Prescription and over-the-counter medicine
Lansoprazole Brand names: Prevacid
Lansoprazole (Prevacid) is a prescription and over-the-counter medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 59 generic labelers, and pharmacies paid $0.106 per lansoprazole DR 30 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the lansoprazole FDA label on DailyMed (effective June 24, 2025, L. Perrigo Company); the NDA 20406 record on Drugs@FDA; every lansoprazole label on DailyMed.
Highlights of the record
FDA label of June 24, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagetreats frequent heartburn (occurs 2 or more days a week)
not intended for immediate relief of heartburn;
Forms and strengths
- 15 mg
- 30 mg
Delayed-release capsule; orally disintegrating delayed-release tablet; capsule (delayed release pellets); orally disintegrating tablet.
On the market
- Earliest approval on file
- May 10, 1995 Prevacid, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 30 first November 10, 2009; 20 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 61 of which 59 under generic applications, 8 under brand applications, repackagers included
- Last listed patent
- April 21, 2036 Lansoprazole tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.106 per capsule Lansoprazole DR 30 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 15 since 2013 0 Class I among all firms' recalls; latest March 27, 2024; 1 more by firms not listed as its makers
- FAERS reports
- 177,061 through July 30, 2026
What is lansoprazole used for?
From the label: indications and usagetreats frequent heartburn (occurs 2 or more days a week)
not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Conditions named in the indications of lansoprazole's FDA labels, with every medicine labeled for each:
From other lansoprazole labelsAcid reflux and ulcers: Treatment of active duodenal ulcer in adults. ( 1.1 ) Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. ( 1.2 ) Maintenance of healed duodenal ulcers in adults. …
FDA pharmacologic class: Proton Pump Inhibitor.
Source: FDA drug label (Prevacid 24 HR), L. Perrigo Company, effective June 24, 2025 (SPL set 205c9c1e-b422-4e86-a4b0-714b608adc19), via openFDA; the full label on DailyMed
What does the patient leaflet for lansoprazole say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information that I should know about PREVACID and PREVACID SoluTab?You should take PREVACID and PREVACID SoluTab exactly as prescribed, at the lowest dose possible and for the shortest time needed. PREVACID and PREVACID SoluTab may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. PREVACID and PREVACID SoluTab can cause serious side effects, including: A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PREVACID and PREVACID SoluTab, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with PPI medicines including PREVACID and PREVACID SoluTab. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. Diarrhea caused by an infection ( Clostridium difficile ) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine. Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body's immune cells attack other cells or organs in the body). Some people who take PPI medicines, including PREVACID and PREVACID SoluTab, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. […]
From the patient leaflet: How should I store PREVACID and PREVACID SoluTab?Store PREVACID at room temperature between 68°F to 77°F (20°C to 25°C). Keep PREVACID and PREVACID SoluTab and all medicines out of the reach of children.
Source: FDA drug label (Prevacid), Takeda Pharmaceuticals America, Inc., effective July 8, 2025 (SPL set 71ba78cb-7e46-43eb-9425-fa130f537f84), via openFDA; the full label on DailyMed
Is there a generic for lansoprazole (Prevacid)?
The FDA approved the first generic lansoprazole on November 10, 2009. 30 generic applications are approved; 20 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists lansoprazole from 59 labelers under a generic (ANDA) application and from 8 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Prevacid tablets; a patent listed only for Lansoprazole tablets runs to April 21, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1995 earliest approval on file
- 2009 first generic approved
- 2036 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lansoprazole (Prevacid)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.106 per Lansoprazole DR 30 mg capsule, about the same as a year earlier. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Lansoprazole DR 30 mg capsule (generic)
- Prevacid DR 30 mg solutab (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ft acid reducer DR 15 mg capsule | Generic | $0.407 per capsule | $12.20 | -10% |
| Gnp lansoprazole DR 15 mg capsule | Generic | $0.407 per capsule | $12.20 | -10% |
| Gs lansoprazole DR 15 mg capsule | Generic | $0.407 per capsule | $12.20 | -10% |
| Lansoprazole DR 15 mg capsule | Generic | $0.147 per capsule | $4.42 | -7% |
| Lansoprazole DR 15 mg ODT | Generic | $1.92 per unit | n/a | +10% |
| Lansoprazole DR 30 mg capsule | Generic | $0.106 per capsule | $3.18 | +0.7% |
| Lansoprazole DR 30 mg ODT | Generic | $2.26 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -6% |
| Qc lansoprazole DR 15 mg capsule | Generic | $0.407 per capsule | $12.20 | -10% |
| Prevacid DR 15 mg solutab | Brand | $13.25 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +0.3% |
| Prevacid DR 30 mg capsule | Brand | $13.22 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $396.58 | -0.2% |
| Prevacid DR 30 mg solutab | Brand | $13.21 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has lansoprazole been recalled?
The FDA's Enforcement Report lists 16 recalls naming lansoprazole since 2013: 0 Class I (the most serious), 14 Class II, 2 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of lansoprazole and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 27, 2024 | Class II | NATCO Pharma Limited | CGMP Deviations |
| February 1, 2024 | Class II | NATCO Pharma Limited | CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to … |
| March 28, 2022 | Class II | Preferred Pharmaceuticals, Inc. | Out of specification results observed in dissolution during long term stability testing. |
| March 23, 2022 | Class II | Dr. Reddy's Laboratories, Inc. | Failed Dissolution Specifications; during long term stability testing. |
| December 3, 2020 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed Dissolution Specifications |
| October 27, 2020 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed Dissolution Specification |
| March 11, 2019 | Class III | Teva Pharmaceuticals USA | Subpotent Drug. |
| September 8, 2016 | Class III | Mckesson Packaging Services | Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lansoprazole label say about other medicines?
The lansoprazole label names 21 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name lansoprazole. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amoxicillin | contraindications (prescription label) | For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with PREVACID or PREVACID SoluTab, refer to the Contraindications section of their prescribing information. |
| Atazanavir | drug interactions (prescription label) | Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. … Intervention: Rilpivirine-containing products: Concomitant use with PREVACID or PREVACID SoluTab is contraindicated [see ]. See prescribing information. … |
| Clarithromycin | contraindications (prescription label) | For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with PREVACID or PREVACID SoluTab, refer to the Contraindications section of their prescribing information. |
| Cyanocobalamin | warnings and precautions (prescription label) | Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.7 ) Hypomagnesemia and Mineral Metabolism: |
| Dasatinib | drug interactions (prescription label) | Clinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid … |
| Digoxin | drug interactions (prescription label) | Clinical Impact: Potential for increased exposure of digoxin. Intervention: Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. See prescribing information for digoxin. |
| Erlotinib | drug interactions (prescription label) | Clinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid … |
| Itraconazole | drug interactions (prescription label) | Clinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid … |
| Ketoconazole | drug interactions (prescription label) | Clinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid … |
| Methotrexate | drug interactions (prescription label) | Methotrexate Clinical Impact: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. … Intervention: A temporary withdrawal of PREVACID or PREVACID SoluTab may be considered in some patients receiving high-dose methotrexate. |
| Mycophenolate mofetil | drug interactions (prescription label) | Clinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid … |
| Mycophenolic acid | drug interactions (prescription label) | Clinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. … receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. … |
| Nelfinavir | drug interactions (prescription label) | Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. … Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with PREVACID or PREVACID SoluTab. See prescribing information for nelfinavir. … |
| Nilotinib | drug interactions (prescription label) | Clinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid … |
Every other medicine the lansoprazole label names
| Medicine named | Section | What the label says |
|---|---|---|
| Rifampin | drug interactions (prescription label) | CYP2C19 OR CYP3A4 Inducers Clinical Impact: Decreased exposure of lansoprazole when used concomitantly with strong inducers. Intervention: St John's Wort, rifampin: Avoid concomitant use with PREVACID or PREVACID SoluTab. Ritonavir-containing products: See prescribing information. |
| Rilpivirine | drug interactions (prescription label) | Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. … Intervention: Rilpivirine-containing products: Concomitant use with PREVACID or PREVACID SoluTab is contraindicated [see ]. See prescribing information. … |
| Sucralfate | drug interactions (prescription label) | Sucralfate Clinical Impact: Decreased and delayed absorption of lansoprazole. Intervention: Take PREVACID or PREVACID SoluTab at least 30 minutes prior to sucralfate [see ]. |
| Tacrolimus | drug interactions (prescription label) | Tacrolimus Clinical Impact: Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19. Intervention: Monitor tacrolimus whole blood trough concentrations. Dose adjustment of tacrolimus may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus. |
| Theophylline | drug interactions (prescription label) | Theophylline Clinical Impact: Increased clearance of theophylline. Intervention: Individual patients may require additional titration of their theophylline dosage when PREVACID or PREVACID SoluTab is started or stopped to ensure clinically effective blood concentrations. |
| Voriconazole | drug interactions (prescription label) | CYP2C19 or CYP3A4 Inhibitors Clinical Impact: Increased exposure of lansoprazole is expected when used concomitantly with strong inhibitors. Intervention: Voriconazole: See prescribing information. |
| Warfarin | drug interactions (prescription label) | Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin. |
Other labels that name lansoprazole
Source: FDA drug label (Prevacid 24 HR), L. Perrigo Company, effective June 24, 2025 (SPL set 205c9c1e-b422-4e86-a4b0-714b608adc19), via openFDA; the full label on DailyMed
What do FAERS reports show for lansoprazole?
The FDA Adverse Event Reporting System holds 177,061 reports that list lansoprazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 19,914 are coded as a death and 64,598 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as lansoprazole?
21 other medicines are given the same way (oral) and in the same FDA class as lansoprazole or labeled mainly for the same use (acid reflux and ulcers), the same class first. Acid reflux and ulcers lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Omeprazole | Acid reflux and ulcers | 121 labelers | $0.0295 per capsule 20 mg capsule | A presentation being discontinued |
| Esomeprazole | Acid reflux and ulcers | 117 labelers | $0.145 per capsule 20 mg capsule | No current entry |
| Pantoprazole | Acid reflux and ulcers | 52 labelers | $0.0358 per tablet 40 mg tablet | No current entry |
| Rabeprazole | Acid reflux and ulcers | 20 labelers | $0.224 per tablet 20 mg tablet | No current entry |
| Omeprazole and sodium bicarbonate | Acid reflux and ulcers | 20 labelers | $7.90 per packet 40-1,680 packet | No current entry |
| Dexlansoprazole | Acid reflux and ulcers | 9 labelers | $3.71 per capsule 60 mg capsule | No current entry |
| Esomeprazole and naproxen | Acid reflux and ulcers | 10 labelers | $1.96 per unit 500-20 mg | No current entry |
| Calcium carbonate | Acid reflux and ulcers | none listed | $0.0315 per tablet 750 mg tablet chewable | No current entry |
Every medicine labeled for the same conditions as lansoprazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does lansoprazole compare with medicines for the same use?
9 side-by-side pages set lansoprazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to lansoprazole
- 21 medicines for the same use
- Other proton pump inhibitors
- the pharmacologic class, with prices and generics
- Lansoprazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other