Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Omeprazole magnesium
Drug ID BADD_D01615
Description Originally approved by the FDA in 1989, omeprazole is a _proton-pump inhibitor_, used to treat gastric acid-related disorders. These disorders may include gastroesophageal reflux disease (GERD), peptic ulcer disease, and other diseases characterized by the oversecretion of gastric acid. This drug was the first clinical useful drug in its class, and its approval was followed by the formulation of many other proton pump inhibitor drugs [A174232]. Omeprazole is generally effective and well-tolerated, promoting its popular use in children and adults [FDA label].
Indications and Usage Omeprazole is indicated for the treatment of duodenal ulcers, benign gastric ulcers, gastroesophageal reflux disease (GERD), heartburn and other symptoms associated with GERD, erosive esophagitis, and long-term treatment of pathological hypersecretory conditions like Zollinger-Ellison syndrome, multiple endocrine adenomas, and systemic mastocytosis.
Marketing Status Prescription; OTC; Discontinued
ATC Code A02BC01
DrugBank ID DB00338
KEGG ID D05259
MeSH ID D009853
PubChem ID 5311083
TTD Drug ID D01XNB
NDC Product Code 41250-064; 0363-0042; 0186-0742; 0363-9980; 37000-459; 70518-2167; 63868-177; 62207-006; 66174-0072; 65862-531; 55111-397; 17228-0750; 69842-027; 0186-0743; 59726-737; 0186-0606; 21130-398; 70515-610; 59726-297; 37000-455; 49711-0117; 55315-367; 58175-0559; 55111-049; 42765-017; 43598-813; 43598-408; 57896-759; 53943-520; 68016-760; 70515-625; 37808-006; 55319-916; 64374-009; 11673-948; 17228-0740; 70000-0232
Synonyms Omeprazole | Prilosec | Omeprazole Sodium | Sodium, Omeprazole | H 168-68 | H 168 68 | H 16868 | Omeprazole Magnesium | Magnesium, Omeprazole
Chemical Information
Molecular Formula C34H36MgN6O6S2
CAS Registry Number 161973-10-0
SMILES CC1=CN=C(C(=C1OC)C)CS(=O)C2=NC3=C([N-]2)C=CC(=C3)OC.CC1=CN=C(C(=C1OC)C)CS(=O)C2= NC3=C([N-]2)C=CC(=C3)OC.[Mg+2]
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Gastric pH decreasedPotassium-transporting ATPase alpha chain 2P54707Not AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Death08.04.01.001--
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Diplopia17.17.01.005; 06.02.06.002--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry eye06.08.02.001--
Dry mouth07.06.01.002--
Dry skin23.03.03.001--
Dysgeusia17.02.07.003; 07.14.03.001--
Epistaxis24.07.01.005; 22.04.03.001--
Erythema multiforme10.01.03.015; 23.03.01.003--
Eye irritation06.04.05.003--Not Available
Faeces discoloured07.01.03.002--Not Available
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Fracture15.08.02.001; 12.04.02.001--
Gamma-glutamyltransferase increased13.03.01.011--
Gastric polyps07.20.01.003; 16.05.03.001--Not Available
Gastrointestinal carcinoma16.13.04.001; 07.21.03.001--Not Available
Glycosuria20.02.01.005--
Gynaecomastia21.05.04.003; 05.05.02.003--
Haematuria24.07.01.047; 20.02.01.006--
Haemolytic anaemia01.06.03.002--Not Available
Hallucination19.10.02.002--
Headache17.14.01.001--
Hepatic encephalopathy17.13.01.003; 09.01.03.006--Not Available
Hepatic failure09.01.03.002--
Hepatic necrosis09.01.07.002--
Hepatitis09.01.07.004--Not Available
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