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

Stem definition	Drug id	CAS RN
iodine-containing contrast media	3302	92339-11-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: iodixanol visipaque	dimeric contrast media; structure given in first source Molecular weight: 1550.19 Formula: C35H44I6N6O15 CLOGP: -4.28 LIPINSKI: 3 HAC: 21 HDO: 13 TPSA: 339.09 ALOGS: -3.92 ROTB: 22

Molecule

Description

Molfile Inchi Smiles

Synonyms:

iodixanol
visipaque

dimeric contrast media; structure given in first source

Molecular weight: 1550.19
Formula: C35H44I6N6O15
CLOGP: -4.28
LIPINSKI: 3
HAC: 21
HDO: 13
TPSA: 339.09
ALOGS: -3.92
ROTB: 22

Drug dosage:

None

ADMET properties:

Property	Value	Reference
Vd (Volume of distribution)	0.20 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.44 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2.10 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
March 22, 1996	FDA	GE HEALTHCARE

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
Pruritus	181.06	40.51	127	2105	361326	63125464
Urticaria	133.97	40.51	79	2153	165723	63321067
Acute generalised exanthematous pustulosis	100.86	40.51	30	2202	11069	63475721
Erythema	99.72	40.51	67	2165	175684	63311106
Contrast encephalopathy	87.20	40.51	12	2220	76	63486714
Rash maculo-papular	63.38	40.51	28	2204	31868	63454922
Anaphylactoid shock	57.42	40.51	10	2222	327	63486463
Rash	56.93	40.51	83	2149	560788	62926002
Contrast media reaction	56.65	40.51	12	2220	1113	63485677
Rash pustular	54.65	40.51	17	2215	7265	63479525
Anaphylactoid reaction	51.59	40.51	14	2218	3709	63483081
Anaphylactic shock	44.54	40.51	20	2212	23613	63463177
Dyspnoea	44.11	40.51	81	2151	661232	62825558

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
Contrast media reaction	246.28	38.02	45	2550	901	34953435
Pruritus	192.24	38.02	123	2472	141858	34812478
Urticaria	174.15	38.02	87	2508	62290	34892046
Erythema	147.95	38.02	88	2507	88692	34865644
Rash	107.16	38.02	105	2490	222647	34731689
Anaphylactic reaction	104.71	38.02	50	2545	32251	34922085
Contrast media allergy	100.60	38.02	19	2576	456	34953880
Acute generalised exanthematous pustulosis	85.19	38.02	28	2567	6748	34947588
Acute kidney injury	83.22	38.02	107	2488	304881	34649455
Rash maculo-papular	57.26	38.02	32	2563	28419	34925917
Eosinophilia	48.73	38.02	28	2567	26194	34928142
Swelling face	43.80	38.02	25	2570	23080	34931256
Anaphylactoid reaction	43.39	38.02	13	2582	2312	34952024
Hypotension	42.61	38.02	66	2529	221583	34732753
Nephropathy toxic	42.28	38.02	20	2575	12568	34941768
Angioedema	39.63	38.02	28	2567	37346	34916990

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
Pruritus	347.34	39.23	241	4534	394407	79345206
Contrast media reaction	280.68	39.23	55	4720	2015	79737598
Urticaria	280.51	39.23	160	4615	185041	79554572
Erythema	225.55	39.23	149	4626	223141	79516472
Acute generalised exanthematous pustulosis	176.99	39.23	58	4717	17196	79722417
Rash	148.55	39.23	177	4598	578181	79161432
Anaphylactic reaction	117.35	39.23	69	4706	83674	79655939
Acute kidney injury	117.02	39.23	149	4626	519255	79220358
Rash maculo-papular	105.24	39.23	56	4719	56022	79683591
Contrast encephalopathy	92.96	39.23	15	4760	173	79739440
Contrast media allergy	92.80	39.23	23	4752	2499	79737114
Anaphylactoid reaction	83.99	39.23	25	4750	5397	79734216
Eosinophilia	81.45	39.23	44	4731	45301	79694312
Anaphylactoid shock	71.63	39.23	15	4760	766	79738847
Angioedema	69.81	39.23	48	4727	75987	79663626
Swelling face	67.85	39.23	46	4729	71166	79668447
Toxic skin eruption	58.62	39.23	28	4747	22265	79717348
Nephropathy toxic	57.85	39.23	27	4748	20392	79719221
Flushing	56.83	39.23	45	4730	88223	79651390
Hypotension	56.25	39.23	97	4678	440220	79299393
Dyspnoea	54.72	39.23	142	4633	856883	78882730
Anaphylactic shock	53.89	39.23	31	4744	35965	79703648
Rash pustular	51.84	39.23	21	4754	11290	79728323
Drug ineffective	47.30	39.23	5	4770	1080908	78658705
Eyelid oedema	44.75	39.23	20	4755	13667	79725946
Nephropathy	40.95	39.23	17	4758	9721	79729892
Throat irritation	40.29	39.23	27	4748	40919	79698694

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	V08AB09	VARIOUS CONTRAST MEDIA X-RAY CONTRAST MEDIA, IODINATED Watersoluble, nephrotropic, low osmolar X-ray contrast media
FDA MoA	N0000010258	X-Ray Contrast Activity
MeSH PA	D003287	Contrast Media
MeSH PA	D064907	Diagnostic Uses of Chemicals
FDA EPC	N0000180185	Radiographic Contrast Agent
CHEBI has role	CHEBI:37338	contrast media

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

None

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.43	acidic
pKa2	10.85	acidic
pKa3	11.21	acidic
pKa4	11.63	acidic
pKa5	12.19	acidic
pKa6	13.65	acidic

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
55%	IODIXANOL	HENGRUI PHARMA	A214271	May 19, 2022	RX	INJECTABLE	INJECTION	Jan. 9, 2023	COMPETITIVE GENERIC THERAPY
65.2%	IODIXANOL	HENGRUI PHARMA	A214271	May 19, 2022	RX	INJECTABLE	INJECTION	Jan. 9, 2023	COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

None

External reference:

ID	Source
4020982	VUID
N0000148453	NUI
D01474	KEGG_DRUG
4020982	VANDF
C0063757	UMLSCUI
CHEBI:31705	CHEBI
CHEMBL1200507	ChEMBL_ID
DB01249	DRUGBANK_ID
C044834	MESH_SUPPLEMENTAL_RECORD_UI
5692	INN_ID
HW8W27HTXX	UNII
3724	PUBCHEM_CID
27729	RXNORM
11441	MMSL
360836	MMSL
4902	MMSL
d04016	MMSL
006060	NDDF
353962003	SNOMEDCT_US
395750001	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2222	INJECTION, SOLUTION	270 mg	INTRAVASCULAR	NDA	28 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2222	INJECTION, SOLUTION	270 mg	INTRAVASCULAR	NDA	28 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2222	INJECTION, SOLUTION	270 mg	INTRAVASCULAR	NDA	28 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2222	INJECTION, SOLUTION	270 mg	INTRAVASCULAR	NDA	28 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2222	INJECTION, SOLUTION	270 mg	INTRAVASCULAR	NDA	28 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2222	INJECTION, SOLUTION	270 mg	INTRAVASCULAR	NDA	28 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2222	INJECTION, SOLUTION	270 mg	INTRAVASCULAR	NDA	28 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2223	INJECTION, SOLUTION	320 mg	INTRAVASCULAR	NDA	31 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2223	INJECTION, SOLUTION	320 mg	INTRAVASCULAR	NDA	31 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2223	INJECTION, SOLUTION	320 mg	INTRAVASCULAR	NDA	31 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2223	INJECTION, SOLUTION	320 mg	INTRAVASCULAR	NDA	31 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2223	INJECTION, SOLUTION	320 mg	INTRAVASCULAR	NDA	31 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2223	INJECTION, SOLUTION	320 mg	INTRAVASCULAR	NDA	31 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2223	INJECTION, SOLUTION	320 mg	INTRAVASCULAR	NDA	31 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2223	INJECTION, SOLUTION	320 mg	INTRAVASCULAR	NDA	31 sections
Visipaque	HUMAN PRESCRIPTION DRUG LABEL	1	0407-2223	INJECTION, SOLUTION	320 mg	INTRAVASCULAR	NDA	31 sections
Iodixanol	HUMAN PRESCRIPTION DRUG LABEL	1	65219-381	INJECTION, SOLUTION	270 mg	INTRAVASCULAR	ANDA	28 sections
Iodixanol	HUMAN PRESCRIPTION DRUG LABEL	1	65219-381	INJECTION, SOLUTION	270 mg	INTRAVASCULAR	ANDA	28 sections
Iodixanol	HUMAN PRESCRIPTION DRUG LABEL	1	65219-383	INJECTION, SOLUTION	320 mg	INTRAVASCULAR	ANDA	28 sections
Iodixanol	HUMAN PRESCRIPTION DRUG LABEL	1	65219-383	INJECTION, SOLUTION	320 mg	INTRAVASCULAR	ANDA	28 sections