Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Prucalopride
Drug ID BADD_D01874
Description Prucalopride is a dihydrobenzofurancarboxamide derivative from the benzofurane family that selectively stimulates 5-HT4 receptors and thus, it presents enterokinetic properties.[A37348] The high selectivity of prucalopride allowed further development as it prevented the cardiac adverse reactions observed due to non-target effects of precedent therapies.[A40254] Prucalopride was developed by Shire Development LLC and approved for use in Europe in 2009,[A40250] in Canada on December 7, 2011 and by the FDA on December 17, 2018.[L4880]
Indications and Usage Prucalopride is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.[L4882] CIC is one of the most common chronic functional gastrointestinal disorders worldwide. The diagnosis of this agent is very hard and it can be confirmed if the patient experience at least two of the following: -Straining during more than 25% of the bowel movements. -Lumpy or hard stools in 25% of the bowel movements. -Sensation of incomplete evacuation in more than 25% of all bowel movements. -Sensation of anorectal blockage or obstruction in more than 25% of the bowel movements. -Manual maneuvers required in more than 25% of the bowel movements. -Fewer than 3 bowel movements per week.[L4883]
Marketing Status approved
ATC Code A06AX05
DrugBank ID DB06480
KEGG ID D09205
MeSH ID C406662
PubChem ID 3052762
TTD Drug ID D04QSJ
NDC Product Code 54092-546; 54092-547
UNII 0A09IUW5TP
Synonyms prucalopride | 4-amino-5-chloro-N-(1-(3-methoxypropyl)-4-piperidinyl)-2,3-dihydro-1-benzofuran-7-carboxamide | motegrity | resotran | resotrans | R 093877 | R093877 | Resolor
Chemical Information
Molecular Formula C18H26ClN3O3
CAS Registry Number 179474-81-8
SMILES COCCCN1CCC(CC1)NC(=O)C2=CC(=C(C3=C2OCC3)N)Cl
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)
Abdominal discomfort07.01.06.0010.002239%Not Available
Abdominal distension07.01.04.0010.003732%
Abdominal pain07.01.05.0020.005971%
Abdominal pain upper07.01.05.003--
Abnormal faeces07.01.03.0010.001493%Not Available
Anxiety19.06.02.0020.002986%
Asthenia08.01.01.001--Not Available
Aura17.02.07.0110.001493%Not Available
Back pain15.03.04.005--
Body temperature increased13.15.01.001--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest discomfort22.12.02.002; 08.01.08.019; 02.02.02.009--Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.001712%Not Available
Colitis ischaemic24.04.08.012; 07.08.01.0040.000439%Not Available
Condition aggravated08.01.03.0040.001493%Not Available
Constipation07.02.02.0010.002239%
Crying19.04.02.002; 17.02.05.013; 12.02.11.001; 08.01.03.0050.001493%Not Available
Depression19.15.01.0010.008957%
Diarrhoea07.02.01.0010.011416%
Discomfort08.01.08.003--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.002678%
Drug ineffective08.06.01.0060.012909%Not Available
Dyspepsia07.01.02.001--
Dysphagia07.01.06.0030.004698%
Dyspnoea02.11.05.003; 22.02.01.004--
Face oedema10.01.05.002; 08.01.07.003; 23.04.01.0040.001493%
Faeces hard07.01.03.0030.001493%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.004479%Not Available
Flatulence07.01.04.0020.002239%
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