Over-the-counter medication · H2 Receptor Antagonist
nizatidine
Also sold as Axid. Nizatidine can treat active duodenal ulcers for up to 8 weeks.
Data updated 2026-05-15
- 1,480
- FDA reportsRarely reported
- 2
- InteractionsFew interactions
- $0.90
- Generic price (NADAC)
What the data shows
nizatidine (Axid) is an over-the-counter H2 Receptor Antagonist, among the least-reported drugs the FDA tracks (1,480 FDA reports), with 2 documented drug interactions.
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.
nizatidine (Axid) is an over-the-counter H2 Receptor Antagonist. Nizatidine can treat active duodenal ulcers for up to 8 weeks.
Nizatidine helps reduce stomach acid. It can treat ulcers and heartburn.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.90/unit
Generic Available
Yes (4 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Nizatidine can treat active duodenal ulcers for up to 8 weeks.
Common side effects
Headache, Abdominal pain, Diarrhea
Key warnings
If you have kidney problems, your doctor may need to lower your dose.
The sections below are summarized in plain English from nizatidine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Nizatidine is an H2 receptor antagonist. This means it blocks histamine from attaching to cells in your stomach. By blocking histamine, the drug reduces the amount of acid your stomach makes.
Side Effects (from patient reports)
Based on 1,480 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for nizatidine, by number of reports
- Chronic Kidney Disease
Chronic Kidney Disease
264 reports
- Acute Kidney Injury
Acute Kidney Injury
161 reports
- Renal Failure
Renal Failure
135 reports
- End Stage Renal Disease 72
End Stage Renal Disease
72 reports
- Nausea 69
Nausea
69 reports
- Vomiting 66
Vomiting
66 reports
- Renal Injury 59
Renal Injury
59 reports
- Gastrooesophageal Reflux Disease 56
Gastrooesophageal Reflux Disease
56 reports
- Dyspnoea 53
Dyspnoea
53 reports
- Diarrhoea 48
Diarrhoea
48 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 nizatidine 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 nizatidine sits
nizatidine has more FDA adverse-event reports than 9% 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 nizatidine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 1,480 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1999–2025.
Total Reports
1,480
Reports Mentioning Death
157
10.6% of reports — not proof of cause
Hospitalization Reports
566
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | CHRONIC KIDNEY DISEASE | 264 |
| 2 | ACUTE KIDNEY INJURY | 161 |
| 3 | RENAL FAILURE | 135 |
| 4 | END STAGE RENAL DISEASE | 72 |
| 5 | NAUSEA | 69 |
| 6 | VOMITING | 66 |
| 7 | RENAL INJURY | 59 |
| 8 | GASTROOESOPHAGEAL REFLUX DISEASE | 56 |
| 9 | DYSPNOEA | 53 |
| 10 | DIARRHOEA | 48 |
| 11 | PYREXIA | 48 |
| 13 | DIZZINESS | 45 |
| 14 | MALAISE | 45 |
| 15 | ANAEMIA | 44 |
| 16 | FATIGUE | 42 |
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
If you have kidney problems, your doctor may need to lower your dose. Before taking this medicine for a stomach ulcer, make sure it is not cancerous.
Known Drug Interactions
albuterol, systemic and inhaled mebendazole amoxicillin medroxyprogesterone ampicillin, with or without sulbactam methylprednisolone atenolol metronidazole azithromycin metoprolol caffeine, dietary ingestion nadolol cefaclor nifedipine co-trimoxazole (trimethoprim and sulfamethoxazole) nizatidine diltiazem norfloxacin dirithromycin ofloxacin enflurane omeprazole famotidine prednisone, prednisolone felodipine ranitidine finasteride rifabutin hydrocortisone roxithromycin isoflurane Sorbitol (purgative doses do not inhibit theophylline absorption) isoniazid sucralfate isradipine terbutaline,...
Mechanism: Nizatidine may interfere with the way your body breaks down theophylline, potentially increasing the risk of side effects.
Nizatidine) — An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics.
Mechanism: Nizatidine changes the acid levels in the stomach, but this does not change how the body absorbs or uses tadalafil.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take nizatidine with food?
How long does it take for nizatidine to heal an ulcer?
Can I take nizatidine long-term?
What should I do if I experience side effects?
Can nizatidine be used for children?
Does nizatidine interact with other medications?
Can I drink alcohol while taking nizatidine?
Is nizatidine available over the counter?
What do the numbers on the capsules mean?
What if my heartburn doesn't get better?
What are the common side effects of nizatidine?
Does nizatidine interact with other medications?
What drug class is nizatidine?
What pregnancy or breastfeeding source fields are listed for nizatidine?
Related Medications in H2 Receptor Antagonist
Other drugs grouped near nizatidine - 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 nizatidine →
aprepitant
Emend
Aprepitant (Emend) is a medicine that helps prevent nausea and vomiting.
Compare with nizatidine →
bisacodyl
Dulcolax
Bisacodyl is a medicine that helps you have a bowel movement.
Compare with nizatidine →
bismuth subsalicylate
Pepto-Bismol
Bismuth subsalicylate (Pepto-Bismol) is a medicine that can treat diarrhea and upset stomach.
Compare with nizatidine →
cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
Compare with nizatidine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for nizatidine: 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: 1,480.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 10.61%.
- ramipril Δ 0.03 pts · 119,507 reports · ACE Inhibitor 10.57%death share
- metronidazole Δ 0.05 pts · 63,731 reports · Nitroimidazole Antibiotic 10.56%death share
- tretinoin Δ 0.07 pts · 7,629 reports · Retinoid (Topical) 10.54%death share
- alogliptin Δ 0.12 pts · 3,393 reports · DPP-4 Inhibitor 10.49%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
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
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
What the FDA Data Shows for nizatidine
The FDA label for nizatidine (sold under brand names such as Axid) classifies it as an over-the-counter product in the H2 Receptor Antagonist class. Nizatidine can treat active duodenal ulcers for up to 8 weeks. Official labeling lists 6 commonly reported side effects, including Headache, Abdominal pain, Diarrhea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,480 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.90.
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, 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 30, 2022
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