iopamidol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| iodine-containing contrast media | 1464 | 60166-93-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiological procedures.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 96 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 1530.44 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| Vd (Volume of distribution) | 0.28 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 1.90 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 |
| S (Water solubility) | 100 mg/mL | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 31, 1985 | FDA | BRACCO |
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 |
|---|---|---|---|---|---|---|
| Contrast media reaction | 277.17 | 31.94 | 47 | 2660 | 1078 | 63485237 |
| Anaphylactic reaction | 152.08 | 31.94 | 68 | 2639 | 66032 | 63420283 |
| Anaphylactic shock | 138.87 | 31.94 | 48 | 2659 | 23585 | 63462730 |
| Contrast encephalopathy | 126.17 | 31.94 | 17 | 2690 | 71 | 63486244 |
| No adverse event | 86.86 | 31.94 | 40 | 2667 | 41365 | 63444950 |
| Urticaria | 78.07 | 31.94 | 61 | 2646 | 165741 | 63320574 |
| Extravasation | 70.27 | 31.94 | 17 | 2690 | 2355 | 63483960 |
| Anaphylactoid reaction | 62.66 | 31.94 | 17 | 2690 | 3706 | 63482609 |
| Throat tightness | 61.57 | 31.94 | 27 | 2680 | 24860 | 63461455 |
| Maternal exposure during pregnancy | 61.19 | 31.94 | 60 | 2647 | 220002 | 63266313 |
| Wrong product administered | 54.26 | 31.94 | 17 | 2690 | 6124 | 63480191 |
| Drug reaction with eosinophilia and systemic symptoms | 53.66 | 31.94 | 27 | 2680 | 33809 | 63452506 |
| Sneezing | 52.42 | 31.94 | 22 | 2685 | 18196 | 63468119 |
| Contrast media allergy | 50.11 | 31.94 | 13 | 2694 | 2388 | 63483927 |
| Hypersensitivity | 47.12 | 31.94 | 60 | 2647 | 292625 | 63193690 |
| Dyspnoea | 44.56 | 31.94 | 91 | 2616 | 661222 | 62825093 |
| Infusion site extravasation | 38.27 | 31.94 | 15 | 2692 | 10411 | 63475904 |
| Cardio-respiratory arrest | 36.96 | 31.94 | 26 | 2681 | 59933 | 63426382 |
| Throat irritation | 32.12 | 31.94 | 20 | 2687 | 37627 | 63448688 |
| Respiratory arrest | 32.11 | 31.94 | 19 | 2688 | 32626 | 63453689 |
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 | 273.52 | 25.99 | 49 | 2487 | 897 | 34953498 |
| Anaphylactic shock | 235.96 | 25.99 | 74 | 2462 | 15867 | 34938528 |
| Anaphylactic reaction | 140.85 | 25.99 | 61 | 2475 | 32240 | 34922155 |
| Contrast media allergy | 107.39 | 25.99 | 20 | 2516 | 455 | 34953940 |
| Contrast encephalopathy | 103.48 | 25.99 | 15 | 2521 | 62 | 34954333 |
| Urticaria | 84.90 | 25.99 | 54 | 2482 | 62323 | 34892072 |
| Hepatic artery stenosis | 71.79 | 25.99 | 12 | 2524 | 142 | 34954253 |
| Pruritus | 47.83 | 25.99 | 55 | 2481 | 141926 | 34812469 |
| Cardio-respiratory arrest | 40.73 | 25.99 | 33 | 2503 | 55240 | 34899155 |
| Extravasation | 37.39 | 25.99 | 11 | 2525 | 1879 | 34952516 |
| No adverse event | 36.56 | 25.99 | 22 | 2514 | 22905 | 34931490 |
| Hypersensitivity | 35.87 | 25.99 | 32 | 2504 | 61003 | 34893392 |
| Cardiac arrest | 31.89 | 25.99 | 37 | 2499 | 96122 | 34858273 |
| Blood pressure decreased | 28.27 | 25.99 | 26 | 2510 | 51489 | 34902906 |
| Vomiting | 27.09 | 25.99 | 57 | 2479 | 247564 | 34706831 |
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 |
|---|---|---|---|---|---|---|
| Contrast media reaction | 505.14 | 24.97 | 91 | 4970 | 1979 | 79737348 |
| Anaphylactic shock | 319.62 | 24.97 | 110 | 4951 | 35886 | 79703441 |
| Anaphylactic reaction | 254.40 | 24.97 | 118 | 4943 | 83625 | 79655702 |
| Contrast encephalopathy | 220.73 | 24.97 | 32 | 5029 | 156 | 79739171 |
| Urticaria | 141.98 | 24.97 | 107 | 4954 | 185094 | 79554233 |
| Contrast media allergy | 116.84 | 24.97 | 28 | 5033 | 2494 | 79736833 |
| Hepatic artery stenosis | 84.11 | 24.97 | 14 | 5047 | 186 | 79739141 |
| Pruritus | 69.73 | 24.97 | 104 | 4957 | 394544 | 79344783 |
| Drug reaction with eosinophilia and systemic symptoms | 69.72 | 24.97 | 46 | 5015 | 64198 | 79675129 |
| Cardio-respiratory arrest | 66.39 | 24.97 | 55 | 5006 | 108455 | 79630872 |
| Anaphylactoid reaction | 65.72 | 24.97 | 21 | 5040 | 5401 | 79733926 |
| Hypersensitivity | 61.07 | 24.97 | 79 | 4982 | 262160 | 79477167 |
| Sneezing | 60.39 | 24.97 | 28 | 5033 | 19655 | 79719672 |
| Extravasation | 60.14 | 24.97 | 18 | 5043 | 3732 | 79735595 |
| Throat tightness | 59.59 | 24.97 | 31 | 5030 | 27876 | 79711451 |
| Throat irritation | 53.56 | 24.97 | 33 | 5028 | 40913 | 79698414 |
| Cardiac arrest | 49.98 | 24.97 | 58 | 5003 | 172038 | 79567289 |
| Pulse absent | 49.48 | 24.97 | 20 | 5041 | 10083 | 79729244 |
| Nephropathy toxic | 47.40 | 24.97 | 24 | 5037 | 20395 | 79718932 |
| Dyspnoea | 46.53 | 24.97 | 139 | 4922 | 856886 | 78882441 |
| Unresponsive to stimuli | 37.72 | 24.97 | 30 | 5031 | 55758 | 79683569 |
| Erythema | 35.30 | 24.97 | 56 | 5005 | 223234 | 79516093 |
| Pharyngeal oedema | 34.51 | 24.97 | 18 | 5043 | 16254 | 79723073 |
| Blood pressure decreased | 33.08 | 24.97 | 36 | 5025 | 99430 | 79639897 |
| Vomiting | 30.50 | 24.97 | 102 | 4959 | 665726 | 79073601 |
| Oxygen saturation decreased | 30.15 | 24.97 | 39 | 5022 | 129008 | 79610319 |
| No adverse event | 29.51 | 24.97 | 22 | 5039 | 37170 | 79702157 |
| Loss of consciousness | 27.74 | 24.97 | 43 | 5018 | 167900 | 79571427 |
| Flushing | 27.70 | 24.97 | 31 | 5030 | 88237 | 79651090 |
| Cyanosis | 27.21 | 24.97 | 18 | 5043 | 25164 | 79714163 |
| Infusion site extravasation | 26.77 | 24.97 | 13 | 5048 | 10095 | 79729232 |
| Spinal cord ischaemia | 25.51 | 24.97 | 5 | 5056 | 172 | 79739155 |
| Drug ineffective | 25.45 | 24.97 | 19 | 5042 | 1080894 | 78658433 |
| Wrong product administered | 25.11 | 24.97 | 12 | 5049 | 9000 | 79730327 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | V08AB04 | 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:35703 | Xenobiotic |
| CHEBI has role | CHEBI:37338 | contrast media |
| CHEBI has role | CHEBI:78298 | environmental contaminants |
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 | 10.76 | acidic |
| pKa2 | 11.36 | acidic |
| pKa3 | 12.12 | acidic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| 4017756 | VUID |
| N0000146122 | NUI |
| D01797 | KEGG_DRUG |
| 4017756 | VANDF |
| C0022026 | UMLSCUI |
| CHEBI:31711 | CHEBI |
| CHEMBL1200932 | ChEMBL_ID |
| D007479 | MESH_DESCRIPTOR_UI |
| DB08947 | DRUGBANK_ID |
| 4399 | INN_ID |
| JR13W81H44 | UNII |
| 65492 | PUBCHEM_CID |
| 5966 | RXNORM |
| 4905 | MMSL |
| d01461 | MMSL |
| 000672 | NDDF |
| 109219007 | SNOMEDCT_US |
| 395754005 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ISOVUE200 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1314 | INJECTION, SOLUTION | 408 mg | INTRAVASCULAR | NDA | 23 sections |
| ISOVUE200 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1314 | INJECTION, SOLUTION | 408 mg | INTRAVASCULAR | NDA | 23 sections |
| ISOVUE200 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1314 | INJECTION, SOLUTION | 408 mg | INTRAVASCULAR | NDA | 23 sections |
| ISOVUE300 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1315 | INJECTION, SOLUTION | 612 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE300 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1315 | INJECTION, SOLUTION | 612 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE300 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1315 | INJECTION, SOLUTION | 612 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE300 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1315 | INJECTION, SOLUTION | 612 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE300 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1315 | INJECTION, SOLUTION | 612 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE300 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1315 | INJECTION, SOLUTION | 612 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE300 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1315 | INJECTION, SOLUTION | 612 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE300 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1315 | INJECTION, SOLUTION | 612 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE370 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1316 | INJECTION, SOLUTION | 755 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE370 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1316 | INJECTION, SOLUTION | 755 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE370 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1316 | INJECTION, SOLUTION | 755 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE370 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1316 | INJECTION, SOLUTION | 755 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE370 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1316 | INJECTION, SOLUTION | 755 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE370 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1316 | INJECTION, SOLUTION | 755 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE370 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1316 | INJECTION, SOLUTION | 755 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE370 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1316 | INJECTION, SOLUTION | 755 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE250 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1317 | INJECTION, SOLUTION | 510 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE250 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1317 | INJECTION, SOLUTION | 510 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE250 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1317 | INJECTION, SOLUTION | 510 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE250 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1317 | INJECTION, SOLUTION | 510 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE250 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1317 | INJECTION, SOLUTION | 510 mg | INTRAVASCULAR | NDA | 24 sections |
| ISOVUE-M | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1411 | INJECTION, SOLUTION | 408 mg | INTRATHECAL | NDA | 22 sections |
| ISOVUE-M | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1411 | INJECTION, SOLUTION | 408 mg | INTRATHECAL | NDA | 22 sections |
| ISOVUE-M | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1412 | INJECTION, SOLUTION | 612 mg | INTRATHECAL | NDA | 22 sections |
| ISOVUE-M | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1412 | INJECTION, SOLUTION | 612 mg | INTRATHECAL | NDA | 22 sections |
| ISOVUE-M 200 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52584-411 | INJECTION, SOLUTION | 408 mg | INTRATHECAL | NDA | 11 sections |
| iopamidol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70436-124 | INJECTION, SOLUTION | 408 mg | INTRATHECAL | ANDA | 21 sections |