Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lansoprazole
Drug ID BADD_D01245
Description Lansoprazole marketed under the brand Prevacid, is a proton pump inhibitor (PPI) and is structurally classified as a substituted benzimidazole.[A177065] It reduces gastric acid secretion by targeting gastric H,K-ATPase pumps and is thus effective at promoting healing in ulcerative diseases, and treating gastroesophageal reflux disease (GERD) along with other pathologies caused by excessive acid secretion.[A177053]
Indications and Usage Lansoprazole is used to reduce gastric acid secretion and is approved for short term treatment of active gastric ulcers, active duodenal ulcers, erosive reflux oesophagitis, symptomatic gastroesophageal reflux disease, and non-steroidal anti-inflammatory drug (NSAID) induced gastric and duodenal ulcers. [A4892][A177065][FDA Label] It may be used in the maintenance and healing of several gastric conditions including duodenal ulcers, NSAID related gastric ulcers, and erosive esophagitis.[FDA Label] Lansoprazole prevents recurrence of gastric ulcers in patients who have a documented history of gastric ulcers who also use NSAIDs chronically. [FDA Label] Predictably, it is also useful in the management of hypersecretory conditions including Zollinger-Ellison syndrome. [FDA Label] Lansoprazole is effective at eradicating H. pylori when used in conjunction with amoxicillin and clarithromycin (triple therapy) or with amoxicillin alone (dual therapy). [FDA Label]
Marketing Status approved; investigational
ATC Code A02BC03
DrugBank ID DB00448
KEGG ID D00355
MeSH ID D064747
PubChem ID 3883
TTD Drug ID D06YYD
NDC Product Code 11532-1441; 49711-0110; 52932-0730; 53104-7526; 55111-044; 16714-185; 0113-0117; 49035-373; 50090-6154; 55111-739; 56062-283; 60687-123; 61919-655; 63629-2340; 0378-8030; 68382-543; 68382-544; 69842-755; 0536-1368; 55111-399; 65628-080; 0093-3008; 0113-0116; 41163-150; 41250-391; 62175-515; 63739-555; 63868-429; 68788-6390; 70000-0612; 71335-0043; 71335-9693; 80425-0148; 43598-109; 66332-1443; 16571-698; 36800-295; 43598-560; 45802-245; 50090-5180; 51079-121; 55111-398; 55154-0253; 55910-307; 0363-0037; 0363-1212; 64764-541; 65862-896; 67877-274; 68071-2734; 71335-1820; 71335-2078; 72189-062; 55154-4848; 61919-890; 63981-117; 0378-6981; 65841-770; 68391-117; 71335-0917; 72288-343; 82009-039; 51927-0064; 65372-1136; 16571-697; 21130-046; 30142-983; 46122-698; 51316-006; 55289-704; 68001-112; 68382-771; 70771-1132; 71335-0058; 71335-9680; 72189-279; 81522-001; 51552-1239; 51927-0262; 65977-0013; 71052-242; 75945-567; 11673-117; 11822-0016; 11822-0019; 16714-186; 0093-3009; 0093-7350; 31722-570; 0113-6117; 41250-117; 43598-161; 43598-561; 46122-107; 60760-544; 64764-046; 68071-2274; 68071-5119; 70000-0069; 71335-1521; 71335-9694; 80425-0174; 0378-3995; 38779-2289; 42765-023; 63850-3309; 64374-007; 65015-658; 66332-1442; 0113-6002; 0113-7116; 41520-816; 49035-411; 50090-6079; 0363-0739; 0378-8015; 65862-895; 68001-111; 68196-045; 71335-0575; 71335-1425; 16571-742; 0093-7351; 30142-192; 51407-324; 0363-1419; 64764-543; 65841-769; 68016-758; 68382-772; 69256-401; 69842-270; 70700-262; 70756-806; 70756-807; 70771-1133; 72288-301; 83324-001; 63415-0060; 11673-280; 11822-3374; 31722-571; 0113-7003; 41163-117; 45865-879; 49348-301; 56062-117; 60687-111; 62011-0168; 63187-152; 63629-4851; 63981-582; 69842-507; 79903-068; 11532-1440; 21130-564; 27241-019; 27241-020; 30142-288; 45802-878; 63187-510; 0363-4069; 63629-2341; 63629-2342; 64764-544; 0378-6982; 67877-275; 68788-7742; 70000-0508; 70677-0124; 0536-1324; 70700-263; 71335-9695; 72288-829; 72476-020; 0904-6662; 51927-0256; 52562-021; 59349-0015; 11822-0117; 21130-181; 30142-117; 0113-1114; 36800-117; 36800-392; 37808-755; 43598-883; 49035-739; 55910-117
UNII 0K5C5T2QPG
Synonyms Lansoprazole | Lansoprazol | 2-(((3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl)sulfinyl)benzimidazole | Lansoprazoles | Ogastro | AG 1749 | AG-1749 | AG1749 | Agopton | Bamalite | Lansol | Lansoprazole Sodium | Sodium, Lansoprazole | Lanzor | Monolitum | Opiren | Prevacid | Pro Ulco | Promeco | Takepron | Ulpax | Zoton | Ogast | Prezal
Chemical Information
Molecular Formula C16H14F3N3O2S
CAS Registry Number 103577-45-3
SMILES CC1=C(C=CN=C1CS(=O)C2=NC3=CC=CC=C3N2)OCC(F)(F)F
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)
Oropharyngeal pain22.12.03.016; 07.05.05.0040.001233%
Kounis syndrome24.04.04.020; 10.01.03.037; 02.02.02.0200.000348%Not Available
Acute kidney injury20.01.03.0160.004177%
Respiratory tract oedema22.02.07.0130.000099%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.001064%Not Available
Drug reaction with eosinophilia and systemic symptoms12.03.01.064; 23.03.05.005; 10.01.01.0210.001790%Not Available
Candida infection11.03.03.021--
Sinus node dysfunction02.03.03.0170.000249%
Multiple organ dysfunction syndrome08.01.03.0570.000796%
Anal incontinence17.05.01.021; 07.01.06.0290.000099%
Depersonalisation/derealisation disorder19.14.01.004--Not Available
Abnormal loss of weight14.03.02.0190.000149%Not Available
Adenocarcinoma gastric16.13.03.002; 07.21.02.0020.000099%Not Available
Gastric mucosal hypertrophy07.11.03.0060.000099%Not Available
Hyponatraemic syndrome14.05.04.0090.000249%Not Available
Rash papulosquamous23.03.08.0140.000099%Not Available
Renal atrophy20.01.06.0010.000149%Not Available
Squamous cell carcinoma of the tongue16.13.07.007; 07.21.07.0100.000149%Not Available
Tachycardia paroxysmal02.03.02.0280.000099%Not Available
Neuroendocrine tumour16.24.01.009; 05.08.01.0130.000298%Not Available
Palatal oedema07.05.04.0080.000348%Not Available
Subacute cutaneous lupus erythematosus23.03.02.020; 15.06.02.012; 10.04.03.0120.002934%Not Available
Nephrogenic anaemia20.01.01.007; 01.03.04.0010.000298%Not Available
Putamen haemorrhage24.07.04.031; 17.08.01.0580.000099%Not Available
Communication disorder19.19.01.0080.000099%Not Available
Spinal pain17.10.01.020; 15.02.01.008; 08.01.08.0300.000099%Not Available
Gastrointestinal polyp haemorrhage16.05.01.008; 24.07.02.046; 07.20.01.0110.000149%Not Available
Pulmonary pain22.12.01.0100.000099%Not Available
Rapid eye movement sleep behaviour disorder19.02.03.010; 17.15.04.0080.000199%Not Available
End stage renal disease20.01.03.0190.001840%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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