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.
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
- Fatigue
Fatigue
19,879 reports
- Nausea
Nausea
16,988 reports
- Diarrhoea
Diarrhoea
16,633 reports
- Dyspnoea
Dyspnoea
16,592 reports
- Pain
Pain
14,962 reports
- Headache
Headache
12,661 reports
- Vomiting
Vomiting
12,157 reports
- Arthralgia
Arthralgia
11,725 reports
- Acute Kidney Injury
Acute Kidney Injury
11,212 reports
- Pyrexia
Pyrexia
11,125 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) 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for pantoprazole?
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)
Related Medications in Proton Pump Inhibitor (PPI)
Other drugs grouped near pantoprazole - same-class peers and common alternatives.
alosetron
Lotronex
Alosetron (Lotronex) is a medicine for women with severe diarrhea-predominant irritable bowel syndrome (IBS).
Compare with pantoprazole →
aprepitant
Emend
Aprepitant (Emend) is a medicine that helps prevent nausea and vomiting.
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bisacodyl
Dulcolax
Bisacodyl is a medicine that helps you have a bowel movement.
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bismuth subsalicylate
Pepto-Bismol
Bismuth subsalicylate (Pepto-Bismol) is a medicine that can treat diarrhea and upset stomach.
Compare with pantoprazole →
cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
Compare with pantoprazole →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for pantoprazole: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 240,800.
- atorvastatin Δ 596 reports · HMG-CoA Reductase Inhibitor (Statin) 240,204reports
- folic acid Δ 633 reports · B Vitamin (Folate) Supplement 241,433reports
- insulin glargine Δ 4,653 reports · Long-Acting Insulin 236,147reports
- simvastatin Δ 4,954 reports · HMG-CoA Reductase Inhibitor (Statin) 245,754reports
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 11.25%.
- zaleplon Δ 0.01 pts · 1,538 reports · Non-Benzodiazepine Hypnotic (Z-Drug) 11.25%death share
- terazosin Δ 0.01 pts · 7,436 reports · Alpha-1 Blocker 11.24%death share
- metronidazole topical Δ 0.02 pts · 45,816 reports · Topical Antibiotic (Rosacea) 11.28%death share
- nifedipine Δ 0.03 pts · 45,410 reports · Calcium Channel Blocker 11.28%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: June 27, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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