Ketamine Side Effects

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Answer the side-effect intent for ketamine without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is ketamine?

Ketamine contains the active ingredient Ketamine hydrochloride.

• Active ingredient — Ketamine hydrochloride
• Registration number — 56/2.1/0426
• Registration holder — Umsebe Healthcare

It is approved for:

• For the induction of anaesthesia, or it may be used on its own or in combination with other anaesthetics, to maintain general anaesthesia
• In children for the management of minor surgical and diagnostic procedures or procedures that require intense analgesia, such as changing burn dressings

Common side effects of ketamine

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• Nausea and vomiting

Less frequent side effects

• Feeling anxious
• Drifting in and out of consciousness (with a feeling of confusion and hallucinations), flashbacks, feeling uneasy, sleeplessness, feeling disorientated
• Feeling dizzy (vertigo)
• Lowering of blood pressure
• Loss of appetite and weight (anorexia)
• Drooling
• Pain, inflammation of the skin or rash at the site of injection

Frequency unknown side effects

• Increase in the production of tears
• Temporary skin rashes

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• Are hypersensitive (allergic) to ketamine hydrochloride or to any of the other ingredients of ZENZIKET (listed in section 6)
• Are suffering from any condition in which an increase of blood pressure may be harmful to you or have suffered in the past from a medical condition which may have been caused/made worse by an increase in blood pressure
• Previously suffered a stroke
• Have or recently had a serious head or brain injury
• Have developed high blood pressure during pregnancy (where your blood pressure was previously normal) called eclampsia or pre-eclampsia
• Have severe heart disease
• Suffer from high pressure in your eye or have an object penetrating your eye
• Are pregnant or breastfeeding

Use with care, and tell your doctor, if

• Recently had a heart attack or suffer from any heart disease or condition
• Suffer from increased pressure on your brain
• Have increased pressure in the eye (glaucoma)
• Have an eye injury, where the eye has been perforated (pierced)
• Drink large amounts of alcohol
• Have problems with your liver or kidneys
• Are dehydrated. : : Submission date: June 2024 Implemented: 25 June 2024
• Have a history of or have current mental health problems
• Have an inherited disease that affects the blood, called porphyria
• Have or ever had seizures (fits)
• Are receiving treatment for your thyroid gland
• Have a chest infection or problems breathing
• Have had any injury of your head or abnormal growth in the brain
• Have a history of drug abuse or addiction. Some people have hallucinations, vivid dreams, nightmares, feel ill at ease, confused, anxious or behave irrationally while recovering from anaesthesia with ZENZIKET. These side effects are collectively known as an “emergence reaction”. You will be allowed to recover from the anaesthetic in a quiet place, which helps to prevent the reaction. If you are receiving ZENZIKET on a long-term basis, you may experience bladder and liver complications. Speak to your doctor, since ZENZIKET is not intended for long-term use. Children and adolescents ZENZIKET must not be used in children aged less than 3 months due to potential respiratory complications

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before being given this medicine
• Safety in pregnancy and breastfeeding has not been established
• ZENZIKET should not be given to you if you are pregnant or breastfeeding

Interactions and medicines to check

The approved leaflet names these interactions.

• Inhalational anaesthetics, such as ether or halothane
• Barbiturates, such as phenobarbital (used to treat epilepsy and anxiety) and thiopental (an anaesthetic agent) or narcotic analgesics (strong painkillers) such as morphine or fentanyl
• Muscle relaxants, such as atracurium or tubocurarine. : : Submission date: June 2024 Implemented: 25 June 2024
• Other central nervous system (CNS) depressants, such as ethanol (alcohol), chlorpromazine (used to treat mental illness), chlorphenamine (used for the treatment of allergies)
• Tranquillisers or sedatives (sleeping tablets and tablets used to treat depression), such as diazepam or zopiclone
• Antihypertensive medicines (medicines to treat high blood pressure), such as atenolol
• Bronchodilators (medicines which help breathing), such as theophylline or aminophylline
• Thyroid hormones used to treat thyroid gland conditions, such as thyroxine
• Medicines called sympathomimetics, which include adrenaline (epinephrine) and noradrenaline (norepinephrine)
• Vasopressin (a hormone with multiple uses, including the treatment of diabetes, to increase blood pressure, to control bleeding)
• Ergometrine (used during or after childbirth to reduce bleeding). Tell your doctor if you are taking any of the above medicines. Ketamine with food and drink It is normal not to eat or drink for at least six hours before an operation; therefore, ZENZIKET is usually given when your stomach is empty. If in an emergency this is not possible and ZENZIKET may still be used

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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