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

Stem definitionDrug idCAS RN
prednisone and prednisolone derivatives 294 5534-09-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • rhinocort
  • beclometasone dipropionate
  • beclomethasone dipropionate
  • beclomethasone dipropionate monohydrate
An anti-inflammatory, synthetic glucocorticoid. It is used topically as an anti-inflammatory agent and in aerosol form for the treatment of ASTHMA.
  • Molecular weight: 521.05
  • Formula: C28H37ClO7
  • CLOGP: 4.26
  • LIPINSKI: 1
  • HAC: 7
  • HDO: 1
  • TPSA: 106.97
  • ALOGS: -5.40
  • ROTB: 8
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.40 mg N
0.80 mg Inhal.aerosol
0.80 mg Inhal.powder
1.50 mg Inhal.solution

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.05 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.29 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 36 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.13 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.50 hours Lombardo F, Berellini G, Obach RS
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.679 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.194 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 50.582 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 84.140 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 1.040 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 1.590 % High 1
herg hERG pIC50 4.871 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 133.352 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 244.343 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 1.230 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,JAK3,MAP2K6,MAP3K7,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKDC,STK33,SYK,TEK,TGFBR1,ZAP70 35
kinase-selectivity-class AXL,GRK2,MAP2K6 3
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 3.890 High 1
mh-clint Mouse hepatocyte intrinsic clearance 187.499 High 1
mppb Mouse plasma protein binding (% unbound) 1.100 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 13.964 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 2.920 % High 1
rh-clint Rat hepatocyte intrinsic clearance 184.077 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 9.190 % High 1
rppb Rat plasma protein binding (% unbound) 1.490 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 6.166 uM High 1

Approvals:

DateAgencyCompanyOrphan
May 12, 1976 FDA

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
Asthma 557.09 13.28 535 29933 241625 90356354
Wheezing 250.61 13.28 352 30116 237728 90360251
Dyspnoea 225.11 13.28 727 29741 880228 89717751
Bacterial disease carrier 218.89 13.28 61 30407 1805 90596174
Bronchial secretion retention 202.94 13.28 67 30401 3548 90594431
Superinfection 188.11 13.28 61 30407 3051 90594928
Bronchospasm 184.32 13.28 104 30364 20605 90577374
Aggression 169.91 13.28 108 30360 26560 90571419
Cough 150.69 13.28 362 30106 368600 90229379
Nightmare 114.12 13.28 78 30390 21647 90576332
Scoliosis 113.98 13.28 57 30411 8850 90589129
Lip swelling 105.20 13.28 94 30374 38516 90559463
Depressed mood 102.08 13.28 104 30364 50118 90547861
Nonspecific reaction 99.69 13.28 37 30431 2772 90595207
Sinus operation 90.27 13.28 35 30433 2956 90595023
Infusion related reaction 89.65 13.28 16 30452 416764 90181215
Swelling face 86.43 13.28 121 30347 81231 90516748
Arthropathy 85.76 13.28 11 30457 366231 90231748
Contraindicated product administered 84.48 13.28 6 30462 320133 90277846
Chest discomfort 84.39 13.28 160 30308 138205 90459774
Atelectasis 84.06 13.28 68 30400 24341 90573638
Sleep disorder due to a general medical condition 80.83 13.28 87 30381 44651 90553328
Myalgia 80.28 13.28 180 30288 174945 90423034
Illness 79.86 13.28 117 30351 81852 90516127
Rib fracture 79.32 13.28 68 30400 26367 90571612
Malaise 78.85 13.28 397 30071 585589 90012390
Palpitations 78.35 13.28 154 30314 136574 90461405
Rheumatoid arthritis 77.80 13.28 14 30454 362600 90235379
Off label use 71.95 13.28 166 30302 1102086 89495893
Pericarditis 71.45 13.28 5 30463 270146 90327833
Systemic lupus erythematosus 71.39 13.28 17 30451 361879 90236100
Glossodynia 69.94 13.28 12 30456 321767 90276212
Eosinophilia 69.02 13.28 65 30403 28468 90569511
Treatment failure 66.80 13.28 11 30457 303917 90294062
Swollen tongue 65.43 13.28 79 30389 45877 90552102
Hepatic enzyme increased 65.40 13.28 20 30448 360716 90237263
Throat tightness 65.33 13.28 64 30404 29420 90568559
Drug ineffective 64.00 13.28 245 30223 1384053 89213926
Duodenal ulcer perforation 61.85 13.28 3 30465 221285 90376694
Middle insomnia 56.27 13.28 46 30422 16705 90581274
Anxiety 51.17 13.28 223 30245 309549 90288430
Impaired quality of life 50.83 13.28 50 30418 23094 90574885
Alopecia 50.74 13.28 55 30413 495016 90102963
Productive cough 49.30 13.28 91 30377 76972 90521007
Mobility decreased 48.99 13.28 12 30456 250722 90347257
Toxicity to various agents 48.60 13.28 18 30450 287828 90310151
Forced expiratory volume decreased 48.53 13.28 28 30440 5780 90592199
Impaired healing 48.18 13.28 10 30458 234189 90363790
Essential tremor 47.92 13.28 18 30450 1394 90596585
Oropharyngeal pain 47.91 13.28 114 30354 115073 90482906
Mood altered 47.20 13.28 42 30426 17102 90580877
Abdominal discomfort 46.76 13.28 55 30413 477273 90120706
Sputum discoloured 46.55 13.28 45 30423 20346 90577633
Asthmatic crisis 46.01 13.28 19 30449 1891 90596088
Respiratory tract infection 45.90 13.28 76 30392 59002 90538977
Nasal oedema 45.28 13.28 28 30440 6556 90591423
Anger 44.67 13.28 37 30431 13683 90584296
Separation anxiety disorder 44.66 13.28 8 30460 25 90597954
Blood cholesterol increased 44.65 13.28 8 30460 208004 90389975
Heart rate increased 44.03 13.28 109 30359 112793 90485186
Blood electrolytes abnormal 43.85 13.28 16 30452 1142 90596837
Discomfort 41.74 13.28 20 30448 274315 90323664
Transient ischaemic attack 41.13 13.28 61 30407 43115 90554864
Obstructive airways disorder 41.02 13.28 47 30421 25822 90572157
Abnormal behaviour 40.85 13.28 44 30424 22584 90575395
Eosinophil count abnormal 40.52 13.28 14 30454 852 90597127
Sleep terror 38.58 13.28 22 30446 4442 90593537
Death 38.23 13.28 59 30409 456492 90141487
Fibromyalgia 38.15 13.28 11 30457 206258 90391721
Pharyngeal swelling 37.01 13.28 29 30439 9915 90588064
Stomatitis 36.09 13.28 24 30444 274674 90323305
Nasal discharge discolouration 35.74 13.28 18 30450 2835 90595144
Treatment noncompliance 35.52 13.28 63 30405 51664 90546315
Anaphylactic reaction 34.65 13.28 85 30383 87439 90510540
Infective pulmonary exacerbation of cystic fibrosis 34.05 13.28 28 30440 10251 90587728
Ill-defined disorder 33.93 13.28 10 30458 184881 90413098
Musculoskeletal stiffness 33.74 13.28 30 30438 296502 90301477
Atrial fibrillation 33.51 13.28 110 30358 133501 90464478
Angioplasty 33.25 13.28 14 30454 1463 90596516
Breast conserving surgery 32.71 13.28 13 30455 1172 90596807
Squamous cell carcinoma of the oral cavity 32.61 13.28 10 30458 416 90597563
Injury 32.20 13.28 13 30455 197336 90400643
Joint range of motion decreased 31.90 13.28 4 30464 135639 90462340
Eosinophilic granulomatosis with polyangiitis 31.81 13.28 16 30452 2514 90595465
Liver injury 31.71 13.28 9 30459 170558 90427421
Bronchitis 31.52 13.28 118 30350 152809 90445170
Flashback 30.76 13.28 9 30459 318 90597661
Bursitis 30.67 13.28 4 30464 131650 90466329
Genital pain 30.67 13.28 11 30457 747 90597232
Wound 30.63 13.28 34 30434 302946 90295033
Irritability 30.60 13.28 48 30420 35614 90562365
Therapeutic product effect decreased 30.49 13.28 29 30439 277542 90320437
Portal vein embolism 30.41 13.28 7 30461 93 90597886
Oesophageal irritation 30.39 13.28 9 30459 332 90597647
Irritable bowel syndrome 30.23 13.28 16 30452 207432 90390547
Joint swelling 28.66 13.28 81 30387 503219 90094760
Crying 28.50 13.28 39 30429 25606 90572373
Vascular device infection 28.46 13.28 27 30441 11925 90586054
Intentional product use issue 28.41 13.28 19 30449 216873 90381106
Influenza 28.32 13.28 107 30361 139157 90458822
Rhinovirus infection 28.02 13.28 20 30448 5943 90592036
Gastric mucosa erythema 27.85 13.28 9 30459 445 90597534
Miller Fisher syndrome 27.72 13.28 7 30461 140 90597839
Sinus disorder 27.68 13.28 45 30423 34402 90563577
Blister 27.59 13.28 27 30441 254971 90343008
Hyponatraemia 27.48 13.28 103 30365 133435 90464544
Arterial spasm 27.27 13.28 6 30462 64 90597915
Periorbital swelling 27.04 13.28 18 30450 4780 90593199
Peripheral vascular disorder 26.66 13.28 20 30448 6411 90591568
Drug monitoring procedure not performed 26.59 13.28 10 30458 777 90597202
Choking 26.43 13.28 26 30442 12007 90585972
Hiccups 26.38 13.28 15 30453 3011 90594968
Musculoskeletal chest pain 26.21 13.28 36 30432 23714 90574265
Abdominal rigidity 26.16 13.28 14 30454 2498 90595481
Maternal exposure during pregnancy 26.05 13.28 51 30417 360012 90237967
Onychophagia 26.04 13.28 6 30462 80 90597899
Blood pressure increased 25.96 13.28 133 30335 197084 90400895
Nail infection 25.85 13.28 14 30454 2558 90595421
Therapy non-responder 25.81 13.28 7 30461 136697 90461282
Dysmetropsia 25.77 13.28 6 30462 84 90597895
Inflammation 25.69 13.28 14 30454 178578 90419401
Drug hypersensitivity 25.58 13.28 253 30215 463356 90134623
Pneumonia 25.16 13.28 326 30142 637733 89960246
Differential white blood cell count abnormal 24.48 13.28 10 30458 968 90597011
Swelling 24.18 13.28 67 30401 418991 90178988
Rales 23.83 13.28 28 30440 15799 90582180
Psoriatic arthropathy 23.76 13.28 25 30443 228310 90369669
Limb injury 23.76 13.28 40 30428 31468 90566511
Genital ulceration 23.58 13.28 10 30458 1063 90596916
Dermatitis allergic 23.38 13.28 29 30439 17298 90580681
Eye movement disorder 22.90 13.28 18 30450 6180 90591799
Gastrointestinal disorder 22.60 13.28 32 30436 256655 90341324
Angioedema 22.55 13.28 60 30408 64816 90533163
Poor peripheral circulation 22.44 13.28 15 30453 4010 90593969
Neutropenic sepsis 22.34 13.28 29 30439 18101 90579878
Fungal infection 21.97 13.28 46 30422 42615 90555364
Status asthmaticus 21.85 13.28 9 30459 890 90597089
Intestinal atony 21.54 13.28 6 30462 177 90597802
Nasal congestion 21.20 13.28 69 30399 83345 90514634
Product use issue 21.14 13.28 50 30418 329869 90268110
Grip strength decreased 21.12 13.28 3 30465 92573 90505406
Vomiting 21.10 13.28 377 30091 787916 89810063
Haemostasis 21.08 13.28 7 30461 377 90597602
Therapeutic product effect incomplete 20.98 13.28 124 30344 193772 90404207
Wound infection 20.95 13.28 5 30463 106397 90491582
Derealisation 20.47 13.28 10 30458 1475 90596504
Decreased activity 20.45 13.28 19 30449 8173 90589806
Eye swelling 20.44 13.28 36 30432 29350 90568629
Dizziness 20.32 13.28 294 30174 588990 90008989
Personality change 20.28 13.28 18 30450 7303 90590676
Musculoskeletal pain 19.86 13.28 17 30451 171234 90426745
Paraesthesia oral 19.76 13.28 37 30431 31622 90566357
Osteoarthritis 19.73 13.28 22 30446 195708 90402271
Rash macular 19.66 13.28 36 30432 30244 90567735
Pneumatosis intestinalis 19.62 13.28 13 30455 3424 90594555
Acute myocardial infarction 19.60 13.28 39 30429 34851 90563128
Butterfly rash 19.51 13.28 11 30457 2174 90595805
Idiopathic orbital inflammation 19.20 13.28 6 30462 266 90597713
Pulmonary oedema 19.19 13.28 55 30413 62025 90535954
Oral mucosal blistering 19.13 13.28 17 30451 6907 90591072
Fall 18.89 13.28 246 30222 481564 90116415
Lethargy 18.61 13.28 55 30413 63084 90534895
Pregnancy with implant contraceptive 18.56 13.28 13 30455 3748 90594231
Necrotising colitis 18.42 13.28 9 30459 1329 90596650
Renal atrophy 18.41 13.28 10 30458 1838 90596141
Product administered to patient of inappropriate age 18.25 13.28 14 30454 4639 90593340
Hyperkinesia 18.06 13.28 10 30458 1909 90596070
Dermatitis atopic 17.96 13.28 30 30438 23442 90574537
Facial pain 17.69 13.28 22 30446 13160 90584819
Malignant neoplasm progression 17.49 13.28 7 30461 106863 90491116
Secretion discharge 17.40 13.28 24 30444 15872 90582107
Lacrimation increased 17.35 13.28 32 30436 27030 90570949
Cytomegalovirus enteritis 17.35 13.28 6 30462 366 90597613
Brain contusion 17.33 13.28 7 30461 658 90597321
Gingival swelling 17.33 13.28 14 30454 4999 90592980
Pubic pain 17.24 13.28 5 30463 171 90597808
Viral infection 17.22 13.28 41 30427 41373 90556606
Diabetic ketoacidosis 17.11 13.28 30 30438 24377 90573602
Respiration abnormal 17.11 13.28 17 30451 7946 90590033
Food poisoning 17.07 13.28 14 30454 5104 90592875
Live birth 17.06 13.28 3 30465 79104 90518875
Sense of oppression 16.97 13.28 8 30460 1092 90596887
Poor quality sleep 16.85 13.28 30 30438 24663 90573316
Hangover 16.83 13.28 10 30458 2179 90595800
Prescribed overdose 16.64 13.28 6 30462 97619 90500360
Psychomotor hyperactivity 16.58 13.28 21 30447 12792 90585187
Eczema 16.49 13.28 47 30421 52823 90545156
Urinary retention 16.38 13.28 38 30430 37706 90560273
Eosinophil count increased 16.24 13.28 21 30447 13060 90584919
Antipsychotic drug level increased 16.22 13.28 12 30456 3767 90594212
Terminal insomnia 16.21 13.28 8 30460 1207 90596772
Hip arthroplasty 16.19 13.28 3 30465 76205 90521774
Tongue pruritus 16.14 13.28 7 30461 786 90597193
Full blood count abnormal 16.05 13.28 37 30431 36560 90561419
Drug abuse 15.96 13.28 4 30464 82343 90515636
Dyspnoea exertional 15.91 13.28 57 30411 72231 90525748
Reperfusion arrhythmia 15.74 13.28 5 30463 234 90597745
Crepitations 15.60 13.28 17 30451 8835 90589144
Obesity 15.57 13.28 8 30460 105499 90492480
Adverse drug reaction 15.55 13.28 79 30389 116622 90481357
Sinusitis 15.52 13.28 180 30288 342908 90255071
Emotional disorder 15.46 13.28 22 30446 14975 90583004
Oesophageal candidiasis 15.45 13.28 15 30453 6814 90591165
Hypoaesthesia 15.44 13.28 54 30414 314156 90283823
Urinary incontinence 15.41 13.28 37 30431 37529 90560450
Pharyngeal oedema 15.39 13.28 21 30447 13750 90584229
Liver disorder 15.37 13.28 11 30457 121258 90476721
Hallucination 15.37 13.28 53 30415 65906 90532073
Loss of personal independence in daily activities 15.34 13.28 88 30380 136017 90461962
Hypertension 15.12 13.28 91 30377 457441 90140538
Oral mucosa erosion 14.67 13.28 8 30460 1481 90596498
Tendonitis 14.63 13.28 26 30442 21346 90576633
Necrosis ischaemic 14.62 13.28 7 30461 988 90596991
Oedema 14.47 13.28 116 30352 200179 90397800
Arthralgia 14.46 13.28 180 30288 778342 89819637
Pneumonia streptococcal 14.46 13.28 9 30459 2132 90595847
Hypercholesterolaemia 14.37 13.28 8 30460 100884 90497095
Respiratory rate increased 14.37 13.28 22 30446 15979 90582000
Platelet count decreased 14.24 13.28 15 30453 136954 90461025
Product administration error 14.20 13.28 29 30439 26394 90571585
Bacterial infection 14.13 13.28 27 30441 23417 90574562
Nasal discomfort 14.11 13.28 13 30455 5535 90592444
Aphonia 14.09 13.28 19 30449 12300 90585679
Bladder irritation 14.05 13.28 5 30463 332 90597647
Mouth ulceration 13.92 13.28 37 30431 39937 90558042
Product cleaning inadequate 13.81 13.28 3 30465 30 90597949
Pulmonary congestion 13.77 13.28 24 30444 19409 90578570
Flat affect 13.64 13.28 8 30460 1703 90596276
Product dosage form issue 13.47 13.28 3 30465 34 90597945
Increased viscosity of bronchial secretion 13.34 13.28 5 30463 385 90597594

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
Asthma 332.42 13.35 238 16254 62076 42542767
Wheezing 155.48 13.35 145 16347 54636 42550207
Dyspnoea 101.18 13.35 387 16105 442234 42162609
Anger 72.17 13.35 51 16441 12967 42591876
Abnormal behaviour 63.64 13.35 64 16428 26387 42578456
Lip swelling 60.97 13.35 54 16438 18999 42585844
Sleep terror 56.63 13.35 26 16466 2900 42601943
Nightmare 55.60 13.35 58 16434 24954 42579889
Ballismus 55.22 13.35 12 16480 103 42604740
Lower respiratory tract infection 49.59 13.35 70 16422 41136 42563707
Mood altered 45.98 13.35 36 16456 10682 42594161
Blood immunoglobulin E increased 42.75 13.35 23 16469 3602 42601241
Chest discomfort 42.60 13.35 83 16409 63533 42541310
Infective pulmonary exacerbation of cystic fibrosis 41.88 13.35 30 16462 7788 42597055
Swollen tongue 41.50 13.35 46 16446 21185 42583658
Malaise 41.36 13.35 177 16315 211979 42392864
Pharyngeal oedema 41.31 13.35 27 16465 6041 42598802
Nasal disorder 36.23 13.35 17 16475 1992 42602851
Adenovirus infection 36.17 13.35 26 16466 6783 42598060
Cough 35.78 13.35 150 16342 177953 42426890
Attention-seeking behaviour 34.26 13.35 7 16485 43 42604800
Sputum discoloured 32.97 13.35 29 16463 10103 42594740
Off label use 32.70 13.35 132 16360 638203 41966640
Acquired macroglossia 31.30 13.35 6 16486 25 42604818
Mood swings 30.21 13.35 26 16466 8800 42596043
Neuropsychiatric symptoms 28.97 13.35 11 16481 761 42604082
Depressed mood 28.53 13.35 40 16452 23344 42581499
Crepitations 27.82 13.35 17 16475 3384 42601459
Toxicity to various agents 27.36 13.35 29 16463 229107 42375736
Productive cough 27.17 13.35 61 16431 51506 42553337
Central obesity 25.70 13.35 10 16482 739 42604104
Death 25.63 13.35 95 16397 471090 42133753
Chorea 25.37 13.35 12 16480 1432 42603411
Pharyngeal swelling 25.27 13.35 16 16476 3391 42601452
Drug abuse 25.11 13.35 5 16487 104766 42500077
Impaired quality of life 24.79 13.35 29 16463 14148 42590695
Idiopathic intracranial hypertension 24.71 13.35 10 16482 820 42604023
Neonatal hyponatraemia 24.55 13.35 6 16486 90 42604753
Dyspnoea at rest 24.36 13.35 17 16475 4232 42600611
Nasal discomfort 24.32 13.35 12 16480 1570 42603273
Adjustment disorder with depressed mood 23.21 13.35 8 16484 419 42604424
Daydreaming 22.52 13.35 9 16483 714 42604129
Neuropsychiatric syndrome 22.39 13.35 6 16486 132 42604711
Disease progression 22.34 13.35 14 16478 143642 42461201
Crying 22.22 13.35 19 16473 6375 42598468
Irritability 21.68 13.35 39 16453 28089 42576754
Paraesthesia oral 21.41 13.35 17 16475 5146 42599697
Anosmia 21.37 13.35 17 16475 5159 42599684
Dermatitis bullous 21.32 13.35 21 16471 8435 42596408
Hepatic cancer 21.27 13.35 21 16471 8459 42596384
Cervicogenic headache 21.20 13.35 4 16488 15 42604828
Blood thyroid stimulating hormone increased 21.04 13.35 17 16475 5275 42599568
Angioedema 20.99 13.35 49 16443 42428 42562415
Gastrointestinal tract irritation 20.93 13.35 7 16485 334 42604509
Platelet count decreased 20.87 13.35 14 16478 138567 42466276
Spleen congestion 20.62 13.35 7 16485 350 42604493
Genital pain 20.52 13.35 9 16483 901 42603942
Completed suicide 20.39 13.35 6 16486 96459 42508384
Self-injurious ideation 19.67 13.35 11 16481 1857 42602986
Urticaria 19.48 13.35 68 16424 73968 42530875
Graft versus host disease in gastrointestinal tract 19.35 13.35 16 16476 5127 42599716
Stenotrophomonas infection 19.35 13.35 14 16478 3690 42601153
Mesothelioma 19.11 13.35 7 16485 438 42604405
Suicidal ideation 19.01 13.35 51 16441 48110 42556733
Headache 18.60 13.35 157 16335 239212 42365631
Sinusitis 18.59 13.35 50 16442 47242 42557601
Convulsive threshold lowered 18.11 13.35 7 16485 508 42604335
Apnoeic attack 18.09 13.35 7 16485 510 42604333
Insomnia 18.08 13.35 92 16400 118161 42486682
Reading disorder 17.68 13.35 7 16485 542 42604301
Malignant neoplasm progression 17.64 13.35 10 16482 108390 42496453
Mononucleosis syndrome 17.58 13.35 5 16487 138 42604705
Multifocal motor neuropathy 17.47 13.35 5 16487 141 42604702
Renal failure 17.35 13.35 18 16474 143708 42461135
Tic 17.19 13.35 11 16481 2372 42602471
Bronchomalacia 16.78 13.35 5 16487 163 42604680
Sleep talking 16.67 13.35 7 16485 630 42604213
Hallucination 16.16 13.35 54 16438 57453 42547390
Muscle spasms 16.11 13.35 71 16421 85973 42518870
Oral pain 16.04 13.35 22 16470 12574 42592269
Locked-in syndrome 16 13.35 6 16486 401 42604442
Thrombocytopenia 15.87 13.35 31 16461 190248 42414595
Dystonia 15.78 13.35 22 16470 12768 42592075
Rash papular 15.60 13.35 21 16471 11790 42593053
Eye swelling 15.45 13.35 21 16471 11899 42592944
Renal aplasia 15.28 13.35 7 16485 776 42604067
Dizziness 15.09 13.35 155 16337 249099 42355744
Abnormal sleep-related event 14.92 13.35 6 16486 484 42604359
Nasal septum perforation 14.82 13.35 5 16487 245 42604598
Infarction 14.79 13.35 11 16481 3024 42601819
Acute graft versus host disease 14.69 13.35 17 16475 8198 42596645
Weaning failure 14.69 13.35 5 16487 252 42604591
Aortic dissection 14.67 13.35 11 16481 3061 42601782
Cystitis haemorrhagic 14.53 13.35 16 16476 7313 42597530
Neonatal seizure 14.42 13.35 6 16486 528 42604315
Violence-related symptom 14.33 13.35 6 16486 536 42604307
Syncope 14.26 13.35 76 16416 99330 42505513
Pruritus 14.22 13.35 123 16369 188648 42416195
Forced expiratory volume decreased 14.00 13.35 16 16476 7614 42597229
Respiratory tract congestion 13.92 13.35 16 16476 7662 42597181
Abdominal symptom 13.91 13.35 6 16486 577 42604266
Liver function test abnormal 13.49 13.35 35 16457 32356 42572487
Tryptase increased 13.47 13.35 5 16487 325 42604518

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
Asthma 732.36 12.08 664 40847 249627 110298161
Wheezing 351.26 12.08 455 41056 254775 110293013
Dyspnoea 286.46 12.08 987 40524 1105885 109441903
Bacterial disease carrier 209.03 12.08 63 41448 2206 110545582
Bronchial secretion retention 174.15 12.08 67 41444 4957 110542831
Lip swelling 168.75 12.08 145 41366 50522 110497266
Nightmare 166.92 12.08 129 41382 38734 110509054
Bronchospasm 151.30 12.08 110 41401 30129 110517659
Superinfection 144.90 12.08 61 41450 5702 110542086
Depressed mood 133.30 12.08 138 41373 60671 110487117
Cough 132.16 12.08 427 41084 461214 110086574
Aggression 125.54 12.08 132 41379 59078 110488710
Scoliosis 111.96 12.08 58 41453 8675 110539113
Anger 110.99 12.08 76 41435 18931 110528857
Abnormal behaviour 110.65 12.08 102 41409 38937 110508851
Malaise 107.19 12.08 517 40994 671302 109876486
Swollen tongue 104.49 12.08 121 41390 60241 110487547
Off label use 101.75 12.08 262 41249 1499923 109047865
Sinus operation 96.97 12.08 38 41473 2953 110544835
Chest discomfort 96.30 12.08 206 41305 173642 110374146
Mood altered 96.27 12.08 73 41438 21302 110526486
Infusion related reaction 90.05 12.08 17 41494 381145 110166643
Nonspecific reaction 89.02 12.08 36 41475 3038 110544750
Sleep terror 87.91 12.08 45 41466 6565 110541223
Swelling face 87.48 12.08 138 41373 92183 110455605
Palpitations 87.42 12.08 188 41323 159024 110388764
Myalgia 85.84 12.08 229 41282 222152 110325636
Illness 78.09 12.08 123 41388 82048 110465740
Drug ineffective 75.49 12.08 305 41206 1520235 109027553
Sleep disorder due to a general medical condition 73.19 12.08 94 41417 52018 110495770
Toxicity to various agents 71.74 12.08 46 41465 480509 110067279
Rheumatoid arthritis 71.53 12.08 13 41498 299600 110248188
Contraindicated product administered 70.82 12.08 6 41505 248261 110299527
Arthropathy 69.68 12.08 12 41499 287510 110260278
Sputum discoloured 69.63 12.08 68 41443 27877 110519911
Completed suicide 68.75 12.08 6 41505 242375 110305413
Hepatic enzyme increased 68.36 12.08 18 41493 320874 110226914
Eosinophilia 68.36 12.08 96 41415 57840 110489948
Infective pulmonary exacerbation of cystic fibrosis 67.74 12.08 51 41460 14720 110533068
Rib fracture 64.05 12.08 71 41440 33699 110514089
Productive cough 62.75 12.08 135 41376 114170 110433618
Atelectasis 62.53 12.08 73 41438 36639 110511149
Pericarditis 58.07 12.08 7 41504 219107 110328681
Impaired quality of life 56.74 12.08 63 41448 29954 110517834
Anxiety 56.62 12.08 268 41243 344810 110202978
Irritability 56.08 12.08 79 41432 47730 110500058
Helicobacter infection 55.95 12.08 3 41508 181874 110365914
Forced expiratory volume decreased 54.96 12.08 43 41468 13133 110534655
Systemic lupus erythematosus 54.67 12.08 14 41497 254324 110293464
Essential tremor 54.63 12.08 22 41489 1836 110545952
Throat tightness 54.40 12.08 65 41446 33424 110514364
Death 53.59 12.08 114 41397 698755 109849033
Genital pain 53.31 12.08 20 41491 1380 110546408
Middle insomnia 53.17 12.08 51 41460 20451 110527337
Pharyngeal swelling 51.78 12.08 40 41471 11992 110535796
Fibromyalgia 49.10 12.08 4 41507 170905 110376883
Separation anxiety disorder 48.81 12.08 9 41502 30 110547758
Glossodynia 48.14 12.08 12 41499 221992 110325796
Crying 47.09 12.08 53 41458 25575 110522213
Pharyngeal oedema 46.69 12.08 43 41468 16385 110531403
Duodenal ulcer perforation 46.30 12.08 6 41505 177694 110370094
Folliculitis 45.31 12.08 5 41506 167648 110380140
Mood swings 45.06 12.08 49 41462 22763 110525025
Oropharyngeal pain 44.96 12.08 132 41379 135144 110412644
Impaired healing 43.90 12.08 10 41501 196707 110351081
Drug abuse 43.87 12.08 7 41504 177404 110370384
Obstructive airways disorder 43.72 12.08 69 41442 46080 110501708
Ballismus 43.56 12.08 12 41499 303 110547485
Nasal discharge discolouration 43.17 12.08 22 41489 3179 110544609
Crepitations 42.28 12.08 34 41477 10801 110536987
Heart rate increased 41.88 12.08 134 41377 143700 110404088
Eosinophil count abnormal 39.65 12.08 15 41496 1059 110546729
Angioedema 39.55 12.08 103 41408 98397 110449391
Treatment failure 39.38 12.08 28 41483 277206 110270582
Nasal oedema 39.11 12.08 27 41484 6812 110540976
Asthmatic crisis 38.76 12.08 18 41493 2124 110545664
Adenovirus infection 37.68 12.08 32 41479 10962 110536826
Dizziness 36.28 12.08 411 41100 697782 109850006
Respiratory tract infection 35.26 12.08 81 41430 71536 110476252
Intentional product use issue 35.25 12.08 25 41486 247881 110299907
Bursitis 34.79 12.08 4 41507 129914 110417874
Breast conserving surgery 34.69 12.08 13 41498 894 110546894
Joint range of motion decreased 34.58 12.08 3 41508 121829 110425959
Choking 34.38 12.08 35 41476 15075 110532713
Attention-seeking behaviour 33.82 12.08 8 41503 107 110547681
Blood cholesterol increased 32.99 12.08 14 41497 184771 110363017
Blood electrolytes abnormal 32.90 12.08 16 41495 2092 110545696
Periorbital swelling 32.11 12.08 22 41489 5483 110542305
Hallucination 31.83 12.08 97 41414 101335 110446453
Cleft palate 31.75 12.08 10 41501 406 110547382
Malignant neoplasm progression 31.53 12.08 13 41498 174554 110373234
Ill-defined disorder 31.18 12.08 10 41501 156843 110390945
Transient ischaemic attack 31.10 12.08 72 41439 63910 110483878
Alopecia 30.93 12.08 56 41455 364697 110183091
Angioplasty 30.88 12.08 15 41496 1956 110545832
Stomatitis 30.33 12.08 34 41477 270208 110277580
Mobility decreased 29.92 12.08 27 41484 237395 110310393
Portal vein embolism 29.10 12.08 7 41504 101 110547687
Paraesthesia oral 28.71 12.08 48 41463 33623 110514165
Dermatitis allergic 28.65 12.08 38 41473 21686 110526102
Dermatitis bullous 28.43 12.08 34 41477 17495 110530293
Blood immunoglobulin E increased 28.18 12.08 23 41488 7459 110540329
Disease progression 28.16 12.08 30 41481 244004 110303784
Osteoarthritis 27.88 12.08 17 41494 182606 110365182
Personality change 27.83 12.08 27 41484 10975 110536813
Injury 27.77 12.08 16 41495 177249 110370539
Anaphylactic reaction 27.56 12.08 100 41411 114200 110433588
Musculoskeletal stiffness 27.45 12.08 39 41472 279783 110268005
Antipsychotic drug level increased 27.34 12.08 22 41489 6993 110540795
Lip dry 27.00 12.08 3 41508 100080 110447708
Platelet count decreased 26.96 12.08 28 41483 230415 110317373
Suicidal ideation 26.87 12.08 87 41424 93850 110453938
Eye swelling 26.70 12.08 46 41465 33002 110514786
Necrotising colitis 26.36 12.08 13 41498 1752 110546036
Nasal congestion 26.30 12.08 89 41422 98193 110449595
Squamous cell carcinoma of the oral cavity 26.14 12.08 10 41501 728 110547060
Oesophageal irritation 26.09 12.08 8 41503 297 110547491
Psychomotor hyperactivity 26.02 12.08 35 41476 20242 110527546
Gingival swelling 25.77 12.08 19 41492 5311 110542477
Musculoskeletal chest pain 25.77 12.08 42 41469 28805 110518983
Peripheral vascular disorder 25.45 12.08 23 41488 8553 110539235
Myelosuppression 25.02 12.08 3 41508 94337 110453451
Poor peripheral circulation 25.02 12.08 17 41494 4180 110543608
Genital ulceration 24.98 12.08 13 41498 1962 110545826
Limb injury 24.85 12.08 48 41463 37588 110510200
Nail infection 24.84 12.08 14 41497 2474 110545314
Influenza 24.60 12.08 127 41384 168974 110378814
Graft versus host disease in gastrointestinal tract 24.57 12.08 23 41488 8945 110538843
Decreased activity 24.21 12.08 25 41486 10949 110536839
Stenotrophomonas infection 24.18 12.08 19 41492 5839 110541949
Abdominal discomfort 24.11 12.08 72 41439 393786 110154002
Therapeutic product effect decreased 24.01 12.08 34 41477 244282 110303506
Rash macular 23.92 12.08 48 41463 38638 110509150
Bleeding time prolonged 23.74 12.08 11 41500 1291 110546497
Liver function test abnormal 23.59 12.08 68 41443 68882 110478906
Vascular device infection 23.51 12.08 30 41481 16482 110531306
Thrombocytopenia 23.41 12.08 61 41450 348824 110198964
Mouth ulceration 23.20 12.08 54 41457 48084 110499704
Sinus disorder 23.17 12.08 43 41468 32685 110515103
Treatment noncompliance 23.08 12.08 70 41441 72920 110474868
Dysmetropsia 23.06 12.08 6 41505 121 110547667
Liver injury 22.96 12.08 14 41497 150399 110397389
Hyponatraemia 22.90 12.08 150 41361 217503 110330285
Tic 22.87 12.08 15 41496 3478 110544310
Jaundice 22.82 12.08 61 41450 59175 110488613
Product administered to patient of inappropriate age 22.77 12.08 21 41490 8015 110539773
Irritable bowel syndrome 22.77 12.08 17 41494 164198 110383590
Pregnancy with implant contraceptive 22.75 12.08 13 41498 2359 110545429
Rhinovirus infection 22.72 12.08 25 41486 11764 110536024
Nasal disorder 22.54 12.08 16 41495 4218 110543570
Bronchitis 22.20 12.08 117 41394 156915 110390873
Abdominal rigidity 22.16 12.08 15 41496 3665 110544123
Psoriatic arthropathy 21.80 12.08 25 41486 196736 110351052
Oral pain 21.43 12.08 45 41466 37399 110510389
Wound infection 21.32 12.08 5 41506 96460 110451328
Arterial spasm 21.22 12.08 6 41505 167 110547621
Miller Fisher syndrome 20.83 12.08 7 41504 350 110547438
Neuropsychiatric symptoms 20.78 12.08 10 41501 1278 110546510
Rales 20.73 12.08 35 41476 24704 110523084
Somnambulism 20.64 12.08 18 41493 6387 110541401
Drug monitoring procedure not performed 20.47 12.08 10 41501 1320 110546468
Adverse drug reaction 20.29 12.08 86 41425 105473 110442315
Grip strength decreased 20.19 12.08 3 41508 80171 110467617
Lethargy 20.18 12.08 79 41432 93497 110454291
Lactic acidosis 20.14 12.08 5 41506 92806 110454982
Poor quality sleep 20.01 12.08 37 41474 28040 110519748
Discomfort 20.00 12.08 31 41480 214676 110333112
Vomiting 19.80 12.08 464 41047 910211 109637577
Neuropsychiatric syndrome 19.72 12.08 6 41505 217 110547571
Mononucleosis syndrome 19.69 12.08 6 41505 218 110547570
Terminal insomnia 19.61 12.08 11 41500 1927 110545861
Red blood cell sedimentation rate increased 19.55 12.08 3 41508 78299 110469489
Eosinophilic granulomatosis with polyangiitis 19.46 12.08 22 41489 10664 110537124
Tendonitis 19.39 12.08 35 41476 26048 110521740
Flashback 19.36 12.08 7 41504 435 110547353
Intestinal atony 19.31 12.08 6 41505 233 110547555
Central obesity 19.10 12.08 11 41500 2025 110545763
Skin exfoliation 18.90 12.08 74 41437 87577 110460211
Gastrointestinal disorder 18.89 12.08 39 41472 241913 110305875
Inflammation 18.88 12.08 27 41484 193211 110354577
C-reactive protein increased 18.87 12.08 33 41478 217886 110329902
Food poisoning 18.73 12.08 17 41494 6355 110541433
Butterfly rash 18.63 12.08 11 41500 2120 110545668
Acquired macroglossia 18.63 12.08 6 41505 262 110547526
Spleen congestion 18.53 12.08 7 41504 492 110547296
Daydreaming 18.39 12.08 9 41502 1193 110546595
Disturbance in attention 18.25 12.08 58 41453 61937 110485851
Full blood count abnormal 17.95 12.08 54 41457 55998 110491790
Differential white blood cell count abnormal 17.93 12.08 11 41500 2273 110545515
Emotional disorder 17.91 12.08 26 41485 16134 110531654
Haemostasis 17.80 12.08 7 41504 549 110547239
Multifocal motor neuropathy 17.80 12.08 5 41506 136 110547652
Hiccups 17.73 12.08 23 41488 12846 110534942
Hypercholesterolaemia 17.68 12.08 6 41505 90831 110456957
Blood pressure increased 17.64 12.08 161 41350 258212 110289576
Drug hypersensitivity 17.46 12.08 253 41258 453837 110093951
Therapy non-responder 17.41 12.08 20 41491 157287 110390501
Oral mucosal blistering 17.36 12.08 18 41493 7916 110539872
Renal failure 17.28 12.08 37 41474 226537 110321251
Overdose 17.16 12.08 39 41472 233755 110314033
Micturition urgency 17.08 12.08 28 41483 19292 110528496
Pulmonary oedema 17.07 12.08 79 41432 100580 110447208
White blood cell count decreased 17.05 12.08 38 41473 229352 110318436
Infection 16.99 12.08 74 41437 362126 110185662
Liver disorder 16.95 12.08 17 41494 142226 110405562
Anaemia 16.92 12.08 128 41383 546958 110000830
Adverse event 16.78 12.08 10 41501 108799 110438989
Hypoaesthesia 16.77 12.08 61 41450 314162 110233626
Upper gastrointestinal haemorrhage 16.75 12.08 49 41462 50047 110497741
Anosmia 16.73 12.08 22 41489 12450 110535338
Chorea 16.71 12.08 12 41499 3223 110544565
Status asthmaticus 16.69 12.08 8 41503 1013 110546775
Idiopathic orbital inflammation 16.66 12.08 6 41505 369 110547419
Urticaria 16.64 12.08 188 41323 318669 110229119
Therapeutic product effect incomplete 16.59 12.08 142 41369 223663 110324125
Joint swelling 16.50 12.08 98 41413 442747 110105041
Encephalopathy 16.40 12.08 5 41506 81050 110466738
Lacrimation increased 16.34 12.08 36 41475 30914 110516874
Pneumatosis intestinalis 16.29 12.08 18 41493 8511 110539277
Dermatitis atopic 16.16 12.08 32 41479 25509 110522279
Eye movement disorder 15.99 12.08 19 41492 9709 110538079
Derealisation 15.94 12.08 10 41501 2148 110545640
Respiration abnormal 15.86 12.08 19 41492 9790 110537998
Dyspnoea exertional 15.72 12.08 79 41432 103981 110443807
Sense of oppression 15.72 12.08 9 41502 1639 110546149
Wound 15.71 12.08 41 41470 234396 110313392
Intentional product misuse 15.71 12.08 16 41495 132888 110414900
Eczema 15.56 12.08 61 41450 72232 110475556
Blood creatinine increased 15.56 12.08 28 41483 182861 110364927
Hepatic cancer 15.46 12.08 20 41491 11136 110536652
Reading disorder 15.44 12.08 8 41503 1197 110546591
Syncope 15.27 12.08 129 41382 202407 110345381
Pulmonary congestion 15.21 12.08 35 41476 30931 110516857
Prescribed underdose 15.17 12.08 3 41508 65171 110482617
Gastrointestinal tract irritation 14.98 12.08 7 41504 838 110546950
Loss of personal independence in daily activities 14.93 12.08 102 41409 149918 110397870
Pubic pain 14.91 12.08 5 41506 248 110547540
Diabetic ketoacidosis 14.89 12.08 42 41469 42016 110505772
Dyspnoea at rest 14.89 12.08 17 41494 8329 110539459
Secretion discharge 14.84 12.08 27 41484 20217 110527571
Tongue pruritus 14.72 12.08 7 41504 871 110546917
Febrile neutropenia 14.68 12.08 65 41446 316702 110231086
Underdose 14.64 12.08 3 41508 63551 110484237
Lower limb fracture 14.63 12.08 5 41506 75343 110472445
Hangover 14.59 12.08 10 41501 2492 110545296
Hypertension 14.54 12.08 122 41389 509962 110037826
Restrictive pulmonary disease 14.38 12.08 11 41500 3248 110544540
Aspirin-exacerbated respiratory disease 14.21 12.08 7 41504 941 110546847
Nasal septum ulceration 14.19 12.08 3 41508 23 110547765
Obesity 14.14 12.08 13 41498 113338 110434450
Reperfusion arrhythmia 13.86 12.08 5 41506 309 110547479
Bronchomalacia 13.83 12.08 5 41506 311 110547477
Night sweats 13.81 12.08 18 41493 133965 110413823
Increased viscosity of bronchial secretion 13.68 12.08 6 41505 620 110547168
Allergic cough 13.63 12.08 7 41504 1028 110546760
Self-injurious ideation 13.58 12.08 12 41499 4334 110543454
Prescribed overdose 13.58 12.08 8 41503 87573 110460215
Convulsive threshold lowered 13.56 12.08 7 41504 1039 110546749
Autoimmune disorder 13.32 12.08 4 41507 65479 110482309
Maternal exposure during pregnancy 13.25 12.08 50 41461 254833 110292955
Viral infection 13.24 12.08 47 41464 53092 110494696
Acute graft versus host disease 13.24 12.08 20 41491 12861 110534927
Mouth swelling 13.15 12.08 15 41496 7339 110540449
Headache 13.05 12.08 428 41083 881949 109665839
Musculoskeletal pain 13.05 12.08 31 41480 182992 110364796
Respiratory rate increased 13.04 12.08 29 41482 25054 110522734
Neoplasm progression 13.04 12.08 4 41507 64591 110483197
Hypomagnesaemia 13.04 12.08 51 41460 60319 110487469
Chest pain 13.02 12.08 206 41305 376169 110171619
Benign prostatic hyperplasia 12.96 12.08 24 41487 18210 110529578
Ageusia 12.90 12.08 25 41486 19620 110528168
Skin fragility 12.89 12.08 7 41504 1151 110546637
Sedation 12.89 12.08 5 41506 69678 110478110
Orthostatic hypotension 12.75 12.08 54 41457 66195 110481593
Suicide attempt 12.73 12.08 12 41499 103382 110444406
Upper-airway cough syndrome 12.72 12.08 22 41489 15835 110531953
Bladder irritation 12.62 12.08 5 41506 400 110547388
Cystitis haemorrhagic 12.61 12.08 19 41492 12190 110535598
Increased bronchial secretion 12.53 12.08 11 41500 3937 110543851
Feeling abnormal 12.53 12.08 113 41398 180598 110367190
Cardio-respiratory arrest 12.53 12.08 15 41496 115821 110431967
Oral mucosa erosion 12.46 12.08 9 41502 2439 110545349
Panic attack 12.38 12.08 31 41480 28909 110518879
Hypovolaemia 12.35 12.08 26 41485 21648 110526140
Decreased interest 12.33 12.08 12 41499 4896 110542892
Sleep talking 12.30 12.08 7 41504 1261 110546527
Sciatica 12.25 12.08 10 41501 92389 110455399
Rash papular 12.23 12.08 30 41481 27609 110520179
Apnoeic attack 12.18 12.08 6 41505 806 110546982
Neutropenic sepsis 12.18 12.08 32 41479 30714 110517074
Drug intolerance 12.14 12.08 96 41415 406416 110141372
Gastroenteritis aeromonas 12.13 12.08 3 41508 49 110547739
Hip arthroplasty 12.12 12.08 3 41508 55810 110491978

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A07EA07 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFLAMMATORY AGENTS
Corticosteroids acting locally
ATC D07AC15 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, potent (group III)
ATC D07CC04 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS
Corticosteroids, potent, combinations with antibiotics
ATC R01AD01 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R03AK08 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK13 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AL09 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03BA01 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Glucocorticoids
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
FDA EPC N0000175576 Corticosteroid
CHEBI has role CHEBI:35472 anti-inflammatory drug
CHEBI has role CHEBI:49167 anti-asthmatic drug
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:50857 anti-allergic agent
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:77715 nasal decongestant
CHEBI has role CHEBI:233423 antifibrotic agent
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D019141 Respiratory System Agents
MeSH PA D001993 Bronchodilator Agents

Related Drugs by ATC class:

A07EA Corticosteroids acting locally 6 drugs
betamethasonebudesonidehydrocortisoneprednisoloneprednisonetixocortol
D07AC Corticosteroids, potent (group III) 20 drugs
amcinonidebetamethasonebudesonidedesoximetasonediflorasone diacetatediflucortolonedifluprednatefluclorolonefludroxycortidefluocinolone acetonidefluocinonidefluocortolone show all 20 →
D07CC Corticosteroids, potent, combinations with antibiotics 5 drugs
betamethasonefludroxycortidefluocinolone acetonidefluocinonidefluocortolone
R01AD Corticosteroids 12 drugs
betamethasonebudesonideciclesonidedexamethasoneflunisolidefluticasone furoatefluticasone propionatehydrocortisonemometasone furoateprednisolonetixocortoltriamcinolone
R03AK Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics 13 drugs
budesonidecromoglicic acidepinephrinefluticasone furoatefluticasone propionateformoterolindacaterolisoprenalinemometasone furoatereproterolsalbutamolsalmeterol show all 13 →
R03AL Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids 14 drugs
aclidinium bromidebudesonidefenoterolfluticasone furoateformoterolglycopyrronium bromideindacaterolipratropiummometasone furoateolodaterolsalbutamoltiotropium bromide show all 14 →
R03BA Glucocorticoids 8 drugs
betamethasonebudesonideciclesonideflunisolidefluticasone furoatefluticasone propionatemometasone furoatetriamcinolone

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

DiseaseRelationSNOMED_IDDOID
Vasomotor rhinitis indication 8229003 DOID:4730
Nasal polyp indication 52756005
Allergic rhinitis indication 61582004
Rhinitis indication 70076002 DOID:4483
Asthma indication 195967001 DOID:2841
Asthma management indication 406162001
Severe chronic obstructive pulmonary disease off-label use 313299006
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Inactive tuberculosis contraindication 11999007
Epistaxis contraindication 12441001
Measles contraindication 14189004 DOID:8622
Disease caused by parasite contraindication 17322007
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Perforation of nasal septum contraindication 80142000
Bacterial infectious disease contraindication 87628006
Mycobacteriosis contraindication 88415009
Operation on nose contraindication 88733004
Bilateral cataracts contraindication 95722004
Ophthalmic herpes simplex contraindication 186542001
Disease of liver contraindication 235856003 DOID:409
Varicella-zoster virus infection contraindication 309465005
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Exposure to varicella contraindication 444453009
Nasal Trauma contraindication
Nasal Candidiasis contraindication
Nasal Septal Ulcers contraindication
Uncontrolled Bacterial Infections contraindication
Untreated Fungal Infection contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.01 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 10159645 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 11590074 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 12357568 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 10159645 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 11590074 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 12357568 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 10617638 Dec. 23, 2034 MAINTENANCE TREATMENT OF ASTHMA
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 10617638 Dec. 23, 2034 MAINTENANCE TREATMENT OF ASTHMA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION May 14, 2029 NEW PRODUCT
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION May 14, 2029 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST Ki 8.43 DRUG MATRIX CHEMBL
Interleukin-5 Cytokine IC50 4.57 CHEMBL
Mineralocorticoid receptor Nuclear hormone receptor EC50 8.32 CHEMBL
Matrix metalloproteinase-9 Enzyme IC50 5.70 CHEMBL
Probable G-protein coupled receptor 97 GPCR AGONIST EC50 8.50 IUPHAR
Progesterone receptor Nuclear hormone receptor IC50 7.55 CHEMBL
Androgen receptor Transcription factor Ki 5.96 CHEMBL
Progesterone receptor Transcription factor Ki 7.57 CHEMBL
Glucocorticoid receptor Transcription factor IC50 8.54 CHEMBL
Interleukin-5 Cytokine IC50 4.58 CHEMBL
Interleukin-5 receptor subunit alpha Membrane receptor IC50 4.58 CHEMBL

External reference:

IDSource
D00689 KEGG_DRUG
77011-63-3 SECONDARY_CAS_RN
1347 RXNORM
C0004906 UMLSCUI
CHEBI:3002 CHEBI
CHEMBL1200500 ChEMBL_ID
CHEMBL1370 ChEMBL_ID
DB00394 DRUGBANK_ID
5894 IUPHAR_LIGAND_ID
21700 PUBCHEM_CID
1167 MMSL
4249 MMSL
71834 MMSL
8263 MMSL
d00760 MMSL
C0004905 UMLSCUI
D019819 MESH_DESCRIPTOR_UI
D001507 MESH_DESCRIPTOR_UI
4419-39-0 SECONDARY_CAS_RN
20469 PUBCHEM_CID
7059 IUPHAR_LIGAND_ID
2307 INN_ID
4018793 VANDF
4019625 VANDF
5B307S63B2 UNII
KGZ1SLC28Z UNII
002179 NDDF
004947 NDDF
116574000 SNOMEDCT_US
116575004 SNOMEDCT_US
1389007 SNOMEDCT_US
426017007 SNOMEDCT_US
CHEBI:3001 CHEBI
KGZ1SLC28Z INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Trimbow HUMAN PRESCRIPTION DRUG LABEL 3 10122-120 AEROSOL 100 ug ORAL NDA 31 sections
Trimbow HUMAN PRESCRIPTION DRUG LABEL 3 10122-121 AEROSOL 200 ug ORAL NDA 31 sections
BECONASE AQ HUMAN PRESCRIPTION DRUG LABEL 1 16590-030 SPRAY, SUSPENSION 42 ug NASAL NDA 13 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 16590-860 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 26 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 50090-1342 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 28 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 50090-3033 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 28 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 50090-3458 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 50090-3459 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 50090-5031 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 50090-5032 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 53002-2436 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 53002-3477 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 54868-5857 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 14 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 54868-5858 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 14 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-302 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-302 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-304 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-304 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QNASL HUMAN PRESCRIPTION DRUG LABEL 1 59310-406 AEROSOL, METERED 40 ug NASAL NDA 27 sections
QNASL HUMAN PRESCRIPTION DRUG LABEL 1 59310-410 AEROSOL, METERED 80 ug NASAL NDA 27 sections
Beclomethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 69238-1289 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) ANDA 26 sections
Beclomethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 69238-1290 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) ANDA 26 sections