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)
Obstructive airways disorder22.03.01.0110.000131%Not Available
Psychotic disorder19.03.01.0020.016333%
Metabolic encephalopathy17.13.01.001; 14.11.01.0130.000196%Not Available
Poor quality sleep19.02.05.005; 17.15.04.0020.003881%Not Available
Muscle contracture15.03.05.0240.000444%Not Available
Increased upper airway secretion22.12.03.0070.000666%Not Available
Bowel movement irregularity07.02.03.0030.000353%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.001868%Not Available
Hypersexuality19.08.03.0050.000444%Not Available
Adverse reaction08.06.01.0180.000797%Not Available
Dementia with Lewy bodies19.20.02.003; 17.03.01.0040.003149%Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.0080.000510%Not Available
Terminal insomnia19.02.01.004; 17.15.03.0040.000510%Not Available
Upper-airway cough syndrome22.12.03.0360.000287%
Slow speech19.19.02.004; 17.02.08.0160.000353%Not Available
Glassy eyes06.08.03.021; 08.01.03.0550.000510%Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.002130%
Abnormal loss of weight14.03.02.0190.000287%Not Available
Cardiac failure chronic02.05.01.0090.000131%Not Available
Progressive supranuclear palsy17.03.01.0020.000131%Not Available
Soliloquy19.05.01.0210.000954%Not Available
Trance19.01.02.0180.000353%Not Available
Terminal state08.01.03.0790.001764%Not Available
Consciousness fluctuating17.02.04.0190.000131%Not Available
Communication disorder19.19.01.0080.001333%Not Available
Multiple system atrophy24.06.03.013; 17.02.10.0230.000131%Not Available
Disorganised speech17.02.08.017; 19.19.02.0050.000510%Not Available
Fine motor skill dysfunction17.01.02.0200.000444%Not Available
Increased viscosity of upper respiratory secretion22.12.03.0080.000444%Not Available
Defiant behaviour19.05.01.0170.000353%Not Available
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