Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Esomeprazole strontium
Drug ID BADD_D00818
Description Esomeprazole, sold under the brand name Nexium, is a proton pump inhibitor (PPI) medication used for the management of gastroesophageal reflux disease (GERD), for gastric protection to prevent recurrence of stomach ulcers or gastric damage from chronic use of NSAIDs, and for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome. It can also be found in quadruple regimens for the treatment of _H. pylori_ infections along with other antibiotics including [DB01060], [DB01211], and [DB00916], for example.[A177271, F4498] Its efficacy is considered similar to other medications within the PPI class including [DB00338], [DB00213], [DB00448], [DB05351], and [DB01129]. Esomeprazole is the s-isomer of [DB00338], which is a racemate of the S- and R-enantiomer. Esomeprazole has been shown to inhibit acid secretion to a similar extent as [DB00338], without any significant differences between the two compounds _in vitro_. Esomeprazole exerts its stomach acid-suppressing effects by preventing the final step in gastric acid production by covalently binding to sulfhydryl groups of cysteines found on the (H+, K+)-ATPase enzyme at the secretory surface of gastric parietal cells. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. As the binding of esomeprazole to the (H+, K+)-ATPase enzyme is irreversible and new enzyme needs to be expressed in order to resume acid secretion, esomeprazole's duration of antisecretory effect persists longer than 24 hours.[FDA Label] PPIs such as esomeprazole have also been shown to inhibit the activity of dimethylarginine dimethylaminohydrolase (DDAH), an enzyme necessary for cardiovascular health. DDAH inhibition causes a consequent accumulation of the nitric oxide synthase inhibitor asymmetric dimethylarginie (ADMA), which is thought to cause the association of PPIs with increased risk of cardiovascular events in patients with unstable coronary syndromes.[A177577, A177580] Due to their good safety profile and as several PPIs are available over the counter without a prescription, their current use in North America is widespread. Long term use of PPIs such as esomeprazole has been associated with possible adverse effects, however, including increased susceptibility to bacterial infections (including gastrointestinal _C. difficile_), reduced absorption of micronutrients such as iron and B12, and an increased risk of developing hypomagnesemia and hypocalcemia which may contribute to osteoporosis and bone fractures later in life.[A177571] Rapid discontinuation of PPIs such as esomeprazole may cause a rebound effect and a short term increase in hypersecretion.[A177574] Esomeprazole doses should be slowly lowered, or tapered, before discontinuing to prevent this rebound effect.
Indications and Usage Esomeprazole is indicated for the treatment of acid-reflux disorders including healing and maintenance of erosive esophagitis, and symptomatic gastroesophageal reflux disease (GERD), peptic ulcer disease, H. pylori eradication, prevention of gastrointestinal bleeds with NSAID use, and for the long-term treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome.
Marketing Status approved; investigational
ATC Code A02BC05
DrugBank ID DB00736
KEGG ID D10120
MeSH ID D064098
PubChem ID 16048656
TTD Drug ID D0C6DT
NDC Product Code 53746-955; 70849-400; 65162-957; 65162-955; 70849-200; 11014-0109; 53746-957
UNII C5N25H3803
Synonyms Esomeprazole | Esomeprazole Sodium | Esomeprazole Strontium | Strontium, Esomeprazole | Esomeprazole Magnesium | Nexium | Esomeprazole Potassium | Esomeprazole Strontium Anhydrous
Chemical Information
Molecular Formula C34H44N6O10S2Sr
CAS Registry Number 934714-36-0
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.O.O.O.O.[Sr+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)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Acne23.02.01.001--Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase13.03.04.002--Not Available
Alanine aminotransferase increased13.03.04.005--
Albuminuria20.02.01.001--Not Available
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anorectal disorder07.03.01.001--Not Available
Apathy19.04.04.002--Not Available
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Arthropathy15.01.01.003--Not Available
Aspartate aminotransferase13.03.04.008--Not Available
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Asthma10.01.03.010; 22.03.01.002--Not Available
Back pain15.03.04.005--
Barrett's oesophagus07.11.03.002--Not Available
Blood alkaline phosphatase13.04.02.010--Not Available
Blood bilirubin13.03.04.015--Not Available
Blood creatinine increased13.13.01.004--
Blood gastrin increased13.10.02.002--Not Available
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