Haloperidol (Intramuscular route)

Pronunciation:

hal-oh-PER-i-dol

Brand Names:

Haldol
Haldol Decanoate

Dosage Forms:

Oil
Solution

Warnings:

Intramuscular route(Injectable)

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared with placebo-treated patients. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that conventional antipsychotic drugs may also increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Haloperidol decanoate is not approved for the treatment of patients with dementia-related psychosis .

Intramuscular route(Solution)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Haloperidol injection is not approved for the treatment of patients with dementia-related psychosis .

Classifications:

Therapeutic—

Antipsychotic

Pharmacologic—

Dopamine Antagonist

Chemical—

Butyrophenone

Uses of This Medicine:

Haloperidol injection is used to treat schizophrenia. This medicine should not be used to treat behavior problems in older adult patients who have dementia-related psychosis.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of haloperidol injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of haloperidol injection in the elderly. However, elderly women are more likely to have an unwanted side effect called tardive dyskinesia, and elderly patients are more likely to have age-related heart problems, which may require an adjustment in the dose for patients receiving haloperidol injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil
Bromopride
Cisapride
Dronedarone
Fluconazole
Levoketoconazole
Levomethadyl
Mesoridazine
Metoclopramide
Nelfinavir
Pimozide
Piperaquine
Posaconazole
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir
Abiraterone Acetate
Acecainide
Adagrasib
Ajmaline
Alfentanil
Alfuzosin
Amiodarone
Amisulpride
Amitriptyline
Anagrelide
Apomorphine
Aprindine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Artemether
Asenapine
Astemizole
Atazanavir
Azimilide
Azithromycin
Bedaquiline
Benzhydrocodone
Bretylium
Bromazepam
Bromocriptine
Buprenorphine
Bupropion
Buserelin
Butorphanol
Cabergoline
Calcium Oxybate
Cannabidiol
Cannabis
Carbamazepine
Celecoxib
Ceritinib
Cetirizine
Chloral Hydrate
Chloroquine
Chlorpromazine
Ciprofloxacin
Citalopram
Clarithromycin
Clobazam
Clofazimine
Clomipramine
Clonazepam
Clothiapine
Clozapine
Cobicistat
Codeine
Conivaptan
Crizotinib
Dabrafenib
Dalfopristin
Daridorexant
Darunavir
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Desvenlafaxine
Deutetrabenazine
Dexmedetomidine
Dibenzepin
Dihydrocodeine
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Doxylamine
Droperidol
Duloxetine
Efavirenz
Encainide
Encorafenib
Enflurane
Entrectinib
Epinephrine
Erythromycin
Escitalopram
Esketamine
Etrasimod
Fedratinib
Fentanyl
Fexinidazole
Fingolimod
Flecainide
Flibanserin
Fluoxetine
Formoterol
Foscarnet
Fosnetupitant
Fostemsavir
Gabapentin
Gabapentin Enacarbil
Gatifloxacin
Gemifloxacin
Gepirone
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halofantrine
Histrelin
Hydrocodone
Hydromorphone
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibutilide
Imipramine
Inotuzumab Ozogamicin
Itraconazole
Ivabradine
Ivosidenib
Ketamine
Ketoconazole
Lacosamide
Lapatinib
Lefamulin
Lemborexant
Lenvatinib
Leuprolide
Levocetirizine
Levodopa
Levofloxacin
Levorphanol
Lithium
Lofexidine
Lopinavir
Lorcainide
Loxapine
Lumefantrine
Macimorelin
Magnesium Oxybate
Mavacamten
Mefloquine
Meperidine
Methadone
Metronidazole
Mifepristone
Mirtazapine
Mobocertinib
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Nafarelin
Nalbuphine
Netupitant
Nilotinib
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olanzapine
Oliceridine
Omaveloxolone
Ondansetron
Osilodrostat
Osimertinib
Oxaliplatin
Oxycodone
Oxymorphone
Ozanimod
Pacritinib
Paliperidone
Panobinostat
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Pentazocine
Pergolide
Periciazine
Phenobarbital
Pimavanserin
Pitolisant
Pixantrone
Ponesimod
Potassium Oxybate
Pramipexole
Pregabalin
Primidone
Probucol
Procainamide
Prochlorperazine
Promethazine
Propafenone
Propranolol
Protriptyline
Quetiapine
Quinidine
Quinine
Quinupristin
Quizartinib
Ranolazine
Relugolix
Remifentanil
Remimazolam
Ribociclib
Risperidone
Ropeginterferon Alfa-2b-njft
Ropinirole
Rotigotine
Selegiline
Selpercatinib
Sematilide
Sertindole
Sertraline
Sevoflurane
Siponimod
Sodium Oxybate
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
Spiramycin
Sufentanil
Sulfamethoxazole
Sulpiride
Sultopride
Sunitinib
Tacrolimus
Tapentadol
Tedisamil
Telavancin
Telithromycin
Tetrabenazine
Topiramate
Toremifene
Tramadol
Trazodone
Triclabendazole
Trifluoperazine
Trimethoprim
Trimipramine
Triptorelin
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Vilanterol
Vinflunine
Voclosporin
Voriconazole
Zolpidem
Zotepine
Zuclopenthixol
Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Benztropine
Betel Nut
Buspirone
Dextromethorphan
Fluvoxamine
Methyldopa
Nefazodone
Procyclidine
Rifampin
Rifapentine
Tacrine
Trihexyphenidyl

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Breast cancer, prolactin-dependent, history of or
Chest pain or
Heart or blood vessel disease, severe or
Hyperprolactinemia (high prolactin in the blood) or
Hypotension (low blood pressure) or
Mania or
Neuroleptic malignant syndrome, history of or
Seizures or epilepsy, history of—Use with caution. May make these conditions worse.

Central nervous system depression, severe or
Coma or
Dementia in the elderly or
Lewy body dementia or
Parkinson's disease—Should not be used in patients with these conditions.

Heart rhythm problems (eg, familial long QT syndrome), history of or
Hypokalemia (low potassium in the blood) or
Hypomagnesemia (low magnesium in the blood) or
Hypothyroidism (underactive thyroid) or
Lung disease (eg, bronchopneumonia) or
Thyrotoxicosis (overactive thyroid)—May increase risk for more serious side effects.

Liver disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into one of your muscles.

Your doctor may give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you receive this medicine to allow for changes in your dose and help reduce any unwanted effects.

Do not stop receiving Haldol® suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.

This medicine may cause serious allergic reactions (eg, anaphylaxis, angioedema, dermatitis exfoliative), which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a cracks in the skin, loss of heat from the body, rash, itching, hoarseness, red, swollen skin, scaly skin, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Contact your doctor as soon as possible if you have chest pain or discomfort, a fast heartbeat, trouble with breathing, or fever and chills. These may be symptoms of a very serious problem with your heart.

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have a lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Check with your doctor right away if you have seizures, difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine will often make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are receiving this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are receiving this medicine.

This medicine may cause some people to become dizzy, drowsy, or may cause trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are receiving this medicine.

Haloperidol can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, a cough or hoarseness, lower back or side pain, or painful or difficult urination.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Less common

Rare (both): Blurred vision; confusion; difficulty opening the mouth; dizziness; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; fainting; fast, pounding, or irregular heartbeat or pulse; high fever; high or low blood pressure; increased sweating; lightheadedness; lockjaw; loss of bladder control; muscle spasm, especially of the neck and back; muscle twitching; seizures; severe muscle stiffness; uncontrolled eye movements; unusual tiredness or weakness; unusually pale skin

Incidence not known (both): Anxiety; black, tarry stools; bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site; chest pain or tightness; chills; clay-colored stools; cold sweats; continuing nausea or vomiting; cool, pale skin; cough; dark urine; decrease in the frequency of urination; deep or fast breathing with dizziness; depression; difficulty in passing urine (dribbling); drooling; dry mouth; eye pain; false or unusual sense of well-being; fever with or without chills; flushed, dry skin; fruit-like breath odor; general feeling of illness, tiredness, or weakness; headache; hoarseness; hot, dry skin; increase in the frequency of seizures; increased hunger; increased thirst; increased urination; irregular heartbeat, recurrent; irritability; itching, skin rash; lack of sweating; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals; lip smacking or puckering; loss of appetite; loss of consciousness; lower back or side pain; muscle weakness; muscle pain or cramps; muscle trembling or jerking; nausea; nervousness; nightmares; noisy breathing; numbness of the feet, hands, and around the mouth; painful or difficult urination; pale skin; pounding in the ears; puffing of the cheeks; rapid or worm-like movements of the tongue; shakiness; shuffling walk; sore throat; sores, ulcers, or white spots on the lips or in the mouth; stomach pain; swelling of the face, ankles, or hands; swollen glands; total body jerking; trouble breathing; trouble with sleeping; twisting movements of the body; uncontrolled chewing movements; unexplained weight loss; unpleasant breath odor; unusual bleeding or bruising; unusual dullness, tiredness, weakness, or feeling of sluggishness; vomiting; vomiting of blood; weakness of the arms and legs; yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Rare (both): Absent, missed, or irregular menstrual periods; acne, pimples; breast discomfort; cramps; decreased interest in sexual intercourse; heavy bleeding; inability to have or keep an erection; increased weight; loss in sexual ability, desire, drive, or performance; medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon; stopping of menstrual bleeding; swelling of the breasts or unusual milk production

Incidence not known (both): Belching; blindness; changes in vision; decreased vision; difficulty having a bowel movement; disturbed color perception; double vision; drowsiness; feeling of constant movement of self or surroundings; fullness or swelling of the breasts; halos around lights; heartburn; increased in sexual ability, desire, drive, or performance; increased interest in sexual intercourse; increased sensitivity of the skin to sunlight; indigestion; loss of hair; night blindness; overbright appearance of lights; pain or tenderness of the breasts; painful or prolonged erection of the penis; redness or other discoloration of the skin; sensation of spinning; severe sunburn; stomach discomfort or upset; tunnel vision; weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Last Updated: 4/24/2024

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