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clobetasol propionate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| prednisone and prednisolone derivatives | 4452 | 25122-46-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A derivative of PREDNISOLONE with high glucocorticoid activity and low mineralocorticoid activity. Absorbed through the skin faster than FLUOCINONIDE, it is used topically in treatment of PSORIASIS but may cause marked adrenocortical suppression.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.11 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 3.625 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 1.062 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 79.068 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 78.343 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 2.880 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 3.910 | % | High | 1 |
| herg | hERG pIC50 | 4.841 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 88.716 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 231.739 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 3.080 | % | High | 1 |
| kinase-safety-class | ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CG,PRKDC,STK33,SYK,TEK,TGFBR1,ZAP70 | 28 | |||
| kinase-selectivity-class | AXL,GRK2,MAP2K6 | 3 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 2.404 | Moderate | 0.65 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 3.802 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 127.644 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 2.570 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 10.593 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 0 | Moderate | 0.70 | |
| pppb | Pig plasma protein binding (% unbound) | 5.680 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.352 | % | Moderate | 0.65 |
| rh-clint | Rat hepatocyte intrinsic clearance | 135.207 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 18.090 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 1.630 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 10.351 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 24, 2021 | PMDA | Maruho Co., Ltd. | |
| Dec. 27, 1985 | FDA | FOUGERA PHARMS |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Dermatitis atopic | 297.10 | 13.56 | 123 | 16083 | 23349 | 90588892 |
| Dry skin | 267.78 | 13.56 | 177 | 16029 | 87896 | 90524345 |
| Skin exfoliation | 260.19 | 13.56 | 158 | 16048 | 67755 | 90544486 |
| Pruritus | 238.86 | 13.56 | 380 | 15826 | 541145 | 90071096 |
| Psoriasis | 226.11 | 13.56 | 197 | 16009 | 147557 | 90464684 |
| Eczema | 172.18 | 13.56 | 111 | 16095 | 52759 | 90559482 |
| Skin atrophy | 163.10 | 13.56 | 54 | 16152 | 5475 | 90606766 |
| Product use in unapproved indication | 157.55 | 13.56 | 243 | 15963 | 335993 | 90276248 |
| Skin fissures | 133.42 | 13.56 | 68 | 16138 | 20741 | 90591500 |
| Squamous cell carcinoma of skin | 129.05 | 13.56 | 49 | 16157 | 7400 | 90604841 |
| Injection site pain | 128.94 | 13.56 | 157 | 16049 | 173542 | 90438699 |
| Product dose omission issue | 87.04 | 13.56 | 173 | 16033 | 291514 | 90320727 |
| Drug ineffective | 72.74 | 13.56 | 458 | 15748 | 1383840 | 89228401 |
| Skin haemorrhage | 69.83 | 13.56 | 45 | 16161 | 21335 | 90590906 |
| Erythema | 58.97 | 13.56 | 128 | 16078 | 229118 | 90383123 |
| Skin plaque | 53.68 | 13.56 | 29 | 16177 | 9946 | 90602295 |
| Infusion related reaction | 53.56 | 13.56 | 6 | 16200 | 416774 | 90195467 |
| Therapeutic response shortened | 48.60 | 13.56 | 37 | 16169 | 22842 | 90589399 |
| Rash | 46.99 | 13.56 | 272 | 15934 | 795828 | 89816413 |
| Skin swelling | 46.45 | 13.56 | 23 | 16183 | 6591 | 90605650 |
| Exposure via skin contact | 46.39 | 13.56 | 27 | 16179 | 10678 | 90601563 |
| Delayed myelination | 45.78 | 13.56 | 6 | 16200 | 0 | 90612241 |
| Synovitis | 44.30 | 13.56 | 4 | 16202 | 329748 | 90282493 |
| Glossodynia | 42.96 | 13.56 | 4 | 16202 | 321775 | 90290466 |
| Systemic lupus erythematosus | 42.25 | 13.56 | 7 | 16199 | 361889 | 90250352 |
| Pemphigus | 41.24 | 13.56 | 5 | 16201 | 326859 | 90285382 |
| Papule | 39.56 | 13.56 | 22 | 16184 | 7980 | 90604261 |
| Cushing's syndrome | 39.41 | 13.56 | 11 | 16195 | 625 | 90611616 |
| Neoplasm skin | 38.16 | 13.56 | 16 | 16190 | 3126 | 90609115 |
| Contraindicated product administered | 37.79 | 13.56 | 6 | 16200 | 320133 | 90292108 |
| Neurodermatitis | 35.32 | 13.56 | 15 | 16191 | 3023 | 90609218 |
| Wound | 35.05 | 13.56 | 6 | 16200 | 302974 | 90309267 |
| Biliary sepsis | 34.65 | 13.56 | 11 | 16195 | 975 | 90611266 |
| Cushingoid | 34.24 | 13.56 | 22 | 16184 | 10373 | 90601868 |
| Illness | 33.77 | 13.56 | 56 | 16150 | 81913 | 90530328 |
| Skin burning sensation | 33.70 | 13.56 | 28 | 16178 | 19583 | 90592658 |
| Ochronosis | 33.18 | 13.56 | 6 | 16200 | 43 | 90612198 |
| Skin weeping | 33.14 | 13.56 | 14 | 16192 | 2786 | 90609455 |
| Accidental exposure to product | 32.51 | 13.56 | 39 | 16167 | 42327 | 90569914 |
| Drug intolerance | 32.41 | 13.56 | 20 | 16186 | 447571 | 90164670 |
| Pain of skin | 29.81 | 13.56 | 24 | 16182 | 16058 | 90596183 |
| Eye pruritus | 29.61 | 13.56 | 31 | 16175 | 28996 | 90583245 |
| Dermatitis bullous | 29.52 | 13.56 | 20 | 16186 | 10296 | 90601945 |
| Rheumatoid arthritis | 27.96 | 13.56 | 15 | 16191 | 362599 | 90249642 |
| Steroid diabetes | 27.92 | 13.56 | 12 | 16194 | 2490 | 90609751 |
| Dry eye | 27.18 | 13.56 | 42 | 16164 | 57889 | 90554352 |
| Arthropathy | 27.02 | 13.56 | 16 | 16190 | 366226 | 90246015 |
| Injection site alopecia | 26.95 | 13.56 | 5 | 16201 | 42 | 90612199 |
| Toxicity to various agents | 26.83 | 13.56 | 9 | 16197 | 287837 | 90324404 |
| Xerosis | 26.39 | 13.56 | 10 | 16196 | 1501 | 90610740 |
| Impaired healing | 26.29 | 13.56 | 5 | 16201 | 234194 | 90378047 |
| Irritable bowel syndrome | 24.22 | 13.56 | 4 | 16202 | 207444 | 90404797 |
| Macule | 23.99 | 13.56 | 11 | 16195 | 2658 | 90609583 |
| Folliculitis | 23.73 | 13.56 | 4 | 16202 | 204349 | 90407892 |
| Resting tremor | 23.56 | 13.56 | 8 | 16198 | 875 | 90611366 |
| Rash macular | 23.44 | 13.56 | 28 | 16178 | 30252 | 90581989 |
| Skin lesion | 23.27 | 13.56 | 31 | 16175 | 37334 | 90574907 |
| Necrotising fasciitis | 22.90 | 13.56 | 12 | 16194 | 3868 | 90608373 |
| Product container issue | 22.84 | 13.56 | 10 | 16196 | 2171 | 90610070 |
| Rash pruritic | 22.36 | 13.56 | 47 | 16159 | 82167 | 90530074 |
| Maternal exposure during pregnancy | 22.26 | 13.56 | 19 | 16187 | 360044 | 90252197 |
| Seborrhoeic keratosis | 22.16 | 13.56 | 11 | 16195 | 3169 | 90609072 |
| Inappropriate schedule of product administration | 22.15 | 13.56 | 68 | 16138 | 149865 | 90462376 |
| Sleep disorder due to a general medical condition | 21.78 | 13.56 | 33 | 16173 | 44705 | 90567536 |
| Swelling | 21.49 | 13.56 | 26 | 16180 | 419032 | 90193209 |
| Dermatitis | 21.37 | 13.56 | 23 | 16183 | 22197 | 90590044 |
| Ocular hyperaemia | 20.99 | 13.56 | 28 | 16178 | 33770 | 90578471 |
| Fibromyalgia | 20.02 | 13.56 | 6 | 16200 | 206263 | 90405978 |
| Lichen planopilaris | 19.74 | 13.56 | 5 | 16201 | 195 | 90612046 |
| Alopecia scarring | 19.64 | 13.56 | 5 | 16201 | 199 | 90612042 |
| Injection site swelling | 19.63 | 13.56 | 37 | 16169 | 59802 | 90552439 |
| Rash pustular | 19.29 | 13.56 | 14 | 16192 | 8035 | 90604206 |
| Drug ineffective for unapproved indication | 19.18 | 13.56 | 39 | 16167 | 66605 | 90545636 |
| Lichenification | 19.11 | 13.56 | 6 | 16200 | 513 | 90611728 |
| Dermatitis contact | 18.50 | 13.56 | 17 | 16189 | 13578 | 90598663 |
| Incorrect dose administered | 17.94 | 13.56 | 42 | 16164 | 78888 | 90533353 |
| Lentigo | 17.80 | 13.56 | 6 | 16200 | 642 | 90611599 |
| Haemangioma of skin | 17.60 | 13.56 | 6 | 16200 | 664 | 90611577 |
| Hypothalamic pituitary adrenal axis suppression | 17.14 | 13.56 | 5 | 16201 | 333 | 90611908 |
| Stress | 17.09 | 13.56 | 42 | 16164 | 81353 | 90530888 |
| Hepatic enzyme increased | 16.83 | 13.56 | 24 | 16182 | 360712 | 90251529 |
| Confusional state | 16.76 | 13.56 | 27 | 16179 | 386178 | 90226063 |
| Skin disorder | 16.37 | 13.56 | 26 | 16180 | 36680 | 90575561 |
| General physical health deterioration | 16.20 | 13.56 | 24 | 16182 | 355091 | 90257150 |
| Bronchiolitis obliterans syndrome | 16.17 | 13.56 | 5 | 16201 | 406 | 90611835 |
| Lacrimation increased | 16.16 | 13.56 | 22 | 16184 | 27040 | 90585201 |
| Pemphigoid | 15.74 | 13.56 | 13 | 16193 | 9013 | 90603228 |
| Skin striae | 15.71 | 13.56 | 7 | 16199 | 1584 | 90610657 |
| Rebound atopic dermatitis | 15.65 | 13.56 | 7 | 16199 | 1597 | 90610644 |
| Product physical consistency issue | 15.53 | 13.56 | 6 | 16200 | 948 | 90611293 |
| Blood cholesterol increased | 15.45 | 13.56 | 9 | 16197 | 208003 | 90404238 |
| Infected dermal cyst | 15.34 | 13.56 | 5 | 16201 | 482 | 90611759 |
| Oral herpes | 15.30 | 13.56 | 24 | 16182 | 33500 | 90578741 |
| Skin abrasion | 15.19 | 13.56 | 14 | 16192 | 11221 | 90601020 |
| Cortisol decreased | 15.03 | 13.56 | 7 | 16199 | 1752 | 90610489 |
| Skin irritation | 14.73 | 13.56 | 15 | 16191 | 13588 | 90598653 |
| Lower respiratory tract infection | 14.56 | 13.56 | 14 | 16192 | 250645 | 90361596 |
| Adrenal insufficiency | 14.46 | 13.56 | 22 | 16184 | 29899 | 90582342 |
| Eyelid skin dryness | 14.45 | 13.56 | 5 | 16201 | 579 | 90611662 |
| Injection site bruising | 14.33 | 13.56 | 30 | 16176 | 52277 | 90559964 |
| Skin discolouration | 14.04 | 13.56 | 27 | 16179 | 44288 | 90567953 |
| Dermatitis exfoliative generalised | 14.03 | 13.56 | 10 | 16196 | 5583 | 90606658 |
| Injury | 14.01 | 13.56 | 9 | 16197 | 197340 | 90414901 |
| Nasal polypectomy | 13.91 | 13.56 | 3 | 16203 | 57 | 90612184 |
| Cutaneous lupus erythematosus | 13.87 | 13.56 | 8 | 16198 | 3110 | 90609131 |
| Injection site pruritus | 13.74 | 13.56 | 30 | 16176 | 53804 | 90558437 |
| Ill-defined disorder | 13.73 | 13.56 | 8 | 16198 | 184883 | 90427358 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Dermatitis atopic | 252.31 | 17.53 | 94 | 8277 | 12310 | 42600654 |
| Psoriasis | 227.81 | 17.53 | 133 | 8238 | 48471 | 42564493 |
| Pruritus | 198.34 | 17.53 | 213 | 8158 | 188558 | 42424406 |
| Skin exfoliation | 169.39 | 17.53 | 104 | 8267 | 41449 | 42571515 |
| Dry skin | 145.44 | 17.53 | 100 | 8271 | 48238 | 42564726 |
| Skin fissures | 142.36 | 17.53 | 58 | 8313 | 9618 | 42603346 |
| Rash | 85.95 | 17.53 | 176 | 8195 | 276778 | 42336186 |
| Eczema | 85.12 | 17.53 | 63 | 8308 | 34023 | 42578941 |
| Skin haemorrhage | 66.51 | 17.53 | 32 | 8339 | 7853 | 42605111 |
| Product use in unapproved indication | 62.80 | 17.53 | 122 | 8249 | 184334 | 42428630 |
| Drug ineffective | 59.41 | 17.53 | 262 | 8109 | 629935 | 41983029 |
| Onychoclasis | 57.18 | 17.53 | 21 | 8350 | 2631 | 42610333 |
| Human herpesvirus 8 infection | 40.39 | 17.53 | 14 | 8357 | 1483 | 42611481 |
| Injection site pain | 40.12 | 17.53 | 53 | 8318 | 57745 | 42555219 |
| Erythema | 38.22 | 17.53 | 73 | 8298 | 108720 | 42504244 |
| Injection site swelling | 32.85 | 17.53 | 27 | 8344 | 16946 | 42596018 |
| Pemphigoid | 32.72 | 17.53 | 23 | 8348 | 11444 | 42601520 |
| Rash erythematous | 31.35 | 17.53 | 35 | 8336 | 32056 | 42580908 |
| Product dose omission issue | 30.07 | 17.53 | 82 | 8289 | 154283 | 42458681 |
| Papule | 30.03 | 17.53 | 17 | 8354 | 5809 | 42607155 |
| Skin atrophy | 29.97 | 17.53 | 13 | 8358 | 2512 | 42610452 |
| Psoriatic arthropathy | 29.28 | 17.53 | 30 | 8341 | 24937 | 42588027 |
| Arthralgia | 28.68 | 17.53 | 97 | 8274 | 205141 | 42407823 |
| Folliculitis | 28.06 | 17.53 | 16 | 8355 | 5542 | 42607422 |
| Skin plaque | 27.27 | 17.53 | 16 | 8355 | 5847 | 42607117 |
| Intentional product misuse to child | 26.59 | 17.53 | 5 | 8366 | 41 | 42612923 |
| Dry eye | 26.57 | 17.53 | 23 | 8348 | 15483 | 42597481 |
| Scratch | 26.18 | 17.53 | 15 | 8356 | 5246 | 42607718 |
| Skin weeping | 25.05 | 17.53 | 10 | 8361 | 1569 | 42611395 |
| Inappropriate schedule of product administration | 25.04 | 17.53 | 57 | 8314 | 95845 | 42517119 |
| Death | 24.71 | 17.53 | 34 | 8337 | 471151 | 42141813 |
| Cushing's syndrome | 24.69 | 17.53 | 7 | 8364 | 383 | 42612581 |
| Necrotising fasciitis | 22.72 | 17.53 | 13 | 8358 | 4533 | 42608431 |
| Injection site erythema | 21.41 | 17.53 | 23 | 8348 | 20172 | 42592792 |
| Therapeutic response decreased | 21.26 | 17.53 | 31 | 8340 | 36981 | 42575983 |
| Therapeutic response shortened | 21.02 | 17.53 | 19 | 8352 | 13535 | 42599429 |
| Therapeutic product effect incomplete | 20.59 | 17.53 | 44 | 8327 | 70895 | 42542069 |
| Blister | 20.29 | 17.53 | 26 | 8345 | 27464 | 42585500 |
| Acarodermatitis | 20.15 | 17.53 | 7 | 8364 | 746 | 42612218 |
| Skin swelling | 19.42 | 17.53 | 10 | 8361 | 2832 | 42610132 |
| Melanocytic naevus | 18.94 | 17.53 | 10 | 8361 | 2982 | 42609982 |
| Angioplasty | 17.92 | 17.53 | 7 | 8364 | 1037 | 42611927 |
| Seborrhoeic keratosis | 17.88 | 17.53 | 8 | 8363 | 1663 | 42611301 |
| Rash pruritic | 17.66 | 17.53 | 27 | 8344 | 33576 | 42579388 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Dermatitis atopic | 329.59 | 13.68 | 134 | 18776 | 25407 | 110544982 |
| Psoriasis | 277.47 | 13.68 | 213 | 18697 | 139780 | 110430609 |
| Pruritus | 244.66 | 13.68 | 390 | 18520 | 581170 | 109989219 |
| Dry skin | 242.69 | 13.68 | 177 | 18733 | 107476 | 110462913 |
| Skin exfoliation | 232.04 | 13.68 | 159 | 18751 | 87492 | 110482897 |
| Skin fissures | 202.97 | 13.68 | 94 | 18816 | 24364 | 110546025 |
| Skin atrophy | 191.97 | 13.68 | 63 | 18847 | 6501 | 110563888 |
| Eczema | 147.46 | 13.68 | 112 | 18798 | 72181 | 110498208 |
| Cushing's syndrome | 137.93 | 13.68 | 32 | 18878 | 898 | 110569491 |
| Product use in unapproved indication | 130.58 | 13.68 | 256 | 18654 | 447121 | 110123268 |
| Injection site pain | 116.93 | 13.68 | 148 | 18762 | 177774 | 110392615 |
| Squamous cell carcinoma of skin | 100.36 | 13.68 | 52 | 18858 | 17151 | 110553238 |
| Skin haemorrhage | 90.20 | 13.68 | 55 | 18855 | 24772 | 110545617 |
| Rash | 74.35 | 13.68 | 307 | 18603 | 820657 | 109749732 |
| Product dose omission issue | 66.10 | 13.68 | 160 | 18750 | 321622 | 110248767 |
| Necrotising fasciitis | 53.24 | 13.68 | 26 | 18884 | 7565 | 110562824 |
| Exposure via skin contact | 52.61 | 13.68 | 31 | 18879 | 13116 | 110557273 |
| Pemphigoid | 47.99 | 13.68 | 34 | 18876 | 19673 | 110550716 |
| Cushingoid | 47.88 | 13.68 | 28 | 18882 | 11684 | 110558705 |
| Delayed myelination | 46.05 | 13.68 | 6 | 18904 | 0 | 110570389 |
| Erythema | 45.62 | 13.68 | 131 | 18779 | 291316 | 110279073 |
| Neoplasm skin | 45.41 | 13.68 | 18 | 18892 | 3186 | 110567203 |
| Incorrect product administration duration | 44.52 | 13.68 | 33 | 18877 | 20465 | 110549924 |
| Inappropriate schedule of product administration | 41.49 | 13.68 | 101 | 18809 | 203536 | 110366853 |
| Skin swelling | 40.28 | 13.68 | 22 | 18888 | 8058 | 110562331 |
| Onychoclasis | 39.71 | 13.68 | 21 | 18889 | 7216 | 110563173 |
| Skin weeping | 39.43 | 13.68 | 17 | 18893 | 3718 | 110566671 |
| Injection site swelling | 38.33 | 13.68 | 50 | 18860 | 61740 | 110508649 |
| Therapeutic response shortened | 37.78 | 13.68 | 35 | 18875 | 29548 | 110540841 |
| Dermatitis bullous | 37.58 | 13.68 | 28 | 18882 | 17501 | 110552888 |
| Toxicity to various agents | 36.95 | 13.68 | 18 | 18892 | 480537 | 110089852 |
| Synovitis | 35.67 | 13.68 | 3 | 18907 | 274089 | 110296300 |
| Hypothalamic pituitary adrenal axis suppression | 34.63 | 13.68 | 10 | 18900 | 672 | 110569717 |
| Infusion related reaction | 32.95 | 13.68 | 12 | 18898 | 381150 | 110189239 |
| Dry eye | 32.83 | 13.68 | 44 | 18866 | 55749 | 110514640 |
| Injection site pruritus | 32.61 | 13.68 | 42 | 18868 | 51216 | 110519173 |
| Adrenal insufficiency | 32.23 | 13.68 | 38 | 18872 | 42352 | 110528037 |
| Accidental exposure to product | 31.85 | 13.68 | 41 | 18869 | 49967 | 110520422 |
| Ochronosis | 31.32 | 13.68 | 6 | 18904 | 64 | 110570325 |
| Sleep disorder due to a general medical condition | 30.52 | 13.68 | 41 | 18869 | 52071 | 110518318 |
| Contraindicated product administered | 29.04 | 13.68 | 4 | 18906 | 248263 | 110322126 |
| Biliary sepsis | 28.40 | 13.68 | 11 | 18899 | 1832 | 110568557 |
| Drug ineffective | 28.17 | 13.68 | 389 | 18521 | 1520151 | 109050238 |
| Systemic lupus erythematosus | 27.71 | 13.68 | 5 | 18905 | 254333 | 110316056 |
| Eye pruritus | 27.65 | 13.68 | 31 | 18879 | 32744 | 110537645 |
| Pain of skin | 26.16 | 13.68 | 24 | 18886 | 20005 | 110550384 |
| Rash pruritic | 25.96 | 13.68 | 54 | 18856 | 98015 | 110472374 |
| Adrenal suppression | 25.70 | 13.68 | 10 | 18900 | 1686 | 110568703 |
| Steroid diabetes | 25.35 | 13.68 | 14 | 18896 | 5240 | 110565149 |
| Wound | 24.71 | 13.68 | 5 | 18905 | 234432 | 110335957 |
| Skin burning sensation | 24.41 | 13.68 | 24 | 18886 | 21801 | 110548588 |
| Skin disorder | 23.97 | 13.68 | 33 | 18877 | 42880 | 110527509 |
| Injection site erythema | 23.93 | 13.68 | 51 | 18859 | 94125 | 110476264 |
| Rebound atopic dermatitis | 23.90 | 13.68 | 10 | 18900 | 2031 | 110568358 |
| Cortisol decreased | 23.83 | 13.68 | 11 | 18899 | 2825 | 110567564 |
| Neurodermatitis | 23.48 | 13.68 | 11 | 18899 | 2921 | 110567468 |
| Beta haemolytic streptococcal infection | 23.34 | 13.68 | 11 | 18899 | 2960 | 110567429 |
| Skin striae | 23.18 | 13.68 | 10 | 18900 | 2191 | 110568198 |
| Glossodynia | 22.85 | 13.68 | 5 | 18905 | 221999 | 110348390 |
| Chorioretinopathy | 22.78 | 13.68 | 10 | 18900 | 2285 | 110568104 |
| Skin irritation | 22.19 | 13.68 | 20 | 18890 | 16299 | 110554090 |
| Rheumatoid arthritis | 21.86 | 13.68 | 12 | 18898 | 299601 | 110270788 |
| Pemphigus | 21.75 | 13.68 | 5 | 18905 | 214565 | 110355824 |
| Human herpesvirus 8 infection | 21.35 | 13.68 | 9 | 18901 | 1862 | 110568527 |
| Drug intolerance | 21.13 | 13.68 | 23 | 18887 | 406489 | 110163900 |
| Kerion | 20.94 | 13.68 | 3 | 18907 | 3 | 110570386 |
| Intentional product misuse to child | 19.67 | 13.68 | 5 | 18905 | 207 | 110570182 |
| Illness | 19.17 | 13.68 | 43 | 18867 | 82128 | 110488261 |
| Lacrimation increased | 19.12 | 13.68 | 25 | 18885 | 30925 | 110539464 |
| Papule | 19.11 | 13.68 | 15 | 18895 | 10118 | 110560271 |
| Resting tremor | 18.71 | 13.68 | 8 | 18902 | 1715 | 110568674 |
| Ocular hyperaemia | 18.70 | 13.68 | 28 | 18882 | 39258 | 110531131 |
| Intentional dose omission | 18.68 | 13.68 | 20 | 18890 | 20060 | 110550329 |
| Irritable bowel syndrome | 18.39 | 13.68 | 3 | 18907 | 164212 | 110406177 |
| Streptococcal infection | 18.16 | 13.68 | 15 | 18895 | 10875 | 110559514 |
| Dermatitis exfoliative generalised | 18.06 | 13.68 | 15 | 18895 | 10957 | 110559432 |
| Lichenoid keratosis | 18.00 | 13.68 | 12 | 18898 | 6290 | 110564099 |
| Dermatitis | 18 | 13.68 | 23 | 18887 | 27814 | 110542575 |
| Drug ineffective for unapproved indication | 17.81 | 13.68 | 48 | 18862 | 102790 | 110467599 |
| Product dose omission in error | 17.74 | 13.68 | 21 | 18889 | 23491 | 110546898 |
| Arthropathy | 17.61 | 13.68 | 14 | 18896 | 287508 | 110282881 |
| Eyelid skin dryness | 17.53 | 13.68 | 6 | 18904 | 703 | 110569686 |
| Cerebral palsy | 17.40 | 13.68 | 5 | 18905 | 330 | 110570059 |
| General physical health deterioration | 17.11 | 13.68 | 29 | 18881 | 425266 | 110145123 |
| Dermatitis contact | 16.84 | 13.68 | 16 | 18894 | 13937 | 110556452 |
| Incorrect dose administered | 16.59 | 13.68 | 47 | 18863 | 103594 | 110466795 |
| Secondary adrenocortical insufficiency | 16.56 | 13.68 | 10 | 18900 | 4424 | 110565965 |
| Cutaneous T-cell lymphoma | 16.28 | 13.68 | 9 | 18901 | 3375 | 110567014 |
| Death | 16.25 | 13.68 | 63 | 18847 | 698806 | 109871583 |
| Skin plaque | 16.22 | 13.68 | 15 | 18895 | 12630 | 110557759 |
| Oral herpes | 16.16 | 13.68 | 25 | 18885 | 36055 | 110534334 |
| Acne | 16.11 | 13.68 | 24 | 18886 | 33496 | 110536893 |
| Rash erythematous | 16.02 | 13.68 | 40 | 18870 | 81792 | 110488597 |
| Scratch | 15.89 | 13.68 | 15 | 18895 | 12964 | 110557425 |
| Hypotension | 15.82 | 13.68 | 42 | 18868 | 523807 | 110046582 |
| Disseminated paracoccidioidomycosis | 15.74 | 13.68 | 3 | 18907 | 31 | 110570358 |
| Urethral disorder | 15.50 | 13.68 | 5 | 18905 | 488 | 110569901 |
| Fibromyalgia | 15.41 | 13.68 | 5 | 18905 | 170904 | 110399485 |
| Confusional state | 15.38 | 13.68 | 36 | 18874 | 468644 | 110101745 |
| Glucose tolerance impaired | 15.27 | 13.68 | 13 | 18897 | 9824 | 110560565 |
| Drug interaction | 15.18 | 13.68 | 40 | 18870 | 500143 | 110070246 |
| Alopecia scarring | 15.14 | 13.68 | 4 | 18906 | 193 | 110570196 |
| Tinea capitis | 14.78 | 13.68 | 3 | 18907 | 44 | 110570345 |
| Myalgia | 14.69 | 13.68 | 76 | 18834 | 222305 | 110348084 |
| Upper limb fracture | 14.69 | 13.68 | 18 | 18892 | 20870 | 110549519 |
| Acarodermatitis | 14.54 | 13.68 | 7 | 18903 | 1974 | 110568415 |
| Erythrodermic psoriasis | 14.44 | 13.68 | 7 | 18903 | 2003 | 110568386 |
| Skin lesion | 14.33 | 13.68 | 29 | 18881 | 51602 | 110518787 |
| Seborrhoeic keratosis | 14.03 | 13.68 | 8 | 18902 | 3184 | 110567205 |
| Burning sensation | 13.73 | 13.68 | 34 | 18876 | 69178 | 110501211 |
| Maternal exposure during pregnancy | 13.71 | 13.68 | 14 | 18896 | 254869 | 110315520 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D07AD01 | DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, very potent (group IV) |
| ATC | D07CD01 | DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS Corticosteroids, very potent, combinations with antibiotics |
| ATC | S01BA17 | SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Corticosteroids, plain |
| FDA MoA | N0000175450 | Corticosteroid Hormone Receptor Agonists |
| FDA EPC | N0000175576 | Corticosteroid |
| MeSH PA | D000893 | Anti-Inflammatory Agents |
| MeSH PA | D005938 | Glucocorticoids |
| MeSH PA | D006728 | Hormones |
| CHEBI has role | CHEBI:35472 | anti-inflammatory drug |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35842 | antirheumatic drug |
| CHEBI has role | CHEBI:50177 | dermatologic drug |
| CHEBI has role | CHEBI:50748 | antipsoriatic |
| CHEBI has role | CHEBI:66981 | ophthalmology drug |
| CHEBI has role | CHEBI:64952 | anti-HSV agent |
| CHEBI has role | CHEBI:131809 | SMO receptor agonist |
Related Drugs by ATC class:
D07AD Corticosteroids, very potent (group IV) 1 drug
S01BA Corticosteroids, plain 15 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Atopic dermatitis | indication | 24079001 | DOID:3310 |
| Contact dermatitis | indication | 40275004 | DOID:2773 |
| Seborrheic dermatitis | indication | 50563003 | DOID:8741 |
| Nummular eczema | indication | 81418003 | |
| Plaque psoriasis | indication | 200965009 | |
| Scalp psoriasis | indication | 238608008 | |
| Dermatosis of scalp | indication | 402694007 | DOID:3136 |
| Inflammatory dermatosis | indication | 703938007 | |
| Folliculitis | contraindication | 13600006 | DOID:4409 |
| Glaucoma | contraindication | 23986001 | DOID:1686 |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Hyperglycemia | contraindication | 80394007 | DOID:4195 |
| Open wound | contraindication | 125643001 | |
| Skin striae | contraindication | 201066002 | |
| Adrenal cortical hypofunction | contraindication | 386584007 | DOID:10493 |
| Atrophoderma | contraindication | 399979006 | |
| Peripheral vascular disease | contraindication | 400047006 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.48 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OLUX E | PHARMOBEDIENT | N022013 | Jan. 12, 2007 | DISCN | AEROSOL, FOAM | TOPICAL | 8460641 | Nov. 5, 2028 | TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES |
| 0.025% | IMPOYZ | PRIMUS PHARMS | N209483 | Nov. 28, 2017 | RX | CREAM | TOPICAL | 10064875 | Aug. 31, 2030 | PSORIASIS |
| 0.025% | IMPOYZ | PRIMUS PHARMS | N209483 | Nov. 28, 2017 | RX | CREAM | TOPICAL | 10064875 | Aug. 31, 2030 | TREATMENT OF MODERATE PLAQUE PSORIASIS |
| 0.025% | IMPOYZ | PRIMUS PHARMS | N209483 | Nov. 28, 2017 | RX | CREAM | TOPICAL | 10064875 | Aug. 31, 2030 | TREATMENT OF PLAQUE PSORIASIS |
| 0.025% | IMPOYZ | PRIMUS PHARMS | N209483 | Nov. 28, 2017 | RX | CREAM | TOPICAL | 10064875 | Aug. 31, 2030 | TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER |
| 0.025% | IMPOYZ | PRIMUS PHARMS | N209483 | Nov. 28, 2017 | RX | CREAM | TOPICAL | 10064875 | Aug. 31, 2030 | TWICE DAILY TOPICAL TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS. |
| 0.025% | IMPOYZ | PRIMUS PHARMS | N209483 | Nov. 28, 2017 | RX | CREAM | TOPICAL | 10588914 | Aug. 31, 2030 | TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER |
| 0.025% | IMPOYZ | PRIMUS PHARMS | N209483 | Nov. 28, 2017 | RX | CREAM | TOPICAL | 11179465 | Aug. 31, 2030 | TREATMENT OF PLAQUE PSORIASIS |
| 0.025% | IMPOYZ | PRIMUS PHARMS | N209483 | Nov. 28, 2017 | RX | CREAM | TOPICAL | 9956231 | Aug. 31, 2030 | PLAQUE PSORIASIS |
| 0.025% | IMPOYZ | PRIMUS PHARMS | N209483 | Nov. 28, 2017 | RX | CREAM | TOPICAL | 9956231 | Aug. 31, 2030 | PSORIASIS |
| 0.025% | IMPOYZ | PRIMUS PHARMS | N209483 | Nov. 28, 2017 | RX | CREAM | TOPICAL | 9956231 | Aug. 31, 2030 | TREATMENT OF MODERATE PLAQUE PSORIASIS |
| 0.025% | IMPOYZ | PRIMUS PHARMS | N209483 | Nov. 28, 2017 | RX | CREAM | TOPICAL | 9956231 | Aug. 31, 2030 | TREATMENT OF PLAQUE PSORIASIS |
| 0.025% | IMPOYZ | PRIMUS PHARMS | N209483 | Nov. 28, 2017 | RX | CREAM | TOPICAL | 9956231 | Aug. 31, 2030 | TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER |
| 0.025% | IMPOYZ | PRIMUS PHARMS | N209483 | Nov. 28, 2017 | RX | CREAM | TOPICAL | 9956231 | Aug. 31, 2030 | TWICE DAILY TOPICAL TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS. |
| 0.05% | BYQLOVI | HARROW EYE | N218158 | March 4, 2024 | RX | SUSPENSION/DROPS | OPHTHALMIC | 11376262 | May 9, 2036 | TREATMENT OF INFLAMMATION |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.05% | BYQLOVI | HARROW EYE | N218158 | March 4, 2024 | RX | SUSPENSION/DROPS | OPHTHALMIC | March 4, 2027 | NEW PRODUCT |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Glucocorticoid receptor | Nuclear hormone receptor | AGONIST | Ki | 9.18 | DRUG MATRIX | CHEMBL | |||
| Annexin A1 | Cytosolic other | WOMBAT-PK | |||||||
| Bile salt export pump | Transporter | IC50 | 5.07 | CHEMBL | |||||
| Cytochrome P450 3A5 | Enzyme | IC50 | 7.68 | CHEMBL | |||||
| Androgen receptor | Transcription factor | Ki | 5.60 | DRUG MATRIX | |||||
| Progesterone receptor | Transcription factor | Ki | 8.82 | DRUG MATRIX | |||||
| Glucocorticoid receptor | Transcription factor | IC50 | 8.50 | CHEMBL | |||||
| Bile salt export pump | Transporter | IC50 | 4.46 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D01272 | KEGG_DRUG |
| 4018898 | VUID |
| N0000179087 | NUI |
| 4018898 | VANDF |
| 4019684 | VANDF |
| XRD | PDB_CHEM_ID |
| CHEMBL1159650 | ChEMBL_ID |
| DB01013 | DRUGBANK_ID |
| 7062 | IUPHAR_LIGAND_ID |
| 779619577M | UNII |
| 32798 | PUBCHEM_CID |
| DB11750 | DRUGBANK_ID |
| 21245 | RXNORM |
| 300 | MMSL |
| 4471 | MMSL |
| 72591 | MMSL |
| 002203 | NDDF |
| 004480 | NDDF |
| 32197004 | SNOMEDCT_US |
| 419129004 | SNOMEDCT_US |
| 48614001 | SNOMEDCT_US |
| C0055895 | UMLSCUI |
| C0008992 | UMLSCUI |
| D002990 | MESH_DESCRIPTOR_UI |
| CHEBI:31414 | CHEBI |
| 25122-41-2 | SECONDARY_CAS_RN |
| 5311051 | PUBCHEM_CID |
| 3154 | INN_ID |
| ADN79D536H | UNII |
| CHEBI:205919 | CHEBI |
| 779619577M | INXIGHT DRUGS |
| ADN79D536H | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0168-0162 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 20 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0168-0163 | CREAM | 0.50 mg | TOPICAL | ANDA | 20 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0168-0269 | SOLUTION | 0.50 mg | TOPICAL | ANDA | 18 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0168-0293 | GEL | 0.50 mg | TOPICAL | ANDA | 20 sections |
| Clobetasol Propionate (emollient) | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0168-0301 | CREAM | 0.50 mg | TOPICAL | ANDA | 25 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0472-0403 | SHAMPOO | 0.05 g | TOPICAL | ANDA | 18 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0472-0404 | LOTION | 0.05 g | TOPICAL | ANDA | 17 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0713-0656 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 19 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-569 | CREAM | 0.50 mg | TOPICAL | ANDA | 10 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-030 | SHAMPOO | 0.05 g | TOPICAL | ANDA | 30 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-782 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 20 sections |
| clobetasol propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-201 | CREAM | 0.50 mg | TOPICAL | ANDA | 21 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-358 | SOLUTION | 0.50 mg | TOPICAL | ANDA | 20 sections |
| clobetasol propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-483 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 21 sections |
| Clobetasol Propionate Cream USP, 0.05%Clobetasol Propionate Cream USP, 0.05% | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21922-016 | CREAM | 0.50 mg | TOPICAL | ANDA | 18 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21922-017 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 18 sections |
| CLOBETASOL PROPIONATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21922-061 | SOLUTION | 0.50 mg | TOPICAL | ANDA | 19 sections |
| Clobetasol Propionate | Human Prescription Drug Label | 1 | 33342-321 | SOLUTION | 0.46 mg | TOPICAL | ANDA | 18 sections |
| Clobetasol Propionate | Human Prescription Drug Label | 1 | 33342-326 | SPRAY | 0.50 mg | TOPICAL | ANDA | 25 sections |
| Clobetasol PropionateANDA | Human Prescription Drug Label | 1 | 33342-506 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 18 sections |
| clobetasol propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 40032-028 | SOLUTION | 0.50 mg | TOPICAL | ANDA | 17 sections |
| clobetasol propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 40032-096 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 17 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42254-153 | CREAM | 0.50 mg | TOPICAL | ANDA | 21 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42254-174 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 21 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-076 | CREAM | 0.50 mg | TOPICAL | ANDA | 17 sections |
| Clobetasol Propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-077 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 20 sections |
| CLOBETASOL PROPIONATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-362 | SOLUTION | 0.50 mg | TOPICAL | ANDA | 10 sections |
| clobetasol propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43386-028 | SOLUTION | 0.50 mg | TOPICAL | ANDA | 17 sections |
| clobetasol propionate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43386-096 | OINTMENT | 0.50 mg | TOPICAL | ANDA | 17 sections |
| Clodan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43538-950 | SHAMPOO | 0.50 mg | TOPICAL | ANDA | 30 sections |