Atypical (Second-generation) Antipsychotic — Dopamine D3/D2 Partial Agonist Pregnancy: Not recommended during pregnancy or in women of childbearing potential not using effective contraception. Women of childbearing potential must be advised to avoid pregnancy while on cariprazine and must use effective contraception during treatment and for at least 10 weeks following the last dose, because of slow elimination of the active moieties. There are no or limited data in pregnant women; animal studies have shown reproductive toxicity including developmental malformations in rats. Neonates exposed to antipsychotics during the third trimester are at risk of extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress or feeding disorder), which in some cases have required intensive care support and prolonged hospitalisation — newborns should be monitored carefully. Breast-feeding should be discontinued during treatment. Fertility: effect on human fertility not evaluated; lower female fertility and conception indices were seen in rat studies.

Cariprazine

Brand names: Reagila

Cariprazine is a second-generation antipsychotic used for the treatment of schizophrenia.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Recommended starting dose 1.5 mg once daily; thereafter the dose can be increased slowly in 1.5 mg increments to a maximum of 6 mg/day if needed

Route: Oral

Frequency: Once daily, at the same time each day, with or without food

Max: 6 mg/day

Source: UK SPC (eMC) for Reagila 1.5 mg hard capsules, §4.2 (https://www.medicines.org.uk/emc/product/9401/smpc). The lowest effective dose should be maintained according to the clinical judgement of the treating physician. LONG HALF-LIFE: because of the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks — patients should be monitored for adverse reactions and treatment response for several weeks after starting cariprazine and after each dose change. SWITCHING: when switching from another antipsychotic to cariprazine, gradual cross-titration should be considered, with gradual discontinuation of the previous treatment while cariprazine is initiated. When switching from cariprazine to another antipsychotic, no gradual cross-titration is needed — the new antipsychotic should be started at its lowest dose while cariprazine is discontinued, bearing in mind that plasma concentrations of cariprazine and its active metabolites decline by 50% in approximately 1 week. MISSED DOSE: take the missed dose as soon as possible; if it is almost time for the next dose, skip the missed dose and take the next dose on schedule — do not take a double dose. ALCOHOL should be avoided when taking cariprazine. ELDERLY: available data in patients aged 65 years and over are not sufficient to determine whether they respond differently from younger patients; dose selection should be more cautious. HEPATIC IMPAIRMENT: no dose adjustment in mild to moderate impairment (Child-Pugh score 5–9); not evaluated and NOT recommended in severe impairment (Child-Pugh score 10–15). PAEDIATRIC: safety and efficacy in children and adolescents aged less than 18 years have not been established and no data are available — no paediatric dose is stated in the UK SPC and none should be inferred; verify any under-18 use against a children's formulary. (For reference only, and NOT a UK-licensed regimen, the US label gives a 0.5 mg once-daily starting dose for patients aged 13–17 years in schizophrenia and 10–17 years in bipolar mania, with a maximum of 4.5 mg once daily.) §4.4 and §4.8 were truncated at the source-fetch limit and §4.5 was not retrieved in this bundle — verify the complete interactions section (interactions listed below are from §4.3 of the UK SPC and the US label's drug-interaction table, as marked).

Dose adjustments

Renal

No dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance >= 30 mL/min and < 89 mL/min). Safety and efficacy have not been evaluated in severe renal impairment (CrCl < 30 mL/min) and use is NOT recommended in these patients.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Concomitant administration of strong CYP3A4 inhibitors
Concomitant administration of strong or moderate CYP3A4 inducers

Side effects

Very common: akathisia (19%) and parkinsonism (17.5%) — most events mild to moderate in severity
Common: sedation, dizziness, dystonia, other extrapyramidal and abnormal movement disorders, sleep disorders (insomnia, abnormal dreams/nightmares, hypersomnia and others), anxiety, restlessness
Common: dyslipidaemia, weight increased, decreased or increased appetite, vomiting, nausea, constipation, hepatic enzymes increased, blood creatine phosphokinase increased, fatigue
Common: hypertension, tachyarrhythmia, vision blurred; uncommon — hypotension, bradyarrhythmia, ECG QT prolonged, cardiac conduction disorders, cataract, intraocular pressure increased
Uncommon: tardive dyskinesia, dyskinesia, seizures/convulsion, suicidal behaviour, depression, delirium, diabetes mellitus, blood glucose increased, hypothyroidism, anaemia, eosinophilia; rare — neutropenia, neuroleptic malignant syndrome, rhabdomyolysis, toxic hepatitis, neonatal drug withdrawal syndrome

Interactions

Strong CYP3A4 inhibitors — concomitant administration is CONTRAINDICATED in the UK SPC (§4.3). The US label instead advises reducing the dose with strong or moderate CYP3A4 inhibitors, as concomitant use increases exposure to cariprazine and its major active metabolite didesmethylcariprazine (DDCAR)
Strong or moderate CYP3A4 inducers — concomitant administration is CONTRAINDICATED in the UK SPC (§4.3); the US label states concomitant use of a CYP3A4 inducer is not recommended, as CYP3A4 is responsible for the formation and elimination of the active metabolites and the net effect is unclear
Alcohol should be avoided when taking cariprazine (UK SPC §4.2, cross-referring to §4.5)

Clinical monograph

How it works

It is a partial agonist at dopamine D3 and D2 receptors and at serotonin 5-HT1A receptors, with antagonism at 5-HT2B and 5-HT2A receptors.

Prescribing in practice

Owing to its long-acting active metabolites, effects and side effects can persist for weeks after stopping, so changes should be made gradually with monitoring.
Akathisia and extrapyramidal symptoms are common, and impulse-control disorders have been reported with dopamine partial agonists.
Avoid in dementia-related psychosis in the elderly and adjust for strong CYP3A4 interactions; avoid in severe hepatic or renal impairment.

Monitoring

Monitor for akathisia and extrapyramidal symptoms, weight, glucose, lipids and mental state.

Counselling the patient

Because the drug stays in the body for some time, side effects may appear or persist after a dose change.
Report restlessness, abnormal movements or new compulsive behaviours.
It may take several weeks to feel the full benefit.

Evidence & guidelines

Randomised controlled trials support cariprazine's efficacy in schizophrenia, including predominant negative symptoms.

Reference: NICE TA810 (Cariprazine for Schizophrenia); Reagila SPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways