Quick answers
- What is Thioguanine used for?
- The FDA-approved label (Tabloid, Waylis Therapeutics LLC, January 8, 2025) says: “a) Acute Nonlymphocytic Leukemias TABLOID brand Thioguanine is indicated for remission induction and remission consolidation treatment of acute nonlymphocytic leukemias. However, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity (see WARNINGS and ADVERSE REACTIONS). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Thioguanine have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Thioguanine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Thioguanine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Thioguanine?
- 1 company lists prescription products of Thioguanine in the FDA NDC Directory, including Waylis Therapeutics LLC.
What Thioguanine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
a) Acute Nonlymphocytic Leukemias TABLOID brand Thioguanine is indicated for remission induction and remission consolidation treatment of acute nonlymphocytic leukemias. However, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity (see WARNINGS and ADVERSE REACTIONS). …
— FDA label: Tabloid, Waylis Therapeutics LLC, effective January 8, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Tabloid |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Waylis Therapeutics LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA012429 THIOGUANINE | Waylis Therap | January 18, 1966 | 17, latest July 9, 2024 2024: Labeling · 2018: Labeling · 2004: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 105590, 198269 |
|---|---|
| SPL set ID of the quoted label | 44b0c461-47fb-4106-ba11-6ed85530235c |
| FDA labels (SPL) | 1 |
| FDA applications | NDA012429 |
| Active ingredients (FDA) | THIOGUANINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tabloid, Waylis Therapeutics LLC, effective January 8, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →