Before you decide to take part in ketamine assisted psychotherapy (KAP), it is important for you to know more information about the potential risks of using sublingual ketamine.

Risks and effects of sublingual ketamine vary depending on a variety of factors, including dose and your body’s reactions to the medicine. The duration and intensity of the effects will also vary, even when the dose remains the same. The following is a list of possible side effects. Because the research continues to evolve, this list is not exhaustive and is not intended to be comprehensive. Please read all materials provided with your prescription and discuss with the pharmacist if you have additional questions.

Hazardous activities: Research shows that Ketamine’s dissociative and anesthetic effects affect a person’s ability to operate a vehicle, including leading to swerving outside of lanes. To reduce the risk of harm, you should not drive a car, operate heavy machinery, or engage in any other form of potentially hazardous activity for 24 hours after sublingual ketamine.

Common side effects: Out of body experiences, hallucinations, vivid dreams and nightmare, change in motor skills, nausea and vomiting, dizziness, blurred vision, increased saliva production, increased heart rate and blood pressure, psychological changes (e.g., sadness, anxiety), insomnia, and risk of falling.

Uncommon side effects: Rash, double vision, increased pressure in the eye, jerky arm movements, and cognitive issues (e.g., memory problems and verbal processing).

Rare side effects: Severe allergic reaction, irregular or slow heart rate, arrhythmia, low blood pressure, laryngospasm (a spasm of vocal cords), inflammation of the bladder (ketamine cystitis), ulcers, and fibrosis, cholecystitis: gallbladder disease, and elevation in liver enzymes (with prolonged use).

Extremely rare side effects:  Death (e.g., fatal allergic reaction to the medication, unidentified medical condition). Some patients may experience a state of severe agitation, confusion, or aggression, which may increase chances of severe harm or bodily injury to both themselves and others. The risk of such a reaction to the medication may be reduced by avoiding loud noises and disturbing external stimuli. It is recommended that you take ketamine only if you are in a calm and relaxed emotional state.
Risk of other medications: If you are currently taking certain daily medications, you may not be able to take these medication(s) while receiving a ketamine treatment without clearance or approval of your treatment team. This is due to concerns for potential increased sedation and / or trouble breathing. Examples include: Sedatives (e.g., clonazepam, lorazepam, alprazolam), Antibiotics (e.g., azithromycin, clarithromycin), Antifungal agents (e.g., ketoconazole), Tramadol, Lamictal, and Grapefruit Juice.

Risks of additional medications potentially prescribed during KAP treatment: There are optional treatments for the side effects of ketamine. After discussion, you may also be prescribed the use of ondansetron (“Zofran”) for nausea, and for clonidine for high blood pressure. Of note, these medications were chosen as they are widely used and well tolerated, especially as single doses. However, side-effects may present unexpectedly based on individual physiology.

1. Ondansetron (Zofran) 4mg, oral disintegrating tablet, 1-2 tablets as needed for nausea. Common reactions include: headache, constipation, fatigue, diarrhea, hypoxia, fever, urinary retention, dizziness, agitation and pruritis. Serious reactions include: severe hypersensitivity and anaphylaxis, bronchospasm, Stevens-Johnson syndrome, toxic epidermal necrolysis, myocardial ischemia, QT prolongation, torsades de pointes, serotonin syndrome, extra pyramidal symptoms, oculogyric crisis, transient blindness.
2. Clonidine 0.1mg tablets, 1-2 tablets as needed for elevated blood pressure, severe anxiety. Common reactions include: somnolence, headache, hypotension, abdominal pain, fatigue, nightmares, nausea, irritability, throat pain, dizziness, temperature elevation, diarrhea, otalgia, sexual dysfunction and constipation. Serious reactions include: syncope, bradycardia, hypersensitivity reaction, and angioedema.

Potential for Ketamine Abuse and Physical Dependence

Ketamine belongs to the same group of chemicals as phencyclidine (Sernyl, PCP, “Angel dust”), which are classified as hallucinogens (also known as psychedelics). Medical evidence regarding the issue of drug abuse and dependence suggests that ketamine’s abuse potential is equivalent to that of phencyclidine and other hallucinogenic substances. Phencyclidine and other hallucinogenic compounds do not meet criteria for chemical dependence, since they do not cause tolerance and withdrawal symptoms. However, cravings have been reported by individuals with the history of heavy use of psychedelic drugs. In addition, ketamine can have effects on mood (feelings), cognition (thinking), and perception (imagery) that may make some people want to use it repeatedly.

Compounded Drugs

The ketamine you will be receiving may be from a compounding pharmacy. Compounding is a practice in which a licensed pharmacist, physician, or an outsourcing facility combines, mixes, or alters ingredients of a drug to create a medication. Compounded medications are custom-prepared to meet specific patient requirements when commercially manufactured drugs are not suitable or available. Compounded drugs are not FDA-approved, which means the FDA has not evaluated their safety, effectiveness, or quality. Compounded drugs that are contaminated or otherwise of poor quality have been associated with serious patient illnesses and deaths. More information can be found here: https://www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-andhealth-care-providers-about-potential-risks-associated-compounded-ketamine