Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pantoprazole sodium
Drug ID BADD_D01669
Description Pantoprazole is a first-generation proton pump inhibitor (PPI) 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 [amoxicillin], [clarithromycin], and [metronidazole], for example.[A177271][F4498] Its efficacy is considered similar to other medications within the PPI class including [omeprazole], [esomeprazole], [lansoprazole], [dexlansoprazole], and [rabeprazole]. Pantoprazole 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 cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. As the binding of pantoprazole to the (H+, K+)-ATPase enzyme is irreversible and new enzyme needs to be expressed in order to resume acid secretion, pantoprazole's duration of antisecretory effect persists longer than 24 hours.[FDA Label] 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 pantoprazole have been associated with possible adverse effects, however, including increased susceptibility to bacterial infections (including gastrointestinal _C. difficile_), reduced absorption of micronutrients including iron and B12, and an increased risk of developing hypomagnesemia and hypocalcemia which may contribute to osteoporosis and bone fractures later in life.[A177571] PPIs such as pantoprazole 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] Pantoprazole doses should be slowly lowered, or tapered, before discontinuing as rapid discontinuation of PPIs such as pantoprazole may cause a rebound effect and a short term increase in hypersecretion.[A177574]
Indications and Usage Short-term (up to 16 weeks) treatment of erosive esophagitis.
Marketing Status Prescription; Discontinued
ATC Code A02BC02
DrugBank ID DB00213
KEGG ID D02593
MeSH ID D000077402
PubChem ID 15008962
TTD Drug ID D0T6XX
NDC Product Code 67850-150; 61919-806; 63187-938; 62175-180; 68084-813; 0615-8308; 0781-3232; 71610-364; 63850-3210; 51407-374; 71610-003; 70518-0860; 62756-128; 47234-0843; 72640-008; 53808-1123; 68225-071; 72969-120; 0008-0841; 82608-004; 67296-1230; 55154-4236; 71335-1667; 65219-433; 55111-051; 70518-0226; 59746-284; 70934-203; 62175-617; 51407-249; 0904-6870; 63629-8112; 50268-585; 68071-4895; 55154-8336; 63739-564; 71335-1429; 50090-5361; 65862-559; 63187-042; 43353-027; 50090-5378; 55154-4225; 80425-0162; 60687-585; 64679-434; 65372-1126; 66993-068; 67296-1812; 51407-612; 68071-5053; 45865-622; 66577-020; 55154-4330; 62756-071; 49452-4972; 80425-0133; 50090-1416; 0008-0923; 62175-618; 71610-481; 62756-129; 68071-4483; 61919-599; 80425-0179; 68788-6326; 13668-096; 55154-4382; 47234-0923; 50090-4905; 0615-8113; 70518-0962; 55154-4232; 55700-318; 58118-0617; 14501-0025; 50090-1850; 80425-0085; 53069-0770; 50742-151; 68071-1963; 0008-0843; 70934-145; 63629-8113; 45865-785; 0378-6688; 64679-433; 50268-636; 0143-9300; 65862-560; 71335-1165; 42765-001; 70518-0012; 60760-613; 72572-550; 68071-4211; 0904-6474; 71335-0310; 64374-008; 71610-227; 68645-491; 71610-416; 59746-283; 43063-618; 0008-2001; 53104-7562; 0008-4001; 71335-0715; 68071-2350; 0143-9284; 65977-0012; 67835-0007; 55154-7634; 50090-5379; 47234-0841; 70518-1788; 68071-4917; 62287-923; 0378-6689; 51079-051; 70934-102; 70518-1298; 35573-428; 70518-2511; 67296-0029; 51407-613; 50090-1415; 60760-151; 68788-7545; 50268-639; 53002-1419; 55150-202; 13668-429; 69575-4047; 72789-086; 61919-134; 68071-4646; 68071-4841; 66993-067; 42291-765; 71610-340; 43353-916; 51407-250; 71610-103; 71335-0212; 55154-0777; 0008-0844; 43353-343; 68071-1571
Synonyms Pantoprazole | Pantoprazole Sodium | SK&F 96022 | SKF-96022 | SKF 96022 | SKF96022 | SK&F-96022 | SK&F96022 | BY 1023 | BY-1023 | BY1023 | Protonix
Chemical Information
Molecular Formula C16H14F2N3NaO4S
CAS Registry Number 138786-67-1
SMILES COC1=C(C(=NC=C1)CS(=O)C2=NC3=C([N-]2)C=CC(=C3)OC(F)F)OC.[Na+]
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Ageusia17.02.07.001; 07.14.03.003--Not Available
Agranulocytosis01.02.03.001--Not Available
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Angioedema23.04.01.001; 10.01.05.009--Not Available
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Blood creatine phosphokinase increased13.04.01.001--
Blood triglycerides increased13.12.03.001--Not Available
Clostridium difficile colitis07.19.01.004; 11.02.02.004--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Death08.04.01.001--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness02.01.02.004; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Erythema multiforme23.03.01.003; 10.01.03.015--
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Fracture15.08.02.001; 12.04.02.001--
Generalised oedema14.05.06.007; 08.01.07.004--
Hallucination19.10.02.002--
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatitis09.01.07.004--Not Available
Hepatocellular injury09.01.07.008--Not Available
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