Risperidone

Risperdal treats schizophrenia in adults and adolescents 13–17 years; acute manic or mixed bipolar I episodes as monotherapy in adults and ages 10–17, and adjunctive to lithium/valproate in adults. It treats irritability associated with autistic disorder, including aggression, self-injury, tantrums and rapidly changing moods. Section 1.3 cites trials ages 5–17; section 8.4 distinguishes the original ages 5–16 trials and an additional 5–17 study. This is not treatment of all autism symptoms or an inferred use below age 5.

Consta and Rykindo have schizophrenia and bipolar I maintenance indications; bipolar maintenance can be monotherapy or adjunctive to lithium/valproate. Uzedy currently includes adult schizophrenia and adult bipolar I maintenance, but bipolar dosing is monthly only. Injectable pediatric efficacy/safety is unestablished. Perseris had adult schizophrenia labeling; Indivior discontinued availability May 31, 2026. Retained labeling does not prove current supply or approval withdrawal.

Severe adult renal impairment (CrCl <30 mL/min) or hepatic impairment (Child-Pugh 10–15 points): start 0.5 mg twice daily; increase in increments ≤0.5 mg twice daily. Above 1.5 mg twice daily, steps ≥1 week apart. Lower/slower dosing may be needed in older or hypotension-prone patients and other renal/liver disease. Food is optional. Solution 1 mg/mL: use supplied calibrated syringe; compatible with water, coffee, orange juice and low-fat milk, not cola or tea. M-Tab: dry hands, peel blister, use whole immediately on tongue, swallow with/without liquid; do not split or chew. After an interval off oral therapy, follow initial titration; no universal catch-up dose supplied.

Retained label: oral 3 mg/day →90 mg monthly or 4 mg/day →120 mg monthly, day after last oral dose; no loading or oral supplement. Stable oral doses below 3 or above 4 mg/day may not be candidates. Healthcare professional injects abdomen or back of upper arm SC, not IM. Renal/hepatic impairment requires oral titration to ≥3 mg/day, then 90 mg monthly if tolerated. Availability discontinued; arrange prescriber transition, not a patient-led substitution.

Uzedy and historical Perseris: give next missed injection as soon as possible, never more frequently than recommended. Consta restart requires oral supplementation; Rykindo restart after interruption uses prior established dose only if medical condition unchanged and requires oral supplementation. Exact lapse duration, oral tolerance and interacting medicines require prescriber/product-label review; no invented universal restart or overlap interval.

Known hypersensitivity to risperidone, its active metabolite paliperidone, or exact formulation components; anaphylaxis and angioedema have been reported. The dementia warning is a boxed risk and unapproved indication, not a fabricated additional formal contraindication.

Selected oral and injectable products box increased mortality in elderly patients with dementia-related psychosis. These products are not approved for that use; oral pediatric or adult schizophrenia approval does not remove this warning.

Reported effects include sedation, dizziness, parkinsonism, akathisia, dystonia, tremor, GI symptoms, increased appetite/weight and fatigue; injection-site pain or, with Uzedy, itching/nodules may occur. Serious postmarketing reports include severe skin reactions, QT prolongation and allergic reactions; frequencies are uncertain and products/trials cannot be directly compared. Overdose can cause severe sedation, hypotension, tachycardia, EPS, seizures or arrhythmia. Seek emergency/Poison Help (1-800-222-1222); no specific antidote, clinical airway/cardiac monitoring and supportive care.

Fluoxetine/paroxetine increase exposure: reduce dose, titrate slowly, adult oral dose must not exceed 8 mg/day with these agents. Carbamazepine and other inducers may require up to double usual oral dose; reassess/reduce after withdrawal. These instructions remain subject to indication/population limits and do not authorize unstudied pediatric doses.

Consta/Rykindo: inhibitor/inducer changes may need advance adjustment 2–4 weeks before planned change and monitoring during initiation; consult exact section 2/7. Rykindo patients requiring 12.5 mg need another IM formulation or interruption, not split/combine its kit. Uzedy: lower dose before strong CYP2D6 inhibitor if needed; at 50 mg monthly or 100 mg every 2 months continue unless interruption warranted. Strong CYP3A4 inducer initiation: monitor first 4–8 weeks, consider dose/oral supplement; reassess after withdrawal. These lowest-dose statements do not authorize every-2-month bipolar treatment. Historical Perseris inhibitor rule lowers to 90 mg monthly 2–4 weeks before; inducer may require 120 mg and/or oral supplement, then reassess on withdrawal.

CNS depressants/alcohol add impairment; BP-lowering drugs can increase hypotension. Risperidone may oppose levodopa/dopamine agonists. Methylphenidate dose changes can trigger EPS; monitor. Clozapine may decrease clearance. Reviewed studies without required lithium/valproate PK adjustment do not eliminate their independent toxicity or monitoring requirements.

Oral renal/liver disease may require reduced dosing; severe thresholds and injectable oral-titration prerequisites appear above. LAI trials generally did not study renal/hepatic impairment; recommendations rely on oral data, not a claim of proved dialysis safety or interchangeable dose reductions.

Oral schizophrenia below 13 and mania below 10 unestablished; autism data below 5 or weight <15 kg do not supply dosing. LAIs lack established pediatric efficacy/safety. Pediatric somnolence, weight/prolactin changes and incomplete long-term growth/sexual-maturation evidence merit review. Older adults require cautious dose selection and renal/fall assessment; dementia-related use remains unapproved.

Balance treatment against untreated psychiatric disease; registry available. Third-trimester exposure may cause neonatal EPS/withdrawal, respiratory or feeding problems requiring observation. Human data have not established overall drug-associated birth-defect risk, but limitations remain. Risperidone/metabolite enter milk; assess feeding benefits/risks and monitor infant sedation, poor growth, jitteriness or abnormal movements. Depot exposure persists after injection and is product-specific. Hyperprolactinemia may reversibly reduce female fertility. Historical Perseris delivery-system animal developmental toxicity is a formulation-specific consideration, not proved human teratogenicity.

Therapeutic mechanism is incompletely understood; dopamine D2 and serotonin 5-HT2 antagonism likely contributes. Active metabolite 9-hydroxyrisperidone is paliperidone; their combined exposure matters. Alpha-adrenergic and other receptor effects contribute to adverse effects.

Oral bioavailability about 70%; peak parent about 1 hour. M-Tab/solution are bioequivalent to reviewed tablets; food does not affect absorption. CYP2D6 converts parent to active metabolite; active-moiety mean elimination half-life about 20 hours, despite differing parent half-life by metabolizer phenotype. Renal elimination of parent/metabolites is substantial; these values do not describe depot duration.

Consta has a main-release lag of about 3 weeks; Rykindo has earlier initial release and stable phase about weeks 2–4. Different SC delivery systems have distinct release/PK and no routine oral overlap. Route, salt/ingredient similarities or equal nominal mg do not establish unsupervised interchangeability.

Reassess psychiatric response and continued need; monitor weight/growth, glucose (baseline/periodic in at-risk patients), lipids, movement effects, prolactin symptoms, orthostatic vitals and falls. CBC monitoring is targeted to relevant history; assess infection urgently. Review kidney/liver function and all medicines before depot selection or CYP changes. No arbitrary universal test interval or movement-scale schedule asserted.

Avoid alcohol, overheating and driving until effects known. Rise slowly; report thirst/polyuria, involuntary movements, breast/menstrual/sexual effects, severe rash or infection. Use measured solution and immediate intact M-Tab instructions. Tell pregnancy/feeding clinicians about last depot date; do not stop or switch independently. Call for a missed injection and for transition after Perseris discontinuation.

Tablet

1 mg, white capsule-shaped; JANSSEN and R1 imprints.

Package

NDC 50458-300-06 · bottle of 60 in selected label.

Status

Prescription oral antipsychotic; no dementia-related psychosis approval.

Oral

Tablets and M-Tab: 0.5, 1, 2, 3, 4 mg. Solution: 1 mg/mL. Generic appearances differ.

IM

Consta kits: 12.5, 25, 37.5, 50 mg. Rykindo kits: 25, 37.5, 50 mg; no 12.5 mg kit.

SC

Uzedy: 50, 75, 100, 125, 150, 200, 250 mg single-dose syringes; dose interval depends on indication. Historical Perseris: 90 or 120 mg kits.

• Risperdal tablets/solution/M-Tab: 15–25°C. Protect tablets from light/moisture; solution from light/freezing. Keep M-Tab in blister until ready.
• Consta/Rykindo: refrigerate 2–8°C, protect light; no more than 7 days ≤25°C outside refrigeration. Use product-specific reconstitution/needle IFU; no kit substitution or combining dose strengths.
• Uzedy: refrigerate 2–8°C original light-protective carton. Unopened original package may be at 20–25°C up to 90 days and returned to refrigeration within that window. Open carton: administer or discard. Allow ≥30 minutes room temperature; follow exact flick/air-bubble/needle IFU.
• Historical Perseris: refrigerate 2–8°C; unopened room temperature 20–25°C ≤30 days after removal then use/discard; allow ≥15 minutes before mixing. Availability is discontinued; this is identification/handling of retained labeling, not current supply guidance.