Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Darifenacin
Drug ID BADD_D00584
Description Darifenacin (Enablex®, Novartis) is a medication used to treat urinary incontinence. Darifenacin blocks M3 muscarinic acetylcholine receptors, which mediate bladder muscle contractions. This block reduces the urgency to urinate and so it should not be used in people with urinary retention. It is unknown if M3 receptor selectivity is clinically advantageous in overactive bladder syndrome treatments.
Indications and Usage For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
Marketing Status approved; investigational
ATC Code G04BD10
DrugBank ID DB00496
KEGG ID D03654
MeSH ID C101207
PubChem ID 444031
TTD Drug ID D0Y5AM
NDC Product Code 46708-223; 13668-202; 16571-768; 33342-276; 65862-862; 46708-224; 65862-861; 13668-203; 62332-224; 16571-767; 33342-277; 62332-223
UNII APG9819VLM
Synonyms darifenacin | darifenacine | darifenicin | (S)-1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-3-pyrrolidineacetamide | darifenacin hydrochloride | Enablex | UK-88525 | darifenacin hydrobromide | Emselex
Chemical Information
Molecular Formula C28H30N2O2
CAS Registry Number 133099-04-4
SMILES C1CN(CC1C(C2=CC=CC=C2)(C3=CC=CC=C3)C(=O)N)CCC4=CC5=C(C=C4)OCC5
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 pain07.01.05.002--
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Arthralgia15.01.02.001--
Asthenia08.01.01.001---
Back pain15.03.04.005--
Bronchitis11.01.09.001; 22.07.01.001--
Confusional state17.02.03.005; 19.13.01.001--
Constipation07.02.02.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dry eye06.08.02.001--
Dry mouth07.06.01.002--
Dry skin23.03.03.001--
Dyspepsia07.01.02.001--
Hallucination19.10.04.003--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Influenza11.05.03.001; 22.07.02.001---
Injury12.01.08.004---
Nausea07.01.07.001--
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Pain08.01.08.004--
Palpitations02.11.04.012--
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Pruritus23.03.12.001--
Rash23.03.13.001---
Rhinitis11.01.13.004; 22.07.03.006--
Sinusitis11.01.13.005; 22.07.03.007--
Urinary tract disorder20.08.01.001---
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ADReCS-Target
Drug Name ADR Term Target
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