FDA-filed SPL labeling · retrieved through openFDA

Nizatidine

Nizatidine is an H2 blocker used to treat duodenal ulcers, gastric ulcers, and acid reflux (GERD), including erosive esophagitis.

Brand names AxidAxid AR
Drug class Histamine-2 Receptor Antagonist
Rx Forms 2 Route Oral
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 4 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 →

At a glance
Linked label effectiveJan 2, 2025
Clinical labels in scope 4
AvailabilityRx
Earliest approval/marketing year 1988
FDA-listed product records 20
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Nizatidine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Nizatidine is a reliable H2 blocker that reduces stomach acid to treat duodenal ulcers, stomach ulcers, and GERD, including erosive esophagitis. It is generally well tolerated, but people with kidney disease need a dose adjustment, and any signs of liver trouble or unusual bleeding should be reported to a doctor right away. Take it exactly as prescribed, and let your pharmacist or doctor know about all other medications you are on.

📖 Nizatidine: Patient Information Guide

A plain-language walkthrough of Nizatidine — 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

Nizatidine is used to treat several conditions linked to excess stomach acid. Supported uses across nizatidine capsules and nizatidine oral solution include:

  • Active duodenal ulcer (ulcer in the upper part of the small intestine) — treatment for up to 8 weeks
  • Maintenance therapy after a healed duodenal ulcer — to prevent it from returning
  • Gastroesophageal reflux disease (GERD), including erosive and ulcerative esophagitis (acid-related damage to the esophagus) and associated heartburn — up to 12 weeks
  • Active benign gastric ulcer (stomach ulcer not caused by cancer) — up to 8 weeks
  • Nizatidine oral solution is additionally approved for adolescents 12 years and older for GERD and erosive esophagitis
⚙️How it works

Nizatidine works by blocking histamine H2 receptors — specialized docking sites on the acid-producing cells in your stomach lining. Histamine normally binds to these receptors and triggers a flood of stomach acid. By blocking them, nizatidine significantly cuts acid production for up to 12 hours, reducing the acidic environment that irritates ulcers and the esophagus and giving damaged tissue time to heal.

Importantly, nizatidine does not interfere with most other medications because it does not significantly affect the liver enzyme system that breaks down many drugs.

💊How it's taken

Nizatidine comes as an oral capsule and an oral liquid solution, both taken by mouth. Depending on what is being treated, it is typically taken once at bedtime or twice a day (morning and evening). It can be taken with or without food. Do not mix nizatidine capsules into apple juice — this significantly reduces how much of the drug is absorbed.

  • For active ulcers and GERD, treatment is usually continued for several weeks as directed
  • If you have kidney disease, your dose will likely be adjusted — do not adjust it on your own
  • If you miss a dose, take it as soon as you remember, but skip it if it's almost time for your next dose — never double up
🤒Side effects — in detail

Most people tolerate nizatidine well. Common side effects reported in clinical trials include:

  • Headache
  • Diarrhea
  • Dizziness
  • Runny nose or nasal symptoms
  • Itching or skin rash
  • Drowsiness
  • Muscle aches
  • Dry mouth

More serious but rare reactions include liver injury (watch for yellowing skin or eyes, dark urine), significant drops in blood platelet counts (unusual bruising or bleeding), and severe allergic reactions including throat swelling or difficulty breathing. Get medical help right away if any of these occur.

⚠️Warnings & precautions
  • Kidney disease: Nizatidine is cleared almost entirely by the kidneys. If your kidneys aren't working well, the drug can build up to harmful levels. A dose reduction is required — your prescriber must know your kidney status before you start.
  • Liver injury: Rare cases of hepatitis and jaundice have been reported. Liver enzyme abnormalities are generally reversible when nizatidine is stopped, but watch for warning signs like yellowing of the skin or eyes.
  • Low platelet counts: Fatal thrombocytopenia (dangerously low platelet levels leading to severe bleeding risk) has been reported rarely. Report any unusual bruising or bleeding to your doctor promptly.
  • Allergic reactions: Rare but serious allergic responses — including anaphylaxis (a life-threatening whole-body allergic reaction), throat swelling, and bronchospasm (airway tightening) — have been reported. Seek emergency help immediately if this occurs.
  • Stomach cancer: Before treating a stomach ulcer with nizatidine, your doctor should rule out cancer, since the symptoms can mimic malignant disease.
🔀What it interacts with

Nizatidine has relatively few drug interactions, but there are a couple worth knowing:

  • High-dose aspirin: Taking very high doses of aspirin alongside nizatidine can raise aspirin levels in your blood — tell your doctor if aspirin is part of your regimen
  • Aluminum/magnesium antacids with simethicone: These can slightly reduce nizatidine absorption — spacing them apart from nizatidine is advisable
  • No significant interaction has been found with theophylline, warfarin, phenytoin, lorazepam, lidocaine, or chlordiazepoxide

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
  • Tell your doctor if you have kidney disease — your dose must be adjusted based on how well your kidneys work
  • Do not take nizatidine if you have ever had an allergic reaction to it or to any other H2 blocker (such as ranitidine, famotidine, or cimetidine) — cross-sensitivity within this drug class has been observed
  • Nizatidine oral solution is approved for patients 12 years and older; use in younger children should be discussed with a pediatric specialist
  • Tell your prescriber if you are pregnant, trying to become pregnant, or breastfeeding
  • Share a full list of all your medications — prescription, over-the-counter, and supplements — with your pharmacist or doctor before starting
🚑If you take too much

Overdoses of nizatidine are rare. Large amounts may produce cholinergic-type effects — symptoms like excessive tearing, drooling, nausea, vomiting, and diarrhea. If an overdose is suspected, contact your local Poison Control Center immediately for guidance. Supportive care is the main treatment, and hemodialysis is not expected to remove nizatidine efficiently due to how the drug distributes in the body.

📡Pharmacodynamics — effects in the body

Nizatidine significantly reduces stomach acid secretion at night (for up to 12 hours) and also suppresses acid triggered by food, caffeine, and other stimulants. It does not affect the digestive enzyme pepsin directly, though total pepsin output falls because less fluid is secreted overall. Nizatidine has no meaningful effect on hormone levels — including testosterone, estrogen, and growth hormone — and has no antiandrogenic (testosterone-blocking) activity.

🔬Pharmacokinetics — how your body processes it

Nizatidine is well absorbed when taken by mouth, with more than 70% of the dose reaching the bloodstream. Peak blood levels occur within 30 minutes to 3 hours of taking a dose. The drug has a short elimination half-life of 1 to 2 hours, meaning it clears from the body relatively quickly — so it doesn't accumulate in people with normal kidney function. More than 90% of a dose is excreted in the urine within 12 hours, mostly as unchanged drug. In people with moderate to severe kidney impairment, the drug stays in the body much longer, which is why a dose reduction is needed.

📦How to store it

Store at 20°-25°C (68°-77°F) in a tightly closed light resistant container.

📄 Written from Nizatidine’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 →

31

Supplements & herbs that interact with Nizatidine

31 supplements and herbal products have documented interactions with Nizatidine 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 · 1
  • Moderate · 9
  • Minor · 21
Every supplement checked against Nizatidine — ranked by severity The full interaction hub: 1 major · 9 moderate · 21 minor · every one linked to its full report. Check Nizatidine 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.

6

Nutrient depletion considerations

Nizatidine has been associated with lower levels of 6 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 · 4
  • Moderate · 1
  • Unrated · 1
See the full Nizatidine 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.

🩺 Pharmacist Counseling Corner

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

What exactly is nizatidine used for?
Nizatidine is used to treat ulcers in the stomach and small intestine, and to manage acid reflux disease (GERD) — including when acid has caused actual damage or inflammation in the esophagus (the tube connecting your mouth to your stomach). It can also be used at a lower dose after an ulcer heals to help keep it from coming back. The liquid form is approved for teens 12 and older as well as adults.
How does nizatidine actually work?
Your stomach has special cells that release acid when a chemical called histamine tells them to. Nizatidine blocks the histamine 'switch' on those cells — called H2 receptors — so far less acid is produced. With less acid, ulcers and irritated tissue have a much better chance to heal.
Can I take nizatidine with food, or does it have to be on an empty stomach?
You can take nizatidine with or without food — it doesn't make a big difference either way. One thing to avoid: if you're taking the capsule form, don't mix or dissolve it in apple juice. Studies show that significantly reduces how much of the drug actually gets into your system. The liquid solution is a separate product and is fine to take as directed.
What side effects should I actually watch out for?
Most people do fine on nizatidine. The most common side effects are headache, diarrhea, and dizziness — similar rates to placebo in studies. The ones worth calling your doctor about are yellowing of your skin or eyes (which could signal liver trouble), unusual bruising or bleeding, or any signs of a serious allergic reaction like throat swelling or trouble breathing. Those are rare but real, and you shouldn't wait to get help.
I have kidney problems — is this safe for me?
You can still use nizatidine, but your dose will need to be lower than the standard amount. Nizatidine is mostly cleared through the kidneys, so if your kidneys aren't working at full capacity, the drug can build up in your system. Your prescriber will calculate the right amount based on your kidney function. Don't adjust the dose yourself — just make sure your doctor has your most recent kidney test results.
Can I take antacids while I'm on nizatidine?
Yes, but with a small caveat. Antacids that contain aluminum and magnesium — like Maalox or Mylanta — can slightly reduce how much nizatidine your body absorbs. It's a modest effect, but to be safe, try to space them apart from your nizatidine dose when you can. If you're not sure, ask your pharmacist — it's an easy thing to sort out.
Is Nizatidine available over the counter?
Nizatidine 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 Nizatidine first available?
Nizatidine has been available in the United States since at least 1988, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Nizatidine?
Nizatidine is supplied by 10 manufacturers listed in the FDA NDC Directory, including Actavis Pharma, Inc., Amneal Pharmaceuticals LLC, Dr Reddy's Laboratories Limited.

💬 Answers drafted from Nizatidine’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

💊 How Nizatidine comes

Nizatidine is available in 2 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.

Capsule

By mouth
How this form is used
What it may be used for
  • Nizatidine capsules are used to treat active duodenal ulcers for up to 8 weeks
  • Nizatidine capsules are used for maintenance therapy to prevent duodenal ulcer recurrence after healing
  • Nizatidine capsules are used to treat GERD, including erosive and ulcerative esophagitis, for up to 12 weeks
  • Nizatidine capsules are used to treat active benign gastric ulcers for up to 8 weeks
Important instructions
  • Nizatidine capsules are taken by mouth, once at bedtime or twice daily depending on the condition — follow your prescriber's instructions
  • Nizatidine capsules can be taken with or without food
  • Do not mix or dissolve Nizatidine capsules in apple juice — this significantly reduces drug absorption
  • For stomach ulcers, your doctor will first rule out stomach cancer before starting Nizatidine capsules
Available strengths 2 strengths
16 FDA-listed product records

Oral solution

By mouth
How this form is used
What it may be used for
  • Nizatidine oral solution is used to treat active duodenal ulcers for up to 8 weeks
  • Nizatidine oral solution is used for maintenance therapy to prevent duodenal ulcer recurrence after healing
  • Nizatidine oral solution is used to treat GERD and erosive esophagitis for up to 12 weeks in adults, and up to 8 weeks in patients 12 years and older
  • Nizatidine oral solution is used to treat active benign gastric ulcers for up to 8 weeks
Important instructions
  • Nizatidine oral solution is taken by mouth; each mL contains 15 mg of nizatidine — use the measuring device provided
  • Nizatidine oral solution can be taken with or without food
  • Nizatidine oral solution is approved for adolescents 12 years of age and older as well as adults
  • Follow your prescriber's dosing schedule — the solution is typically given twice daily for GERD and erosive esophagitis in adolescents
Available strengths 1 strength
2 FDA-listed product records

📊 Nizatidine across the U.S. market

How Nizatidine 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.

2
Dose forms
10
Manufacturers
1
Brand names
20
FDA-listed product records
1988
First marketed

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 (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Actavis Pharma, Inc.30%
Amneal Pharmaceuticals LLC10%
Dr Reddy's Laboratories Limited10%
Epic Pharma, LLC10%
Glenmark Pharmaceuticals Inc., USA10%
NuCare Pharmaceuticals,Inc.10%
Other makers20%

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

📈 How widely Nizatidine is used

A general measure of how commonly Nizatidine 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 Nizatidine 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.

6,555
Medicaid prescriptions filled (Q1–Q4 2025)
$300,399 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Nizatidine prescribed? Of the 1,596 medications we measure, Nizatidine ranks #1,003 by Medicaid prescriptions — more than 37% of them.

Where Nizatidine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Nizatidine 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 150 mg oral capsule is the most-dispensed Nizatidine product — about 89% of these Medicaid prescriptions.

nizatidine 150 MG Oral Capsule Most dispensed

5,824 Medicaid prescriptions (Q1–Q4 2025) 89% of Nizatidine prescriptions shown $276,932 gross reimbursement (before rebates) ≈ $48 per prescription (gross)

Summed across the 2 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312025

nizatidine 300 MG Oral Capsule

731 Medicaid prescriptions (Q1–Q4 2025) 11% of Nizatidine prescriptions shown $23,468 gross reimbursement (before rebates) ≈ $32 per prescription (gross)

Summed across the 1 of 24 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198041

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 Nizatidine, 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 3 of 53 listed Nizatidine NDCs with Medicaid activity.

🔍 Compare Nizatidine products

A representative set of FDA-listed product records for Nizatidine — 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 20 of 20 products — FDA National Drug Code Directory. See every product, package size and price: browse all 20 Nizatidine NDCs →

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) Nizatidine RxCUI 42319 4 dose forms · 5 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 377199 No current FDA listing
    Clinical drug / strength (SCD) 25 MG/ML RxCUI 250851
  2. Dose form (SCDF) Oral Capsule RxCUI 373110 In current FDA listings
    Clinical drug / strength (SCD) 150 MG RxCUI 312025 300 MG RxCUI 198041
  3. Dose form (SCDF) Oral Solution RxCUI 476874 In current FDA listings
    Clinical drug / strength (SCD) 15 MG/ML RxCUI 476872
  4. Dose form (SCDF) Oral Tablet RxCUI 373111 No current FDA listing
    Clinical drug / strength (SCD) 75 MG RxCUI 199420

Look up RxCUI 42319 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.

🏷️ Sold under these brand names

Axid Axid AR

🏭 Manufacturers & labelers

Actavis Pharma, Inc. 6 Amneal Pharmaceuticals LLC 2 Dr Reddy's Laboratories Limited 2 Epic Pharma, LLC 2 Glenmark Pharmaceuticals Inc., USA 2 NuCare Pharmaceuticals,Inc. 2 Bryant Ranch Prepack 1 Dr. Reddy's Laboratories Limited 1 Proficient Rx LP 1 Solara Active Pharma Sciences Limited 1

RxNorm drug class

Nizatidine belongs to the Histamine-2 Receptor Antagonist class.

Pharmacologic class Histamine-2 Receptor Antagonist
Drug family (ATC) H2-receptor antagonists
How it works Histamine H2 Receptor Antagonists

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.

🔬 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 Jan 2, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Nizatidine.
📈
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 Nizatidine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
4
NDC products indexed
20
Distinct labelers/manufacturers represented
10
Linked representative label
Epic Pharma, LLC
Linked label effective
Jan 2, 2025
Composite sections available
16
Linked SPL Set ID
e9957997-8b85-48a0-9bb3-b878cb223236
Linked SPL Document ID
e9957997-8b85-48a0-9bb3-b878cb223236
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 4 FDA-filed SPL label sets 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. Epic Pharma, LLC 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.