What it isD2 and 5-HT2A antagonist and active risperidone metabolite; schizophrenia and schizoaffective disorder.
Why it mattersIts long-acting injections offer the longest maintenance intervals available in psychiatry.
What it changesRenal clearance requires dose adjustment in CKD. Prolactin elevation, EPS, and QT prolongation can end treatment.
FDA-approved for
- schizophrenia (2006)
- schizoaffective disorder (2009)
FDA label
Read the full label on DailyMed ↗
BOXED WARNING Increased mortality in elderly patients with dementia-related psychosis; not approved for dementia-related psychosis.
| FDA dosing | Population | Start | Target | Max |
| Schizophrenia | Adults | 6 mg QD | 3–12 mg QD | 12 mg QD |
| Schizophrenia | Adolescents 12–17 yr | 3 mg QD | 3–12 mg QD (wt-dependent) | 6 mg (<51 kg) / 12 mg (≥51 kg) QD |
| Schizoaffective disorder | Adults | 6 mg QD | 3–12 mg QD | 12 mg QD |
Titration >5 days between increases (>4 days for schizoaffective); 3 mg/day increments
Renal Mild (CrCl 50–<80): start 3 mg QD, max 6 mg QD. Moderate–severe (CrCl 10–<50): 3 mg QOD or 1.5 mg QD, max 3 mg QD. CrCl <10: not recommended.
Hepatic Mild–moderate (Child-Pugh A/B): no adjustment. Severe: not studied.
Instructions
- Swallow tablet whole with liquid; do not chew, divide, or crush
- Take with or without food
Cautions
- Increased mortality/cerebrovascular reactions in elderly dementia patients
- Neuroleptic malignant syndrome
- QT prolongation — avoid with other QT-prolonging drugs
- Tardive dyskinesia
- Metabolic changes: hyperglycemia, dyslipidemia, weight gain
- Hyperprolactinemia
- Orthostatic hypotension and syncope
- Leukopenia, neutropenia, agranulocytosis
- Seizures
- GI narrowing/obstruction (non-deformable ER shell)
- Cognitive/motor impairment
Adverse reactions
- EPS, akathisia, tachycardia
- Somnolence
- Adolescents: tremor, dystonia, cogwheel rigidity, anxiety, weight increased
- Schizoaffective: dyspepsia, constipation, nasopharyngitis, weight increased
Pregnancy Third-trimester exposure risks neonatal EPS/withdrawal symptoms; no clearly established increased malformation risk.
Lactation Present in human milk; monitor infant for sedation, failure to thrive, jitteriness, EPS.
⚠ BOXED WARNING
- Increased mortality in elderly patients with dementia-related psychosis
Cost, est. cash$5–$150/month
Generic entry2015
Classes and tags
Clinical profile
Therapeutic safety burden2 / 4
Overdose danger2 / 4
Weight-gain liability2 / 4
Sedation liability2 / 4
QT / Torsades2 / 4
Direct muscarinic antagonism0 / 4
Embryofetal risk2 / 4
Legacy pregnancy categoryC
Defining liabilityMetabolic effects, extrapyramidal symptoms/tardive dyskinesia and agent-specific QT or orthostatic risk.
Mechanism of action: Paliperidone ballicule
Open Paliperidone in the interactive console ↗
Memory aids: mascots and interaction avatars
“Pale lips In Vegas”
Spooky mascot → antipsychotic
Variation of risperidone Frankenstein mascot → paliperidone is active metabolite
Box: minimal PK interactions
Open Paliperidone in the interactive console ↗