HALOPERIDOL 5 mg Tablet, 1,000-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Typical Antipsychotic class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Haloperidol is used to manage psychotic disorders (mental illness that cause disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). It is also used to control motor tics (uncontrollable need to repeat certain body movements) and verbal tics (uncontrollable need to repeat sounds or words) in people who have Tourette's disorder (condition characterized by motor or verbal tics). Haloperidol is in a group of medications called antipsychotics. It works by changing the activity of certain natural substances.
Read the full MedlinePlus article ↗- Haloperidol is mainly used to manage symptoms of psychotic disorders — things like hallucinations and severely disorganized thinking. It's also used to control the tics and vocal s...
- The most common things people notice early on are muscle stiffness, tremors, or a restless, can't-sit-still feeling. Some people also feel drowsy or notice their blood pressure dip...
- What side effects should I watch out for when I first start taking it?
- Yes — a few things need prompt attention. If you develop sudden muscle spasms in your neck or jaw, throat tightening, or trouble swallowing or breathing, get help right away. Also...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Haloperidol — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII ZK64F7XSTX
A red synthetic colorant made by combining D&C Red No. 27 dye with aluminum salts. It's used to give tablets, capsules, or other medicines their red or pink color.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII H8AV0SQX4D
A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2329 | $232.90 / 1000 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Haloperidol 5 mg 00832-1540-01 | Upsher-Smith | 100 tablets | $0.175 | AB | Availability likely | — |
| Haloperidol 5 mg 00378-0327-01 | Mylan | 100 tablets | $0.178 | AB | Discontinued | — |
| Haloperidol 5 mg 00904-6782-61 | Major | 100 tablets | $0.178 | AB | Availability likely | — |
| Haloperidol 5 mg 11788-0074-01 | AiPing | 100 tablets | $0.178 | AB | Availability likely | — |
| Haloperidol 5 mg 51079-0736-20 | Mylan | 100 tablets | $0.178 | AB | Availability likely | — |
| Haloperidol 5 mg 58657-0703-01 | Method | 100 tablets | $0.178 | AB | Availability likely | — |
| Haloperidol 5 mg 58657-0903-01 | Method | 100 tablets | $0.178 | AB | Availability likely | — |
| Haloperidol 5 mg 59651-0792-01 | Aurobindo | 100 tablets | $0.178 | AB | Availability likely | — |
| Haloperidol 5 mg 60687-0161-01 | American | 100 tablets | $0.178 | AB | Availability likely | — |
| Haloperidol 5 mg 68382-0079-01 | Zydus | 100 tablets | $0.178 | AB | Availability likely | — |
| Haloperidol 5 mg 69292-0586-01 | Amici | 100 tablets | $0.178 | AB | Availability likely | — |
| Haloperidol 5 mg 70756-0004-11 | Lifestar | 100 tablets | $0.178 | AB | Availability likely | — |
| Haloperidol 5 mg 71247-0153-01 | Innogenix, | 100 tablets | $0.185 | AB | FDA listed | — |
| Haloperidol 5 mg 00615-8626-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 10135-0755-01 | Marlex | 100 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 55154-3566-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 55154-5059-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 63629-9273-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 63629-9274-01 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 65841-0626-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 67046-0053-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 67046-1603-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 70518-1182-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 70518-1269-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 70518-3608-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 70518-4285-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 71335-2912-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 72162-1686-00 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 72162-2624-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 72205-0067-91 | Novadoz | 100 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 72789-0558-01 | PD-Rx | 100 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mgthis 82619-0108-03 | Creekwood | 1000 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 87441-0037-01 | Unit | 30 tablets | — | AB | FDA listed | — |
| Haloperidol 5 mg 67046-0329-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 82619-0108-01 | 30 TABLET in 1 BOTTLE (82619-108-01) | 2026-01-05 | Active |
| 82619-0108-02 | 100 TABLET in 1 BOTTLE (82619-108-02) | 2026-01-05 | Active |
| 82619-0108-03 You're viewing this | 1000 TABLET in 1 BOTTLE (82619-108-03) | 2026-01-05 | Active |
You're viewing the largest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 82619-0108-03?
What is the difference between NDC 82619-0108-03 and NDC 82619-0108-01?
What NDC number is used to bill for this package of HALOPERIDOL 5 mg Tablet?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
BOXED WARNING WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.
Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.
Haloperidol is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation).
Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION There is considerable variation from patient to patient in the amount of medication required for treatment. As with all antipsychotic drugs, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control.
To determine the initial dosage, consideration should be given to the patient's age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Children, debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels, as recommended below.
Clinical experience suggests the following recommendations: Oral Administration Initial Dosage Range Adults Moderate Symptomatology - 0.5 mg to 2 mg b.i.d. or t.i.d. Severe Symptomatology - 3 mg to 5 mg b.i.d. or t.i.d. To achieve prompt control, higher doses may be required in some cases.
Geriatric or Debilitated Patients - 0.5 mg to 2 mg b.i.d. or t.i.d. Chronic or Resistant Patients - 3 mg to 5 mg b.i.d. or t.i.d Patients who remain severely disturbed or inadequately controlled may require dosage adjustment. Daily dosages up to 100 mg may be necessary in some cases to achieve an optimal response.
Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses Children The following recommendations apply to children between the ages of 3 and 12 years (weight range 15 kg to 40 kg). Haloperidol is not intended for children under 3 years old. Therapy should begin at the lowest dose possible (0.5 mg per day).
If required, the dose should be increased by an increment of 0.5 mg at 5 to 7 day intervals until the desired therapeutic effect is obtained. (See chart below.) The total dose may be divided, to be given b.i.d. or t.i.d. Psychotic Disorders - 0.05 mg/kg/day to 0.15 mg/kg/day Nonpsychotic Behavior Disorders and Tourette's Disorder - 0.05 mg/kg/day to 0.075 mg/kg/day Severely disturbed psychotic children may require higher doses.
In severely disturbed, non-psychotic children or in hyperactive children with accompanying conduct disorders, who have failed to respond to psychotherapy or medications other than antipsychotics, it should be noted that since these behaviors may be short lived, short term administration of haloperidol may suffice. There is no evidence establishing a maximum effective dosage. There is little evidence that behavior improvement is further enhanced in dosages beyond 6 mg per day Maintenance Dosage Upon achieving a satisfactory therapeutic response, dosage should then be gradually reduced to the lowest effective maintenance level.
Switchover Procedure The oral form should supplant the injectable as soon as practicable. In the absence of bioavailability studies establishing bioequivalence between these two dosage forms the following guidelines for dosage are suggested. For an initial approximation of the total daily dose required, the parenteral dose administered in the preceding 24 hours may be used.
Since this dose is only an initial estimate, it is recommended that careful monitoring of clinical signs and symptoms, including clinical efficacy, sedation, and adverse effects, be carried out periodically for the first several days following the initiation of switchover. In this way, dosage adjustments, either upward or downward, can be quickly accomplished. Depending on the patient's clinical status, the first oral dose should be given within 12 to 24 hours following the last parenteral dose.
⛔ Contraindications ▾
CONTRAINDICATIONS Haloperidol tablets are contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this drug or have Parkinson's disease.
⚠️ Warnings ▾
WARNINGS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Haloperidol is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). Cardiovascular Effects Cases of sudden death, QT-prolongation, and Torsades de pointes have been reported in patients receiving haloperidol.
Higher than recommended doses of any formulation of haloperidol appear to be associated with a higher risk of QT-prolongation and Torsades de pointes. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome). Tardive Dyskinesia A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs.
Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase.
However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process.
The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Given these considerations, antipsychotic drugs should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and, 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate.
In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically. If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered.
However, some patients may require treatment despite the presence of the syndrome. (For further information about the description of tardive dyskinesia and its clinical detection, please refer to ADVERSE REACTIONS .) Neuroleptic Malignant Syndrome (NMS) A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status (including catatonic signs) and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure. The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where th…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Cardiovascular Effects Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of Torsades de pointes, and may occur more frequently with high doses and in predisposed patients (see WARNINGS and PRECAUTIONS ). Cases of sudden and unexpected death have been reported in association with the administration of haloperidol.
The nature of the evidence makes it impossible to determine definitively what role, if any, haloperidol played in the outcome of the reported cases. The possibility that haloperidol caused death cannot, of course, be excluded, but it is to be kept in mind that sudden and unexpected death may occur in psychotic patients when they go untreated or when they are treated with other antipsychotic drugs. CNS Effects Extrapyramidal Symptoms (EPS) EPS during the administration of haloperidol have been reported frequently, often during the first few days of treatment.
EPS can be categorized generally as Parkinson-like symptoms, akathisia, or dystonia (including opisthotonos and oculogyric crisis). While all can occur at relatively low doses, they occur more frequently and with greater severity at higher doses. The symptoms may be controlled with dose reductions or administration of antiparkinson drugs such as benztropine mesylate, USP or trihexyphenidyl hydrochloride, USP.
It should be noted that persistent EPS have been reported; the drug may have to be discontinued in such cases. Dystonia Class Effect Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue.
While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups. Withdrawal Emergent Neurological Signs Generally, patients receiving short-term therapy experience no problems with abrupt discontinuation of antipsychotic drugs.
However, some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal. In certain of these cases the dyskinetic movements are indistinguishable from the syndrome described below under "Tardive Dyskinesia" except for duration. It is not known whether gradual withdrawal of antipsychotic drugs will reduce the rate of occurrence of withdrawal emergent neurological signs but until further evidence becomes available, it seems reasonable to gradually withdraw use of haloperidol.
Tardive Dyskinesia As with all antipsychotic agents, haloperidol has been associated with persistent dyskinesias. Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may appear in some patients on long-term therapy or may occur after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high dose therapy, especially females.
The symptoms are persistent and in some patients appear irreversible. The syndrome is characterized by rhythmical involuntary movements of tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities and the trunk.
There is no known effective treatment for tardive dyskinesia; antiparkinson agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, t…
🤰 Pregnancy ▾
Usage in Pregnancy Pregnancy Nonteratogenic Effects Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.
Haloperidol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Rodents given 2 to 20 times the usual maximum human dose of haloperidol by oral or parenteral routes showed an increase in incidence of resorption, reduced fertility, delayed delivery and pup mortality. No teratogenic effect has been reported in rats, rabbits or dogs at dosages within this range, but cleft palate has been observed in mice given 15 times the usual maximum human does.
Cleft palate in mice appears to be a nonspecific response to stress or nutritional imbalance as well as to a variety of drugs, and there is no evidence to relate this phenomenon to predictable human risk for most of these agents. There are no well controlled studies with haloperidol in pregnant women. There are reports, however, of cases of limb malformations observed following maternal use of haloperidol along with other drugs which have suspected teratogenic potential during the first trimester of pregnancy.
Causal relationships were not established in these cases. Since such experience does not exclude the possibility of fetal damage due to haloperidol, this drug should be used during pregnancy or in women likely to become pregnant only if the benefit clearly justifies a potential risk to the fetus. Infants should not be nursed during drug treatment.
Pregnancy Nonteratogenic Effects Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.
Haloperidol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Rodents given 2 to 20 times the usual maximum human dose of haloperidol by oral or parenteral routes showed an increase in incidence of resorption, reduced fertility, delayed delivery and pup mortality. No teratogenic effect has been reported in rats, rabbits or dogs at dosages within this range, but cleft palate has been observed in mice given 15 times the usual maximum human does.
Cleft palate in mice appears to be a nonspecific response to stress or nutritional imbalance as well as to a variety of drugs, and there is no evidence to relate this phenomenon to predictable human risk for most of these agents. There are no well controlled studies with haloperidol in pregnant women. There are reports, however, of cases of limb malformations observed following maternal use of haloperidol along with other drugs which have suspected teratogenic potential during the first trimester of pregnancy.
Causal relationships were not established in these cases. Since such experience does not exclude the possibility of fetal damage due to haloperidol, this drug should be used during pregnancy or in women likely to become pregnant only if the benefit clearly justifies a potential risk to the fetus. Infants should not be nursed during drug treatment.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of haloperidol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not consistently identified differences in responses between the elderly and younger patients. However, the prevalence of tardive dyskinesia appears to be highest among the elderly, especially elderly women (see WARNINGS : Tardive Dyskinesia ).
Also, the pharmacokinetics of haloperidol in geriatric patients generally warrants the use of lower doses (see DOSAGE AND ADMINISTRATION ).
🆘 Overdosage ▾
OVERDOSAGE Manifestations In general, the symptoms of overdosage would be an exaggeration of known pharmacologic effects and adverse reactions, the most prominent of which would be: 1) severe extrapyramidal reactions, 2) hypotension, or 3) sedation. The patient would appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state. The extrapyramidal reaction would be manifest by muscular weakness or rigidity and a generalized or localized tremor as demonstrated by the akinetic or agitans types respectively.
With accidental overdosage, hypertension rather than hypotension occurred in a 2 year old child. The risk of ECG changes associated with Torsades de pointes should be considered. (For further information regarding Torsades de pointes, please refer to ADVERSE REACTIONS .) Treatment Gastric lavage or induction of emesis should be carried out immediately followed by administration of activated charcoal.
Since there is no specific antidote, treatment is primarily supportive. A patent airway must be established by use of an oropharyngeal airway or endotracheal tube or, in prolonged cases of coma, by tracheostomy. Respiratory depression may be counteracted by artificial respiration and mechanical respirators.
Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma, or concentrated albumin, and vasopressor agents such as metaraminol, phenylephrine and norepinephrine. Epinephrine should not be used. In case of severe extrapyramidal reactions, antiparkinson medication should be administered.
ECG and vital signs should be monitored especially for signs of Q-T prolongation or dysrhythmias and monitoring should continue until the ECG is normal. Severe arrhythmias should be treated with appropriate antiarrhythmic measures.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The precise mechanism of action has not been clearly established.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Haloperidol Tablets, USP are available containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP. The 0.5 mg tablets are white to off white, round shaped flat faced beveled edge uncoated tablets functionally scored on one side and debossed with '298' on other side. They are available as follows: NDC 82619-105-01 bottles of 100 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
NDC 82619-105-02 bottles of 1000 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The 1 mg tablets are yellow, round shaped flat faced beveled edge uncoated tablets functionally scored on one side and debossed with '299' on other side. They are available as follows: NDC 82619-106-01 bottles of 100 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
NDC 82619-106-02 bottles of 1000 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The 2 mg tablets are yellow, round shaped flat faced beveled edge uncoated tablets functionally scored on one side and debossed with '297' on other side. They are available as follows: NDC 82619-107-01 bottles of 100 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
NDC 82619-107-02 bottles of 1000 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The 5 mg tablets are pale pink, round shaped flat faced beveled edge uncoated tablets functionally scored on one side and debossed with '300' on other side. They are available as follows: NDC 82619-108-01 bottles of 30 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
NDC 82619-108-02 bottles of 100 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. NDC 82619-108-03 bottles of 1000 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The 10 mg tablets are pale pink, round shaped flat faced beveled edge uncoated tablets functionally scored on one side and debossed with '301' on other side.
They are available as follows: NDC 82619-109-01 bottles of 30 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. NDC 82619-109-02 bottles of 100 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. NDC 82619-109-03 bottles of 1000 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
The 20 mg tablets are pale pink, round shaped flat faced beveled edge uncoated tablets functionally scored on one side and debossed with '302' on other side. They are available as follows: NDC 82619-110-01 bottles of 30 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. NDC 82619-110-02 bottles of 100 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.] Protect from light. Manufactured by: V-Ensure Pharma Technologies Pvt. Ltd.
Raigad, Maharashtra-410206, India. Distributed by: Creekwood Pharmaceuticals LLC. Parsippany, NJ 07054 PA1050103 Revised: 12/2025
📋 Description ▾
DESCRIPTION Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula: C 21 H 23 ClFNO 2 375.87 Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose 102, hypromellose E3 Premium LV, sodium starch glycolate type A, colloidal silicon dioxide, and magnesium stearate.
In addition, the 1 mg and 2 mg tablets also contain D&C Yellow # 10 Aluminum Lake and 5 mg, 10 mg and 20 mg tablets also contain Lake Pigment HT 6027 D&C Red#27/Phloxine Aluminum Lake. Image