Over-the-counter medication · Proton Pump Inhibitor (PPI)
lansoprazole
Also sold as Prevacid. Lansoprazole can treat several conditions caused by too much stomach acid.
Data updated 2026-05-15
- 173,086
- FDA reportsHeavily reported
- 14
- InteractionsSeveral interactions
- 71% less
- Generic vs brandBig savings
- 1
- Recall record
What the data shows
lansoprazole (Prevacid) is an over-the-counter Proton Pump Inhibitor (PPI), more reported than roughly 9 in 10 tracked drugs (173,086 FDA reports), whose generic runs roughly half the brand price or less (71% less).
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.
lansoprazole (Prevacid) is an over-the-counter Proton Pump Inhibitor (PPI). Lansoprazole can treat several conditions caused by too much stomach acid.
Lansoprazole is a medicine that reduces the amount of acid in your stomach. It belongs to a class of drugs called proton pump inhibitors (PPIs).
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$0.55/unit
Generic Price
$0.16/unit
Generic Savings
71%
Generic Available
Yes (17 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: LANSOPRAZOLE DR 15 MG CAPSULE
Same CMS presentation as the headline generic unit price above (6 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: +35.6% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| January 17, 2024 | $0.4362/EA | - | 3 |
| February 21, 2024 | $0.4339/EA | -0.5% | 1 |
| March 20, 2024 | $0.4182/EA | -3.6% | 1 |
| April 17, 2024 | $0.3441/EA | -17.7% | 4 |
| October 23, 2024 | $0.1972/EA | -42.7% | 1 |
| December 18, 2024 | $0.2675/EA | +35.6% | 20 |
What it does
Lansoprazole can treat several conditions caused by too much stomach acid.
Common side effects
Diarrhea, Abdominal pain, Nausea
Key warnings
Lansoprazole may hide the symptoms of stomach cancer.
The sections below are summarized in plain English from lansoprazole's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Lansoprazole works by blocking the enzyme in the stomach that produces acid. This helps to lower the amount of acid made. Lowering acid helps to heal damage and relieve symptoms.
Side Effects (from patient reports)
Based on 173,086 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for lansoprazole, by number of reports
- Chronic Kidney Disease
Chronic Kidney Disease
32,775 reports
- Acute Kidney Injury
Acute Kidney Injury
18,670 reports
- Renal Failure
Renal Failure
13,811 reports
- End Stage Renal Disease 9,782
End Stage Renal Disease
9,782 reports
- Renal Injury 9,520
Renal Injury
9,520 reports
- Nausea 8,964
Nausea
8,964 reports
- Diarrhoea 8,752
Diarrhoea
8,752 reports
- Dyspnoea 7,945
Dyspnoea
7,945 reports
- Fatigue 7,633
Fatigue
7,633 reports
- Vomiting 7,064
Vomiting
7,064 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 lansoprazole 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 lansoprazole sits
lansoprazole has more FDA adverse-event reports than 93% 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 lansoprazole; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 173,086 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1997–2025.
Total Reports
173,086
Reports Mentioning Death
19,347
11.2% of reports — not proof of cause
Hospitalization Reports
62,821
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | CHRONIC KIDNEY DISEASE | 32,775 |
| 2 | ACUTE KIDNEY INJURY | 18,670 |
| 3 | RENAL FAILURE | 13,811 |
| 4 | END STAGE RENAL DISEASE | 9,782 |
| 5 | RENAL INJURY | 9,520 |
| 6 | NAUSEA | 8,964 |
| 7 | DIARRHOEA | 8,752 |
| 8 | DYSPNOEA | 7,945 |
| 9 | FATIGUE | 7,633 |
| 10 | VOMITING | 7,064 |
| 12 | HEADACHE | 6,742 |
| 13 | PAIN | 6,733 |
| 15 | DIZZINESS | 6,013 |
| 16 | MALAISE | 5,795 |
| 17 | PYREXIA | 5,494 |
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
Lansoprazole may hide the symptoms of stomach cancer. If you have a poor response or early return of symptoms, your doctor may do more tests. Long-term use of PPIs like lansoprazole may increase your risk of bone fractures. It may also cause low magnesium levels or Vitamin B-12 deficiency.
Known Drug Interactions
Combination Therapy with Clarithromycin and Amoxicillin Clinical Impact: Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions, including potentially fatal arrhythmias, and are contraindicated. Amoxicillin also has drug interactions. See Drug Interactions in prescribing information for amoxicillin.
Mechanism: Using these drugs together as part of a treatment plan can increase the risk of side effects or change how other medicines work.
Combination Therapy with Clarithromycin and Amoxicillin Clinical Impact: Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions, including potentially fatal arrhythmias, and are contraindicated. Intervention : See Contraindications and Warnings and Precautions in prescribing information for clarithromycin.
Mechanism: Clarithromycin can cause serious and potentially fatal heart rhythm problems when combined with certain other drugs.
Clinically Relevant Interactions Affecting Lansoprazole Delayed Release Capsules When CoAdministered with Other Drugs CYP2C19 OR CYP3A4 Inducers Clinical Impact: Decreased exposure of lansoprazole when used concomitantly with strong inducers [ see Clinical Pharmacology ( 12.3 )] Intervention : St John’s Wort, rifampin : Avoid concomitant use with Lansoprazole.
Mechanism: Rifampin causes the body to break down lansoprazole too quickly, which makes the medicine less effective.
Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and Precautions ( 5.7 , 5.10 , 5.11 )] .
Mechanism: Lansoprazole makes it harder for your body to get rid of tacrolimus. This can cause the medicine to build up to unsafe levels in your system.
Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin.
Mechanism: Lansoprazole can change how your body handles warfarin, which can make your blood thinner than it should be.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I crush or chew the lansoprazole capsule?
How long does it take for lansoprazole to work?
Can I take lansoprazole with other medications?
What should I do if I experience side effects?
Can I take lansoprazole long-term?
Is lansoprazole safe for children?
Can lansoprazole cause diarrhea?
Does lansoprazole interact with food?
Can lansoprazole cause headaches?
What if lansoprazole doesn't relieve my symptoms?
What are the common side effects of lansoprazole?
Does lansoprazole interact with other medications?
What drug class is lansoprazole?
Is there a generic version of lansoprazole?
What pregnancy or breastfeeding source fields are listed for lansoprazole?
Has lansoprazole been recalled?
Active Recalls
CGMP Deviations: product held outside appropriate storage temperature conditions.
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Related Medications in Proton Pump Inhibitor (PPI)
Other drugs grouped near lansoprazole - 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 lansoprazole →
aprepitant
Emend
Aprepitant (Emend) is a medicine that helps prevent nausea and vomiting.
Compare with lansoprazole →
bisacodyl
Dulcolax
Bisacodyl is a medicine that helps you have a bowel movement.
Compare with lansoprazole →
bismuth subsalicylate
Pepto-Bismol
Bismuth subsalicylate (Pepto-Bismol) is a medicine that can treat diarrhea and upset stomach.
Compare with lansoprazole →
cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
Compare with lansoprazole →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for lansoprazole: 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: 173,086.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 11.18%.
- prasugrel Δ 0.04 pts · 2,254 reports · P2Y12 Inhibitor (Antiplatelet) 11.14%death share
- ascorbic acid Δ 0.05 pts · 22,556 reports · Vitamin C Supplement 11.13%death share
- terazosin Δ 0.06 pts · 7,436 reports · Alpha-1 Blocker 11.24%death share
- zaleplon Δ 0.07 pts · 1,538 reports · Non-Benzodiazepine Hypnotic (Z-Drug) 11.25%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 lansoprazole
The FDA label for lansoprazole (sold under brand names such as Prevacid) classifies it as an over-the-counter product in the Proton Pump Inhibitor (PPI) class. Lansoprazole can treat several conditions caused by too much stomach acid. Official labeling lists 4 commonly reported side effects, including Diarrhea, Abdominal pain, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 173,086 voluntary reports. The database also lists 14 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 $0.16 versus $0.55 for the brand - a 71% 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: April 15, 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