Prescription medicine
Mercaptopurine Brand names: Purixan; first approved as Purinethol
Mercaptopurine (Purinethol) is a prescription medicine with an FDA approval on record since 1953. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $1.07 per mercaptopurine 50 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the mercaptopurine FDA label on DailyMed (effective July 20, 2026, Nova Laboratories, Ltd); the NDA 9053 record on Drugs@FDA; every mercaptopurine label on DailyMed.
Highlights of the record
FDA label of July 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageMERCAPTOPURINE is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
Forms and strengths
- 50 mg
- 20 mg/ml
Suspension; tablet.
On the market
- Earliest approval on file
- September 11, 1953 Purinethol, Stason Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first February 11, 2004; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 2 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.07 per tablet Mercaptopurine 50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2012 0 Class I among all firms' recalls; latest February 9, 2024
- FAERS reports
- 17,961 through July 30, 2026
What is mercaptopurine used for?
From the label: indications and usageMERCAPTOPURINE is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia MERCAPTOPURINE is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
Conditions named in the indications of mercaptopurine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nucleoside Metabolic Inhibitor.
Source: FDA drug label (MERCAPTOPURINE), Nova Laboratories, Ltd, effective July 20, 2026 (SPL set 9c6fc66b-522f-499d-961a-cde6ca0ec2e5), via openFDA; the full label on DailyMed
What does the patient leaflet for mercaptopurine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking MERCAPTOPURINE?MERCAPTOPURINE can make your skin more sensitive to sunlight. Protect yourself from sunlight during treatment with MERCAPTOPURINE.
From the patient leaflet: How should I store MERCAPTOPURINE?MERCAPTOPURINE comes in a bottle with a child-resistant cap. Store MERCAPTOPURINE between 59ºF to 77ºF (15ºC to 25ºC), in a dry place. Do not store above 25°C. Store the oral dispensing syringe in a clean place, with the medicine. MERCAPTOPURINE oral suspension should be used within 8 weeks after opening the bottle. Dispose of (throw away) any unused medicine after 8 weeks. Do not use after the expiry date which is stated on the carton and the bottle after ‘EXP’. Keep the bottle tightly closed to prevent spoilage of the medicine and reduce the risk of accidental spillage. Keep MERCAPTOPURINE out of the reach of children, preferably in a locked cupboard. If a child accidentally takes MERCAPTOPURINE, it could cause death.
Source: FDA drug label (MERCAPTOPURINE), Nova Laboratories, Ltd, effective July 20, 2026 (SPL set 9c6fc66b-522f-499d-961a-cde6ca0ec2e5), via openFDA; the full label on DailyMed
Is there a generic for mercaptopurine (Purinethol)?
The FDA approved the first generic mercaptopurine on February 11, 2004. 4 generic applications are approved; 3 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 mercaptopurine from 2 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1953 earliest approval on file
- 2004 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 mercaptopurine (Purinethol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.07 per Mercaptopurine 50 mg tablet, down 7% from $1.16 on October 8, 2025. 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.
- Mercaptopurine 50 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Mercaptopurine 50 mg tablet | Generic | $1.07 per tablet | $32.14 | -7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has mercaptopurine been recalled?
The FDA's Enforcement Report lists 6 recalls naming mercaptopurine since 2012: 0 Class I (the most serious), 4 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 9, 2024 | Class III | Stason Pharmaceuticals, Inc. | Failed Dissolution Specifications: results slightly under spec at at 9-months. |
| November 19, 2014 | Class II | American Health Packaging | Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. … |
| October 22, 2014 | Class II | Prometheus Laboratories Inc. | Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. |
| April 4, 2014 | Class III | Boehringer Ingelheim Roxane Inc | Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed … |
| July 23, 2012 | Class II | American Health Packaging | Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. … |
| June 29, 2012 | Class II | Prometheus Laboratories Inc. | Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the mercaptopurine label say about other medicines?
The mercaptopurine label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name mercaptopurine. 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 |
|---|---|---|
| Allopurinol | drug interactions | DRUG INTERACTIONS Allopurinol: Reduce the dose of MERCAPTOPURINE when co-administered with allopurinol. |
| Mesalamine | drug interactions | Aminosalicylates (e.g., mesalamine, olsalazine or sulfasalazine) may inhibit the TPMT enzyme, which may increase the risk of myelosuppression when coadministered with mercaptopurine tablets. |
| Olsalazine | drug interactions | Aminosalicylates (e.g., mesalamine, olsalazine or sulfasalazine) may inhibit the TPMT enzyme, which may increase the risk of myelosuppression when coadministered with mercaptopurine tablets. |
| Sulfasalazine | drug interactions | Aminosalicylates (e.g., mesalamine, olsalazine or sulfasalazine) may inhibit the TPMT enzyme, which may increase the risk of myelosuppression when coadministered with mercaptopurine tablets. |
| Warfarin | drug interactions | Monitor INR and adjust warfarin dose as appropriate. ( 7.2 ) See FDA approved patient labeling and |
Other labels that name mercaptopurine
Source: FDA drug label (MERCAPTOPURINE), Nova Laboratories, Ltd, effective July 20, 2026 (SPL set 9c6fc66b-522f-499d-961a-cde6ca0ec2e5), via openFDA; the full label on DailyMed
What do FAERS reports show for mercaptopurine?
The FDA Adverse Event Reporting System holds 17,961 reports that list mercaptopurine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,979 are coded as a death and 7,995 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 mercaptopurine?
37 other medicines are given the same way (oral) and in the same FDA class as mercaptopurine or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 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 |
|---|---|---|---|---|
| Azacitidine | Leukemia, lymphoma and myeloma | none listed | n/a | In shortage |
| Cedazuridine and decitabine | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as mercaptopurine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to mercaptopurine
- 37 medicines for the same use
- Other nucleoside metabolic inhibitors
- the pharmacologic class, with prices and generics
- Mercaptopurine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other