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

Stem definitionDrug idCAS RN
4261 141-01-5

Description:

MoleculeDescription

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:

DoseUnitRoute
0.20 g O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
July 18, 1986 FDA GD SEARLE LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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)

DiseaseRelationSNOMED_IDDOID
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:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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