hydrocortisone Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
corticosteroids, except prednisolone derivatives 1388 50-23-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • hydrocortisone
  • 17-hydroxycorticosterone
  • acticort
  • cetacort
  • hydracort
  • hydrasson
  • hydrocortisyl
  • cortisol
The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions.
  • Molecular weight: 362.47
  • Formula: C21H30O5
  • CLOGP: 1.89
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 3
  • TPSA: 94.83
  • ALOGS: -3.26
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
30 mg O
30 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.42 mg/mL Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 353.81 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.38 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.20 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.60 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 5, 1952 FDA MERCK

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
Drug hypersensitivity 2934.39 22.64 835 2977 45808 2308465
Febrile bone marrow aplasia 533.86 22.64 101 3711 756 2353517
Neuropathy peripheral 267.10 22.64 99 3713 11333 2342940
Steroid withdrawal syndrome 263.34 22.64 42 3770 90 2354183
Hypofibrinogenaemia 250.84 22.64 41 3771 109 2354164
Drug ineffective 244.85 22.64 192 3620 101432 2252841
Tendonitis 243.15 22.64 63 3749 2164 2352109
Adrenal insufficiency 230.16 22.64 55 3757 1345 2352928
Arthralgia 204.74 22.64 135 3677 54150 2300123
Urticaria 201.28 22.64 101 3711 24160 2330113
Diarrhoea 196.69 22.64 156 3656 83408 2270865
Rash 195.72 22.64 136 3676 59422 2294851
Febrile neutropenia 182.04 22.64 74 3738 10808 2343465
Adrenocortical insufficiency acute 172.00 22.64 32 3780 214 2354059
Urinary tract infection 157.01 22.64 92 3720 29850 2324423
Tendon rupture 156.24 22.64 41 3771 1477 2352796
Pain 154.93 22.64 120 3692 61737 2292536
Pruritus 149.20 22.64 102 3710 43238 2311035
Pain in extremity 146.15 22.64 100 3712 42440 2311833
Exposure during pregnancy 144.17 22.64 82 3730 25137 2329136
Nausea 136.78 22.64 145 3667 112044 2242229
Pyrexia 136.12 22.64 105 3707 53603 2300670
Septic shock 128.34 22.64 51 3761 7003 2347270
Hypersensitivity 127.55 22.64 74 3738 23519 2330754
Asphyxia 122.21 22.64 31 3781 973 2353300
Asthenia 121.58 22.64 93 3719 46833 2307440
Dizziness 117.52 22.64 100 3712 58565 2295708
Angioedema 116.44 22.64 50 3762 8346 2345927
Sepsis 116.13 22.64 64 3748 18424 2335849
Product use in unapproved indication 114.85 22.64 54 3758 11146 2343127
Arteriosclerosis coronary artery 112.66 22.64 30 3782 1143 2353130
Vomiting 111.73 22.64 106 3706 71496 2282777
Hypoaesthesia 108.14 22.64 63 3749 20152 2334121
Hypotension 105.93 22.64 74 3738 32362 2321911
Hepatocellular injury 105.16 22.64 38 3774 4017 2350256
Abdominal pain 102.06 22.64 74 3738 34300 2319973
Maternal exposure during pregnancy 100.37 22.64 54 3758 14809 2339464
Clostridium difficile colitis 99.88 22.64 31 3781 2048 2352225
Nervous system disorder 99.13 22.64 34 3778 3082 2351191
Paraesthesia 97.87 22.64 61 3751 22027 2332246
Condition aggravated 95.27 22.64 69 3743 31910 2322363
Tendon disorder 93.44 22.64 24 3788 792 2353481
Bacterial infection 89.64 22.64 29 3783 2192 2352081
Hypoalbuminaemia 89.50 22.64 26 3786 1368 2352905
Dyspnoea 88.96 22.64 98 3714 78635 2275638
Musculoskeletal injury 88.38 22.64 14 3798 28 2354245
Tendon pain 88.28 22.64 22 3790 641 2353632
Muscular weakness 86.49 22.64 49 3763 14848 2339425
Headache 85.78 22.64 97 3715 80082 2274191
Off label use 85.54 22.64 93 3719 73505 2280768
Hypokalaemia 84.13 22.64 43 3769 10611 2343662
Bronchopulmonary aspergillosis 83.84 22.64 23 3789 981 2353292
Antithrombin III 80.56 22.64 11 3801 1 2354272
Respiratory acidosis 78.84 22.64 21 3791 800 2353473
Myalgia 77.88 22.64 54 3758 23279 2330994
Anxiety 77.65 22.64 59 3753 29300 2324973
Secondary immunodeficiency 77.26 22.64 14 3798 79 2354194
Hyperlipidaemia 76.65 22.64 27 3785 2647 2351626
Prescription drug used without a prescription 76.33 22.64 16 3796 209 2354064
Human bocavirus infection 74.94 22.64 11 3801 9 2354264
Burning sensation 74.87 22.64 36 3776 7792 2346481
Perfume sensitivity 74.28 22.64 13 3799 58 2354215
Erythema 74.22 22.64 54 3758 25105 2329168
Confusional state 73.52 22.64 53 3759 24291 2329982
Lung hyperinflation 73.24 22.64 14 3798 110 2354163
Gait disturbance 72.49 22.64 51 3761 22494 2331779
Allergy test positive 70.45 22.64 12 3800 44 2354229
Pancytopenia 70.06 22.64 39 3773 11413 2342860
Decreased appetite 69.72 22.64 55 3757 28836 2325437
Hypoglycaemia 69.48 22.64 35 3777 8372 2345901
Malaise 69.35 22.64 73 3739 55512 2298761
Hypertension 67.99 22.64 53 3759 27308 2326965
Hypercapnia 66.94 22.64 17 3795 535 2353738
Airway peak pressure increased 66.53 22.64 11 3801 32 2354241
Rhinovirus infection 65.75 22.64 15 3797 296 2353977
Cushing's syndrome 65.53 22.64 18 3794 771 2353502
Drug reaction with eosinophilia and systemic symptoms 63.98 22.64 29 3783 5489 2348784
Fatigue 63.74 22.64 86 3726 84787 2269486
Feeling abnormal 63.66 22.64 48 3764 23533 2330740
Blood bicarbonate decreased 63.52 22.64 16 3796 487 2353786
Mucosal inflammation 62.30 22.64 28 3784 5196 2349077
Skin injury 61.82 22.64 14 3798 267 2354006
PCO2 increased 61.79 22.64 13 3799 173 2354100
Hepatic failure 60.01 22.64 28 3784 5661 2348612
PO2 decreased 60.01 22.64 14 3798 306 2353967
Mental disorder 59.27 22.64 25 3787 3982 2350291
Depression 58.25 22.64 49 3763 28083 2326190
Multiple organ dysfunction syndrome 57.87 22.64 30 3782 7611 2346662
Acute respiratory distress syndrome 57.04 22.64 23 3789 3269 2351004
Enterobacter infection 56.77 22.64 13 3799 261 2354012
Blood lactic acid increased 55.18 22.64 16 3796 835 2353438
Hyponatraemia 54.44 22.64 35 3777 13290 2340983
Neutropenia 54.06 22.64 42 3770 21506 2332767
Anaphylactic reaction 53.81 22.64 31 3781 9674 2344599
Neuralgia 53.35 22.64 21 3791 2801 2351472
Disseminated intravascular coagulation 53.24 22.64 22 3790 3328 2350945
Somnolence 52.98 22.64 43 3769 23442 2330831
Colitis 52.90 22.64 25 3787 5201 2349072
Enterococcal sepsis 52.45 22.64 11 3801 144 2354129
Acute kidney injury 52.16 22.64 46 3766 28076 2326197
Coronary artery dissection 51.89 22.64 11 3801 152 2354121
Adrenal suppression 51.69 22.64 11 3801 155 2354118
Herpes simplex 51.61 22.64 16 3796 1051 2353222
Back pain 51.31 22.64 48 3764 31611 2322662
Toxic epidermal necrolysis 51.16 22.64 21 3791 3123 2351150
Delirium 49.86 22.64 24 3788 5199 2349074
Pneumonia 49.77 22.64 58 3754 49238 2305035
Insomnia 49.46 22.64 43 3769 25744 2328529
Blood pH decreased 49.24 22.64 13 3799 478 2353795
Drug interaction 48.76 22.64 45 3767 29118 2325155
Mastocytosis 47.99 22.64 9 3803 63 2354210
Haemorrhage intracranial 47.98 22.64 19 3793 2575 2351698
Crohn's disease 47.17 22.64 25 3787 6630 2347643
Enteritis 47.17 22.64 15 3797 1071 2353202
Metabolic acidosis 46.71 22.64 24 3788 5974 2348299
Mucormycosis 46.50 22.64 12 3800 403 2353870
Cushingoid 46.44 22.64 13 3799 597 2353676
Staphylococcal infection 46.42 22.64 23 3789 5303 2348970
Pneumatosis intestinalis 46.27 22.64 12 3800 411 2353862
Neoplasm recurrence 46.21 22.64 12 3800 413 2353860
Frequent bowel movements 45.77 22.64 17 3795 1937 2352336
Seizure 45.32 22.64 40 3772 24426 2329847
Posterior reversible encephalopathy syndrome 45.29 22.64 18 3794 2462 2351811
Blood pressure increased 44.54 22.64 34 3778 16952 2337321
Dehydration 44.42 22.64 38 3774 22257 2332016
Osteoporosis 44.31 22.64 21 3791 4393 2349880
Premature delivery 44.12 22.64 19 3793 3181 2351092
Bacteraemia 44.03 22.64 16 3796 1714 2352559
Enterococcal infection 43.77 22.64 13 3799 738 2353535
Haemophagocytic lymphohistiocytosis 43.61 22.64 15 3797 1368 2352905
Herpes simplex hepatitis 43.17 22.64 8 3804 52 2354221
Perioral dermatitis 42.96 22.64 7 3805 18 2354255
Caesarean section 42.77 22.64 20 3792 4061 2350212
Klebsiella infection 42.69 22.64 13 3799 804 2353469
Wheezing 42.49 22.64 23 3789 6361 2347912
Enterocolitis 42.33 22.64 13 3799 827 2353446
Subclavian vein thrombosis 42.13 22.64 10 3802 236 2354037
Hyperadrenocorticism 41.94 22.64 8 3804 62 2354211
Eczema herpeticum 41.24 22.64 7 3805 25 2354248
Palpitations 41.09 22.64 32 3780 16424 2337849
Cyanosis 40.94 22.64 18 3794 3167 2351106
Status asthmaticus 40.77 22.64 9 3803 152 2354121
Musculoskeletal pain 40.69 22.64 27 3785 10803 2343470
Abdominal pain upper 40.66 22.64 36 3776 22064 2332209
Restlessness 40.64 22.64 20 3792 4543 2349730
Oedema peripheral 40.35 22.64 37 3775 23726 2330547
Feeding intolerance 39.17 22.64 7 3805 36 2354237
Lipase increased 38.99 22.64 14 3798 1448 2352825
Blood creatinine increased 38.94 22.64 26 3786 10507 2343766
Breakthrough pain 38.87 22.64 9 3803 190 2354083
Emotional distress 38.77 22.64 19 3793 4276 2349997
Vulvovaginal discomfort 38.54 22.64 11 3801 542 2353731
Respiratory rate increased 38.46 22.64 14 3798 1506 2352767
Injury 38.37 22.64 21 3791 5933 2348340
Gait inability 38.37 22.64 21 3791 5934 2348339
Product dispensing error 38.06 22.64 16 3796 2525 2351748
Corona virus infection 37.98 22.64 7 3805 44 2354229
Human herpesvirus 6 infection 37.81 22.64 10 3802 370 2353903
Encephalopathy 37.69 22.64 19 3793 4542 2349731
Hallucination 37.27 22.64 23 3789 8125 2346148
Normal tension glaucoma 37.24 22.64 6 3806 14 2354259
Gestational hypertension 37.06 22.64 10 3802 400 2353873
Swelling 36.98 22.64 30 3782 16320 2337953
Alanine aminotransferase increased 36.58 22.64 28 3784 14004 2340269
Gastroenteritis norovirus 36.58 22.64 9 3803 248 2354025
Aspergillus infection 36.52 22.64 12 3800 951 2353322
Swelling face 36.46 22.64 24 3788 9469 2344804
Oxygen saturation decreased 36.19 22.64 22 3790 7564 2346709
Non-consummation 36.14 22.64 5 3807 1 2354272
Anorectal ulcer 35.37 22.64 5 3807 2 2354271
Respiratory failure 35.28 22.64 27 3785 13501 2340772
Asthma 34.94 22.64 25 3787 11289 2342984
Weight decreased 34.81 22.64 37 3775 28334 2325939
Skin reaction 34.75 22.64 14 3798 1983 2352290
Infection 34.42 22.64 30 3782 17999 2336274
Pleural effusion 34.24 22.64 25 3787 11643 2342630
Cytomegalovirus infection 33.80 22.64 15 3797 2698 2351575
Disturbance in attention 33.75 22.64 19 3793 5666 2348607
Hyperglycaemia 33.62 22.64 18 3794 4867 2349406
Fungal infection 33.61 22.64 18 3794 4871 2349402
Meningitis candida 33.58 22.64 5 3807 5 2354268
Herpes zoster meningoencephalitis 33.55 22.64 6 3806 31 2354242
Musculoskeletal stiffness 33.16 22.64 25 3787 12222 2342051
Blood glucose increased 33.08 22.64 25 3787 12265 2342008
Thrombocytopenia 32.88 22.64 30 3782 19101 2335172
Tremor 32.81 22.64 31 3781 20630 2333643
Tinnitus 32.78 22.64 18 3794 5117 2349156
Leukopenia 32.56 22.64 23 3789 10173 2344100
Pancreatitis 32.43 22.64 21 3791 8058 2346215
Inflammation 32.18 22.64 19 3793 6194 2348079
Syncope 32.05 22.64 28 3784 16847 2337426
Treatment failure 32.00 22.64 20 3792 7219 2347054
Disorientation 31.74 22.64 19 3793 6353 2347920
Sleep disorder 31.42 22.64 19 3793 6470 2347803
Panic attack 31.29 22.64 16 3796 3940 2350333
Vulvovaginal pain 31.25 22.64 9 3803 458 2353815
Hypothalamic pituitary adrenal axis suppression 31.18 22.64 6 3806 49 2354224
Systemic inflammatory response syndrome 30.70 22.64 10 3802 771 2353502
Dysbiosis 30.66 22.64 6 3806 54 2354219
Renal impairment 30.47 22.64 22 3790 10070 2344203
Stevens-Johnson syndrome 30.17 22.64 16 3796 4243 2350030
Hyperammonaemia 30.07 22.64 10 3802 822 2353451
Scratch 29.99 22.64 10 3802 829 2353444
Hypothalamo-pituitary disorder 29.96 22.64 7 3805 154 2354119
Muscle spasms 29.82 22.64 30 3782 21536 2332737
Antithrombin III decreased 29.73 22.64 6 3806 64 2354209
Liver injury 29.49 22.64 13 3799 2301 2351972
Incorrect route of product administration 29.44 22.64 17 3795 5319 2348954
Vaginal infection 29.28 22.64 10 3802 892 2353381
Cardiovascular disorder 29.27 22.64 13 3799 2342 2351931
Physical disability 28.91 22.64 7 3805 180 2354093
Pancreatitis acute 28.79 22.64 15 3797 3838 2350435
Enterocolitis haemorrhagic 28.65 22.64 8 3804 364 2353909
Pulmonary embolism 28.45 22.64 27 3785 18056 2336217
Bone marrow failure 28.44 22.64 17 3795 5669 2348604
C-reactive protein decreased 28.43 22.64 6 3806 81 2354192
Pulmonary mass 28.41 22.64 12 3800 1914 2352359
Eczema 28.39 22.64 14 3798 3191 2351082
Peripheral nerve injury 28.23 22.64 6 3806 84 2354189
Otitis externa 28.14 22.64 7 3805 202 2354071
Symptom masked 27.97 22.64 6 3806 88 2354185
Flank pain 27.46 22.64 11 3801 1534 2352739
Abdominal discomfort 27.34 22.64 26 3786 17430 2336843
Pyelonephritis 27.19 22.64 12 3800 2129 2352144
Weight increased 27.16 22.64 29 3783 22308 2331965
Colitis ulcerative 27.11 22.64 13 3799 2789 2351484
Skin necrosis 27.07 22.64 10 3802 1121 2353152
Candida infection 26.80 22.64 13 3799 2860 2351413
Venous thrombosis 26.25 22.64 9 3803 812 2353461
Joint swelling 26.24 22.64 25 3787 16794 2337479
Bronchospasm 26.17 22.64 13 3799 3011 2351262
Aspartate aminotransferase increased 26.12 22.64 22 3790 12590 2341683
Acute respiratory failure 26.11 22.64 13 3799 3025 2351248
Ischaemic hepatitis 26.08 22.64 7 3805 274 2353999
Viral infection 26.07 22.64 15 3797 4661 2349612
Anal incontinence 26.01 22.64 11 3801 1761 2352512
Cystitis 25.98 22.64 16 3796 5626 2348647
Blister 25.71 22.64 17 3795 6754 2347519
Hypernatraemia 25.50 22.64 9 3803 885 2353388
Unresponsive to stimuli 25.48 22.64 15 3797 4861 2349412
Hypertriglyceridaemia 25.48 22.64 9 3803 887 2353386
Muscle tightness 25.24 22.64 11 3801 1894 2352379
Respiratory distress 24.78 22.64 15 3797 5114 2349159
Intracranial pressure increased 24.64 22.64 9 3803 977 2353296
Gastrointestinal scarring 24.47 22.64 5 3807 57 2354216
Shared psychotic disorder 24.35 22.64 4 3808 11 2354262
Blood bilirubin increased 24.21 22.64 15 3797 5330 2348943
Aborted pregnancy 24.10 22.64 4 3808 12 2354261
Diabetes insipidus 24.03 22.64 7 3805 371 2353902
Myelopathy 23.96 22.64 7 3805 375 2353898
Loss of consciousness 23.94 22.64 25 3787 18742 2335531
Anaemia macrocytic 23.74 22.64 7 3805 387 2353886
Quadriplegia 23.74 22.64 7 3805 387 2353886
Coagulopathy 23.68 22.64 12 3800 2897 2351376
Skin striae 23.64 22.64 6 3806 188 2354085
Epstein-Barr virus infection 23.59 22.64 9 3803 1102 2353171
Bone pain 23.54 22.64 18 3794 8978 2345295
Pneumocystis jirovecii pneumonia 23.38 22.64 11 3801 2262 2352011
Cellulitis 23.18 22.64 18 3794 9183 2345090
Pseudomonas infection 23.17 22.64 9 3803 1157 2353116
Peritoneal haemorrhage 23.03 22.64 7 3805 430 2353843
Shock 22.74 22.64 13 3799 3991 2350282
Facial paralysis 22.73 22.64 11 3801 2408 2351865
Pericardial effusion 22.72 22.64 13 3799 3996 2350277
Product use issue 22.71 22.64 20 3792 12149 2342124
Acute lymphocytic leukaemia recurrent 22.71 22.64 6 3806 221 2354052

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
Febrile bone marrow aplasia 454.00 24.26 91 2648 787 1743255
Drug hypersensitivity 364.92 24.26 140 2599 14995 1729047
Hypofibrinogenaemia 261.76 24.26 46 2693 172 1743870
Hypertriglyceridaemia 249.73 24.26 59 2680 1150 1742892
Febrile neutropenia 211.98 24.26 87 2652 11013 1733029
Neuropathy peripheral 171.34 24.26 71 2668 9182 1734860
Adrenal insufficiency 153.64 24.26 41 2698 1324 1742718
Arthralgia 152.78 24.26 88 2651 23356 1720686
Hyperbilirubinaemia 149.84 24.26 45 2694 2242 1741800
Septic shock 149.31 24.26 62 2677 8047 1735995
Tendon pain 138.19 24.26 31 2708 473 1743569
Tendon rupture 134.13 24.26 39 2700 1733 1742309
Tendonitis 128.50 24.26 36 2703 1397 1742645
Mucosal inflammation 127.04 24.26 46 2693 4123 1739919
Pain 122.26 24.26 80 2659 26577 1717465
Paraesthesia 118.74 24.26 57 2682 10394 1733648
Pyrexia 114.94 24.26 96 2643 46304 1697738
Drug ineffective 110.79 24.26 108 2631 63693 1680349
Hypoaesthesia 109.77 24.26 53 2686 9782 1734260
Diarrhoea 104.50 24.26 97 2642 53755 1690287
Pain in extremity 98.40 24.26 61 2678 18411 1725631
Off label use 97.87 24.26 81 2658 38490 1705552
Multiple organ dysfunction syndrome 97.69 24.26 48 2691 9194 1734848
Candida infection 96.50 24.26 31 2708 1927 1742115
Steroid withdrawal syndrome 90.51 24.26 16 2723 62 1743980
Nervous system disorder 85.78 24.26 30 2709 2424 1741618
Leukoencephalopathy 85.12 24.26 23 2716 777 1743265
Tendon disorder 84.95 24.26 21 2718 495 1743547
Anxiety 84.48 24.26 52 2687 15475 1728567
Neutropenia 84.02 24.26 55 2684 18205 1725837
Diabetes insipidus 83.93 24.26 20 2719 402 1743640
Abdominal pain 82.85 24.26 58 2681 21432 1722610
Hypotension 78.71 24.26 64 2675 29590 1714452
Tinnitus 70.96 24.26 28 2711 3167 1740875
Gait disturbance 70.33 24.26 43 2696 12627 1731415
Condition aggravated 69.87 24.26 52 2687 21098 1722944
Nausea 69.29 24.26 76 2663 51120 1692922
Alanine aminotransferase increased 66.43 24.26 41 2698 12237 1731805
Adrenocortical insufficiency acute 64.10 24.26 14 2725 187 1743855
Confusional state 62.96 24.26 49 2690 21229 1722813
Insomnia 62.82 24.26 44 2695 16232 1727810
Rash erythematous 61.85 24.26 27 2712 3938 1740104
Hypertrophic cardiomyopathy 60.62 24.26 14 2725 244 1743798
Rash 60.36 24.26 62 2677 38631 1705411
Sepsis 58.01 24.26 45 2694 19393 1724649
Weight decreased 57.96 24.26 48 2691 22705 1721337
Periorbital infection 57.96 24.26 9 2730 11 1744031
Tachycardia 57.92 24.26 38 2701 12590 1731452
Hypersensitivity 56.79 24.26 35 2704 10409 1733633
Headache 55.25 24.26 56 2683 34320 1709722
Product use in unapproved indication 54.88 24.26 33 2706 9389 1734653
Mucormycosis 54.53 24.26 16 2723 731 1743311
Bacteraemia 54.43 24.26 20 2719 1860 1742182
Meningitis candida 54.02 24.26 8 2731 5 1744037
Vomiting 53.68 24.26 58 2681 38257 1705785
Skin necrosis 52.98 24.26 16 2723 808 1743234
Leukopenia 52.77 24.26 31 2708 8449 1735593
Hypokalaemia 52.46 24.26 28 2711 6346 1737696
Posterior reversible encephalopathy syndrome 51.40 24.26 18 2721 1457 1742585
Pruritus 50.99 24.26 45 2694 23177 1720865
Anaphylactic reaction 50.72 24.26 27 2712 6086 1737956
Lichen planus 50.54 24.26 12 2727 237 1743805
Hepatocellular injury 50.37 24.26 22 2717 3209 1740833
Urinary tract infection 50.10 24.26 32 2707 10121 1733921
Fatigue 49.77 24.26 64 2675 50717 1693325
Strongyloidiasis 48.73 24.26 13 2726 417 1743625
Asthenia 47.69 24.26 52 2687 34618 1709424
Functional gastrointestinal disorder 46.72 24.26 12 2727 331 1743711
Musculoskeletal injury 46.58 24.26 8 2731 25 1744017
Myelopathy 46.55 24.26 12 2727 336 1743706
Injury 45.64 24.26 20 2719 2940 1741102
Foetal exposure during pregnancy 44.23 24.26 25 2714 6334 1737708
Depression 44.15 24.26 36 2703 16633 1727409
Acute kidney injury 43.91 24.26 50 2689 34894 1709148
Anaemia 43.69 24.26 46 2693 29411 1714631
Bacterial infection 43.38 24.26 17 2722 1885 1742157
Perioral dermatitis 43.32 24.26 7 2732 13 1744029
Enterococcal infection 43.28 24.26 14 2725 887 1743155
Skin exfoliation 43.26 24.26 22 2717 4513 1739529
Mental disorder 43.15 24.26 19 2720 2824 1741218
Graft versus host disease 43.03 24.26 16 2723 1537 1742505
Vasculitis 42.82 24.26 16 2723 1559 1742483
Pancytopenia 42.15 24.26 30 2709 11327 1732715
Skin injury 41.95 24.26 10 2729 201 1743841
Chest discomfort 40.93 24.26 25 2714 7306 1736736
Gamma-glutamyltransferase increased 40.83 24.26 22 2717 5076 1738966
Skin papilloma 40.53 24.26 11 2728 377 1743665
Erythema 40.45 24.26 32 2707 14156 1729886
Panic attack 40.30 24.26 16 2723 1836 1742206
Emotional distress 40.08 24.26 16 2723 1862 1742180
Optic nerve disorder 39.34 24.26 9 2730 150 1743892
Chills 39.11 24.26 29 2710 11658 1732384
Thrombocytopenia 38.49 24.26 37 2702 21212 1722830
Body height below normal 38.48 24.26 8 2731 83 1743959
Dehydration 38.29 24.26 34 2705 17624 1726418
Neurological symptom 38.22 24.26 12 2727 690 1743352
Oedema peripheral 37.87 24.26 32 2707 15518 1728524
Muscular weakness 37.85 24.26 27 2712 10222 1733820
Hyperglycaemia 37.80 24.26 21 2718 5144 1738898
Fungal infection 37.20 24.26 16 2723 2246 1741796
Stevens-Johnson syndrome 37.09 24.26 18 2721 3339 1740703
Peptic ulcer haemorrhage 36.96 24.26 8 2731 102 1743940
Immunosuppressant drug level increased 36.03 24.26 11 2728 576 1743466
Seizure 35.90 24.26 35 2704 20406 1723636
Cushingoid 35.85 24.26 10 2729 380 1743662
Myalgia 35.64 24.26 31 2708 15627 1728415
Stomatitis 34.24 24.26 20 2719 5384 1738658
Inappropriate antidiuretic hormone secretion 34.23 24.26 14 2725 1734 1742308
Tremor 34.00 24.26 28 2711 13103 1730939
Cryptococcal fungaemia 33.98 24.26 6 2733 23 1744019
Gastrointestinal disorder 33.91 24.26 19 2720 4729 1739313
Pallor 33.85 24.26 17 2722 3394 1740648
Drug ineffective for unapproved indication 33.61 24.26 14 2725 1815 1742227
Colitis 33.36 24.26 18 2721 4162 1739880
Toxic epidermal necrolysis 33.27 24.26 15 2724 2356 1741686
Infusion related reaction 33.05 24.26 21 2718 6572 1737470
Blood culture positive 32.94 24.26 11 2728 770 1743272
Disseminated intravascular coagulation 32.92 24.26 17 2722 3597 1740445
Product use issue 32.61 24.26 23 2716 8548 1735494
Psychiatric symptom 32.60 24.26 11 2728 795 1743247
Palpitations 32.41 24.26 21 2718 6793 1737249
Osteoporosis 32.32 24.26 13 2726 1542 1742500
Crohn's disease 31.79 24.26 18 2721 4569 1739473
Joint swelling 31.26 24.26 20 2719 6333 1737709
Infection 31.25 24.26 26 2713 12334 1731708
Cardiac arrest 31.24 24.26 29 2710 15901 1728141
Lichenoid keratosis 31.06 24.26 9 2730 393 1743649
Ascites 31.04 24.26 19 2720 5567 1738475
Abdominal distension 30.99 24.26 20 2719 6424 1737618
Tumour lysis syndrome 30.83 24.26 13 2726 1738 1742304
Necrotising fasciitis 30.83 24.26 10 2729 639 1743403
Cholangitis infective 30.60 24.26 6 2733 45 1743997
Haematochezia 30.58 24.26 18 2721 4914 1739128
Musculoskeletal pain 30.10 24.26 18 2721 5056 1738986
Hypoxia 29.90 24.26 19 2720 5944 1738098
Shared psychotic disorder 29.79 24.26 5 2734 13 1744029
Tachycardia foetal 29.63 24.26 6 2733 54 1743988
Hyponatraemia 29.35 24.26 22 2717 8978 1735064
Pneumoretroperitoneum 29.26 24.26 5 2734 15 1744027
Metabolic acidosis 29.06 24.26 18 2721 5384 1738658
Epidural lipomatosis 29.06 24.26 6 2733 60 1743982
Dizziness 28.50 24.26 40 2699 34321 1709721
Muscle atrophy 28.37 24.26 11 2728 1184 1742858
Hypertension 28.13 24.26 30 2709 19418 1724624
Amnesia 28.11 24.26 17 2722 4874 1739168
Paraparesis 28.00 24.26 8 2731 332 1743710
Respiratory failure 27.65 24.26 26 2713 14479 1729563
Rash pruritic 27.53 24.26 16 2723 4266 1739776
Oral candidiasis 27.40 24.26 11 2728 1298 1742744
Eczema herpeticum 26.76 24.26 5 2734 28 1744014
Chorioretinopathy 26.71 24.26 8 2731 392 1743650
Pneumocystis jirovecii pneumonia 26.62 24.26 13 2726 2443 1741599
Disorientation 26.36 24.26 17 2722 5452 1738590
Streptococcal infection 26.32 24.26 9 2730 677 1743365
Hypoalbuminaemia 26.24 24.26 11 2728 1449 1742593
Mucosal infection 26.06 24.26 5 2734 33 1744009
Diarrhoea haemorrhagic 26.04 24.26 10 2729 1049 1742993
General physical health deterioration 25.94 24.26 24 2715 13094 1730948
Potentiating drug interaction 25.93 24.26 9 2730 708 1743334
Pulmonary oedema 25.81 24.26 18 2721 6568 1737474
Bronchopulmonary aspergillosis 25.49 24.26 11 2728 1555 1742487
Drug interaction 25.36 24.26 34 2705 27924 1716118
Proteus infection 25.19 24.26 6 2733 120 1743922
Constipation 25.04 24.26 25 2714 14975 1729067
Respiratory distress 24.78 24.26 16 2723 5141 1738901
Pneumonia 24.75 24.26 44 2695 46138 1697904
Decreased appetite 24.73 24.26 31 2708 23840 1720202
Posturing 24.52 24.26 6 2733 135 1743907
Premature baby 24.40 24.26 13 2726 2929 1741113
Pancreatitis 24.39 24.26 18 2721 7169 1736873
Product administration error 24.35 24.26 13 2726 2940 1741102

Pharmacologic Action:

SourceCodeDescription
ATC A01AC03 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Corticosteroids for local oral treatment
ATC A07EA02 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFLAMMATORY AGENTS
Corticosteroids acting locally
ATC C05AA01 CARDIOVASCULAR SYSTEM
VASOPROTECTIVES
AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
Corticosteroids
ATC D07AA02 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, weak (group I)
ATC D07XA01 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, OTHER COMBINATIONS
Corticosteroids, weak, other combinations
ATC H02AB09 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
CORTICOSTEROIDS FOR SYSTEMIC USE
CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
Glucocorticoids
ATC S01BA02 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Corticosteroids, plain
ATC S01CB03 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Corticosteroids/antiinfectives/mydriatics in combination
ATC S02BA01 SENSORY ORGANS
OTOLOGICALS
CORTICOSTEROIDS
Corticosteroids
ATC D07BA04 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, COMBINATIONS WITH ANTISEPTICS
Corticosteroids, weak, combinations with antiseptics
ATC D07CA01 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS
Corticosteroids, weak, combinations with antibiotics
ATC R01AD60 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC S01BB01 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Corticosteroids and mydriatics in combination
ATC S01CA03 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Corticosteroids and antiinfectives in combination
ATC S02CA03 SENSORY ORGANS
OTOLOGICALS
CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION
Corticosteroids and antiinfectives in combination
ATC S03CA04 SENSORY ORGANS
OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION
Corticosteroids and antiinfectives in combination
FDA EPC N0000175576 Corticosteroid
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
MeSH PA D000893 Anti-Inflammatory Agents
CHEBI has role CHEBI:35472 anti-inflammatory drug
CHEBI has role CHEBI:50857 anti-allergic agent
CHEBI has role CHEBI:49167 anti-asthmatic drug
CHEBI has role CHEBI:88188 drug allergen

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Disorder of musculoskeletal system indication 928000 DOID:17
Cerebral edema indication 2032001
Otitis externa indication 3135009
Proctitis indication 3951002 DOID:3127
Keratitis indication 5888003 DOID:4677
Tinea pedis indication 6020002 DOID:12403
Berylliosis indication 8247009 DOID:10322
Psoriasis indication 9014002 DOID:8893
Ankylosing spondylitis indication 9631008 DOID:7147
Cyclitis indication 17657000
Rheumatic heart disease indication 23685000
Atopic dermatitis indication 24079001 DOID:3310
Inflammatory bowel disease indication 24526004 DOID:0050589
Multiple sclerosis indication 24700007 DOID:2377
Severe adrenal insufficiency indication 24867002
Sarcoidosis indication 31541009 DOID:11335
Idiopathic thrombocytopenic purpura indication 32273002 DOID:8924
Psoriasis with arthropathy indication 33339001
Crohn's disease indication 34000006
Tendinitis indication 34840004 DOID:971
Erythema multiforme indication 36715001
Contact dermatitis indication 40275004 DOID:2773
Angioedema indication 41291007 DOID:1558
Humoral hypercalcemia of malignancy indication 47709007
Articular gout indication 48440001 DOID:13189
Seborrheic dermatitis indication 50563003 DOID:8741
Edema of larynx indication 51599000
Chronic ulcerative proctitis indication 52231000
Nephrotic syndrome indication 52254009 DOID:1184
Lichen simplex chronicus indication 53891004
Systemic lupus erythematosus indication 55464009 DOID:9074
Allergic rhinitis indication 61582004
Ulcerative colitis indication 64766004 DOID:8577
Löffler's syndrome indication 64936001 DOID:9503
Iritis indication 65074000 DOID:1406
Pemphigus indication 65172003 DOID:9182
Granuloma annulare indication 65508009 DOID:3777
Tenosynovitis indication 67801009 DOID:970
Blepharoconjunctivitis indication 68659002 DOID:2456
Rheumatoid arthritis indication 69896004 DOID:7148
Hemorrhoids indication 70153002 DOID:9746
Transfusion reaction due to serum protein reaction indication 72284000
Acquired thrombocytopenia indication 74576004 DOID:11126
Iridocyclitis indication 77971008
Thyroiditis indication 82119001 DOID:7166
Bursitis indication 84017003 DOID:2965
Tinea corporis indication 84849002
Autoimmune disease indication 85828009
Corneal abrasion indication 85848002
Infective otitis externa indication 86981007 DOID:9463
Infection by larvae of Trichinella spiralis indication 88264003
Acne vulgaris indication 88616000
Congenital hypoplastic anemia indication 88854002 DOID:1339
Pruritus ani indication 90446007
Corneal ulcer indication 91514001 DOID:8463
Acute lymphoid leukemia indication 91857003 DOID:9952
Dermatitis herpetiformis indication 111196000 DOID:8505
Hodgkin's disease indication 118599009
Non-Hodgkin's lymphoma indication 118601006
Mycosis fungoides indication 118618005
Uveitis indication 128473001 DOID:13141
Aspiration pneumonitis indication 155597006
Asthma indication 195967001 DOID:2841
Discoid lupus erythematosus indication 200938002
Plaque psoriasis indication 200965009
Transplanted organ rejection indication 213148006
Malignant otitis externa due to Pseudomonas aeruginosa indication 232230009
Scalp psoriasis indication 238608008
Punctate keratopathy indication 246936005
Adrenogenital disorder indication 267395000 DOID:0050811
Pruritus of genital organs indication 267802000
Eruption of skin indication 271807003 DOID:0050486
Infective blepharitis indication 312219000
Bacterial keratitis indication 314557000
Disorder of eye indication 371405004 DOID:5614
Primary adrenocortical insufficiency indication 373662000
Adrenal cortical hypofunction indication 386584007 DOID:10493
Herpes zoster keratitis indication 397573005
Rosacea indication 398909004 DOID:8881
Tinea cruris indication 399029005
Erythroderma indication 399992009
Primary cutaneous T-cell lymphoma indication 400122007
Recurrent herpes simplex labialis indication 402892009
Autoimmune hemolytic anemia indication 413603009 DOID:718
Synovitis indication 416209007 DOID:2703
Aphthous ulcer of mouth indication 426965005 DOID:9663
Allergic conjunctivitis indication 473460002 DOID:11204
Post traumatic osteoarthritis indication 699262001
Itching of ear indication 699392007
Inflammatory dermatosis indication 703938007
Diagnostic Test for Cushing's Syndrome indication
Post-Op Ocular Inflammation indication
Mastoidectomy Cavity Infections indication
Gingival Disorders indication
Minor Bacterial Skin Infections indication
Transfusion Reaction Urticaria indication
Systemic Dermatomyositis indication
Staphylococcus Aureus Otitis Externa indication
Synovitis due to Osteoarthritis indication
Superficial Ocular Infection indication
Erythroblastic Anemia indication
Chronic purulent otitis media off-label use 38394007 DOID:14247
Respiratory distress syndrome in the newborn off-label use 46775006
Adrenoleukodystrophy off-label use 65389002 DOID:10588
Pityriasis simplex off-label use 200767005
Congenital adrenal hyperplasia off-label use 237751000
Allergic otitis externa off-label use 405821001
Itching of skin off-label use 418363000
Otitis Externa Seborrhea off-label use
Neonatal Bronchopulmonary Dysplasia off-label use
Congenital Pituitary Hypoplasia off-label use
Otitis Externa Eczema off-label use
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Herpes simplex keratitis contraindication 9389005
Bacterial septicemia contraindication 10001005 DOID:0040085
Inactive tuberculosis contraindication 11999007
Peptic ulcer contraindication 13200003 DOID:750
Measles contraindication 14189004 DOID:8622
Esophagitis contraindication 16761005 DOID:11963
Mood swings contraindication 18963009
Infection of skin AND/OR subcutaneous tissue contraindication 19824006
Cirrhosis of liver contraindication 19943007 DOID:5082
Herpes zoster auricularis contraindication 21954000 DOID:9210
Glaucoma contraindication 23986001 DOID:1686
Abscess of intestine contraindication 24557004
Acute tuberculosis contraindication 25629007
Shock contraindication 27942005
Herpes simplex dendritic keratitis contraindication 29943008
Fungal infection of eye contraindication 31194008
Bullous myringitis contraindication 33528003 DOID:13791
Severe myopia contraindication 34187009
Hyperthyroidism contraindication 34486009 DOID:7998
Gastrointestinal fistula contraindication 37831005
Hypertensive disorder contraindication 38341003 DOID:10763
Infectious disease contraindication 40733004
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Chronic heart failure contraindication 48447003
Tuberculosis of eye contraindication 49107007
Duodenal ulcer disease contraindication 51868009 DOID:1724
Perforation of tympanic membrane contraindication 60442001
Osteoporosis contraindication 64859006 DOID:11476
Psychotic disorder contraindication 69322001
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Third degree burn injury contraindication 80247002
Hyperglycemia contraindication 80394007 DOID:4195
Decreased respiratory function contraindication 80954004
Open-angle glaucoma contraindication 84494001 DOID:1067
Krukenberg spindle contraindication 85430004
Herpes simplex contraindication 88594005 DOID:8566
Kidney disease contraindication 90708001 DOID:557
Disorder of mucous membrane contraindication 95351003
Bilateral cataracts contraindication 95722004
Open wound contraindication 125643001
Eye infection contraindication 128351009
Seizure disorder contraindication 128613002
Bacterial infection of eye contraindication 128984004
Disorder of muscle contraindication 129565002 DOID:423
Tuberculosis of ear contraindication 186269001
Ophthalmic herpes simplex contraindication 186542001
Heart block contraindication 233916004
Anastomosis of intestine contraindication 235407009
Disease of liver contraindication 235856003 DOID:409
Condyloma acuminatum contraindication 240542006 DOID:11168
Telangiectasia disorder contraindication 247479008
Diverticulitis of gastrointestinal tract contraindication 271366000
Injury of eye region contraindication 282752000
Varicella-zoster virus infection contraindication 309465005
Viral eye infection contraindication 312132001
Viral ear infection contraindication 312137007
Fungal ear infection contraindication 312148000
Infective otitis media contraindication 312218008
Skin irritation contraindication 367466007
Vaccinia keratitis contraindication 397552005
Gastric ulcer contraindication 397825006 DOID:10808
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
Blister contraindication 417237009
Denuded skin contraindication 418242004
Exposure to varicella contraindication 444453009

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.31 acidic
pKa2 13.65 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1% XERESE BAUSCH N022436 July 31, 2009 RX CREAM TOPICAL 7223387 Nov. 13, 2022 COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION HEALING TIME IN ADULTS AND CHILDREN (6 YEARS OF AGE AND OLDER)
1% XERESE BAUSCH N022436 July 31, 2009 RX CREAM TOPICAL 7223387 Nov. 13, 2022 NEW COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION HEALING TIME IN ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OLDER)

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST EC50 8.50 WOMBAT-PK CHEMBL
Nitric oxide synthase, inducible Enzyme IC50 8 WOMBAT-PK
Corticosteroid-binding globulin Secreted Ki 7.88 WOMBAT-PK
Annexin A1 Cytosolic other WOMBAT-PK
Sex hormone-binding globulin Secreted Kd 6.20 CHEMBL
Mineralocorticoid receptor Nuclear hormone receptor AGONIST IC50 9.95 IUPHAR
Glucocorticoid receptor Transcription factor Kd 7.37 CHEMBL

External reference:

IDSource
D006854 MESH_DESCRIPTOR_UI
4017941 VUID
N0000146291 NUI
C0020268 UMLSCUI
D00088 KEGG_DRUG
16602005 SNOMEDCT_US
2500 MMSL
5492 RXNORM
396458002 SNOMEDCT_US
4837 MMSL
d00254 MMSL
4017941 VANDF
002147 NDDF
CHEMBL389621 ChEMBL_ID
DB00741 DRUGBANK_ID
HCY PDB_CHEM_ID
CHEBI:17650 CHEBI
WI4X0X7BPJ UNII
38 INN_ID
2868 IUPHAR_LIGAND_ID
5754 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 0009-0012 TABLET 5 mg ORAL NDA 11 sections
CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 0009-0031 TABLET 10 mg ORAL NDA 11 sections
CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 0009-0044 TABLET 20 mg ORAL NDA 11 sections
CIPRO HUMAN PRESCRIPTION DRUG LABEL 2 0065-8531 SUSPENSION 10 mg AURICULAR (OTIC) NDA 11 sections
Aquanil HC HUMAN OTC DRUG LABEL 1 0096-0732 LOTION 0.01 g TOPICAL OTC monograph not final 10 sections
good sense anti itch HUMAN OTC DRUG LABEL 1 0113-0541 CREAM 1 g TOPICAL OTC monograph not final 9 sections
basic care hydrocortisone HUMAN OTC DRUG LABEL 1 0113-0793 CREAM 1 g TOPICAL OTC monograph not final 9 sections
Good Sense Anti Itch HUMAN OTC DRUG LABEL 1 0113-0973 CREAM 1 g TOPICAL OTC monograph not final 9 sections
good sense anti itch HUMAN OTC DRUG LABEL 1 0113-1369 CREAM 1 g TOPICAL OTC monograph not final 9 sections
Basic Case Hydrocortisone Anti-Itch HUMAN OTC DRUG LABEL 1 0113-7006 CREAM 1 g TOPICAL OTC monograph not final 13 sections
basic care hydrocortisone HUMAN OTC DRUG LABEL 1 0113-7369 CREAM 1 g TOPICAL OTC monograph not final 9 sections
HYDROCORTISONE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1696 TABLET 5 mg ORAL ANDA 11 sections
HYDROCORTISONE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1697 TABLET 10 mg ORAL ANDA 11 sections
HYDROCORTISONE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1700 TABLET 20 mg ORAL ANDA 11 sections
HYDROCORTISONE HUMAN OTC DRUG LABEL 1 0168-0014 CREAM 5 mg TOPICAL OTC monograph final 9 sections
hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0168-0015 CREAM 10 mg TOPICAL ANDA 11 sections
HYDROCORTISONE HUMAN OTC DRUG LABEL 1 0168-0016 OINTMENT 5 mg TOPICAL OTC monograph final 9 sections
Hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0168-0020 OINTMENT 10 mg TOPICAL ANDA 11 sections
Hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0168-0080 CREAM 25 mg TOPICAL ANDA 11 sections
Hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0168-0146 OINTMENT 25 mg TOPICAL ANDA 11 sections
HYDROCORTISONE HUMAN OTC DRUG LABEL 1 0168-0154 CREAM 10 mg TOPICAL OTC monograph not final 9 sections
HYDROCORTISONE HUMAN OTC DRUG LABEL 1 0168-0181 OINTMENT 10 mg TOPICAL OTC monograph not final 9 sections
Hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0168-0288 LOTION 25 mg TOPICAL ANDA 11 sections
Texacort HUMAN PRESCRIPTION DRUG LABEL 1 0178-0455 SOLUTION 25 mg TOPICAL ANDA 11 sections
Hydrocortisone HUMAN OTC DRUG LABEL 1 0179-8016 CREAM 0.50 g TOPICAL OTC monograph not final 10 sections
KAISER PERMANENTE HUMAN OTC DRUG LABEL 1 0179-8711 OINTMENT 1 g TOPICAL OTC monograph not final 10 sections
CeraVe HUMAN OTC DRUG LABEL 1 0187-2486 CREAM 10 mg TOPICAL OTC monograph not final 10 sections
Xerese HUMAN PRESCRIPTION DRUG LABEL 2 0187-5104 CREAM 10 mg TOPICAL NDA 17 sections
Cortaid HUMAN OTC DRUG LABEL 1 0187-5518 SPRAY 10 g TOPICAL OTC monograph not final 10 sections
Cortaid 12-Hour Advanced HUMAN OTC DRUG LABEL 1 0187-5519 CREAM 1 g TOPICAL OTC monograph not final 14 sections