Quick answers
- What is Arsenic trioxide used for?
- The FDA-approved label (Arsenic Trioxide, Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc, November 7, 2025) says: “Arsenic trioxide injection is an arsenical indicated: For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Arsenic trioxide have a boxed warning?
- Yes. The FDA label for Arsenic Trioxide has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Arsenic trioxide?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated September 21, 2026). Ask your pharmacist about alternatives.
- Has Arsenic trioxide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Arsenic trioxide?
- 17 companies list prescription products of Arsenic trioxide in the FDA NDC Directory, including Zydus Pharmaceuticals USA Inc., Sintetica US LLC and Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc.
What Arsenic trioxide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Arsenic trioxide injection is an arsenical indicated: For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. …
— FDA label: Arsenic Trioxide, Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc, effective November 7, 2025. Read the full label on DailyMed →
The FDA has 20 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
18 of 20 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 28 in the FDA NDC Directory |
| Brand names | Trisenox |
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.
- Zydus Pharmaceuticals USA Inc.4 products
- Sintetica US LLC2 products
- Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc2 products
- Novadoz Pharmaceuticals LLC2 products
- Orbicular Pharmaceutical Technologies Private Limited2 products
- Sagent Pharmaceuticals2 products
- Amneal Pharmaceuticals LLC2 products
- Zydus Lifesciences Limited2 products
- Gland Pharma Limited2 products
- NorthStar Rx LLC1 product
- Sandoz Inc1 product
- Ingenus Pharmaceuticals, LLC1 product
- Fresenius Kabi USA, LLC1 product
- Eugia US LLC1 product
- Nordic Pharma, Inc.1 product
- Nexus Pharmaceuticals LLC1 product
- Cephalon, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021248 TRISENOX | Cephalon | September 25, 2000 | 8, latest October 20, 2020 2020: Labeling · 2019: Labeling · 2018: Efficacy |
Generic approvals (10)
- ANDA208231Fresenius Kabi USA · August 31, 2018
- ANDA206228Zydus Pharms · November 13, 2018
- ANDA210802J Molner · November 13, 2018
- ANDA209315Ingenus Pharms LLC · November 15, 2018
- ANDA209780Nexus · November 15, 2018
- ANDA210739Amneal · January 25, 2021
- ANDA215059Gland · October 7, 2021
- ANDA214011Eugia Pharma · October 15, 2021
- ANDA215359Sandoz · December 2, 2021
- ANDA217413Msn · April 20, 2023
Shortage status
To be discontinued · updated September 21, 2026 · first posted September 21, 2026
| Product | Arsenic Trioxide, Injection, 1 mg/1 mL (NDC 63323-637-10) |
|---|---|
| Company | Fresenius Kabi USA, LLC |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 829926, 1992545 |
|---|---|
| SPL set ID of the quoted label | 8dddfe9e-06bf-4983-9c55-71b19da8fcdc |
| FDA labels (SPL) | 20 |
| FDA applications | NDA021248, 10 ANDA |
| Active ingredients (FDA) | ARSENIC TRIOXIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Arsenic Trioxide, Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc, effective November 7, 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 →