Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pimavanserin
Drug ID BADD_D02451
Description Psychotic symptoms associated with Parkinson's disease (PD) are relatively common, reducing quality of life and prognosis for individuals with PD.[A232783] Pimavanserin (ACP-103), marketed under the trade name Nuplazid, is a drug developed by Acadia Pharmaceuticals for the treatment of psychosis related to Parkinson's disease. Due to its actions at serotonin receptors and lack of effects on dopamine receptors, pimavanserin treats hallucinations and delusions without causing extrapyramidal symptoms.[A232613] It was initially approved by the FDA in 2016 and is now under review as a potential treatment for dementia related psychosis. As of April 2021, FDA approval has not been granted for this indication, despite previous breakthrough designation.[L32913]
Indications and Usage Pimavanserin is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.[L32883]
Marketing Status approved; investigational
ATC Code N05AX17
DrugBank ID DB05316
KEGG ID D08969
MeSH ID C510793
PubChem ID 10071196
TTD Drug ID D0J8JP
NDC Product Code Not Available
UNII JZ963P0DIK
Synonyms pimavanserin | N-(4-fluorophenylmethyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phenylmethyl)carbamide | ACP 103 | ACP103 | ACP-103 | Nuplazid | pimavanserin tartrate | urea, n-((4-fluorophenyl)methyl)-n-(1-methyl-4-piperidinyl)-n'-((4-(2-methylpropoxy)phenyl)methyl)-, (2R,3R)-2,3-dihydroxybutanedioate (2:1) | bis(1-(4-fluorobenzyl)-1-(1-methylpiperidin-4-yl)-3-(4-(2-methylpropoxy)benzyl)urea) (2R,3R)-2,3-dihydroxybutanedioate
Chemical Information
Molecular Formula C25H34FN3O2
CAS Registry Number 706779-91-1
SMILES CC(C)COC1=CC=C(C=C1)CNC(=O)N(CC2=CC=C(C=C2)F)C3CCN(CC3)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abnormal dreams19.02.03.001; 17.15.02.0010.008741%Not Available
Aggression19.05.01.0010.029073%Not Available
Agitation19.06.02.001; 17.02.05.0120.019796%
Amnesia19.20.01.001; 17.03.02.0010.004991%
Anger19.04.02.0010.006389%Not Available
Aortic aneurysm24.02.03.0010.000131%Not Available
Aphasia19.21.01.001; 17.02.03.0010.002587%
Aspiration22.02.07.0070.000392%
Asthenia08.01.01.0010.023624%Not Available
Belligerence19.05.01.0150.000862%Not Available
Blindness transient06.02.10.006; 17.17.01.0040.000131%Not Available
Blood pressure fluctuation24.06.01.0020.000954%Not Available
Bradykinesia17.01.02.0040.000353%Not Available
Catatonia19.11.01.0010.001751%Not Available
Choking22.12.03.0030.000392%Not Available
Circadian rhythm sleep disorder19.02.06.002; 17.15.06.0020.000353%Not Available
Clumsiness17.01.02.0050.000510%Not Available
Condition aggravated08.01.03.0040.032483%Not Available
Confusional state17.02.03.005; 19.13.01.0010.101513%
Constipation07.02.02.0010.020749%
Coordination abnormal17.02.02.0040.002287%Not Available
Crying19.04.02.002; 17.02.05.013; 12.02.11.001; 08.01.03.0050.003593%Not Available
Death08.04.01.0010.137119%
Decreased activity19.11.01.002; 08.01.01.0060.000666%Not Available
Decubitus ulcer23.03.11.0060.000836%Not Available
Delusion19.10.01.0010.056578%
Dementia17.03.01.001; 19.20.02.0010.015157%Not Available
Dementia Alzheimer's type19.20.03.001; 17.03.06.0010.000614%Not Available
Derealisation19.10.05.0040.001686%Not Available
Diet refusal14.03.01.0110.000261%Not Available
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