pharmacopeia

Pantoprazole

Proton pump inhibitorsProton Pump InhibitorProton Pump InhibitorsInhibition Gastric Acid SecretionUS-FDASourced from openFDAOrange Book · AB · generic
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2D structure
6-(difluoromethoxy)-2-[(3,4-dimethoxy-2-pyridinyl)methylsulfinyl]-1H-benzimidazole
SMILES COC1=C(C(=NC=C1)CS(=O)C2=NC3=C(N2)C=C(C=C3)OC(F)F)OC
InChIKey IQPSEEYGBUAQFF-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.

Proton Pump

Indications

Sourced from openFDA
  • Pantoprazole Sodium for Injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.ICD-10: K21.00, K21.9

Contraindications

Sourced from openFDA
  • Pantoprazole sodium is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2 , 5.4 ) and Adverse Reactions (6) ] .contraindicated

Dosage & administration

Sourced from openFDA

GERD and a History of EE Adults: The recommended dosage is 40 mg once daily by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes) for up to 10 days. ( 2.1 ) Discontinue as soon as the patient is able to receive oral treatment. Switch to an appropriate oral medication within 10 days of starting pantoprazole sodium for injection. ( 2.1 ) Pathological Hypersecretion Conditions, Including ZE Syndrome The recommended adult dosage is 80 mg every 12 hours by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes). ( 2.2 ) For information on how to adjust dosing for individual patient needs, see the full prescribing information. ( 2.2 ) When switching between intravenous to oral formulations of gastric acid inhibitors, consider the pharmacodynamic action of the drugs to ensure continuity of acid suppression. ( 2.2 ) Preparation and Administration Instructions See full prescribing information for preparation and administration instructions by indication. ( 2.3 , 2.4 ) 2.1 Recommended Dosage for GERD Associated with a History of EE Adult Patients The recommended adult dosage of pantoprazole sodium for injection is 40 mg once daily by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes) for up to 10 days. Discontinue pantoprazole sodium for injection as soon as the patient is able to tolerate oral treatment. Switch to an appropriate oral medication within 10 days of starting pantoprazole sodium for injection. Pediatric use information is approved for Pfizer Inc.'s PROTONIX® I.V.

Warnings & precautions

Sourced from openFDA

Gastric Malignancy : In adults, symptomatic response to therapy with pantoprazole sodium does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Injection Site Reactions : Thrombophlebitis is associated with the administration of intravenous pantoprazole sodium. Assess the patient and remove the catheter if clinically indicated. ( 5.2 ) Potential Exacerbation of Zinc Deficiency : Consider zinc supplementation in patients who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously. ( 5.3 ) Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. ( 5.4 ) Clostridioides difficile -Associated Diarrhea : PPI therapy may be associated with increased risk. ( 5.5 ) Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. ( 5.6 ) Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.7 ) Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue treatment and refer to specialist for evaluation. ( 5.8 ) Hepatic Effects : Elevations of transaminases observed. ( 5.9 ) Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged treatment with PPIs.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are described below and elsewhere in labeling: Injection Site Reactions [see Warnings and Precautions (5.2) ] Potential for Exacerbation of Zinc Deficiency [see Warnings and Precautions (5.3) ] Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.4) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.5) ] Bone Fracture [see Warnings and Precautions (5.6) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.7) ] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.8) ] Hepatic Effects [see Warnings and Precautions (5.9) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.10) ] Fundic Gland Polyps [see Warnings and Precautions (5.11) ] Most common adverse reactions (> 2%) are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Use in specific populations

Sourced from openFDA

Pregnancy : Based on animal data, may cause fetal harm. ( 8.1 ) Pediatric use information is approved for Pfizer Inc.'s PROTONIX® I.V. (pantoprazole sodium) for Injection. However, due to Pfizer Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. 8.1 Pregnancy Risk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole sodium. Reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose) with administration of pantoprazole sodium during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to pantoprazole in this study (see Data ) . A pre-and post-natal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. Oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21.

Pharmacokinetics

Sourced from openFDA
Metabolism
Pantoprazole sodium for injection peak serum concentration (C max ) and area under the serum concentration-time curve (AUC) increase in a manner proportional to intravenous doses from 10 mg to 80 mg. Pantoprazole sodium for injection does not accumulate and its pharmacokinetics are unaltered with multiple daily dosing.

Overdosage

Sourced from openFDA

Experience in patients taking very high doses of pantoprazole (greater than 240 mg) is limited. Adverse reactions seen in spontaneous reports of overdose generally reflect the known safety profile of pantoprazole sodium. Pantoprazole is not removed by hemodialysis. In case of overdose, treatment should be symptomatic and supportive. Single intravenous doses of pantoprazole at 378, 230, and 266 mg/kg (38, 46, and 177 times the recommended human dose based on body surface area) were lethal to mice, rats and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.

Approval history

Sourced from openFDA
  • Feb 2, 2000NDANDA020987Wyeth Pharms
  • Mar 22, 2001NDANDA020988Wyeth Pharms
  • Nov 14, 2007NDANDA022020Wyeth Pharms
  • Jan 19, 2011ANDAANDA090074Torrent Pharms
  • Jan 19, 2011ANDAANDA077619Dr Reddys Labs Ltd
  • Jan 19, 2011ANDAANDA090970Mylan Pharms Inc
  • Jun 30, 2017NDANDA209463Hikma
  • Feb 14, 2024NDANDA217512Baxter Hlthcare Corp

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
323,516 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Chronic Kidney Disease29,2289.0%
  2. 2Fatigue24,1337.5%
  3. 3Nausea22,1256.8%
  4. 4Acute Kidney Injury21,2126.6%
  5. 5Diarrhoea20,6346.4%
  6. 6Dyspnoea20,2156.2%
  7. 7Drug Ineffective19,7976.1%
  8. 8Off Label Use19,7636.1%
  9. 9Pain18,9115.8%
  10. 10Headache15,8754.9%
  11. 11Vomiting15,2034.7%
  12. 12Renal Failure14,7044.5%
  13. 13Arthralgia13,8794.3%
  14. 14Asthenia13,7404.2%
  15. 15Dizziness13,1514.1%

Literature

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Recent PubMed references pinned to Pantoprazole as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 252 ClinicalTrials.gov registrations naming Pantoprazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Pantoprazole. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Pantoprazole work?
Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.
What is Pantoprazole used for?
According to FDA labeling, Pantoprazole carries indications including: Pantoprazole Sodium for Injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Pantoprazole?
Pantoprazole is classified as Proton pump inhibitors, Proton Pump Inhibitor, Proton Pump Inhibitors, Inhibition Gastric Acid Secretion.
What are the brand names for Pantoprazole?
Pantoprazole is marketed under brand names including Protonix.
What are the contraindications for Pantoprazole?
Pantoprazole labeling lists contraindications including: Pantoprazole sodium is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2 , 5.4 ) and Adverse Reactions (6) ] .. Always consult the full prescribing information and a clinician.
Note. Data for pantoprazole is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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