Important Safety Information:
Ketamine can cause serious side effects, including:
Sedation and dissociation. Ketamine may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.Abuse and misuse. There is a risk for abuse and psychological dependence (typically seen in recreational users) with Ketamine treatment. You must inform your Better U clinical provider of any or signs of abuse and dependence before and during treatment with Ketamine.
Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
Ketamine is not for use in children
Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:Suicide attemptsThoughts about suicide or dyingOther unusual changes in behavior or mood
Do not take Ketamine if you:
Have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)Have an abnormal connection between your veins and arteries (arteriovenous malformation)Have a history of bleeding in the brainAre allergic to esketamine or ketamineIf you are not sure if you have any of the above conditions, talk to your healthcare provider before taking Ketamine.
Before you take Ketamine, tell your healthcare provider about all of your medical conditions, including if you Have heart or brain problems, including:
high blood pressure (hypertension), slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or faintingHistory of heart attack
- History of stroke
- Heart valve disease or heart failure
- History of brain injury or any condition where there is increased pressure in the brain
- Have liver problemsHave ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
- Are currently abusing other illicit or prescription drugs or alcohol
- Are pregnant or plan to become pregnant. Ketamine may harm your baby. You should not take Ketamine if you are pregnant. Tell your healthcare provider right away if you become pregnant during treatment with Ketamine. If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with Ketamine. There is a pregnancy registry for women who are exposed to Ketamine during pregnancy. The purpose of the registry is to collect information about the health of women exposed to Ketamine and their baby. If you become pregnant during treatment with Ketamine, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
Are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with Ketamine.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking Ketamine with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
What should I avoid while taking Ketamine?
Ketamine Therapy, Water Safety, and Mobility Assistance
As you embark on your ketamine therapy journey, your safety and well-being are our top priorities. To ensure a secure and beneficial therapeutic experience, we strongly advise the following precautions:
- Avoid Water Environments Post-Therapy: Ketamine can alter perception, balance, and coordination. It is crucial to steer clear of environments near water such as bathtubs, pools, hot tubs, lakes, or any other body of water for at least 24 hours after your therapy session. The risk of accidents, including drowning, is significantly heightened in these settings.
- Utilize Peer Support for Mobility: Ketamine may impair your motor skills, increasing the risk of falls and injuries. It is required to have a trusted friend or peer support present to assist you with walking and moving around, especially for necessary activities like going to the bathroom, immediately following your session.
- Refrain from Driving or Operating Machinery: Your ability to safely control vehicles or heavy machinery may be compromised after ketamine therapy. Please arrange for transportation and avoid operating any machinery until you have fully recovered or after a full night (8 hours of sleep) of rest.
- Be Aware of Fall Risks: The biggest concern post-therapy is the risk of falling due to impaired motor skills. Having someone to support you physically can greatly reduce this risk. Please take this seriously and plan accordingly. Your adherence to these guidelines is essential for your safety.
What are the possible side effects of Ketamine?
Ketamine may cause serious side effects including:
Increased blood pressure. Ketamine can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking Ketamine.
Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of Ketamine when used along with an antidepressant taken by mouth include:
- Feeling disconnected from yourself, your thoughts, feelings and things around youDizziness
- Nausea
- Feeling sleepy
- Spinning sensation
- Decreased feeling of sensitivity (numbness)
- Feeling anxiousLack of energy
- Increased blood pressure
- Vomiting
- Feeling drunk
- Feeling very happy or excited
If these common side effects occur, they usually happen right after taking Ketamine and go away the same day.
These are not all the possible side effects of Ketamine.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ketamine is not FDA-approved for the treatment of depression or anxiety.
Internal research and data analysis to contribute to the emerging psychedelic industry.
At Better U, we believe that the future of psychedelic medicine require physician collaboration, social enterprise strategies, and a prioritization of patient care over financial gain. This is why we have allocated a large portion of our resources into research studies. We are soon publishing the first ever safety study analyzing the risk profile of our at-home therapy protocol. We plan to share this internal data and conduct IRB studies to advance the acceptance of psychedelic medicine.