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)
Insomnia19.02.01.002; 17.15.03.0020.030210%
Judgement impaired19.05.01.009; 17.03.03.0050.001398%Not Available
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.010179%
Libido increased21.03.02.007; 19.08.03.0020.000666%
Listless19.04.04.003; 08.01.01.0120.000666%Not Available
Logorrhoea19.19.02.001; 17.02.08.0060.001620%Not Available
Mastication disorder15.03.05.022; 17.05.03.006; 07.01.06.0160.000666%Not Available
Memory impairment19.20.01.003; 17.03.02.0030.008924%
Mental impairment17.03.03.002; 19.21.02.0030.001032%Not Available
Middle insomnia17.15.03.003; 19.02.01.0030.004038%Not Available
Movement disorder17.01.02.0100.002417%Not Available
Muscle rigidity17.05.02.005; 15.05.04.0010.001281%Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.009734%
Nervousness19.06.02.0030.004769%Not Available
Nightmare19.02.03.0030.015157%Not Available
Nocturia20.02.03.0010.000353%Not Available
Nonspecific reaction08.01.03.0400.024591%Not Available
Obsessive-compulsive disorder19.06.05.0020.001176%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.017208%
Oesophageal pain07.01.05.0120.000444%
Oral discomfort07.05.05.0010.000889%Not Available
Orthostatic hypotension24.06.03.004; 17.05.01.0200.016699%Not Available
Panic attack19.06.04.0010.002705%Not Available
Paranoia19.05.01.0050.009748%Not Available
Parkinsonism17.01.05.0030.000771%Not Available
Personality change19.05.01.006; 17.02.05.0190.003240%
Personality disorder19.05.02.0020.000444%Not Available
Photopsia06.02.06.004; 17.17.01.0060.000131%
Posture abnormal15.03.05.029; 17.02.05.0330.004547%Not Available
Productive cough22.02.03.0050.001816%
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