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)
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hypomagnesaemia14.04.02.001--
Hyponatraemia14.05.04.002--
Influenza22.07.02.001; 11.05.03.001--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Irritable bowel syndrome07.02.04.003; 19.24.01.003--Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.004--Not Available
Leukocytosis01.02.01.002--
Leukopenia01.02.02.001--Not Available
Liver disorder09.01.08.001--Not Available
Malaise08.01.01.003--
Muscle spasms15.05.03.004--
Muscular weakness17.05.03.005; 15.05.06.001--
Myalgia15.05.02.001--
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Neutropenia01.02.03.004--Not Available
Oedema peripheral02.05.04.007; 14.05.06.011; 08.01.07.007--
Oesophageal candidiasis11.03.03.008; 07.19.06.001--Not Available
Optic atrophy06.09.02.001--Not Available
Optic ischaemic neuropathy24.04.10.001; 17.04.05.006; 06.07.03.001--Not Available
Optic neuritis06.04.08.002; 17.04.05.001; 10.04.10.002--Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Palpitations02.01.02.003--
Pancreatitis07.18.01.001--
Pancytopenia01.03.03.003--Not Available
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