ferric carboxymaltose Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	5128	53858-86-9

Description:

Molecule	Description
Synonyms: ferric carboxymaltose injectafer iron dextri-maltose	effective for treatment of postpartum anemia Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

ferric carboxymaltose
injectafer
iron dextri-maltose

effective for treatment of postpartum anemia

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
July 25, 2013	FDA	LUITPOLD

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
Hypophosphataemia	615.66	25.56	166	9487	7201	46669208
Urticaria	290.38	25.56	220	9433	117672	46558737
Pruritus	242.52	25.56	273	9380	242079	46434330
Infusion site discolouration	235.86	25.56	47	9606	509	46675900
Maternal exposure during pregnancy	181.51	25.56	158	9495	102391	46574018
Flushing	173.03	25.56	127	9526	64487	46611922
Blood phosphorus decreased	153.42	25.56	49	9604	3831	46672578
Infusion site extravasation	146.50	25.56	51	9602	5205	46671204
Extravasation	136.65	25.56	39	9614	2076	46674333
Chest discomfort	126.26	25.56	122	9531	90147	46586262
Tachycardia	125.20	25.56	127	9526	99495	46576914
Dyspnoea	122.17	25.56	303	9350	515245	46161164
Drug ineffective	104.64	25.56	10	9643	677828	45998581
Exposure during pregnancy	104.42	25.56	120	9533	108092	46568317
Nausea	95.43	25.56	334	9319	687120	45989289
Skin discolouration	91.36	25.56	66	9587	32614	46643795
Respiratory distress	66.23	25.56	54	9599	31862	46644547
Serum ferritin increased	63.96	25.56	28	9625	5255	46671154
Circulatory collapse	63.46	25.56	45	9608	21579	46654830
Dizziness	61.94	25.56	182	9471	340232	46336177
Product preparation error	60.84	25.56	25	9628	4014	46672395
Anhedonia	59.51	25.56	33	9620	10302	46666107
Erythema	59.31	25.56	106	9547	142714	46533695
Infusion site pain	57.45	25.56	32	9621	10075	46666334
Headache	56.37	25.56	221	9432	478131	46198278
Angioedema	54.57	25.56	53	9600	39289	46637120
Myalgia	53.20	25.56	93	9560	122995	46553414
Suspected product quality issue	51.68	25.56	11	9642	168	46676241
Product quality issue	51.28	25.56	49	9604	35599	46640810
Throat irritation	49.90	25.56	44	9609	28857	46647552
Hyperventilation	49.75	25.56	24	9629	5623	46670786
Iron overload	48.99	25.56	14	9639	748	46675661
Osteomalacia	46.44	25.56	13	9640	644	46675765
Rash	46.25	25.56	170	9483	356342	46320067
Pneumonia	45.52	25.56	11	9642	376309	46300100
Chest pain	44.92	25.56	107	9546	176217	46500192
Anaphylactoid reaction	43.88	25.56	19	9634	3472	46672937
Feeling hot	43.30	25.56	46	9607	37882	46638527
Throat tightness	42.97	25.56	35	9618	20604	46655805
Anaphylactic reaction	41.50	25.56	53	9600	53059	46623350
Emotional distress	40.03	25.56	40	9613	30667	46645742
Presyncope	35.90	25.56	34	9619	24420	46651989
Hypotension	35.36	25.56	117	9536	232472	46443937
Vomiting	35.06	25.56	185	9468	452609	46223800
Death	34.77	25.56	13	9640	335535	46340874
Influenza like illness	33.74	25.56	50	9603	57520	46618889
Bronchospasm	33.46	25.56	27	9626	15680	46660729
Malaise	32.56	25.56	145	9508	331087	46345322
Paraesthesia	31.76	25.56	73	9580	117364	46559045
Urine phosphorus increased	31.61	25.56	5	9648	11	46676398
Hypersensitivity	30.74	25.56	84	9569	150237	46526172
Fall	30.51	25.56	15	9638	329082	46347327
Chills	29.69	25.56	63	9590	95969	46580440
Drug hypersensitivity	29.69	25.56	7	9646	243818	46432591
Hyperphosphaturia	29.58	25.56	5	9648	19	46676390
Ear swelling	28.36	25.56	10	9643	1058	46675351
Pallor	28.04	25.56	29	9624	23137	46653272
Loss of consciousness	26.78	25.56	65	9588	108173	46568236

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
Hypophosphataemia	208.36	29.52	55	1650	8190	29942583
Osteomalacia	64.53	29.52	14	1691	894	29949879
Hypophosphataemic osteomalacia	63.26	29.52	10	1695	106	29950667
Fibroblast growth factor 23 increased	43.88	29.52	5	1700	0	29950773
Blood phosphorus decreased	43.57	29.52	13	1692	2979	29947794
Extravasation	40.41	29.52	11	1694	1817	29948956
Foetal exposure during pregnancy	34.29	29.52	23	1682	36848	29913925
Skin discolouration	33.95	29.52	17	1688	15777	29934996
Malaise	30.23	29.52	42	1663	166920	29783853

Pharmacologic Action:

None

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Iron deficiency anemia	indication	87522002

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
9007-72-1	SECONDARY_CAS_RN
D08920	KEGG_DRUG
4032651	VANDF
C2001867	UMLSCUI
CHEMBL2108597	ChEMBL_ID
DB08917	DRUGBANK_ID
C522335	MESH_SUPPLEMENTAL_RECORD_UI
8853	INN_ID
6897GXD6OE	UNII
86278165	PUBCHEM_CID
1433693	RXNORM
204720	MMSL
29586	MMSL
d07305	MMSL
012722	NDDF
430077004	SNOMEDCT_US
430819007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Injectafer	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0620	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections
Injectafer	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0650	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections