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 **Pantoprazole Injection**: **Treatment of gastroesophageal reflux disease associated with a history of erosive esophagitis** Pantoprazole for injection is indicated for short-term treatment (7-10 days) of patients having gastroesophageal reflux disease (GERD) with a history of erosive esophagitis, as an alternative to oral medication in patients who are unable to continue taking pantoprazole delayed-release tablets. _Safety and efficacy of pantoprazole injection as the initial treatment of patients having GERD with a history of erosive esophagitis have not been demonstrated at this time_.[FDA label] **Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome** Pantoprazole for injection is indicated for the treatment of pathological hypersecretory conditions associated with Zollinger-Ellison Syndrome or other neoplastic conditions.[FDA label] **Pantoprazole delayed-release oral suspension**: **Short-Term Treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD)** Indicated in adults and pediatric patients five years of age and above for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been determined.[F3202] **Maintenance of healing of erosive esophagitis** Indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD.[F3202] **Pathological hypersecretory conditions including Zollinger-Ellison syndrome** Indicated for the long-term treatment of the above conditions.[F3202]
Marketing Status approved
ATC Code A02BC02
DrugBank ID DB00213
KEGG ID D02593
MeSH ID D000077402
PubChem ID 15008962
TTD Drug ID D0T6XX
NDC Product Code 80425-0133; 47234-0841; 49452-4972; 53069-0770; 72969-120; 0008-4001; 42291-765; 51407-612; 51655-797; 55154-4232; 60687-725; 60687-736; 0378-6688; 67850-150; 68071-5053; 68083-493; 72162-1746; 47234-0923; 53104-7562; 13668-429; 25021-751; 43353-343; 50090-5378; 50268-639; 51079-051; 65862-559; 68645-491; 65862-560; 31722-204; 0008-0843; 50268-585; 59746-284; 60760-639; 62175-618; 62756-071; 62756-129; 65219-433; 67296-0029; 70518-2511; 70934-102; 70934-861; 71335-0310; 53808-1123; 55154-4225; 60687-585; 60760-151; 62135-534; 62175-617; 0378-6689; 68788-6326; 70518-1788; 71335-1429; 71335-1667; 71610-003; 0615-8113; 0904-6870; 64374-008; 82608-004; 27241-256; 0008-0841; 0008-0923; 0143-9284; 55154-4382; 71839-122; 0615-8308; 72603-128; 72789-086; 0904-6474; 69575-4047; 43353-027; 50742-151; 51407-250; 63187-042; 63739-564; 71288-600; 0615-7629; 80425-0179; 62287-923; 65372-1126; 65977-0012; 72640-008; 0143-9300; 42799-952; 45865-622; 55154-8336; 63187-938; 68071-4917; 72572-550; 0781-3232; 80425-0278; 63850-3210; 67835-0007; 13668-096; 50090-5379; 51655-075; 55154-4165; 55154-7634; 62135-533; 67296-1812; 68084-813; 70095-024; 70518-1298; 71335-0715; 71335-1165; 71610-103; 72205-180; 80425-0085; 80425-0162; 68225-071; 60760-646; 67296-2047; 0480-4111; 14501-0025; 47234-0843; 66577-020; 35573-428; 0008-0844; 42708-180; 43353-916; 45865-785; 55154-4236; 63629-8112; 67296-1230; 70518-0860; 42765-001; 55111-051; 50090-1850; 50090-5361; 51407-374; 51407-613; 53002-1419; 55150-202; 55154-4346
UNII 6871619Q5X
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
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)
Hypersensitivity10.01.03.003--
Hypomagnesaemia14.04.02.001--
Hyponatraemia14.05.04.002--
Insomnia19.02.01.002; 17.15.03.002--
Jaundice09.01.01.004; 01.06.04.004; 23.03.03.030--Not Available
Leukopenia01.02.02.001--Not Available
Malaise08.01.01.003--
Myalgia15.05.02.001--
Nausea07.01.07.001--
Pancytopenia01.03.03.003--Not Available
Photosensitivity reaction23.03.09.003--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rhabdomyolysis15.05.05.002--
Somnolence19.02.05.003; 17.02.04.006--
Stevens-Johnson syndrome12.03.01.014; 11.07.01.005; 10.01.01.045; 23.03.01.007--
Thrombocytopenia01.08.01.002--Not Available
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urticaria23.04.02.001; 10.01.06.001--
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Tubulointerstitial nephritis20.05.02.002--Not Available
Weight abnormal13.15.01.016--Not Available
Dermatologic examination abnormal13.15.01.019--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
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