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, according to the FDA label [FDA label] is a proton pump inhibitor (PPI) used for the following purposes: • Treatment of active duodenal ulcer in adults • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults • Treatment of active benign gastric ulcer in adults • Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older • Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older • Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older • Pathologic hypersecretory conditions in adults
Marketing Status approved; investigational; vet_approved
ATC Code A02BC01
DrugBank ID DB00338
KEGG ID D05259
MeSH ID D009853
PubChem ID 5311083
TTD Drug ID D01XNB
NDC Product Code 0186-0606; 17228-0750; 59726-737; 63868-177; 79903-112; 0186-0742; 62207-006; 65862-531; 66174-0072; 0186-0743; 41250-064; 55315-367; 55111-397; 58175-0559; 64374-009; 11673-948; 0363-9980; 68016-760; 69842-027; 70515-610; 49711-0117; 21130-398; 0363-0042; 55111-049; 42765-017; 59726-297; 72288-023; 17228-0740; 37808-006; 57896-759; 43598-813; 53943-520; 70000-0232; 70515-625; 37000-455; 37000-459; 55319-916
UNII 426QFE7XLK
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
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)
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; 02.11.04.006--
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 increased13.03.04.024--
Gastric polyps16.05.03.001; 07.20.01.003--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--
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.047--
Haemolytic anaemia01.06.03.002--Not Available
Hallucination19.10.04.003--
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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