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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 usage

MERCAPTOPURINE 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September 11, 1953 Purinethol, Stason Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 usage

MERCAPTOPURINE 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)
$1.72
$0.823
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Mercaptopurine 50 mg tabletGeneric$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.

StartedClassCompanyReason
February 9, 2024Class IIIStason Pharmaceuticals, Inc.Failed Dissolution Specifications: results slightly under spec at at 9-months.
November 19, 2014Class IIAmerican Health PackagingFailed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. …
October 22, 2014Class IIPrometheus Laboratories Inc.Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
April 4, 2014Class IIIBoehringer Ingelheim Roxane IncLabeling: 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, 2012Class IIAmerican Health PackagingFailed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. …
June 29, 2012Class IIPrometheus 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 namedSectionWhat the label says
Allopurinoldrug interactionsDRUG INTERACTIONS Allopurinol: Reduce the dose of MERCAPTOPURINE when co-administered with allopurinol.
Mesalaminedrug interactionsAminosalicylates (e.g., mesalamine, olsalazine or sulfasalazine) may inhibit the TPMT enzyme, which may increase the risk of myelosuppression when coadministered with mercaptopurine tablets.
Olsalazinedrug interactionsAminosalicylates (e.g., mesalamine, olsalazine or sulfasalazine) may inhibit the TPMT enzyme, which may increase the risk of myelosuppression when coadministered with mercaptopurine tablets.
Sulfasalazinedrug interactionsAminosalicylates (e.g., mesalamine, olsalazine or sulfasalazine) may inhibit the TPMT enzyme, which may increase the risk of myelosuppression when coadministered with mercaptopurine tablets.
Warfarindrug interactionsMonitor INR and adjust warfarin dose as appropriate. ( 7.2 ) See FDA approved patient labeling and

Other labels that name mercaptopurine

Check mercaptopurine against other medicines

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

  • Febrile Neutropenia1,923
  • Off Label Use (a use or a product term, not a reaction)1,380
  • Pyrexia1,225
  • Drug Ineffective (a use or a product term, not a reaction)1,117
  • Nausea (named in the label)815
  • Vomiting (named in the label)783
  • Abdominal Pain719
  • Diarrhoea (named in the label)716

Side effects: the label's list and every FAERS reaction

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.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
AzacitidineLeukemia, lymphoma and myelomanone listedn/aIn shortage
Cedazuridine and decitabineLeukemia, lymphoma and myelomanone listedn/aNo current entry
LenalidomideLeukemia, lymphoma and myeloma18 labelersn/aNo current entry
DasatinibLeukemia, lymphoma and myeloma14 labelers$26.46 per tablet 100 mg tabletNo current entry
PomalidomideLeukemia, lymphoma and myeloma11 labelersn/aNo current entry
ImatinibLeukemia, lymphoma and myeloma20 labelers$0.624 per tablet 100 mg tabletNo current entry
Arsenic trioxideLeukemia, lymphoma and myelomanone listedn/aA presentation being discontinued
NilotinibLeukemia, lymphoma and myeloma6 labelersn/aNo 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