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Haldol

Last reviewed on RxList: 7/28/2020
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.

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Haldol Consumer Information

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. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take haloperidol, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.

Call your doctor at once if you have:

  • sudden mood changes, agitation, hallucinations, unusual thoughts or behavior;
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • stiffness in your neck, tightness in your throat, trouble breathing or swallowing;
  • sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, easy bruising or bleeding;
  • stabbing chest pain, feeling short of breath, cough with yellow or green mucus;
  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • seizure (convulsions); 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:

  • headache, dizziness, spinning sensation, drowsiness;
  • tremors, restless feeling, uncontrolled muscle movements;
  • stiffness in the muscles of your neck or back, speech problems;
  • sleep problems (insomnia);
  • feeling restless or anxious;
  • breast enlargement, irregular menstrual periods, loss of interest in sex; or
  • overactive reflexes.

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)

QUESTION

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

SIDE EFFECTS

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

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
Constipation 4.2 1.8
Dry mouth 1.8 0.4
Salivary hypersecretion 1.2 0.7
Nervous System Disorders
Extrapyramidal disordera 50.7 16.0
Hyperkinesia 10.2 2.5
Tremor 8.1 3.6
Hypertonia 7.4 0.7
Dystonia 6.7 0.4
Bradykinesia 4.2 0.4
Somnolence 5.3 1.1
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

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)

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© 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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