FDA-filed SPL labeling · retrieved through openFDA

Arsenic Trioxide

Arsenic trioxide is a chemotherapy agent used intravenously to treat acute promyelocytic leukemia (APL), both in newly diagnosed low-risk cases and in relapsed or treatment-resistant disease.

Brand names TrisenoxArsenicum albumArsenicum Album 30CArsenicum Album Kit RefillArsenicum Album 200C +2 more
Rx/OTC Forms 6 Routes Intravenous · Oral · Sublingual
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 21 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJun 30, 2025
Clinical labels in scope ⓘ21
AvailabilityRx/OTC
Earliest approval/marketing year ⓘ1983
FDA-listed product records ⓘ101
Boxed warningYes
How we combine label and product data →
Other forms & routes:
Injection
⭐ Arsenic Trioxide at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Arsenic trioxide injection is a powerful chemotherapy used to treat acute promyelocytic leukemia (APL), either as first-line therapy (with tretinoin) or for relapsed/refractory disease. It requires close monitoring for serious heart rhythm problems, a dangerous inflammatory reaction called differentiation syndrome, and brain toxicity — all of which need immediate medical attention if they occur. This drug is only given in a supervised clinical setting, and your care team will watch you carefully throughout every treatment cycle.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Arsenic trioxide injection carries three serious boxed warnings that every patient and caregiver should know about.

1. Differentiation Syndrome: This is a potentially life-threatening reaction where the body responds to dying leukemia cells with severe inflammation. Symptoms can include unexplained fever, trouble breathing, fluid buildup around the lungs or heart, sudden weight gain, low blood pressure, and organ problems. If this happens, the drug must be stopped immediately and emergency treatment started.

2. Heart Rhythm Problems: Arsenic trioxide can cause dangerous changes to the heart's electrical system — including a prolonged QT interval and a serious arrhythmia called torsade de pointes — which can be fatal. Before starting and during treatment, your heart rhythm will be checked by ECG, electrolytes (potassium, magnesium) will be monitored, and any other drugs that affect heart rhythm should be stopped if possible.

3. Brain Toxicity (Encephalopathy including Wernicke's): Serious brain problems have occurred, including Wernicke's encephalopathy — a neurological emergency caused by thiamine (vitamin B1) deficiency. Watch for confusion, vision changes, difficulty walking, or decreased alertness. If Wernicke's encephalopathy is suspected, the drug must be stopped immediately and thiamine given urgently.

Read the full warning on DailyMed →

📖 Arsenic Trioxide: Patient Information Guide

A plain-language walkthrough of Arsenic Trioxide — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Arsenic trioxide injection is a chemotherapy used specifically for acute promyelocytic leukemia (APL), a type of blood cancer confirmed by the presence of a specific genetic abnormality.

  • Trisenox (intravenous injection) is approved in combination with tretinoin for adults with newly diagnosed low-risk APL whose cancer carries the t(15;17) translocation or PML/RAR-alpha gene expression
  • Trisenox (intravenous injection) is also approved for relapsed or refractory APL — meaning APL that has come back or stopped responding to retinoid and anthracycline chemotherapy — to induce remission and consolidate treatment
  • Arsenic trioxide injection (intravenous) is approved in combination with tretinoin for adults with newly diagnosed low-risk APL
  • Arsenic trioxide injection (intravenous) is approved for relapsed or refractory APL induction and consolidation in patients who have not responded to or relapsed after retinoid and anthracycline chemotherapy
⚙️How it works▾

Arsenic trioxide's exact mechanism is not completely understood, but it works in at least two key ways against leukemia cells. First, it triggers apoptosis — a form of programmed cell death — causing the cancerous promyelocytes to break down and self-destruct. Second, it damages or degrades an abnormal protein called PML/RAR-alpha, which is the molecular engine driving this specific type of leukemia. By dismantling that protein, the drug removes a major signal that keeps the cancer cells growing.

💊How it's taken▾

Arsenic trioxide injection is given intravenously (into a vein) in a clinical or hospital setting — it is never taken at home or by mouth for its approved uses. Treatment is divided into an induction phase (daily infusions until remission is achieved) and a consolidation phase (structured cycles of daily infusions over several weeks). For newly diagnosed APL, consolidation involves multiple cycles given alongside tretinoin; for relapsed/refractory APL, there is one induction and one consolidation cycle. Your prescriber will set the exact schedule and monitor you closely throughout. Always follow your treatment team's instructions — do not adjust your schedule without checking with them first.

🤒Side effects — in detail▾

Arsenic trioxide injection causes a range of side effects; the most common ones (reported in more than 30% of patients in clinical trials) include:

  • Nausea, vomiting, abdominal pain, and diarrhea
  • Fatigue and fever
  • Headache
  • Cough and shortness of breath
  • Rapid heartbeat (tachycardia)
  • Low potassium (hypokalemia) and low magnesium (hypomagnesemia) levels
  • High blood sugar (hyperglycemia)
  • Swelling (edema) and rigors (shaking chills)
  • Skin rash (dermatitis) and itching
  • Joint pain (arthralgia) and tingling or numbness (paresthesia)
  • Trouble sleeping (insomnia)

More serious reactions — including differentiation syndrome, dangerous heart rhythm changes, brain toxicity (encephalopathy), and liver damage — require immediate medical attention if they occur. See the warnings section for details.

⚠️Warnings & precautions▾
  • Differentiation Syndrome: A potentially fatal inflammatory reaction that occurred in 16–23% of APL patients in clinical trials. Watch for unexplained fever, sudden difficulty breathing, rapid weight gain, fluid around the lungs or heart, low blood pressure, or organ problems. Treatment must be stopped and emergency corticosteroids started immediately.
  • Heart Rhythm Problems (QT prolongation / Torsade de Pointes): Arsenic trioxide can dangerously alter the heart's electrical system. In one trial, 40% of relapsed/refractory patients had QTc intervals over 500 msec. ECG monitoring, electrolyte management, and avoiding other QT-prolonging drugs are essential throughout treatment.
  • Brain Toxicity — Wernicke's Encephalopathy: A neurological emergency caused by thiamine (vitamin B1) deficiency. Symptoms include confusion, vision problems, difficulty walking, and decreased consciousness. The drug must be stopped immediately and thiamine given urgently if this is suspected. Patients at risk (e.g., poor nutrition, alcohol use) should have thiamine levels checked and may need preventive thiamine supplementation.
  • Liver Damage (Hepatotoxicity): Elevated liver enzymes occurred in 44% of newly diagnosed APL patients treated with arsenic trioxide plus tretinoin. Liver function is monitored closely, and the drug may need to be withheld if elevations become significant.
  • Carcinogenesis: Arsenic trioxide is a known human carcinogen. Patients should be monitored for the development of a second cancer during and after treatment.
  • Embryo-Fetal Toxicity: Arsenic trioxide can cause serious harm or death to a developing baby. Effective contraception is required during and after treatment.
🔀What it interacts with▾

Arsenic trioxide can interact with several types of drugs in ways that increase the risk of serious side effects:

  • QT-prolonging drugs (certain antibiotics, antifungals, antipsychotics, antiarrhythmics) — combining these with arsenic trioxide significantly raises the risk of a dangerous heart rhythm called torsade de pointes; these should be stopped or switched if possible
  • Diuretics (water pills) and amphotericin B — these lower potassium and magnesium levels, which increases the heart rhythm risk; electrolytes must be monitored closely if these cannot be avoided
  • Drugs that cause liver toxicity — using these alongside arsenic trioxide (especially with tretinoin) increases the risk of serious liver damage; liver function tests need more frequent monitoring in these cases

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy to arsenic: Arsenic trioxide injection is contraindicated — must not be used — in anyone with a known hypersensitivity (allergic reaction) to arsenic
  • Heart conditions: Patients with a ventricular arrhythmia or a prolonged QTc interval must not receive arsenic trioxide until those conditions are resolved; patients with congestive heart failure or a history of torsade de pointes are at higher risk
  • Pregnancy: Arsenic trioxide can harm or kill a developing fetus — pregnant women must be told of the risk; a pregnancy test is required before starting treatment
  • Breastfeeding: Arsenic trioxide passes into breast milk; do not breastfeed during treatment or for 2 weeks after the last dose
  • Contraception: Women of childbearing potential must use effective contraception during treatment and for 6 months after the last dose; men with female partners of childbearing potential should use contraception during treatment and for 3 months after
  • Male fertility: Animal studies suggest arsenic trioxide may impair sperm production; discuss fertility preservation with your doctor before starting treatment
  • Severe kidney disease: Patients with a creatinine clearance below 30 mL/min have higher drug exposure; more frequent monitoring is required, and dose reduction may be needed; not studied in dialysis patients
  • Severe liver disease (Child-Pugh Class C): Limited data available; monitor closely for toxicity
  • Older adults: Studies support use in older patients, but published data suggest lower survival rates in elderly APL patients; frequent monitoring is advised
  • Children: Arsenic trioxide as a single agent for relapsed/refractory APL has been used in children as young as 5 years old with similar efficacy and safety as adults; the combination with tretinoin for newly diagnosed APL has not been established in pediatric patients
  • Nutritional deficiency or alcohol use: These raise the risk of thiamine deficiency and Wernicke's encephalopathy; thiamine levels should be checked and supplementation given if needed
🚑If you take too much▾

Too much arsenic trioxide can cause seizures (convulsions), muscle weakness, and confusion. If an overdose is suspected, the drug must be stopped immediately. Treatment may include chelation therapy — a protocol to help the body eliminate arsenic — using agents such as dimercaprol (by injection) followed by penicillamine (by mouth), as directed by a medical team.

📡Pharmacodynamics — effects in the body▾

Arsenic trioxide has a measurable effect on heart electrical activity: in a clinical trial, 40% of patients receiving the drug had a QTc interval (a measure of heart rhythm on an ECG) exceed 500 milliseconds, which is well above the normal range. This prolongation appeared within 1 to 5 weeks of starting infusions and generally returned toward baseline within 8 weeks after infusions ended. This is why heart monitoring before and throughout treatment is required.

🔬Pharmacokinetics — how your body processes it▾

When arsenic trioxide injection is dissolved for infusion, it rapidly converts to its active form, arsenious acid (As III). After a 2-hour infusion, blood levels peak at the end of the infusion and then decline in two stages — first rapidly, then more slowly — with an elimination half-life of roughly 10 to 14 hours. The drug distributes widely throughout body tissues. It is broken down mainly in the liver into less toxic metabolites (MMA and DMA), which are excreted primarily in the urine; about 15% of the original drug is excreted in the urine unchanged. With repeated dosing, the drug and its metabolites build up (accumulate) in the body. In patients with severe kidney disease, arsenic levels can be about 48% higher than in patients with normal kidney function, which is why closer monitoring is needed in that group.

📦How to store it▾

Store at 20° to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59°F to 86°F) . Do not freeze.

📄 Written from Arsenic Trioxide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Arsenic Trioxide — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is arsenic trioxide treating in my body? ▾
Arsenic trioxide is used to treat a specific type of blood cancer called acute promyelocytic leukemia, or APL. This cancer involves abnormal white blood cells that carry a particular genetic marker. The drug works by triggering those cancer cells to self-destruct and by breaking down the abnormal protein that's fueling the cancer. It's a targeted treatment for this particular leukemia — not a general-purpose chemotherapy.
How is this medicine given, and will I need to stay in the hospital? ▾
Arsenic trioxide is given as an intravenous infusion — directly into a vein — by a nurse or doctor, typically over about 2 hours. You'll receive it in a clinic or hospital setting, not at home. Treatment happens in cycles: a daily induction phase until remission, then a consolidation phase with a set schedule of infusion days. Your care team will map out your exact plan based on your diagnosis.
What side effects should I expect, and which ones mean I need to call someone right away? ▾
Common side effects include nausea, fatigue, fever, headache, diarrhea, cough, and skin rash — most people experience some of these. What you need to act on immediately: sudden trouble breathing, rapid unexplained weight gain, confusion or seizures, your heart racing or feeling like it's skipping beats, or your skin or eyes turning yellow. These can be signs of rare but serious reactions — including differentiation syndrome, heart rhythm problems, or liver or brain toxicity — that need emergency medical attention.
Is this medicine safe if I'm pregnant or thinking about getting pregnant? ▾
Arsenic trioxide can seriously harm or even cause the loss of a developing baby — animal studies showed it caused birth defects and embryo death. You'll need a pregnancy test before starting, and you must use reliable contraception during treatment and for 6 months after your last dose if you're a woman of childbearing age. If you're a man with a female partner who could become pregnant, use contraception during treatment and for 3 months after. Do not breastfeed during treatment or for 2 weeks after stopping, since the drug passes into breast milk.
I've heard arsenic is a poison — is this medicine safe? ▾
Arsenic trioxide is indeed derived from arsenic, and it's a powerful drug that requires very close medical supervision. It's given at carefully controlled doses in a clinical setting with regular blood tests and heart monitoring to catch problems early. The risks are real and the warnings are serious — but for APL, the benefits of treatment are well established, and your oncology team is trained to manage these risks. Never adjust your dose or stop without talking to your doctor.
Are there medicines I should avoid while I'm getting arsenic trioxide? ▾
Yes — several types of drugs can interact with arsenic trioxide in dangerous ways. Medicines that affect heart rhythm (certain antibiotics, antifungals, or heart medications) can raise the risk of a serious arrhythmia. Diuretics (water pills) can lower your potassium and magnesium, which also raises that heart risk. Some drugs that stress the liver can make liver side effects worse. Make sure every doctor and pharmacist you see knows you're on arsenic trioxide, and don't start any new medication — prescription or over-the-counter — without checking first.
Is Arsenic Trioxide available over the counter? ▾
Both — Arsenic Trioxide is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
When was Arsenic Trioxide first available? ▾
Arsenic Trioxide has been available in the United States since at least 1983, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Arsenic Trioxide? ▾
Arsenic Trioxide is supplied by 36 manufacturers listed in the FDA NDC Directory, including Boiron, Zydus Pharmaceuticals USA Inc., Sevene Usa.

💬 Answers drafted from Arsenic Trioxide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerArsenic Trioxide vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Arsenic Trioxide NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Arsenic Trioxide comes

Arsenic Trioxide is available in 6 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Into a vein
Brands Trisenox
How this form is used
What it may be used for
  • Trisenox (intravenous injection) is approved in combination with tretinoin for adults with newly diagnosed low-risk acute promyelocytic leukemia (APL) carrying the t(15;17) translocation or PML/RAR-alpha gene expression
  • Trisenox (intravenous injection) is approved for induction of remission and consolidation in APL patients whose disease has relapsed or is refractory to retinoid and anthracycline chemotherapy
  • Arsenic trioxide intravenous injection is approved in combination with tretinoin for adults with newly diagnosed low-risk APL
  • Arsenic trioxide intravenous injection is approved for relapsed or refractory APL in patients whose disease returned or did not respond to prior retinoid and anthracycline chemotherapy
Important instructions
  • Trisenox and arsenic trioxide injection are given intravenously (into a vein) by a healthcare professional — not self-administered at home
  • Treatment follows structured induction and consolidation cycles; the schedule is determined by your prescriber based on your specific APL diagnosis
  • During treatment, regular blood tests (blood counts, electrolytes, liver and coagulation studies) and heart rhythm monitoring (ECG) are required
  • Arsenic trioxide injection should be used with caution in patients with severe kidney or liver impairment — closer monitoring is required
Available strengths 3 strengths
1 mg/mL 2 mg/2 mL 2 mg/mL
54 FDA-listed product records ⓘ

Sublingual tablet

Under the tongue
Brands Arsenicum Album Arsenicum Album 6c Arsenicum Album 30c
Available strengths 3 strengths
6 [hp_C] 30 [hp_C] 200 [kp_C]
7 FDA-listed product records ⓘ

Oral powder

By mouth
Brands Arsenicum Album
Available strengths 1 strength
6 [hp_X]
2 FDA-listed product records ⓘ

Tablet

By mouth
Brands Arsenicum Album
Available strengths 1 strength
6 [hp_X]
2 FDA-listed product records ⓘ

📊 Arsenic Trioxide across the U.S. market

How Arsenic Trioxide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

6
Dose forms ⓘ
36
Manufacturers
8
Brand names
101
FDA-listed product records ⓘ
1983
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Boiron24%
Zydus Pharmaceuticals USA Inc.10%
Sevene Usa7%
Ingenus Pharmaceuticals, LLC4%
Amneal Pharmaceuticals LLC4%
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc4%
Other makers48%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Arsenic Trioxide is used

A general measure of how commonly Arsenic Trioxide is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Arsenic Trioxide is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

2,519
Medicaid prescriptions filled (Q1–Q4 2025)
$445,998 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Arsenic Trioxide prescribed? Of the 1,596 medications we measure, Arsenic Trioxide ranks #1,157 by Medicaid prescriptions — more than 28% of them.

Where Arsenic Trioxide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,157 of 1,596
#1,152 Deferiprone 2,586 Rx #1,153 Calcifediol 2,586 Rx #1,154 Ponatinib 2,562 Rx #1,155 Tafluprost Ophthalmic 2,553 Rx #1,156 Cytarabine 2,537 Rx #1,157 Arsenic Trioxide Injec... 2,519 Rx #1,158 Arsenic Trioxide 2,519 Rx #1,159 Dimenhydrinate 2,518 Rx #1,160 Ceftolozane and Tazoba... 2,515 Rx #1,161 Guaifenesin / Pseudoep... 2,506 Rx #1,162 Tiagabine 2,499 Rx

Utilization by Arsenic Trioxide product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mL / 1 mg/mL injection is the most-dispensed Arsenic Trioxide product — about 90% of these Medicaid prescriptions.

10 ML arsenic trioxide 1 MG/ML Injection Most dispensed

2,255 Medicaid prescriptions (Q1–Q4 2025) 90% of Arsenic Trioxide prescriptions shown $340,865 gross reimbursement (before rebates) ≈ $151 per prescription (gross)

Summed across the 10 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 829926

6 ML arsenic trioxide 2 MG/ML Injection

264 Medicaid prescriptions (Q1–Q4 2025) 10% of Arsenic Trioxide prescriptions shown $105,133 gross reimbursement (before rebates) ≈ $398 per prescription (gross)

Summed across the 4 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1992545

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Arsenic Trioxide, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 14 of 59 listed Arsenic Trioxide NDCs with Medicaid activity.

🔍 Compare Arsenic Trioxide products

A representative set of FDA-listed product records for Arsenic Trioxide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 101 of 101 products — FDA National Drug Code Directory. See every product, package size and price: browse all 101 Arsenic Trioxide NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Arsenic Trioxide RxCUI 18330 1 dose form · 2 strengths

Look up RxCUI 18330 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Trisenox Arsenicum album Arsenicum Album 30C Arsenicum Album Kit Refill Arsenicum Album 200C Arsenicum Album 200ck Arsenicum Album 6c

🏭 Manufacturers & labelers

Boiron 24 Zydus Pharmaceuticals USA Inc. 10 Sevene Usa 7 Ingenus Pharmaceuticals, LLC 4 Amneal Pharmaceuticals LLC 4 Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc 4 Gland Pharma Limited 4 Washington Homeopathic Products 4 Cephalon, LLC 3 Sintetica US LLC 2 Seroyal USA 2 Sandoz Inc 2 Sagent Pharmaceuticals 2 Orbicular Pharmaceutical Technologies Private Limited 2 Novadoz Pharmaceuticals LLC 2 Zydus Lifesciences Limited 2 Natural Creations, Inc. 2 Fresenius Kabi USA, LLC 2 Amring Pharmaceuticals Inc. 2 Eugia US LLC 1 Hyland's 1 Athenex Pharmaceutical Division, LLC. 1 AuroMedics Pharma LLC 1 Umicore Argentina S.A. 1

…and 12 more on the FDA NDC directory.

RxNorm drug class

Arsenic Trioxide belongs to the Other antineoplastic agents class.

Drug family (ATC) Other antineoplastic agents

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 30, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Arsenic Trioxide.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Arsenic Trioxide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
21
NDC products indexed
101
Distinct labelers/manufacturers represented
36
Linked representative label ⓘ
AuroMedics Pharma LLC
Linked label effective
Jun 30, 2025
Composite sections available
25
Linked SPL Set ID
2a999752-f350-4eff-97e7-e7106dfa85b5
Linked SPL Document ID
28fe0658-5c6d-4176-95cc-1b74cf1d8a37
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 21 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. AuroMedics Pharma LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.