ferrous sulfate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
4528 7720-78-7

Description:

MoleculeDescription

Synonyms:

  • ferrous sulfate
  • ferrous sulfate, dried
Ferro-Gradumet is ferrous sulfate in controlled release form; RN given refers to Fe(+2)[1:1] salt
  • Molecular weight: 151.90
  • Formula: FeO4S
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA: 80.26
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.20 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 570 mg/mL Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 30.56 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Aug. 13, 1946 FDA LEDERLE

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 282.01 10.37 662 62539 319725 90245521
Anaemia 199.26 10.37 619 62582 352183 90213063
Synovitis 188.99 10.37 10 63191 329742 90235504
Hand deformity 183.39 10.37 5 63196 296357 90268889
Glossodynia 177.61 10.37 12 63189 321767 90243479
Systemic lupus erythematosus 177.12 10.37 22 63179 361874 90203372
Drug ineffective 172.49 10.37 452 62749 1383846 89181400
Pericarditis 149.29 10.37 10 63191 270141 90295105
Drug intolerance 137.95 10.37 70 63131 447521 90117725
Contraindicated product administered 131.34 10.37 31 63170 320108 90245138
Wound 124.96 10.37 29 63172 302951 90262295
Arthropathy 124.20 10.37 50 63151 366192 90199054
Folliculitis 120.91 10.37 5 63196 204348 90360898
Hepatic enzyme increased 119.49 10.37 51 63150 360685 90204561
Joint swelling 118.55 10.37 106 63095 503194 90062052
Treatment failure 115.98 10.37 34 63167 303894 90261352
Infusion related reaction 107.79 10.37 80 63121 416700 90148546
Muscle injury 105.60 10.37 4 63197 176650 90388596
Hypervolaemia 103.64 10.37 121 63080 32636 90532610
Impaired healing 99.41 10.37 21 63180 234178 90331068
Therapeutic product effect decreased 95.54 10.37 37 63164 277534 90287712
Irritable bowel syndrome 93.57 10.37 16 63185 207432 90357814
Haemoglobin decreased 92.91 10.37 286 62915 161670 90403576
Discomfort 90.47 10.37 39 63162 274296 90290950
Alopecia 88.64 10.37 130 63071 494941 90070305
Rheumatoid arthritis 86.97 10.37 75 63126 362539 90202707
Death 83.80 10.37 575 62626 455976 90109270
Mobility decreased 83.71 10.37 35 63166 250699 90314547
Gastrointestinal haemorrhage 83.00 10.37 190 63011 90058 90475188
Abdominal discomfort 80.97 10.37 130 63071 477198 90088048
Psoriatic arthropathy 77.64 10.37 31 63170 228304 90336942
Pulmonary hypertension 76.07 10.37 119 63082 42404 90522842
Hyperkalaemia 72.59 10.37 148 63053 64816 90500430
Urinary tract infection 72.34 10.37 411 62790 305221 90260025
Premature delivery 71.47 10.37 110 63091 38652 90526594
Hypersensitivity 71.45 10.37 130 63071 454547 90110699
Blister 69.77 10.37 46 63155 254952 90310294
Fibromyalgia 68.51 10.37 29 63172 206240 90359006
Musculoskeletal stiffness 67.89 10.37 64 63137 296468 90268778
General physical health deterioration 66.75 10.37 90 63111 355025 90210221
Pulmonary malformation 66.23 10.37 20 63181 370 90564876
Liver injury 65.18 10.37 19 63182 170548 90394698
Pulmonary arterial hypertension 64.01 10.37 85 63116 26102 90539144
Melaena 63.11 10.37 98 63103 34699 90530547
Fall 62.46 10.37 560 62641 481250 90083996
Hypotension 61.52 10.37 413 62788 324984 90240262
Foetal exposure during pregnancy 60.47 10.37 108 63093 42867 90522379
Hospitalisation 59.80 10.37 211 62990 127889 90437357
Lower respiratory tract infection 58.67 10.37 53 63148 250606 90314640
Drug hypersensitivity 58.35 10.37 150 63051 463459 90101787
Blood cholesterol increased 57.60 10.37 37 63164 207975 90357271
Acute respiratory failure 53.04 10.37 102 63099 42816 90522430
Grip strength decreased 52.38 10.37 3 63198 92573 90472673
Hypoxia 52.32 10.37 139 63062 72260 90492986
Product use issue 52.08 10.37 94 63107 329825 90235421
C-reactive protein increased 51.97 10.37 31 63170 181358 90383888
Bursitis 51.53 10.37 14 63187 131640 90433606
Hypophosphataemia 50.57 10.37 57 63144 14797 90550449
Lung cyst 50.28 10.37 17 63184 458 90564788
Faeces discoloured 50.27 10.37 68 63133 21252 90543994
Metabolic acidosis 49.83 10.37 116 63085 55560 90509686
Dyspnoea 49.71 10.37 876 62325 880079 89685167
Ill-defined disorder 49.69 10.37 34 63167 184857 90380389
Lip dry 49.66 10.37 6 63195 100949 90464297
Injury 49.52 10.37 39 63162 197310 90367936
Iron deficiency anaemia 49.13 10.37 71 63130 23591 90541655
Cardiac failure congestive 49.05 10.37 166 63035 98528 90466718
Sleep disorder 48.61 10.37 40 63161 197990 90367256
Stomatitis 48.25 10.37 73 63128 274625 90290621
Transfusion 47.81 10.37 60 63141 17428 90547818
Respiratory tract malformation 47.24 10.37 13 63188 170 90565076
Cardiac failure acute 46.22 10.37 49 63152 11880 90553366
Diarrhoea 46.10 10.37 914 62287 938276 89626970
Pre-eclampsia 45.71 10.37 47 63154 11001 90554245
Hypoglycaemia 45.40 10.37 129 63072 69719 90495527
Joint range of motion decreased 45.14 10.37 19 63182 135624 90429622
Right ventricular failure 44.90 10.37 61 63140 19144 90546102
Lactic acidosis 41.77 10.37 102 63099 50361 90514885
Inflammation 41.49 10.37 38 63163 178554 90386692
Sepsis 41.30 10.37 240 62961 179574 90385672
Completed suicide 41.26 10.37 25 63176 145033 90420213
Cellulitis 40.53 10.37 148 63053 91189 90474057
Swelling 40.38 10.37 153 63048 418905 90146341
Dyspnoea exertional 39.88 10.37 126 63075 72162 90493084
Autoimmune disorder 39.16 10.37 4 63197 76740 90488506
Cardiac failure 38.55 10.37 165 63036 109331 90455915
Pneumonia 37.16 10.37 638 62563 637421 89927825
Hypokalaemia 36.88 10.37 185 63016 130931 90434315
Gastrointestinal tract mucosal pigmentation 36.68 10.37 15 63186 694 90564552
Hypomagnesaemia 36.16 10.37 78 63123 35510 90529736
Arthralgia 36.11 10.37 358 62843 778164 89787082
Therapeutic product effect incomplete 35.53 10.37 50 63151 193846 90371400
Urticaria 35.00 10.37 107 63094 312627 90252619
Chronic kidney disease 34.89 10.37 95 63106 50096 90515150
Exposure via breast milk 34.49 10.37 21 63180 2294 90562952
Dehydration 34.45 10.37 243 62958 194204 90371042
Product administration interrupted 34.37 10.37 43 63158 12449 90552797
COVID-19 34.11 10.37 218 62983 168625 90396621
Hyponatraemia 33.81 10.37 183 63018 133355 90431891
Prescribed overdose 33.58 10.37 13 63188 97612 90467634
Chronic obstructive pulmonary disease 33.07 10.37 120 63081 73709 90491537
Metabolic alkalosis 33.00 10.37 24 63177 3525 90561721
Product dose omission issue 32.73 10.37 329 62872 291358 90273888
Respiratory failure 32.54 10.37 166 63035 118252 90446994
Renal failure 32.14 10.37 178 63023 130829 90434417
Congenital umbilical hernia 31.57 10.37 11 63190 325 90564921
Pulmonary fibrosis 31.31 10.37 18 63183 107485 90457761
Congenital ovarian anomaly 31.03 10.37 6 63195 12 90565234
Haematocrit decreased 30.91 10.37 81 63120 41751 90523495
Peripheral venous disease 30.87 10.37 10 63191 83911 90481335
Hypercholesterolaemia 30.69 10.37 16 63185 100876 90464370
Blood iron decreased 30.38 10.37 49 63152 17910 90547336
Haematemesis 29.88 10.37 70 63131 33656 90531590
Blood loss anaemia 29.67 10.37 36 63165 10104 90555142
Epistaxis 28.99 10.37 127 63074 84998 90480248
Pain 28.96 10.37 505 62696 995836 89569410
Musculoskeletal pain 28.64 10.37 47 63154 171204 90394042
Congenital skin dimples 28.63 10.37 8 63193 111 90565135
Atrial fibrillation 28.53 10.37 175 63026 133436 90431810
Type 2 diabetes mellitus 28.52 10.37 62 63139 203182 90362064
Full blood count abnormal 28.21 10.37 72 63129 36525 90528721
Heavy menstrual bleeding 28.12 10.37 51 63150 20479 90544767
Night sweats 28.05 10.37 29 63172 128737 90436509
Transferrin saturation increased 27.81 10.37 7 63194 63 90565183
Upper gastrointestinal haemorrhage 27.64 10.37 54 63147 22922 90542324
Transferrin increased 27.41 10.37 5 63196 6 90565240
Red blood cell sedimentation rate increased 26.79 10.37 12 63189 82583 90482663
Asthenia 26.59 10.37 521 62680 533230 90032016
Haemorrhoids 26.53 10.37 58 63143 26644 90538602
Troponin increased 26.34 10.37 39 63162 13242 90552004
Stillbirth 26.09 10.37 29 63172 7414 90557832
Infection 26.07 10.37 147 63054 361947 90203299
Constipation 25.78 10.37 304 62897 280091 90285155
Wound infection 25.48 10.37 22 63179 106380 90458866
Clostridium difficile colitis 25.40 10.37 57 63144 26649 90538597
Pulmonary oedema 25.38 10.37 98 63103 61982 90503264
Autoimmune haemolytic anaemia 25.15 10.37 25 63176 5620 90559626
Dry mouth 25.13 10.37 57 63144 184002 90381244
Syncope 24.79 10.37 168 63033 132495 90432751
Anhedonia 24.76 10.37 35 63166 11396 90553850
Mental status changes 24.75 10.37 78 63123 44601 90520645
Blood creatinine increased 24.36 10.37 137 63064 101249 90463997
Hypothyroidism 24.34 10.37 87 63114 53040 90512206
Osteoarthritis 23.31 10.37 65 63136 195665 90369581
Maternal exposure during breast feeding 23.13 10.37 25 63176 6195 90559051
Infective pulmonary exacerbation of cystic fibrosis 23.05 10.37 32 63169 10247 90554999
Intentional product use issue 22.99 10.37 76 63125 216816 90348430
Hepatic encephalopathy 22.51 10.37 37 63164 13735 90551511
Sinus polyp degeneration 22.51 10.37 6 63195 69 90565177
Haemorrhage 22.49 10.37 102 63099 69267 90495979
International normalised ratio increased 22.12 10.37 78 63123 47238 90518008
Haemoptysis 22.10 10.37 62 63139 33258 90531988
Therapy interrupted 22.06 10.37 81 63120 50027 90515219
Gastrointestinal disorder 22.02 10.37 98 63103 256589 90308657
Onychomadesis 21.98 10.37 3 63198 45995 90519251
Product confusion 21.87 10.37 7 63194 158 90565088
Platelet count decreased 21.86 10.37 167 63034 136802 90428444
Sopor 21.67 10.37 51 63150 24593 90540653
Hypovolaemia 21.14 10.37 34 63167 12397 90552849
Nasopharyngitis 21.06 10.37 182 63019 406922 90158324
Wheezing 20.96 10.37 90 63111 237990 90327256
Clostridium difficile infection 20.75 10.37 64 63137 36181 90529065
Gingival hypertrophy 20.74 10.37 15 63186 2185 90563061
Diastasis recti abdominis 20.73 10.37 5 63196 37 90565209
Haematochezia 20.60 10.37 101 63100 70812 90494434
Gastritis 20.53 10.37 70 63131 41683 90523563
Nail disorder 20.09 10.37 8 63193 59059 90506187
Transfusion-associated dyspnoea 20.07 10.37 5 63196 43 90565203
Prescribed underdose 19.87 10.37 14 63187 75005 90490241
Drug abuse 19.75 10.37 17 63184 82330 90482916
Internal haemorrhage 19.71 10.37 23 63178 6197 90559049
Epilepsy 19.68 10.37 17 63184 82189 90483057
Glucocorticoids increased 19.43 10.37 6 63195 120 90565126
Hypothermia 19.22 10.37 37 63164 15538 90549708
Fluid retention 19.19 10.37 116 63085 87975 90477271
Thermohypoaesthesia 19.11 10.37 6 63195 127 90565119
Thrombosis 18.95 10.37 101 63100 73150 90492096
Therapy non-responder 18.93 10.37 42 63159 136662 90428584
Oesophagitis 18.91 10.37 39 63162 17210 90548036
Uterine leiomyoma 18.87 10.37 30 63171 10834 90554412
Hyperglycaemia 18.86 10.37 78 63123 50892 90514354
Sinus node dysfunction 18.82 10.37 21 63180 5391 90559855
Sciatica 18.71 10.37 26 63175 101356 90463890
Gait inability 18.68 10.37 47 63154 146409 90418837
Lower limb fracture 18.68 10.37 19 63182 84994 90480252
Hospice care 18.53 10.37 28 63173 9676 90555570
Exostosis 18.40 10.37 7 63194 53127 90512119
Lethargy 18.39 10.37 90 63111 63049 90502197
Oesophageal injury 18.34 10.37 5 63196 63 90565183
Sight disability 18.17 10.37 6 63195 150 90565096
Lactation disorder 18.15 10.37 8 63193 446 90564800
Urine output decreased 18.15 10.37 32 63169 12571 90552675
Abnormal cord insertion 18.09 10.37 4 63197 19 90565227
Non-cardiogenic pulmonary oedema 17.97 10.37 11 63190 1213 90564033
Illness 17.90 10.37 108 63093 81861 90483385
Knee arthroplasty 17.81 10.37 19 63182 83163 90482083
Vaginal haemorrhage 17.70 10.37 55 63146 31216 90534030
Postpartum haemorrhage 17.41 10.37 14 63187 2387 90562859
Duodenitis 17.04 10.37 18 63183 4345 90560901
Rash 17.02 10.37 424 62777 795676 89769570
Nasal congestion 17.02 10.37 108 63093 83306 90481940
Cough 16.97 10.37 356 62845 368606 90196640
Lung disorder 16.95 10.37 51 63150 149832 90415414
Discharge 16.56 10.37 12 63189 1752 90563494
Blepharospasm 16.55 10.37 9 63192 55436 90509810
Neuroleptic malignant syndrome 16.39 10.37 34 63167 15062 90550184
Back injury 16.38 10.37 6 63195 46616 90518630
Off label use 16.24 10.37 617 62584 1101635 89463611
Lower gastrointestinal haemorrhage 16.06 10.37 25 63176 8867 90556379
Abdominal pain 16.04 10.37 375 62826 395346 90169900
Wrong patient 16.01 10.37 9 63192 848 90564398
Foetal malnutrition 15.96 10.37 5 63196 105 90565141
Ischaemic gastritis 15.87 10.37 3 63198 5 90565241
Maternal condition affecting foetus 15.87 10.37 6 63195 225 90565021
Blood urea increased 15.85 10.37 52 63149 30361 90534885
Hypoosmolar state 15.82 10.37 6 63195 227 90565019
Haemoglobin abnormal 15.76 10.37 22 63179 7078 90558168
Blood creatine phosphokinase MM increased 15.70 10.37 4 63197 38 90565208
Hip arthroplasty 15.67 10.37 18 63183 76190 90489056
Azotaemia 15.67 10.37 19 63182 5329 90559917
Threatened labour 15.61 10.37 9 63192 889 90564357
Blood pressure abnormal 15.51 10.37 39 63162 19606 90545640
Secretion discharge 15.20 10.37 34 63167 15862 90549384
Drug interaction 15.16 10.37 274 62927 276179 90289067
Poor sucking reflex 15.12 10.37 7 63194 438 90564808
Congenital cystic lung 15.09 10.37 4 63197 45 90565201
Atrial flutter 15.08 10.37 27 63174 10731 90554515
Contusion 14.98 10.37 108 63093 251108 90314138
Agranulocytosis 14.92 10.37 56 63145 34946 90530300
Full blood count decreased 14.80 10.37 50 63151 29639 90535607
Injection site reaction 14.72 10.37 26 63175 92054 90473192
Essential hypertension 14.67 10.37 20 63181 6295 90558951
Palatal polyp 14.65 10.37 3 63198 9 90565237
Oxygen consumption increased 14.59 10.37 17 63184 4572 90560674
Haemoperitoneum 14.58 10.37 15 63186 3513 90561733
Haemorrhagic erosive gastritis 14.36 10.37 7 63194 492 90564754
Blood alkaline phosphatase increased 14.34 10.37 69 63132 48010 90517236
Portal hypertensive gastropathy 14.34 10.37 9 63192 1038 90564208
Myelosuppression 14.20 10.37 10 63191 53581 90511665
Carbuncle 14.01 10.37 10 63191 1426 90563820
Genital prolapse 13.91 10.37 4 63197 62 90565184
Bradycardia 13.80 10.37 103 63098 83744 90481502
Ketosis 13.78 10.37 8 63193 801 90564445
Glomerular filtration rate decreased 13.77 10.37 34 63167 16898 90548348
Left ventricular failure 13.76 10.37 20 63181 6680 90558566
Renal tubular acidosis 13.69 10.37 12 63189 2303 90562943
Presyncope 13.65 10.37 51 63150 31754 90533492
Balance disorder 13.65 10.37 115 63086 96965 90468281
Diabetic ketosis 13.58 10.37 7 63194 554 90564692
Periodontitis 13.48 10.37 15 63186 3838 90561408
Insurance issue 13.48 10.37 26 63175 10932 90554314
Haemoglobin increased 13.46 10.37 21 63180 7460 90557786
Euglycaemic diabetic ketoacidosis 13.45 10.37 19 63182 6182 90559064
Nocturia 13.44 10.37 25 63176 10230 90555016
Drug ineffective for unapproved indication 13.42 10.37 16 63185 66628 90498618
Road traffic accident 13.37 10.37 35 63166 107591 90457655
Sinusitis 13.36 10.37 164 63037 342924 90222322
Renal arteriosclerosis 13.36 10.37 5 63196 182 90565064
Iron deficiency 13.32 10.37 24 63177 9588 90555658
Blood iron increased 13.31 10.37 11 63190 1948 90563298
Scleroderma 13.31 10.37 19 63182 6242 90559004
Arteriovenous malformation 13.30 10.37 10 63191 1545 90563701
Enuresis 13.19 10.37 14 63187 3400 90561846
Respiratory distress 13.17 10.37 58 63143 38888 90526358
Abdominal distension 13.07 10.37 144 63057 130457 90434789
Metabolic surgery 12.99 10.37 10 63191 1601 90563645
Inflammatory bowel disease 12.97 10.37 17 63184 5154 90560092
Infected neoplasm 12.95 10.37 6 63195 376 90564870
Dyspepsia 12.90 10.37 83 63118 198077 90367169
Therapeutic response decreased 12.89 10.37 27 63174 89702 90475544
Blood albumin decreased 12.89 10.37 33 63168 16770 90548476
Hypermagnesaemia 12.89 10.37 9 63192 1240 90564006
Palpitations 12.89 10.37 149 63052 136579 90428667
Onychomycosis 12.81 10.37 5 63196 37371 90527875
Angina unstable 12.78 10.37 20 63181 7123 90558123
Laryngitis 12.76 10.37 10 63191 50743 90514503
Peritoneal disorder 12.66 10.37 7 63194 638 90564608
Urosepsis 12.63 10.37 38 63163 21194 90544052
Small intestinal obstruction 12.62 10.37 38 63163 21196 90544050
Gestational hypertension 12.62 10.37 13 63188 3049 90562197
Obesity 12.58 10.37 35 63166 105472 90459774
Pyuria 12.56 10.37 11 63190 2108 90563138
Unwanted awareness during anaesthesia 12.55 10.37 6 63195 404 90564842
Rhinovirus infection 12.53 10.37 18 63183 5945 90559301
Chronic hepatic failure 12.52 10.37 7 63194 652 90564594
Nasal obstruction 12.45 10.37 12 63189 2600 90562646
Blood glucose increased 12.44 10.37 111 63090 95135 90470111
Umbilical discharge 12.39 10.37 4 63197 93 90565153
Coeliac disease 12.25 10.37 8 63193 44602 90520644
Cholestasis 12.23 10.37 54 63147 36245 90529001
Rectal haemorrhage 12.16 10.37 99 63102 82645 90482601
Somnolence 12.09 10.37 209 62992 208875 90356371
Intentional product misuse 12.02 10.37 28 63173 89576 90475670
Upper airway obstruction 11.99 10.37 8 63193 1024 90564222
Vitamin D deficiency 11.97 10.37 33 63168 17523 90547723
Adverse reaction 11.93 10.37 3 63198 29709 90535537
Urinary retention 11.86 10.37 55 63146 37689 90527557
Adverse event 11.86 10.37 42 63159 117376 90447870
Renal impairment 11.85 10.37 119 63082 105302 90459944
Haematoma muscle 11.77 10.37 10 63191 1840 90563406
Hip fracture 11.75 10.37 50 63151 33027 90532219
Intentional dose omission 11.70 10.37 33 63168 17750 90547496
Application site haematoma 11.63 10.37 3 63198 30 90565216
Drug tolerance decreased 11.52 10.37 4 63197 32126 90533120
Sedation 11.48 10.37 10 63191 48161 90517085
Back pain 11.47 10.37 296 62905 316879 90248367
Flatulence 11.36 10.37 58 63143 41309 90523937
Foetal death 11.31 10.37 36 63165 20687 90544559
Hyponatraemic seizure 11.31 10.37 6 63195 504 90564742
Oedema peripheral 11.25 10.37 247 62954 257668 90307578
N-terminal prohormone brain natriuretic peptide increased 11.18 10.37 12 63189 2950 90562296
Hyperdynamic left ventricle 11.18 10.37 5 63196 289 90564957
Total bile acids increased 11.15 10.37 4 63197 129 90565117
Pericardial effusion 11.08 10.37 53 63148 36780 90528466
Internal fixation of fracture 11.08 10.37 7 63194 817 90564429
Subdural haematoma 11.06 10.37 31 63170 16614 90548632
Meningism 11.04 10.37 6 63195 529 90564717
Gastric antral vascular ectasia 11.04 10.37 7 63194 822 90564424
Cardiac hypertrophy 11.03 10.37 8 63193 1170 90564076
Hypophagia 11.02 10.37 52 63149 35885 90529361
Surgery 11.01 10.37 61 63140 44826 90520420
Brain natriuretic peptide increased 11.01 10.37 17 63184 5988 90559258
Uterine haemorrhage 10.96 10.37 15 63186 4737 90560509
Haematoma 10.90 10.37 55 63146 38993 90526253
Endometritis 10.90 10.37 8 63193 1192 90564054
Meconium in amniotic fluid 10.71 10.37 5 63196 319 90564927
Abnormal loss of weight 10.71 10.37 18 63183 6805 90558441
Diabetes mellitus inadequate control 10.70 10.37 33 63168 18651 90546595
Gastrointestinal arteriovenous malformation 10.64 10.37 6 63195 569 90564677
Exposure during pregnancy 10.61 10.37 229 62972 238181 90327065
Bronchial wall thickening 10.55 10.37 10 63191 2121 90563125
Sinus arrest 10.49 10.37 10 63191 2136 90563110
Emotional distress 10.49 10.37 52 63149 36610 90528636
Right ventricular dilatation 10.43 10.37 9 63192 1690 90563556
Varices oesophageal 10.38 10.37 13 63188 3766 90561480

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
Drug ineffective 109.05 11.01 219 34500 629978 41956638
Acute kidney injury 83.09 11.01 547 34172 366790 42219826
Hyperkalaemia 63.57 11.01 176 34543 80282 42506334
Foetal exposure during pregnancy 60.73 11.01 125 34594 47186 42539430
Foetal disorder 59.59 11.01 25 34694 1054 42585562
Anaemia 57.06 11.01 407 34312 279871 42306745
Gastrointestinal haemorrhage 52.47 11.01 187 34532 97539 42489077
Neutropenia neonatal 49.75 11.01 21 34698 899 42585717
Completed suicide 48.03 11.01 10 34709 96455 42490161
Gastrointestinal tract mucosal pigmentation 48.03 11.01 18 34701 561 42586055
Hospitalisation 47.66 11.01 151 34568 74179 42512437
Premature baby 46.06 11.01 74 34645 23079 42563537
Haemoglobin decreased 45.52 11.01 221 34498 132250 42454366
Encephalitis toxic 44.02 11.01 14 34705 263 42586353
Faeces discoloured 41.81 11.01 60 34659 16954 42569662
Toxicity to various agents 41.65 11.01 77 34642 229059 42357557
Low birth weight baby 40.24 11.01 45 34674 9910 42576706
Lymph node calcification 38.20 11.01 11 34708 145 42586471
Death 36.20 11.01 561 34158 470624 42115992
Periodontitis 34.87 11.01 22 34697 2189 42584427
Asthenia 33.18 11.01 362 34357 280431 42306185
Blood loss anaemia 31.06 11.01 39 34680 9697 42576919
Febrile neutropenia 27.43 11.01 70 34649 185633 42400983
Iron deficiency anaemia 26.38 11.01 42 34677 12997 42573619
Normocytic anaemia 25.39 11.01 22 34697 3555 42583061
Drug abuse 25.09 11.01 29 34690 104742 42481874
Fibrin D dimer increased 24.51 11.01 25 34694 4960 42581656
Cardiac dysfunction 24.32 11.01 21 34698 3378 42583238
Transfusion 24.27 11.01 36 34683 10478 42576138
Fall 23.94 11.01 294 34425 234226 42352390
Upper gastrointestinal haemorrhage 23.62 11.01 66 34653 30233 42556383
Therapy interrupted 23.10 11.01 54 34665 22196 42564420
Hyperlactacidaemia 22.84 11.01 23 34696 4493 42582123
Drug ineffective for unapproved indication 22.53 11.01 5 34714 46158 42540458
Gastrointestinal angiodysplasia 22.46 11.01 11 34708 667 42585949
Clostridium difficile infection 22.45 11.01 54 34665 22605 42564011
Diarrhoea 21.94 11.01 510 34209 460339 42126277
Urinary tract infection 21.77 11.01 147 34572 99137 42487479
Red blood cell sedimentation rate decreased 20.83 11.01 8 34711 267 42586349
Pancreatic duct stenosis 19.98 11.01 7 34712 179 42586437
Foreign body aspiration 19.61 11.01 8 34711 314 42586302
Lower gastrointestinal haemorrhage 19.42 11.01 33 34686 10775 42575841
Implant site inflammation 19.32 11.01 6 34713 104 42586512
Full blood count decreased 19.30 11.01 48 34671 20512 42566104
Pancreatic calcification 19.25 11.01 7 34712 200 42586416
Congenital umbilical hernia 18.83 11.01 8 34711 348 42586268
Decreased appetite 18.78 11.01 240 34479 192897 42393719
Pancreatic mass 18.78 11.01 11 34708 957 42585659
Mental impairment 18.77 11.01 35 34684 12282 42574334
Hypervolaemia 18.65 11.01 51 34668 23074 42563542
Neglect of personal appearance 18.53 11.01 8 34711 362 42586254
Ventricular septal defect 17.98 11.01 20 34699 4379 42582237
Gingival hypertrophy 17.31 11.01 15 34704 2424 42584192
Cardiac ventricular disorder 17.03 11.01 7 34712 280 42586336
Dyspnoea 16.97 11.01 476 34243 442145 42144471
Myelosuppression 16.75 11.01 6 34713 40455 42546161
Essential thrombocythaemia 16.48 11.01 6 34713 172 42586444
Mental status changes 16.45 11.01 73 34646 42042 42544574
Fatigue 16.28 11.01 467 34252 435174 42151442
Cortical visual impairment 15.48 11.01 4 34715 34 42586582
Treatment failure 15.35 11.01 17 34702 62607 42524009
Hospice care 15.30 11.01 26 34693 8487 42578129
Exposure during pregnancy 15.22 11.01 26 34693 8522 42578094
Haematemesis 14.68 11.01 56 34663 30143 42556473
Therapeutic product effect incomplete 14.56 11.01 22 34697 70917 42515699
Interstitial lung disease 14.55 11.01 26 34693 78436 42508180
Benign soft tissue neoplasm 14.53 11.01 5 34714 121 42586495
Hypotension 14.41 11.01 292 34427 257339 42329277
Clostridium difficile colitis 14.37 11.01 44 34675 21208 42565408
Colon injury 14.27 11.01 5 34714 128 42586488
Body temperature abnormal 14.00 11.01 9 34710 925 42585691
Tendinous contracture 13.88 11.01 5 34714 139 42586477
Hepatic function abnormal 13.77 11.01 13 34706 51554 42535062
Drug-induced liver injury 13.73 11.01 7 34712 38266 42548350
Mucosal inflammation 13.72 11.01 12 34707 49362 42537254
Off label use 13.46 11.01 407 34312 637928 41948688
Failure to thrive 13.40 11.01 26 34693 9396 42577220
Cytomegalovirus infection 13.02 11.01 5 34714 32301 42554315
Dysaesthesia 12.89 11.01 13 34706 2544 42584072
Parkinsonian rest tremor 12.89 11.01 6 34713 325 42586291
Hydrocele 12.78 11.01 13 34706 2570 42584046
Depressed mood 12.74 11.01 45 34674 23339 42563277
Product use in unapproved indication 12.69 11.01 93 34626 184363 42402253
Asocial behaviour 12.68 11.01 4 34715 73 42586543
Drug resistance 12.68 11.01 6 34713 34242 42552374
Fistula discharge 12.60 11.01 9 34710 1099 42585517
Flight of ideas 12.60 11.01 6 34713 342 42586274
Fluid retention 12.49 11.01 55 34664 31564 42555052
Capillaritis 12.48 11.01 12 34707 2216 42584400
Crystal urine 12.44 11.01 4 34715 78 42586538
Respiratory distress 12.40 11.01 67 34652 41753 42544863
Lip blister 12.30 11.01 8 34711 839 42585777
Cardiac failure congestive 12.29 11.01 115 34604 85487 42501129
Serotonin syndrome 12.21 11.01 3 34716 25842 42560774
Pancreatic injury 12.14 11.01 5 34714 201 42586415
Intracardiac mass 12.09 11.01 5 34714 203 42586413
Hypovolaemia 12.06 11.01 28 34691 11457 42575159
Enterocolitis bacterial 11.96 11.01 6 34713 383 42586233
Regurgitation 11.93 11.01 11 34708 1929 42584687
Nasal flaring 11.88 11.01 3 34716 23 42586593
Ludwig angina 11.87 11.01 5 34714 213 42586403
Chronic kidney disease 11.60 11.01 72 34647 47169 42539447
Depression 11.56 11.01 49 34670 111314 42475302
Acute respiratory failure 11.35 11.01 62 34657 38796 42547820
Joint swelling 11.34 11.01 24 34695 67998 42518618
Haemoptysis 11.11 11.01 70 34649 46097 42540519

FDA Adverse Event Reporting System (Geriatric)

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 348.09 9.97 1157 81847 634273 109872022
Anaemia 219.91 9.97 902 82102 546184 109960111
Drug ineffective 210.13 9.97 526 82478 1520014 108986281
Synovitis 162.74 9.97 11 82993 274081 110232214
Hand deformity 149.16 9.97 3 83001 218503 110287792
Hyperkalaemia 143.76 9.97 316 82688 135480 110370815
Gastrointestinal haemorrhage 136.03 9.97 349 82655 165169 110341126
Systemic lupus erythematosus 132.96 9.97 17 82987 254321 110251974
Haemoglobin decreased 126.90 9.97 443 82561 248284 110258011
Duodenal ulcer perforation 119.09 9.97 3 83001 177697 110328598
Drug intolerance 118.33 9.97 80 82924 406432 110099863
Glossodynia 118.09 9.97 14 82990 221990 110284305
Death 116.78 9.97 910 82094 697959 109808336
Helicobacter infection 115.08 9.97 5 82999 181872 110324423
Joint swelling 113.81 9.97 99 82905 442746 110063549
Hypervolaemia 112.43 9.97 161 82843 49299 110456996
Pericarditis 111.31 9.97 16 82988 219098 110287197
Folliculitis 101.66 9.97 6 82998 167647 110338648
Faeces discoloured 96.18 9.97 123 82881 33825 110472470
Arthropathy 95.82 9.97 48 82956 287474 110218821
Contraindicated product administered 92.95 9.97 35 82969 248232 110258063
Treatment failure 92.81 9.97 46 82958 277188 110229107
Hepatic enzyme increased 92.22 9.97 64 82940 320828 110185467
Impaired healing 91.87 9.97 18 82986 196699 110309596
Completed suicide 91.03 9.97 34 82970 242347 110263948
Infusion related reaction 85.48 9.97 96 82908 381066 110125229
Gastrointestinal tract mucosal pigmentation 84.75 9.97 33 82971 1244 110505051
Wound 82.96 9.97 36 82968 234401 110271894
Irritable bowel syndrome 81.09 9.97 13 82991 164202 110342093
Therapeutic product effect decreased 81.08 9.97 41 82963 244275 110262020
Fall 77.68 9.97 742 82262 602740 109903555
Fibromyalgia 77.00 9.97 17 82987 170892 110335403
Hospitalisation 73.65 9.97 255 82749 142238 110364057
Pulmonary hypertension 71.92 9.97 140 82864 55080 110451215
Psoriatic arthropathy 71.56 9.97 29 82975 196732 110309563
Transfusion 70.13 9.97 91 82913 25381 110480914
Mobility decreased 70.01 9.97 46 82958 237376 110268919
Dyspnoea 69.92 9.97 1192 81812 1105680 109400615
Urinary tract infection 69.55 9.97 451 82553 325831 110180464
Alopecia 67.36 9.97 106 82898 364647 110141648
Discomfort 66.91 9.97 39 82965 214668 110291627
Blood cholesterol increased 65.97 9.97 28 82976 184757 110321538
Iron deficiency anaemia 64.88 9.97 98 82906 31461 110474834
Bursitis 64.78 9.97 10 82994 129908 110376387
Hypotension 64.38 9.97 638 82366 523211 109983084
Rheumatoid arthritis 63.36 9.97 79 82925 299534 110206761
Drug hypersensitivity 63.11 9.97 156 82848 453934 110052361
Melaena 62.79 9.97 151 82853 68606 110437689
Musculoskeletal stiffness 62.14 9.97 71 82933 279751 110226544
Lip dry 59.42 9.97 4 83000 100079 110406216
Inflammation 58.94 9.97 36 82968 193202 110313093
Pulmonary arterial hypertension 58.44 9.97 95 82909 32473 110473822
Cardiac failure congestive 58.09 9.97 246 82758 150754 110355541
Haematemesis 56.34 9.97 132 82872 58976 110447319
Hypoxia 56.17 9.97 219 82785 129296 110376999
Upper gastrointestinal haemorrhage 55.74 9.97 119 82885 49977 110456318
Pulmonary malformation 55.64 9.97 16 82988 229 110506066
Blood loss anaemia 52.14 9.97 66 82938 17959 110488336
Liver injury 50.25 9.97 25 82979 150388 110355907
Blister 50.14 9.97 58 82946 227318 110278977
Periodontitis 50.08 9.97 37 82967 5171 110501124
Acute respiratory failure 49.18 9.97 146 82858 75114 110431181
Hypersensitivity 47.09 9.97 151 82853 403847 110102448
Toxicity to various agents 46.55 9.97 194 82810 480361 110025934
Diarrhoea 45.72 9.97 1148 81856 1138357 109367938
Ill-defined disorder 45.41 9.97 31 82973 156822 110349473
Cardiac failure 45.37 9.97 268 82736 187358 110318937
Lactic acidosis 45.28 9.97 163 82841 92648 110413647
Mental status changes 44.46 9.97 142 82862 75980 110430315
Urticaria 43.92 9.97 110 82894 318747 110187548
Therapeutic product effect incomplete 43.26 9.97 63 82941 223742 110282553
Stomatitis 43.12 9.97 86 82918 270156 110236139
Cardiac failure acute 42.88 9.97 70 82934 24008 110482287
Drug abuse 41.60 9.97 43 82961 177368 110328927
Metabolic acidosis 41.10 9.97 166 82838 99578 110406717
Abdominal discomfort 40.66 9.97 155 82849 393703 110112592
Lung cyst 40.38 9.97 15 82989 496 110505799
Encephalitis toxic 40.04 9.97 13 82991 285 110506010
Hypoglycaemia 39.97 9.97 183 82821 115921 110390374
Gingival hypertrophy 39.93 9.97 30 82974 4301 110501994
Chronic kidney disease 39.81 9.97 137 82867 76154 110430141
Clostridium difficile infection 38.80 9.97 106 82898 52023 110454272
Sleep disorder 38.31 9.97 56 82948 198588 110307707
Hyponatraemia 38.18 9.97 287 82717 217366 110288929
Joint range of motion decreased 38.13 9.97 22 82982 121810 110384485
General physical health deterioration 37.37 9.97 178 82826 425117 110081178
Arthralgia 37.15 9.97 390 82614 779242 109727053
Dehydration 37.02 9.97 346 82658 279165 110227130
Dyspnoea exertional 36.55 9.97 165 82839 103895 110402400
Injury 36.16 9.97 48 82956 177217 110329078
Lower gastrointestinal haemorrhage 36.02 9.97 56 82948 18430 110487865
Asthenia 35.33 9.97 719 82285 688280 109818015
Right ventricular failure 35.26 9.97 67 82937 25887 110480408
Drug ineffective for unapproved indication 33.00 9.97 18 82986 102820 110403475
Musculoskeletal pain 32.99 9.97 54 82950 182969 110323326
Respiratory tract malformation 32.91 9.97 9 82995 106 110506189
Hypokalaemia 32.80 9.97 242 82762 182206 110324089
Clostridium difficile colitis 32.56 9.97 89 82915 43689 110462606
Myelosuppression 32.55 9.97 15 82989 94325 110411970
Premature delivery 32.06 9.97 71 82933 30561 110475734
Hypovolaemia 32.01 9.97 58 82946 21616 110484679
Dry mouth 31.57 9.97 64 82940 199884 110306411
Haemoptysis 31.21 9.97 121 82883 71233 110435062
C-reactive protein increased 30.92 9.97 74 82930 217845 110288450
Pre-eclampsia 30.46 9.97 35 82969 8615 110497680
Exposure via breast milk 30.28 9.97 15 82989 1013 110505282
Haemorrhoids 30.08 9.97 76 82928 35596 110470699
Cellulitis 29.81 9.97 179 82825 125837 110380458
Peripheral venous disease 29.61 9.97 13 82991 84104 110422191
International normalised ratio increased 29.30 9.97 136 82868 86636 110419659
Haematochezia 29.21 9.97 167 82837 115357 110390938
Product dose omission issue 29.02 9.97 369 82635 321413 110184882
Essential thrombocythaemia 28.70 9.97 11 82993 397 110505898
Full blood count abnormal 28.67 9.97 100 82904 55952 110450343
Pneumonia 28.49 9.97 860 82144 875854 109630441
Product use issue 28.22 9.97 129 82875 311566 110194729
Sopor 27.88 9.97 75 82929 36471 110469824
Atrial fibrillation 27.80 9.97 279 82725 229363 110276932
Pulmonary oedema 27.78 9.97 149 82855 100510 110405785
Hypomagnesaemia 27.74 9.97 104 82900 60266 110446029
Sepsis 27.68 9.97 371 82633 326975 110179320
Fluid retention 27.68 9.97 142 82862 94165 110412130
Gastrointestinal angiodysplasia 27.65 9.97 15 82989 1223 110505072
Hospice care 27.46 9.97 40 82964 12433 110493862
Syncope 27.45 9.97 252 82752 202284 110304011
Lymph node calcification 27.22 9.97 11 82993 458 110505837
Obesity 27.11 9.97 27 82977 113324 110392971
Nasopharyngitis 27.05 9.97 179 82825 394182 110112113
Lower respiratory tract infection 26.84 9.97 93 82911 243013 110263282
Night sweats 26.59 9.97 37 82967 133946 110372349
Hypercholesterolaemia 26.22 9.97 18 82986 90819 110415476
Haemorrhage 26.17 9.97 153 82851 106539 110399756
Infection 26.06 9.97 162 82842 362038 110144257
Prescribed overdose 25.76 9.97 17 82987 87564 110418731
Therapy interrupted 25.58 9.97 89 82915 49733 110456562
Lethargy 25.47 9.97 138 82866 93438 110412857
Blood iron decreased 25.36 9.97 49 82955 19165 110487130
Chronic obstructive pulmonary disease 25.15 9.97 154 82850 109004 110397291
Red blood cell sedimentation rate increased 24.70 9.97 14 82990 78288 110428007
Respiratory failure 24.35 9.97 258 82746 215074 110291221
Swelling 24.24 9.97 159 82845 350882 110155413
Intentional product use issue 24.02 9.97 100 82904 247806 110258489
Blood creatinine increased 24.00 9.97 226 82778 182663 110323632
Small intestinal obstruction 23.47 9.97 65 82939 32148 110474147
Cytomegalovirus infection 23.36 9.97 6 82998 54438 110451857
Haematocrit decreased 23.34 9.97 105 82899 66012 110440283
Sinusitis 23.31 9.97 129 82875 296559 110209736
Heavy menstrual bleeding 23.17 9.97 43 82961 16322 110489973
Transferrin saturation increased 22.90 9.97 8 82996 221 110506074
Sinus node dysfunction 22.87 9.97 31 82973 9016 110497279
Poor sucking reflex 22.65 9.97 7 82997 130 110506165
Drug dependence 22.47 9.97 5 82999 50015 110456280
Product use in unapproved indication 22.42 9.97 221 82783 447156 110059139
Secretion discharge 22.41 9.97 48 82956 20196 110486099
Transferrin increased 22.04 9.97 5 82999 25 110506270
Metabolic alkalosis 22.04 9.97 24 82980 5571 110500724
Blood iron increased 22.00 9.97 16 82988 2182 110504113
Sinus polyp degeneration 21.99 9.97 6 82998 70 110506225
Nail disorder 21.95 9.97 8 82996 57927 110448368
Wound infection 21.92 9.97 24 82980 96441 110409854
Insurance issue 21.88 9.97 33 82971 10579 110495716
Stillbirth 21.71 9.97 21 82983 4243 110502052
COVID-19 21.65 9.97 280 82724 244780 110261515
Migraine 21.52 9.97 62 82942 171590 110334705
Transfusion-associated dyspnoea 21.26 9.97 6 82998 80 110506215
Epistaxis 21.23 9.97 169 82835 130203 110376092
Hip fracture 20.91 9.97 66 82938 35085 110471210
Nocturia 20.82 9.97 42 82962 16948 110489347
Hepatic encephalopathy 20.57 9.97 57 82947 28199 110478096
Epilepsy 20.57 9.97 27 82977 100182 110406113
Injection site reaction 20.41 9.97 22 82982 89048 110417247
Hyperlactacidaemia 20.35 9.97 28 82976 8258 110498037
Product administration interrupted 20.34 9.97 33 82971 11259 110495036
Hypothermia 20.09 9.97 54 82950 26248 110480047
Off label use 19.96 9.97 922 82082 1499263 109007032
Pain 19.71 9.97 556 82448 954399 109551896
Renal failure 19.64 9.97 258 82746 226316 110279979
Therapy non-responder 19.58 9.97 57 82947 157250 110349045
Fibrin D dimer increased 19.43 9.97 30 82974 9815 110496480
Foreign body aspiration 19.39 9.97 9 82995 526 110505769
Fibroma 18.96 9.97 11 82993 1021 110505274
Glucocorticoids increased 18.90 9.97 6 82998 122 110506173
Osteoarthritis 18.74 9.97 72 82932 182551 110323744
Vaginal haemorrhage 18.67 9.97 51 82953 25023 110481272
Varices oesophageal 18.66 9.97 25 82979 7190 110499105
Flight of ideas 18.54 9.97 10 82994 806 110505489
Pancreatic duct stenosis 18.50 9.97 7 82997 244 110506051
Abdominal pain 18.48 9.97 510 82494 512479 109993816
Neglect of personal appearance 18.30 9.97 8 82996 406 110505889
Rectal haemorrhage 18.25 9.97 153 82851 119680 110386615
Intentional product misuse 18.16 9.97 46 82958 132858 110373437
Maternal exposure during breast feeding 18.14 9.97 19 82985 4219 110502076
Pancreatic calcification 17.97 9.97 7 82997 264 110506031
Lower limb fracture 17.96 9.97 18 82986 75330 110430965
Rash 17.70 9.97 475 82529 820489 109685806
Mucosal inflammation 17.66 9.97 28 82976 96113 110410182
Drug-induced liver injury 17.64 9.97 40 82964 120027 110386268
Implant site inflammation 17.54 9.97 7 82997 282 110506013
Gastrointestinal disorder 17.51 9.97 108 82896 241844 110264451
Infective pulmonary exacerbation of cystic fibrosis 17.49 9.97 36 82968 14735 110491560
Type 2 diabetes mellitus 17.47 9.97 71 82933 177161 110329134
Discharge 17.46 9.97 14 82990 2208 110504087
Gastric antral vascular ectasia 17.45 9.97 11 82993 1186 110505109
Lactation disorder 17.37 9.97 7 82997 289 110506006
Gastritis 17.27 9.97 83 82921 53616 110452679
Postpartum haemorrhage 17.22 9.97 13 82991 1876 110504419
Uterine leiomyoma 17.15 9.97 25 82979 7775 110498520
Portal hypertensive gastropathy 17.11 9.97 13 82991 1895 110504400
Haemoglobin abnormal 17.08 9.97 27 82977 9011 110497284
Respiratory distress 17.04 9.97 99 82905 68775 110437520
Acidosis 16.95 9.97 46 82958 22485 110483810
Maternal condition affecting foetus 16.52 9.97 6 82998 186 110506109
Exostosis 16.33 9.97 7 82997 45949 110460346
Hypothyroidism 16.26 9.97 102 82902 72797 110433498
Oesophagitis 16.25 9.97 53 82951 28662 110477633
Tubulointerstitial nephritis 16.11 9.97 82 82922 54202 110452093
Pericardial effusion 15.99 9.97 85 82919 57132 110449163
Glomerular filtration rate decreased 15.99 9.97 53 82951 28903 110477392
Back injury 15.64 9.97 8 82996 47391 110458904
Ischaemic gastritis 15.50 9.97 4 83000 37 110506258
Foetal death 15.47 9.97 36 82968 16009 110490286
Serotonin syndrome 15.44 9.97 13 82991 59140 110447155
Haematuria 15.42 9.97 111 82893 82894 110423401
Peritonitis bacterial 15.32 9.97 28 82976 10505 110495790
Pancreatic mass 15.24 9.97 12 82992 1843 110504452
Inability to afford medication 15.22 9.97 17 82987 4059 110502236
Bradycardia 15.15 9.97 181 82823 155336 110350959
Blood creatine phosphokinase MM increased 15.13 9.97 4 83000 41 110506254
Blood pressure abnormal 15.12 9.97 44 82960 22380 110483915
Thermohypoaesthesia 15.09 9.97 5 82999 117 110506178
Drug eruption 15.00 9.97 11 82993 53648 110452647
Cortical visual impairment 14.88 9.97 4 83000 44 110506251
Non-cardiogenic pulmonary oedema 14.53 9.97 12 82992 1972 110504323
Benign soft tissue neoplasm 14.52 9.97 5 82999 132 110506163
Gait inability 14.49 9.97 53 82951 136323 110369972
Blepharospasm 14.38 9.97 12 82992 54839 110451456
Urine output decreased 14.37 9.97 40 82964 19836 110486459
Hyperglycaemia 14.23 9.97 111 82893 84979 110421316
Inflammatory bowel disease 14.21 9.97 22 82982 7212 110499083
Constipation 14.11 9.97 360 82644 357426 110148869
Autoimmune haemolytic anaemia 14.01 9.97 27 82977 10540 110495755
Meconium in amniotic fluid 13.83 9.97 5 82999 153 110506142
Regurgitation 13.81 9.97 15 82989 3470 110502825
Abnormal cord insertion 13.77 9.97 3 83001 12 110506283
Failure to thrive 13.69 9.97 31 82973 13543 110492752
Internal haemorrhage 13.68 9.97 26 82978 10045 110496250
Oesophageal injury 13.68 9.97 6 82998 307 110505988
Azotaemia 13.66 9.97 26 82978 10059 110496236
Oedema peripheral 13.64 9.97 333 82671 328327 110177968
Onychomycosis 13.49 9.97 6 82998 38525 110467770
Haemorrhagic erosive gastritis 13.49 9.97 8 82996 774 110505521
Internal fixation of fracture 13.44 9.97 7 82997 526 110505769
Incorrect route of product administration 13.41 9.97 17 82987 64044 110442251
Lip swelling 13.30 9.97 74 82930 50593 110455702
Gestational hypertension 13.29 9.97 12 82992 2222 110504073
Coeliac disease 13.23 9.97 8 82996 43179 110463116
Carbuncle 13.17 9.97 10 82994 1457 110504838
Complication associated with device 13.16 9.97 39 82965 20034 110486261
Coma 13.06 9.97 45 82959 117824 110388471
Hiatus hernia 13.05 9.97 48 82956 27558 110478737
Mental impairment 13.00 9.97 42 82962 22597 110483698
Wrong patient 12.97 9.97 10 82994 1489 110504806
Poisoning 12.89 9.97 3 83001 29102 110477193
Haemosiderosis 12.83 9.97 7 82997 577 110505718
Laryngitis 12.79 9.97 8 82996 42403 110463892
Cardiac hypertrophy 12.67 9.97 11 82993 1936 110504359
Troponin increased 12.63 9.97 50 82954 29716 110476579
Illness 12.56 9.97 105 82899 82066 110424229
Haematoma 12.53 9.97 81 82923 58395 110447900
Vitamin B12 deficiency 12.49 9.97 25 82979 10030 110496265
Capillaritis 12.39 9.97 12 82992 2427 110503868
Hypermagnesaemia 12.27 9.97 10 82994 1613 110504682
Iron deficiency 12.21 9.97 36 82968 18440 110487855
Chronic hepatic failure 12.15 9.97 9 82995 1262 110505033
Unwanted awareness during anaesthesia 12.14 9.97 6 82998 403 110505892
Sight disability 12.13 9.97 5 82999 219 110506076
Asocial behaviour 12.10 9.97 4 83000 93 110506202
Renal cyst ruptured 12.10 9.97 4 83000 93 110506202
Hydrocele 12.09 9.97 9 82995 1272 110505023
Uterine haemorrhage 12.07 9.97 14 82990 3480 110502815
Hypoosmolar state 12.01 9.97 6 82998 413 110505882
Blood chloride increased 11.99 9.97 19 82985 6353 110499942
Therapeutic response decreased 11.98 9.97 35 82969 96464 110409831
Wheezing 11.98 9.97 128 82876 255102 110251193
Antipsychotic drug level increased 11.96 9.97 20 82984 6995 110499300
Prescribed underdose 11.95 9.97 19 82985 65155 110441140
Road traffic accident 11.90 9.97 41 82963 107357 110398938
Blood prolactin increased 11.88 9.97 16 82988 4626 110501669
Knee arthroplasty 11.85 9.97 19 82985 64929 110441366
Abdominal distension 11.85 9.97 191 82813 174912 110331383
Colon cancer 11.80 9.97 33 82971 16410 110489885
Normocytic anaemia 11.78 9.97 19 82985 6448 110499847
Lung consolidation 11.78 9.97 25 82979 10451 110495844
Drug resistance 11.76 9.97 15 82989 56359 110449936
Brain natriuretic peptide increased 11.75 9.97 26 82978 11183 110495112
Unresponsive to stimuli 11.68 9.97 85 82919 63705 110442590
Eosinophilia 11.66 9.97 79 82925 57857 110448438
Productive cough 11.56 9.97 134 82870 114171 110392124
Pyuria 11.51 9.97 12 82992 2651 110503644
Hip arthroplasty 11.49 9.97 15 82989 55798 110450497
Cardiac disorder 11.40 9.97 97 82907 76183 110430112
Mitral valve stenosis 11.37 9.97 9 82995 1393 110504902
Adverse reaction 11.36 9.97 4 83000 29590 110476705
Full blood count decreased 11.34 9.97 51 82953 32048 110474247
Nasal congestion 11.21 9.97 118 82886 98164 110408131
Crystal urine 11.20 9.97 4 83000 118 110506177
Sciatica 11.12 9.97 34 82970 92365 110413930
Blood urea increased 11.10 9.97 75 82929 54882 110451413
Balance disorder 11.06 9.97 135 82869 116425 110389870
Meningism 11.05 9.97 7 82997 762 110505533
Foetal exposure during pregnancy 10.98 9.97 20 82984 7485 110498810
Device dislocation 10.93 9.97 50 82954 31654 110474641
Dialysis 10.91 9.97 36 82968 19583 110486712
Influenza 10.90 9.97 183 82821 168918 110337377
Ludwig angina 10.89 9.97 5 82999 285 110506010
Pancreatitis 10.85 9.97 35 82969 93498 110412797
Chronic respiratory failure 10.83 9.97 14 82990 3889 110502406
Angiodysplasia 10.82 9.97 9 82995 1493 110504802
Large intestinal obstruction 10.82 9.97 14 82990 3894 110502401
Administration site warmth 10.77 9.97 3 83001 38 110506257
Oxygen consumption increased 10.77 9.97 17 82987 5668 110500627
Polyhydramnios 10.76 9.97 10 82994 1923 110504372
Renal arteriosclerosis 10.74 9.97 6 82998 518 110505777
Intracardiac mass 10.71 9.97 5 82999 296 110505999
Arteriovenous malformation 10.68 9.97 10 82994 1941 110504354
Oxygen saturation decreased 10.53 9.97 171 82833 156811 110349484
Pancreatic injury 10.45 9.97 5 82999 313 110505982
Premature labour 10.45 9.97 22 82982 9150 110497145
Essential hypertension 10.34 9.97 20 82984 7827 110498468
Gastric ulcer 10.34 9.97 58 82946 39769 110466526
Walking aid user 10.31 9.97 3 83001 25072 110481223
Pleural effusion 10.27 9.97 189 82815 177520 110328775
Gastric varices 10.19 9.97 7 82997 872 110505423
Monoclonal immunoglobulin present 10.19 9.97 11 82993 2529 110503766
Disability 10.13 9.97 5 82999 30218 110476077
Acute hepatic failure 10.07 9.97 54 82950 36414 110469881
Hyperdynamic left ventricle 10.06 9.97 6 82998 586 110505709
Tricuspid valve incompetence 10.04 9.97 40 82964 23833 110482462
Infected neoplasm 10.03 9.97 6 82998 589 110505706

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B03AA07 BLOOD AND BLOOD FORMING ORGANS
ANTIANEMIC PREPARATIONS
IRON PREPARATIONS
Iron bivalent, oral preparations
ATC B03AD03 BLOOD AND BLOOD FORMING ORGANS
ANTIANEMIC PREPARATIONS
IRON PREPARATIONS
Iron in combination with folic acid
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:50247 antidote
CHEBI has role CHEBI:75835 anti-anaemic agent

Related Drugs by ATC class:

B03AA Iron bivalent, oral preparations 8 drugs
ferrous ascorbateferrous aspartateferrous carbonateferrous chlorideferrous fumarateferrous gluconateferrous succinateferrous tartrate
B03AD Iron in combination with folic acid 3 drugs
ferrous fumarateferrous gluconatefolic acid

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

DiseaseRelationSNOMED_IDDOID
Anemia of prematurity indication 47100003 DOID:11243
Megaloblastic anemia due to folate deficiency indication 85649008 DOID:14026
Vitamin deficiency indication 85670002
Iron deficiency anemia indication 87522002
Mineral deficiency indication 111379007
Mineral Deficiency Prevention indication
Vitamin Deficiency Prevention indication
Peptic ulcer contraindication 13200003 DOID:750
Operation on stomach contraindication 16453004
Primary hyperoxaluria contraindication 17901006 DOID:2977
Gastroenteritis contraindication 25374005 DOID:2326
Hemosiderosis contraindication 39011001 DOID:12119
Hemolytic anemia contraindication 61261009 DOID:583
Ulcerative colitis contraindication 64766004 DOID:8577
Anemia due to enzyme deficiency contraindication 111577008
Hb SS disease contraindication 127040003 DOID:10923
Esophageal dysmotility contraindication 266434009 DOID:9192
Diverticular disease contraindication 397881000
Hemochromatosis contraindication 399187006 DOID:2352
Repeated Blood Transfusions contraindication




🐶 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:

IDSource
D04172 KEGG_DRUG
4017707 VUID
N0000146077 NUI
7782-63-0 SECONDARY_CAS_RN
4017662 VANDF
4017664 VANDF
4017707 VANDF
CHEBI:75832 CHEBI
CHEMBL1200830 ChEMBL_ID
C020748 MESH_SUPPLEMENTAL_RECORD_UI
39R4TAN1VT UNII
24947 RXNORM
4725 MMSL
4920 MMSL
6168 MMSL
63844 MMSL
d03824 MMSL
000840 NDDF
007813 NDDF
387402000 SNOMEDCT_US
71724000 SNOMEDCT_US
C0060282 UMLSCUI
24393 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Quflora FE Pediatric Drops HUMAN PRESCRIPTION DRUG LABEL 14 15370-102 LIQUID 9.50 mg ORAL UNAPPROVED DRUG OTHER 11 sections
FERROUS SULFATE HUMAN OTC DRUG LABEL 1 50436-5890 TABLET 325 mg ORAL Unapproved drug other 10 sections
FERROUS SULFATE HUMAN OTC DRUG LABEL 1 53807-177 ELIXIR 220 mg ORAL UNAPPROVED DRUG OTHER 15 sections
FERROUS SULFATE HUMAN OTC DRUG LABEL 1 53808-0918 TABLET 325 mg ORAL UNAPPROVED DRUG OTHER 10 sections
Ferrous Sulfate HUMAN OTC DRUG LABEL 1 54738-963 TABLET 325 mg ORAL unapproved drug other 11 sections
Ferrous Sulfate HUMAN OTC DRUG LABEL 1 54738-963 TABLET 325 mg ORAL unapproved drug other 11 sections
FERROUS SULFATE HUMAN OTC DRUG LABEL 2 58607-113 TABLET 65 mg ORAL unapproved drug other 9 sections
Multi-Vitamin Drops with Fluoride and Iron HUMAN PRESCRIPTION DRUG LABEL 10 58657-327 LIQUID 10 mg ORAL unapproved drug other 10 sections
Multi-Vitamin Drops with Fluoride and Iron HUMAN PRESCRIPTION DRUG LABEL 10 58657-327 LIQUID 10 mg ORAL unapproved drug other 10 sections
Ferrous Sulfate HUMAN OTC DRUG LABEL 1 67296-1555 TABLET, FILM COATED 325 mg ORAL unapproved drug other 10 sections
Ferrous Sulfate Human OTC Drug Label 1 76413-308 TABLET, FILM COATED 325 mg ORAL UNAPPROVED DRUG OTHER 10 sections
Ferrous Sulfate Human OTC Drug Label 1 76413-356 TABLET, FILM COATED 325 mg ORAL UNAPPROVED DRUG OTHER 11 sections