Prescription medicine
Arsenic trioxide Brand names: Trisenox
Arsenic trioxide (Trisenox) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 16 generic labelers.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the arsenic trioxide FDA label on DailyMed (effective July 23, 2021, Amneal Pharmaceuticals LLC); the NDA 21248 record on Drugs@FDA; every arsenic trioxide label on DailyMed.
Highlights of the record
FDA label of July 23, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
DIFFERENTIATION SYNDROME, CARDIAC CONDUCTION ABNORMALITIES AND ENCEPHALOPATHY INCLUDING WERNICKE’S.
Differentiation Syndrome: Patients with acute promyelocytic leukemia (APL) treated with arsenic trioxide have experienced differentiation syndrome, which may be life-threatening or fatal. Signs and symptoms may include unexplained fever, dyspnea, hypoxia, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, weight gain, peripheral edema, hypotension, renal insufficiency, hepatopathy, and multi-organ dysfunction, in the presence or absence of leukocytosis. If differentiation syndrome is suspected, immediately initiate high-dose corticosteroids and hemodynamic monitoring until resolution. Temporarily withhold arsenic trioxide [see Dosage and Administration (2.3), Warnings and Precautions (5.1) ]. Cardiac Conduction Abnormalities: Arsenic trioxide can cause QTc interval prolongation, complete atrioventricular block and torsade de pointes, which can be fatal. Before administering arsenic trioxide, assess the QTc interval, correct electrolyte abnormalities, and consider discontinuing drugs known to prolong QTc interval. Do not administer arsenic trioxide to patients with a ventricular arrhythmia or prolonged QTc interval. […]
Used for
From the label: indications and usageArsenic 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.
Forms and strengths
- 1 mg/ml
- 2 mg/ml
- 2 mg/2ml
Injection (solution); injection.
On the market
- Earliest approval on file
- September 25, 2000 Trisenox, Cephalon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first August 31, 2018; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 16 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,138 through July 30, 2026
What is arsenic trioxide used for?
From the label: indications and usageArsenic 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. ( 1.2 ) 1.2 Relapsed or Refractory APL Arsenic trioxide injection is 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.
Conditions named in the indications of arsenic trioxide's FDA labels, with every medicine labeled for each:
From other arsenic trioxide labelsLeukemia, lymphoma and myeloma: In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. …
Source: FDA drug label (Arsenic Trioxide), Amneal Pharmaceuticals LLC, effective July 23, 2021 (SPL set 5845022e-8c01-451b-ae49-a28e58c5f845), via openFDA; the full label on DailyMed
Is there a generic for arsenic trioxide (Trisenox)?
The FDA approved the first generic arsenic trioxide on August 31, 2018. 11 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists arsenic trioxide from 16 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.
- 2000 earliest approval on file
- 2018 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is arsenic trioxide in shortage?
No arsenic trioxide presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated September 21, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Arsenic Trioxide, Injection, 1 mg/1 mL (NDC 50742-438-10) | Ingenus Pharmaceuticals LLC | To Be Discontinued | February 24, 2026 |
| Arsenic Trioxide, Injection, 1 mg/1 mL (NDC 63323-637-10) | Fresenius Kabi USA, LLC | To Be Discontinued | September 21, 2026 |
Every arsenic trioxide presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the arsenic trioxide label say about other medicines?
The arsenic trioxide label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name arsenic trioxide. 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 |
|---|---|---|
| Amphotericin b | warnings and precautions | The risk may be increased when arsenic trioxide is co-administered with medications that can lead to electrolyte abnormalities (such as diuretics or amphotericin B) [see Drug Interactions (7) ]. |
| Dexamethasone | warnings and precautions | If differentiation syndrome is suspected, temporarily withhold arsenic trioxide and immediately initiate dexamethasone 10 mg intravenously every 12 hours and hemodynamic monitoring until resolution of signs and symptoms for a minimum of 3 days [see Dosage and Administration (2.3) ]. |
| Furosemide | warnings and precautions | Consider testing thiamine levels in patients at risk for thiamine deficiency (e.g., chronic alcohol use, malabsorption, nutritional deficiency, concomitant use of furosemide). |
| Prednisone | warnings and precautions | When TRISENOX is used in combination with tretinoin, prophylaxis with prednisone is recommended during the induction cycle [see Dosage and Administration ( 2.1 )]. |
| Thiamine | boxed warning | Consider testing thiamine levels in patients at risk for thiamine deficiency. |
| Tretinoin | drug interactions | Drugs That Can Lead to Hepatotoxicity Concomitant use of these drugs and TRISENOX, particularly when given in combination with tretinoin, may increase the risk of serious hepatotoxicity [see Warnings and Precautions ( 5.4 )]. |
Other labels that name arsenic trioxide
Source: FDA drug label (Arsenic Trioxide), Amneal Pharmaceuticals LLC, effective July 23, 2021 (SPL set 5845022e-8c01-451b-ae49-a28e58c5f845), via openFDA; the full label on DailyMed
What do FAERS reports show for arsenic trioxide?
The FDA Adverse Event Reporting System holds 1,138 reports that list arsenic trioxide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 145 are coded as a death and 400 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 arsenic trioxide?
37 other medicines are given the same way (oral) and in the same FDA class as arsenic trioxide 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 |
|---|---|---|---|---|
| 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 |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Hydroxyurea | Leukemia, lymphoma and myeloma | 10 labelers | $0.184 per capsule 500 mg capsule | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 4 labelers | $1.67 per capsule 50 mg capsule | No current entry |
| Bosutinib | Leukemia, lymphoma and myeloma | 3 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Arsenic trioxide side effects
- the label's list beside FAERS reports
- Arsenic trioxide shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other