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Pimavanserin

Pimavans · ATC code N05AX17

Key facts
Active substance
Pimavanserin
Drug class
Antipsychotics
ATC code
N05AX17
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Boxed warning

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia who experience psychosis unless their hallucinations and delusions are related to Parkinson's disease [see Warnings and Precautions (5.1)].

Key facts

Pimavanserin is an antipsychotic acting as an inverse agonist and antagonist at serotonin 5-HT2A receptors. Per the US prescribing information (NUPLAZID), it is used for hallucinations and delusions associated with Parkinson's disease psychosis.

What it is used for

  • Hallucinations and delusions associated with Parkinson's disease psychosis

Dosing

  • 34 mg orally once daily without titration, with or without food
  • Swallow capsules whole or open them and sprinkle onto a tablespoon (15 mL) of applesauce, yogurt, pudding or liquid nutritional supplement; consume immediately without chewing
  • With strong CYP3A4 inhibitors: 10 mg once daily; avoid strong or moderate CYP3A4 inducers
  • Severe renal impairment and end stage renal disease: use caution

Contraindications

  • History of hypersensitivity reaction to pimavanserin or any component (including rash, urticaria, angioedema)

Important warnings

  • Boxed warning: increased mortality in elderly patients with dementia-related psychosis; not approved for dementia with psychosis unless the symptoms are related to Parkinson's disease
  • In trials, death rates of about 4.5% vs 2.6% with placebo, mostly cardiovascular or infectious
  • QT prolongation; avoid with known QT prolongation, history of arrhythmias, bradycardia, hypokalemia or hypomagnesemia

Side effects

  • Peripheral edema 7%, nausea 7%, confusional state 6%, hallucination 5%, constipation 4%, gait disturbance 2%

Interactions

  • QT-prolonging drugs (e.g. class 1A and 3 antiarrhythmics, certain antipsychotics and antibiotics): avoid
  • Strong CYP3A4 inhibitors: increased exposure, reduce the dose
  • Strong or moderate CYP3A4 inducers: reduced efficacy, avoid

Pregnancy and breastfeeding

  • No data in pregnant women to assess the drug-associated risk
  • No information on presence in human milk

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

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Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Turkey

  • PimavansHUMANİS SAĞLIK A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • NuplazidAcadia Pharmaceuticals Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. NUPLAZID (Acadia Pharmaceuticals Inc.) – Prescribing Information, 2026-06-18. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1e6bea44-57d6-4bac-9328-46e1ee59f83b
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  4. Wikidata (CC0): ATC N05AX.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.