Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Darifenacin hydrobromide
Drug ID BADD_D00585
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 D01699
MeSH ID C101207
PubChem ID 444030
TTD Drug ID D0Y5AM
NDC Product Code 53104-7706; 65862-881; 66039-861; 52605-067; 63415-0529; 70700-182; 69097-431; 71205-900; 71205-901; 48087-0110; 65372-1168; 50370-0007; 70700-183; 52605-068; 69097-432
UNII CR02EYQ8GV
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 C28H31BrN2O2
CAS Registry Number 133099-07-7
SMILES C1CN(CC1C(C2=CC=CC=C2)(C3=CC=CC=C3)C(=O)N)CCC4=CC5=C(C=C4)OCC5.Br
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)
Gallbladder disorder09.03.02.001---
Gastrointestinal disorder07.11.01.001---
Gastrointestinal pain07.01.05.005--
Granuloma annulare23.03.15.005---
Hallucination19.10.04.003--
Headache17.14.01.001--
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Infection11.01.08.002---
Influenza11.05.03.001; 22.07.02.001---
Injury12.01.08.004---
Insomnia17.15.03.002; 19.02.01.002--
Loss of consciousness17.02.04.004---
Mental disability26.01.01.001---
Mouth ulceration07.05.06.004---
Nasal dryness22.04.03.002---
Nausea07.01.07.001--
Nervous system disorder17.02.10.001---
Oedema08.01.07.006; 14.05.06.010---
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--
Shock24.06.02.002---
Sinusitis11.01.13.005; 22.07.03.007--
Skin disorder23.03.03.007---
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