) This may increase your risk of dissociation. For more information, see "Precautions for Spravato" below.
What You Can Do to Reduce the Risk of Sedation. After administering a dose of Spravato, a healthcare professional will monitor you for at least 2 hours. They will conduct an assessment to ensure you are alert and it is safe for you to leave. It is important to inform them if you have any symptoms of sedation, which can include:
- feeling extremely tired
- difficulty in thinking clearly
- being too drowsy to drive or operate heavy machinery
You will need to have someone, such as a family member or trusted friend, drive you home after receiving your dose.
What You Can Do to Reduce the Risk of Suicidal Thoughts and Behaviors. During Spravato treatment, your doctor will monitor you for symptoms of suicidal thoughts and behaviors, which can include:
Worsening depression, contemplations of self-harm, and attempts at suicide are signs to look out for, not only in yourself but also in your friends and loved ones. If you notice any of these symptoms, promptly consult with your doctor or seek immediate emergency care.
Suicide Prevention Guidelines
In case you encounter someone currently at risk of harming themselves or others, take the following steps:
- Directly ask the question: "Are you contemplating suicide?"
- Provide an attentive ear, free of judgment.
- Call emergency services (911) or your local emergency number. Alternatively, text "TALK" to 741741 to communicate with a trained crisis counselor.
- Stay by the person's side until professional assistance arrives.
- Securely remove any potential hazards, such as weapons, medications, or dangerous objects, if it's safe to do so.
If you or someone close to you is grappling with thoughts of suicide, various aid hotlines can offer assistance. Reach out to the 988 Suicide and Crisis Lifeline, which is accessible 24/7 at 988. For those who are deaf or hard of hearing, use your preferred relay service or dial 711 then 988 during a crisis.
Spravato Precautions
This drug includes various warnings and advisories.
Boxed Warnings
Spravato carries several boxed warnings, which represent the Food and Drug Administration's (FDA) most substantial concerns. The boxed warnings apply to the following issues:
- Risk of misuse. See the section below titled "Spravato and misuse."
- Risk of dissociation. For more information, scan the section above titled "Side effect specifics."
- Risk of sedation. Learn more in the section above titled "Side effect specifics."
- Risk of suicidal thoughts and behaviors. More details can be found in the section above titled "Side effect specifics."
Additional Precautions
Before initiating Spravato therapy, discuss your medical background with your healthcare provider, as the drug may not be suitable for individuals with certain conditions or related factors. Considerations include:
- Pre-existing psychosis. There's a possibility that Spravato may cause dissociation (a sensation of separation from both your mind and your body). If you've experienced psychosis in the past, inform your doctor before starting Spravato treatment to determine if you're at an increased risk of encountering a severe dissociative or psychotic incident.
- Substance misuse history. Previous drug or alcohol misuse may elevate your risk of misusing Spravato. If you've struggled with substance misuse, inform your healthcare provider before receiving the drug. The medication has a boxed warning about misuse. For more information, consult the section below titled "Spravato and misuse."
- Liver disease. If you have liver problems, communicate with your doctor before initiating Spravato treatment. Your risk of experiencing side effects from the drug might be amplified and may traverse an extended period, even after you receive the medication. Monitoring may be required for a lengthier durations post-dosage admission if you have moderate liver disease.
- High blood pressure. Spravato has the potential to elevate blood pressure, which can affect your heart, blood vessels, and brain. If you have high blood pressure, consult your doctor regarding the safety of Spravato usage.
A contraindication is a health factor that may prevent your doctor from prescribing a specific medication due to the potential risk of harm. Spravato is typically not prescribed in the presence of:
- Aneurysms or certain blood vessels issues. Spravato's ability to elevate blood pressure increases the risk of severe bleeding events, such as stroke. This risk is amplified if you have or have experienced an arteriovenous malformation (AVD) or aneurysmal vascular disease (AVD). AVD refers to the weakness of a blood vessel wall, resulting in a balloon-like expansion. Disclose any previous experiences with these conditions to your doctor.
- Brain bleed. While on Spravato therapy, your blood pressure may fluctuate, potentially impacting your brain and heightening the danger of internal brain bleeding. Reveal any past experiences of brain bleeds to your healthcare provider.
- Ketamine allergy. If you've experienced an allergic reaction to Ketalar (ketamine), discuss alternate treatment options with your doctor. Since Ketalar is similar to Spravato, an allergy to ketamine may also translate to an allergy to Spravato.
- Spravato or its components allergy. If you've suffered an allergic reaction to Spravato or any of its constituents, consult your doctor about other suitable medications for your wellbeing.
If you're prescribed Spravato during pregnancy, consider joining a pregnancy registry. This registry gathers info about the drug's safety during pregnancy. For more details, chat with your doc or check out the registry site or call 866-961-2388.
Spravato and Abuse
Spravato carries a serious warning about the danger of abuse. This is the most severe warning from the Food and Drug Administration (FDA).
Abuse means using a drug in a manner not directed by your doctor. Spravato has potential for abuse.
Given the severity of the abuse warning, Spravato is only distributed through a restricted program called Spravato Risk Evaluation and Mitigation Strategy (REMS). This involves the doctor's office and pharmacy joining the program. You're enrolled too. The purpose is to ensure safe use of Spravato.
Your doctor will monitor you for signs of abuse during Spravato treatment. You might be at a higher risk of abuse if you've abused drugs or alcohol in the past. For more info, see "Precautions for Spravato" above. You can also find more details about Spravato REMS on the program site or call .
When to Speak with Your Doctor
Treatment with Spravato may lead to mild and serious side effects. Many common side effects are mild. However, Spravato can cause serious side effects in some situations. If you experience severe or bothersome side effects, talk to your doctor.
If you'd like to know more about Spravato, chat with your doctor or pharmacist. They can clarify any questions about the drug's side effects.
Besides talking with your doctor, you can conduct your own research. These resources might help:
- More Info on Spravato. Get details about other Spravato aspects in this resource.
- Drug Comparison. Learn how Spravato stacks up against Abilify and Symbyax in the “Spravato vs. Other Drugs” section of this resource.
- Dosage Guide. Get details about Spravato dosage in this resource.
- Understanding Depression. If you'd like to know more about your condition, check out our mental health hub and list of articles on depression.
Disclaimer: Medical News Today has made every effort to ensure all information is factually correct, comprehensive, and up-to-date. However, this article should not replace the knowledge and expertise of a licensed healthcare professional. Always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
Spravato can lead to increased side effects when used with certain oral antidepressants, such as Zoloft or Prozac. These additional side effects might include:
- enhanced feelings of dizziness and spinning (vertigo)
- greater anxiety levels
- increased lethargy
Spravato can also exacerbate some side effects already associated with oral antidepressants, such as nausea and vomiting. It's crucial to inform your doctor about the antidepressants you're currently taking to optimize your treatment plan and minimize potential side effects.
