Haldol (Oral)

Haloperidol is used to treat nervous, emotional, and mental conditions (for example, schizophrenia). It is also used to help control the symptoms of Tourette's disorder. This medicine should not be used to treat behavior problems in older adult patients who have dementia.

Haloperidol is also used to treat severe behavioral problems (such as aggressive or impulsive behavior) or hyperactivity in children who have already tried psychotherapy or other medicines that did not work well.

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

Your doctor should check how you are doing at regular visits, especially in the first few months after starting this medicine. The amount of haloperidol you take may be adjusted to suit your condition and to help prevent side effects.

Do not stop taking this medicine without first consulting your doctor. Your doctor may want you to slowly lower your dose before stopping completely. This will give your body time to adjust and help prevent a worsening of your medical condition.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that cause drowsiness or reduce alertness). Some examples of CNS depressants include antihistamines or allergy/cold medicines, sedatives, tranquilizers, sleeping medicines, prescription pain medicines or narcotics, seizure medications or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these while using this medicine.

This medicine may cause some people to feel dizzy, drowsy, or have difficulty thinking or controlling body movements, which could lead to falls, fractures, or other injuries. Even if you take haloperidol at bedtime, you might feel drowsy or less alert when you wake up. Make sure you know how this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you are dizzy or not alert.

Dizziness, lightheadedness, or fainting may happen, especially when you stand up from lying or sitting down. Getting up slowly may help. If this problem continues or worsens, consult your doctor.

This medicine often makes you sweat less, which can lead to an increase in body temperature. Be extra careful not to get overheated during exercise or in hot weather while taking this medicine, as overheating may lead to heat stroke. Additionally, hot baths or saunas may cause dizziness or fainting while you are on this medicine.

Haloperidol may make your skin more sensitive to sunlight. Even brief exposure to sunlight may cause skin rash, itching, redness, or severe sunburn. When you start taking this medicine:

• Stay out of direct sunlight, especially between 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, such as a hat or sunglasses.
• Use a sunblock with a sun protection factor (SPF) of at least 15. Some patients may need a higher SPF, especially if they have fair skin. If you have questions, consult your doctor.
• Use a sunblock lipstick with at least SPF 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction to the sun, consult your doctor.

Haloperidol may cause dry mouth. For temporary relief, try sugarless candy or gum, melting ice in your mouth, or using a saliva substitute. However, if your mouth remains dry for more than 2 weeks, consult your medical doctor or dentist. Ongoing dry mouth may increase the risk of dental issues, including tooth decay, gum disease, and fungal infections.

Contact your doctor as soon as possible if you experience chest pain or discomfort, a fast heartbeat, trouble breathing, or fever and chills. These may be signs of a serious heart issue.

This medicine may lead to tardive dyskinesia (a movement disorder). Consult your doctor immediately if you notice any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like tongue movements, uncontrolled chewing, or uncontrolled movements of the arms and legs.

Consult your doctor right away if you experience any of the following while using this medicine: convulsions, trouble breathing, a fast heartbeat, high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be signs of a serious condition called neuroleptic malignant syndrome (NMS).

Do not take other medicines without discussing them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medication or any other medications. As well inform 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of haloperidol in children younger than 3 years of age. Safety and efficacy have not been established.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

Although certain drugs 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 taking this medication, it is especially essential that your healthcare professional know if you are using any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following drugs is not recommended. Your doctor may decide not to treat you with this drug or change some of the other medications 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 normally not recommended, but may be required in some cases. If both medicines are prescribed together, your clinician may change the dose or how frequently 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
• 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
• 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 drug with any of the following medicines may cause an increased chance of certain side effects, but using both drugs may be the best therapy for you. If both medications are prescribed together, your doctor may change the dose or how frequently you use one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medications 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 drug with any of the following is normally not advised, 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 Issues

The presence of other medical problems may affect the use of this drug. Make sure you inform your clinician if you have any other medical issues, especially:

• Angina (severe chest pain) or
• Breast cancer, history of or
• Encephalopathy or
• Heart or blood vessel disease, severe or
• Hyperprolactinemia (high prolactin in the blood) or
• Hypotension (low blood pressure) or
• Lung or breathing issues (eg, bronchopneumonia) or
• Mania or
• Neuroleptic malignant syndrome, history of or
• Seizures, history of—Use with caution. May make these conditions worse.

• Central nervous system depression, serious or
• Coma or
• Dementia in elderly 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
• Thyroid issues—May increase chance for more severe side effects.

Along with its needed effects, Haldol (Oral) may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

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

More common

• Difficulty with speaking or swallowing
• Inability to move the eyes
• Loss of balance control
• Mask-like face
• Muscle spasms, especially of the neck and back
• Restlessness or need to keep moving (severe)
• Shuffling walk
• Stiffness of the arms and legs
• Trembling and shaking of the fingers and hands
• Twisting movements of the body
• Weakness of the arms and legs

Less common

• Decreased thirst
• Difficulty in urination
• Dizziness, lightheadedness, or fainting
• Hallucinations (seeing or hearing things that are not there)
• Lip smacking or puckering
• Puffing of the cheeks
• Rapid or worm-like movements of the tongue
• Skin rash
• Uncontrolled chewing movements
• Uncontrolled movements of the arms and legs

Rare

• Confusion
• Convulsions (seizures)
• Difficult or fast breathing
• Fast heartbeat or irregular pulse
• Fever (high)
• Hot, dry skin, or lack of sweating
• Increased blinking or spasms of the eyelid
• Increased sweating
• Loss of bladder control
• Muscle stiffness (severe)
• Muscle weakness
• Sore throat and fever
• Uncontrolled twisting movements of the neck, trunk, arms, or legs
• Unusual bleeding or bruising
• Unusual facial expressions or body positions
• Unusual tiredness or weakness
• Unusually pale skin
• Yellow eyes or skin

Incidence not known

• Continuing nausea or vomiting
• Increase in the frequency of seizures
• Loss of appetite
• Swelling of the face
• Tiredness and weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Difficulty with breathing (severe)
• Dizziness (severe)
• Drowsiness (severe)
• Muscle trembling, jerking, stiffness, or uncontrolled movements (severe)
• Unusual tiredness or weakness (severe)

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 Haldol (Oral). Your health care professional may also 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, are bothersome, or if you have any questions about them:

More common

• Blurred vision
• Changes in menstrual period
• Constipation
• Dryness of the mouth
• Swelling or pain in the breasts (in females)
• Unusual secretion of milk
• Weight gain

Less common

• Decreased sexual ability
• Drowsiness
• Increased sensitivity of the skin to sun (skin rash, itching, redness or other discoloration of skin, or severe sunburn)
• Nausea or vomiting

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.

In the U.S.

• Haldol

In Canada

• Alti-Haloperidol
• Apo-Haloperidol
• Novo-Peridol
• Peridol
• Pms-Haloperidol
• Ratio-Haloperidol

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: Antipsychotic

Pharmacologic Class: Dopamine Antagonist

Chemical Class: Butyrophenone

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is particularly important for elderly patients, since they may react very strongly to this medicine.

For patients taking the liquid form of this medicine:

• This medicine is to be taken by mouth and it comes in a dropper bottle. Each dose is to be measured with the specially marked dropper provided with your bottle. Do not use other droppers since they may not deliver the correct amount of medicine.
• This medicine should be mixed with water or a beverage, such as orange juice, apple juice, tomato juice, or cola, and taken immediately after mixing.

Continue taking this medicine for the full time of treatment. Sometimes haloperidol must be taken for several days to several weeks before its full effect is reached.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (solution or tablets): For nervous, emotional, or mental conditions: Adults and children 13 years of age and older—At first, 0.5 to 5 milligrams (mg) 2 or 3 times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 100 mg per day. Older adults—At first, 0.5 to 2 mg 2 or 3 times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 100 mg per day. Children 3 to 12 years of age and weighs 15 to 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. Children younger than 3 years of age—Use and dose must be determined by the doctor. For Tourette's disorder: Children 3 to 12 years of age and weighs 15 to 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.05 to 0.075 milligram (mg) per kilogram (kg) of body weight per day. Children younger than 3 years of age—Use and dose must be determined by the doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• What drugs cause tardive dyskinesia?