Prescription medication · Proton Pump Inhibitor (PPI)
pantoprazole
Also sold as Protonix. This medicine treats gastroesophageal reflux disease (GERD) and erosive esophagitis (EE) in adults, for up to 10 days.
Data updated 2026-05-15
- 240,800
- FDA reportsHeavily reported
- 5
- InteractionsFew interactions
- 45% less
- Generic vs brandReal savings
- 1
- Recall record
What the data shows
pantoprazole (Protonix) is a prescription Proton Pump Inhibitor (PPI), in the top 5% of tracked drugs by FAERS report volume (240,800 FDA reports), with a lower-cost generic available (45% less than brand).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
pantoprazole (Protonix) is a prescription Proton Pump Inhibitor (PPI). This medicine treats gastroesophageal reflux disease (GERD) and erosive esophagitis (EE) in adults, for up to 10 days.
Pantoprazole is a drug that reduces stomach acid. It belongs to a class of drugs called proton pump inhibitors (PPIs).
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$13.75/unit
Generic Price
$7.63/unit
Generic Savings
45%
Generic Available
Yes (27 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats gastroesophageal reflux disease (GERD) and erosive esophagitis (EE) in adults, for up to 10 days.
Common side effects
Headache, Diarrhea, Nausea
Key warnings
Pantoprazole can hide the symptoms of stomach cancer, so tell your doctor if your symptoms don't improve.
The sections below are summarized in plain English from pantoprazole's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Pantoprazole works by blocking the enzyme in the stomach that produces acid. This reduces the amount of acid your stomach makes. It helps to heal damage to the esophagus caused by acid reflux.
How to Take It
Pantoprazole is given through a vein (IV). For GERD and EE, the usual dose is 40 mg once a day for up to 10 days. For high acid conditions, the usual dose is 80 mg every 12 hours. Your doctor will switch you to an oral medicine as soon as you can take pills.
This is a plain-language summary of pantoprazole's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Based on animal studies, this medicine may harm your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
This is a plain-language summary of pantoprazole's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
Since this medicine is given in a hospital or clinic, you are not likely to miss a dose. Contact your doctor immediately if you think you missed a dose.
This is a plain-language summary of pantoprazole's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature, away from light.
Side Effects (from patient reports)
Based on 240,800 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for pantoprazole, by number of reports
- Tiredness
Tiredness
19,880 reports
- Feeling sick to your stomach
Feeling sick to your stomach
16,991 reports
- Loose, watery stools
Loose, watery stools
16,631 reports
- Difficulty breathing
Difficulty breathing
16,590 reports
- Discomfort or aching
Discomfort or aching
14,965 reports
- Pain in your head
Pain in your head
12,659 reports
- Throwing up
Throwing up
12,159 reports
- Joint pain
Joint pain
11,725 reports
- Sudden damage to the kidneys
Sudden damage to the kidneys
11,212 reports
- Fever
Fever
11,126 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for pantoprazole each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where pantoprazole sits
pantoprazole has more FDA adverse-event reports than 96% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is pantoprazole; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 240,800 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
240,800
Reports Mentioning Death
27,099
11.3% of reports — not proof of cause
Hospitalization Reports
111,504
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 19,879 |
| 3 | NAUSEA | 16,988 |
| 4 | DIARRHOEA | 16,633 |
| 5 | DYSPNOEA | 16,592 |
| 7 | PAIN | 14,962 |
| 8 | HEADACHE | 12,661 |
| 9 | VOMITING | 12,157 |
| 10 | ARTHRALGIA | 11,725 |
| 11 | ACUTE KIDNEY INJURY | 11,212 |
| 12 | PYREXIA | 11,125 |
| 13 | ASTHENIA | 10,938 |
| 14 | CHRONIC KIDNEY DISEASE | 10,553 |
| 15 | DIZZINESS | 10,360 |
| 16 | PNEUMONIA | 10,146 |
| 17 | RASH | 10,116 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Pantoprazole can hide the symptoms of stomach cancer, so tell your doctor if your symptoms don't improve. It may also increase your risk of diarrhea caused by a bacteria called *C. difficile*. Long-term use may increase your risk of bone fractures. This medicine may also cause kidney problems, lupus, low magnesium levels, and polyps in the stomach.
Known Drug Interactions
Clopidogrel Clinical Impact: Concomitant administration of pantoprazole sodium and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition [see Clinical Pharmacology (12.3) ]. Intervention: No dose adjustment of clopidogrel is necessary when administered with an approved dose of pantoprazole sodium.
Mechanism: These two drugs do not have a meaningful effect on each other when taken at the same time.
What to do: You do not need to change your dose of clopidogrel when taking it with this medication.
Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole sodium, and warfarin concomitantly. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin.
Mechanism: Pantoprazole can increase the effects of warfarin, which may make your blood too thin.
What to do: Your doctor may need to adjust your warfarin dose and check your blood clotting levels more often.
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. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warnings and Precautions (5.14) ] . Intervention: A temporary withdrawal of pantoprazole sodium may be considered in some patients receiving high-dose methotrexate.
Mechanism: Pantoprazole can cause methotrexate to stay in your body longer, which can lead to harmful side effects.
What to do: Your doctor may tell you to stop taking pantoprazole for a short time while you are using high doses of methotrexate.
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
Mechanism: Pantoprazole reduces stomach acid, but ketoconazole needs acid to be absorbed into your bloodstream.
What to do: Talk to your doctor, as this combination may make the ketoconazole less effective at treating infections.
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
Mechanism: Pantoprazole lowers stomach acid, which itraconazole needs to be absorbed into your body. This can make the itraconazole less effective.
What to do: Your doctor may need to monitor your treatment or adjust how you take these medications.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take pantoprazole if I am allergic to similar drugs?
How long can I take pantoprazole?
Can pantoprazole be taken with other medications?
What should I do if I experience side effects?
Does pantoprazole affect my bones?
Can pantoprazole cause kidney problems?
Is it safe to take pantoprazole during breastfeeding?
What if my symptoms come back after I stop taking pantoprazole?
Can pantoprazole cause diarrhea?
What are the common side effects of pantoprazole?
Does pantoprazole interact with other medications?
What drug class is pantoprazole?
Is there a generic version of pantoprazole?
Is pantoprazole safe during pregnancy?
Has pantoprazole been recalled?
Active Recalls
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Hetero Labs Limited (Unit V)
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for pantoprazole
The FDA label for pantoprazole (sold under brand names such as Protonix) classifies it as a prescription-only medication in the Proton Pump Inhibitor (PPI) class. This medicine treats gastroesophageal reflux disease (GERD) and erosive esophagitis (EE) in adults, for up to 10 days. Official labeling lists 8 commonly reported side effects, including Headache, Diarrhea, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 240,800 voluntary reports. The database also lists 5 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $7.63 versus $13.75 for the brand - a 45% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: June 27, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages