FDA-filed SPL labeling · retrieved through openFDA

Vonoprazan and Amoxicillin

Vonoprazan and amoxicillin are an acid blocker and antibiotic combination used together — in two different co-packaged products, Voquezna Dual Pak and Voquezna Triple Pak — to treat H. pylori (Helicobacter pylori) bacterial infections in adults.

Brand names Voquezna Dual PakVoquezna Triple Pak
Rx
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 1 clinical label set 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 →

At a glance
Linked label effectiveJul 16, 2026
AvailabilityRx
Earliest approval/marketing year 2023
FDA-listed product records 4
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
💊
HelloPharmacist Editorial Team Bottom Line
Vonoprazan combined with amoxicillin — in either Voquezna Dual Pak or Voquezna Triple Pak — is a 14-day prescription treatment for H. pylori bacterial infections in adults. It's important to complete the full course, be aware of the many potential drug interactions, and know which warning signs to act on right away. Talk to your pharmacist or doctor before starting if you take other medications or have kidney, liver, or heart concerns.

📖 Vonoprazan and Amoxicillin: Patient Information Guide

A plain-language walkthrough of Vonoprazan and Amoxicillin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Vonoprazan and amoxicillin are used together as part of two co-packaged prescription products to treat bacterial infection.

  • Voquezna Dual Pak (vonoprazan + amoxicillin) is indicated to treat Helicobacter pylori (H. pylori) infection in adults.
  • Voquezna Triple Pak (vonoprazan + amoxicillin + clarithromycin) is also indicated to treat H. pylori infection in adults.
  • Both products should only be used when H. pylori infection is confirmed or strongly suspected, to reduce the risk of antibiotic resistance.
⚙️How it works

Vonoprazan is a potassium-competitive acid blocker (PCAB) — it shuts down the stomach's acid-producing proton pump by blocking the enzyme that generates acid. Unlike older acid blockers, vonoprazan does not need stomach acid to become active, so it works quickly and consistently. A less acidic stomach environment helps H. pylori bacteria replicate more actively, and also helps amoxicillin (and clarithromycin in the Triple Pak) stay stable and effective in the stomach — making the antibiotics more likely to fully clear the infection.

Amoxicillin is a penicillin-type antibiotic that kills H. pylori bacteria directly by disrupting their cell walls.

💊How it's taken

Both paks are taken by mouth with or without food for a full 14 days. Voquezna Triple Pak is taken twice daily — morning and evening, roughly 12 hours apart. Voquezna Dual Pak involves vonoprazan twice daily (morning and evening) and amoxicillin three times daily (morning, midday, and evening). Follow your prescriber's instructions exactly for each product.

  • If you miss a dose, take it as soon as you realize — but only if it has been less than 4 hours since the missed dose.
  • If more than 4 hours have passed, skip the missed dose and continue your normal schedule. Do not double up.
  • Dosage adjustments may be needed for kidney or liver problems — your prescriber will determine what is appropriate for you.
🤒Side effects — in detail

The most commonly reported side effects differ slightly between the two paks.

  • Voquezna Dual Pak: diarrhea, abdominal pain, vulvovaginal yeast infection, nasopharyngitis (cold-like symptoms)
  • Voquezna Triple Pak: altered taste (dysgeusia), diarrhea, vulvovaginal yeast infection, headache, abdominal pain, high blood pressure

Seek medical attention right away for severe or bloody diarrhea (possible C. diff infection), any blistering or peeling skin rash, signs of a severe allergic reaction (throat swelling, difficulty breathing), or symptoms of liver problems such as yellowing of the skin or eyes, dark urine, or severe stomach pain.

⚠️Warnings & precautions
  • Serious allergic reactions: Anaphylaxis and severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported. Stop the medication immediately and get emergency help if you develop widespread rash, blistering, facial swelling, or trouble breathing.
  • C. difficile diarrhea: Antibiotics can allow C. diff bacteria to overgrow in the gut, causing severe diarrhea that may occur up to 2 months after finishing treatment. Report persistent or severe diarrhea to your doctor.
  • Kidney inflammation (acute tubulointerstitial nephritis): A type of kidney injury has been reported with vonoprazan. Tell your doctor if you notice reduced urination or signs of kidney problems.
  • Heart rhythm problems (Voquezna Triple Pak): Clarithromycin can prolong the QT interval, potentially causing dangerous arrhythmias. Avoid Voquezna Triple Pak if you have a heart rhythm disorder or take other QT-prolonging drugs.
  • Liver injury (Voquezna Triple Pak): Clarithromycin has been linked to serious liver damage. Stop the Triple Pak and contact your doctor if you develop jaundice, dark urine, or abdominal pain.
  • Pregnancy (Voquezna Triple Pak): Not recommended in pregnancy unless no other option exists — clarithromycin has been associated with miscarriage and possible fetal abnormalities.
  • Mononucleosis: Amoxicillin is very likely to cause a skin rash in people who have mono — avoid these paks if you have mononucleosis.
  • False lab test results: Vonoprazan can raise chromogranin A (CgA) levels, which may produce a false-positive result on tests for neuroendocrine tumors. Wait at least 4 weeks after finishing treatment before this test.
🔀What it interacts with

These combination paks interact with a wide range of medications — some interactions are serious enough to be life-threatening. Key ones to know:

  • Rilpivirine (HIV medication): Contraindicated with both paks — vonoprazan reduces stomach acid, which lowers rilpivirine absorption.
  • Pimozide, lomitapide, lovastatin, simvastatin, ergotamine, lurasidone: Contraindicated with Voquezna Triple Pak due to dangerous drug interactions with clarithromycin.
  • Warfarin (blood thinner): Clarithromycin can significantly increase bleeding risk — INR must be monitored closely.
  • Clopidogrel (anti-platelet drug): Vonoprazan may reduce its effectiveness — your doctor may consider an alternative.
  • Colchicine (gout medication): Life-threatening toxicity possible with Voquezna Triple Pak, especially if you have kidney or liver problems.
  • Diabetes medications or insulin: Clarithromycin (Triple Pak) can increase the risk of low blood sugar — glucose monitoring is recommended.
  • Immunosuppressants (tacrolimus, cyclosporine): Drug levels may rise dangerously with Voquezna Triple Pak — frequent monitoring required.
  • Benzodiazepines (triazolam, midazolam): Clarithromycin may increase sedation — use with caution.
  • Strong CYP3A inducers (certain seizure or HIV drugs): May reduce vonoprazan and clarithromycin levels, making the treatment less effective — avoid if possible.
  • Allopurinol: Higher rate of skin rash when combined with amoxicillin.
  • Probenecid (gout medication): Can increase amoxicillin levels — monitor for increased side effects.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Penicillin or antibiotic allergy: Do not take if you are allergic to penicillins, cephalosporins, or (for Triple Pak) macrolide antibiotics like erythromycin.
  • Kidney problems: Both paks are not recommended if your kidney function is severely reduced (estimated GFR below 30 mL/min). Dosage adjustments may be needed for mild to moderate kidney impairment.
  • Liver problems: Both paks are not recommended in moderate or severe liver impairment (Child-Pugh Class B or C). Mild liver impairment may still be manageable with standard dosing.
  • Pregnancy: Voquezna Triple Pak is not recommended during pregnancy due to risks from clarithromycin. A pregnancy registry exists — ask your doctor about registering. The safety of Voquezna Dual Pak in pregnancy has not been well established.
  • Breastfeeding: Discuss the risks and benefits with your doctor before breastfeeding while taking either pak.
  • Older adults: May have a higher risk of QT prolongation (heart rhythm changes) with Voquezna Triple Pak.
  • Mononucleosis (mono): Avoid amoxicillin-containing paks — a skin rash is very likely.
  • Myasthenia gravis (muscle-weakness condition): Clarithromycin in the Triple Pak may worsen symptoms.
  • Heart rhythm disorders or electrolyte imbalances: Avoid Voquezna Triple Pak if you have QT prolongation, low potassium, or low magnesium, or take antiarrhythmic drugs.
🚑If you take too much

There are no reports of overdose with vonoprazan in humans, and a high single test dose did not cause serious reactions in studies. Amoxicillin overdose may cause gastrointestinal symptoms and, in rare cases, kidney injury from crystal formation in the urine — staying well hydrated is important. Clarithromycin overdose can cause nausea, vomiting, abdominal pain, and diarrhea. If you suspect an overdose, contact a poison control center, your doctor, or an emergency room immediately.

📡Pharmacodynamics — effects in the body

Vonoprazan begins raising stomach pH (reducing acid) within 2 to 3 hours of a single dose, and acid suppression lasts more than 24 hours. With repeated daily dosing, the acid-lowering effect increases and reaches a stable level by around day 4. After stopping the medication, acid suppression gradually fades but stomach pH remains elevated for 24 to 48 hours. Vonoprazan also raises gastrin levels (a hormone that stimulates acid production) during treatment, which return to normal within about 4 weeks of stopping — and these elevated levels can temporarily affect certain diagnostic lab tests.

🔬Pharmacokinetics — how your body processes it

Vonoprazan is absorbed quickly by mouth, reaching peak blood levels in about 2.5 to 3 hours, and its levels in the body build up to a stable state within 3 to 4 days of regular dosing. It is broken down by liver enzymes (mainly CYP3A4/5, CYP2C19, and CYP2D6) into inactive forms, then mostly cleared through the urine. Food does not meaningfully affect absorption. People with significant kidney or liver impairment have higher vonoprazan exposure, which is why dose adjustments or avoiding these paks altogether may be necessary in those groups.

📦How to store it

Store between 20°C and 25°C (68°F and 77°F). Protect from light.

📄 Written from Vonoprazan and Amoxicillin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

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

What exactly is H. pylori, and why do I need two or three medications to treat it?
H. pylori is a type of bacteria that lives in the stomach lining and can cause ulcers and ongoing stomach inflammation. It's tough to eliminate because the stomach's acidic environment makes antibiotics less stable and effective there. That's why vonoprazan is included — it lowers stomach acid quickly, which helps the antibiotic (amoxicillin, and clarithromycin in the Triple Pak) work much better. It takes the combination and a full 14 days to reliably clear the infection.
Does it matter which pak I was prescribed — Dual or Triple?
Yes — they're different regimens. Voquezna Dual Pak contains vonoprazan and amoxicillin, taken three times a day. Voquezna Triple Pak adds clarithromycin and is taken twice a day. Your prescriber chose the one that's right for you, often based on local antibiotic resistance patterns or other health factors. Don't swap between them — follow exactly what's prescribed for your pack.
Can I eat normally while I'm taking this?
Yes — both paks can be taken with or without food, so eating habits don't need to change much. Just try to take your doses at consistent times (morning, evening, and midday for the Dual Pak) to keep the medication working steadily. If your stomach feels upset, taking it with a small amount of food may help.
What side effects are most likely, and which ones should make me call my doctor?
The most common ones are diarrhea, stomach pain, and a yeast infection — these are manageable and usually mild. The Triple Pak may also cause a metallic or altered taste. What you do want to call your doctor about right away: severe or bloody diarrhea (which could signal a C. diff infection), any skin blistering or peeling, yellowing of the skin or eyes, or a severe allergic reaction like throat swelling or trouble breathing. Don't wait on those — they need prompt attention.
I take several other medications. Should I be worried about interactions?
Definitely something to flag with your pharmacist or doctor before you start. These paks — especially the Triple Pak — interact with a surprisingly wide range of drugs. Some interactions are serious: for example, the Triple Pak should not be used with certain cholesterol medications (lovastatin, simvastatin), the antipsychotic pimozide, or the HIV drug rilpivirine. Even warfarin and some diabetes medications need extra monitoring. Give your pharmacist a full list of everything you take, including over-the-counter medications and supplements.
I might be pregnant — is it safe to take this?
If you're pregnant or think you might be, tell your doctor right away before starting either pak. Voquezna Triple Pak is not recommended during pregnancy because the clarithromycin in it has been linked to a higher risk of miscarriage and possible birth defects. The safety of Voquezna Dual Pak in pregnancy is not well established either. There is a pregnancy registry for women who are exposed — your doctor can provide more information. Your prescriber will weigh the risks and benefits and discuss your options with you.
Is Vonoprazan and Amoxicillin available over the counter?
Vonoprazan and Amoxicillin is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Vonoprazan and Amoxicillin first available?
Vonoprazan and Amoxicillin has been available in the United States since at least 2023, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Vonoprazan and Amoxicillin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊 Vonoprazan and Amoxicillin across the U.S. market

How Vonoprazan and Amoxicillin 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.

1
Manufacturers
1
Brand names
4
FDA-listed product records
2023
First marketed

Also listed with the FDA, not a patient dose form: Kit (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

📈 How widely Vonoprazan and Amoxicillin is used

A general measure of how commonly Vonoprazan and Amoxicillin 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 Vonoprazan and Amoxicillin 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.

273
Medicaid prescriptions filled (Q1–Q4 2025)
$225,283 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Vonoprazan and Amoxicillin prescribed? Of the 1,596 medications we measure, Vonoprazan and Amoxicillin ranks #1,429 by Medicaid prescriptions — more than 10% of them.

Where Vonoprazan and Amoxicillin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Vonoprazan and Amoxicillin, 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 1 of 1 listed Vonoprazan and Amoxicillin NDCs with Medicaid activity.

🔍 Compare Vonoprazan and Amoxicillin products

A representative set of FDA-listed product records for Vonoprazan and Amoxicillin — 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.)

Manufacturer / Labeler Category Details
💊Kits
Phathom Pharmaceuticals Inc. × 4 listings NDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Vonoprazan and Amoxicillin NDCs →

🏷️ Sold under these brand names

Voquezna Dual Pak Voquezna Triple Pak

🏭 Manufacturers & labelers

Phathom Pharmaceuticals Inc. 4

🔬 Where this comes from

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 Jul 16, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Vonoprazan and Amoxicillin.
📈
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 Vonoprazan and Amoxicillin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
4
Distinct labelers/manufacturers represented
1
Linked representative label
Phathom Pharmaceuticals Inc.
Linked label effective
Jul 16, 2026
Composite sections available
22
Linked SPL Set ID
0cb2ee04-8581-46c8-a781-7be170ab5c86
Linked SPL Document ID
09164411-fd35-40b3-a208-ac9492cbc201
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Phathom Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.