Haldol (Haloperidol Krka) 2 mg and 10 mg tablets and 5 mg/mL injection – haloperidol for schizophrenia, mania, delirium and tics

Haldol is the former name of the Krka antipsychotic which in Serbia is now marketed as Haloperidol Krka (name change decisions of December 2022). The active substance is haloperidol, a butyrophenone antipsychotic used for illnesses affecting the way a person thinks, feels and behaves.

The medicine is available as 2 mg and 10 mg tablets (for adults, adolescents and children from 6 years, depending on the indication) and as a 5 mg/mL solution for injection (adults only, given in a healthcare institution). The long-acting injection given once every 4 weeks is described on the separate Haldol Depot (Haloperidol Krka depo) page.

What is Haldol (Haloperidol Krka) used for and how is it used correctly?

Key facts about the medicine

Name of the medicine	Haloperidol Krka (formerly Haldol®), 2 mg and 10 mg, tablets; Haloperidol Krka, 5 mg/mL, solution for injection
Active substance	haloperidol
Strength	tablet 2 mg or 10 mg; solution for injection 5 mg haloperidol in 1 mL (1 ampoule)
Pharmaceutical form	tablet (round, light yellow, scored – can be divided into equal doses); solution for injection (clear, colourless) for intramuscular use
Therapeutic group	psycholeptics – antipsychotics, butyrophenone derivatives (ATC N05AD01)
Pack	2 mg tablets: glass bottle of 25 tablets; 10 mg tablets: glass bottle of 30 tablets; injection: 10 ampoules of 1 mL (2 blisters of 5)
Marketing authorisation holder / manufacturer	marketing authorisation holder Krka-Farma d.o.o. Belgrade; manufacturer Krka d.d., Novo mesto, Slovenia
ALIMS authorisation number	2 mg tablets: 515-01-04971-22-001; 10 mg tablets: 515-01-04972-22-001; injection: 515-01-04973-22-001 – all dated 09.11.2023
Supply status in Serbia	tablets: R – prescription-only; injection: Z – for use in healthcare institutions

What is Haldol (Haloperidol Krka) used for?

Tablets – adults (18 years and over):

• schizophrenia and schizoaffective disorder;
• acute delirium when non-drug measures have failed;
• moderate to severe manic episodes in bipolar I disorder;
• acute psychomotor agitation associated with psychotic disorder or manic episodes;
• persistent aggression and psychotic symptoms in moderate to severe Alzheimer's and vascular dementia, when non-drug treatments have failed and there is a risk of harm to self or others;
• severe tic disorders, including Tourette's syndrome, when other treatments have failed;
• mild to moderate chorea in Huntington's disease, when other medicines are ineffective or not tolerated.

Tablets – children and adolescents: schizophrenia in adolescents aged 13 to 17; persistent severe aggression in children and adolescents aged 6 to 17 with autism or pervasive developmental disorders; severe tic disorders (including Tourette's syndrome) aged 10 to 17 – always when other treatments have failed.Solution for injection – adults only: rapid control of severe acute psychomotor agitation when oral treatment is not possible, acute delirium, Huntington's chorea when oral treatment is not possible, and prevention and treatment of postoperative nausea and vomiting when other medicines are ineffective.

How is it used and dosed?

The dose is always determined by the doctor – usually starting low and adjusted to the response. It depends on age, the condition treated, kidney and liver function and other medicines.

• Tablets – adults: usually 0.5 to 10 mg a day; the maximum dose, depending on the condition, is 5 mg to 20 mg a day.
• Tablets – elderly: usually start with 0.5 mg a day or half the lowest adult dose; maximum 5 mg a day unless the doctor decides otherwise.
• Tablets – children and adolescents aged 6 to 17: usually 0.5 to 3 mg a day; adolescents with schizophrenia or behavioural problems may take up to 5 mg a day.
• How to take the tablets: swallow with a little water; the tablet can be divided into equal doses.
• Injection – adults: given into a muscle by a doctor or nurse; starting dose usually 1–5 mg, additional doses usually 1 to 4 hours apart, no more than 20 mg a day in total (no more than 10 mg a day for delirium and chorea). Elderly: half the lowest adult dose, maximum 5 mg a day.

It may take some time before the full effect is felt. The doctor may request an ECG and blood potassium and magnesium tests before and during treatment.

Special patient groups

• Children under 6 years: the tablets are not intended for this age group; the injection is not intended for under-18s.
• Elderly patients and patients with dementia: lower doses; in elderly people with dementia a small increase in deaths and stroke has been reported with antipsychotics.
• Liver impairment: haloperidol is extensively metabolised in the liver – halving the starting dose is advised (SmPC).
• Kidney impairment: caution; in severe impairment a lower starting dose may be needed.

Contraindications – when the medicine must not be used

Do not take/receive Haldol (Haloperidol Krka):

• if you are allergic to haloperidol or any of the excipients;
• if you are less aware of your surroundings or your reactions become unusually slow;
• if you have Parkinson's disease, dementia with Lewy bodies or progressive supranuclear palsy;
• if you have a prolonged QT interval or another heart rhythm problem, heart failure or a recent heart attack;
• if you have untreated low blood potassium;
• if you take medicines for irregular heart rhythm (amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine, sotalol), depression (citalopram, escitalopram), psychoses (e.g. fluphenazine, levomepromazine, perphenazine, pimozide, prochlorperazine, promazine, sertindole, thioridazine, trifluoperazine, triflupromazine, ziprasidone), bacterial infections (azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, telithromycin), fungal infections (pentamidine), malaria (halofantrine), nausea (dolasetron) or cancer (toremifene, vandetanib).

Warnings and precautions

Talk to your doctor before use if:

• you have a slow heart rate, heart disease or a close relative died suddenly of heart problems;
• you have low blood pressure or feel dizzy on sitting up or standing;
• you have low potassium, magnesium or other electrolytes in your blood;
• you have had bleeding in the brain or have an increased risk of stroke;
• you have epilepsy or have had convulsions;
• you have kidney, liver or thyroid problems;
• you have high prolactin or a cancer that may be prolactin-dependent (e.g. breast cancer);
• you or a family member have had blood clots;
• you have depression, or bipolar disorder and start feeling depressed.

The medicine contains lactose and sucrose (2 mg tablets) – if you have an intolerance to some sugars, consult your doctor.

Interactions with other medicines, food and drink

Tell your doctor about all medicines you take. In addition to the contraindicated medicines listed above:

• lithium: additional monitoring is needed – contact your doctor immediately and stop both medicines if unexplained fever, uncontrollable movements, confusion, disorientation, headache, balance problems and drowsiness occur;
• medicines that alter the effect of haloperidol and increase the cardiac risk: alprazolam, buspirone, duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, venlafaxine, St John's wort, bupropion, carbamazepine, phenobarbital, phenytoin, rifampicin, itraconazole, posaconazole, voriconazole, ketoconazole tablets, indinavir, ritonavir, saquinavir, chlorpromazine, promethazine, verapamil, blood pressure medicines and diuretics;
• medicines whose effect haloperidol alters: tranquillisers and sleeping medicines, strong painkillers, tricyclic antidepressants, guanethidine and methyldopa, adrenaline, stimulants (ADHD, narcolepsy), levodopa, phenindione.

Alcohol: may increase drowsiness and reduce alertness – discuss alcohol intake with your doctor.

Pregnancy and breast-feeding

• Pregnancy: consult your doctor – you may be advised not to use the medicine. Newborns of mothers who took it in the last trimester may show trembling, stiffness or weakness of muscles, sleepiness or agitation and breathing or feeding problems.
• Breast-feeding: small amounts pass into breast milk; the doctor weighs the benefits and risks.
• Fertility: haloperidol may raise prolactin, which can affect fertility in men and women.

Driving and using machines

According to the leaflet, Haloperidol Krka has a strong effect on psychophysical abilities – driving a motor vehicle or working with machines is not permitted during treatment.

Possible side effects

Like all medicines, haloperidol can cause side effects, although not everybody gets them.

• Serious – see a doctor immediately: heart rhythm disorders, fast heartbeat, palpitations (uncommon; sudden deaths have also been reported); neuroleptic malignant syndrome (rare); extrapyramidal disorders – tardive dyskinesia, restlessness, slowed movements, tremor, stiffness, mask-like face (very common); severe allergic reaction (uncommon); blood clots in the leg veins.
• Very common (more than 1 in 10): agitation, sleeping problems, headache.
• Common (up to 1 in 10): delusions or hallucinations, depression, abnormal muscle tension, dizziness, orthostatic hypotension, sleepiness, uncontrolled eye movements, blurred vision, low blood pressure, nausea, vomiting, constipation, dry mouth or increased saliva, rash, difficulty urinating, impotence, weight change, abnormal liver tests.
• Uncommon (up to 1 in 100): reduced blood cell counts, confusion, reduced sex drive, convulsions, muscle stiffness and spasms (including the neck), walking problems, shortness of breath, jaundice, photosensitivity, itching, sweating, menstrual disorders, milk secretion, breast pain, fever, swelling.
• Rare and not known: raised prolactin, narrowing of the airways, difficulty opening the mouth, sexual dysfunction, SIADH, low blood sugar, swelling of the larynx, acute liver failure, cholestasis, skin peeling, vasculitis, rhabdomyolysis, priapism, breast enlargement in men, low body temperature.

Overdose, missed dose and stopping treatment

• Overdose (tablets): if you have taken more tablets or someone else has taken them, contact a doctor or the nearest healthcare facility immediately.
• Missed dose (tablets): take the next dose at the usual time; do not take a double dose.
• Injection: given by a healthcare professional, so a missed dose or overdose is unlikely.
• Stopping treatment: treatment is withdrawn gradually unless the doctor decides otherwise; stopping suddenly can cause nausea, vomiting and sleeping problems.

Related information

For questions about dosing, ECG and electrolyte checks and combining with other medicines, contact the psychiatrist who prescribed the treatment or your pharmacist. The long-acting injection given once every 4 weeks is described on the Haldol Depot page.

Composition, pack and manufacturer

• 2 mg tablets: haloperidol 2 mg; excipients lactose monohydrate; sucrose; maize starch; talc (E553b); hydrogenated vegetable oil; Quinoline Yellow (E104).
• 10 mg tablets: haloperidol 10 mg; excipients calcium hydrogen phosphate dihydrate; maize starch; magnesium stearate; Quinoline Yellow (E104).
• Solution for injection: haloperidol 5 mg in 1 mL; excipients lactic acid and water for injections; amber glass ampoules.
• Marketing authorisation holder: Krka-Farma d.o.o. Belgrade, Jurija Gagarina 26/V/II, Belgrade. Manufacturer: Krka d.d., Novo mesto, Šmarješka cesta 6, Slovenia.

Storage

• Tablets: store below 25 °C.
• Solution for injection: store below 25 °C in the original package to protect from light.
• Keep out of the sight and reach of children; return unused medicine to a pharmacy that collects it.

Frequently asked questions

Is Haldol the same as Haloperidol Krka?

Yes. Krka's Haldol 10 mg tablets and 5 mg/mL solution for injection were renamed Haloperidol Krka in December 2022; the active substance and manufacturer are the same, and the authorisations were renewed on 09.11.2023.

Can I drive while taking haloperidol?

No. According to the leaflet, the medicine strongly affects psychophysical abilities, and driving or working with machines is not permitted during treatment.

Why does the doctor ask for an ECG before and during treatment?

Haloperidol can prolong the QT interval and cause heart rhythm disorders. An ECG and checks of potassium and magnesium help detect the risk in time.

What if involuntary movements or stiffness appear?

Extrapyramidal disorders are very common. Tell your doctor – you may need additional treatment or a dose change. Do not stop the medicine suddenly on your own.

Sources

• ALIMS – Summary of Product Characteristics, Haloperidol Krka 2 mg and 10 mg tablets (SmPC, Serbian)
• ALIMS – Patient leaflet, Haloperidol Krka 2 mg and 10 mg tablets (PIL, November 2023, Serbian)
• ALIMS – Summary of Product Characteristics, Haloperidol Krka 5 mg/mL solution for injection (SmPC, Serbian)
• ALIMS – Patient leaflet, Haloperidol Krka 5 mg/mL solution for injection (PIL, November 2023, Serbian)

Sources checked on: 25 October 2026.