Prescription medicine
Pantoprazole Brand names: Protonix
Pantoprazole (Protonix) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 66 generic labelers, and pharmacies paid $0.0358 per pantoprazole sod DR 40 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the pantoprazole FDA label on DailyMed (effective May 18, 2026, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.); the NDA 20987 record on Drugs@FDA; every pantoprazole label on DailyMed.
Highlights of the record
FDA label of May 18, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for: PROTONIX is a proton pump inhibitor (PPI) indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 )
Maintenance of Healing of Erosive Esophagitis ( 1.2 )
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome
Forms and strengths
- 20 mg
- 40 mg
- 40 mg/10ml
- 40 mg/100ml
- 40 mg/50ml
- 80 mg/100ml
Delayed-release tablet; injection (powder) for solution; injection (powder) (lyophilized) for solution; delayed-release granule; injection (solution).
On the market
- Earliest approval on file
- February 2, 2000 Protonix, Wyeth Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 42 first August 2, 2007; 31 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 70 of which 66 under generic applications, 5 under brand applications, repackagers included
- Last listed patent
- December 7, 2026 Protonix for oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0358 per tablet Pantoprazole sod DR 40 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 25 since 2013 1 Class I among all firms' recalls; latest August 6, 2026; 1 more by firms not listed as its makers
- FAERS reports
- 330,183 through July 30, 2026
What is pantoprazole used for?
From the label: indications and usagePROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for: PROTONIX is a proton pump inhibitor (PPI) indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 )
Maintenance of Healing of Erosive Esophagitis ( 1.2 )
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome ( 1.3 ) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) PROTONIX is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). […]
Conditions named in the indications of pantoprazole's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Proton Pump Inhibitor.
Source: FDA drug label (Protonix Delayed-Release), Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective May 18, 2026 (SPL set 08098cb2-c048-4640-f387-6beec4a38936), via openFDA; the full label on DailyMed
What does the patient leaflet for pantoprazole say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about PROTONIX?You should take PROTONIX exactly as prescribed, at the lowest dose possible and for the shortest time needed. PROTONIX may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. PROTONIX can cause serious side effects, including: • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PROTONIX, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with PROTONIX. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea caused by an infection ( Clostridium difficile ) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. • Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine. • Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body's immune cells attack other cells or organs in the body). Some people who take PPI medicines, including PROTONIX, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. • Low magnesium and other mineral levels in your body can happen in people who have taken PROTONIX for at least 3 months. […]
From the patient leaflet: How should I store PROTONIX?Store PROTONIX at room temperature between 68°F to 77°F (20°C to 25°C). Keep PROTONIX and all medicines out of the reach of children.
Source: FDA drug label (Protonix Delayed-Release), Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective May 18, 2026 (SPL set 08098cb2-c048-4640-f387-6beec4a38936), via openFDA; the full label on DailyMed
Is there a generic for pantoprazole (Protonix)?
The FDA approved the first generic pantoprazole on August 2, 2007. 42 generic applications are approved; 31 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists pantoprazole from 66 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Protonix Iv injection; a patent listed only for Protonix for oral suspension runs to December 7, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2000 earliest approval on file
- 2007 first generic approved
- 2026 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pantoprazole (Protonix)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0358 per Pantoprazole sod DR 40 mg tablet, down 4% from $0.0371 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Pantoprazole sod DR 40 mg tablet (generic)
- Protonix 40 mg suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pantoprazole DR 40 mg suspension packet | Generic | $3.85 per pen many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -31% |
| Pantoprazole sod DR 20 mg tablet | Generic | $0.0426 per tablet | $1.28 | -9% |
| Pantoprazole sod DR 40 mg tablet | Generic | $0.0358 per tablet | $1.07 | -4% |
| Pantoprazole sodium 40 mg vial | Generic | $2.37 per vial many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +28% |
| Protonix 40 mg suspension | Brand | $14.07 per pen many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +2% |
| Protonix DR 20 mg tablet | Brand | $14.31 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $429.40 | +3% |
| Protonix DR 40 mg tablet | Brand | $14.24 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $427.06 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has pantoprazole been recalled?
The FDA's Enforcement Report lists 26 recalls naming pantoprazole since 2013: 1 Class I (the most serious), 22 Class II, 3 Class III; 3 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of pantoprazole and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 6, 2026 | Class II | Baxter Healthcare Corporation | CGMP Deviations |
| March 26, 2026 | Class II | Hetero Labs Limited (Unit V) | Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots." |
| September 5, 2023 | Class II | BE PHARMACEUTICALS AG | Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials. |
| April 7, 2023 | Class II | Methapharm Inc | CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures. |
| March 14, 2023 | Class II | Hetero USA Inc | CGMP Deviations: Discoloration |
| December 27, 2022 | Class II | Sentara Infusion Services not a listed maker | Lack of sterility assurance |
| July 25, 2022 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Discoloration |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pantoprazole label say about other medicines?
The pantoprazole label names 16 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name pantoprazole. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions | 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. … Intervention: Rilpivirine-containing products: Concomitant use with PROTONIX is contraindicated [see ]. See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. … |
| Clopidogrel | drug interactions | Clopidogrel Clinical Impact: Concomitant administration of pantoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition. Intervention: No dose adjustment of clopidogrel is necessary when administered with an approved dose of PROTONIX. |
| Cyanocobalamin | warnings and precautions | Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. |
| Dasatinib | drug interactions | Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of pantoprazole sodium in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite … |
| Digoxin | warnings and precautions | For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see Adverse Reactions (6.2) ]. |
| Edetate | warnings and precautions | Exacerbation of Zinc Deficiency Pantoprazole sodium in 0.9% sodium chloride injection contains edetate disodium (the salt form of EDTA), a chelator of metal ions including zinc. |
| Erlotinib | drug interactions | Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of pantoprazole sodium in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite … |
| Itraconazole | drug interactions | Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of pantoprazole sodium in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite … |
| Ketoconazole | drug interactions | Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of pantoprazole sodium in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite … |
| Methotrexate | drug interactions | Methotrexate Clinical Impact: 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. … Intervention: A temporary withdrawal of PROTONIX may be considered in some patients receiving high-dose methotrexate. |
| Mycophenolate mofetil | drug interactions | Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of pantoprazole sodium in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite … |
| Mycophenolic acid | drug interactions | Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. … receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH [see ]. … |
| Nelfinavir | drug interactions | 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. … Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with PROTONIX. See prescribing information for nelfinavir. … |
| Nilotinib | drug interactions | Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of pantoprazole sodium in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite … |
Every other medicine the pantoprazole label names
| Medicine named | Section | What the label says |
|---|---|---|
| Rilpivirine | drug interactions | 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. … Intervention: Rilpivirine-containing products: Concomitant use with PROTONIX is contraindicated [see ]. See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. … |
| Warfarin | drug interactions | Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin. |
Other labels that name pantoprazole
Source: FDA drug label (Protonix Delayed-Release), Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective May 18, 2026 (SPL set 08098cb2-c048-4640-f387-6beec4a38936), via openFDA; the full label on DailyMed
What do FAERS reports show for pantoprazole?
The FDA Adverse Event Reporting System holds 330,183 reports that list pantoprazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 36,440 are coded as a death and 139,578 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as pantoprazole?
21 other medicines are given the same way (oral) and in the same FDA class as pantoprazole or labeled mainly for the same use (acid reflux and ulcers), the same class first. Acid reflux and ulcers lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Omeprazole | Acid reflux and ulcers | 121 labelers | $0.0295 per capsule 20 mg capsule | A presentation being discontinued |
| Esomeprazole | Acid reflux and ulcers | 117 labelers | $0.145 per capsule 20 mg capsule | No current entry |
| Lansoprazole | Acid reflux and ulcers | 59 labelers | $0.106 per capsule 30 mg capsule | No current entry |
| Rabeprazole | Acid reflux and ulcers | 20 labelers | $0.224 per tablet 20 mg tablet | No current entry |
| Omeprazole and sodium bicarbonate | Acid reflux and ulcers | 20 labelers | $7.90 per packet 40-1,680 packet | No current entry |
| Dexlansoprazole | Acid reflux and ulcers | 9 labelers | $3.71 per capsule 60 mg capsule | No current entry |
| Esomeprazole and naproxen | Acid reflux and ulcers | 10 labelers | $1.96 per unit 500-20 mg | No current entry |
| Calcium carbonate | Acid reflux and ulcers | none listed | $0.0315 per tablet 750 mg tablet chewable | No current entry |
Every medicine labeled for the same conditions as pantoprazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does pantoprazole compare with medicines for the same use?
10 side-by-side pages set pantoprazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to pantoprazole
- 21 medicines for the same use
- Other proton pump inhibitors
- the pharmacologic class, with prices and generics
- Pantoprazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other