Over-the-counter medication · H2 Receptor Antagonist
ranitidine
Also sold as Zantac. This medicine treats heartburn caused by acid indigestion and sour stomach.
Data updated 2026-05-15
- 197,405
- FDA reportsHeavily reported
- 15
- InteractionsSeveral interactions
- 12
- Recall records
What the data shows
ranitidine (Zantac) is an over-the-counter H2 Receptor Antagonist, in the top 5% of tracked drugs by FAERS report volume (197,405 FDA reports), with 15 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.
ranitidine (Zantac) is an over-the-counter H2 Receptor Antagonist. This medicine treats heartburn caused by acid indigestion and sour stomach.
Ranitidine (Zantac) helps reduce stomach acid. It can relieve heartburn and sour stomach.
Verify with FDA → · CMS NADAC pricing →
What it does
This medicine treats heartburn caused by acid indigestion and sour stomach.
Common side effects
Headache
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
The sections below are summarized in plain English from ranitidine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Ranitidine is an H2 receptor antagonist. It works by blocking histamine. Blocking histamine reduces the amount of acid your stomach makes.
Side Effects (from patient reports)
Based on 197,405 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for ranitidine, by number of reports
- Breast Cancer
Breast Cancer
24,853 reports
- Prostate Cancer
Prostate Cancer
22,252 reports
- Colorectal Cancer
Colorectal Cancer
17,674 reports
- Bladder Cancer
Bladder Cancer
16,746 reports
- Renal Cancer
Renal Cancer
16,278 reports
- Oesophageal Carcinoma 9,648
Oesophageal Carcinoma
9,648 reports
- Incorrect Dose Administered 9,631
Incorrect Dose Administered
9,631 reports
- Hepatic Cancer 7,592
Hepatic Cancer
7,592 reports
- Gastric Cancer 7,538
Gastric Cancer
7,538 reports
- Pancreatic Carcinoma 6,840
Pancreatic Carcinoma
6,840 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 ranitidine 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 ranitidine sits
ranitidine has more FDA adverse-event reports than 95% 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 ranitidine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 197,405 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1999–2025.
Total Reports
197,405
Reports Mentioning Death
15,440
7.8% of reports — not proof of cause
Hospitalization Reports
25,953
Top Indication
Dyspepsia
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | BREAST CANCER | 24,853 |
| 2 | PROSTATE CANCER | 22,252 |
| 3 | COLORECTAL CANCER | 17,674 |
| 4 | BLADDER CANCER | 16,746 |
| 5 | RENAL CANCER | 16,278 |
| 6 | OESOPHAGEAL CARCINOMA | 9,648 |
| 7 | INCORRECT DOSE ADMINISTERED | 9,631 |
| 8 | HEPATIC CANCER | 7,592 |
| 9 | GASTRIC CANCER | 7,538 |
| 10 | PANCREATIC CARCINOMA | 6,840 |
| 11 | LUNG NEOPLASM MALIGNANT | 6,759 |
| 12 | NAUSEA | 4,715 |
| 13 | CHRONIC KIDNEY DISEASE | 4,687 |
| 14 | FATIGUE | 4,464 |
| 16 | HEADACHE | 3,932 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Known Drug Interactions
Dose adjustment is not recommended for risperidone tablets when co-administered with ranitidine, cimetidine, amitriptyline, or erythromycin [see Table 18 ] . Do not exceed twice the patient’s usual dose Enzyme (CYP3A) inhibitors Ranitidine 150 mg twice daily 1 mg single dose 1.2 1.4 Dose adjustment not needed Cimetidine 400 mg twice daily 1 mg single dose 1.1 1.3 Dose adjustment not needed Erythromycin 500 mg four times daily 1 mg single dose 1.1 0.94 Dose adjustment not needed Other Drugs Amitriptyline 50 mg twice daily 3 mg twice daily 1.2 1.1 Dose adjustment not Needed *Change relative...
Mechanism: Ranitidine causes a small increase in risperidone levels, but it is not enough to change how the drug works or its safety.
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: Ranitidine can slow down how quickly your liver processes theophylline, which may cause the drug to build up to unsafe levels in your body.
Cimetidine and Ranitidine Cimetidine and ranitidine do not affect the clearance of valproate.
Mechanism: Ranitidine does not change how the body processes or removes valproate from your system. There is no known interaction between these two drugs based on the provided information.
Other Drug Interactions Caution is advised when midazolam is administered concomitantly with drugs that are known to inhibit the P450-3A4 enzyme system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. The effect of single oral doses of 800 mg cimetidine and 300 mg ranitidine on steady-state concentrations of midazolam was examined in a randomized crossover study (n=8). Ranitidine increased the mean steady-state concentration to 62 ng/mL.
Mechanism: Ranitidine can cause midazolam levels to build up in your body. This happens because the drug is processed more slowly than usual.
Effect of Other Drugs on the Pharmacokinetics of Clonazepam: Literature reports suggest that ranitidine, an agent that decreases stomach acidity, does not greatly alter clonazepam pharmacokinetics.
Mechanism: Ranitidine reduces stomach acid but does not have a major effect on how clonazepam moves through your body.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What is ranitidine used for?
How often can I take ranitidine?
Can children take ranitidine?
How long before eating should I take ranitidine?
How many tablets can I take in a day?
What should I do if I miss a dose?
Can I take ranitidine while pregnant?
Can I take ranitidine while breastfeeding?
Does ranitidine have side effects?
How should I store ranitidine?
What are the common side effects of ranitidine?
Does ranitidine interact with other medications?
What drug class is ranitidine?
Has ranitidine been recalled?
Active Recalls
CGMP Deviations: Presence of NDMA impurity detected in product.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Presence of NDMA impurity detected in product.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Presence of NDMA impurity detected in product.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Presence of NDMA impurity detected in product.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Granules India Limited
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Amneal Pharmaceuticals, Inc.
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
AuroMedics Pharma LLC
CGMP Deviations: Presence of NDMA impurity detected in product.
Sanofi-Aventis U.S. LLC
CGMP Deviations: Presence of NDMA impurity detected in product.
Sanofi-Aventis U.S. LLC
CGMP Deviations: Presence of NDMA impurity detected in product.
Sanofi-Aventis U.S. LLC
CGMP Deviations: Presence of NDMA impurity detected in product.
Sanofi-Aventis U.S. LLC
CGMP Deviations: Presence of NDMA impurity detected in product.
Sanofi-Aventis U.S. LLC
Related Medications in H2 Receptor Antagonist
Other drugs grouped near ranitidine - 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 ranitidine →
aprepitant
Emend
Aprepitant (Emend) is a medicine that helps prevent nausea and vomiting.
Compare with ranitidine →
bisacodyl
Dulcolax
Bisacodyl is a medicine that helps you have a bowel movement.
Compare with ranitidine →
bismuth subsalicylate
Pepto-Bismol
Bismuth subsalicylate (Pepto-Bismol) is a medicine that can treat diarrhea and upset stomach.
Compare with ranitidine →
cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
Compare with ranitidine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for ranitidine: 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: 197,405.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 7.82%.
- etodolac Δ 0.02 pts · 5,880 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 7.81%death share
- cefdinir Δ 0.05 pts · 7,348 reports · Third-Generation Cephalosporin 7.77%death share
- cannabidiol Δ 0.06 pts · 22,227 reports · Cannabinoid (Anticonvulsant) 7.77%death share
- dofetilide Δ 0.07 pts · 10,302 reports · Class III Antiarrhythmic 7.76%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 ranitidine
The FDA label for ranitidine (sold under brand names such as Zantac) classifies it as an over-the-counter product in the H2 Receptor Antagonist class. This medicine treats heartburn caused by acid indigestion and sour stomach. Official labeling lists 1 commonly reported side effect, including Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 197,405 voluntary reports. The database also lists 15 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
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 12 recall records 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).
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: May 23, 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