ferrous fumarate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4261	141-01-5

Description:

Molecule	Description
Synonyms: ferrous fumarate iron fumarate	used in treatment of iron deficiency anemia; RN given refers to Fe(+2)[1:1] salt Molecular weight: 169.90 Formula: C4H2FeO4 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

ferrous fumarate
iron fumarate

used in treatment of iron deficiency anemia; RN given refers to Fe(+2)[1:1] salt

Molecular weight: 169.90
Formula: C4H2FeO4
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
0.20	g	O

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
July 18, 1986	FDA	GD SEARLE LLC

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
Acute kidney injury	80.39	13.72	196	13234	235659	46436973
Hyponatraemia	66.82	13.72	111	13319	101221	46571411
Presbyacusis	58.11	13.72	24	13406	2798	46669834
Pleural thickening	56.61	13.72	23	13407	2572	46670060
Blood magnesium increased	56.49	13.72	24	13406	3003	46669629
Disability	52.37	13.72	34	13396	10133	46662499
Confusional state	50.29	13.72	129	13301	159763	46512869
Pleural fibrosis	49.56	13.72	23	13407	3546	46669086
Red blood cell sedimentation rate abnormal	47.73	13.72	36	13394	13613	46659019
Haematocrit decreased	46.77	13.72	54	13376	35003	46637629
C-reactive protein abnormal	45.07	13.72	42	13388	21228	46651404
Red blood cell count decreased	44.78	13.72	51	13379	32572	46640060
Deafness neurosensory	44.52	13.72	23	13407	4471	46668161
Epigastric discomfort	39.46	13.72	23	13407	5661	46666971
Starvation ketoacidosis	33.59	13.72	7	13423	67	46672565
Haemoglobin decreased	32.51	13.72	96	13334	128853	46543779
Large intestine polyp	30.33	13.72	22	13408	7839	46664793
Blood lactic acid	30.16	13.72	7	13423	114	46672518
Orthostatic hypotension	29.60	13.72	36	13394	24622	46648010
Osteopenia	29.39	13.72	30	13400	16931	46655701
Fall	29.32	13.72	178	13252	328919	46343713
Blindness cortical	29.06	13.72	9	13421	454	46672178
C-reactive protein increased	28.15	13.72	56	13374	58534	46614098
Blood pressure diastolic decreased	28.08	13.72	27	13403	14184	46658448
Metabolic encephalopathy	27.65	13.72	18	13412	5385	46667247
Colitis microscopic	26.79	13.72	19	13411	6537	46666095
Cerebellar haematoma	26.58	13.72	8	13422	366	46672266
Hippocampal sclerosis	26.51	13.72	6	13424	87	46672545
Thyroiditis acute	25.95	13.72	6	13424	96	46672536
Hip fracture	25.94	13.72	35	13395	26521	46646111
Cyst	25.84	13.72	24	13406	12076	46660556
Parkinsonian rest tremor	25.34	13.72	6	13424	107	46672525
Heart rate	24.37	13.72	5	13425	44	46672588
Narrow anterior chamber angle	24.08	13.72	5	13425	47	46672585
Haematemesis	23.74	13.72	35	13395	28771	46643861
Periodic limb movement disorder	22.94	13.72	6	13424	163	46672469
Upper gastrointestinal haemorrhage	22.68	13.72	26	13404	16712	46655920
Blood potassium increased	22.39	13.72	26	13404	16941	46655691
Infected neoplasm	21.71	13.72	6	13424	202	46672430
Hyperkalaemia	21.46	13.72	46	13384	50663	46621969
Blood pressure systolic increased	20.93	13.72	33	13397	28754	46643878
Renal impairment	20.30	13.72	57	13373	74315	46598317
Body temperature decreased	20.17	13.72	22	13408	13387	46659245
Ear infection viral	19.37	13.72	5	13425	129	46672503
Melaena	19.04	13.72	31	13399	27741	46644891
Aura	18.90	13.72	8	13422	991	46671641
Chillblains	18.49	13.72	5	13425	155	46672477
Temporal lobe epilepsy	18.10	13.72	6	13424	377	46672255
Multiple fractures	17.96	13.72	14	13416	5553	46667079
Lethargy	17.85	13.72	43	13387	51128	46621504
Skin depigmentation	17.55	13.72	7	13423	746	46671886
Circulatory collapse	17.42	13.72	26	13404	21598	46651034
Acquired epidermolysis bullosa	17.42	13.72	4	13426	62	46672570
Lower respiratory tract infection	16.81	13.72	44	13386	55045	46617587
Foetal exposure during pregnancy	16.74	13.72	31	13399	30716	46641916
Blood pressure measurement	16.57	13.72	5	13425	231	46672401
Liver function test abnormal	16.14	13.72	39	13391	46448	46626184
Contraindicated product administered	15.99	13.72	55	13375	79892	46592740
Parkinsonism	15.51	13.72	15	13415	7933	46664699
Otitis externa	15.15	13.72	8	13422	1625	46671007
Discharge	14.96	13.72	6	13424	648	46671984
Mania	14.95	13.72	17	13413	10829	46661803
Hepatobiliary infection	14.88	13.72	3	13427	24	46672608
Blood creatinine increased	14.79	13.72	52	13378	76351	46596281
Mixed anxiety and depressive disorder	14.61	13.72	4	13426	130	46672502
Dry eye	14.58	13.72	29	13401	30293	46642339
Subarachnoid haemorrhage	14.56	13.72	17	13413	11136	46661496
Hypovolaemic shock	14.52	13.72	12	13418	5171	46667461
Intracranial haematoma	14.45	13.72	5	13425	358	46672274
Medical device site joint infection	14.41	13.72	4	13426	137	46672495
Iron deficiency anaemia	14.31	13.72	21	13409	17185	46655447
Joint swelling	14.21	13.72	89	13341	165984	46506648
Myotonia	13.96	13.72	4	13426	154	46672478
Initial insomnia	13.94	13.72	11	13419	4441	46668191
Uterine dilation and evacuation	13.78	13.72	3	13427	36	46672596

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
Clear cell renal cell carcinoma	70.37	17.83	19	5582	912	29945965
Lymphoproliferative disorder	57.00	17.83	20	5581	2310	29944567
Neutropenic sepsis	46.28	17.83	28	5573	11381	29935496
Acute kidney injury	45.76	17.83	133	5468	273709	29673168
Fall	42.26	17.83	100	5501	181772	29765105
Congenital oesophageal anomaly	39.73	17.83	8	5593	102	29946775
Polyhydramnios	33.42	17.83	8	5593	235	29946642
High frequency ablation	30.56	17.83	7	5594	169	29946708
Faeces discoloured	29.72	17.83	23	5578	13923	29932954
Microcytic anaemia	29.02	17.83	12	5589	2166	29944711
Paraneoplastic rash	28.65	17.83	6	5595	94	29946783
Upper gastrointestinal haemorrhage	27.93	17.83	27	5574	22001	29924876
Confusional state	27.91	17.83	71	5530	134763	29812114
Haematemesis	27.52	17.83	29	5572	26174	29920703
Femoral neck fracture	25.55	17.83	12	5589	2930	29943947
Cardiac flutter	25.24	17.83	10	5591	1616	29945261
Iron deficiency anaemia	23.98	17.83	17	5584	9007	29937870
Malaise	23.92	17.83	77	5524	166885	29779992
Hyponatraemia	23.79	17.83	44	5557	67158	29879719
Lymphoedema	23.58	17.83	12	5589	3487	29943390
Agitated depression	23.40	17.83	6	5595	235	29946642
Apnoeic attack	22.32	17.83	6	5595	283	29946594
Melaena	20.94	17.83	28	5573	32409	29914468
Skin plaque	20.24	17.83	11	5590	3651	29943226
Abdominal symptom	18.97	17.83	6	5595	502	29946375
Toxicity to various agents	18.75	17.83	5	5596	177178	29769699
Hypomagnesaemia	18.55	17.83	19	5582	16579	29930298
White blood cell count increased	18.00	17.83	29	5572	39644	29907233

Pharmacologic Action:

Source	Code	Description
ATC	B03AA02	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS IRON PREPARATIONS Iron bivalent, oral preparations
ATC	B03AD02	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS IRON PREPARATIONS Iron in combination with folic acid
MeSH PA	D018977	Micronutrients
MeSH PA	D014131	Trace Elements

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Contraception	indication	13197004
Anemia of prematurity	indication	47100003	DOID:11243
Megaloblastic anemia due to folate deficiency	indication	85649008	DOID:14026
Iron deficiency anemia	indication	87522002
Acne vulgaris	indication	88616000
Pregnancy, function	indication	289908002
Breastfeeding (mother)	indication	413712001
Amenorrhea	off-label use	14302001	DOID:13938
Female hypogonadism syndrome	off-label use	16041008
Polycystic ovaries	off-label use	69878008
Endometriosis	off-label use	129103003
Dysmenorrhea	off-label use	266599000
Abnormal uterine bleeding unrelated to menstrual cycle	off-label use	312984006
Menorrhagia	off-label use	386692008
Prevention of Fetal Neural Tube Defects during Pregnancy	off-label use
Heart valve disorder	contraindication	368009	DOID:4079
Peptic ulcer	contraindication	13200003	DOID:750
Hypercholesterolemia	contraindication	13644009
Constipation	contraindication	14760008	DOID:2089
Primary hyperoxaluria	contraindication	17901006	DOID:2977
Hyperphosphatemia	contraindication	20165001	DOID:0050459
Myocardial infarction	contraindication	22298006	DOID:5844
Gastroenteritis	contraindication	25374005	DOID:2326
Hypervitaminosis D	contraindication	27712000	DOID:9971
Sarcoidosis	contraindication	31541009	DOID:11335
Dehydration	contraindication	34095006
Depressive disorder	contraindication	35489007
Migraine	contraindication	37796009	DOID:6364
Hypertensive disorder	contraindication	38341003	DOID:10763
Hemosiderosis	contraindication	39011001	DOID:12119
Disorder of gallbladder	contraindication	39621005	DOID:0060262
Hypokalemia	contraindication	43339004
Body fluid retention	contraindication	43498006
Thrombosis of retinal vein	contraindication	46085004
Gastrectomy	contraindication	53442002
Hyperlipidemia	contraindication	55822004	DOID:1168
Benign mammary dysplasia	contraindication	57993004
Leber's optic atrophy	contraindication	58610003	DOID:705
Obstructive hyperbilirubinemia	contraindication	59848001
Hemolytic anemia	contraindication	61261009	DOID:583
Thrombophlebitis	contraindication	64156001	DOID:3875
Ulcerative colitis	contraindication	64766004	DOID:8577
Intermenstrual bleeding - irregular	contraindication	64996003
Hypercalcemia	contraindication	66931009	DOID:12678
Hyperparathyroidism	contraindication	66999008	DOID:13543
Diabetes mellitus	contraindication	73211009	DOID:9351
Hyperglycemia	contraindication	80394007	DOID:4195
Atrophic gastritis	contraindication	84568007	DOID:8929
Kidney disease	contraindication	90708001	DOID:557
Malignant neoplasm of liver	contraindication	93870000	DOID:3571
Kidney stone	contraindication	95570007
Anemia due to enzyme deficiency	contraindication	111577008
Hb SS disease	contraindication	127040003	DOID:10923
Deep venous thrombosis	contraindication	128053003
Liver function tests abnormal	contraindication	166603001
Angina pectoris	contraindication	194828000
Osteolysis	contraindication	203522001
Cerebrovascular accident	contraindication	230690007
Pulmonary thromboembolism	contraindication	233935004
Disease of liver	contraindication	235856003	DOID:409
Cholestasis of pregnancy	contraindication	235888006
Endometrial carcinoma	contraindication	254878006	DOID:2871
Hypertriglyceridemia	contraindication	302870006
Arteriosclerosis obliterans	contraindication	361133006	DOID:5160
Malignant tumor of cervix	contraindication	363354003	DOID:4362
Thromboembolic disorder	contraindication	371039008
Cardiovascular event risk	contraindication	395112001
Diverticular disease	contraindication	397881000
Hemochromatosis	contraindication	399187006	DOID:2352
Disorder of coronary artery	contraindication	414024009
Obesity	contraindication	414916001	DOID:9970
Estrogen receptor positive tumor	contraindication	416053008
Porphyria	contraindication	418470004
Hypertensive urgency	contraindication	443482000
Carcinoma of female breast	contraindication	447782002
Smokes tobacco daily	contraindication	449868002
Nonspecific Abnormal Papanicolaou Smear of Cervix	contraindication
Repeated Blood Transfusions	contraindication
Major Surgery with Prolonged Post-Operative Immobilization	contraindication

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
4017694	VUID
N0000146068	NUI
D01194	KEGG_DRUG
4017630	VANDF
4017694	VANDF
C0060276	UMLSCUI
CHEBI:31607	CHEBI
CHEMBL1200640	ChEMBL_ID
DB14491	DRUGBANK_ID
C031621	MESH_SUPPLEMENTAL_RECORD_UI
R5L488RY0Q	UNII
5478817	PUBCHEM_CID
24941	RXNORM
4723	MMSL
4919	MMSL
6955	MMSL
d03920	MMSL
000833	NDDF
387289009	SNOMEDCT_US
52108005	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CitraNatal Medley	HUMAN PRESCRIPTION DRUG LABEL	8	0178-0896	CAPSULE, GELATIN COATED	2 mg	ORAL	unapproved drug other	10 sections
BACMIN	HUMAN PRESCRIPTION DRUG LABEL	19	0682-3001	TABLET, COATED	27 mg	ORAL	UNULLPPROVED DRUG OTHER	10 sections
O-Cal Prenatal Vitamin	HUMAN PRESCRIPTION DRUG LABEL	16	0813-0202	TABLET	15 mg	ORAL	UNULLPPROVED DRUG OTHER	6 sections
PRENULLTAL PLUS	HUMAN PRESCRIPTION DRUG LABEL	15	10544-549	TABLET, FILM COATED	27 mg	ORAL	unapproved drug other	8 sections
Se-Natal 19	HUMAN PRESCRIPTION DRUG LABEL	15	13925-116	TABLET	29 mg	ORAL	unapproved drug other	15 sections
Se-Natal 19 Chewable	HUMAN PRESCRIPTION DRUG LABEL	14	13925-117	TABLET, CHEWABLE	29 mg	ORAL	unapproved drug other	16 sections
Se-Tan PLUS	HUMAN PRESCRIPTION DRUG LABEL	13	13925-118	CAPSULE, GELATIN COATED	162 mg	ORAL	unapproved drug other	19 sections
PRENULLTAL PLUS	HUMAN PRESCRIPTION DRUG LABEL	15	15338-522	TABLET, FILM COATED	27 mg	ORAL	unapproved drug other	8 sections
PRENULLTAL PLUS	HUMAN PRESCRIPTION DRUG LABEL	15	17856-0668	TABLET, FILM COATED	27 mg	ORAL	UNULLPPROVED DRUG OTHER	6 sections
C-Nate DHA	HUMAN PRESCRIPTION DRUG LABEL	13	23359-105	CAPSULE, GELATIN COATED	28 mg	ORAL	unapproved drug other	15 sections
PNV-Select	HUMAN PRESCRIPTION DRUG LABEL	18	42192-320	TABLET, FILM COATED	27 mg	ORAL	unapproved drug other	10 sections
PNV-DHA	HUMAN PRESCRIPTION DRUG LABEL	10	42192-321	CAPSULE, GELATIN COATED	27 mg	ORAL	unapproved drug other	11 sections
PNV-DHA	HUMAN PRESCRIPTION DRUG LABEL	8	42192-323	CAPSULE, GELATIN COATED	27 mg	ORAL	unapproved drug other	11 sections
PNV-Omega	HUMAN PRESCRIPTION DRUG LABEL	13	42192-332	CAPSULE, GELATIN COATED	28 mg	ORAL	unapproved drug other	12 sections
Prenaissance	HUMAN PRESCRIPTION DRUG LABEL	9	42192-341	CAPSULE, LIQUID FILLED	29 mg	ORAL	UNULLPPROVED DRUG OTHER	10 sections
PRENULLTAL PLUS	HUMAN PRESCRIPTION DRUG LABEL	15	42291-686	TABLET, FILM COATED	27 mg	ORAL	unapproved drug other	8 sections
PreNatal 19	HUMAN PRESCRIPTION DRUG LABEL	15	42937-706	TABLET, COATED	29 mg	ORAL	UNULLPPROVED DRUG OTHER	12 sections
PreNatal 19	HUMAN PRESCRIPTION DRUG LABEL	14	42937-707	TABLET, CHEWABLE	29 mg	ORAL	UNULLPPROVED DRUG OTHER	12 sections
PNV Prenatal VitaminPlus Vitamin A	HUMAN PRESCRIPTION DRUG LABEL	12	44946-1046	TABLET	27 mg	ORAL	UNULLPPROVED DRUG OTHER	9 sections
PNV Prenatal Plus Multivitamin	HUMAN PRESCRIPTION DRUG LABEL	15	50090-0617	TABLET	27 mg	ORAL	Unapproved drug other	9 sections
Concept OB	HUMAN PRESCRIPTION DRUG LABEL	15	52747-620	CAPSULE	130 mg	ORAL	unapproved drug other	13 sections
Concept DHA	HUMAN PRESCRIPTION DRUG LABEL	15	52747-621	CAPSULE, LIQUID FILLED	53.50 mg	ORAL	unapproved drug other	7 sections
Integra F	HUMAN PRESCRIPTION DRUG LABEL	5	52747-711	CAPSULE	191.20 mg	ORAL	unapproved drug other	14 sections
Integra Plus	HUMAN PRESCRIPTION DRUG LABEL	10	52747-712	CAPSULE	191.20 mg	ORAL	unapproved drug other	12 sections
M-Natal Plus	HUMAN PRESCRIPTION DRUG LABEL	14	58657-170	TABLET	27 mg	ORAL	unapproved drug other	7 sections
PureVit DualFe Plus	HUMAN PRESCRIPTION DRUG LABEL	13	59088-112	CAPSULE	53 mg	ORAL	unapproved drug other	12 sections
Vitrexyl plus Iron	HUMAN PRESCRIPTION DRUG LABEL	18	59088-165	TABLET	27 mg	ORAL	unapproved drug other	13 sections
Prenatrix	HUMAN PRESCRIPTION DRUG LABEL	20	59088-166	TABLET	27 mg	ORAL	unapproved drug other	13 sections
Vitrexate FE	HUMAN PRESCRIPTION DRUG LABEL	18	59088-168	TABLET	27 mg	ORAL	unapproved drug other	13 sections
Prenatryl	HUMAN PRESCRIPTION DRUG LABEL	20	59088-169	TABLET	27 mg	ORAL	unapproved drug other	13 sections