doxycycline ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antibiotics, protein-synthesis inhibitors, tetracycline derivatives 961 564-25-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • doxycycline
  • doxycycline hyclate
  • doxycycline calcium
  • doxycycline hydrochloride
  • doxycycline hydrate
  • doxycycline HCl
  • acticlate
A synthetic tetracycline derivative with similar antimicrobial activity.
  • Molecular weight: 444.44
  • Formula: C22H24N2O8
  • CLOGP: -0.98
  • LIPINSKI: 1
  • HAC: 10
  • HDO: 6
  • TPSA: 181.62
  • ALOGS: -2.85
  • ROTB: 2

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.10 g O
0.10 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 41 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.43 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 93 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.69 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.46 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.12 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 14 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 5, 1967 FDA PFIZER

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
Abortion incomplete 2014.19 10.29 522 82535 2609 63403356
Drug hypersensitivity 1159.36 10.29 1707 81350 308980 63096985
Haemorrhage 912.89 10.29 705 82352 60317 63345648
Jarisch-Herxheimer reaction 277.40 10.29 70 82987 307 63405658
Pregnancy 201.82 10.29 245 82812 36591 63369374
Cholangitis sclerosing 193.69 10.29 75 82982 1566 63404399
Oesophageal ulcer 158.83 10.29 89 82968 4401 63401564
Endometritis 136.26 10.29 51 83006 967 63404998
Heavy menstrual bleeding 131.10 10.29 138 82919 17635 63388330
Gastrointestinal mucosal necrosis 122.54 10.29 24 83033 17 63405948
Anti-neutrophil cytoplasmic antibody positive vasculitis 98.58 10.29 56 83001 2843 63403122
Deep vein thrombosis postoperative 96.07 10.29 95 82962 11274 63394691
Vomiting 93.11 10.29 1129 81928 558488 62847477
Death 92.54 10.29 222 82835 374159 63031806
Pelvic inflammatory disease 90.52 10.29 44 83013 1618 63404347
Completed suicide 88.26 10.29 40 83017 145633 63260332
Injury 85.71 10.29 250 82807 72997 63332968
Autoimmune disorder 84.06 10.29 108 82949 17069 63388896
Toxicity to various agents 76.10 10.29 129 82928 247121 63158844
Fall 71.48 10.29 268 82789 392066 63013899
Drug ineffective for unapproved indication 70.70 10.29 145 82912 33918 63372047
Idiopathic intracranial hypertension 69.66 10.29 45 83012 2886 63403079
Pancreatitis acute 66.54 10.29 124 82933 27042 63378923
Swollen joint count increased 65.07 10.29 145 82912 35909 63370056
Uterine perforation 62.23 10.29 60 82997 6903 63399062
Photoonycholysis 62.05 10.29 11 83046 0 63405965
Sciatica 57.46 10.29 134 82923 34190 63371775
Wheezing 56.94 10.29 262 82795 95333 63310632
Gastrointestinal injury 56.54 10.29 23 83034 549 63405416
Photosensitivity reaction 54.93 10.29 82 82975 14912 63391053
Intestinal sepsis 54.38 10.29 19 83038 293 63405672
Glomerulonephritis minimal lesion 54.12 10.29 18 83039 237 63405728
Rash 52.93 10.29 1028 82029 559843 62846122
Nausea 51.18 10.29 1470 81587 853001 62552964
Rheumatic fever 50.27 10.29 147 82910 42964 63363001
Coma 48.85 10.29 12 83045 64352 63341613
Intracranial pressure increased 48.53 10.29 46 83011 5181 63400784
Oesophagitis 47.88 10.29 77 82980 14931 63391034
Bone erosion 47.36 10.29 84 82973 17633 63388332
Pelvic pain 46.79 10.29 72 82985 13447 63392518
C-reactive protein 45.40 10.29 43 83014 4839 63401126
Papilloedema 42.91 10.29 38 83019 3922 63402043
Prescribed overdose 42.29 10.29 119 82938 34034 63371931
Lip swelling 41.21 10.29 111 82946 30952 63375013
Febrile neutropenia 41.01 10.29 57 83000 118392 63287573
Hidradenitis 40.57 10.29 32 83025 2814 63403151
Product use in unapproved indication 40.16 10.29 384 82673 178696 63227269
Hyperkalaemia 39.43 10.29 11 83046 54192 63351773
Drug abuse 39.31 10.29 23 83034 72495 63333470
Lyme disease 37.18 10.29 33 83024 3416 63402549
Hypereosinophilic syndrome 36.62 10.29 14 83043 282 63405683
Muscle spasms 35.59 10.29 336 82721 155814 63250151
Urticaria 34.96 10.29 351 82706 165451 63240514
Retained products of conception 34.87 10.29 11 83046 121 63405844
Sinusitis 34.80 10.29 451 82606 226202 63179763
Anxiety 34.72 10.29 436 82621 217105 63188860
Depressed level of consciousness 34.64 10.29 19 83038 62059 63343906
Swollen tongue 34.38 10.29 112 82945 34688 63371277
Apparent death 34.06 10.29 21 83036 1241 63404724
Retinitis 33.57 10.29 41 83016 6155 63399810
Liver injury 33.20 10.29 162 82895 60358 63345607
Road traffic accident 32.74 10.29 114 82943 36518 63369447
Blood pressure increased 32.60 10.29 106 82951 161956 63244009
Blister 31.94 10.29 284 82773 129530 63276435
Lower limb fracture 30.58 10.29 85 82972 24136 63381829
Ectopic pregnancy 30.58 10.29 26 83031 2541 63403424
C-reactive protein abnormal 30.19 10.29 130 82927 45966 63359999
Fibromyalgia 29.97 10.29 194 82863 80226 63325739
Lip dry 29.93 10.29 64 82993 15406 63390559
Urticaria contact 29.81 10.29 7 83050 21 63405944
Type 2 diabetes mellitus 29.52 10.29 163 82894 63705 63342260
Q fever 29.06 10.29 10 83047 147 63405818
Asthma 28.82 10.29 274 82783 127287 63278678
Dermatitis acneiform 28.61 10.29 34 83023 4962 63401003
Dizziness 28.50 10.29 750 82307 429175 62976790
Conjunctival cyst 27.63 10.29 8 83049 64 63405901
Toxic epidermal necrolysis 27.28 10.29 84 82973 25250 63380715
Malignant neoplasm progression 26.96 10.29 41 83016 82080 63323885
Lupus vulgaris 26.71 10.29 36 83021 5958 63400007
X-ray abnormal 26.40 10.29 42 83015 8068 63397897
Visual impairment 26.32 10.29 195 82862 84251 63321714
Hepatotoxicity 26.06 10.29 8 83049 37033 63368932
Exostosis 25.91 10.29 66 82991 17796 63388169
Cerebrovascular accident 25.87 10.29 65 82992 107959 63298006
Trichomegaly 25.87 10.29 8 83049 82 63405883
Adjustment disorder with depressed mood 25.52 10.29 47 83010 10157 63395808
Hypotension 25.40 10.29 231 82826 272373 63133592
Hypoaesthesia 25.38 10.29 334 82723 168059 63237906
Periarticular thenar erythema with onycholysis 25.37 10.29 7 83050 46 63405919
IIIrd nerve injury 25.27 10.29 5 83052 4 63405961
Blood pressure systolic increased 24.34 10.29 16 83041 47381 63358584
Keratitis 24.22 10.29 26 83031 3396 63402569
Hepatitis chronic active 24.18 10.29 7 83050 56 63405909
Emotional distress 23.83 10.29 95 82962 32454 63373511
Swelling face 23.57 10.29 153 82904 63322 63342643
Infection 23.56 10.29 426 82631 228747 63177218
Aspartate aminotransferase increased 23.47 10.29 52 83005 90225 63315740
Wound infection 23.06 10.29 71 82986 21339 63384626
Oesophageal irritation 23.04 10.29 8 83049 121 63405844
Hepatic cirrhosis 23 10.29 78 82979 24656 63381309
Osteoarthritis 22.63 10.29 207 82850 95136 63310829
Drug reaction with eosinophilia and systemic symptoms 22.60 10.29 96 82961 33740 63372225
Skin odour abnormal 22.18 10.29 18 83039 1648 63404317
Disinhibition 22.08 10.29 14 83043 869 63405096
Device capturing issue 22.07 10.29 6 83051 37 63405928
Macular degeneration 21.80 10.29 3 83054 24373 63381592
Pneumococcal infection 21.68 10.29 11 83046 444 63405521
Neutropenia 21.65 10.29 137 82920 174868 63231097
Cardio-respiratory arrest 21.61 10.29 28 83029 59931 63346034
Onychomadesis 21.48 10.29 32 83025 5808 63400157
Breast cancer 21.44 10.29 19 83038 48364 63357601
Platelet count decreased 21.29 10.29 79 82978 116043 63289922
Infusion related reaction 21.19 10.29 212 82845 245309 63160656
Vasculitis 21.14 10.29 62 82995 18147 63387818
Rash macular 21.13 10.29 73 82984 23291 63382674
Scar 21.12 10.29 52 83005 13730 63392235
Abortion spontaneous 20.85 10.29 119 82938 47076 63358889
Nodular vasculitis 20.60 10.29 5 83052 18 63405947
Premature delivery 20.49 10.29 7 83050 30274 63375691
Psoriatic arthropathy 20.37 10.29 196 82861 91324 63314641
Blood cholesterol increased 20.25 10.29 200 82857 93832 63312133
Treatment failure 20.10 10.29 369 82688 198674 63207291
SLE arthritis 20.10 10.29 12 83045 669 63405296
Sedation 20.07 10.29 13 83044 38796 63367169
Joint dislocation 19.93 10.29 62 82995 18738 63387227
VIth nerve paralysis 19.80 10.29 13 83044 857 63405108
Disease progression 19.69 10.29 88 82969 122670 63283295
Lipoedema 19.64 10.29 9 83048 289 63405676
Lupus-like syndrome 19.63 10.29 54 83003 15241 63390724
Acne pustular 19.62 10.29 8 83049 192 63405773
Thrombocytopenia 19.38 10.29 117 82940 151040 63254925
Erosive oesophagitis 19.38 10.29 17 83040 1733 63404232
Terminal state 19.15 10.29 19 83038 2263 63403702
Adverse drug reaction 18.88 10.29 173 82884 79541 63326424
Nephrogenic diabetes insipidus 18.65 10.29 13 83044 946 63405019
Rhabdomyolysis 18.60 10.29 18 83039 43933 63362032
Bronchomalacia 18.48 10.29 8 83049 224 63405741
Injection site reaction 18.47 10.29 30 83027 58494 63347471
Headache 18.39 10.29 1008 82049 632233 62773732
Internal injury 18.36 10.29 9 83048 337 63405628
Alopecia 18.29 10.29 321 82736 337215 63068750
Small intestine ulcer 18.10 10.29 9 83048 348 63405617
Rocky mountain spotted fever 17.98 10.29 5 83052 34 63405931
Cerebral haemorrhage 17.74 10.29 9 83048 30720 63375245
Rosacea 17.71 10.29 26 83031 4658 63401307
Infective pulmonary exacerbation of cystic fibrosis 17.67 10.29 37 83020 8780 63397185
Bradycardia 17.58 10.29 44 83013 73183 63332782
Foetal exposure during pregnancy 17.51 10.29 10 83047 31952 63374013
Mouth swelling 17.47 10.29 26 83031 4714 63401251
Acne conglobata 17.29 10.29 4 83053 11 63405954
Multiple sclerosis relapse 17.10 10.29 23 83034 48455 63357510
Overlap syndrome 17.09 10.29 12 83045 884 63405081
Chest pain 17.05 10.29 386 82671 215573 63190392
Overdose 16.99 10.29 85 82972 114993 63290972
Odynophagia 16.89 10.29 33 83024 7453 63398512
Herpes simplex oesophagitis 16.80 10.29 7 83050 178 63405787
Electrocardiogram QT prolonged 16.56 10.29 33 83024 59497 63346468
Ulcerative keratitis 16.44 10.29 19 83038 2691 63403274
Tendon pain 16.41 10.29 21 83036 3305 63402660
Myocardial infarction 16.39 10.29 71 82986 99822 63306143
Burn oesophageal 16.37 10.29 7 83050 190 63405775
Gait inability 16.33 10.29 122 82935 52837 63353128
Laryngitis 16.21 10.29 54 83003 16913 63389052
Rheumatoid factor positive 16.03 10.29 175 82882 84231 63321734
Medical device discomfort 16.01 10.29 16 83041 1923 63404042
Blood glucose increased 16 10.29 56 83001 83700 63322265
Haemoglobin decreased 15.95 10.29 118 82939 145367 63260598
Blood creatinine increased 15.94 10.29 60 82997 87784 63318181
Pseudoporphyria 15.91 10.29 7 83050 204 63405761
Seizure 15.80 10.29 105 82952 132529 63273436
Cholecystitis chronic 15.78 10.29 39 83018 10322 63395643
Proteinuria 15.76 10.29 58 82999 19087 63386878
Secondary amyloidosis 15.64 10.29 6 83051 122 63405843
Malaria 15.63 10.29 7 83050 213 63405752
Premature baby 15.47 10.29 4 83053 20731 63385234
Cardiac failure 15.47 10.29 62 82995 89080 63316885
Ear infection 15.36 10.29 94 82963 38119 63367846
Blood pressure fluctuation 15.32 10.29 23 83034 46294 63359671
Drug ineffective 15.14 10.29 1170 81887 1043595 62362370
Weight increased 14.77 10.29 246 82811 260546 63145419
Hemiparesis 14.71 10.29 6 83051 23276 63382689
Hypocalcaemia 14.61 10.29 12 83045 31701 63374264
Hypokalaemia 14.57 10.29 78 82979 103726 63302239
Abdominal pain 14.54 10.29 494 82563 292962 63113003
Noninfective oophoritis 14.50 10.29 5 83052 74 63405891
Corneal perforation 14.49 10.29 9 83048 539 63405426
Malaise 14.28 10.29 673 82384 415281 62990684
Eosinophilic pneumonia 14.26 10.29 16 83041 2195 63403770
Arthralgia 14.24 10.29 605 82452 569105 62836860
Perforation 14.13 10.29 12 83045 1171 63404794
Pemphigus 14.09 10.29 163 82894 183563 63222402
Amyloid arthropathy 14.02 10.29 9 83048 571 63405394
Coronary artery disease 14.01 10.29 13 83044 32364 63373601
Red blood cell sedimentation rate increased 13.95 10.29 102 82955 43880 63362085
Cytomegalovirus infection 13.91 10.29 5 83052 20947 63385018
Leukopenia 13.89 10.29 53 83004 77237 63328728
Injection site pain 13.88 10.29 106 82951 129694 63276271
Oesophagitis ulcerative 13.86 10.29 9 83048 582 63405383
Arthropathy 13.78 10.29 220 82837 234572 63171393
Glomerulonephritis rapidly progressive 13.78 10.29 11 83046 984 63404981
Heart rate decreased 13.78 10.29 24 83033 45536 63360429
Facet joint syndrome 13.77 10.29 41 83016 12097 63393868
Colitis ulcerative 13.71 10.29 69 82988 26022 63379943
Cholestatic liver injury 13.70 10.29 17 83040 2593 63403372
Gastric ulcer perforation 13.67 10.29 12 83045 1224 63404741
Asymptomatic bacteriuria 13.65 10.29 7 83050 289 63405676
Medical device site hyperaesthesia 13.63 10.29 3 83054 6 63405959
Post treatment Lyme disease syndrome 13.63 10.29 3 83054 6 63405959
Diabetes insipidus 13.63 10.29 17 83040 2608 63403357
Colorectal cancer metastatic 13.56 10.29 9 83048 604 63405361
Drug monitoring procedure not performed 13.50 10.29 9 83048 609 63405356
Neutrophil count decreased 13.46 10.29 34 83023 56372 63349593
Diabetic ketoacidosis 13.43 10.29 5 83052 20500 63385465
Blood creatine phosphokinase increased 13.42 10.29 12 83045 30418 63375547
Metabolic acidosis 13.40 10.29 24 83033 45045 63360920
Naevoid melanoma 13.32 10.29 3 83054 7 63405958
Foreign body reaction 13.30 10.29 5 83052 96 63405869
Cardiac arrest 13.29 10.29 69 82988 92476 63313489
Herpes zoster 13.29 10.29 59 82998 82403 63323562
Immunoglobulins decreased 13.21 10.29 12 83045 1280 63404685
Eosinophilic pneumonia chronic 13.12 10.29 6 83051 192 63405773
Hallucinations, mixed 13.04 10.29 23 83034 4806 63401159
Medical device pain 12.97 10.29 13 83044 1567 63404398
Dermatitis bullous 12.93 10.29 32 83025 8476 63397489
Illness 12.93 10.29 109 82948 48950 63357015
Erythema nodosum 12.88 10.29 23 83034 4852 63401113
Suicide attempt 12.83 10.29 39 83018 60879 63345086
Injection site haemorrhage 12.77 10.29 8 83049 24306 63381659
Gastric mucosal lesion 12.63 10.29 8 83049 496 63405469
Eosinophilic cellulitis 12.60 10.29 4 83053 45 63405920
Post inflammatory pigmentation change 12.53 10.29 7 83050 344 63405621
Systemic lupus erythematosus 12.51 10.29 195 82862 208723 63197242
Metastases to bone 12.37 10.29 6 83051 21013 63384952
Hypertrichosis 12.36 10.29 11 83046 1143 63404822
Intrusive thoughts 12.31 10.29 6 83051 222 63405743
Cognitive disorder 12.29 10.29 35 83022 55780 63350185
Compartment syndrome 12.19 10.29 15 83042 2269 63403696
Oesophageal injury 12.14 10.29 4 83053 51 63405914
Alcohol use disorder 12.11 10.29 3 83054 12 63405953
Oedema 12.04 10.29 187 82870 97435 63308530
Lactobacillus infection 11.94 10.29 4 83053 54 63405911
Duodenal ulcer perforation 11.91 10.29 170 82887 87039 63318926
Infusion site erythema 11.91 10.29 38 83019 11641 63394324
Impaired work ability 11.89 10.29 4 83053 17471 63388494
Device expulsion 11.89 10.29 17 83040 34905 63371060
Infertility female 11.87 10.29 8 83049 551 63405414
Accidental exposure to product 11.86 10.29 11 83046 27394 63378571
Constipation 11.83 10.29 215 82842 224728 63181237
Blood test abnormal 11.69 10.29 3 83054 15626 63390339
Suicidal ideation 11.66 10.29 129 82928 62292 63343673
Oxygen saturation decreased 11.65 10.29 68 82989 88517 63317448
Bronchial obstruction 11.65 10.29 12 83045 1495 63404470
Elbow deformity 11.59 10.29 12 83045 1503 63404462
Indifference 11.58 10.29 5 83052 139 63405826
Polyserositis 11.57 10.29 7 83050 400 63405565
Hypercalcaemia 11.53 10.29 12 83045 28310 63377655
Pulmonary infarction 11.49 10.29 16 83041 2731 63403234
Alanine aminotransferase increased 11.45 10.29 84 82973 103686 63302279
Joint effusion 11.44 10.29 4 83053 17056 63388909
Slow response to stimuli 11.38 10.29 10 83047 1022 63404943
Spinal cord disorder 11.37 10.29 11 83046 1270 63404695
Breast cancer stage II 11.37 10.29 31 83026 8705 63397260
Pulmonary fibrosis 11.32 10.29 90 82967 39719 63366246
Cutaneous tuberculosis 11.14 10.29 5 83052 153 63405812
Injection site bruising 11.01 10.29 24 83033 41886 63364079
Orthostatic hypotension 10.98 10.29 19 83038 36141 63369824
Tinnitus 10.94 10.29 82 82975 35546 63370419
Fistula discharge 10.88 10.29 10 83047 1083 63404882
Genital discomfort 10.88 10.29 4 83053 72 63405893
Foreign body sensation in eyes 10.86 10.29 14 83043 2220 63403745
Product prescribing error 10.86 10.29 11 83046 26278 63379687
Inflammatory bowel disease 10.83 10.29 19 83038 3954 63402011
Skin lesion 10.77 10.29 73 82984 30648 63375317
Paronychia 10.74 10.29 23 83034 5542 63400423
Anal candidiasis 10.71 10.29 3 83054 21 63405944
Gastrointestinal bacterial overgrowth 10.64 10.29 9 83048 873 63405092
Pneumonia aspiration 10.62 10.29 18 83039 34522 63371443
Gastric perforation 10.57 10.29 12 83045 1667 63404298
Ruptured ectopic pregnancy 10.56 10.29 7 83050 469 63405496
Accidental overdose 10.51 10.29 9 83048 23300 63382665
Jaw fracture 10.51 10.29 15 83042 2619 63403346
Cerebral thrombosis 10.50 10.29 12 83045 1679 63404286
Post viral fatigue syndrome 10.45 10.29 6 83051 311 63405654
Papule 10.39 10.29 23 83034 5668 63400297
Dehydration 10.31 10.29 162 82895 173192 63232773
Septic pulmonary embolism 10.31 10.29 4 83053 84 63405881

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
Jarisch-Herxheimer reaction 755.41 11.24 166 38210 425 34918130
Gastrointestinal mucosal necrosis 133.99 11.24 33 38343 159 34918396
Rash 124.01 11.24 528 37848 222224 34696331
Drug hypersensitivity 115.83 11.24 266 38110 80263 34838292
Congenital hiatus hernia 115.33 11.24 41 38335 803 34917752
Photosensitivity reaction 99.78 11.24 87 38289 10507 34908048
Gastrointestinal injury 97.08 11.24 31 38345 430 34918125
Breath sounds abnormal 86.84 11.24 67 38309 6814 34911741
Drug ineffective for unapproved indication 81.97 11.24 115 38261 23600 34894955
Oesophageal ulcer 78.60 11.24 48 38328 3333 34915222
Cholangitis sclerosing 78.57 11.24 36 38340 1385 34917170
Soft tissue mass 73.11 11.24 31 38345 988 34917567
Drug abuse 72.71 11.24 11 38365 99085 34819470
Neutrophilic dermatosis 71.39 11.24 21 38355 217 34918338
Multimorbidity 68.72 11.24 29 38347 913 34917642
Oesophageal perforation 62.01 11.24 29 38347 1170 34917385
Malignant melanoma in situ 57.51 11.24 31 38345 1697 34916858
Acquired haemophilia 54.01 11.24 25 38351 985 34917570
Stevens-Johnson syndrome 52.34 11.24 82 38294 18557 34899998
Lip swelling 49.75 11.24 74 38302 16006 34902549
Superinfection 49.13 11.24 32 38344 2487 34916068
Inflammatory marker increased 48.77 11.24 42 38334 4986 34913569
Fixed eruption 47.02 11.24 27 38349 1673 34916882
Malaise 44.31 11.24 352 38024 185473 34733082
Lung consolidation 42.79 11.24 42 38334 5894 34912661
Drug ineffective 42.18 11.24 719 37657 456032 34462523
Bronchiectasis 40.71 11.24 52 38324 9749 34908806
Swollen tongue 40.65 11.24 64 38312 14541 34904014
Acne fulminans 39.65 11.24 13 38363 197 34918358
Dyspnoea 39.55 11.24 606 37770 376176 34542379
Gastric mucosal lesion 39.34 11.24 17 38359 568 34917987
Myocardial infarction 39.29 11.24 45 38331 121040 34797515
Transplant failure 39.26 11.24 32 38344 3521 34915034
Bacterial pericarditis 38.48 11.24 10 38366 62 34918493
Wheezing 38.20 11.24 116 38260 41286 34877269
Hidradenitis 37.67 11.24 20 38356 1062 34917493
Pulmonary function test abnormal 36.44 11.24 27 38349 2583 34915972
Factitious disorder 35.78 11.24 9 38367 48 34918507
Asthma 34.32 11.24 114 38262 42542 34876013
Dermatitis acneiform 34.22 11.24 38 38338 6151 34912404
Lower respiratory tract infection 33.38 11.24 93 38283 31544 34887011
Chronic obstructive pulmonary disease 32.70 11.24 123 38253 48795 34869760
Febrile neutropenia 32.58 11.24 63 38313 136786 34781769
Painful respiration 32.51 11.24 19 38357 1217 34917338
Intracranial pressure increased 32.34 11.24 30 38346 3925 34914630
Asthma-chronic obstructive pulmonary disease overlap syndrome 31.79 11.24 19 38357 1268 34917287
Drug resistance 31.17 11.24 80 38296 25847 34892708
Micturition urgency 30.93 11.24 37 38339 6488 34912067
Chest injury 30.51 11.24 20 38356 1571 34916984
Sleep disorder due to a general medical condition 30.51 11.24 33 38343 5188 34913367
Productive cough 30.36 11.24 101 38275 37712 34880843
Autoimmune hepatitis 29.86 11.24 30 38346 4330 34914225
Nephrogenic diabetes insipidus 28.79 11.24 18 38358 1303 34917252
Pruritus 28.53 11.24 259 38117 141722 34776833
Corneal perforation 28.21 11.24 10 38366 194 34918361
Q fever 28.11 11.24 9 38367 126 34918429
Intentional overdose 27.50 11.24 7 38369 43667 34874888
Oral candidiasis 26.94 11.24 48 38328 12062 34906493
Bronchial hyperreactivity 26.87 11.24 19 38357 1690 34916865
Skin plaque 26.67 11.24 29 38347 4585 34913970
Urethritis mycoplasmal 26.60 11.24 6 38370 18 34918537
Melanocytic naevus 25.66 11.24 21 38355 2323 34916232
Hypotension 25.53 11.24 141 38235 221508 34697047
Skin exfoliation 25.43 11.24 77 38299 27355 34891200
Infective pulmonary exacerbation of cystic fibrosis 25.02 11.24 34 38342 6767 34911788
Full blood count abnormal 24.97 11.24 60 38316 18608 34899947
Walking aid user 24.85 11.24 19 38357 1905 34916650
Lyme disease 24.84 11.24 15 38361 1020 34917535
Ulcerative keratitis 24.39 11.24 18 38358 1711 34916844
Tubulointerstitial nephritis 24.38 11.24 64 38312 20960 34897595
Drug-induced liver injury 24.03 11.24 78 38298 28754 34889801
Death 24.02 11.24 301 38075 397748 34520807
Hypercholesterolaemia 23.84 11.24 38 38338 8724 34909831
Acute generalised exanthematous pustulosis 23.61 11.24 33 38343 6743 34911812
Crystal nephropathy 23.47 11.24 11 38365 446 34918109
Immunosuppressant drug level increased 23.39 11.24 31 38345 6024 34912531
Tachyarrhythmia 23.20 11.24 24 38352 3584 34914971
Treatment failure 23.04 11.24 107 38269 46590 34871965
Bronchitis 22.84 11.24 99 38277 41864 34876691
Distal intestinal obstruction syndrome 22.81 11.24 10 38366 346 34918209
Periorbital swelling 22.81 11.24 12 38364 625 34917930
Cough 22.54 11.24 258 38118 149882 34768673
C-reactive protein increased 22.43 11.24 16 38360 54082 34864473
Drug reaction with eosinophilia and systemic symptoms 22.05 11.24 83 38293 32929 34885626
Benign prostatic hyperplasia 22.04 11.24 49 38327 14446 34904109
Obstructive airways disorder 22.03 11.24 51 38325 15443 34903112
Swelling face 21.55 11.24 65 38311 23040 34895515
Psoriasis 21.46 11.24 92 38284 38720 34879835
Blood glucose increased 21.40 11.24 25 38351 66693 34851862
Joint injury 21.23 11.24 37 38339 9136 34909419
Antinuclear antibody negative 21.05 11.24 5 38371 20 34918535
Skin depigmentation 20.87 11.24 10 38366 426 34918129
Radiation fibrosis - lung 20.86 11.24 5 38371 21 34918534
Overdose 20.73 11.24 43 38333 91016 34827539
Aortic aneurysm 20.68 11.24 31 38345 6748 34911807
Angina bullosa haemorrhagica 20.66 11.24 6 38370 59 34918496
Rales 20.49 11.24 38 38338 9845 34908710
Dermatitis 20.38 11.24 37 38339 9431 34909124
Oesophageal stenosis 20 11.24 16 38360 1714 34916841
General physical health deterioration 19.92 11.24 73 38303 128196 34790359
Blood creatinine increased 19.86 11.24 47 38329 94929 34823626
Pancreatitis acute 19.84 11.24 72 38304 28069 34890486
Jaundice 19.53 11.24 78 38298 31804 34886751
Flashback 19.32 11.24 7 38369 145 34918410
Autoimmune blistering disease 19.22 11.24 4 38372 7 34918548
Cardiomegaly 18.93 11.24 48 38328 15390 34903165
Papule 18.85 11.24 23 38353 4116 34914439
Platelet count decreased 18.67 11.24 68 38308 119649 34798906
Acne 18.65 11.24 39 38337 11027 34907528
Oesophageal carcinoma 18.33 11.24 35 38341 9269 34909286
Coma 18.30 11.24 14 38362 45664 34872891
Rash pruritic 18.21 11.24 68 38308 26873 34891682
Tinnitus 18.20 11.24 56 38320 20062 34898493
Gastroduodenal haemorrhage 18.13 11.24 7 38369 174 34918381
Tooth injury 18.03 11.24 13 38363 1192 34917363
Penile erythema 17.95 11.24 7 38369 179 34918376
SAPHO syndrome 17.93 11.24 8 38368 289 34918266
Erythema migrans 17.82 11.24 5 38371 43 34918512
Mouth ulceration 17.81 11.24 40 38336 11870 34906685
Rash erythematous 17.69 11.24 64 38312 24913 34893642
Dysphagia 17.55 11.24 123 38253 62258 34856297
Splenic infarction 17.47 11.24 16 38360 2059 34916496
Laryngeal injury 17.45 11.24 3 38373 0 34918555
Gastrooesophageal reflux disease 17.33 11.24 85 38291 37839 34880716
Periostosis 17.05 11.24 4 38372 15 34918540
Fall 16.90 11.24 142 38234 202743 34715812
Abscess limb 16.76 11.24 20 38356 3497 34915058
Haemoglobin decreased 16.67 11.24 72 38304 120700 34797855
Methaemoglobinaemia 16.47 11.24 20 38356 3561 34914994
Loss of personal independence in daily activities 16.34 11.24 76 38300 33103 34885452
Red blood cell sedimentation rate decreased 16.24 11.24 5 38371 61 34918494
Oropharyngeal pain 15.83 11.24 79 38297 35406 34883149
Pustule 15.81 11.24 9 38367 548 34918007
Ocular surface squamous neoplasia 15.80 11.24 4 38372 22 34918533
Babesiosis 15.70 11.24 6 38370 145 34918410
Hyperkalaemia 15.59 11.24 33 38343 69356 34849199
Respiratory tract infection bacterial 15.51 11.24 14 38362 1768 34916787
Papillary renal cell carcinoma 15.48 11.24 7 38369 261 34918294
Vitamin K deficiency 15.43 11.24 7 38369 263 34918292
Arthritis gonococcal 15.37 11.24 3 38373 3 34918552
Hypoacusis 15.33 11.24 46 38330 16255 34902300
Gastrointestinal haemorrhage 15.33 11.24 48 38328 88429 34830126
Post infection glomerulonephritis 15.18 11.24 5 38371 77 34918478
Gastritis erosive 15.15 11.24 25 38351 5907 34912648
Ischaemic cardiomyopathy 15.08 11.24 26 38350 6363 34912192
Retinopathy hypertensive 15.02 11.24 7 38369 280 34918275
Infective exacerbation of bronchiectasis 14.92 11.24 8 38368 433 34918122
Cerebral haemorrhage 14.92 11.24 10 38366 34927 34883628
Hair colour changes 14.89 11.24 14 38362 1863 34916692
Blister 14.87 11.24 57 38319 22801 34895754
Breast inflammation 14.85 11.24 4 38372 29 34918526
Lactic acidosis 14.79 11.24 10 38366 34762 34883793
Prescription form tampering 14.51 11.24 8 38368 458 34918097
Mastocytosis 14.19 11.24 4 38372 35 34918520
Idiopathic intracranial hypertension 13.90 11.24 9 38367 692 34917863
Clostridium difficile infection 13.87 11.24 49 38327 18849 34899706
Nodule 13.86 11.24 26 38350 6793 34911762
Depressed level of consciousness 13.79 11.24 16 38360 42825 34875730
Blood pressure increased 13.76 11.24 50 38326 88052 34830503
Rheumatoid arthritis 13.75 11.24 13 38363 38225 34880330
Odynophagia 13.74 11.24 23 38353 5498 34913057
Rosacea 13.72 11.24 11 38365 1182 34917373
Amoebic dysentery 13.72 11.24 4 38372 40 34918515
PaO2/FiO2 ratio decreased 13.72 11.24 4 38372 40 34918515
Skin lesion 13.67 11.24 54 38322 21907 34896648
Protein total abnormal 13.65 11.24 7 38369 346 34918209
Limb mass 13.62 11.24 9 38367 717 34917838
Hypersomnia 13.60 11.24 37 38339 12370 34906185
Symmetrical drug-related intertriginous and flexural exanthema 13.57 11.24 7 38369 350 34918205
Rhinorrhoea 13.54 11.24 60 38316 25608 34892947
Respiratory tract infection 13.52 11.24 50 38326 19662 34898893
Loss of consciousness 13.52 11.24 46 38330 82621 34835934
Loose body in joint 13.45 11.24 4 38372 43 34918512
Necrotising panniculitis 13.45 11.24 4 38372 43 34918512
Overlap syndrome 13.44 11.24 5 38371 112 34918443
Staphylococcal infection 13.27 11.24 71 38305 32689 34885866
Suicide attempt 13.26 11.24 14 38362 39102 34879453
Pathogen resistance 13.25 11.24 31 38345 9451 34909104
Mouth swelling 13.13 11.24 13 38363 1843 34916712
Tendon disorder 13.13 11.24 16 38360 2859 34915696
Weight increased 13.12 11.24 55 38321 92978 34825577
Malignant neoplasm progression 13.08 11.24 51 38325 87995 34830560
Rhinocerebral mucormycosis 13.04 11.24 8 38368 560 34917995
Rebound effect 13.01 11.24 17 38359 3257 34915298
Red blood cell burr cells present 12.98 11.24 4 38372 49 34918506
Serotonin syndrome 12.93 11.24 3 38373 19930 34898625
Genital rash 12.91 11.24 8 38368 570 34917985
Loss of proprioception 12.82 11.24 7 38369 393 34918162
Hepatic function abnormal 12.80 11.24 18 38358 44345 34874210
Immune reconstitution inflammatory syndrome 12.63 11.24 29 38347 8730 34909825
Cinchonism 12.63 11.24 3 38373 12 34918543
Product use in unapproved indication 12.62 11.24 190 38186 117309 34801246
Eyelid margin crusting 12.58 11.24 6 38370 253 34918302
Prostate cancer 12.56 11.24 15 38361 39634 34878921
Contraindicated product prescribed 12.55 11.24 7 38369 410 34918145
Blood pressure fluctuation 12.54 11.24 6 38370 25243 34893312
White blood cell count decreased 12.51 11.24 58 38318 95387 34823168
Interleukin-2 receptor increased 12.46 11.24 5 38371 138 34918417
Tendon discomfort 12.43 11.24 6 38370 260 34918295
Herpes dermatitis 12.43 11.24 4 38372 57 34918498
Calciphylaxis 12.41 11.24 10 38366 1082 34917473
Dermatitis bullous 12.37 11.24 25 38351 6897 34911658
Portal hypertensive gastropathy 12.31 11.24 8 38368 619 34917936
Cardiac arrest 12.27 11.24 59 38317 96100 34822455
Papilloedema 12.23 11.24 15 38361 2698 34915857
Cardiac failure 12.22 11.24 55 38321 91193 34827362
Arthritis allergic 12.09 11.24 3 38373 15 34918540
Psychogenic visual disorder 12.09 11.24 3 38373 15 34918540
Oesophagitis 12.08 11.24 37 38339 13224 34905331
Altered state of consciousness 12.06 11.24 5 38371 22888 34895667
Gastrointestinal disorder 12.05 11.24 71 38305 33877 34884678
Skin reaction 11.98 11.24 21 38355 5209 34913346
Cutaneous sarcoidosis 11.95 11.24 5 38371 154 34918401
Intentional product use issue 11.93 11.24 109 38267 59707 34858848
Viral pharyngitis 11.77 11.24 5 38371 160 34918395
Rash maculo-papular 11.76 11.24 62 38314 28389 34890166
Erythema 11.74 11.24 149 38227 88631 34829924
Intentional product misuse 11.73 11.24 20 38356 45591 34872964
Burn oesophageal 11.67 11.24 4 38372 70 34918485
Hepatic encephalopathy 11.58 11.24 39 38337 14646 34903909
Skin hyperpigmentation 11.53 11.24 16 38360 3248 34915307
Photoonycholysis 11.49 11.24 3 38373 19 34918536
Orbital infection 11.49 11.24 3 38373 19 34918536
Penile rash 11.49 11.24 3 38373 19 34918536
Toxicity to various agents 11.48 11.24 153 38223 200209 34718346
Ischaemic stroke 11.34 11.24 3 38373 18247 34900308
Folliculitis 11.33 11.24 19 38357 4547 34914008
Infusion related reaction 11.29 11.24 26 38350 53031 34865524
Cat scratch disease 11.25 11.24 5 38371 179 34918376

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
Abortion incomplete 2016.52 10.01 520 103561 2544 79637763
Drug hypersensitivity 1032.55 10.01 1584 102497 297332 79342975
Jarisch-Herxheimer reaction 913.98 10.01 219 103862 738 79639569
Haemorrhage 691.80 10.01 717 103364 90401 79549906
Cholangitis sclerosing 274.59 10.01 110 103971 2527 79637780
Pregnancy 258.93 10.01 241 103840 26610 79613697
Gastrointestinal mucosal necrosis 242.36 10.01 57 104024 173 79640134
Rash 174.66 10.01 1321 102760 577037 79063270
Oesophageal ulcer 160.90 10.01 105 103976 6870 79633437
Gastrointestinal injury 149.25 10.01 54 104027 929 79639378
Heavy menstrual bleeding 147.26 10.01 132 103949 13879 79626428
Endometritis 144.01 10.01 50 104031 758 79639549
Drug abuse 136.19 10.01 24 104057 162667 79477640
Photosensitivity reaction 131.71 10.01 150 103931 20977 79619330
Drug ineffective for unapproved indication 128.61 10.01 236 103845 51002 79589305
Completed suicide 116.65 10.01 90 103991 245677 79394630
Congenital hiatus hernia 105.73 10.01 40 104041 784 79639523
Swollen joint count increased 104.46 10.01 139 103942 22788 79617519
Deep vein thrombosis postoperative 98.84 10.01 94 103987 10658 79629649
Death 98.59 10.01 393 103688 566121 79074186
Fall 96.22 10.01 321 103760 487308 79152999
Toxicity to various agents 92.72 10.01 264 103817 421276 79219031
Pelvic inflammatory disease 85.50 10.01 40 104041 1352 79638955
Rheumatic fever 84.04 10.01 141 103940 28384 79611923
Lip swelling 83.84 10.01 173 103908 40738 79599569
Pancreatitis acute 82.63 10.01 193 103888 49411 79590896
Vomiting 82.41 10.01 1272 102809 664556 78975751
Autoimmune disorder 82.35 10.01 105 103976 16507 79623800
Febrile neutropenia 81.78 10.01 109 103972 230890 79409417
Wheezing 80.00 10.01 333 103748 116331 79523976
Injury 77.48 10.01 250 103831 77246 79563061
Anti-neutrophil cytoplasmic antibody positive vasculitis 73.69 10.01 51 104030 3678 79636629
Idiopathic intracranial hypertension 73.09 10.01 48 104033 3174 79637133
Swollen tongue 70.21 10.01 165 103916 42405 79597902
Intracranial pressure increased 67.61 10.01 68 104013 8254 79632053
Photoonycholysis 67.02 10.01 14 104067 19 79640288
Coma 66.62 10.01 24 104057 100625 79539682
Uterine perforation 65.48 10.01 59 104022 6244 79634063
Soft tissue mass 63.97 10.01 32 104049 1256 79639051
Blister 63.96 10.01 317 103764 119159 79521148
Sciatica 60.59 10.01 134 103947 33088 79607219
Hypotension 57.03 10.01 339 103742 439978 79200329
Pelvic pain 54.72 10.01 77 104004 13304 79627003
Depressed level of consciousness 54.56 10.01 29 104052 96623 79543684
Hyperkalaemia 52.84 10.01 43 104038 114355 79525952
Oesophageal perforation 52.55 10.01 30 104051 1541 79638766
Gastric mucosal lesion 51.26 10.01 25 104056 928 79639379
Blood pressure increased 51.24 10.01 126 103955 211234 79429073
Myocardial infarction 51.00 10.01 102 103979 184027 79456280
Papilloedema 50.76 10.01 51 104030 6182 79634125
Multimorbidity 49.54 10.01 28 104053 1411 79638896
Neutrophilic dermatosis 49.19 10.01 21 104060 569 79639738
Q fever 49.07 10.01 17 104064 256 79640051
Urticaria 48.49 10.01 410 103671 184791 79455516
Platelet count decreased 48.01 10.01 115 103966 194549 79445758
Asthma 47.14 10.01 320 103761 134775 79505532
Nephrogenic diabetes insipidus 46.49 10.01 31 104050 2103 79638204
Type 2 diabetes mellitus 45.55 10.01 171 103910 56951 79583356
C-reactive protein 44.76 10.01 43 104038 4936 79635371
Dermatitis acneiform 44.62 10.01 60 104021 9933 79630374
Lupus vulgaris 44.31 10.01 36 104045 3310 79636997
Lyme disease 44.27 10.01 36 104045 3314 79636993
Liver injury 43.92 10.01 168 103913 56446 79583861
Fixed eruption 43.87 10.01 34 104047 2920 79637387
Nausea 43.78 10.01 1592 102489 955604 78684703
Bone erosion 43.26 10.01 81 104000 17766 79622541
Oesophagitis 42.09 10.01 96 103985 24193 79616114
Stevens-Johnson syndrome 41.56 10.01 129 103952 39037 79601270
Overdose 41.43 10.01 114 103967 184092 79456215
Treatment failure 41.28 10.01 371 103710 170115 79470192
Ulcerative keratitis 41.25 10.01 36 104045 3653 79636654
Swelling face 41.02 10.01 193 103888 71019 79569288
Malaise 40.76 10.01 880 103201 488989 79151318
Malignant neoplasm progression 40.58 10.01 72 104009 135918 79504389
Fibromyalgia 39.74 10.01 178 103903 64162 79576145
Ectopic pregnancy 39.62 10.01 26 104055 1717 79638590
Drug reaction with eosinophilia and systemic symptoms 39.13 10.01 177 103904 64067 79576240
Cardio-respiratory arrest 38.58 10.01 51 104030 108459 79531848
Malignant melanoma in situ 38.12 10.01 29 104052 2423 79637884
Prescribed overdose 37.66 10.01 122 103959 37761 79602546
Psoriatic arthropathy 36.91 10.01 200 103881 77799 79562508
Acne fulminans 36.80 10.01 13 104068 208 79640099
Haemoglobin decreased 36.70 10.01 157 103924 221962 79418345
Bacterial pericarditis 36.10 10.01 10 104071 67 79640240
X-ray abnormal 35.77 10.01 41 104040 5772 79634535
Retained products of conception 35.40 10.01 11 104070 115 79640192
Acquired haemophilia 35.12 10.01 25 104056 1886 79638421
Intestinal sepsis 35.08 10.01 19 104062 880 79639427
Retinitis 35.06 10.01 40 104041 5603 79634704
Blood creatinine increased 34.84 10.01 96 103985 154961 79485346
Glomerulonephritis minimal lesion 34.57 10.01 18 104063 769 79639538
Rheumatoid factor positive 34.33 10.01 162 103919 59677 79580630
Cerebrovascular accident 34.26 10.01 97 103984 155195 79485112
Cerebral haemorrhage 33.00 10.01 17 104064 57656 79582651
Inflammatory marker increased 32.85 10.01 54 104027 10686 79629621
Corneal perforation 32.23 10.01 17 104064 746 79639561
Blood glucose increased 31.56 10.01 64 104017 114911 79525396
Cardiac arrest 31.36 10.01 117 103964 171979 79468328
Breath sounds abnormal 30.89 10.01 66 104015 15918 79624389
Infective pulmonary exacerbation of cystic fibrosis 30.74 10.01 58 104023 12793 79627514
Onychomadesis 30.62 10.01 36 104045 5206 79635101
Blood pressure fluctuation 30.06 10.01 26 104055 67119 79573188
Osteoarthritis 29.96 10.01 206 103875 87103 79553204
Lower limb fracture 29.95 10.01 82 103999 23133 79617174
Blood pressure systolic increased 29.92 10.01 26 104055 66960 79573347
Urticaria contact 29.82 10.01 7 104074 21 79640286
Rash macular 29.57 10.01 94 103987 28805 79611502
Intentional overdose 29.07 10.01 59 104022 105901 79534406
Lip dry 29.03 10.01 63 104018 15355 79624952
Micturition urgency 28.94 10.01 56 104025 12585 79627722
Burn oesophageal 28.91 10.01 11 104070 219 79640088
Duodenal ulcer perforation 28.81 10.01 166 103915 66045 79574262
Hidradenitis 28.72 10.01 27 104054 3017 79637290
Rhabdomyolysis 28.65 10.01 57 104024 103074 79537233
Exostosis 28.51 10.01 66 104015 16792 79623515
Hypereosinophilic syndrome 28.36 10.01 14 104067 534 79639773
Bradycardia 28.21 10.01 87 103994 135470 79504837
Odynophagia 28.19 10.01 52 104029 11275 79629032
Mouth swelling 28.04 10.01 37 104044 6014 79634293
Cardiac failure 27.74 10.01 106 103975 154736 79485571
Lupus-like syndrome 27.68 10.01 58 104023 13799 79626508
Anxiety 27.67 10.01 467 103614 248045 79392262
Conjunctival cyst 27.65 10.01 8 104073 64 79640243
Superinfection 27.54 10.01 33 104048 4869 79635438
Hypoaesthesia 27.41 10.01 356 103725 178996 79461311
Lung consolidation 27.39 10.01 45 104036 8902 79631405
Heart rate decreased 27.15 10.01 31 104050 70285 79570022
VIth nerve paralysis 27.01 10.01 20 104061 1604 79638703
Drug resistance 26.99 10.01 118 103963 42095 79598212
Adjustment disorder with depressed mood 26.88 10.01 45 104036 9041 79631266
Trichomegaly 26.78 10.01 9 104072 123 79640184
Suicide attempt 26.50 10.01 42 104039 82890 79557417
Thrombocytopenia 26.08 10.01 221 103860 265038 79375269
Abdominal discomfort 26.06 10.01 466 103615 250261 79390046
Weight increased 25.99 10.01 234 103847 277152 79363155
Injection site pain 25.85 10.01 85 103996 129753 79510554
Pruritus 25.80 10.01 686 103395 393962 79246345
Transplant failure 25.67 10.01 31 104050 4610 79635697
Seizure 25.67 10.01 143 103938 188691 79451616
Urethritis mycoplasmal 25.56 10.01 6 104075 18 79640289
IIIrd nerve injury 25.28 10.01 5 104076 4 79640303
Metabolic acidosis 25.25 10.01 43 104038 82486 79557821
Neutropenia 25.12 10.01 247 103834 287463 79352844
Muscle spasms 25.11 10.01 343 103738 174387 79465920
Factitious disorder 25.03 10.01 9 104072 152 79640155
Chronic obstructive pulmonary disease 24.99 10.01 194 103887 85225 79555082
Somnolence 24.92 10.01 196 103885 238785 79401522
Product use in unapproved indication 24.86 10.01 462 103619 249897 79390410
Gastritis erosive 24.77 10.01 48 104033 10799 79629508
Periarticular thenar erythema with onycholysis 24.76 10.01 7 104074 51 79640256
Blood cholesterol increased 24.41 10.01 190 103891 83530 79556777
Neutrophil count decreased 24.37 10.01 54 104027 93905 79546402
Dermatitis bullous 24.35 10.01 56 104025 14189 79626118
Hemiparesis 24.16 10.01 7 104074 33726 79606581
Posterior reversible encephalopathy syndrome 24.00 10.01 3 104078 26278 79614029
Tinnitus 23.97 10.01 118 103963 44215 79596092
White blood cell count decreased 23.78 10.01 146 103935 188142 79452165
Adverse drug reaction 23.59 10.01 158 103923 66234 79574073
Gastrointestinal haemorrhage 23.43 10.01 106 103975 147613 79492694
Jaundice 23.37 10.01 134 103947 53215 79587092
Oesophageal irritation 23.30 10.01 8 104073 117 79640190
Skin exfoliation 23.23 10.01 137 103944 54963 79585344
Autoimmune hepatitis 23.17 10.01 49 104032 11734 79628573
Drug-induced liver injury 22.68 10.01 156 103925 65961 79574346
Overlap syndrome 22.61 10.01 15 104066 1009 79639298
Malaria 22.49 10.01 11 104070 411 79639896
Hypokalaemia 22.46 10.01 104 103977 143936 79496371
Folliculitis 22.27 10.01 136 103945 55244 79585063
Joint dislocation 22.02 10.01 60 104021 16879 79623428
Device capturing issue 21.69 10.01 6 104075 40 79640267
Bronchial hyperreactivity 21.39 10.01 23 104058 3017 79637290
Benign prostatic hyperplasia 21.35 10.01 47 104034 11565 79628742
Visual impairment 21.02 10.01 198 103883 91933 79548374
Keratitis 20.92 10.01 27 104054 4295 79636012
Toxic epidermal necrolysis 20.87 10.01 114 103967 44467 79595840
Multiple sclerosis relapse 20.85 10.01 18 104063 46515 79593792
Erosive oesophagitis 20.62 10.01 22 104059 2860 79637447
Periorbital swelling 20.53 10.01 22 104059 2874 79637433
Acute generalised exanthematous pustulosis 20.35 10.01 59 104022 17195 79623112
Antinuclear antibody negative 20.19 10.01 5 104076 20 79640287
Aggression 20.18 10.01 22 104059 50936 79589371
Sinusitis 20.18 10.01 363 103718 195138 79445169
Intentional product use issue 20.01 10.01 294 103787 151818 79488489
Pneumonia aspiration 19.48 10.01 36 104045 66931 79573376
Acute myocardial infarction 19.38 10.01 45 104036 76991 79563316
Medical device discomfort 19.38 10.01 17 104064 1737 79638570
Respiratory depression 19.31 10.01 6 104075 27624 79612683
Breast cancer 19.26 10.01 10 104071 33771 79606536
Chest injury 19.25 10.01 21 104060 2800 79637507
Acne conglobata 19.13 10.01 5 104076 26 79640281
Painful respiration 19.00 10.01 23 104058 3430 79636877
Scar 18.93 10.01 53 104028 15143 79625164
Myelosuppression 18.78 10.01 15 104066 40281 79600026
Skin hyperpigmentation 18.77 10.01 34 104047 7269 79633038
Road traffic accident 18.69 10.01 109 103972 43555 79596752
Cytokine release syndrome 18.61 10.01 12 104069 35986 79604321
Lactic acidosis 18.60 10.01 40 104041 70319 79569988
Premature delivery 18.49 10.01 4 104077 23463 79616844
Dehydration 18.48 10.01 221 103860 247966 79392341
Gait inability 18.46 10.01 136 103945 58781 79581526
Disease progression 18.38 10.01 153 103928 184209 79456098
Hepatic function abnormal 18.16 10.01 43 104038 73064 79567243
Headache 18.07 10.01 1034 103047 652738 78987569
Sleep disorder due to a general medical condition 17.99 10.01 50 104031 14227 79626080
Emotional distress 17.91 10.01 101 103980 39868 79600439
Suicidal ideation 17.89 10.01 165 103916 76175 79564132
Penile erythema 17.88 10.01 7 104074 151 79640156
Injection site haemorrhage 17.84 10.01 7 104074 27863 79612444
Sedation 17.82 10.01 25 104056 51870 79588437
Infection 17.79 10.01 427 103654 241285 79399022
Drug intolerance 17.78 10.01 461 103620 263658 79376649
C-reactive protein abnormal 17.72 10.01 116 103965 48251 79592056
Nodular vasculitis 17.62 10.01 5 104076 37 79640270
Internal injury 17.61 10.01 9 104072 370 79639937
Apparent death 17.28 10.01 20 104061 2845 79637462
Symmetrical drug-related intertriginous and flexural exanthema 17.23 10.01 12 104069 874 79639433
Ischaemic stroke 17.19 10.01 11 104070 33120 79607187
Pulmonary function test abnormal 17.17 10.01 24 104057 4120 79636187
Immunosuppressant drug level increased 17.13 10.01 37 104044 8990 79631317
Oral candidiasis 16.84 10.01 80 104001 29548 79610759
Diabetic ketoacidosis 16.80 10.01 12 104069 34110 79606197
Angina pectoris 16.72 10.01 26 104055 51706 79588601
Erythema nodosum 16.62 10.01 27 104054 5290 79635017
Rebound effect 16.53 10.01 32 104049 7194 79633113
Skin odour abnormal 16.49 10.01 17 104064 2124 79638183
Flashback 16.43 10.01 8 104073 296 79640011
Infusion related reaction 16.39 10.01 207 103874 230030 79410277
SLE arthritis 16.36 10.01 10 104071 583 79639724
Periostosis 16.36 10.01 4 104077 15 79640292
Hallucinations, mixed 16.33 10.01 31 104050 6868 79633439
Laryngitis 16.25 10.01 52 104029 15987 79624320
Cytomegalovirus infection 16.24 10.01 19 104062 42625 79597682
Distal intestinal obstruction syndrome 16.11 10.01 11 104070 776 79639531
Melanocytic naevus 16.10 10.01 25 104056 4716 79635591
Wound infection 16.05 10.01 68 104013 23923 79616384
Hepatitis chronic active 15.96 10.01 7 104074 203 79640104
Neuroleptic malignant syndrome 15.95 10.01 8 104073 27551 79612756
Cognitive disorder 15.92 10.01 43 104038 69883 79570424
Cholecystitis chronic 15.90 10.01 38 104043 9868 79630439
Radiation fibrosis - lung 15.86 10.01 5 104076 55 79640252
Respiratory arrest 15.82 10.01 32 104049 57518 79582789
Aspartate aminotransferase increased 15.73 10.01 111 103970 138530 79501777
Anuria 15.67 10.01 4 104077 20959 79619348
Facet joint syndrome 15.67 10.01 41 104040 11261 79629046
Wrong technique in product usage process 15.66 10.01 47 104034 73828 79566479
Rash pustular 15.65 10.01 41 104040 11270 79629037
Tendon discomfort 15.63 10.01 9 104072 470 79639837
Cardiogenic shock 15.62 10.01 19 104062 41895 79598412
Rosacea 15.58 10.01 23 104058 4149 79636158
Helicobacter infection 15.50 10.01 149 103932 69555 79570752
Creatinine renal clearance decreased 15.47 10.01 3 104078 18999 79621308
Ureaplasma infection 15.41 10.01 12 104069 1038 79639269
Asthma-chronic obstructive pulmonary disease overlap syndrome 15.40 10.01 20 104061 3201 79637106
Tendon pain 15.39 10.01 27 104054 5631 79634676
Altered state of consciousness 15.16 10.01 21 104060 43801 79596506
Poisoning 15.14 10.01 7 104074 25265 79615042
Hypercholesterolaemia 15.10 10.01 65 104016 23030 79617277
Disease recurrence 15.09 10.01 104 103977 44005 79596302
Acute myeloid leukaemia 15.03 10.01 11 104070 30874 79609433
Chest pain 14.93 10.01 478 103603 281826 79358481
Arthritis gonococcal 14.85 10.01 3 104078 3 79640304
Neoplasm progression 14.84 10.01 28 104053 51654 79588653
Lower respiratory tract infection 14.79 10.01 244 103837 128976 79511331
Hypercalcaemia 14.77 10.01 17 104064 38413 79601894
Ear infection 14.76 10.01 86 103995 34346 79605961
Prostate cancer 14.75 10.01 13 104068 33255 79607052
Mucosal inflammation 14.68 10.01 50 104031 75530 79564777
Injection site reaction 14.60 10.01 31 104050 54754 79585553
Noninfective oophoritis 14.51 10.01 5 104076 74 79640233
Rash pruritic 14.42 10.01 150 103931 71479 79568828
Colitis ulcerative 14.40 10.01 86 103995 34656 79605651
Blood pressure decreased 14.24 10.01 74 104007 99392 79540915
Corneal neovascularisation 14.21 10.01 6 104075 158 79640149
Dizziness 14.21 10.01 831 103250 525610 79114697
Hepatic cirrhosis 14.21 10.01 86 103995 34820 79605487
Accidental exposure to product 14.18 10.01 12 104069 31310 79608997
Pneumococcal infection 14.17 10.01 11 104070 947 79639360
Papillary renal cell carcinoma 14.15 10.01 7 104074 268 79640039
Dysphagia 14.12 10.01 231 103850 121905 79518402
Medical device pain 14.09 10.01 13 104068 1418 79638889
Herpes zoster 14.04 10.01 68 104013 93015 79547292
Amyloid arthropathy 14.04 10.01 9 104072 571 79639736
Product prescribing error 14.03 10.01 23 104058 44790 79595517
Live birth 14.03 10.01 55 104026 18689 79621618
Eosinophilic pneumonia 14.01 10.01 25 104056 5285 79635022
SAPHO syndrome 13.98 10.01 8 104073 413 79639894
Tumour lysis syndrome 13.78 10.01 7 104074 23932 79616375
Gastroduodenal haemorrhage 13.71 10.01 7 104074 287 79640020
Colorectal cancer metastatic 13.68 10.01 12 104069 1226 79639081
Foot deformity 13.68 10.01 65 104016 24009 79616298
Drug monitoring procedure not performed 13.65 10.01 11 104070 1000 79639307
Post treatment Lyme disease syndrome 13.64 10.01 3 104078 6 79640301
Medical device site hyperaesthesia 13.64 10.01 3 104078 6 79640301
PaO2/FiO2 ratio decreased 13.61 10.01 4 104077 34 79640273
Tubulointerstitial nephritis 13.58 10.01 91 103990 38144 79602163
Dermatomyositis 13.57 10.01 20 104061 3603 79636704
Abscess limb 13.56 10.01 29 104052 6998 79633309
Blood urea increased 13.52 10.01 27 104054 48763 79591544
Blood potassium increased 13.52 10.01 11 104070 29264 79611043
Infertility female 13.50 10.01 8 104073 441 79639866
Underdose 13.48 10.01 14 104067 33137 79607170
Palmar-plantar erythrodysaesthesia syndrome 13.46 10.01 14 104067 33120 79607187
Neoplasm malignant 13.43 10.01 13 104068 31797 79608510
Walking aid user 13.24 10.01 36 104045 10112 79630195
Rhinocerebral mucormycosis 13.21 10.01 11 104070 1047 79639260
Pharyngeal oedema 13.21 10.01 49 104032 16223 79624084
Pathogen resistance 13.19 10.01 45 104036 14297 79626010
Granuloma annulare 13.18 10.01 9 104072 635 79639672
Bronchiectasis 13.12 10.01 61 104020 22325 79617982
Weight decreased 13.11 10.01 358 103723 354840 79285467
Chronic cutaneous lupus erythematosus 13.10 10.01 8 104073 466 79639841
Eye pain 13.09 10.01 89 103992 37489 79602818
Knee arthroplasty 13.08 10.01 99 103982 43149 79597158
Post infection glomerulonephritis 13.08 10.01 5 104076 101 79640206
Pulmonary oedema 13.01 10.01 65 104016 88189 79552118
Haematocrit decreased 13 10.01 39 104042 61273 79579034
Vasculitis 12.99 10.01 66 104015 25036 79615271
Pulmonary fibrosis 12.79 10.01 100 103981 44012 79596295
Sunburn 12.72 10.01 20 104061 3813 79636494
Drug dependence 12.69 10.01 21 104060 40748 79599559
Retinopathy hypertensive 12.60 10.01 8 104073 499 79639808
Naevoid melanoma 12.54 10.01 3 104078 10 79640297
Rash maculo-papular 12.53 10.01 120 103961 55958 79584349
Gastrointestinal bacterial overgrowth 12.53 10.01 9 104072 689 79639618
Extrapyramidal disorder 12.51 10.01 7 104074 22672 79617635
Angina bullosa haemorrhagica 12.50 10.01 6 104075 215 79640092
Lipoedema 12.47 10.01 6 104075 216 79640091
Secondary amyloidosis 12.47 10.01 6 104075 216 79640091
Oxygen saturation decreased 12.45 10.01 108 103973 128939 79511368
Full blood count abnormal 12.43 10.01 93 103988 40381 79599926
Ventricular fibrillation 12.40 10.01 14 104067 31912 79608395
Blood lactate dehydrogenase increased 12.36 10.01 20 104061 39150 79601157
Loss of consciousness 12.32 10.01 150 103931 167793 79472514
Genital haemorrhage 12.28 10.01 26 104055 6229 79634078
Perforation 12.23 10.01 12 104069 1414 79638893
Therapy partial responder 12.18 10.01 50 104031 17347 79622960
Sleep apnoea syndrome 12.11 10.01 18 104063 36460 79603847
Herpes simplex oesophagitis 12.08 10.01 7 104074 370 79639937
Hip arthroplasty 12.05 10.01 84 103997 35672 79604635
Tendon disorder 12.01 10.01 28 104053 7158 79633149
Heart rate irregular 11.98 10.01 15 104066 32664 79607643
Urinary tract infection 11.94 10.01 270 103811 274242 79366065
Renal disorder 11.93 10.01 23 104058 42082 79598225
Bronchitis 11.90 10.01 238 103843 130406 79509901
Breast cancer stage II 11.82 10.01 30 104051 8090 79632217
Red blood cell burr cells present 11.81 10.01 4 104077 56 79640251
Dyspnoea 11.80 10.01 1284 102797 855741 78784566
Interleukin-2 receptor increased 11.80 10.01 6 104075 244 79640063
Ischaemic cardiomyopathy 11.80 10.01 29 104052 7666 79632641
Laryngeal injury 11.74 10.01 3 104078 14 79640293
Anaphylactic shock 11.72 10.01 18 104063 35978 79604329
Respiratory tract infection bacterial 11.70 10.01 14 104067 2063 79638244
Infective exacerbation of bronchiectasis 11.69 10.01 9 104072 765 79639542
Stoma site discomfort 11.66 10.01 5 104076 137 79640170
Musculoskeletal stiffness 11.63 10.01 305 103776 174703 79465604
Alanine aminotransferase increased 11.62 10.01 146 103935 162424 79477883
Ear pain 11.54 10.01 78 104003 32791 79607516
Dermatitis atopic 11.49 10.01 34 104047 10022 79630285
Gamma-glutamyltransferase increased 11.44 10.01 35 104046 54645 79585662
Rash morbilliform 11.43 10.01 25 104056 6125 79634182
Arthritis allergic 11.26 10.01 3 104078 17 79640290
Cerebral infarction 11.24 10.01 27 104054 45649 79594658
Ruptured ectopic pregnancy 11.21 10.01 7 104074 424 79639883
Therapy non-responder 11.20 10.01 176 103905 92129 79548178
Tuberculosis 11.17 10.01 3 104078 15195 79625112
Respiratory tract infection viral 11.17 10.01 20 104061 4239 79636068
Skin fissures 11.15 10.01 40 104041 13033 79627274
Hypocalcaemia 11.14 10.01 31 104050 49893 79590414
Penile rash 11.11 10.01 3 104078 18 79640289
Acne 11.07 10.01 67 104014 27123 79613184
Sudden death 10.98 10.01 8 104073 22503 79617804
Cinchonism 10.98 10.01 3 104078 19 79640288
Foreign body reaction 10.88 10.01 5 104076 162 79640145
Status epilepticus 10.84 10.01 10 104071 25031 79615276
Infusion site erythema 10.82 10.01 32 104049 9428 79630879
Dry skin 10.81 10.01 136 103945 67859 79572448
Glomerulonephritis rapidly progressive 10.78 10.01 12 104069 1636 79638671
Asthenia 10.75 10.01 552 103529 511137 79129170
Ototoxicity 10.75 10.01 17 104064 3257 79637050
Ileus 10.73 10.01 11 104070 26200 79614107
Splenic infarction 10.64 10.01 18 104063 3646 79636661
Abdominal pain upper 10.56 10.01 374 103707 223445 79416862
Depressed mood 10.47 10.01 103 103978 48377 79591930
Papule 10.40 10.01 27 104054 7380 79632927
Mydriasis 10.39 10.01 5 104076 17638 79622669
Frequent bowel movements 10.38 10.01 14 104067 29525 79610782
Hypokinesia 10.35 10.01 6 104075 19054 79621253
Orthostatic hypotension 10.34 10.01 38 104043 56126 79584181
Fracture 10.31 10.01 8 104073 21793 79618514
Diabetes mellitus 10.30 10.01 60 104021 78330 79561977
Device breakage 10.27 10.01 34 104047 10641 79629666
Ocular surface squamous neoplasia 10.26 10.01 3 104078 25 79640282
Anal candidiasis 10.26 10.01 3 104078 25 79640282
Crystal nephropathy 10.22 10.01 11 104070 1444 79638863
Femur fracture 10.19 10.01 22 104059 38630 79601677
Interstitial lung disease 10.10 10.01 96 103985 112504 79527803
Oesophagitis ulcerative 10.09 10.01 10 104071 1193 79639114
Small intestine ulcer 10.08 10.01 8 104073 711 79639596
Growth of eyelashes 10.07 10.01 5 104076 193 79640114
Onychalgia 10.06 10.01 9 104072 943 79639364

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A01AB22 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Antiinfectives and antiseptics for local oral treatment
ATC J01AA02 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
TETRACYCLINES
Tetracyclines
FDA Chemical/Ingredient N0000007948 Tetracyclines
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000962 Antimalarials
MeSH PA D000977 Antiparasitic Agents
MeSH PA D000981 Antiprotozoal Agents
FDA EPC N0000175882 Tetracycline-class Drug
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:38068 antimalarials
CHEBI has role CHEBI:50846 Immunologic factor
CHEBI has role CHEBI:67079 anti-inflammatory agents
CHEBI has role CHEBI:176497 geroprotectors

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

DiseaseRelationSNOMED_IDDOID
Trachoma indication 2576002 DOID:11265
Listeriosis indication 4241002 DOID:11573
Inhalational anthrax indication 11389007
Actinomycotic infection indication 11817007 DOID:8478
Gonorrhea indication 15628003 DOID:7551
Tularemia indication 19265001
Infection of skin AND/OR subcutaneous tissue indication 19824006
Acute gonococcal cervicitis indication 20943002 DOID:10615
Murine typhus indication 25668000 DOID:11256
Granuloma inguinale indication 28867007 DOID:9113
Acute gonococcal urethritis indication 29864006
Acute gonococcal epididymo-orchitis indication 30168008 DOID:10802
Bronchitis indication 32398004 DOID:6132
Sinusitis indication 36971009
Disease caused by rickettsiae indication 37246009
Louse-borne typhus indication 39111003 DOID:11256
Gonorrhea of rectum indication 42746002
Pneumonia due to Mycoplasma pneumoniae indication 46970008
Brill-Zinsser disease indication 47761007 DOID:11254
Bacterial pneumonia indication 53084003 DOID:874
Cholera indication 63650001 DOID:1498
Acute gonococcal endometritis indication 65295003 DOID:7527
Yaws indication 70647001 DOID:10371
Gonorrhea of pharynx indication 74372003
Rickettsialpox indication 75096007 DOID:11103
Ornithosis indication 75116005 DOID:11262
Acute bacterial sinusitis indication 75498004
Brucellosis indication 75702008 DOID:11077
Syphilis indication 76272004
Nongonococcal urethritis indication 84619001
Cutaneous anthrax indication 84980006 DOID:7426
Acne vulgaris indication 88616000
Q fever endocarditis indication 95890006
Chlamydial infection indication 105629000
Gastrointestinal anthrax indication 111798006 DOID:13386
Rocky Mountain spotted fever indication 186772009
Boutonneuse fever indication 186774005 DOID:14095
Q fever indication 186788009 DOID:11100
Lymphogranuloma venereum indication 186946009 DOID:13819
Inclusion conjunctivitis indication 266109000
Bartonellosis indication 266123003 DOID:11102
Chancroid indication 266143009 DOID:13778
Scrub typhus indication 271425001 DOID:13371
Bacterial urinary infection indication 312124009
Pharyngitis indication 405737000 DOID:2275
Anthrax indication 409498004 DOID:7427
Relapsing fever indication 420079008 DOID:13034
Chlamydia trachomatis infection of genital structure indication 428015005
Periodontitis Adjunct Therapy indication
Chloroquine-Resistant Plasmodium Falciparum Malaria Prevention indication
Typhus Infections indication
Disseminated Gonococcal Infection indication
Severe Recalcitrant Nodular Rosacea indication
Rectal Chlamydia Trachomatis Infection indication
Traveler's diarrhea off-label use 11840006
Gingivostomatitis off-label use 20607006
Lyme disease off-label use 23502006 DOID:11729
Vivax malaria off-label use 27052006 DOID:12978
Lyme arthritis off-label use 33937009
Enterocolitis off-label use 43752006
Plague off-label use 58750007 DOID:3482
Malaria off-label use 61462000 DOID:12365
Ehrlichiosis off-label use 77361002
Leptospirosis off-label use 77377001 DOID:2297
Lyme carditis off-label use 77863005
Atypical mycobacterial infection off-label use 111812000
Ocular rosacea off-label use 200933006
Chlamydial epididymitis off-label use 236767000
Rosacea off-label use 398909004 DOID:8881
Sexual Transmitted Disease Exposure from Sexual Assault off-label use
Postexposure Plague Prophylaxis off-label use
Lyme Disease Prevention off-label use
Pleural Malignant Effusions off-label use
Chloroquine Resistant Plasmodium Falciparum Malaria off-label use
Esophageal dysmotility contraindication 266434009 DOID:9192
Pregnancy, function contraindication 289908002
Pseudomembranous enterocolitis contraindication 397683000




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Dogs Periodontal disease Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Doxirobe Gel Zoetis Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.23 acidic
pKa2 7.13 acidic
pKa3 9.78 acidic
pKa4 11.26 acidic
pKa5 12.46 acidic
pKa6 13.08 acidic
pKa7 9.07 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
40MG ORACEA GALDERMA LABS LP N050805 May 26, 2006 RX CAPSULE ORAL 8394405 April 7, 2024 TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
40MG ORACEA GALDERMA LABS LP N050805 May 26, 2006 RX CAPSULE ORAL 8394406 April 7, 2024 TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
40MG ORACEA GALDERMA LABS LP N050805 May 26, 2006 RX CAPSULE ORAL 8470364 April 7, 2024 TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
40MG ORACEA GALDERMA LABS LP N050805 May 26, 2006 RX CAPSULE ORAL 8709478 April 7, 2024 TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
40MG ORACEA GALDERMA LABS LP N050805 May 26, 2006 RX CAPSULE ORAL 8206740 Dec. 24, 2025 TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
40MG ORACEA GALDERMA LABS LP N050805 May 26, 2006 RX CAPSULE ORAL 7749532 Dec. 19, 2027 TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
EQ 120MG BASE DORYX MPC MAYNE PHARMA N050795 May 20, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9295652 Oct. 23, 2034 TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-RELEASE TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET
EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** DORYX MPC MAYNE PHARMA N050795 May 20, 2016 RX TABLET, DELAYED RELEASE ORAL 9295652 Oct. 23, 2034 TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-RELEASE TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET
EQ 120MG BASE DORYX MPC MAYNE PHARMA N050795 May 20, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9446057 Dec. 23, 2034 TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-RELEASE TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET
EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** DORYX MPC MAYNE PHARMA N050795 May 20, 2016 RX TABLET, DELAYED RELEASE ORAL 9446057 Dec. 23, 2034 TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-RELEASE TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
72 kDa type IV collagenase Enzyme IC50 4.62 CHEMBL
Stromelysin-1 Enzyme IC50 4.60 CHEMBL
Neutrophil collagenase Enzyme INHIBITOR IC50 4.60 IUPHAR
Collagenase 3 Enzyme INHIBITOR IC50 4.40 CHEMBL
Matrilysin Enzyme INHIBITOR Kd 4.14 IUPHAR
50S ribosomal protein L10 Ribosomal protein WOMBAT-PK
Tetracycline resistance protein, class B Transporter IC50 5.04 WOMBAT-PK
Zinc finger protein mex-5 Cytosolic other EC50 4.42 WOMBAT-PK

External reference:

IDSource
4017742 VUID
N0000146109 NUI
D00307 KEGG_DRUG
24390-14-5 SECONDARY_CAS_RN
94088-85-4 SECONDARY_CAS_RN
4017738 VANDF
4017740 VANDF
4017742 VANDF
C0013090 UMLSCUI
CHEBI:60648 CHEBI
DXT PDB_CHEM_ID
CHEMBL1200699 ChEMBL_ID
CHEMBL3989740 ChEMBL_ID
CHEMBL1200567 ChEMBL_ID
CHEMBL2364574 ChEMBL_ID
D004318 MESH_DESCRIPTOR_UI
DB00254 DRUGBANK_ID
6464 IUPHAR_LIGAND_ID
10592-13-9 SECONDARY_CAS_RN
N12000U13O UNII
54671203 PUBCHEM_CID
1543946 RXNORM
21502 MMSL
227071 MMSL
230639 MMSL
30716 MMSL
3375 MMSL
4641 MMSL
4642 MMSL
d00037 MMSL
002748 NDDF
002749 NDDF
002750 NDDF
006525 NDDF
10504007 SNOMEDCT_US
372478003 SNOMEDCT_US
63559007 SNOMEDCT_US
71417000 SNOMEDCT_US
734475000 SNOMEDCT_US
CHEMBL1256723 ChEMBL_ID
17086-28-1 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Vibramycin Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0069-0950 CAPSULE 100 mg ORAL NDA 28 sections
Vibramycin Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0069-0950 CAPSULE 100 mg ORAL NDA 28 sections
Vibramycin Monohydrate HUMAN PRESCRIPTION DRUG LABEL 1 0069-0970 POWDER, FOR SUSPENSION 25 mg ORAL NDA 28 sections
Vibramycin Monohydrate HUMAN PRESCRIPTION DRUG LABEL 1 0069-0970 POWDER, FOR SUSPENSION 25 mg ORAL NDA 28 sections
Vibramycin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0069-0971 SYRUP 50 mg ORAL NDA 28 sections
Vibramycin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0069-0971 SYRUP 50 mg ORAL NDA 28 sections
Vibra-Tabs HUMAN PRESCRIPTION DRUG LABEL 1 0069-0990 TABLET, FILM COATED 100 mg ORAL NDA 28 sections
Vibra-Tabs HUMAN PRESCRIPTION DRUG LABEL 1 0069-0990 TABLET, FILM COATED 100 mg ORAL NDA 28 sections
Doxycycline HUMAN PRESCRIPTION DRUG LABEL 1 0115-1327 CAPSULE 150 mg ORAL ANDA 28 sections
Doxycycline HUMAN PRESCRIPTION DRUG LABEL 1 0143-2112 TABLET, COATED 100 mg ORAL ANDA 25 sections
Doxycycline HUMAN PRESCRIPTION DRUG LABEL 1 0143-2112 TABLET, COATED 100 mg ORAL ANDA 25 sections
Doxycycline Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0143-3141 CAPSULE, GELATIN COATED 50 mg ORAL ANDA 23 sections
Doxycycline Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0143-3141 CAPSULE, GELATIN COATED 50 mg ORAL ANDA 23 sections
Doxycycline Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0143-3142 CAPSULE, GELATIN COATED 100 mg ORAL ANDA 23 sections
Doxycycline Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0143-3142 CAPSULE, GELATIN COATED 100 mg ORAL ANDA 23 sections
Doxycycline HUMAN PRESCRIPTION DRUG LABEL 1 0143-9381 INJECTION, POWDER, FOR SOLUTION 100 mg INTRAVENOUS ANDA 15 sections
Doxycycline Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9802 CAPSULE 50 mg ORAL ANDA 27 sections
Doxycycline Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9802 CAPSULE 50 mg ORAL ANDA 27 sections
Doxycycline Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9803 CAPSULE 100 mg ORAL ANDA 27 sections
Doxycycline Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9803 CAPSULE 100 mg ORAL ANDA 27 sections
ORACEA HUMAN PRESCRIPTION DRUG LABEL 1 0299-3822 CAPSULE 40 mg ORAL NDA 27 sections
ORACEA HUMAN PRESCRIPTION DRUG LABEL 1 0299-3822 CAPSULE 40 mg ORAL NDA 27 sections
ORACEA HUMAN PRESCRIPTION DRUG LABEL 1 0299-3822 CAPSULE 40 mg ORAL NDA 27 sections
Doxycycline Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0378-4535 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 29 sections
DOXYCYCLINE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9855 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 11 sections
DOXYCYCLINE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9855 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 11 sections
DOXYCYCLINE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9855 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 11 sections
Doxycyclate Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0440-1481 CAPSULE 100 mg ORAL ANDA 25 sections
Doxycycline Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0440-7481 CAPSULE 100 mg ORAL ANDA 22 sections
Doxycycline Hyclate HUMAN PRESCRIPTION DRUG LABEL 1 0440-7482 TABLET 100 mg ORAL ANDA 24 sections