Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Omeprazole
Drug ID BADD_D01614
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 D00455
MeSH ID D009853
PubChem ID 4594
TTD Drug ID D01XNB
NDC Product Code 81522-915; 82009-022; 82009-023; 38779-1935; 66174-0013; 21130-128; 30142-394; 43598-286; 43598-841; 49035-119; 50268-620; 53943-016; 55910-915; 59640-047; 60505-0065; 61919-807; 63187-828; 63941-006; 65841-761; 68016-759; 68462-395; 69842-941; 70518-3368; 71205-960; 71335-1639; 72288-401; 72288-915; 72789-257; 80425-0109; 42765-010; 59651-003; 11822-0061; 16714-714; 0113-7520; 41250-349; 42708-158; 49348-846; 50090-3876; 50268-619; 50268-656; 51407-130; 51407-287; 51660-061; 55910-215; 57237-160; 58602-729; 59779-503; 0363-0915; 62756-377; 0363-1607; 63629-8108; 65841-759; 65841-760; 67091-316; 70677-0148; 0536-1322; 71335-1746; 71610-248; 72789-155; 0781-2234; 76162-470; 79903-113; 80425-0071; 11722-053; 51927-3445; 59651-050; 65862-395; 71747-001; 11673-346; 11822-0453; 16714-123; 16714-715; 21130-137; 30142-992; 0113-1803; 37835-189; 41163-915; 41250-915; 41520-802; 46122-616; 55111-645; 55910-712; 57896-960; 59651-002; 59779-580; 60505-0145; 0363-1008; 63187-170; 0363-1819; 63187-820; 63868-471; 68071-2893; 68071-3007; 68391-915; 70518-2791; 70518-3278; 70934-015; 71205-157; 0615-8079; 72036-981; 72288-047; 55681-306; 55910-713; 56062-915; 58602-850; 62135-530; 64380-183; 67296-0706; 67296-1367; 68071-2199; 69256-915; 69618-054; 70000-0521; 70934-994; 71205-959; 71335-1636; 71610-663; 0615-8406; 80425-0070; 63850-3153; 65628-070; 37808-354; 37808-401; 37808-915; 41163-634; 41520-939; 42708-170; 45802-888; 45865-966; 49035-983; 50594-011; 51407-303; 51655-452; 53002-2688; 55154-2332; 58602-826; 58602-837; 60760-868; 61919-847; 68071-2432; 68382-411; 68382-412; 68788-6881; 68788-7626; 71205-501; 71335-0332; 72476-473; 80136-852; 61876-0724; 66603-704; 0113-7401; 0113-7915; 46122-029; 50090-5901; 51316-061; 53002-1688; 57237-162; 59651-001; 62175-136; 68071-2243; 68462-396; 70000-0381; 70518-0199; 71335-1532; 71713-301; 0781-2785; 0904-5834; 51552-1050; 53104-7520; 10202-722; 62207-983; 65129-3069; 73476-644; 16714-634; 30142-557; 0113-0520; 0113-1723; 36800-915; 43063-743; 50090-2769; 55111-643; 55111-644; 55301-915; 55319-037; 56062-401; 60505-0146; 0363-0007; 62175-118; 63187-061; 68071-2262; 68196-915; 68382-500; 68462-397; 68788-6995; 70518-2235; 70700-150; 71335-0559; 71335-0569; 71335-1852; 71610-280; 71610-704; 0781-2859; 0781-2868; 79481-0075; 38779-3183; 62991-2400; 66039-922; 73476-643; 30142-077; 41520-915; 49999-265; 51407-256; 51407-816; 51660-029; 60505-3952; 60687-608; 62175-114; 63187-787; 63940-242; 68071-1943; 68071-2688; 68071-2741; 68196-303; 69230-318; 69842-791; 70518-2295; 71335-0490; 71335-1851; 71335-9744; 71610-688; 76420-055; 79481-0061; 49452-4891; 51927-0055; 51991-995; 53069-0260; 60592-508; 65977-0041; 75945-234; 21130-018; 0113-0915; 42708-159; 51407-129; 55111-158; 55154-8191; 55700-410; 57237-161; 62011-0157; 63187-070; 63187-805; 68001-441; 68071-2655; 68084-128; 68788-7804; 70518-0403; 70700-149; 71205-907; 71335-0299; 71335-1191; 71335-9609; 71713-201; 72288-123; 72559-010; 72559-014; 0781-2790; 80425-0169; 0904-6917; 55111-981; 63126-905; 65977-0044; 68981-006; 11673-018; 11673-915; 30142-593; 31722-528; 36800-121; 36800-601; 41250-401; 46122-281; 50268-657; 51407-641; 51655-893; 55111-157; 55111-159; 55319-915; 57483-840; 60760-489; 0363-6101; 63981-915; 64024-915; 64380-182; 67296-1615; 68391-103; 69842-661; 71205-613; 71335-1395; 38779-3293; 51838-100; 55111-006; 59651-310; 64239-303; 64374-100; 11673-212; 11822-1190; 21130-401; 31722-527; 37835-001; 43353-829; 46122-686; 49035-915; 51407-664; 55315-996; 55319-251; 57483-120; 57483-740
UNII KG60484QX9
Synonyms Omeprazole | Prilosec | Omeprazole Sodium | Sodium, Omeprazole | H 168-68 | H 168 68 | H 16868 | Omeprazole Magnesium | Magnesium, Omeprazole
Chemical Information
Molecular Formula C17H19N3O3S
CAS Registry Number 73590-58-6
SMILES CC1=CN=C(C(=C1OC)C)CS(=O)C2=NC3=C(N2)C=C(C=C3)OC
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)
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.003--Not Available
Syncope02.11.04.015; 17.02.04.008; 24.06.02.0120.000015%
Tachycardia02.03.02.007--Not Available
Tension19.06.02.005--Not Available
Testicular pain21.13.01.005--
Therapeutic response decreased08.06.01.016--Not Available
Throat tightness22.12.03.031; 19.01.02.005--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tongue discolouration07.14.02.006--Not Available
Toxic epidermal necrolysis11.07.01.006; 10.01.01.006; 23.03.01.008; 12.03.01.015--
Tremor17.01.06.002--
Unresponsive to stimuli17.02.05.0310.000010%Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.0010.000030%
Vascular purpura23.06.01.008; 01.01.04.007; 24.07.06.011--Not Available
Vertigo04.04.01.003; 17.02.12.002--
Vision blurred17.17.01.010; 06.02.06.0070.000015%
Visual acuity reduced06.02.10.012; 17.17.01.011--
Visual impairment06.02.10.0130.000018%Not Available
Vomiting07.01.07.0030.000074%
Weight increased13.15.01.006--
Wheezing22.03.01.009--
Tubulointerstitial nephritis20.05.02.0020.000034%Not Available
Emotional distress19.04.02.0080.000038%Not Available
General physical health deterioration08.01.03.0180.000007%Not Available
Deep vein thrombosis24.01.02.0030.000020%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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