Prescription medicine
Rabeprazole Brand names: Aciphex
Rabeprazole (Aciphex) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $0.224 per rabeprazole sod DR 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the rabeprazole FDA label on DailyMed (effective January 27, 2026, Waylis Therapeutics LLC); the NDA 20973 record on Drugs@FDA; every rabeprazole label on DailyMed.
Highlights of the record
FDA label of January 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageACIPHEX delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1.1 ).
Forms and strengths
- 20 mg
Delayed-release tablet.
On the market
- Earliest approval on file
- August 19, 1999 Aciphex, Waylis Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first November 8, 2013; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 21 of which 20 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.224 per tablet Rabeprazole sod DR 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2016 0 Class I among all firms' recalls; latest December 12, 2016
- FAERS reports
- 38,147 through July 30, 2026
What is rabeprazole used for?
From the label: indications and usageACIPHEX delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1.1 ). Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2 ). Treatment of Symptomatic GERD ( 1.3 ). Healing of Duodenal Ulcers ( 1.4 ). Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence ( 1.5 ). Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 1.6 ). […]
Conditions named in the indications of rabeprazole's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Proton Pump Inhibitor.
Source: FDA drug label (Aciphex), Waylis Therapeutics LLC, effective January 27, 2026 (SPL set 1eb38279-0237-4967-be7a-c53a826c1138), via openFDA; the full label on DailyMed
What does the patient leaflet for rabeprazole 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 I should know about ACIPHEX?You should take ACIPHEX exactly as prescribed, at the lowest dose possible and for the shortest time needed. ACIPHEX may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. ACIPHEX can cause serious side effects, including: A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including ACIPHEX, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with ACIPHEX. 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 ACIPHEX, 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. Talk to your doctor about your risk of these serious side effects. ACIPHEX can have other serious side effects. […]
From the patient leaflet: How should I store ACIPHEX?Store ACIPHEX tablets in a dry place at room temperature between 68°F to 77°F (20°C to 25°C). Keep ACIPHEX and all medicines out of the reach of children. General Information about the safe and effective use of ACIPHEX. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ACIPHEX for a condition for which it was not prescribed. Do not give ACIPHEX to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about ACIPHEX that is written for health professionals.
Source: FDA drug label (Aciphex), Waylis Therapeutics LLC, effective January 27, 2026 (SPL set 1eb38279-0237-4967-be7a-c53a826c1138), via openFDA; the full label on DailyMed
Is there a generic for rabeprazole (Aciphex)?
The FDA approved the first generic rabeprazole on November 8, 2013. 10 generic applications are approved; 8 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 rabeprazole from 20 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2013 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for rabeprazole (Aciphex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.224 per Rabeprazole sod DR 20 mg tablet, about the same as a year earlier. 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.
- Rabeprazole sod DR 20 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Rabeprazole sod DR 20 mg tablet | Generic | $0.224 per tablet | $6.72 | -0.4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has rabeprazole been recalled?
The FDA's Enforcement Report lists 1 recall naming rabeprazole since 2016: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 12, 2016 | Class II | Amneal Pharmaceuticals LLC | Failed Dissolution Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the rabeprazole label say about other medicines?
The rabeprazole label names 17 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name rabeprazole. 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 | For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with ACIPHEX delayed-release tablets, refer to the Contraindications section of their package inserts. |
| Atazanavir | drug interactions | Antiretrovirals Clinical Impact: The effect of PPI 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 ACIPHEX delayed-release tablets is contraindicated [see ]. See prescribing information. … |
| Clarithromycin | contraindications | For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with ACIPHEX delayed-release tablets, refer to the Contraindications section of their package inserts. |
| Cyanocobalamin | warnings and precautions | Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin (5.8). |
| Dasatinib | drug interactions | Clinical Impact: Rabeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration 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 | 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 | Clinical Impact: Rabeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration 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 | Clinical Impact: Rabeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration 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 | Clinical Impact: Rabeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration 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 | Methotrexate Clinical Impact: Concomitant use of rabeprazole with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. … Intervention: A temporary withdrawal of ACIPHEX delayed-release tablets may be considered in some patients receiving high dose methotrexate administration. |
| Mycophenolate mofetil | drug interactions | Clinical Impact: Rabeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration 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 | Clinical Impact: Rabeprazole 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 | Antiretrovirals Clinical Impact: The effect of PPI 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 ACIPHEX delayed-release tablets. See prescribing information for nelfinavir. … |
| Nilotinib | drug interactions | Clinical Impact: Rabeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration 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 rabeprazole label names
| Medicine named | Section | What the label says |
|---|---|---|
| Rilpivirine | drug interactions | Antiretrovirals Clinical Impact: The effect of PPI 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 ACIPHEX delayed-release tablets is contraindicated [see ]. See prescribing information. … |
| Tacrolimus | drug interactions | 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. |
| Warfarin | drug interactions | Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including rabeprazole, 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 rabeprazole
Source: FDA drug label (Aciphex), Waylis Therapeutics LLC, effective January 27, 2026 (SPL set 1eb38279-0237-4967-be7a-c53a826c1138), via openFDA; the full label on DailyMed
What do FAERS reports show for rabeprazole?
The FDA Adverse Event Reporting System holds 38,147 reports that list rabeprazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,481 are coded as a death and 13,139 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 rose sharply in 2018 (6,767, against a median of 1,935 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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 rabeprazole?
21 other medicines are given the same way (oral) and in the same FDA class as rabeprazole 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 |
| Lansoprazole | Acid reflux and ulcers | 59 labelers | $0.106 per capsule 30 mg capsule | 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 rabeprazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does rabeprazole compare with medicines for the same use?
7 side-by-side pages set rabeprazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to rabeprazole
- 21 medicines for the same use
- Other proton pump inhibitors
- the pharmacologic class, with prices and generics
- Rabeprazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other