Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Diphenoxylate hydrochloride
Drug ID BADD_D00688
Description A meperidine congener used as an antidiarrheal, usually in combination with atropine. At high doses, it acts like morphine. Its unesterified metabolite difenoxin has similar properties and is used similarly. It has little or no analgesic activity. This medication is classified as a Schedule V under the Controlled Substances Act by the Food and Drug Administration (FDA) and the DEA in the United States when used in preparations. When diphenoxylate is used alone, it is classified as a Schedule II.
Indications and Usage For as adjunctive therapy in the management of diarrhea
Marketing Status approved; illicit
ATC Code A07DA01
DrugBank ID DB01081
KEGG ID D03860
MeSH ID D004157
PubChem ID 6432394
TTD Drug ID D0J2TN
NDC Product Code 0406-1592; 0406-1593; 63804-5500; 72166-011
UNII W24OD7YW48
Synonyms Diphenoxylate | Diphenoxylate Hydrochloride | Hydrochloride, Diphenoxylate | Diphenoxylate Monohydrochloride | Monohydrochloride, Diphenoxylate
Chemical Information
Molecular Formula C30H33ClN2O2
CAS Registry Number 3810-80-8
SMILES CCOC(=O)C1(CCN(CC1)CCC(C#N)(C2=CC=CC=C2)C3=CC=CC=C3)C4=CC=CC=C4.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 discomfort07.01.06.001--Not Available
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Depression19.15.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry skin23.03.03.001--
Euphoric mood19.04.02.006--
Flushing08.01.03.025; 24.03.01.002; 23.06.05.003--
Gingival swelling07.09.13.013--Not Available
Headache17.14.01.001--
Hyperthermia12.05.01.002; 08.05.01.001--Not Available
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Ileus paralytic07.02.05.001--Not Available
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Malaise08.01.01.003--
Megacolon07.02.05.002--Not Available
Mucosal dryness08.01.06.001--Not Available
Nausea07.01.07.001--
Pancreatitis07.18.01.001--
Pruritus23.03.12.001--
Restlessness19.11.02.002; 17.02.05.021--
Sedation17.02.04.005--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Tachycardia02.03.02.007--Not Available
Urinary retention20.02.02.011--
Urticaria10.01.06.001; 23.04.02.001--
Vomiting07.01.07.003--
Decreased appetite08.01.09.028; 14.03.01.005--
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