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iopamidol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK2,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 | 49 | |||
| kinase-selectivity-class | ALK,AURKA,AURKC,AXL,BMX,BRAF,CAMK2B,CAMK2D,CDK1,CDK16,CDK2,CDK3,CDK4,CDK6,CDK7,CDK9,CLK2,CLK4,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3A,GSK3B,IRAK3,MAP2K6,MAP3K21,MAP4K1,MAPK1,MAPK11,MAPK7,MET,PDK1,PIK3CB,PIK3CD,PIK3CG,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1 | 45 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
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 | 338.11 | 28.00 | 56 | 3538 | 1195 | 90623658 |
| Anaphylactic reaction | 200.97 | 28.00 | 88 | 3506 | 87436 | 90537417 |
| Anaphylactic shock | 158.43 | 28.00 | 56 | 3538 | 31561 | 90593292 |
| Contrast encephalopathy | 154.21 | 28.00 | 22 | 3572 | 163 | 90624690 |
| Urticaria | 97.64 | 28.00 | 88 | 3506 | 312646 | 90312207 |
| No adverse event | 96.10 | 28.00 | 49 | 3545 | 67933 | 90556920 |
| Drug reaction with eosinophilia and systemic symptoms | 88.33 | 28.00 | 40 | 3554 | 42718 | 90582135 |
| Contrast media allergy | 77.06 | 28.00 | 19 | 3575 | 3062 | 90621791 |
| Throat tightness | 75.20 | 28.00 | 32 | 3562 | 29452 | 90595401 |
| Sneezing | 74.80 | 28.00 | 32 | 3562 | 29837 | 90595016 |
| Extravasation | 72.73 | 28.00 | 18 | 3576 | 2946 | 90621907 |
| Sialoadenitis | 62.45 | 28.00 | 15 | 3579 | 2167 | 90622686 |
| Anaphylactoid reaction | 60.80 | 28.00 | 17 | 3577 | 4451 | 90620402 |
| Cardio-respiratory arrest | 57.33 | 28.00 | 34 | 3560 | 63106 | 90561747 |
| Dyspnoea | 51.90 | 28.00 | 110 | 3484 | 880845 | 89744008 |
| Wrong product administered | 51.75 | 28.00 | 17 | 3577 | 7648 | 90617205 |
| Throat irritation | 48.90 | 28.00 | 28 | 3566 | 48667 | 90576186 |
| Maternal exposure during pregnancy | 43.64 | 28.00 | 62 | 3532 | 360001 | 90264852 |
| Hypersensitivity | 42.00 | 28.00 | 69 | 3525 | 454608 | 90170245 |
| Pulse absent | 39.15 | 28.00 | 13 | 3581 | 6042 | 90618811 |
| Respiratory arrest | 38.46 | 28.00 | 21 | 3573 | 33290 | 90591563 |
| Infusion site extravasation | 35.88 | 28.00 | 14 | 3580 | 10314 | 90614539 |
| Unresponsive to stimuli | 35.82 | 28.00 | 21 | 3573 | 38100 | 90586753 |
| Cardiac arrest | 35.52 | 28.00 | 31 | 3563 | 104904 | 90519949 |
| Erythema | 34.65 | 28.00 | 44 | 3550 | 229202 | 90395651 |
| Pruritus | 32.16 | 28.00 | 68 | 3526 | 541457 | 90083396 |
| Product physical issue | 32.05 | 28.00 | 11 | 3583 | 5649 | 90619204 |
| Pharyngeal oedema | 31.99 | 28.00 | 14 | 3580 | 13757 | 90611096 |
| Blood pressure decreased | 29.18 | 28.00 | 24 | 3570 | 74871 | 90549982 |
| Rapidly progressive osteoarthritis | 28.62 | 28.00 | 4 | 3590 | 25 | 90624828 |
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 | 285.37 | 24.75 | 52 | 3001 | 1064 | 42617218 |
| Anaphylactic shock | 259.05 | 24.75 | 87 | 2966 | 23430 | 42594852 |
| Anaphylactic reaction | 178.53 | 24.75 | 78 | 2975 | 42665 | 42575617 |
| Contrast encephalopathy | 150.74 | 24.75 | 23 | 3030 | 146 | 42618136 |
| Hepatic artery stenosis | 149.04 | 24.75 | 23 | 3030 | 159 | 42618123 |
| Contrast media allergy | 121.44 | 24.75 | 24 | 3029 | 763 | 42617519 |
| Urticaria | 84.10 | 24.75 | 57 | 2996 | 73979 | 42544303 |
| Extravasation | 61.39 | 24.75 | 17 | 3036 | 2373 | 42615909 |
| Hepatic artery occlusion | 47.77 | 24.75 | 8 | 3045 | 97 | 42618185 |
| Cardio-respiratory arrest | 45.71 | 24.75 | 36 | 3017 | 58600 | 42559682 |
| Kounis syndrome | 43.13 | 24.75 | 14 | 3039 | 3354 | 42614928 |
| Pruritus | 41.79 | 24.75 | 59 | 2994 | 188712 | 42429570 |
| No adverse event | 39.42 | 24.75 | 28 | 3025 | 38993 | 42579289 |
| Cardiac arrest | 36.57 | 24.75 | 42 | 3011 | 109278 | 42509004 |
| Blood pressure decreased | 35.42 | 24.75 | 31 | 3022 | 58301 | 42559981 |
| Drug reaction with eosinophilia and systemic symptoms | 35.31 | 24.75 | 27 | 3026 | 42048 | 42576234 |
| Hypersensitivity | 31.55 | 24.75 | 32 | 3021 | 72338 | 42545944 |
| Sialoadenitis | 31.43 | 24.75 | 8 | 3045 | 807 | 42617475 |
| Unresponsive to stimuli | 30.48 | 24.75 | 22 | 3031 | 31381 | 42586901 |
| Vomiting | 29.14 | 24.75 | 64 | 2989 | 289659 | 42328623 |
| Oxygen saturation decreased | 28.92 | 24.75 | 29 | 3024 | 64658 | 42553624 |
| Throat irritation | 24.87 | 24.75 | 14 | 3039 | 13022 | 42605260 |
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 | 585.39 | 23.93 | 104 | 6296 | 2294 | 110580605 |
| Anaphylactic shock | 372.55 | 23.93 | 132 | 6268 | 51414 | 110531485 |
| Anaphylactic reaction | 335.90 | 23.93 | 153 | 6247 | 114147 | 110468752 |
| Contrast encephalopathy | 298.01 | 23.93 | 45 | 6355 | 337 | 110582562 |
| Hepatic artery stenosis | 172.42 | 23.93 | 27 | 6373 | 263 | 110582636 |
| Contrast media allergy | 162.06 | 23.93 | 38 | 6362 | 3385 | 110579514 |
| Urticaria | 133.48 | 23.93 | 125 | 6275 | 318732 | 110264167 |
| Drug reaction with eosinophilia and systemic symptoms | 115.36 | 23.93 | 67 | 6333 | 82028 | 110500871 |
| Cardio-respiratory arrest | 94.23 | 23.93 | 67 | 6333 | 115769 | 110467130 |
| Sialoadenitis | 92.24 | 23.93 | 23 | 6377 | 2650 | 110580249 |
| Sneezing | 84.89 | 23.93 | 40 | 6360 | 31944 | 110550955 |
| Extravasation | 83.12 | 23.93 | 24 | 6376 | 4821 | 110578078 |
| Throat irritation | 75.97 | 23.93 | 44 | 6356 | 53508 | 110529391 |
| Throat tightness | 74.16 | 23.93 | 37 | 6363 | 33452 | 110549447 |
| Pruritus | 68.09 | 23.93 | 121 | 6279 | 581439 | 110001460 |
| Cardiac arrest | 65.16 | 23.93 | 68 | 6332 | 196685 | 110386214 |
| Pulse absent | 63.18 | 23.93 | 24 | 6376 | 11268 | 110571631 |
| Anaphylactoid reaction | 62.87 | 23.93 | 21 | 6379 | 6805 | 110576094 |
| Unresponsive to stimuli | 61.51 | 23.93 | 41 | 6359 | 63749 | 110519150 |
| Erythema | 52.55 | 23.93 | 74 | 6326 | 291373 | 110291526 |
| Hypersensitivity | 52.35 | 23.93 | 88 | 6312 | 403910 | 110178989 |
| Dyspnoea | 50.32 | 23.93 | 159 | 6241 | 1106713 | 109476186 |
| Kounis syndrome | 49.73 | 23.93 | 17 | 6383 | 5908 | 110576991 |
| Blood pressure decreased | 49.67 | 23.93 | 46 | 6354 | 115045 | 110467854 |
| Hepatic artery occlusion | 48.75 | 23.93 | 8 | 6392 | 107 | 110582792 |
| Oxygen saturation decreased | 47.95 | 23.93 | 52 | 6348 | 156930 | 110425969 |
| Nephropathy toxic | 42.77 | 23.93 | 24 | 6376 | 27454 | 110555445 |
| Rapidly progressive osteoarthritis | 41.17 | 23.93 | 6 | 6394 | 34 | 110582865 |
| Loss of consciousness | 40.12 | 23.93 | 53 | 6347 | 196253 | 110386646 |
| Cyanosis | 38.38 | 23.93 | 23 | 6377 | 29718 | 110553181 |
| No adverse event | 36.76 | 23.93 | 32 | 6368 | 73807 | 110509092 |
| Product physical issue | 36.68 | 23.93 | 13 | 6387 | 5023 | 110577876 |
| Pharyngeal oedema | 35.91 | 23.93 | 18 | 6382 | 16410 | 110566489 |
| Vomiting | 35.20 | 23.93 | 124 | 6276 | 910551 | 109672348 |
| Flushing | 34.27 | 23.93 | 36 | 6364 | 104700 | 110478199 |
| Foaming at mouth | 33.46 | 23.93 | 10 | 6390 | 2260 | 110580639 |
| Respiratory arrest | 32.57 | 23.93 | 27 | 6373 | 58272 | 110524627 |
| Acute kidney injury | 32.21 | 23.93 | 95 | 6305 | 635335 | 109947564 |
| Chest discomfort | 31.08 | 23.93 | 44 | 6356 | 173804 | 110409095 |
| Drug ineffective | 28.22 | 23.93 | 28 | 6372 | 1520512 | 109062387 |
| Nausea | 27.31 | 23.93 | 142 | 6258 | 1235548 | 109347351 |
| Angioedema | 27.25 | 23.93 | 31 | 6369 | 98469 | 110484430 |
| Wrong product administered | 26.91 | 23.93 | 13 | 6387 | 10947 | 110571952 |
| Infusion site extravasation | 26.17 | 23.93 | 13 | 6387 | 11621 | 110571278 |
| Documented hypersensitivity to administered product | 25.76 | 23.93 | 7 | 6393 | 1127 | 110581772 |
| Blood pressure immeasurable | 24.50 | 23.93 | 8 | 6392 | 2415 | 110580484 |
| Spinal cord ischaemia | 24.36 | 23.93 | 5 | 6395 | 239 | 110582660 |
| Aphasia | 24.32 | 23.93 | 23 | 6377 | 58974 | 110523925 |
| Product deposit | 23.99 | 23.93 | 6 | 6394 | 699 | 110582200 |
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 |
| FDA EPC | N0000180185 | Radiographic Contrast Agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35703 | xenobiotic |
| CHEBI has role | CHEBI:37338 | radioopaque medium |
| CHEBI has role | CHEBI:78298 | environmental contaminant |
Related Drugs by ATC class:
V08AB Watersoluble, nephrotropic, low osmolar X-ray contrast media 11 drugs
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)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 41% | ISOVUE-200 | BRACCO | N018735 | July 7, 1987 | RX | INJECTABLE | INJECTION | Oct. 10, 2028 | FOR ORAL ADMINISTRATION TO DELINEATE THE GASTROINTESTINAL TRACT ON COMPUTED TOMOGRAPHY OF THE ABDOMEN AND PELVIS IN ADULT AND PEDIATRIC PATIENTS |
| 51% | ISOVUE-250 | BRACCO | N018735 | July 6, 1992 | RX | INJECTABLE | INJECTION | Oct. 10, 2028 | FOR ORAL ADMINISTRATION TO DELINEATE THE GASTROINTESTINAL TRACT ON COMPUTED TOMOGRAPHY OF THE ABDOMEN AND PELVIS IN ADULT AND PEDIATRIC PATIENTS |
| 61% | ISOVUE-300 | BRACCO | N018735 | Dec. 31, 1985 | RX | INJECTABLE | INJECTION | Oct. 10, 2028 | FOR ORAL ADMINISTRATION TO DELINEATE THE GASTROINTESTINAL TRACT ON COMPUTED TOMOGRAPHY OF THE ABDOMEN AND PELVIS IN ADULT AND PEDIATRIC PATIENTS |
| 76% | ISOVUE-370 | BRACCO | N018735 | Dec. 31, 1985 | RX | INJECTABLE | INJECTION | Oct. 10, 2028 | FOR ORAL ADMINISTRATION TO DELINEATE THE GASTROINTESTINAL TRACT ON COMPUTED TOMOGRAPHY OF THE ABDOMEN AND PELVIS IN ADULT AND PEDIATRIC PATIENTS |
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 |
| 206534 | MMSL |
| 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 | 21 sections |
| ISOVUE200 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1314 | INJECTION, SOLUTION | 408 mg | INTRAVASCULAR | NDA | 21 sections |
| ISOVUE300 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1315 | INJECTION, SOLUTION | 612 mg | INTRAVASCULAR | NDA | 21 sections |
| ISOVUE300 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1315 | INJECTION, SOLUTION | 612 mg | INTRAVASCULAR | NDA | 21 sections |
| ISOVUE300 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1315 | INJECTION, SOLUTION | 612 mg | INTRAVASCULAR | NDA | 21 sections |
| ISOVUE370 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1316 | INJECTION, SOLUTION | 755 mg | INTRAVASCULAR | NDA | 21 sections |
| ISOVUE370 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1316 | INJECTION, SOLUTION | 755 mg | INTRAVASCULAR | NDA | 21 sections |
| ISOVUE370 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1316 | INJECTION, SOLUTION | 755 mg | INTRAVASCULAR | NDA | 21 sections |
| ISOVUE250 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1317 | INJECTION, SOLUTION | 510 mg | INTRAVASCULAR | NDA | 21 sections |
| ISOVUE250 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1317 | INJECTION, SOLUTION | 510 mg | INTRAVASCULAR | NDA | 21 sections |
| ISOVUE-M | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1411 | INJECTION, SOLUTION | 408 mg | INTRATHECAL | NDA | 17 sections |
| ISOVUE-M | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-1412 | INJECTION, SOLUTION | 612 mg | INTRATHECAL | NDA | 17 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 |
| iopamidol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70436-125 | INJECTION, SOLUTION | 510 mg | INTRAVASCULAR | ANDA | 27 sections |
| iopamidol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70436-126 | INJECTION, SOLUTION | 612 mg | INTRATHECAL | ANDA | 21 sections |
| iopamidol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70436-127 | INJECTION, SOLUTION | 755 mg | INTRAVASCULAR | ANDA | 27 sections |
| iopamidol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70436-211 | INJECTION, SOLUTION | 408 mg | INTRAVASCULAR | ANDA | 27 sections |
| iopamidol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70436-219 | INJECTION, SOLUTION | 612 mg | INTRAVASCULAR | ANDA | 27 sections |