All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
diagnostic agents, gadolinium derivatives	1267	92943-93-6

Description:

Molecule	Description
Synonyms: dotarem gadoterate meglumine magnescope Gd-DOTA meglumine	Molecular weight: 753.86 Formula: C23H42GdN5O13 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
March 20, 2013	FDA	GUERBET

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
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

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
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

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
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

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
MeSH PA	D003287	Contrast Media
MeSH PA	D064907	Diagnostic Uses of Chemicals

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

Disease	Relation	SNOMED_ID	DOID
Magnetic resonance imaging	indication	113091000

🐶 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)

None

Bioactivity Summary:

None

External reference:

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

Pharmaceutical products:

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