arsenic trioxide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	244	1327-53-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: trisenox arsenic trioxide arsenic oxide arsenious oxide arsenious trioxide white arsenic	Arsenic trioxide causes morphological changes and DNA fragmentation characteristic of apoptosis in NB4 human promyelocytic leukemia cells in vitro. Arsenic trioxide also causes damage or degradation of the fusion protein promyelocytic leukemia (PML) retinoic acid receptor (RAR)-alpha. Molecular weight: 197.84 Formula: As2O3 CLOGP: -2.60 LIPINSKI: None HAC: 3 HDO: 0 TPSA: 43.37 ALOGS: ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

trisenox
arsenic trioxide
arsenic oxide
arsenious oxide
arsenious trioxide
white arsenic

Arsenic trioxide causes morphological changes and DNA fragmentation characteristic of apoptosis in NB4 human promyelocytic leukemia cells in vitro. Arsenic trioxide also causes damage or degradation of the fusion protein promyelocytic leukemia (PML) retinoic acid receptor (RAR)-alpha.

Molecular weight: 197.84
Formula: As2O3
CLOGP: -2.60
LIPINSKI: None
HAC: 3
HDO: 0
TPSA: 43.37
ALOGS:
ROTB: 2

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.76 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	37 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Nov. 14, 2019	EMA	ACCORD HEALTHCARE SLU
Sept. 25, 2000	FDA	CEPHALON

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Differentiation syndrome	550.04	13.46	101	9190	1002	63478729
Electrocardiogram QT prolonged	170.61	13.46	107	9184	59423	63420308
Febrile neutropenia	94.72	13.46	101	9190	118348	63361383
Hepatic function abnormal	87.28	13.46	59	9232	37083	63442648
Platelet count decreased	43.43	13.46	68	9223	116054	63363677
White blood cell count decreased	39.46	13.46	72	9219	139032	63340699
Alanine aminotransferase increased	36.36	13.46	59	9232	103711	63376020
Myelosuppression	33.98	13.46	28	9263	23675	63456056
Aspartate aminotransferase increased	33.93	13.46	53	9238	90224	63389507
Leukaemia recurrent	33.52	13.46	11	9280	1327	63478404
Neutrophil count decreased	33.03	13.46	41	9250	56365	63423366
Lower respiratory tract infection fungal	32.72	13.46	8	9283	331	63479400
Disseminated intravascular coagulation	32.65	13.46	25	9266	19026	63460705
Idiopathic intracranial hypertension	28.41	13.46	12	9279	2919	63476812
Haematopoietic neoplasm	28.40	13.46	5	9286	38	63479693
Leukocytosis	25.95	13.46	25	9266	25910	63453821
Pyrexia	24.31	13.46	134	9157	470344	63009387
Drug ineffective	24.09	13.46	76	9215	1044689	62435042
Chromosomal deletion	23.76	13.46	5	9286	104	63479627
Pericardial effusion	22.86	13.46	25	9266	30033	63449698
Acute myeloid leukaemia	21.99	13.46	19	9272	17128	63462603
Gamma-glutamyltransferase increased	21.97	13.46	26	9265	34005	63445726
Gambling	19.71	13.46	5	9286	241	63479490
Intracranial pressure increased	19.10	13.46	11	9280	5216	63474515
Drug intolerance	18.70	13.46	11	9280	308650	63171081
Systemic lupus erythematosus	18.48	13.46	4	9287	208914	63270817
Sweat gland tumour	17.97	13.46	4	9287	109	63479622
VIth nerve paralysis	17.25	13.46	6	9285	864	63478867
Blood lactate dehydrogenase increased	17.19	13.46	19	9272	23097	63456634
Laryngeal inflammation	17.03	13.46	4	9287	139	63479592
Blast cell count increased	16.76	13.46	5	9286	441	63479290
Oedematous pancreatitis	15.46	13.46	5	9286	576	63479155
Ventricular extrasystoles	15.09	13.46	13	9278	11674	63468057
Leukostasis syndrome	14.94	13.46	3	9288	49	63479682
Pneumonia	14.92	13.46	116	9175	456651	63023080

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Differentiation syndrome	565.70	17.66	111	6032	1327	34949461
Electrocardiogram QT prolonged	287.16	17.66	141	6002	40811	34909977
Idiopathic intracranial hypertension	118.71	17.66	27	6116	674	34950114
Hyperleukocytosis	99.37	17.66	29	6114	1973	34948815
Febrile neutropenia	89.69	17.66	115	6028	136734	34814054
Myelosuppression	62.27	17.66	40	6103	19225	34931563
Hepatic function abnormal	58.48	17.66	54	6089	44309	34906479
Hypokalaemia	42.92	17.66	52	6091	58162	34892626
Alanine aminotransferase increased	37.97	17.66	58	6085	80757	34870031
Platelet count decreased	35.39	17.66	70	6073	119647	34831141
Disseminated intravascular coagulation	33.57	17.66	29	6114	21787	34929001
Haematopoietic neoplasm	32.49	17.66	6	6137	50	34950738
Acute myeloid leukaemia	31.64	17.66	26	6117	18244	34932544
Aspartate aminotransferase increased	24.19	17.66	43	6100	67740	34883048
Pneumonia	22.57	17.66	124	6019	362503	34588285
Periarthritis	22.10	17.66	8	6135	1076	34949712
Pericardial effusion	21.44	17.66	24	6119	24638	34926150
White blood cell count increased	21.40	17.66	31	6112	41120	34909668
Blood lactate dehydrogenase increased	21.07	17.66	23	6120	22967	34927821
Septic embolus	20.89	17.66	8	6135	1257	34949531
Extremity necrosis	20.67	17.66	9	6134	1963	34948825
Pleural effusion	19.76	17.66	44	6099	81502	34869286
Leukaemia recurrent	19	17.66	8	6135	1607	34949181
Activated partial thromboplastin time prolonged	18.55	17.66	14	6129	8681	34942107
Hypomagnesaemia	18.55	17.66	21	6122	21830	34928958
Jugular vein thrombosis	18.54	17.66	8	6135	1707	34949081
Blood alkaline phosphatase increased	18.46	17.66	25	6118	31150	34919638
White blood cell count decreased	18.28	17.66	47	6096	95398	34855390

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Differentiation syndrome	1052.29	13.16	203	13156	2321	79728708
Electrocardiogram QT prolonged	356.16	13.16	209	13150	90177	79640852
Febrile neutropenia	178.21	13.16	206	13153	230793	79500236
Hepatic function abnormal	148.50	13.16	112	13247	72995	79658034
Idiopathic intracranial hypertension	128.52	13.16	39	13320	3183	79727846
Hyperleukocytosis	114.50	13.16	34	13325	2576	79728453
Myelodysplastic syndrome transformation	98.91	13.16	23	13336	666	79730363
Myelosuppression	93.66	13.16	67	13292	40229	79690800
Platelet count decreased	85.54	13.16	132	13227	194532	79536497
Alanine aminotransferase increased	64.16	13.16	105	13254	162465	79568564
White blood cell count decreased	61.71	13.16	112	13247	188176	79542853
Haematopoietic neoplasm	61.06	13.16	11	13348	83	79730946
Disseminated intravascular coagulation	59.94	13.16	49	13310	35793	79695236
Acute myeloid leukaemia	53.28	13.16	43	13316	30842	79700187
Aspartate aminotransferase increased	51.28	13.16	87	13272	138554	79592475
Leukaemia recurrent	44.67	13.16	17	13342	2757	79728272
Neutrophil count decreased	41.60	13.16	64	13295	93895	79637134
Pneumonia	40.96	13.16	218	13141	660028	79071001
Leukocytosis	40.70	13.16	43	13316	43412	79687617
Blood lactate dehydrogenase increased	37.11	13.16	39	13320	39131	79691898
Pericardial effusion	36.79	13.16	42	13317	46195	79684834
Hypokalaemia	33.15	13.16	74	13285	143966	79587063
Pyrexia	31.06	13.16	207	13152	678502	79052527
White blood cell count increased	30.48	13.16	49	13310	74584	79656445
Pleural effusion	26.28	13.16	68	13291	145194	79585835
Completed suicide	25.68	13.16	5	13354	245762	79485267
Lower respiratory tract infection fungal	24.03	13.16	8	13351	880	79730149
Gamma-glutamyltransferase increased	23.84	13.16	37	13322	54643	79676386
Drug ineffective	23.17	13.16	98	13261	1080815	78650214
Sepsis	22.45	13.16	97	13262	269331	79461698
Chromosomal deletion	20.93	13.16	5	13354	163	79730866
Septic embolus	20.74	13.16	9	13350	2042	79728987
Blood alkaline phosphatase increased	19.72	13.16	37	13322	63627	79667402
Pancytopenia	18.97	13.16	66	13293	165679	79565350
Protein total decreased	18.59	13.16	14	13345	9078	79721951
Staphylococcal infection	18.20	13.16	34	13325	58261	79672768
Liver disorder	17.54	13.16	38	13321	72379	79658650
Bone marrow failure	17.47	13.16	31	13328	51076	79679953
Neutropenia	17.07	13.16	94	13265	287616	79443413
Extremity necrosis	17.03	13.16	9	13350	3152	79727877
Hypomagnesaemia	16.74	13.16	29	13330	46882	79684147
Central nervous system leukaemia	16.32	13.16	5	13354	421	79730608
Ventricular extrasystoles	15.84	13.16	18	13341	19686	79711343
Therapeutic product effect decreased	15.77	13.16	4	13355	163859	79567170
Cytogenetic abnormality	14.95	13.16	6	13353	1119	79729910
Laryngeal inflammation	14.95	13.16	4	13355	207	79730822
Treatment failure	14.87	13.16	5	13354	170481	79560548
Maternal exposure before pregnancy	14.31	13.16	9	13350	4364	79726665
Toxicity to various agents	14.16	13.16	31	13328	421509	79309520
Bronchopulmonary aspergillosis	14.05	13.16	18	13341	22276	79708753
Bone marrow necrosis	13.72	13.16	4	13355	284	79730745
Blast cell count increased	13.65	13.16	6	13353	1404	79729625
Acute promyelocytic leukaemia	13.33	13.16	6	13353	1485	79729544
Streptococcal bacteraemia	13.27	13.16	8	13351	3598	79727431

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01XX27	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents
MeSH PA	D000970	Antineoplastic Agents
CHEBI has role	CHEBI:24852	insecticides
CHEBI has role	CHEBI:35610	antineoplastic agents

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Acute promyelocytic leukemia, FAB M3	indication	110004001
Acute myelomonocytic leukemia, FAB M4	indication	110005000
Myelodysplastic syndrome	off-label use	109995007
Hyperkalemia	contraindication	14140009
Complete atrioventricular block	contraindication	27885002
Torsades de pointes	contraindication	31722008
Hypokalemia	contraindication	43339004
Chronic heart failure	contraindication	48447003
Kidney disease	contraindication	90708001	DOID:557
Prolonged QT interval	contraindication	111975006
Hypomagnesemia	contraindication	190855004
Disease of liver	contraindication	235856003	DOID:409
Pregnancy, function	contraindication	289908002
Breastfeeding (mother)	contraindication	413712001
Congenital long QT syndrome	contraindication	442917000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TRISENOX	CEPHALON	N021248	Sept. 25, 2000	DISCN	INJECTABLE	INJECTION	Jan. 12, 2025	ARSENIC TRIOXIDE FOR USE 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
2MG/ML	TRISENOX	CEPHALON	N021248	Oct. 13, 2017	RX	INJECTABLE	INJECTION	Jan. 12, 2025	ARSENIC TRIOXIDE FOR USE 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

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Thioredoxin reductase 1, cytoplasmic	Enzyme	Q16881	TRXR1_HUMAN	INHIBITOR				CHEMBL	CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	5.82		WOMBAT-PK

External reference:

ID	Source
D02106	KEGG_DRUG
18330	RXNORM
C0052416	UMLSCUI
CHEBI:30621	CHEBI
CHEMBL2362016	ChEMBL_ID
CHEMBL1200978	ChEMBL_ID
DB01169	DRUGBANK_ID
D000077237	MESH_DESCRIPTOR_UI
14888	PUBCHEM_CID
S7V92P67HO	UNII
15787	MMSL
40534	MMSL
71831	MMSL
d04720	MMSL
400907001	SNOMEDCT_US
72251000	SNOMEDCT_US
4021238	VANDF
007172	NDDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Arsenic Trioxide	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3498	INJECTION, SOLUTION	2 mg	INTRAVENOUS	ANDA	28 sections
Arsenic Trioxide	HUMAN PRESCRIPTION DRUG LABEL	1	14789-600	INJECTION	1 mg	INTRAVENOUS	ANDA	31 sections
Arsenic Trioxide	HUMAN PRESCRIPTION DRUG LABEL	1	14789-600	INJECTION	1 mg	INTRAVENOUS	ANDA	31 sections
Arsenic Trioxide	Human Prescription Drug Label	1	23155-869	INJECTION	2 mg	INTRAVENOUS	ANDA	31 sections
Arsenic Trioxide	Human Prescription Drug Label	1	23155-870	INJECTION	1 mg	INTRAVENOUS	ANDA	31 sections
Arsenic Trioxide	HUMAN PRESCRIPTION DRUG LABEL	1	25021-226	INJECTION	1 mg	INTRAVENOUS	ANDA	31 sections
Arsenic Trioxide	HUMAN PRESCRIPTION DRUG LABEL	1	25021-227	INJECTION	2 mg	INTRAVENOUS	ANDA	31 sections
AllerstatI	HUMAN OTC DRUG LABEL	9	44911-0178	LIQUID	12 [hp_X]	ORAL	unapproved homeopathic	9 sections
Vertitone	HUMAN OTC DRUG LABEL	9	44911-0181	LIQUID	12 [hp_X]	ORAL	unapproved homeopathic	9 sections
Nightshade Antigens	HUMAN OTC DRUG LABEL	10	44911-0350	LIQUID	12 [hp_X]	ORAL	unapproved homeopathic	9 sections
Sinus HP	HUMAN OTC DRUG LABEL	11	44911-0629	LIQUID	30 [hp_X]	ORAL	unapproved drug other	9 sections
Jointox BB	HUMAN OTC DRUG LABEL	17	44911-0642	LIQUID	30 [hp_C]	ORAL	unapproved drug other	9 sections
Jointox BB	HUMAN OTC DRUG LABEL	17	44911-0642	LIQUID	30 [hp_C]	ORAL	unapproved drug other	9 sections
Arsenic trioxide	HUMAN PRESCRIPTION DRUG LABEL	1	49315-005	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	1 sections
Arsenic trioxide	HUMAN PRESCRIPTION DRUG LABEL	1	49315-005	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	1 sections
Arsenic trioxide	HUMAN PRESCRIPTION DRUG LABEL	1	49315-007	INJECTION, SOLUTION	2 mg	INTRAVENOUS	ANDA	1 sections
Arsenic trioxide	HUMAN PRESCRIPTION DRUG LABEL	1	49315-007	INJECTION, SOLUTION	2 mg	INTRAVENOUS	ANDA	1 sections
ARSENIC TRIOXIDE	HUMAN PRESCRIPTION DRUG LABEL	1	50742-438	INJECTION	1 mg	INTRAVENOUS	ANDA	24 sections
ARSENIC TRIOXIDE	HUMAN PRESCRIPTION DRUG LABEL	1	50742-438	INJECTION	1 mg	INTRAVENOUS	ANDA	24 sections
Arsenic Trioxide	HUMAN PRESCRIPTION DRUG LABEL	1	54879-027	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	27 sections
Arsenic Trioxide	HUMAN PRESCRIPTION DRUG LABEL	1	54879-027	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	27 sections
7 Heavy Metal Detox	HUMAN OTC DRUG LABEL	61	55146-007	LIQUID	12 [hp_X]	ORAL	unapproved homeopathic	9 sections
1 Detoxification	HUMAN OTC DRUG LABEL	81	55146-011	LIQUID	12 [hp_X]	ORAL	unapproved homeopathic	9 sections
ARSENIC TRIOXIDE	Human Prescription Drug Label	1	55150-366	INJECTION, SOLUTION	2 mg	INTRAVENOUS	ANDA	28 sections
Hay Fever	HUMAN OTC DRUG LABEL	55	55714-2562	LIQUID	15 [hp_X]	ORAL	unapproved homeopathic	10 sections
BronCare	HUMAN OTC DRUG LABEL	29	55714-4840	PELLET	15 [hp_X]	ORAL	unapproved homeopathic	10 sections
Homeopathic Moon drops	HUMAN OTC DRUG LABEL	9	57556-008	LOZENGE	30 [hp_X]	ORAL	unapproved drug other	6 sections
Sleep Aid	HUMAN OTC DRUG LABEL	14	57955-2640	LIQUID	59 [hp_X]	ORAL	unapproved homeopathic	9 sections
Arsenic Trioxide	HUMAN PRESCRIPTION DRUG LABEL	1	63323-637	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	29 sections
Trisenox	HUMAN PRESCRIPTION DRUG LABEL	1	63459-601	INJECTION, SOLUTION	2 mg	INTRAVENOUS	NDA	28 sections