Trifluoperazine: Uses, Side Effects and Dosage

Serious warnings and precautions box

What TRIFLUOPERAZINE is used for:

TRIFLUOPERAZINE is used in adults and children to:

• control symptoms of excessive anxiety, tension and agitation associated with certain mental health conditions.
• treat or prevent nausea and vomiting.

• manage the symptoms of psychotic disorders such as:

  • certain types of schizophrenia and psychosis; and
  • the manic episodes in bipolar disorder.

TRIFLUOPERAZINE is not indicated for children younger than 6 years of age.

How TRIFLUOPERAZINE works:

TRIFLUOPERAZINE belongs to a class of medicines known as antipsychotics. The exact way TRIFLUOPERAZINE works is not known. However, it is thought to re-adjust the balance of certain chemicals in the brain (i.e., dopamine and serotonin) that allow communication between nerve cells.

The ingredients in TRIFLUOPERAZINE are:

Medicinal ingredient: Trifluoperazine hydrochloride

Non-medicinal ingredients: Carnauba wax, corn starch (1 mg, 2 mg), croscarmellose sodium (5 mg,

• TRIFLUOPERAZINE belongs to a group of medicines called antipsychotics. These medicines have been linked to a higher rate of death when used in elderly patients with dementia (loss of memory and other mental abilities).
• TRIFLUOPERAZINE is not to be used if you are elderly and have dementia.

10 mg and 20 mg), hydroxypropyl methylcellulose, lactose monohydrate, indigotine AL lake 12-14% (Blue #2), magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.

TRIFLUOPERAZINE comes in the following dosage form:

Tablets: 1 mg, 2 mg, 5 mg, 10 mg and 20 mg trifluoperazine (as trifluoperazine hydrochloride).

Do not use TRIFLUOPERAZINE if:

• you have an allergy to trifluoperazine, phenothiazines (a type of antipsychotic) or to any of the other ingredients in TRIFLUOPERAZINE.

• you are in a deep state of prolonged unconsciousness (coma) or have decreased alertness caused by certain medications or alcohol.

• you have liver damage.
• you have a blood cell disorder (e.g., low levels of red or white blood cells, or platelets).
• you have bone marrow depression (a condition where the bone marrow does not make enough blood cells and platelets).
• you have or have a family history of long QT syndrome (a heart rhythm condition that causes fast, chaotic heartbeats) or develop this syndrome during your treatment with TRIFLUOPERAZINE.
• you have or have had a condition that causes you to have an abnormal heart rhythm (e.g., Torsade de Pointes, atrial fibrillation, low heart rate).

• you take any medications that affect how your heart beats. For example:

  • medicines used to treat an abnormal heart rhythm.
  • antidepressant medications known as Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., citalopram).
  • any medications that can cause an electrolyte imbalance (e.g., diuretics, also known as “water pills”).
• you have a medical condition known as pheochromocytoma (a tumor of the adrenal gland).
• you have severe heart or blood vessel problems.
• you have kidney problems.
• you have or have had brain damage.
• you are receiving or plan to receive anesthesia (medicines used to induce sleep and prevent pain during surgery).
• you are taking hypnotics (medicines used to help with sleep).
• you are at risk for urinary retention due to disorders of the urethra or prostate.
• you are at risk of having glaucoma (increased pressure in the eye).
• are taking medicines known as dopaminergics.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TRIFLUOPERAZINE. Talk about any health conditions or problems you may have, including if you:

• are currently taking any other medicines.
• are addicted to alcohol. You should not take TRIFLUOPERAZINE if you are under the effects of alcohol.
• exercise strenuously. TRIFLUOPERAZINE may interfere with your body’s ability to adjust to heat. Avoid becoming overheated or dehydrated (for example with vigorous exercise or exposure to extreme heat) while taking TRIFLUOPERAZINE.
• have or have had breast cancer.
• are prone to low blood pressure.
• have chest pain (angina pectoris).
• have a condition that affects your heart and blood vessels.
• you have a type of muscle weakness called myasthenia gravis.

• are at risk for Torsade de Pointes (a heart rhythm condition). Risk factors include, but are not-limited to:

  • being female.
  • being 65 years of age or older.
  • being genetically predisposed for heart rhythm conditions.
  • having a family history of sudden death in individuals less than 50 years of age.
  • having heart disease (e.g., heart attack, congestive heart failure, enlarged left ventricle of the heart, diseases affecting the electrical signals of your heart).
  • having an electrolyte imbalance (e.g., low levels of potassium, magnesium or calcium in the blood).
  • having a condition that affects the brain (e.g., brain bleed, stroke, head trauma).
  • having liver or kidney problems.
  • being known to poorly metabolize certain medicines.
  • having diabetes.
  • having poor nutrition.
  • having damage to the nerves that control automatic body functions (e.g., blood pressure, temperature control, bladder function, etc.).

• are at risk for developing blood clots. Risk factors include:

  • a family history of blood clots
  • being over the age of 65
  • smoking
  • being overweight
  • having a recent major surgery (such as hip or knee replacement)
  • not being able to move due to air travel or other reasons
  • taking oral birth control (“The Pill”)
• have had long-term treatment with trifluoperazine tablets and/or other antipsychotic medications.
• have Parkinson’s disease or dementia.
• have seizures, epilepsy, abnormal electrical activity in the brain or brain damage. TRIFLUOPERAZINE may make you more prone to seizures.
• suffer from an increased pressure within the eye(s) (glaucoma).

• have one of the following rare hereditary diseases:

  • Galactose intolerance
  • Lapp lactase deficiency
  • Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in TRIFLUOPERAZINE.

• are receiving or plan to receive:

  • anesthesia (medicines used to induce sleep and prevent pain during surgery).
  • computed tomography (CT) scans or radiography (X-ray imaging) with a chemical called metrizamide. TRIFLUOPERAZINE should not be taken with metrizamide. Your healthcare professional will tell you when to stop and resume your treatment with TRIFLUOPERAZINE for your examination.
• are pregnant, think you might be pregnant or are planning to become pregnant. TRIFLUOPERAZINE should not be used during pregnancy unless your healthcare professional considers that the benefits to you markedly outweigh the potential risks to the fetus.
• are breast-feeding or planning to breast-feed. TRIFLUOPERAZINE can pass into your breast milk and may harm a breast-fed baby. You and your healthcare professional will decide if you should take TRIFLUOPERAZINE or breast-feed. You should not do both.
• have or have ever had a low number of white blood cells.
• have previously had to stop taking other medicines for psychiatric problems like TRIFLUOPERAZINE (known as phenothiazines) because they have affected your blood cells or caused jaundice (yellowing of the skin and eyes).
• have liver problems.

Other warnings you should know about:

Driving and using machines: TRIFLUOPERAZINE may affect your mental and physical abilities. This may be more likely to occur when you start your treatment and when your dose is increased. Before you drive or do tasks that require special attention, wait until you know how you respond to TRIFLUOPERAZINE. You should be cautious when driving a car or operating machinery.

Testing and check-ups: Your healthcare professional will monitor your health throughout your treatment. They may do this by performing certain tests before and periodically during your treatment. This will tell your healthcare professional how TRIFLUOPERAZINE is affecting you. These tests may monitor:

• the electrical activity of your heart (electrocardiogram; ECG);
• your blood sugar (glucose) level;
• your body weight;
• the profile of your blood (e.g., red blood cell, white blood cell, and platelet counts);
• your liver and kidney function; and
• your eyes.

Eye problems: TRIFLUOPERAZINE can cause eye problems such as mydriasis. Mydriasis is a condition where your pupils widen in an unusual way. This can cause a build-up of fluid and pressure in your eyes. Tell your healthcare professional right away if you experience visions changes, eye pain, redness in or around the eye.

Hyperprolactinemia (increased levels of prolactin): TRIFLUOPERAZINE can raise your levels of a hormone called “prolactin”. This is measured with a blood test. Symptoms may include:

• In men:

  • swelling in the breast;
  • difficulty in getting or maintaining an erection or other sexual dysfunction.

• In women:

  • discomfort in the breasts;
  • leaking of milk from the breasts (even if not pregnant);
  • missing your menstrual period or other problems with your cycle.

If you have high levels of prolactin and a condition called hypogonadism, you may be at an increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

Pregnancy: You should not take TRIFLUOPERAZINE while you are pregnant or if you are planning on becoming pregnant unless you have talked to your healthcare professional about it. If you took TRIFLUOPERAZINE at any time while you were pregnant or if you took it before you became pregnant, the following symptoms may happen in your newborn baby:

• shaking;
• stiffness in their muscles and/or weakness;
• sleepiness;
• agitation;
• breathing problems; or
• difficulty feeding.

Get medical help right away if your newborn has any of these symptoms.

Taking TRIFLUOPERAZINE may also affect your pregnancy tests by producing false-positive or false-negative pregnancy results. TRIFLUOPERAZINE may also give false positive phenylketonuria (PKU) test results (a blood test given to newborns one to three days after birth).

Neuroleptic Malignant Syndrome (NMS): NMS is a potentially life-threatening reaction that has been reported with the use of antipsychotic drugs. Symptoms of NMS include:

• severe muscle stiffness or inflexibility with high fever,
• rapid or irregular heartbeat,
• sweating,
• state of confusion or reduced consciousness

Call your healthcare professional right away if you start to have any of these symptoms while taking TRIFLUOPERAZINE.

Tardive Dyskinesia: Like other antipsychotic drugs, TRIFLUOPERAZINE may cause potentially irreversible muscle twitching or unusual/abnormal movement of the face or tongue or other parts of your body.

Falls: TRIFLUOPERAZINE may cause tiredness, low blood pressure and unstable muscle coordination. This may lead to falls and injuries.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious drug interactions:

Do not take TRIFLUOPERAZINE with:

• medicines that can affect how your heart beats. These include, but are not limited to:

  • medicines used to treat an abnormal heart rhythm (e.g., quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide).
  • other antipsychotic medications (e.g., droperidol, chlorpromazine, pimozide).
  • medicines used to treat depression (e.g., fluoxetine, venlafaxine, tricyclic/tetracyclic antidepressants, selective serotonin reuptake inhibitors [SSRIs] such as citalopram).
  • opioids, medicines used to relieve pain (e.g., methadone, codeine and tramadol).
  • medicines used to treat bacterial infections (e.g., erythromycin, clarithromycin, moxifloxacin).
  • pentamidine, used to treat a serious type of pneumonia (i.e., Pneumocystic carinii pneumonia).
  • medicines used to treat malaria (e.g., quinine).
  • medicines used to treat fungal infections (e.g., ketoconazole, fluconazole, itraconazole, voriconazole).
  • domperidone, used to speed up the movements of the stomach and bowel.
  • tacrolimus, used to prevent organ transplant rejection.
  • other medicines used to treat nausea and vomiting (e.g., ondansetron).
  • medicines used to treat breathing problems like asthma and lung disease (e.g., salmeterol, formoterol).
  • lithium, used to treat mood disorders.
  • medicines that can cause an electrolyte imbalance (e.g., diuretics, also known as “water pills”).

• medicines known as dopaminergics such as:

  • cabergoline and quinagolide, used to treat high levels of prolactin in the blood.

The following may also interact with TRIFLUOPERAZINE:

• alcohol. TRIFLUOPERAZINE can increase the effects of alcohol. You should avoid consuming alcohol while taking TRIFLUOPERAZINE.
• medicines used to control seizures (e.g., phenytoin).
• analgesics, medicines used to relieve pain.
• barbiturates, medicines used to relax the body and help with sleeping.
• medicines used treat high blood pressure and certain heart conditions (e.g., propranolol).
• atropine, used to treat eye problems, a low heart rate, insecticide or mushroom poisoning, or reduce saliva and fluid in the respiratory tract during surgery.
• medicines used to treat gastrointestinal problems, such as magnesium, aluminum and calcium salts, oxides and hydroxides.
• phosphorus insecticides used for farming, treating animals (e.g., flea and tick control), and treating pests around the house or garden. TRIFLUOPERAZINE can increase the toxicity from these types of insecticides, so caution must be taken when using these products.
• desferrioxamine, a medicine to remove excess iron from the body.
• sedatives and tranquilizers, medicines used to treat anxiety and/or insomnia.
• metrizamide, a radiocontrast agent used to improve the contrast of internal body structures using different imaging techniques such as computed tomography (CT) scans or radiography (X-ray imaging).
• anaesthetics, medicines used during surgery.
• levodopa, used to treat Parkinson’s disease.
• oral anticoagulants, medicines used to prevent and treat blood clots (e.g., warfarin).
• antacids, used to treat indigestion.
• muscle relaxants, medicines used to treat muscle spasms and back pain.
• antihistamines, medicines used to treat allergies and may cause drowsiness (e.g., diphenhydramine).
• medicines that may make you sleepy or drowsy (e.g., cough-and-cold medicines, sleeping pills). You should not take TRIFLUOPERAZINE if you have drowsiness caused by other medicines.
• epinephrine, used for the emergency treatment of severe allergic reactions
• antihypertensive agents, medicines used for high blood pressure (e.g., guanethidine and guanadrel).

How to take TRIFLUOPERAZINE:

• Take TRIFLUOPERAZINE exactly as your healthcare professional has told you.

• Your healthcare professional will decide on the best dose for your depending on:

  • the severity of your symptoms; and
  • how you respond to your treatment.
• During the first few days of your treatment, your healthcare professional may gradually increase your dose. This is to allow your body to adjust and minimize side effects.
• Do not take TRIFLUOPERAZINE more often or increase your dose without consulting your healthcare professional. Taking more than you should will not improve your condition any faster. Instead, you will increase your risk of serious side effects.
• Do not stop taking this medicine suddenly without your healthcare professional’s approval.

Usual dose:

Adults:

• For mild to moderate symptoms: The usual dose is 1 or 2 mg twice daily. If necessary, your dose may be increased to 6 mg daily. However, above this amount, side effects are more likely to occur in some patients.
• For moderate to severe symptoms: The usual starting dose is 5 mg, taken 2 or 3 times daily. Your dose will be increased gradually. The usual maintenance dose is 15 to 20 mg per day. However, some patients may require more.

Children:

• For behavioural disorders: The usual dose is 1 mg once or twice daily, depending on the child’s bodyweight.
• For psychosis: The usual starting dose is 1 mg once or twice daily, depending on the child’s bodyweight. The dose may be gradually increased until symptoms are controlled or until side effects become troublesome. The lowest effective dosage will be given. In most cases, it is not necessary to exceed 15 mg of TRIFLUOPERAZINE daily.

Overdose:

Symptoms of overdose with TRIFLUOPERAZINE include:

• muscle twitching
• drowsiness
• dry mouth
• weakness
• seizures
• shortness of breath
• shaking (tremor)
• irregular heartbeat
• low blood pressure
• agitation
• confusion
• dizziness
• increased salivation
• trouble swallowing
• loss of balance or coordination
• fainting
• repetitive and involuntary muscle contractions
• neck problems (torticollis)
• unusually weak breathing

If you think you, or a person you are caring for, have taken too much TRIFLUOPERAZINE, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your next dose as scheduled. Never take two doses at once to make up for a missed dose.

Possible side effects from using TRIFLUOPERAZINE:

These are not all the possible side effects you may have when taking TRIFLUOPERAZINE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with TRIFLUOPERAZINE may include:

• feeling tired or weak
• feeling dizzy
• dry mouth
• lack of energy
• increased or loss of appetite
• feeling agitated or jittery
• nausea
• constipation
• headache
• stuffy nose
• changes in bodyweight
• skin rashes, itching and redness
• skin colouring (pigmentation)
• trouble falling and/or staying asleep
• vomiting
• gastric irritation
• change in sexual drive (altered libido)
• menstrual cycle changes
• enlargement of the breast tissue in men
• swelling in the hands, arms, legs or feet
• asthma
• inability to ejaculate
• leaking of urine due to loss of bladder control (urinary incontinence)
• drowsiness

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Store TRIFLUOPERAZINE at room temperature (15°C - 30°C) in well closed containers. Protect from light.
• Do not use after the expiry date shown on the packaging.
• Keep out of reach and sight of children.

If you want more information about TRIFLUOPERAZINE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (https://www.aapharma.ca/en/); or by calling 1-877-998-9097.

Date of Authorization: 2025-10-14