Arsenic Trioxide
Other Antineoplastic Agents
Sold as Edema · Nausia · Endopar · B-Force · Shing-V
- Drug class
- Other Antineoplastic Agents
- Availability
- Prescription and OTC
- Routes
- Oral, Sublingual, Intravenous
- Markets covered
- 4
- Products on record
- 78
- FDA reports (12 mo)
- 202
Overview
Arsenic Trioxide is an active pharmaceutical ingredient in the Other Antineoplastic Agents group (L01XX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 62 | March 11, 2026 |
| GB United Kingdom | MHRA | 7 | May 15, 2026 |
| CA Canada | Health Canada | 6 | September 15, 2025 |
| EU European Union | EMA | 3 | April 21, 2026 |
USUnited States· FDA
62 products
Uses
Uses For temporary relief of discomfort associated with lymphatic swelling and edema. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
How to take
GBUnited Kingdom· MHRA
7 products
Uses
Arsenic Trioxide STADA is indicated for induction of remission, and consolidation in adult patients with: • Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/μl) in combination with all-trans-retinoic acid (ATRA) • Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR- alpha) gene.
The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.
How to take
CACanada· Health Canada
6 products
Uses
Arsenic Trioxide for Injection (arsenic trioxide) is indicated for: • induction of remission and consolidation in patients with acute promyelocytic leukemia (APL), which is refractory to or has relapsed from retinoid and anthracycline therapy, and whose APL is characterized by the presence of the t(15;17) translocation or promyelocytic leukemia-retinoic-acid-receptor alpha (PML-RARα) gene expression.
The indication is based on complete response rate. The duration of remission induced by arsenic trioxide has not been determined. The response rate of other acute myelogenous leukemia subtypes to arsenic trioxide has not been examined.
1 Pediatrics Pediatrics (< 18 years of age): Safety and effectiveness in relapsed APL pediatric patients below the age of 5 years have not been studied. There is limited clinical data on the use of arsenic trioxide in pediatric patients > 5 years and < 18 years of age with relapsed or refractory APL (see 14 CLINICAL TRIALS).
EUEuropean Union· EMA
3 products
Uses
Arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with: • Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (ATRA) • Relapsed/refractory APL (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RARα) gene.
The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.
How to take
Drug interactions
Known interactions involving Arsenic Trioxide. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 317. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 02661e24-1270-4b… · revised December 20, 2022 [PDF]
- [2]MHRA (UK) · PL208970118 · revised June 7, 2019
- [3]Health Canada (DPD) · 02492768 · revised March 22, 2025
- [4]European Medicines Agency · EMEA/H/C/005218 · revised April 21, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.