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Pantoprazole

Pantoprazole is a proton pump inhibitor (PPI), a stomach-acid reducer, used to heal and prevent erosive esophagitis from GERD and to treat conditions where the stomach makes too much acid, such as Zollinger-Ellison syndrome.

Brand names ProtonixProtonix I.V.Protonix Delayed-Release
Drug class Proton Pump Inhibitor
Rx Forms 5
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 122 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record · 3
Other forms & routes:
Injection
Pantoprazole at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Pantoprazole (Protonix) is a proton pump inhibitor (PPI) that shuts down the stomach's acid pumps, a usual first choice for healing esophagus damage from GERD and for Zollinger-Ellison syndrome, where the stomach makes far too much acid; on the market since about 2000 and available as a generic, it is one of the most familiar acid reducers. Most people tolerate it well, and the side effects that do show up are usually mild ones like headache, diarrhea, nausea or belly pain. Act quickly on diarrhea that will not let up, which can signal a C. difficile gut infection, or on any blistering or peeling rash.

Clinical pearls

  • The tablets work with or without food, but the granule suspension should be taken about 30 minutes before a meal.
  • Never combine it with rilpivirine HIV medicines, and flag it to whoever manages your warfarin or high-dose methotrexate.
  • Iron supplements and certain antifungals and cancer drugs need stomach acid to absorb, so pantoprazole can blunt them.
  • Long-term use can lower magnesium and vitamin B-12 and raise fracture risk, so aim for the lowest dose, shortest time.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asDelayed-release tablet, Injection, Oral powder +2
Earliest FDA record2000
Companies listing it with the FDA67
FDA label last updatedAug 11, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Pantoprazole, written from its FDA label.

What Pantoprazole is used for

▾

Pantoprazole lowers stomach acid. Its approved uses depend on the product.

  • Erosive esophagitis with GERD (short-term): oral delayed-release tablets and oral suspension, including Protonix, for adults and children 5 years and older, for up to 8 weeks.
  • Maintenance of healing of erosive esophagitis: oral forms, in adults with GERD.
  • Pathological hypersecretory conditions, including Zollinger-Ellison syndrome: oral forms and IV forms in adults.
  • GERD with a history of erosive esophagitis (IV): pantoprazole sodium for injection in adults for up to 10 days. Protonix I.V. also covers children 3 months and older for up to 7 days.

How Pantoprazole works

▾

Pantoprazole is a proton pump inhibitor. It binds to the (H+, K+)-ATPase enzyme, the “acid pump,” in the stomach’s acid-producing cells. This blocks the final step of acid production, both between meals and when the stomach is stimulated. The effect lasts more than 24 hours.

Pantoprazole dosage

▾

Oral pantoprazole comes as delayed-release tablets or as granules for an oral suspension. Dosing is usually once or twice daily depending on the condition.

  • Tablets may be taken without regard to meals.
  • The granule suspension should be taken about 30 minutes before a meal.
  • The IV form is given by a healthcare professional and is switched to an oral medicine as soon as possible.

Follow your prescriber’s directions and the product label.

Dosing details from the FDA-approved label

From the Pantoprazole prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • GERD and a History of EE (Adults)
    • 40 mg once daily by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes) for up to 10 days
    • Discontinue as soon as the patient is able to receive oral treatment; switch to an appropriate oral medication within 10 days of starting
  • Pathological Hypersecretion Conditions, Including ZE Syndrome (Adults)
    • 80 mg every 12 hours by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes)
    • In patients who need a higher dosage, 80 mg intravenously every 8 hours is expected to maintain acid output below 10 mEq/h
    • Adjust the frequency of dosing to individual patient needs based on acid output measurements
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD ( 2.1 ) Adults 40 mg Once Daily for up to 8 wks Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis ( 2.1 ) Adults 40 mg Once Daily Controlled studies did not extend beyond 12 months Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome ( 2.1 ) Adults 40 mg Twice Daily See full prescribing information for administration instructions 2.1 Recommended Dosing Schedule PROTONIX is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets. The recommended dosages are outlined in Table 1. Table 1: Recommended Dosing Schedule for PROTONIX Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once daily Controlled studies did not extend beyond 12 months Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered. 2.2 Administration Instructions Directions for method of administration for each dosage form are presented in Table 2. Table 2: Administration Instructions Formulation Route Instructions Do not split, chew, or crush PROTONIX Delayed-Release Tablets and PROTONIX For Delayed-Release Oral Suspension. Delayed-Release Tablets Oral Swallowed whole, with or without food For Delayed-Release Oral Suspension Oral Administered in 1 teaspoonful of applesauce or apple juice approximately 30 minutes prior to a meal For Delayed-Release Oral Suspension Nasogastric tube See instructions below Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Pantoprazole side effects

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Most side effects are mild. In adults, the most common are:

Common side effects

  • Headache
  • Diarrhea
  • Nausea
  • Abdominal (belly) pain
  • Vomiting
  • Gas (flatulence)
  • Dizziness
  • Joint pain (arthralgia)

When to get medical help

  • Call your doctor right away for a severe rash, blistering or peeling skin, or signs of an allergic reaction such as swelling or trouble breathing.
  • Tell your doctor about diarrhea that does not get better, which could be a Clostridium difficile infection.
  • Report new or worsening rash or joint pain, which may signal lupus, especially if the rash appears on sun-exposed skin.
  • Report symptoms of kidney inflammation, such as feeling unwell, nausea, or loss of appetite.
  • Seek help for muscle spasms, irregular heartbeat, or seizures, which can be signs of low magnesium.
  • Tell your doctor if heartburn symptoms come back soon after treatment ends or do not improve, since relief does not rule out a stomach cancer.

In children, upper respiratory infections, fever, and rash were also commonly reported. Seek help for severe skin reactions, signs of allergic reaction, persistent diarrhea, or symptoms of low magnesium such as muscle spasms, irregular heartbeat, or seizures.

Pantoprazole warnings and precautions

▾
  • Serious skin and allergic reactions: stop the medicine and get help if you develop severe rash, blistering, or swelling.
  • Kidney inflammation (acute tubulointerstitial nephritis): can occur at any time during treatment.
  • C. difficile diarrhea: consider this if diarrhea does not improve.
  • Bone fractures: risk is higher with high doses and use of a year or longer.
  • Lupus: new or worsening disease has been reported.
  • Low vitamin B-12 and low magnesium: can occur with long-term use.
  • Fundic gland polyps: risk rises with use beyond one year.
  • Gastric cancer: symptom relief does not rule it out.
  • In animal studies, long-term use caused tumors, and the relevance to humans is unknown.

Pantoprazole interactions

▾

Pantoprazole can change how other medicines work, and some affect it.

  • Rilpivirine: must not be combined.
  • Nelfinavir: avoid together.
  • Atazanavir and saquinavir: levels may change, so follow their instructions.
  • Warfarin: may raise INR and bleeding risk.
  • High-dose methotrexate: levels may rise.
  • Iron, erlotinib, dasatinib, nilotinib, ketoconazole, itraconazole: absorption depends on stomach acid.
  • Mycophenolate mofetil: exposure may drop.
  • Clopidogrel: no dose change is needed.
  • Lab tests: can cause false-positive THC urine tests and affect chromogranin A testing.

Interactions listed in the FDA-approved label

From the Pantoprazole prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Antiretrovirals: The effect of PPIs on antiretroviral drugs is variable; decreased exposure of some (e.g., rilpivirine, atazanavir, nelfinavir) may reduce antiviral effect and promote drug resistance, while increased exposure of others (e.g., saquinavir) may increase toxicity. Other antiretroviral drugs do not result in clinically relevant interactions with pantoprazole. Rilpivirine-containing products: concomitant use is contraindicated. Atazanavir: see atazanavir prescribing information for dosing. Nelfinavir: avoid concomitant use. Saquinavir: see saquinavir prescribing information and monitor for potential saquinavir toxicities. Other antiretrovirals: see prescribing information.
  • Warfarin: Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly; increases may lead to abnormal bleeding and even death. Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range.
  • Clopidogrel: Concomitant administration in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition. No dose adjustment of clopidogrel is necessary with an approved dose of pantoprazole.
  • Methotrexate: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. A temporary withdrawal of pantoprazole may be considered in some patients receiving high-dose methotrexate.
  • Drugs dependent on gastric pH for absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole): Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity; with mycophenolate mofetil it has been reported to reduce exposure to mycophenolic acid. Use with caution in transplant patients receiving MMF. See the prescribing information for other drugs dependent on gastric pH for absorption.
  • Investigations of neuroendocrine tumors (CgA testing): CgA levels increase secondary to PPI-induced decreases in gastric acidity, which may cause false positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop pantoprazole at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high; use the same commercial laboratory for serial tests.
  • Urine screening tests for THC: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs. An alternative confirmatory method should be considered to verify positive results.
Read the label’s full interactions text

7 DRUG INTERACTIONS Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with pantoprazole sodium for delayed-release oral suspension and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 4: Clinically Relevant Interactions Affecting Drugs Co-Administered with Pantoprazole Sodium for Delayed-Release Oral Suspension and Interactions with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with pantoprazole may reduce antiviral effect and promote the development of drug resistance. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with pantoprazole may increase toxicity of the antiretroviral drugs. There are other antiretroviral drugs which do not result in clinically relevant interactions with pantoprazole. Intervention: Rilpivirine-containing products: Concomitant use with pantoprazole sodium for delayed-release oral suspension is contraindicated [see Contraindications (4) ] . See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with pantoprazole sodium for delayed-release oral suspension. See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir and monitor for potential saquinavir toxicities. Other antiretrovirals: See prescribing information. Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole, and warfarin concomitantly.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿152 supplements and herbs with documented Pantoprazole interactions, ranked by severity Check Pantoprazole against a supplement or herb →

Before taking Pantoprazole

▾
  • Do not take if you are allergic to pantoprazole or related medicines.
  • Do not take with rilpivirine-containing medicines.
  • Tell your prescriber if you are pregnant or breastfeeding.
  • Oral forms are for children 5 and older for erosive esophagitis. Use beyond 8 weeks has not been established in children.
  • Tell your doctor if you are at risk of osteoporosis, have low magnesium or calcium, or have lupus.
  • Older adults had somewhat higher drug levels, though only slight to moderate increases.

Pantoprazole overdose

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Experience with very high doses is limited, and overdose reports have generally matched the known safety profile. Pantoprazole is not removed by hemodialysis, and treatment is symptom-based and supportive. If you think too much was taken, call Poison Control at 1-800-222-1222.

What Pantoprazole does in the body

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Pantoprazole reduces stomach acid in a dose-related way. After one 40 mg oral dose, acid output dropped about 51% by 2.5 hours. After 7 days of once-daily dosing, it dropped about 85%. Acid secretion returned to normal within a week of stopping, with no rebound. Gastrin levels rise during treatment and return to normal by about 3 months after short-term use.

How your body processes Pantoprazole

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The tablets are enteric-coated, so absorption starts after they leave the stomach. Peak levels occur in about 2.5 hours, and the half-life is about one hour. Pantoprazole is mostly broken down in the liver by CYP enzymes, mainly CYP2C19. About 71% of a dose leaves in the urine and 18% in the feces. Food can delay absorption of the tablets without changing how much is absorbed, but a high-fat meal reduced absorption of the granules.

How to store Pantoprazole

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Store PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

152

Supplements & herbs that interact with Pantoprazole

152 supplements and herbal products have documented interactions with Pantoprazole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 100
  • Minor · 49
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate AMERICAN ELDER Moderate ARTICHOKE Moderate +144 more
Every supplement checked against Pantoprazole — ranked by severity The full interaction hub: 3 major · 100 moderate · 49 minor · every one linked to its full report. Check Pantoprazole against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

9

Nutrient depletion considerations

Pantoprazole has been associated with lower levels of 9 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 5
  • Moderate · 1
  • Unrated · 3
CALCIUM Insignificant Depletion FOLIC ACID Insignificant Depletion IRON Insignificant Depletion MAGNESIUM Major Depletion ZINC Insignificant Depletion VITAMIN B12 Moderate Depletion BETA-CAROTENE Insufficient Evidence CHROMIUM Insufficient Evidence +1 more
See the full Pantoprazole nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Pantoprazole: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Pantoprazole — the kind of thing our pharmacy team would talk through with you at the counter.

What is pantoprazole for?

▾
It lowers stomach acid. It is used to heal and keep healed the irritation of the esophagus caused by GERD, and to treat conditions where the stomach makes too much acid, like Zollinger-Ellison syndrome. The IV form is for short-term use in hospital settings.

How should I take it?

▾
Tablets can be taken with or without meals. If you use the granule suspension, take it about 30 minutes before a meal. Follow your prescriber’s schedule and the directions on your label.

What side effects are normal?

▾
The most common are headache, diarrhea, nausea, belly pain, gas, and dizziness. Call your doctor for a severe rash, diarrhea that will not clear up, muscle spasms or an irregular heartbeat, or signs of an allergic reaction.

Can I stay on it long term?

▾
Some people need it long term, but your prescriber should use the lowest dose for the shortest time that works. Long-term use has been linked to fractures, low vitamin B-12, low magnesium, and stomach polyps. Do not stop or change it on your own.

Does it interact with my other medicines?

▾
It can. It must not be used with rilpivirine HIV medicines, and it can affect warfarin, high-dose methotrexate, and drugs that need stomach acid to be absorbed. Tell me everything you take, including iron and HIV medicines.

Is it safe in pregnancy?

▾
Human studies have not shown an increased risk of major birth defects, but animal studies showed bone changes in offspring. Talk with your prescriber if you are pregnant or breastfeeding, since small amounts pass into breast milk.

Is Pantoprazole available over the counter?

▾
No. Pantoprazole is a prescription medicine: every Pantoprazole product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Pantoprazole first available?

▾
The earliest FDA record we hold for Pantoprazole is from 2000: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Pantoprazole was first used.

Who makes Pantoprazole?

▾
67 companies currently list Pantoprazole products in the FDA's NDC Directory, including Cardinal Health 107, LLC, NuCare Pharmaceuticals,Inc., Bryant Ranch Prepack. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Pantoprazole on HelloPharmacist

📊Pantoprazole supplement interactions152 checked — ranked by severity 🌿Drug & Supplement CheckerPantoprazole vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Pantoprazole NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Pantoprazole Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Pantoprazole forms and strengths (how it comes)

Pantoprazole is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Delayed-release tablet

By mouth
Brands Protonix
How this form is used
What it may be used for
  • Pantoprazole Sodium DR delayed-release tablets are used for short-term treatment of erosive esophagitis with GERD.
  • Pantoprazole Sodium DR delayed-release tablets are used for maintaining healing of erosive esophagitis in adults.
  • Pantoprazole Sodium DR delayed-release tablets are used for long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Important instructions
  • Protonix delayed-release tablets are taken once daily for erosive esophagitis, for up to 8 weeks in short-term treatment.
  • Protonix delayed-release tablets are taken twice daily for pathological hypersecretory conditions in adults.
  • Protonix is supplied as delayed-release tablets or as granules for oral suspension.
Available strengths 2 strengths
20 mg 40 mg
260 FDA-listed product records ⓘ

Injection

By injection · Into a vein
Brands Protonix
How this form is used
What it may be used for
  • Pantoprazole Sodium for injection is used in adults for GERD with a history of erosive esophagitis for up to 10 days.
  • Pantoprazole Sodium for injection is used in adults for pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
  • Protonix I.V. is also used for GERD with a history of erosive esophagitis in children 3 months and older for up to 7 days.
  • Pantoprazole Sodium for injection has not been shown to be safe and effective for upper gastrointestinal bleeding.
Important instructions
  • Pantoprazole Sodium for injection is given into a vein as an injection or a 15-minute infusion.
  • Protonix I.V. should be stopped as soon as you can take an oral treatment.
  • Protonix I.V. in children is given as a 15-minute infusion once daily, with the dose based on age and weight.
Available strengths 5 strengths
40 mg 40 mg/10 mL 40 mg/50 mL 40 mg/100 mL 80 mg/100 mL
71 FDA-listed product records ⓘ

Oral powder

By mouth
Brands Protonix
How this form is used
What it may be used for
  • Pantoprazole Sodium delayed-release granules for oral suspension are used for short-term treatment of erosive esophagitis with GERD in adults and children 5 years and older.
  • Pantoprazole Sodium granules are used for maintenance of healing of erosive esophagitis and for pathological hypersecretory conditions.
Important instructions
  • Protonix granules are supplied in packets for preparation of an oral suspension.
  • Pantoprazole Sodium granules are taken once daily for erosive esophagitis and twice daily for hypersecretory conditions in adults.
Available strengths 1 strength
40 mg
11 FDA-listed product records ⓘ

Oral suspension

By mouth
How this form is used
What it may be used for
  • Pantoprazole Sodium Delayed-release oral suspension is used for short-term treatment of erosive esophagitis with GERD in adults and children 5 years and older.
  • Pantoprazole Sodium Delayed-release oral suspension is used for maintenance of healing of erosive esophagitis and for pathological hypersecretory conditions including Zollinger-Ellison syndrome.
Important instructions
  • Pantoprazole sodium delayed-release oral suspension should be taken about 30 minutes before a meal.
  • Pantoprazole sodium granules were shown to work similarly when sprinkled on applesauce or mixed with apple juice.
Available strengths 1 strength
40 mg
5 FDA-listed product records ⓘ

Tablet

By mouth
How this form is used
What it may be used for
  • Pantoprazole sodium delayed-release tablets are used for short-term treatment of erosive esophagitis with GERD in adults and children 5 years and older.
  • Pantoprazole sodium delayed-release tablets are used for maintenance of healing of erosive esophagitis in adults.
  • Pantoprazole sodium delayed-release tablets are used for pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Important instructions
  • Pantoprazole sodium delayed-release tablets are enteric-coated, so absorption begins after the tablet leaves the stomach.
  • Pantoprazole sodium delayed-release tablets may be taken without regard to timing of meals.
Available strengths 2 strengths
20 mg 40 mg
4 FDA-listed product records ⓘ

Pantoprazole on the U.S. market: products, makers and brands

How Pantoprazole appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

67 companies list 166 Pantoprazole product records with the FDA, mostly as delayed-release tablet, injection, oral powder; the earliest marketing or approval year on record is 2000. Brand names on the directory include Protonix, Protonix I.V., Protonix Delayed-Release; the rest are generics.

5
Dose forms ⓘ
67
Labelers (makers, repackagers, distributors)
9
Brand names
166
FDA-listed product records ⓘ
2000
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (28) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Cardinal Health 107, LLC6%
NuCare Pharmaceuticals,Inc.6%
Bryant Ranch Prepack4%
A-S Medication Solutions4%
Asclemed USA, Inc.4%
NorthStar RxLLC3%
Other makers73%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Pantoprazole is used (Medicaid data)

A general measure of how commonly Pantoprazole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Pantoprazole is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

5,789,599
Medicaid prescriptions filled (Q1–Q4 2025)
$65.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Pantoprazole prescribed? Of the 1,601 medications we measure, Pantoprazole ranks #32 by Medicaid prescriptions — more than 98% of them.

Where Pantoprazole ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #32 of 1,601
#27 Aspirin 6,339,210 Rx #28 Losartan 5,992,816 Rx #29 Metoprolol 5,974,670 Rx #30 Clonidine 5,852,758 Rx #31 Semaglutide 5,813,664 Rx #32 Pantoprazole 5,789,599 Rx #33 Quetiapine 5,743,048 Rx #34 Triamcinolone 5,724,276 Rx #35 Methylphenidate 5,663,940 Rx #36 Semaglutide Injection 5,616,018 Rx #37 Amoxicillin / Clavulan... 5,453,053 Rx

Utilization by Pantoprazole product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 40 mg delayed release oral tablet is the most-dispensed Pantoprazole product — about 87% of these Medicaid prescriptions.

pantoprazole 40 MG Delayed Release Oral Tablet Most dispensed

5,019,462 Medicaid prescriptions (Q1–Q4 2025) 87% of Pantoprazole prescriptions shown $49.2M gross reimbursement (before rebates) ≈ $9.81 per prescription (gross)

Summed across the 30 of 265 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314200

pantoprazole 20 MG Delayed Release Oral Tablet

686,680 Medicaid prescriptions (Q1–Q4 2025) 12% of Pantoprazole prescriptions shown $6.8M gross reimbursement (before rebates) ≈ $9.91 per prescription (gross)

Summed across the 16 of 242 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 251872

pantoprazole 40 MG Injection

65,430 Medicaid prescriptions (Q1–Q4 2025) 1% of Pantoprazole prescriptions shown $3.5M gross reimbursement (before rebates) ≈ $54 per prescription (gross)

Summed across the 21 of 71 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 283669

pantoprazole 40 MG Oral Granules

18,027 Medicaid prescriptions (Q1–Q4 2025) <1% of Pantoprazole prescriptions shown $6.2M gross reimbursement (before rebates) ≈ $345 per prescription (gross)

Summed across the 9 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 763306

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pantoprazole, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 76 of 596 listed Pantoprazole NDCs with Medicaid activity.

Compare Pantoprazole products

A representative set of FDA-listed product records for Pantoprazole — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 93 of 166 products — FDA National Drug Code Directory. See every product, package size and price: browse all 166 Pantoprazole NDCs →

Pantoprazole recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 6 Pantoprazole recalls since July 2021. Three of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Aug 6, 2026 · Baxter Healthcare Corporation
CGMP Deviations
  • Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60… Lots: Lot # NC194129, Exp Date: 05/07/2028. FDA record D-0812-2026 →
Ongoing Class II Mar 26, 2026 · Hetero Labs Limited (Unit V)
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
  • Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Po… Lots: Batch # FD253967, Exp Date: 06/26/2027 FDA record D-0484-2026 →
Ongoing Class II Mar 14, 2023 · Hetero USA Inc
CGMP Deviations: Discoloration
  • Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Ja… Lots: Lot #: PAN22542, Exp. Date: 9/2024 FDA record D-0530-2023 →
Class II Sep 5, 2023 · Terminated · BE PHARMACEUTICALS AG
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
  • Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. i… Lots: Lots: (a) GSC04002A, GSC04003A, GSC04004A, GSC04006A, Exp Mar-2024; GSC05001A, GSC05006A, GSC05007A, Exp April-2024; GSC10003A, GSC10005A Exp Sep-2024;GSC06004A, GSC06005A, Exp May-2024; GSC07001A, GSC07007A, GSC07008A, GSC07009A, Exp Jun-… FDA record D-1148-2023 →
Class II Jul 25, 2022 · Terminated · SUN PHARMACEUTICAL INDUSTRIES INC
Discoloration
  • Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (s… Lots: Lot #: MHC1317A, Exp 07/2023 FDA record D-0068-2023 →
Class II Apr 11, 2022 · Terminated · Torrent Pharma Inc
CGMP deviations: tablets cracking
  • Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., L… Lots: Lot #s: BA34G021, BA34G022, Exp. 09/2022 FDA record D-0852-2022 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Pantoprazole RxCUI 40790 3 dose forms · 7 strengths
  1. Dose form (SCDF) Delayed Release Oral Tablet RxCUI 373222 In current FDA listings
    Clinical drug / strength (SCD) 20 MG RxCUI 251872 40 MG RxCUI 314200
  3. Dose form (SCDF) Oral Granules RxCUI 763305 In current FDA listings
    Clinical drug / strength (SCD) 40 MG RxCUI 763306

Look up RxCUI 40790 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Pantoprazole costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Delayed Release · Oral 40 mg $14.24 per tablet NDC details & price history
Tablet, Delayed Release · Oral 20 mg $14.31 per tablet NDC details & price history
Injection, Powder, For Solution · Intravenous 40 mg $2.37 each NDC details & price history
Injection, Powder, Lyophilized, For Solution · Intravenous 40 mg/10 mL $2.37 each NDC details & price history
Injection, Powder, Lyophilized, For Solution · Intravenous 40 mg $2.37 each NDC details & price history
Granule, Delayed Release · Oral 40 mg $14.07 each NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Pantoprazole brand names

Pantoprazole is sold under 3 brand names in the FDA directory — Protonix, Protonix I.V., Protonix Delayed-Release. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Protonix Protonix I.V. Protonix Delayed-Release

Who makes Pantoprazole: manufacturers and labelers

67 companies list Pantoprazole products with the FDA. By number of product records, the largest are Cardinal Health 107, LLC, NuCare Pharmaceuticals,Inc., Bryant Ranch Prepack. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Cardinal Health 107, LLC 10 NuCare Pharmaceuticals,Inc. 10 Bryant Ranch Prepack 7 A-S Medication Solutions 6 Asclemed USA, Inc. 6 NorthStar RxLLC 5 Proficient Rx LP 5 Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 5 Advanced Rx Pharmacy of Tennessee, LLC 4 Camber Pharmaceuticals, Inc. 4 Hawaii Repack, Inc. 4 Advanced Rx of Tennessee, LLC 3 American Health Packaging 3 Aphena Pharma Solutions - Tennessee, LLC 3 Aurobindo Pharma Limited 3 AvPAK 3 Baxter Healthcare Corporation 3 Coupler LLC 3 Major Pharmaceuticals 3 Northwind Health Company, LLC 3 QPharma Inc 3 Remedyrepack Inc. 3 Amneal Pharmaceuticals LLC 2 Chartwell RX, LLC 2

…and 43 more on the FDA NDC directory.

Pantoprazole drug class (RxNorm)

Pantoprazole belongs to the Proton Pump Inhibitor class.

Pharmacologic class Proton Pump Inhibitor
Drug family (ATC) Proton pump inhibitors
How it works Proton Pump Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Pantoprazole page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 11, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Pantoprazole.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Pantoprazole after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
122
Finished products in the current FDA directory
166
Companies listing them (makers, repackagers, distributors)
67
FDA labeler codes behind them ⓘ
69
Linked representative label ⓘ
Preferred Pharmaceuticals Inc.
Linked label effective
Aug 11, 2026
Composite sections available
23
Linked SPL Set ID
5c14e2f3-625d-4089-a404-440b0ecf72e7
Linked SPL Document ID
b7c006b5-a176-4266-a076-e49595cc7266
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Preferred Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →