minocycline ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antibiotics, protein-synthesis inhibitors, tetracycline derivatives 1813 10118-90-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • minocycline
  • minocycline hydrochloride
  • minocycline HCl
A TETRACYCLINE analog, having a 7-dimethylamino and lacking the 5 methyl and hydroxyl groups, which is effective against tetracycline-resistant STAPHYLOCOCCUS infections.
  • Molecular weight: 457.48
  • Formula: C23H27N3O7
  • CLOGP: 0.05
  • LIPINSKI: 0
  • HAC: 10
  • HDO: 5
  • TPSA: 164.63
  • ALOGS: -2.17
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1 mg O
0.20 g O
0.20 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 11 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.87 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 97 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.20 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 17 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK2,CDK4,CDK5,CDK9,DDR1,DYRK1B,DYRK3,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GRK3,GSK3A,GSK3B,IKBKB,ITK,JAK1,JAK2,JAK3,KDR,KIT,MAP2K6,MAP3K14,MAP3K2,MAP3K21,MAP3K3,MAP3K7,MAP4K1,MAPK1,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MAPKAPK5,MARK4,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIM1,PIM2,PIM3,PLK1,PLK2,PLK3,PLK4,PRKCD,PRKDC,PTK2,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ULK2,ZAP70 79
kinase-selectivity-class ACVR2B,AXL,CDK4,CDK9,DDR1,EIF2AK3,EPHB4,ERBB2,GRK2,JAK2,MAP2K6,MAP3K14,MAP3K7,MAPK7,SIK2,STK33,SYK,TEK,TTK 19
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1

Approvals:

DateAgencyCompanyOrphan
June 30, 1971 FDA TRIAX PHARMS

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
Onychomadesis 697.39 19.00 475 86775 45523 90495674
Back injury 529.35 19.00 404 86846 46218 90494979
Onychomycosis 508.00 19.00 361 86889 37015 90504182
C-reactive protein increased 427.36 19.00 685 86565 180704 90360493
Blepharospasm 384.88 19.00 362 86888 55083 90486114
Osteoarthritis 376.07 19.00 675 86575 195055 90346142
Liver function test increased 359.91 19.00 426 86824 84429 90456768
Finger deformity 347.07 19.00 273 86977 32624 90508573
Hypercholesterolaemia 342.40 19.00 453 86797 100439 90440758
Nail disorder 328.92 19.00 342 86908 58725 90482472
Polyarteritis nodosa 319.26 19.00 72 87178 256 90540941
Drug-induced liver injury 308.73 19.00 407 86843 89911 90451286
Facet joint syndrome 294.89 19.00 416 86834 97973 90443224
Breast cancer stage III 284.70 19.00 378 86872 84069 90457128
Type 2 diabetes mellitus 280.25 19.00 610 86640 202634 90338563
Product label confusion 279.24 19.00 207 87043 22643 90518554
Exostosis 278.66 19.00 298 86952 52836 90488361
Peripheral venous disease 275.80 19.00 371 86879 83550 90457647
Adverse reaction 272.04 19.00 227 87023 29485 90511712
Lupus-like syndrome 268.68 19.00 281 86969 48565 90492632
Retinitis 268.59 19.00 252 86998 38206 90502991
Neck pain 258.11 19.00 423 86827 113540 90427657
Taste disorder 257.64 19.00 307 86943 61239 90479958
Coeliac disease 255.02 19.00 262 86988 44348 90496849
Joint dislocation 253.35 19.00 261 86989 44321 90496876
Bone erosion 242.83 19.00 277 86973 52744 90488453
Bursitis 242.46 19.00 446 86804 131208 90409989
Epilepsy 238.08 19.00 342 86908 81864 90459333
Psoriatic arthropathy 235.34 19.00 612 86638 227723 90313474
Rheumatic fever 232.35 19.00 478 86772 152643 90388554
Sleep disorder 231.60 19.00 557 86693 197473 90343724
Hepatitis 231.31 19.00 312 86938 70427 90470770
Pericarditis 227.92 19.00 673 86577 269478 90271719
Blood cholesterol increased 215.84 19.00 559 86691 207453 90333744
Gait inability 213.78 19.00 450 86800 146006 90395191
Mobility decreased 212.78 19.00 626 86624 250108 90291089
Foot deformity 205.62 19.00 270 86980 59381 90481816
General physical health deterioration 198.94 19.00 771 86479 354344 90186853
Live birth 197.43 19.00 307 86943 78800 90462397
Obesity 196.21 19.00 359 86891 105148 90436049
Grip strength decreased 195.40 19.00 333 86917 92243 90448954
Night sweats 195.34 19.00 402 86848 128364 90412833
Inflammation 194.64 19.00 489 86761 178103 90363094
Product quality issue 192.63 19.00 304 86946 79021 90462176
Folliculitis 186.68 19.00 524 86726 203829 90337368
Abdominal distension 185.62 19.00 397 86853 130204 90410993
Therapeutic product effect incomplete 184.84 19.00 505 86745 193391 90347806
Fibromyalgia 180.71 19.00 521 86729 205748 90335449
Anti-cyclic citrullinated peptide antibody positive 180.61 19.00 569 86681 235864 90305333
Injection site reaction 179.72 19.00 320 86930 91760 90449437
Drug intolerance 178.27 19.00 877 86373 446714 90094483
Synovitis 176.61 19.00 706 86544 329046 90212151
Cough 173.62 19.00 69 87181 368893 90172304
Pemphigus 172.80 19.00 697 86553 326167 90215030
Systemic lupus erythematosus 170.53 19.00 745 86505 361151 90180046
Joint stiffness 167.69 19.00 283 86967 77759 90463438
Osteoporosis 167.65 19.00 319 86931 96212 90444985
Urinary tract infection 166.99 19.00 44 87206 305588 90235609
Anaemia 165.96 19.00 66 87184 352736 90188461
C-reactive protein abnormal 165.93 19.00 374 86876 127055 90414142
Product dose omission issue 165.16 19.00 39 87211 291648 90249549
Helicobacter infection 165.12 19.00 537 86713 226313 90314884
Lip dry 163.60 19.00 324 86926 100631 90440566
Hypotension 162.97 19.00 55 87195 325342 90215855
Wound infection 162.32 19.00 333 86917 106069 90435128
Toxicity to various agents 161.97 19.00 39 87211 287807 90253390
Back pain 161.67 19.00 52 87198 317123 90224074
Constipation 159.72 19.00 37 87213 280358 90260839
Hepatic cirrhosis 158.55 19.00 246 87004 63007 90478190
Drug interaction 156.44 19.00 37 87213 276416 90264781
Duodenal ulcer perforation 154.04 19.00 516 86734 220772 90320425
Lung disorder 152.51 19.00 400 86850 149483 90391714
Treatment failure 147.19 19.00 631 86619 303297 90237900
Injury 147.06 19.00 471 86779 196878 90344319
Infusion site reaction 143.08 19.00 130 87120 18909 90522288
Dry mouth 141.45 19.00 444 86806 183615 90357582
Dyspepsia 141.39 19.00 466 86784 197694 90343503
Wound 138.30 19.00 618 86632 302362 90238835
Idiopathic intracranial hypertension 138.24 19.00 68 87182 3513 90537684
Red blood cell sedimentation rate increased 136.13 19.00 267 86983 82328 90458869
Hypoaesthesia 133.11 19.00 627 86623 313583 90227614
Acute kidney injury 132.01 19.00 72 87178 320315 90220882
Intentional product use issue 129.61 19.00 481 86769 216411 90324786
Laryngitis 129.45 19.00 199 87051 50554 90490643
Hepatic enzyme increased 127.56 19.00 684 86566 360052 90181145
Liver injury 126.97 19.00 407 86843 170160 90371037
Gastrooesophageal reflux disease 126.64 19.00 400 86850 165937 90375260
Glossodynia 120.52 19.00 620 86630 321159 90220038
Joint range of motion decreased 120.05 19.00 344 86906 135299 90405898
Death 118.30 19.00 160 87090 456391 90084806
Somnolence 116.27 19.00 29 87221 209055 90332142
Drug hypersensitivity 115.08 19.00 802 86448 462807 90078390
Neutropenia 114.34 19.00 37 87213 224867 90316330
Ochronosis 113.24 19.00 22 87228 27 90541170
Therapeutic product effect decreased 106.12 19.00 538 86712 277033 90264164
Irritable bowel syndrome 104.44 19.00 436 86814 207012 90334185
Haemoglobin decreased 103.60 19.00 16 87234 161940 90379257
Muscle injury 103.19 19.00 389 86861 176265 90364932
Contraindicated product administered 103.09 19.00 592 86658 319547 90221650
Hand deformity 102.03 19.00 558 86692 295804 90245393
Product use in unapproved indication 101.97 19.00 612 86638 335624 90205573
Skin hyperpigmentation 101.97 19.00 70 87180 6781 90534416
Blood pressure increased 101.03 19.00 32 87218 197185 90344012
Completed suicide 100.79 19.00 11 87239 145047 90396150
Blister 98.70 19.00 496 86754 254502 90286695
Infusion related reaction 95.27 19.00 707 86543 416073 90125124
Drug reaction with eosinophilia and systemic symptoms 94.41 19.00 157 87093 42601 90498596
Eosinophilic myocarditis 92.89 19.00 32 87218 653 90540544
Sepsis 92.42 19.00 29 87221 179785 90361412
Injection site pain 91.10 19.00 27 87223 173672 90367525
Muscular weakness 88.59 19.00 414 86836 206252 90334945
Hyperhidrosis 88.25 19.00 13 87237 136292 90404905
Overlap syndrome 88.11 19.00 70 87180 8478 90532719
Influenza 86.30 19.00 15 87235 139249 90401948
Weight decreased 85.95 19.00 146 87104 379764 90161433
Hyponatraemia 85.85 19.00 13 87237 133525 90407672
Congenital anomaly 85.48 19.00 61 87189 6286 90534911
Adverse drug reaction 85.47 19.00 277 86973 116424 90424773
Maternal exposure during pregnancy 84.66 19.00 615 86635 359448 90181749
Cerebrovascular accident 84.24 19.00 10 87240 123523 90417674
Dyspnoea 82.50 19.00 504 86746 880451 89660746
Conjunctival pigmentation 82.39 19.00 18 87232 53 90541144
Impaired healing 81.94 19.00 443 86807 233756 90307441
Tremor 81.82 19.00 23 87227 153150 90388047
Ill-defined disorder 81.16 19.00 373 86877 184518 90356679
Dehydration 81.07 19.00 43 87207 194404 90346793
Stomatitis 80.07 19.00 495 86755 274203 90266994
Lupus vulgaris 79.54 19.00 150 87100 44909 90496288
Ear infection 79.02 19.00 194 87056 69581 90471616
Pyrexia 78.57 19.00 348 86902 660137 89881060
COVID-19 77.03 19.00 33 87217 168810 90372387
Feeling abnormal 75.79 19.00 33 87217 167202 90373995
Normal newborn 74.74 19.00 102 87148 23260 90517937
Abdominal pain 74.05 19.00 170 87080 395551 90145646
Memory impairment 73.71 19.00 380 86870 196864 90344333
Diarrhoea 73.71 19.00 566 86684 938624 89602573
Fatigue 73.58 19.00 734 86516 1153289 89387908
Renal failure 73.15 19.00 18 87232 130989 90410208
Palpitations 72.16 19.00 21 87229 136707 90404490
Chest discomfort 69.88 19.00 23 87227 138342 90402855
Atrial fibrillation 69.64 19.00 21 87229 133590 90407607
Loss of consciousness 69.63 19.00 24 87226 140214 90400983
Febrile neutropenia 69.03 19.00 33 87217 158316 90382881
Flushing 69.00 19.00 4 87246 88487 90452710
Blood creatinine increased 67.20 19.00 9 87241 101377 90439820
Musculoskeletal pain 66.84 19.00 334 86916 170917 90370280
Pruritus 65.77 19.00 283 86967 541242 89999955
Syncope 65.35 19.00 23 87227 132640 90408557
Scleral pigmentation 65.24 19.00 12 87238 8 90541189
Chills 64.81 19.00 23 87227 131958 90409239
Injection site erythema 64.68 19.00 9 87241 98493 90442704
Erythema 62.74 19.00 77 87173 229169 90312028
White blood cell count decreased 62.56 19.00 42 87208 167067 90374130
Bradycardia 61.85 19.00 5 87245 83842 90457355
Seizure 61.80 19.00 35 87215 152594 90388603
Paraesthesia 60.76 19.00 431 86819 249895 90291302
Platelet count decreased 60.54 19.00 28 87222 136941 90404256
Epistaxis 60.30 19.00 6 87244 85119 90456078
Myocardial infarction 60.26 19.00 14 87236 105958 90435239
Muscle spasms 60.16 19.00 432 86818 251451 90289746
Depression 59.80 19.00 494 86756 300107 90241090
Thyroiditis 58.51 19.00 39 87211 3598 90537599
Bone hyperpigmentation 58.31 19.00 11 87239 10 90541187
Musculoskeletal stiffness 58.28 19.00 486 86764 296046 90245151
Underdose 57.81 19.00 147 87103 53870 90487327
Disease progression 57.77 19.00 40 87210 156575 90384622
Blood glucose increased 57.41 19.00 11 87239 95235 90445962
Joint swelling 56.58 19.00 736 86514 502564 90038633
Cardiac failure congestive 56.20 19.00 13 87237 98681 90442516
Eosinophilic pneumonia acute 54.91 19.00 22 87228 693 90540504
Depressed level of consciousness 54.64 19.00 4 87246 72780 90468417
Abdominal discomfort 54.48 19.00 700 86550 476628 90064569
Drug abuse 52.96 19.00 8 87242 82339 90458858
Cardiac failure 52.21 19.00 20 87230 109476 90431721
Coma 51.76 19.00 5 87245 72627 90468570
Influenza like illness 51.46 19.00 8 87242 80603 90460594
Dysphagia 51.11 19.00 22 87228 112256 90428941
Cardiac arrest 50.32 19.00 19 87231 104916 90436281
Hidradenitis 50.02 19.00 38 87212 4309 90536888
Heart rate increased 50.02 19.00 23 87227 112879 90428318
Incorrect dose administered 50.01 19.00 8 87242 78922 90462275
Product use issue 49.82 19.00 511 86739 329408 90211789
Arthritis 49.64 19.00 303 86947 167012 90374185
Rhinorrhoea 49.56 19.00 12 87238 88304 90452893
Pigmentation disorder 49.42 19.00 43 87207 5906 90535291
Adverse event 49.38 19.00 234 87016 117184 90424013
Gastrointestinal haemorrhage 49.22 19.00 13 87237 90235 90450962
Cardio-respiratory arrest 48.78 19.00 3 87247 63137 90478060
Migraine 48.64 19.00 332 86918 190060 90351137
Wrong technique in product usage process 48.28 19.00 6 87244 71565 90469632
Rheumatoid arthritis 47.98 19.00 547 86703 362067 90179130
Pulmonary oedema 47.81 19.00 3 87247 62077 90479120
Bone pain 47.72 19.00 3 87247 61980 90479217
Hypokalaemia 47.68 19.00 34 87216 131082 90410115
Balance disorder 47.52 19.00 17 87233 97063 90444134
Oxygen saturation decreased 47.45 19.00 22 87228 107461 90433736
Herpes zoster 47.32 19.00 16 87234 94628 90446569
Visual impairment 46.67 19.00 251 86999 132114 90409083
Vision blurred 46.53 19.00 24 87226 110269 90430928
Cataract 46.37 19.00 7 87243 72085 90469112
Haemorrhage 46.35 19.00 6 87244 69363 90471834
Swelling 46.30 19.00 611 86639 418447 90122750
Vasculitis necrotising 45.54 19.00 19 87231 665 90540532
Intentional overdose 44.97 19.00 17 87233 93817 90447380
Thrombocytopenia 44.64 19.00 83 87167 208642 90332555
Chest pain 44.53 19.00 158 87092 319487 90221710
Swelling face 43.83 19.00 12 87238 81340 90459857
Mucosal inflammation 43.74 19.00 3 87247 57622 90483575
Pulmonary embolism 43.67 19.00 37 87213 130783 90410414
Sinusitis 43.64 19.00 176 87074 342912 90198285
Inappropriate schedule of product administration 43.55 19.00 48 87202 149885 90391312
Chronic obstructive pulmonary disease 43.50 19.00 9 87241 73820 90467377
Cardiac disorder 43.06 19.00 3 87247 56869 90484328
Neuropathy peripheral 43.02 19.00 41 87209 136929 90404268
Colitis 42.31 19.00 8 87242 69934 90471263
Agitation 42.06 19.00 7 87243 67091 90474106
Dysarthria 40.88 19.00 3 87247 54479 90486718
Dysphonia 40.86 19.00 6 87244 63078 90478119
Gliosis 40.70 19.00 16 87234 479 90540718
Type 2 lepra reaction 40.50 19.00 10 87240 57 90541140
Oropharyngeal pain 40.42 19.00 31 87219 115156 90426041
Lower respiratory tract infection 40.12 19.00 393 86857 250266 90290931
Hot flush 40.09 19.00 5 87245 59483 90481714
Papilloedema 39.64 19.00 34 87216 4581 90536616
Metabolic acidosis 39.23 19.00 4 87246 55672 90485525
Polyserositis 39.19 19.00 17 87233 656 90540541
Thrombosis 39.10 19.00 11 87239 73240 90467957
Blood pressure systolic increased 39.09 19.00 5 87245 58340 90482857
Haematochezia 39.08 19.00 10 87240 70903 90470294
Hallucination 38.95 19.00 8 87242 65951 90475246
Malignant neoplasm progression 38.48 19.00 28 87222 106842 90434355
Electrocardiogram QT prolonged 38.46 19.00 11 87239 72445 90468752
Myalgia 37.12 19.00 70 87180 175055 90366142
Productive cough 36.87 19.00 14 87236 77049 90464148
Pancytopenia 36.61 19.00 37 87213 120226 90420971
Blood pressure fluctuation 36.33 19.00 4 87246 52409 90488788
Injection site bruising 36.24 19.00 4 87246 52303 90488894
Urticaria 36.20 19.00 460 86790 312274 90228923
Pouchitis 35.86 19.00 16 87234 661 90540536
Illness 35.84 19.00 17 87233 81952 90459245
Monocytosis 35.78 19.00 18 87232 976 90540221
Injection site pruritus 35.15 19.00 5 87245 53829 90487368
Anxiety 35.07 19.00 166 87084 309606 90231591
Heart rate decreased 34.86 19.00 5 87245 53500 90487697
Gait disturbance 34.80 19.00 131 87119 260365 90280832
Lethargy 34.61 19.00 9 87241 63130 90478067
Cholelithiasis 33.99 19.00 5 87245 52501 90488696
Stress 33.91 19.00 18 87232 81377 90459820
Cystitis 33.84 19.00 11 87239 66707 90474490
Vertigo 32.87 19.00 13 87237 69798 90471399
Nasal congestion 32.52 19.00 20 87230 83394 90457803
Confusional state 32.38 19.00 537 86713 385668 90155529
Gastric disorder 31.79 19.00 87 87163 33297 90507900
Hypoxia 31.68 19.00 15 87235 72384 90468813
Cellulitis 31.51 19.00 25 87225 91312 90449885
Wheezing 31.39 19.00 359 86891 237721 90303476
Dermatitis acneiform 30.44 19.00 34 87216 6320 90534877
Sedation 30.25 19.00 5 87245 48166 90493031
Anti-cyclic citrullinated peptide antibody 30.08 19.00 75 87175 27146 90514051
Diverticulitis 29.97 19.00 4 87246 45183 90496014
Spondylitis 29.88 19.00 51 87199 14127 90527070
Therapy interrupted 29.74 19.00 6 87244 50102 90491095
Renal impairment 29.26 19.00 35 87215 105386 90435811
Respiratory failure 29.11 19.00 43 87207 118375 90422822
Eye pain 29.08 19.00 4 87246 44164 90497033
Hypertension 28.93 19.00 609 86641 456923 90084274
Incorrect product administration duration 28.88 19.00 60 87190 19262 90521935
Breast cancer 28.83 19.00 8 87242 53753 90487444
Dyspnoea exertional 28.65 19.00 17 87233 72271 90468926
Transient ischaemic attack 28.21 19.00 4 87246 43172 90498025
Optic atrophy 28.20 19.00 18 87232 1543 90539654
Vomiting 28.02 19.00 563 86687 787730 89753467
Depressed mood 27.83 19.00 7 87243 50215 90490982
Pulmonary hypertension 27.64 19.00 4 87246 42519 90498678
Angioedema 27.54 19.00 14 87236 64862 90476335
International normalised ratio increased 27.40 19.00 6 87244 47310 90493887
Alanine aminotransferase increased 27.15 19.00 45 87205 118293 90422904
Tuberculin test positive 27.13 19.00 25 87225 3700 90537497
Fluid retention 26.92 19.00 27 87223 88064 90453133
Myelosuppression 26.89 19.00 9 87241 53582 90487615
Rhabdomyolysis 26.80 19.00 8 87242 51248 90489949
Throat irritation 26.58 19.00 7 87243 48688 90492509
Femur fracture 26.37 19.00 6 87244 46076 90495121
Leukopenia 26.32 19.00 35 87215 100675 90440522
Swollen tongue 26.26 19.00 6 87244 45950 90495247
Hyperkalaemia 26.14 19.00 15 87235 64949 90476248
Urinary retention 25.86 19.00 3 87247 37741 90503456
Premature menopause 25.70 19.00 16 87234 1313 90539884
Exposure during pregnancy 25.61 19.00 346 86904 238064 90303133
Abdominal pain upper 25.49 19.00 456 86794 332218 90208979
Mouth ulceration 25.44 19.00 4 87246 39970 90501227
Proctectomy 25.41 19.00 9 87241 200 90540997
Intracranial pressure increased 25.29 19.00 32 87218 6779 90534418
Disturbance in attention 25.28 19.00 7 87243 47102 90494095
Arrhythmia 25.27 19.00 5 87245 42327 90498870
Injection site swelling 25.27 19.00 13 87237 59826 90481371
Deep vein thrombosis 24.81 19.00 31 87219 91589 90449608
Disorientation 24.74 19.00 6 87244 44108 90497089
Respiratory tract infection 24.70 19.00 13 87237 59065 90482132
Hepatic enzyme 24.59 19.00 28 87222 5316 90535881
Gastrointestinal disorder 24.56 19.00 365 86885 256322 90284875
Flatulence 24.46 19.00 5 87245 41362 90499835
Pleural effusion 24.41 19.00 44 87206 111947 90429250
Seronegative arthritis 24.24 19.00 54 87196 18180 90523017
Rash pruritic 24.22 19.00 26 87224 82188 90459009
Pain in jaw 24.18 19.00 8 87242 47977 90493220
Restlessness 24.08 19.00 3 87247 35717 90505480
Aspartate aminotransferase increased 23.75 19.00 39 87211 102898 90438299
Aphasia 23.66 19.00 6 87244 42806 90498391
Accidental exposure to product 23.29 19.00 6 87244 42360 90498837
Suicide attempt 23.17 19.00 23 87227 75376 90465821
Hypoglycaemia 23.01 19.00 20 87230 69828 90471369
Blood pressure decreased 22.84 19.00 23 87227 74872 90466325
Retinal pigmentation 22.83 19.00 7 87243 97 90541100
Barotrauma 22.70 19.00 8 87242 175 90541022
Ovarian failure 22.61 19.00 16 87234 1627 90539570
Skin ulcer 22.49 19.00 10 87240 50065 90491132
Dyskinesia 22.48 19.00 4 87246 36530 90504667
Coronary artery disease 22.24 19.00 3 87247 33620 90507577
Basal cell carcinoma 22.03 19.00 3 87247 33386 90507811
Pain in extremity 21.82 19.00 578 86672 449951 90091246
Hip fracture 21.76 19.00 3 87247 33074 90508123
Pollakiuria 21.70 19.00 3 87247 33002 90508195
Lactic acidosis 21.25 19.00 11 87239 50452 90490745
Septic shock 21.23 19.00 30 87220 84130 90457067
Burning sensation 21.10 19.00 18 87232 63434 90477763
Arthropathy 21.07 19.00 481 86769 365761 90175436
Haematocrit decreased 21.03 19.00 7 87243 41825 90499372
Rheumatoid factor positive 20.92 19.00 255 86995 171395 90369802
Dysuria 20.87 19.00 6 87244 39395 90501802
Hepatotoxicity 20.83 19.00 9 87241 45833 90495364
Pleuropericarditis 20.73 19.00 9 87241 348 90540849
Sinus disorder 20.71 19.00 4 87246 34443 90506754
Blood potassium decreased 20.71 19.00 10 87240 47717 90493480
Hypocholesterolaemia 20.39 19.00 28 87222 6421 90534776
Candida infection 20.38 19.00 4 87246 34053 90507144
Pneumonia aspiration 20.32 19.00 7 87243 40933 90500264
Nephrolithiasis 20.23 19.00 11 87239 49074 90492123
Hyperglycaemia 20.18 19.00 12 87238 50958 90490239
Mental status changes 19.94 19.00 9 87241 44670 90496527
Unresponsive to stimuli 19.84 19.00 6 87244 38115 90503082
Neoplasm progression 19.80 19.00 9 87241 44477 90496720
Encephalopathy 19.74 19.00 10 87240 46434 90494763
Intentional product misuse 19.71 19.00 35 87215 89569 90451628
Ulcer 19.39 19.00 4 87246 32878 90508319
Orthostatic hypotension 19.35 19.00 8 87242 41819 90499378
Gastritis 19.29 19.00 8 87242 41745 90499452
Hypervolaemia 19.28 19.00 4 87246 32753 90508444
Alopecia 19.27 19.00 618 86632 494453 90046744
Joint injury 19.20 19.00 4 87246 32660 90508537
Generalised tonic-clonic seizure 19.08 19.00 5 87245 34898 90506299
Hypothyroidism 19.02 19.00 14 87236 53113 90488084

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
Photosensitivity reaction 248.67 18.76 103 11711 12599 42596922
Apparent death 243.73 18.76 74 11740 3634 42605887
Skin hyperpigmentation 226.67 18.76 72 11742 4109 42605412
Terminal state 210.52 18.76 69 11745 4354 42605167
Red blood cell sedimentation rate increased 206.22 18.76 84 11730 9840 42599681
C-reactive protein abnormal 194.53 18.76 79 11735 9182 42600339
Pulmonary thrombosis 188.43 18.76 75 11739 8273 42601248
Interstitial lung disease 179.86 18.76 159 11655 78303 42531218
Stomatitis 174.69 18.76 130 11684 50199 42559322
Type 2 lepra reaction 164.88 18.76 34 11780 321 42609200
Intestinal sepsis 149.77 18.76 36 11778 715 42608806
Polyarteritis nodosa 147.56 18.76 31 11783 323 42609198
Dermatitis acneiform 138.83 18.76 59 11755 7680 42601841
Pigmentation disorder 137.35 18.76 46 11768 3102 42606419
Diverticulitis 132.26 18.76 81 11733 22692 42586829
Scleral pigmentation 129.45 18.76 18 11796 0 42609521
Joint arthroplasty 116.26 18.76 31 11783 946 42608575
Herpes zoster 114.20 18.76 91 11723 38786 42570735
Ochronosis 107.88 18.76 15 11799 0 42609521
Bone hyperpigmentation 101.47 18.76 15 11799 8 42609513
Contraindicated product administered 100.62 18.76 71 11743 25201 42584320
Urticaria 90.53 18.76 107 11707 73929 42535592
Drug reaction with eosinophilia and systemic symptoms 87.85 18.76 81 11733 41994 42567527
Arthropathy 86.30 18.76 69 11745 29528 42579993
Paronychia 84.89 18.76 35 11779 4220 42605301
Joint swelling 84.31 18.76 99 11715 67923 42541598
Scleral discolouration 82.49 18.76 19 11795 311 42609210
C-reactive protein increased 81.26 18.76 94 11720 63466 42546055
Feeling abnormal 75.78 18.76 95 11719 69691 42539830
Drug intolerance 75.68 18.76 102 11712 80322 42529199
Knee arthroplasty 71.68 18.76 39 11775 8742 42600779
Drug ineffective 71.39 18.76 353 11461 629844 41979677
Eosinophilic pneumonia acute 69.86 18.76 20 11794 797 42608724
Thrombosis 69.23 18.76 90 11724 68421 42541100
Retinal pigmentation 68.55 18.76 10 11804 4 42609517
Deep vein thrombosis 65.49 18.76 93 11721 76864 42532657
Stent placement 64.70 18.76 31 11783 5329 42604192
Thyroiditis 62.46 18.76 26 11788 3210 42606311
Drug hypersensitivity 54.12 18.76 98 11716 99291 42510230
Intentional product use issue 49.94 18.76 79 11735 71754 42537767
Anti-neutrophil cytoplasmic antibody positive vasculitis 49.93 18.76 18 11796 1510 42608011
Haemoglobin decreased 49.86 18.76 112 11702 132359 42477162
Lupus-like syndrome 49.85 18.76 22 11792 3132 42606389
Drug-induced liver injury 49.54 18.76 57 11757 38216 42571305
Pulmonary embolism 49.42 18.76 105 11709 119507 42490014
Cardiac valve discolouration 43.15 18.76 6 11808 0 42609521
Nail discolouration 42.15 18.76 15 11799 1212 42608309
Thyroiditis acute 41.90 18.76 9 11805 105 42609416
Renal failure 40.75 18.76 109 11705 143617 42465904
Skin discolouration 39.33 18.76 38 11776 20852 42588669
Leukaemoid reaction 39.09 18.76 9 11805 147 42609374
Drug ineffective for unapproved indication 36.62 18.76 54 11760 46109 42563412
Tissue discolouration 35.96 18.76 5 11809 0 42609521
Sepsis 35.01 18.76 128 11686 199206 42410315
Autoimmune thyroiditis 34.93 18.76 14 11800 1568 42607953
Hepatic function abnormal 34.84 18.76 56 11758 51511 42558010
Glomerulonephritis rapidly progressive 34.48 18.76 12 11802 908 42608613
Red blood cell sedimentation rate abnormal 34.00 18.76 18 11796 3818 42605703
Peripheral sensory neuropathy 33.43 18.76 24 11790 8738 42600783
Death 30.98 18.76 52 11762 471133 42138388
Serum sickness-like reaction 30.06 18.76 8 11806 242 42609279
Dyspnoea 29.88 18.76 48 11766 442573 42166948
Pemphigoid 29.76 18.76 25 11789 11442 42598079
Skin depigmentation 29.29 18.76 9 11805 459 42609062
Conjunctival deposit 28.77 18.76 4 11810 0 42609521
Gingival hyperpigmentation 28.77 18.76 4 11810 0 42609521
Myocardial infarction 26.44 18.76 85 11729 123924 42485597
Melanocytic naevus 26.40 18.76 14 11800 2978 42606543
Acute febrile neutrophilic dermatosis 26.14 18.76 12 11802 1872 42607649
Nail pigmentation 25.01 18.76 6 11808 118 42609403
Madarosis 24.49 18.76 8 11806 498 42609023
Conjunctival scar 23.98 18.76 7 11807 299 42609222
Off label use 23.62 18.76 275 11539 638060 41971461
Hypotension 23.61 18.76 22 11792 257609 42351912
IIIrd nerve paralysis 23.54 18.76 8 11806 563 42608958
Testicular infarction 23.00 18.76 5 11809 62 42609459
Protein total abnormal 22.04 18.76 7 11807 398 42609123
Joint deposit 21.57 18.76 3 11811 0 42609521
Vasculitis 21.48 18.76 26 11788 18368 42591153
Hyperthyroidism 21.37 18.76 23 11791 14318 42595203
Jarisch-Herxheimer reaction 20.88 18.76 8 11806 795 42608726
Tooth injury 20.66 18.76 9 11805 1242 42608279
Toxicity to various agents 20.48 18.76 20 11794 229116 42380405
Breast inflammation 20.33 18.76 4 11810 29 42609492
Post procedural infection 20.15 18.76 15 11799 5770 42603751
Testicular pain 19.96 18.76 12 11802 3242 42606279
Acoustic neuroma 18.93 18.76 5 11809 147 42609374
Drug resistance 18.90 18.76 34 11780 34214 42575307
Drug interaction 18.88 18.76 28 11786 266971 42342550

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
Onychomadesis 768.96 18.03 479 92585 45184 110451051
Back injury 585.96 18.03 410 92654 46989 110449246
Onychomycosis 556.53 18.03 367 92697 38164 110458071
C-reactive protein increased 478.80 18.03 741 92323 217178 110279057
Blepharospasm 438.53 18.03 366 92698 54485 110441750
Pemphigus 422.37 18.03 694 92370 213876 110282359
Systemic lupus erythematosus 393.51 18.03 740 92324 253598 110242637
Polyarteritis nodosa 392.56 18.03 94 92970 541 110495694
Liver function test increased 391.88 18.03 426 92638 88122 110408113
Hypercholesterolaemia 384.65 18.03 427 92637 90410 110405825
Finger deformity 382.93 18.03 275 92789 32817 110463418
Osteoarthritis 376.09 18.03 603 92461 182020 110314215
Pericarditis 374.94 18.03 666 92398 218448 110277787
Nail disorder 363.72 18.03 337 92727 57598 110438637
Type 2 diabetes mellitus 361.94 18.03 583 92481 176649 110319586
Rheumatic fever 360.41 18.03 479 92585 122100 110374135
Facet joint syndrome 354.13 18.03 422 92642 96406 110399829
Psoriatic arthropathy 353.40 18.03 611 92453 196150 110300085
Breast cancer stage III 350.73 18.03 381 92683 78736 110417499
Drug-induced liver injury 331.39 18.03 455 92609 119612 110376623
Lupus-like syndrome 325.63 18.03 272 92792 40520 110455715
Anti-cyclic citrullinated peptide antibody positive 324.02 18.03 563 92501 181421 110314814
Peripheral venous disease 321.51 18.03 375 92689 83742 110412493
Folliculitis 320.03 18.03 535 92529 167118 110329117
Synovitis 317.92 18.03 708 92356 273384 110222851
Adverse reaction 306.43 18.03 230 92834 29364 110466871
Glossodynia 305.56 18.03 615 92449 221389 110274846
Retinitis 303.47 18.03 237 92827 32090 110464145
Product label confusion 303.36 18.03 206 92858 22471 110473764
C-reactive protein abnormal 301.51 18.03 453 92611 129242 110366993
Bursitis 298.07 18.03 451 92613 129467 110366768
Contraindicated product administered 293.18 18.03 646 92418 247621 110248614
Taste disorder 290.00 18.03 315 92749 65072 110431163
Sleep disorder 289.88 18.03 564 92500 198080 110298155
Gait inability 289.88 18.03 457 92607 135919 110360316
Coeliac disease 288.21 18.03 260 92804 42927 110453308
Wound 287.04 18.03 619 92445 233818 110262417
Blood cholesterol increased 284.81 18.03 537 92527 184248 110311987
Neck pain 277.60 18.03 424 92640 122706 110373529
Duodenal ulcer perforation 273.35 18.03 516 92548 177184 110319051
Skin hyperpigmentation 271.77 18.03 137 92927 8559 110487676
Treatment failure 266.92 18.03 666 92398 276568 110219667
Drug intolerance 265.29 18.03 848 92216 405664 110090571
Grip strength decreased 261.69 18.03 330 92734 79844 110416391
Mobility decreased 261.54 18.03 601 92463 236821 110259414
Fibromyalgia 261.29 18.03 495 92569 170414 110325821
Live birth 259.24 18.03 306 92758 69178 110427057
Helicobacter infection 257.59 18.03 510 92554 181367 110314868
Red blood cell sedimentation rate increased 255.10 18.03 322 92742 77980 110418255
Hypotension 254.09 18.03 64 93000 523785 109972450
Toxicity to various agents 252.66 18.03 49 93015 480506 110015729
Drug interaction 250.67 18.03 57 93007 500126 109996109
Product quality issue 240.98 18.03 311 92753 76988 110419247
Exostosis 240.67 18.03 242 92822 45714 110450521
Hand deformity 239.41 18.03 552 92512 217954 110278281
Epilepsy 231.41 18.03 349 92715 99860 110396375
Night sweats 227.37 18.03 406 92658 133577 110362658
Joint dislocation 226.48 18.03 205 92859 33985 110462250
Inflammation 223.71 18.03 499 92565 192739 110303496
Stomatitis 223.06 18.03 613 92451 269629 110226606
Wound infection 222.80 18.03 336 92728 96129 110400106
Hepatitis 221.39 18.03 323 92741 89731 110406504
Injection site reaction 221.19 18.03 321 92743 88749 110407486
Obesity 219.25 18.03 364 92700 112987 110383248
Injury 215.67 18.03 467 92597 176798 110319437
Liver injury 210.79 18.03 420 92644 149993 110346242
Bone erosion 203.16 18.03 222 92842 46149 110450086
Drug hypersensitivity 200.15 18.03 834 92230 453256 110042979
Hepatic enzyme increased 199.79 18.03 659 92405 320233 110176002
Irritable bowel syndrome 199.04 18.03 432 92632 163783 110332452
Lip dry 198.40 18.03 325 92739 99758 110396477
Cough 193.98 18.03 73 92991 461568 110034667
Muscle injury 192.30 18.03 389 92675 140418 110355817
Therapeutic product effect decreased 190.57 18.03 543 92521 243773 110252462
Dyspepsia 190.26 18.03 465 92599 190500 110305735
Ochronosis 188.62 18.03 35 93029 35 110496200
Acute kidney injury 186.10 18.03 157 92907 635273 109860962
Foot deformity 183.30 18.03 215 92849 48265 110447970
Maternal exposure during pregnancy 181.12 18.03 548 92516 254335 110241900
Anaemia 181.02 18.03 119 92945 546967 109949268
Death 177.58 18.03 196 92868 698673 109797562
Joint range of motion decreased 174.05 18.03 343 92721 121489 110374746
Infusion site reaction 173.27 18.03 133 92931 17549 110478686
General physical health deterioration 171.11 18.03 760 92304 424535 110071700
Blister 169.24 18.03 497 92567 226879 110269356
Intentional product use issue 167.75 18.03 524 92540 247382 110248853
Infusion related reaction 164.68 18.03 696 92368 380466 110115769
Type 2 lepra reaction 164.33 18.03 43 93021 372 110495863
Completed suicide 164.02 18.03 10 93054 242371 110253864
Joint swelling 163.78 18.03 772 92292 442073 110054162
Scleral pigmentation 163.25 18.03 28 93036 8 110496227
Dry mouth 160.38 18.03 449 92615 199499 110296736
Neutropenia 159.42 18.03 58 93006 374562 110121673
Impaired healing 157.05 18.03 441 92623 196276 110299959
Ill-defined disorder 156.26 18.03 382 92682 156471 110339764
Lung disorder 155.04 18.03 415 92649 179632 110316603
Hypoaesthesia 154.19 18.03 597 92467 313626 110182609
Therapeutic product effect incomplete 154.12 18.03 476 92588 223329 110272906
Joint stiffness 152.10 18.03 232 92832 67011 110429224
Laryngitis 151.94 18.03 183 92881 42228 110454007
Abdominal distension 151.17 18.03 404 92660 174699 110321536
Gastrooesophageal reflux disease 151.12 18.03 411 92653 179565 110316670
Product dose omission issue 150.80 18.03 42 93022 321740 110174495
Apparent death 150.76 18.03 65 92999 2837 110493398
Somnolence 148.69 18.03 34 93030 297415 110198820
Back pain 147.11 18.03 64 93000 370932 110125303
Hepatic cirrhosis 146.90 18.03 229 92835 67397 110428838
Osteoporosis 142.58 18.03 260 92804 86892 110409343
Constipation 139.84 18.03 63 93001 357723 110138512
Pigmentation disorder 139.15 18.03 83 92981 7228 110489007
Abdominal discomfort 137.18 18.03 675 92389 393183 110103052
Urinary tract infection 136.32 18.03 52 93012 326230 110170005
Bone hyperpigmentation 136.27 18.03 25 93039 22 110496213
Arthropathy 134.34 18.03 538 92526 286984 110209251
Drug abuse 127.43 18.03 5 93059 177406 110318829
Eosinophilic pneumonia acute 126.59 18.03 49 93015 1616 110494619
Drug reaction with eosinophilia and systemic symptoms 121.93 18.03 235 92829 81860 110414375
Blood pressure increased 113.32 18.03 38 93026 258335 110237900
Febrile neutropenia 112.91 18.03 63 93001 316704 110179531
Hyponatraemia 112.58 18.03 23 93041 217630 110278605
Dyspnoea 109.85 18.03 519 92545 1106353 109389882
Lupus vulgaris 109.77 18.03 139 92925 33744 110462491
Swelling 107.83 18.03 581 92483 350460 110145775
Cerebrovascular accident 107.65 18.03 13 93051 181271 110314964
Tremor 107.48 18.03 20 93044 202212 110294023
Alopecia 106.21 18.03 595 92469 364158 110132077
Terminal state 104.39 18.03 63 93001 5604 110490631
Exposure during pregnancy 102.40 18.03 342 92722 167082 110329153
Urticaria 102.20 18.03 534 92530 318323 110177912
Atrial fibrillation 102.06 18.03 33 93031 229609 110266626
Hyperhidrosis 100.67 18.03 18 93046 187280 110308955
Memory impairment 100.47 18.03 379 92685 196565 110299670
Rheumatoid arthritis 98.25 18.03 505 92559 299108 110197127
Dermatitis acneiform 97.88 18.03 83 92981 12612 110483623
Musculoskeletal stiffness 97.64 18.03 480 92584 279342 110216893
Overlap syndrome 97.32 18.03 72 92992 8987 110487248
Product use issue 94.43 18.03 514 92550 311181 110185054
Seizure 92.77 18.03 35 93029 221150 110275085
Normal newborn 92.72 18.03 103 92961 21793 110474442
Thyroiditis 90.98 18.03 61 93003 6512 110489723
Photosensitivity reaction 90.97 18.03 110 92954 25479 110470756
Chills 90.89 18.03 24 93040 190556 110305679
Adverse drug reaction 89.49 18.03 242 92822 105317 110390918
Ear infection 88.80 18.03 176 92888 62556 110433679
COVID-19 88.39 18.03 48 93016 245012 110251223
Injection site pain 87.57 18.03 21 93043 177901 110318334
Syncope 86.71 18.03 31 93033 202505 110293730
Idiopathic intracranial hypertension 86.15 18.03 49 93015 3903 110492332
Muscular weakness 85.80 18.03 425 92639 248043 110248192
Bradycardia 85.65 18.03 14 93050 155503 110340732
Musculoskeletal pain 85.04 18.03 342 92722 182681 110313554
Migraine 84.80 18.03 327 92737 171325 110324910
Cardiac failure congestive 82.26 18.03 14 93050 150986 110345249
Conjunctival pigmentation 82.00 18.03 18 93046 65 110496170
Blood creatinine increased 81.76 18.03 26 93038 182863 110313372
Influenza 81.20 18.03 21 93043 169080 110327155
Cardiac arrest 81.07 18.03 32 93032 196721 110299514
Pyrexia 80.54 18.03 436 92628 897829 109598406
Intestinal sepsis 77.94 18.03 30 93034 974 110495261
Loss of consciousness 77.54 18.03 34 93030 196272 110299963
Abdominal pain 77.34 18.03 201 92863 512788 109983447
Coma 76.41 18.03 6 93058 117863 110378372
Scleral discolouration 73.80 18.03 26 93038 654 110495581
Product use in unapproved indication 73.79 18.03 635 92429 446742 110049493
Depression 72.32 18.03 486 92578 316849 110179386
Chest discomfort 72.08 18.03 28 93036 173820 110322415
Thrombocytopenia 70.98 18.03 115 92949 348770 110147465
Disease progression 70.43 18.03 61 93003 243973 110252262
Dehydration 70.15 18.03 79 92985 279432 110216803
Weight decreased 69.31 18.03 185 92879 467872 110028363
Lower respiratory tract infection 69.00 18.03 394 92670 242712 110253523
Blood glucose increased 68.50 18.03 14 93050 132482 110363753
Muscle spasms 68.24 18.03 434 92630 277723 110218512
Cardiac failure 67.28 18.03 37 93027 187589 110308646
Erythema 67.20 18.03 88 92976 291359 110204876
Palpitations 67.08 18.03 25 93039 159187 110337048
Epistaxis 66.94 18.03 14 93050 130358 110365877
Eosinophilic myocarditis 65.59 18.03 33 93031 2052 110494183
Gastrointestinal disorder 65.33 18.03 387 92677 241565 110254670
Agitation 64.95 18.03 9 93055 113042 110383193
Adverse event 64.50 18.03 220 92844 108589 110387646
Paraesthesia 64.50 18.03 426 92638 276095 110220140
Pulmonary thrombosis 63.56 18.03 68 92996 13795 110482440
Rheumatoid factor positive 63.55 18.03 249 92815 131391 110364844
Intentional overdose 62.58 18.03 17 93047 132484 110363751
Paronychia 61.04 18.03 60 93004 11021 110485214
Flushing 60.98 18.03 8 93056 104728 110391507
Cardio-respiratory arrest 60.38 18.03 12 93052 115824 110380411
Underdose 60.30 18.03 152 92912 63402 110432833
Joint arthroplasty 59.23 18.03 37 93027 3500 110492735
Gastrointestinal haemorrhage 58.83 18.03 33 93031 165485 110330750
Injection site erythema 57.80 18.03 6 93058 94170 110402065
Metabolic acidosis 57.16 18.03 8 93056 99736 110396499
Chronic obstructive pulmonary disease 55.47 18.03 12 93052 109146 110387089
Productive cough 55.25 18.03 14 93050 114291 110381944
Wrong technique in product usage process 55.09 18.03 5 93059 87343 110408892
Platelet count decreased 53.71 18.03 69 92995 230374 110265861
Incorrect dose administered 53.47 18.03 11 93053 103630 110392605
White blood cell count decreased 53.14 18.03 69 92995 229321 110266914
Visual impairment 52.98 18.03 239 92825 134189 110362046
Retinal pigmentation 52.22 18.03 13 93051 90 110496145
Mucosal inflammation 52.17 18.03 9 93055 96132 110400103
Heart rate increased 52.10 18.03 28 93036 143806 110352429
International normalised ratio increased 52.05 18.03 6 93058 86766 110409469
Oxygen saturation decreased 52.01 18.03 34 93030 156948 110339287
Heart rate decreased 51.49 18.03 5 93059 82751 110413484
Thyroiditis acute 51.45 18.03 15 93049 200 110496035
Diarrhoea 51.36 18.03 664 92400 1138841 109357394
Pulmonary oedema 51.28 18.03 11 93053 100648 110395587
Anti-cyclic citrullinated peptide antibody 51.06 18.03 73 92991 19891 110476344
Blood pressure fluctuation 50.85 18.03 3 93061 74821 110421414
Vision blurred 49.92 18.03 23 93041 128999 110367236
Balance disorder 49.60 18.03 18 93046 116542 110379693
Pruritus 49.45 18.03 287 92777 581273 109914962
Blood pressure systolic increased 49.14 18.03 6 93058 82985 110413250
Chest pain 48.98 18.03 158 92906 376217 110120018
Colitis 48.56 18.03 13 93051 102310 110393925
Depressed level of consciousness 48.36 18.03 17 93047 112261 110383974
Hallucination 47.92 18.03 13 93051 101419 110394816
Dysarthria 47.62 18.03 7 93057 84114 110412121
Rhabdomyolysis 47.31 18.03 21 93043 120380 110375855
Stress 47.03 18.03 15 93049 105333 110390902
Vasculitis necrotising 46.73 18.03 24 93040 1559 110494676
Influenza like illness 46.41 18.03 9 93055 88403 110407832
Haemorrhage 46.22 18.03 16 93048 106676 110389559
Fatigue 46.19 18.03 733 92331 1215225 109281010
Seronegative arthritis 45.79 18.03 56 93008 13121 110483114
Spondylitis 45.72 18.03 52 93012 11286 110484949
Pancytopenia 45.58 18.03 66 92998 209547 110286688
Inappropriate schedule of product administration 45.39 18.03 63 93001 203574 110292661
Rhinorrhoea 45.16 18.03 15 93049 102651 110393584
Electrocardiogram QT prolonged 44.42 18.03 18 93046 108942 110387293
Sepsis 44.29 18.03 135 92929 327211 110169024
Cataract 44.11 18.03 7 93057 79478 110416757
Haematochezia 44.07 18.03 21 93043 115503 110380732
Hypoxia 42.97 18.03 28 93036 129487 110366748
Anti-neutrophil cytoplasmic antibody positive vasculitis 42.96 18.03 36 93028 5381 110490854
Gastric disorder 42.95 18.03 90 92974 33267 110462968
Anxiety 42.75 18.03 148 92916 344930 110151305
Oropharyngeal pain 42.55 18.03 31 93033 135245 110360990
Dysphagia 42.38 18.03 40 93024 153560 110342675
Hidradenitis 42.27 18.03 35 93029 5145 110491090
Lactic acidosis 41.82 18.03 13 93051 92798 110403437
Plasma cell myeloma 41.36 18.03 3 93061 62933 110433302
Urinary retention 41.35 18.03 5 93059 69678 110426557
Angina pectoris 40.85 18.03 3 93061 62292 110433943
Abdominal pain upper 40.64 18.03 461 92603 348650 110147585
Lethargy 40.59 18.03 14 93050 93562 110402673
Wheezing 40.31 18.03 359 92705 254871 110241364
Cardiac disorder 39.55 18.03 8 93056 76272 110419963
Transient ischaemic attack 39.46 18.03 4 93060 63978 110432257
Cytokine release syndrome 39.45 18.03 6 93058 70300 110425935
Respiratory failure 39.23 18.03 76 92988 215256 110280979
Angioedema 38.98 18.03 17 93047 98483 110397752
Dislocation of vertebra 38.82 18.03 102 92962 43619 110452616
Intentional product misuse 38.60 18.03 33 93031 132871 110363364
Hot flush 38.54 18.03 5 93059 66031 110430204
Aggression 38.41 18.03 3 93061 59207 110437028
Cellulitis 38.20 18.03 30 93034 125986 110370249
Hyperkalaemia 37.90 18.03 35 93029 135761 110360474
Hypoglycaemia 37.31 18.03 26 93038 116078 110380157
Dysphonia 37.27 18.03 9 93055 75920 110420315
Acute myocardial infarction 37.27 18.03 12 93052 83765 110412470
Hypokalaemia 37.21 18.03 60 93004 182388 110313847
Gliosis 36.73 18.03 16 93048 716 110495519
Myalgia 36.72 18.03 83 92981 222298 110273937
Dysuria 36.54 18.03 4 93060 60227 110436008
Cardiac valve discolouration 36.49 18.03 6 93058 0 110496235
Myelosuppression 36.21 18.03 17 93047 94323 110401912
Suicide attempt 36.18 18.03 21 93043 103373 110392862
Breast cancer stage II 35.41 18.03 74 92990 27301 110468934
Unresponsive to stimuli 34.55 18.03 6 93058 63784 110432451
Polyserositis 34.40 18.03 17 93047 1017 110495218
Nasal congestion 34.34 18.03 20 93044 98262 110397973
Leukopenia 34.20 18.03 45 93019 148746 110347489
Blood pressure decreased 34.13 18.03 28 93036 115063 110381172
Tissue discolouration 34.06 18.03 6 93058 3 110496232
Vomiting 33.83 18.03 551 92513 910124 109586111
Neuropathy peripheral 33.78 18.03 62 93002 179215 110317020
Mental status changes 33.69 18.03 11 93053 76111 110420124
Prescribed underdose 33.67 18.03 126 92938 65048 110431187
Diabetes mellitus 33.63 18.03 21 93043 99360 110396875
Disorientation 33.49 18.03 9 93055 70662 110425573
Restlessness 33.47 18.03 4 93060 56255 110439980
Swelling face 33.39 18.03 18 93046 92303 110403932
Incorrect product administration duration 33.31 18.03 61 93003 20437 110475798
Disturbance in attention 33.21 18.03 6 93058 61989 110434246
Aphasia 33.18 18.03 5 93059 58992 110437243
Haemoglobin decreased 32.63 18.03 104 92960 248623 110247612
Hypersensitivity 32.59 18.03 499 92565 403499 110092736
Coronary artery disease 32.37 18.03 10 93054 71680 110424555
Ovarian failure 32.33 18.03 16 93048 960 110495275
Hepatic enzyme 32.32 18.03 30 93034 5133 110491102
Cholelithiasis 32.16 18.03 7 93057 63415 110432820
Injection site pruritus 32.15 18.03 3 93061 51255 110444980
Haematocrit decreased 32.14 18.03 8 93056 66109 110430126
Encephalopathy 32.06 18.03 14 93050 81041 110415194
Swollen tongue 31.99 18.03 6 93058 60356 110435879
X-ray abnormal 31.90 18.03 87 92977 38030 110458205
Psychotic disorder 31.90 18.03 3 93061 50934 110445301
Malignant neoplasm progression 31.46 18.03 62 93002 174505 110321730
Premature menopause 31.34 18.03 16 93048 1026 110495209
Vertigo 31.32 18.03 17 93047 86853 110409382
Cerebral haemorrhage 31.31 18.03 8 93056 64960 110431275
Pallor 31.27 18.03 5 93059 56462 110439773
Ventricular tachycardia 31.17 18.03 3 93061 50006 110446229
Accidental exposure to product 31.17 18.03 3 93061 50005 110446230
Monocytosis 31.17 18.03 19 93045 1721 110494514
Gingival hyperpigmentation 30.61 18.03 6 93058 10 110496225
Pulmonary hypertension 30.33 18.03 5 93059 55215 110441020
Arthritis 30.30 18.03 243 92821 167343 110328892
Depressed mood 30.26 18.03 7 93057 60802 110435433
Septic shock 30.10 18.03 54 93010 157474 110338761
Urinary incontinence 30.06 18.03 3 93061 48584 110447651
Neuralgia 29.97 18.03 3 93061 48475 110447760
Pain in extremity 29.65 18.03 575 92489 486543 110009692
Injection site bruising 29.64 18.03 4 93060 51259 110444976
Serum sickness-like reaction 29.36 18.03 14 93050 774 110495461
Hepatocellular injury 29.16 18.03 4 93060 50638 110445597
Respiratory tract infection 28.91 18.03 12 93052 71605 110424630
Dyspnoea exertional 28.82 18.03 27 93037 104033 110392202
Spinal fusion surgery 28.76 18.03 37 93027 9119 110487116
Illness 28.31 18.03 17 93047 82154 110414081
Deep vein thrombosis postoperative 27.67 18.03 111 92953 59180 110437055
Renal impairment 27.46 18.03 75 92989 188370 110307865
Haematuria 27.46 18.03 18 93046 82987 110413248
Product prescribing error 27.42 18.03 5 93059 51326 110444909
Mouth ulceration 27.26 18.03 4 93060 48134 110448101
Injection site swelling 27.22 18.03 9 93055 61781 110434454
Haematemesis 27.13 18.03 8 93056 59100 110437135
Melaena 27.00 18.03 12 93052 68745 110427490
Pouchitis 26.95 18.03 16 93048 1381 110494854
Anaphylactic reaction 26.85 18.03 34 93030 114266 110381969
Confusional state 26.77 18.03 548 92516 468132 110028103
Cystitis 26.76 18.03 11 93053 66025 110430210
Gait disturbance 26.54 18.03 132 92932 278076 110218159
Pneumonia aspiration 26.35 18.03 18 93046 81215 110415020
Bone pain 26.16 18.03 11 93053 65122 110431113
Hypertension 26.11 18.03 587 92477 509497 109986738
Arrhythmia 26.00 18.03 13 93051 69562 110426673
Generalised tonic-clonic seizure 25.84 18.03 7 93057 54673 110441562
Burning sensation 25.76 18.03 13 93051 69199 110427036
Obstructive airways disorder 25.75 18.03 4 93060 46145 110450090
Head injury 25.74 18.03 3 93061 43014 110453221
Autoimmune disorder 25.47 18.03 116 92948 65367 110430868
Nephrolithiasis 25.31 18.03 12 93052 66200 110430035
Suicidal ideation 25.29 18.03 25 93039 93912 110402323
Insomnia 24.48 18.03 433 92631 360157 110136078
Ventricular fibrillation 24.42 18.03 3 93061 41310 110454925
Drug dependence 24.41 18.03 6 93058 50014 110446221
Fluid retention 24.36 18.03 26 93038 94281 110401954
Pollakiuria 24.28 18.03 4 93060 44191 110452044
Rash pruritic 24.28 18.03 28 93036 98041 110398194
Nasopharyngitis 24.15 18.03 466 92598 393895 110102340
Pericardial effusion 24.06 18.03 9 93055 57208 110439027
Flatulence 24.04 18.03 7 93057 52142 110444093
Hyperglycaemia 23.66 18.03 22 93042 85068 110411167
Peripheral swelling 23.59 18.03 474 92590 403560 110092675
Dyskinesia 23.55 18.03 7 93057 51439 110444796
Pleural effusion 23.52 18.03 74 92990 177635 110318600
Hypocholesterolaemia 23.47 18.03 28 93036 6393 110489842
Joint injury 23.41 18.03 3 93061 39991 110456244
Circulatory collapse 23.38 18.03 4 93060 42989 110453246
Barotrauma 23.14 18.03 8 93056 190 110496045
Osteonecrosis of jaw 22.97 18.03 6 93058 48011 110448224
Basal cell carcinoma 22.95 18.03 5 93059 45265 110450970
Walking aid user 22.77 18.03 59 93005 25016 110471219
Hypophagia 22.60 18.03 8 93056 52618 110443617
Antiphospholipid syndrome 22.60 18.03 18 93046 2505 110493730
Femur fracture 22.36 18.03 5 93059 44464 110451771
Rash 22.32 18.03 873 92191 820091 109676144
Red blood cell count decreased 22.21 18.03 14 93050 65909 110430326
Proctectomy 22.12 18.03 9 93055 339 110495896
Drug withdrawal syndrome 21.92 18.03 3 93061 38051 110458184
Renal failure 21.89 18.03 107 92957 226467 110269768
Fall 21.75 18.03 367 92697 603115 109893120
Haematoma 21.74 18.03 11 93053 58465 110437770
Gastritis 21.67 18.03 9 93055 53690 110442545
Knee arthroplasty 21.61 18.03 110 92954 64838 110431397
Bacterial infection 21.56 18.03 6 93058 46030 110450205
Mononeuropathy 21.52 18.03 9 93055 364 110495871
Cholestasis 21.33 18.03 14 93050 64504 110431731
Product administration error 21.29 18.03 3 93061 37214 110459021
Lip swelling 21.26 18.03 8 93056 50659 110445576
Rectal haemorrhage 21.21 18.03 43 93021 119790 110376445
Candida infection 21.14 18.03 7 93057 48002 110448233
Nail pigmentation 21.13 18.03 9 93055 381 110495854
Upper gastrointestinal haemorrhage 20.87 18.03 8 93056 50088 110446147
Myocardial infarction 20.78 18.03 87 92977 191996 110304239
Papillary thyroid cancer 20.44 18.03 18 93046 2876 110493359
Accidental overdose 20.42 18.03 9 93055 51825 110444410
Discomfort 20.40 18.03 273 92791 214434 110281801
Respiratory arrest 20.17 18.03 12 93052 58287 110437948
Neoplasm progression 20.05 18.03 15 93049 64580 110431655
Throat irritation 20.02 18.03 10 93054 53542 110442693
Leukaemoid reaction 19.82 18.03 9 93055 445 110495790
Orthostatic hypotension 19.79 18.03 16 93048 66233 110430002
Arthralgia 19.78 18.03 823 92241 778809 109717426
Viral infection 19.75 18.03 10 93054 53129 110443106
Chronic kidney disease 19.74 18.03 21 93043 76270 110419965
Hip fracture 19.72 18.03 3 93061 35148 110461087
Tooth discolouration 19.71 18.03 13 93051 1350 110494885
Agranulocytosis 19.62 18.03 14 93050 61746 110434489
Lymphocyte count decreased 19.50 18.03 12 93052 57231 110439004
Neutrophil count increased 19.34 18.03 3 93061 34649 110461586
Drug level increased 19.26 18.03 8 93056 47711 110448524
Clostridium difficile infection 19.09 18.03 10 93054 52119 110444116
Heart rate irregular 19.06 18.03 3 93061 34271 110461964
Therapy cessation 18.96 18.03 7 93057 44850 110451385
Blood potassium decreased 18.92 18.03 11 93053 54103 110442132
Hypervolaemia 18.85 18.03 9 93055 49451 110446784
Feeling cold 18.84 18.03 3 93061 33984 110462251
Anaphylactic shock 18.71 18.03 10 93054 51536 110444699
Tachypnoea 18.70 18.03 5 93059 39390 110456845
Skin exfoliation 18.65 18.03 28 93036 87623 110408612
Exposure to SARS-CoV-2 18.34 18.03 17 93047 2902 110493333
Joint deposit 18.24 18.03 3 93061 0 110496235
Eye swelling 18.13 18.03 3 93061 33045 110463190
Breast cancer 18.09 18.03 5 93059 38537 110457698
Acute respiratory failure 18.08 18.03 22 93042 75238 110420997

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A01AB23 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Antiinfectives and antiseptics for local oral treatment
ATC D10AF07 DERMATOLOGICALS
ANTI-ACNE PREPARATIONS
ANTI-ACNE PREPARATIONS FOR TOPICAL USE
Antiinfectives for treatment of acne
ATC J01AA08 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
TETRACYCLINES
Tetracyclines
FDA CS M0021223 Tetracyclines
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents
FDA EPC N0000175882 Tetracycline-class Drug
FDA PE N0000193995 Decreased Prothrombin Activity
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:36047 antibacterial drug
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:76971 <em>Escherichia coli</em> metabolite
CHEBI has role CHEBI:176497 geroprotector
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

A01AB Antiinfectives and antiseptics for local oral treatment 22 drugs
D10AF Antiinfectives for treatment of acne 6 drugs
J01AA Tetracyclines 13 drugs

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

DiseaseRelationSNOMED_IDDOID
Trachoma indication 2576002 DOID:11265
Listeriosis indication 4241002 DOID:11573
Actinomycotic infection indication 11817007 DOID:8478
Gonorrhea indication 15628003 DOID:7551
Tularemia indication 19265001
Infection of skin AND/OR subcutaneous tissue indication 19824006
Gingivostomatitis indication 20607006
Acute gonococcal cervicitis indication 20943002 DOID:10615
Granuloma inguinale indication 28867007 DOID:9113
Acute gonococcal urethritis indication 29864006
Bronchitis indication 32398004 DOID:6132
Sinusitis indication 36971009
Periodontitis indication 41565005 DOID:824
Gonorrhea of rectum indication 42746002
Plague indication 58750007 DOID:3482
Cholera indication 63650001 DOID:1498
Acute gonococcal endometritis indication 65295003 DOID:7527
Urinary tract infectious disease indication 68566005
Yaws indication 70647001 DOID:10371
Gonorrhea of pharynx indication 74372003
Rickettsialpox indication 75096007 DOID:11103
Ornithosis indication 75116005 DOID:11262
Brucellosis indication 75702008 DOID:11077
Syphilis indication 76272004
Acne vulgaris indication 88616000
Infection by Campylobacter fetus indication 111835002
Meningococcus carrier indication 170486006
Rocky Mountain spotted fever indication 186772009
Q fever indication 186788009 DOID:11100
Lymphogranuloma venereum indication 186946009 DOID:13819
Pneumonia indication 233604007 DOID:552
Inclusion conjunctivitis indication 266109000
Bartonellosis indication 266123003 DOID:11102
Chancroid indication 266143009 DOID:13778
Infective otitis media indication 312218008
Fusospirochetal pharyngitis indication 399095008
Pharyngitis indication 405737000 DOID:2275
Anthrax indication 409498004 DOID:7427
Relapsing fever indication 420079008 DOID:13034
Chlamydia trachomatis infection of genital structure indication 428015005
Rectal Chlamydia Trachomatis Infection indication
Ureaplasma Urealyticum Infections indication
Typhus Infections indication
Nocardiosis off-label use 29227009 DOID:2312
Enterocolitis off-label use 43752006
Pneumonia due to Mycoplasma pneumoniae off-label use 46970008
Rheumatoid arthritis off-label use 69896004 DOID:7148
Leprosy off-label use 81004002 DOID:1024
Cholangitis off-label use 82403002 DOID:9446
Mycobacteriosis off-label use 88415009
Chlamydial infection off-label use 105629000
Infectious disease of abdomen off-label use 128070006
Ocular rosacea off-label use 200933006
Benign intracranial hypertension contraindication 68267002 DOID:11459
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Esophageal dysmotility contraindication 266434009 DOID:9192
Pregnancy, function contraindication 289908002
Pseudomembranous enterocolitis contraindication 397683000
Breastfeeding (mother) contraindication 413712001
Azotemia contraindication 445009001




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.13 acidic
pKa2 8.85 acidic
pKa3 11.14 acidic
pKa4 11.96 acidic
pKa5 13.08 acidic
pKa6 9.55 Basic
pKa7 4.82 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLODYN BAUSCH N050808 Aug. 27, 2010 DISCN TABLET, EXTENDED RELEASE ORAL 7919483 March 7, 2027 TREATMENT OF ACNE
EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLODYN BAUSCH N050808 July 23, 2009 DISCN TABLET, EXTENDED RELEASE ORAL 7919483 March 7, 2027 TREATMENT OF ACNE
EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLODYN BAUSCH N050808 May 8, 2006 DISCN TABLET, EXTENDED RELEASE ORAL 7919483 March 7, 2027 TREATMENT OF ACNE
EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLODYN BAUSCH N050808 May 8, 2006 DISCN TABLET, EXTENDED RELEASE ORAL 7919483 March 7, 2027 TREATMENT OF ACNE
EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLODYN BAUSCH N050808 Aug. 27, 2010 DISCN TABLET, EXTENDED RELEASE ORAL 7919483 March 7, 2027 TREATMENT OF ACNE
EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLODYN BAUSCH N050808 July 23, 2009 DISCN TABLET, EXTENDED RELEASE ORAL 7919483 March 7, 2027 TREATMENT OF ACNE
EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLODYN BAUSCH N050808 Aug. 27, 2010 DISCN TABLET, EXTENDED RELEASE ORAL 7919483 March 7, 2027 TREATMENT OF ACNE
EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLODYN BAUSCH N050808 May 8, 2006 DISCN TABLET, EXTENDED RELEASE ORAL 7919483 March 7, 2027 TREATMENT OF ACNE
EQ 135MG BASE XIMINO JOURNEY N201922 July 11, 2012 DISCN CAPSULE, EXTENDED RELEASE ORAL 7919483 March 7, 2027 TREATMENT OF ACNE
EQ 45MG BASE XIMINO JOURNEY N201922 July 11, 2012 DISCN CAPSULE, EXTENDED RELEASE ORAL 7919483 March 7, 2027 TREATMENT OF ACNE
EQ 90MG BASE XIMINO JOURNEY N201922 July 11, 2012 DISCN CAPSULE, EXTENDED RELEASE ORAL 7919483 March 7, 2027 TREATMENT OF ACNE
EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLODYN BAUSCH N050808 May 8, 2006 DISCN TABLET, EXTENDED RELEASE ORAL 7541347 April 2, 2027 TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
EQ 135MG BASE XIMINO JOURNEY N201922 July 11, 2012 DISCN CAPSULE, EXTENDED RELEASE ORAL 7541347 April 2, 2027 TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
EQ 45MG BASE XIMINO JOURNEY N201922 July 11, 2012 DISCN CAPSULE, EXTENDED RELEASE ORAL 7541347 April 2, 2027 TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
EQ 90MG BASE XIMINO JOURNEY N201922 July 11, 2012 DISCN CAPSULE, EXTENDED RELEASE ORAL 7541347 April 2, 2027 TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
EQ 4% BASE AMZEEQ JOURNEY N212379 Oct. 18, 2019 RX AEROSOL, FOAM TOPICAL 10086080 Oct. 1, 2030 TREATMENT OF NON-NODULAR ACNE VULGARIS
EQ 4% BASE AMZEEQ JOURNEY N212379 Oct. 18, 2019 RX AEROSOL, FOAM TOPICAL 10137200 Oct. 1, 2030 TREATMENT OF NON-NODULAR ACNE VULGARIS
EQ 4% BASE AMZEEQ JOURNEY N212379 Oct. 18, 2019 RX AEROSOL, FOAM TOPICAL 10213512 Oct. 1, 2030 TREATMENT OF NON-NODULAR ACNE VULGARIS
EQ 4% BASE AMZEEQ JOURNEY N212379 Oct. 18, 2019 RX AEROSOL, FOAM TOPICAL 10517882 Oct. 1, 2030 TREATMENT OF NON-NODULAR ACNE VULGARIS
EQ 4% BASE AMZEEQ JOURNEY N212379 Oct. 18, 2019 RX AEROSOL, FOAM TOPICAL 10821187 Oct. 1, 2030 TREATMENT OF NON-NODULAR ACNE VULGARIS
EQ 4% BASE AMZEEQ JOURNEY N212379 Oct. 18, 2019 RX AEROSOL, FOAM TOPICAL 8865139 Oct. 1, 2030 TREATMENT OF NON-NODULAR ACNE VULGARIS
EQ 4% BASE AMZEEQ JOURNEY N212379 Oct. 18, 2019 RX AEROSOL, FOAM TOPICAL 8992896 Oct. 1, 2030 TREATMENT OF NON-NODULAR ACNE VULGARIS
EQ 4% BASE AMZEEQ JOURNEY N212379 Oct. 18, 2019 RX AEROSOL, FOAM TOPICAL 9675700 Oct. 1, 2030 TREATMENT OF NON-NODULAR ACNE VULGARIS
EQ 1.5% BASE ZILXI JOURNEY N213690 May 28, 2020 RX AEROSOL, FOAM TOPICAL 10213512 Oct. 1, 2030 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA
EQ 1.5% BASE ZILXI JOURNEY N213690 May 28, 2020 RX AEROSOL, FOAM TOPICAL 10322186 Oct. 1, 2030 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA
EQ 1.5% BASE ZILXI JOURNEY N213690 May 28, 2020 RX AEROSOL, FOAM TOPICAL 10946101 Oct. 1, 2030 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA
EQ 1.5% BASE ZILXI JOURNEY N213690 May 28, 2020 RX AEROSOL, FOAM TOPICAL 12138311 Oct. 1, 2030 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA
EQ 1.5% BASE ZILXI JOURNEY N213690 May 28, 2020 RX AEROSOL, FOAM TOPICAL 8865139 Oct. 1, 2030 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA
EQ 1.5% BASE ZILXI JOURNEY N213690 May 28, 2020 RX AEROSOL, FOAM TOPICAL 8992896 Oct. 1, 2030 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA
EQ 1.5% BASE ZILXI JOURNEY N213690 May 28, 2020 RX AEROSOL, FOAM TOPICAL 9675700 Oct. 1, 2030 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA
EQ 100MG BASE/VIAL MINOCIN REMPEX N050444 None RX INJECTABLE INJECTION 9084802 May 12, 2031 METHOD OF TREATING BACTERIAL INFECTIONS
EQ 100MG BASE/VIAL MINOCIN REMPEX N050444 None RX INJECTABLE INJECTION 9278105 May 12, 2031 METHOD OF TREATING BACTERIAL INFECTIONS
EQ 4% BASE AMZEEQ JOURNEY N212379 Oct. 18, 2019 RX AEROSOL, FOAM TOPICAL 10398641 Sept. 8, 2037 TREATMENT OF NON-NODULAR ACNE VULGARIS
EQ 4% BASE AMZEEQ JOURNEY N212379 Oct. 18, 2019 RX AEROSOL, FOAM TOPICAL 10849847 Sept. 8, 2037 TREATMENT OF NON-NODULAR ACNE VULGARIS
EQ 40MG BASE EMROSI JOURNEY N219015 Nov. 1, 2024 RX CAPSULE, EXTENDED RELEASE ORAL 10905664 Jan. 7, 2039 EMROSI IS INDICATED TO TREAT INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA IN ADULTS
EQ 40MG BASE EMROSI JOURNEY N219015 Nov. 1, 2024 RX CAPSULE, EXTENDED RELEASE ORAL 11191740 Jan. 7, 2039 EMROSI IS INDICATED TO TREAT INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA IN ADULTS
EQ 40MG BASE EMROSI JOURNEY N219015 Nov. 1, 2024 RX CAPSULE, EXTENDED RELEASE ORAL 11364212 Jan. 7, 2039 EMROSI IS INDICATED TO TREAT INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA IN ADULTS
EQ 40MG BASE EMROSI JOURNEY N219015 Nov. 1, 2024 RX CAPSULE, EXTENDED RELEASE ORAL 12594252 Jan. 7, 2039 EMROSI IS INDICATED TO TREAT INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA IN ADULTS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 40MG BASE EMROSI JOURNEY N219015 Nov. 1, 2024 RX CAPSULE, EXTENDED RELEASE ORAL Nov. 1, 2027 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Tetracycline resistance protein, class B Transporter IC50 5.64 WOMBAT-PK
30S ribosomal protein S4 Ribosomal protein Ka 6 WOMBAT-PK
30S ribosomal protein S9 Ribosomal protein Ka 5.76 WOMBAT-PK

External reference:

IDSource
4019841 VUID
N0000147928 NUI
D00850 KEGG_DRUG
13614-98-7 SECONDARY_CAS_RN
4017916 VANDF
4019841 VANDF
C0026187 UMLSCUI
CHEBI:50694 CHEBI
MIY PDB_CHEM_ID
CHEMBL1434 ChEMBL_ID
CHEMBL1200881 ChEMBL_ID
D008911 MESH_DESCRIPTOR_UI
DB01017 DRUGBANK_ID
10831 IUPHAR_LIGAND_ID
1646 INN_ID
FYY3R43WGO UNII
54675783 PUBCHEM_CID
6979 RXNORM
1213 MMSL
21389 MMSL
5118 MMSL
d00110 MMSL
002754 NDDF
004864 NDDF
13512003 SNOMEDCT_US
372653009 SNOMEDCT_US
52886009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Minocycline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0440-7805 CAPSULE 100 mg ORAL ANDA 24 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-3153 CAPSULE 75 mg ORAL ANDA 14 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-5694 CAPSULE 50 mg ORAL ANDA 14 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-5695 CAPSULE 100 mg ORAL ANDA 14 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6888 CAPSULE 100 mg ORAL ANDA 21 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-482 CAPSULE 50 mg ORAL ANDA 21 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-483 CAPSULE 75 mg ORAL ANDA 21 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-484 CAPSULE 100 mg ORAL ANDA 21 sections
MINOCYCLINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 13668-485 TABLET 50 mg ORAL ANDA 13 sections
MINOCYCLINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 13668-486 TABLET 75 mg ORAL ANDA 13 sections
MINOCYCLINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 13668-487 TABLET 100 mg ORAL ANDA 13 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-693 CAPSULE 50 mg ORAL ANDA 23 sections
Minocycline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 33261-434 CAPSULE 100 mg ORAL ANDA 24 sections
Minocycline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 33261-871 CAPSULE 50 mg ORAL ANDA 24 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43063-736 CAPSULE 100 mg ORAL ANDA 21 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-2339 CAPSULE 100 mg ORAL ANDA 21 sections
Minocycline Hydrochloride Human Prescription Drug Label 1 50090-2579 CAPSULE 100 mg ORAL ANDA 26 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-2971 CAPSULE 50 mg ORAL ANDA 21 sections
Minocycline Hydrochloride Human Prescription Drug Label 1 50090-3016 CAPSULE 50 mg ORAL ANDA 26 sections
minocycline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-3644 CAPSULE 50 mg ORAL ANDA 23 sections
minocycline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-3697 CAPSULE 100 mg ORAL ANDA 24 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-5710 CAPSULE 50 mg ORAL ANDA 25 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51655-004 CAPSULE 100 mg ORAL ANDA 25 sections
Minocycline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51655-753 CAPSULE 50 mg ORAL ANDA 22 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 53002-2210 CAPSULE 100 mg ORAL ANDA 20 sections
Minocycline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 53002-2880 CAPSULE 50 mg ORAL ANDA 26 sections
Minocycline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 54868-2390 CAPSULE 50 mg ORAL ANDA 24 sections
Minocycline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 54868-2391 CAPSULE 100 mg ORAL ANDA 24 sections
Minocycline hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 54868-5040 CAPSULE 75 mg ORAL ANDA 24 sections
Solodyn HUMAN PRESCRIPTION DRUG LABEL 1 54868-6285 TABLET, FILM COATED, EXTENDED RELEASE 80 mg ORAL NDA 29 sections