Stem definition | Drug id | CAS RN |
---|---|---|
diagnostic agents, gadolinium derivatives | 1267 | 92943-93-6 |
Molecule | Description |
---|---|
Synonyms:
|
|
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
March 20, 2013 | FDA | GUERBET |
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 |
---|---|---|---|---|---|---|
Urticaria | 630.96 | 49.85 | 277 | 4100 | 129284 | 50471463 |
Erythema | 287.03 | 49.85 | 170 | 4207 | 146244 | 50454503 |
Pruritus | 265.11 | 49.85 | 208 | 4169 | 283360 | 50317387 |
Sneezing | 199.38 | 49.85 | 66 | 4311 | 13978 | 50586769 |
Dyspnoea | 173.47 | 49.85 | 223 | 4154 | 547385 | 50053362 |
Throat irritation | 156.66 | 49.85 | 68 | 4309 | 30171 | 50570576 |
Product use in unapproved indication | 145.70 | 49.85 | 102 | 4275 | 115717 | 50485030 |
Cough | 120.89 | 49.85 | 125 | 4252 | 241139 | 50359608 |
Vomiting | 116.95 | 49.85 | 169 | 4208 | 460589 | 50140158 |
Contrast media reaction | 111.00 | 49.85 | 24 | 4353 | 983 | 50599764 |
Nausea | 89.96 | 49.85 | 191 | 4186 | 705207 | 49895540 |
Feeling hot | 74.94 | 49.85 | 45 | 4332 | 39157 | 50561590 |
Throat tightness | 73.72 | 49.85 | 36 | 4341 | 20811 | 50579936 |
Chest discomfort | 69.08 | 49.85 | 60 | 4317 | 92662 | 50508085 |
Type I hypersensitivity | 67.18 | 49.85 | 19 | 4358 | 2366 | 50598381 |
Gadolinium deposition disease | 65.33 | 49.85 | 10 | 4367 | 52 | 50600695 |
Laryngeal discomfort | 56.19 | 49.85 | 11 | 4366 | 273 | 50600474 |
Eye swelling | 54.38 | 49.85 | 29 | 4348 | 20115 | 50580632 |
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 |
---|---|---|---|---|---|---|
Urticaria | 389.72 | 50.45 | 136 | 1506 | 54524 | 29518361 |
Pruritus | 155.35 | 50.45 | 90 | 1552 | 116759 | 29456126 |
Erythema | 144.05 | 50.45 | 74 | 1568 | 75532 | 29497353 |
Nausea | 101.15 | 50.45 | 100 | 1542 | 289155 | 29283730 |
Vomiting | 98.43 | 50.45 | 86 | 1556 | 212174 | 29360711 |
Throat irritation | 78.06 | 50.45 | 26 | 1616 | 8759 | 29564126 |
Nephrogenic systemic fibrosis | 66.14 | 50.45 | 19 | 1623 | 3923 | 29568962 |
Dyspnoea | 52.06 | 50.45 | 76 | 1566 | 326656 | 29246229 |
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 |
---|---|---|---|---|---|---|
Urticaria | 928.64 | 55.51 | 385 | 5553 | 146932 | 64345862 |
Erythema | 411.06 | 55.51 | 239 | 5699 | 186831 | 64305963 |
Pruritus | 410.07 | 55.51 | 288 | 5650 | 312112 | 64180682 |
Sneezing | 241.29 | 55.51 | 79 | 5859 | 15172 | 64477622 |
Throat irritation | 226.26 | 55.51 | 92 | 5846 | 32619 | 64460175 |
Dyspnoea | 200.00 | 55.51 | 284 | 5654 | 718390 | 63774404 |
Vomiting | 189.95 | 55.51 | 242 | 5696 | 550875 | 63941919 |
Product use in unapproved indication | 168.19 | 55.51 | 135 | 5803 | 176483 | 64316311 |
Nausea | 168.11 | 55.51 | 275 | 5663 | 785525 | 63707269 |
Cough | 151.01 | 55.51 | 161 | 5777 | 301987 | 64190807 |
Contrast media reaction | 131.22 | 55.51 | 31 | 5907 | 1781 | 64491013 |
Feeling hot | 88.27 | 55.51 | 54 | 5884 | 45609 | 64447185 |
Gadolinium deposition disease | 84.37 | 55.51 | 13 | 5925 | 66 | 64492728 |
Type I hypersensitivity | 83.64 | 55.51 | 25 | 5913 | 3549 | 64489245 |
Nephrogenic systemic fibrosis | 83.04 | 55.51 | 28 | 5910 | 5864 | 64486930 |
Throat tightness | 82.47 | 55.51 | 41 | 5897 | 23119 | 64469675 |
Eye swelling | 78.03 | 55.51 | 39 | 5899 | 22242 | 64470552 |
Chest discomfort | 76.34 | 55.51 | 72 | 5866 | 116034 | 64376760 |
Laryngeal discomfort | 66.14 | 55.51 | 14 | 5924 | 485 | 64492309 |
Rash | 63.71 | 55.51 | 134 | 5804 | 458415 | 64034379 |
Laryngeal oedema | 63.13 | 55.51 | 24 | 5914 | 7089 | 64485705 |
Eyelid oedema | 63.06 | 55.51 | 28 | 5910 | 12251 | 64480543 |
Anaphylactic reaction | 55.78 | 55.51 | 48 | 5890 | 68616 | 64424178 |
None
Source | Code | Description |
---|---|---|
MeSH PA | D003287 | Contrast Media |
MeSH PA | D064907 | Diagnostic Uses of Chemicals |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Magnetic resonance imaging | indication | 113091000 |
None
None
None
None
None
None
ID | Source |
---|---|
4032690 | VUID |
N0000188988 | NUI |
4032690 | VANDF |
C0118538 | UMLSCUI |
CHEBI:73727 | CHEBI |
CHEMBL2219415 | ChEMBL_ID |
C072417 | MESH_SUPPLEMENTAL_RECORD_UI |
121841 | PUBCHEM_CID |
L0ND3981AG | UNII |
1421151 | RXNORM |
29771 | MMSL |
92135 | MMSL |
d06307 | MMSL |
006172 | NDDF |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
CLARISCAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0407-2943 | INJECTION, SOLUTION | 376.90 mg | INTRAVENOUS | ANDA | 33 sections |
CLARISCAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0407-2943 | INJECTION, SOLUTION | 376.90 mg | INTRAVENOUS | ANDA | 33 sections |
Gadoterate Meglumine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65219-080 | INJECTION | 376.90 mg | INTRAVENOUS | ANDA | 29 sections |
Gadoterate Meglumine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65219-082 | INJECTION | 376.90 mg | INTRAVENOUS | ANDA | 29 sections |
Gadoterate Meglumine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65219-084 | INJECTION | 376.90 mg | INTRAVENOUS | ANDA | 29 sections |
Gadoterate Meglumine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65219-086 | INJECTION | 376.90 mg | INTRAVENOUS | ANDA | 29 sections |
DOTAREM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67684-2000 | Injection | 376.90 mg | Intravenous | NDA | 29 sections |
DOTAREM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67684-2000 | Injection | 376.90 mg | Intravenous | NDA | 29 sections |
DOTAREM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67684-2001 | Injection | 376.90 mg | Intravenous | NDA | 29 sections |
DOTAREM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67684-2001 | Injection | 376.90 mg | Intravenous | NDA | 29 sections |
DOTAREM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67684-3001 | Injection | 376.90 mg | Intravenous | NDA | 29 sections |