Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pinaverium bromide
Drug ID BADD_D01775
Description Pinaverium is a spasmolytic agent used for functional gastrointestinal disorders. It is a quaternary ammonium compound that acts as an atypical calcium antagonist to restore normal bowel function. It is shown to relieve GI spasm and pain, transit disturbances and other symptoms related to motility disorders [A19697] and may be considered as effective first-lline therapy for patients with irritable bowel syndrome (IBS) [A19702]. Pinaverium bromide is the common ingredient in formulations, mostly as oral tablets. Although it is not a currently approved drug by the FDA, pinaverium is available in over 60 countries including Canada.
Indications and Usage Pinaverium is indicated for the symptomatic treatment of irritable bowel syndrome (IBS) and functional disorders of the biliary tract.
Marketing Status approved
ATC Code A03AX04
DrugBank ID DB09090
KEGG ID D07094
MeSH ID C013199
PubChem ID 40703
TTD Drug ID D0J1NQ
NDC Product Code 65372-1135; 52128-175
UNII 7SCF54H12J
Synonyms pinaverium | Dicetel | pinaverium bromide | 4-(6-bromoveratryl)-4-(2-(2-(6,6-dimethyl-2-norpinyl)ethoxy)ethyl)morpholinium bromide | Eldicet
Chemical Information
Molecular Formula C26H41Br2NO4
CAS Registry Number 53251-94-8
SMILES CC1(C2CCC(C1C2)CCOCC[N+]3(CCOCC3)CC4=CC(=C(C=C4Br)OC)OC)C.[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)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001--Not Available
Colitis ulcerative10.02.01.004; 07.08.01.005--Not Available
Constipation07.02.02.001--
Dermatitis allergic23.03.04.003; 10.01.03.014--Not Available
Dermatitis atopic23.03.04.016; 10.01.04.004--Not Available
Diarrhoea07.02.01.001--
Dizziness17.02.05.003; 02.11.04.006; 24.06.02.007--
Drug ineffective08.06.01.006--Not Available
Dry mouth07.06.01.002--
Dyspepsia07.01.02.001--
Fatigue08.01.01.002--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Irritable bowel syndrome19.24.01.003; 07.02.04.003--Not Available
Multiple sclerosis17.16.01.001; 10.04.10.008--Not Available
Muscle spasms15.05.03.004--
Nausea07.01.07.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Vertigo17.02.12.002; 04.04.01.003--
Vomiting07.01.07.003--
General physical health deterioration08.01.03.018--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Acute kidney injury20.01.03.016--
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