Haldol

Last updated on RxList: 12/2/2020
Haldol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Haldol?

Haldol (haloperidol) is an antipsychotic drug that decreases excitement in the brain. Haldol is used to treat psychotic disorders like schizophrenia, to control motor (movement) and verbal (for example, Tourette's syndrome) tics and is used to treat severe behavior problems in children. Haldol is available in generic form. Haldol is not approved for use in older adults with dementia because of increased chances of death during treatment.

What Are Side Effects of Haldol?

Common side effects of Haldol include:

  • nausea,
  • vomiting,
  • diarrhea,
  • dry mouth,
  • nervousness,
  • headache,
  • dizziness,
  • spinning sensation,
  • drowsiness,
  • sleep problems (insomnia),
  • restlessness,
  • anxiety,
  • skin rash,
  • itching,
  • spontaneous eye movements,
  • mood changes,
  • breast enlargement,
  • irregular menstrual periods,
  • loss of interest in sex,
  • blurred vision,
  • difficulty urinating or urinating less than usual, and
  • occasional movement disorders

Severe side effects of Haldol include:

  • death in the elderly,
  • prolongation of the QT heartbeat interval,
  • tardive dyskinesia (involuntary movements), prolonged erection (hours),
  • a symptom complex sometimes referred to as neuroleptic malignant syndrome (NMS) with fever,
  • irregular heartbeats,
  • mental status changes, and
  • renal failure

Dosage for Haldol

Haldol is available in sterile vials containing 5 mg strength Haldol per 1 ml of fluid used for injection. Usual starting dose is 2.5-5 mg intramuscularly. Dose may vary according to patient response to the drug. Switch to an oral form of this drug is recommended as soon as possible.

What Drugs, Substances, or Supplements Interact with Haldol?

Haldol may interact with other drugs so the patient needs close observation or monitoring to determine if other side effects develop.

Haldol During Pregnancy and Breastfeeding

Haldol should only be used during pregnancy or in women likely to become pregnant only if the benefit clearly justifies a potential risk to the fetus; fetal abnormalities and fetal exposure to Haldol in the third trimester have shown dependence at birth. Women who are breastfeeding should not take Haldol because the drug may affect the infant. Although reports of use for behavior modification exist, the drug is not approved for use in children.

Additional Information

Our Haldol Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Schizophrenia is the most disabling mental illness. See Answer
Haldol Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of haloperidol can cause a serious movement disorder that may not be reversible. The longer you use haloperidol, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Call your doctor at once if you have:

  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
  • muscle spasms in your neck, tightness in your throat, trouble swallowing;
  • rapid changes in mood or behavior;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • cough with mucus, chest pain, feeling short of breath;
  • low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; or
  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects may include:

  • drowsiness;
  • headache;
  • dizziness, spinning sensation;
  • uncontrolled muscle movements;
  • feeling restless or anxious;
  • sleep problems (insomnia); or
  • breast enlargement, irregular menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Haldol (Haloperidol Injection)

SLIDESHOW

Schizophrenia: Symptoms, Types, Causes, Treatment See Slideshow
Haldol Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • WARNINGS, Increased Mortality In Elderly Patients With Dementia-Related Psychosis
  • WARNINGS, Cardiovascular Effects
  • WARNINGS, Tardive Dyskinesia
  • WARNINGS, Neuroleptic Malignant Syndrome
  • WARNINGS, Hypersensitivity Reactions
  • WARNINGS, Falls
  • WARNINGS, Usage In Pregnancy
  • WARNINGS, Combined Use Of HALDOL And Lithium
  • WARNINGS, General
  • PRECAUTIONS, Leukopenia, Neutropenia, And Agranulocytosis
  • PRECAUTIONS, Withdrawal Emergent Dyskinesia
  • PRECAUTIONS, Other

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.

The data described below reflect exposure to haloperidol in the following:

  • 284 patients who participated in 3 double-blind, placebo-controlled clinical trials with haloperidol (oral formulation, 2 to 20 mg/day); two trials were in the treatment of schizophrenia and one in the treatment of bipolar disorder.
  • 1295 patients who participated in 16 double-blind, active comparator-controlled clinical trials with haloperidol (injection or oral formulation, 1 to 45 mg/day) in the treatment of schizophrenia.

Based on the pooled safety data, the most common adverse reactions in haloperidol-treated patients from these double-blind placebo-controlled clinical trials (≥5%) were: extrapyramidal disorder, hyperkinesia, tremor, hypertonia, dystonia, and somnolence.

Adverse Reactions Reported At ≥1% Incidence In Double-Blind Placebo-Controlled Clinical Trials With Oral Haloperidol

Adverse reactions occurring in ≥1% of haloperidol-treated patients and at higher rate than placebo in 3 double-blind, parallel, placebo-controlled, clinical trials with the oral formulation are shown in Table 1.

Table 1. Adverse Reactions Occurring in ≥1% of Haloperidol-Treated Patients in Double-Blind, Parallel Placebo-Controlled Clinical Trials (Oral Haloperidol)

System/Organ Class
Adverse Reaction
Haloperidol
(n=284)
%
Placebo
(n=282)
%
Gastrointestinal Disorders
  Constipation4.21.8
  Dry mouth1.80.4
  Salivary hypersecretion1.20.7
Nervous System Disorders
  Extrapyramidal disordera50.716.0
    Hyperkinesia10.22.5
    Tremor8.13.6
    Hypertonia7.40.7
    Dystonia6.70.4
    Bradykinesia4.20.4
  Somnolence5.31.1
a Represents the total reporting rate for extrapyramidal disorder (reported term) and individual symptoms of extrapyramidal disorder, including events that did not meet the threshold of ≥1% for inclusion in this table

Additional Adverse Reactions Reported In Double-Blind, Placebo-Or Active Comparator-Controlled Clinical Trials With Injectable Or Oral Haloperidol

Additional adverse reactions that are listed below were reported by haloperidol-treated patients in double-blind, active comparator-controlled clinical trials with the injectable or oral formulation, or at <1% incidence in double-blind, parallel, placebo-controlled, clinical trials with the oral formulation.

Cardiac Disorders: Tachycardia

Endocrine Disorders: Hyperprolactinemia

Eye Disorders: Vision blurred

Investigations: Weight increased

Musculoskeletal and Connective Tissue Disorders: Torticollis, Trismus, Muscle rigidity, Muscle twitching

Nervous System Disorders: Akathisia, Dizziness, Dyskinesia, Hypokinesia, Neuroleptic malignant syndrome, Nystagmus, Oculogyric crisis, Parkinsonism, Sedation, Tardive dyskinesia

Psychiatric Disorders: Loss of libido, Restlessness

Reproductive System and Breast Disorders: Amenorrhea, Galactorrhea, Dysmenorrhea, Erectile dysfunction, Menorrhagia, Breast discomfort

Skin and Subcutaneous Tissue Disorders: Acneiform skin reactions

Vascular Disorders: Hypotension, Orthostatic hypotension

Adverse Reactions Identified In Clinical Trials With Haloperidol Decanoate

The adverse reactions listed below were identified in clinical trials with haloperidol decanoate (long-acting depot formulation), and reflect exposure to the active moiety haloperidol in 410 patients who participated in 13 clinical trials with haloperidol decanoate (15 to 500 mg/month) in the treatment of schizophrenia or schizoaffective disorder. These clinical trials comprised:

  • 1 double-blind, active comparator-controlled trial with fluphenazine decanoate.
  • 2 trials comparing the decanoate formulation to oral haloperidol.
  • 9 open-label trials.
  • 1 dose-response trial.

Nervous System Disorders: Akinesia, Cogwheel rigidity, Masked facies.

Postmarketing Experience

The following adverse reactions relating to the active moiety haloperidol have been identified during postapproval use of haloperidol or haloperidol decanoate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Pancytopenia, Agranulocytosis, Thrombocytopenia, Leukopenia, Neutropenia

Cardiac Disorders: Ventricular fibrillation, Torsade de pointes, Ventricular tachycardia, Extrasystoles

Endocrine Disorders: Inappropriate antidiuretic hormone secretion

Gastrointestinal Disorders: Vomiting, Nausea

General Disorders and Administration Site Conditions: Sudden death, Face edema, Edema, Hyperthermia, Hypothermia

Hepatobiliary Disorders: Acute hepatic failure, Hepatitis, Cholestasis, Jaundice, Liver function test abnormal

Immune System Disorders: Anaphylactic reaction, Hypersensitivity

Investigations: Electrocardiogram QT prolonged, Weight decreased

Metabolic and Nutritional Disorders: Hypoglycemia

Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis

Nervous System Disorders: Convulsion, Headache, Opisthotonus, Tardive dystonia

Pregnancy, Puerperium and Perinatal Conditions: Drug withdrawal syndrome neonatal

Psychiatric Disorders: Agitation, Confusional state, Depression, Insomnia

Renal and Urinary Disorders: Urinary retention

Reproductive System and Breast Disorders: Priapism, Gynecomastia

Respiratory, Thoracic and Mediastinal Disorders: Laryngeal edema, Bronchospasm, Laryngospasm, Dyspnea

Skin and Subcutaneous Tissue Disorders: Angioedema, Dermatitis exfoliative, Hypersensitivity vasculitis, Photosensitivity reaction, Urticaria, Pruritus, Rash, Hyperhidrosis

Read the entire FDA prescribing information for Haldol (Haloperidol Injection)

© Haldol Patient Information is supplied by Cerner Multum, Inc. and Haldol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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