mometasone furoate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
prednisone and prednisolone derivatives 1832 83919-23-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • mometasone furoate hydrate
  • mometasone furoate
  • asmanex
  • ecural
  • elomet
  • nasonex
  • mometasone furoate monohydrate
A pregnadienediol derivative ANTI-ALLERGIC AGENT and ANTI-INFLAMMATORY AGENT that is used in the management of ASTHMA and ALLERGIC RHINITIS. It is also used as a topical treatment for skin disorders.
  • Molecular weight: 521.43
  • Formula: C27H30Cl2O6
  • CLOGP: 4.12
  • LIPINSKI: 1
  • HAC: 6
  • HDO: 1
  • TPSA: 93.81
  • ALOGS: -4.68
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.20 mg N
0.40 mg Inhal.powder

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.02 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 2.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 12.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 30, 1987 FDA MERCK SHARP DOHME
June 29, 2020 PMDA Novartis Pharma K.K.

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
Product quality issue 4458.57 11.95 1527 49934 29331 50524332
No adverse event 2849.04 11.95 1124 50337 32454 50521209
Poor quality device used 2520.60 11.95 540 50921 1311 50552352
Product dose omission issue 1727.10 11.95 1452 50009 182386 50371277
Product container issue 640.93 11.95 170 51291 1262 50552401
Device malfunction 551.51 11.95 281 51180 14840 50538823
Asthma 527.89 11.95 547 50914 88790 50464873
Circumstance or information capable of leading to medication error 401.93 11.95 143 51318 3045 50550618
Gastrooesophageal reflux disease 369.16 11.95 421 51040 76007 50477656
Wheezing 353.82 11.95 373 51088 61674 50491989
Sputum discoloured 221.25 11.95 149 51312 13246 50540417
Cough 219.54 11.95 639 50822 240625 50313038
Ejection fraction 198.64 11.95 66 51395 1134 50552529
Productive cough 192.10 11.95 252 51209 52442 50501221
Pneumonia aspiration 175.88 11.95 186 51275 30818 50522845
Rhinitis allergic 168.84 11.95 100 51361 7100 50546563
Incorrect dose administered 154.39 11.95 217 51244 48197 50505466
Infective pulmonary exacerbation of cystic fibrosis 152.64 11.95 97 51364 7812 50545851
Sleep disorder due to a general medical condition 151.29 11.95 94 51367 7277 50546386
Toxicity to various agents 151.28 11.95 19 51442 212480 50341183
Sensitisation 147.99 11.95 57 51404 1525 50552138
Dyspnoea 146.61 11.95 1004 50457 546604 50007059
Presbyacusis 141.74 11.95 65 51396 2711 50550952
Sleep apnoea syndrome 140.38 11.95 146 51315 23722 50529941
Steroid withdrawal syndrome 137.38 11.95 41 51420 486 50553177
Polycystic ovaries 135.80 11.95 61 51400 2423 50551240
Pleural fibrosis 135.39 11.95 67 51394 3317 50550346
Pleural thickening 130.02 11.95 60 51401 2539 50551124
Blood magnesium increased 118.14 11.95 58 51403 2822 50550841
Deafness neurosensory 114.74 11.95 66 51395 4435 50549228
Synovitis 108.31 11.95 4 51457 123861 50429802
Nasal polyps 106.46 11.95 52 51409 2502 50551161
Obstructive airways disorder 105.33 11.95 103 51358 15549 50538114
Blood test abnormal 104.61 11.95 89 51372 11230 50542433
Glossodynia 100.13 11.95 4 51457 115565 50438098
Systemic lupus erythematosus 96.63 11.95 14 51447 140608 50413055
Epigastric discomfort 96.21 11.95 65 51396 5805 50547858
Chest discomfort 95.24 11.95 257 51204 92465 50461198
Nasal congestion 93.23 11.95 178 51283 50942 50502721
Hand deformity 88.41 11.95 3 51458 100196 50453467
Full blood count abnormal 85.40 11.95 112 51349 23276 50530387
Underdose 84.97 11.95 104 51357 20174 50533489
Death 84.62 11.95 125 51336 325254 50228409
Coma 83.47 11.95 181 51280 56698 50496965
Acute kidney injury 81.99 11.95 67 51394 227991 50325672
Cyst 81.63 11.95 80 51381 12107 50541556
Contraindicated product administered 79.81 11.95 26 51435 148932 50404731
Asthma-chronic obstructive pulmonary disease overlap syndrome 70.23 11.95 24 51437 451 50553212
Bone cyst 69.09 11.95 36 51425 1988 50551675
Product taste abnormal 68.18 11.95 34 51427 1711 50551952
Sinusitis 68.07 11.95 348 51113 170210 50383453
Asthma exercise induced 65.61 11.95 20 51441 256 50553407
Osteopenia 64.48 11.95 83 51378 16935 50536728
Therapeutic product effect incomplete 62.50 11.95 220 51241 91295 50462368
Wrong technique in device usage process 62.16 11.95 36 51425 2450 50551213
Neutropenia 61.69 11.95 37 51424 147928 50405735
Maternal exposure during pregnancy 61.14 11.95 44 51417 159734 50393929
Thrombocytopenia 60.53 11.95 27 51434 127646 50426017
Factor V Leiden mutation 59.31 11.95 17 51444 173 50553490
Pericarditis 58.53 11.95 6 51455 78683 50474980
Wound 57.48 11.95 18 51443 105776 50447887
Anaemia 57.18 11.95 106 51355 252350 50301313
Nephrectomy 57.05 11.95 24 51437 811 50552852
Rhinitis 56.54 11.95 55 51406 8246 50545417
Dry eye 56.35 11.95 110 51351 31985 50521678
Poor quality product administered 55.45 11.95 35 51426 2784 50550879
Vomiting 54.67 11.95 262 51199 460496 50093167
Sleep disorder 53.09 11.95 153 51308 57130 50496533
Overdose 52.36 11.95 18 51443 99709 50453954
Off label use 51.61 11.95 278 51183 474148 50079515
Intentional overdose 51.44 11.95 3 51458 62501 50491162
Osteosclerosis 51.18 11.95 36 51425 3431 50550232
Somnolence 50.26 11.95 299 51162 154686 50398977
Total lung capacity increased 50.02 11.95 21 51440 706 50552957
Drug interaction 48.65 11.95 80 51381 199541 50354122
Bronchiectasis 48.45 11.95 56 51405 10227 50543436
Drug abuse 46.00 11.95 4 51457 59842 50493821
Swelling 45.77 11.95 84 51377 200788 50352875
Lung opacity 45.20 11.95 27 51434 1946 50551717
Abdominal discomfort 45.08 11.95 106 51355 231535 50322128
Confusional state 44.85 11.95 75 51386 185853 50367810
Cardiac arrest 44.08 11.95 15 51446 83636 50470027
Pancytopenia 42.69 11.95 16 51445 84014 50469649
Alopecia 42.40 11.95 119 51342 244928 50308735
Middle insomnia 41.75 11.95 51 51410 9870 50543793
Forced expiratory volume decreased 41.52 11.95 35 51426 4359 50549304
Leukopenia 41.42 11.95 9 51452 67519 50486144
Upper-airway cough syndrome 41.02 11.95 47 51414 8503 50545160
Prolonged expiration 40.35 11.95 18 51443 703 50552960
Joint swelling 40.34 11.95 122 51339 245164 50308499
Hypotension 40.26 11.95 115 51346 235354 50318309
Blood potassium increased 40.13 11.95 65 51396 16333 50537330
Oropharyngeal pain 40.00 11.95 171 51290 77630 50476033
Asthenopia 39.80 11.95 25 51436 1972 50551691
Heart sounds 39.38 11.95 17 51444 613 50553050
Discomfort 38.70 11.95 32 51429 108348 50445315
Carpal tunnel syndrome 38.70 11.95 65 51396 16828 50536835
Skin weeping 38.67 11.95 15 51446 409 50553254
Occupational asthma 38.02 11.95 11 51450 116 50553547
Eosinophilic granulomatosis with polyangiitis 37.77 11.95 24 51437 1931 50551732
Bronchopulmonary aspergillosis allergic 37.30 11.95 20 51441 1171 50552492
Sinus disorder 37.05 11.95 67 51394 18391 50535272
Rhinorrhoea 36.92 11.95 126 51335 51457 50502206
Helicobacter infection 36.42 11.95 4 51457 49698 50503965
Dehydration 36.29 11.95 62 51399 152387 50401276
Incorrect dose administered by product 35.93 11.95 11 51450 143 50553520
Cardio-respiratory arrest 35.56 11.95 6 51455 53886 50499777
General physical health deterioration 34.76 11.95 57 51404 142377 50411286
Skin lesion 34.66 11.95 81 51380 26646 50527017
Multiple organ dysfunction syndrome 34.58 11.95 5 51456 50332 50503331
Condition aggravated 33.38 11.95 172 51289 296886 50256777
Bronchial obstruction 33.10 11.95 19 51442 1271 50552392
Hyperkalaemia 32.52 11.95 5 51456 48084 50505579
Hyponatraemia 32.37 11.95 30 51431 96109 50457554
Infusion related reaction 31.85 11.95 79 51382 169478 50384185
Respiration abnormal 31.41 11.95 32 51429 5070 50548593
Fall 31.19 11.95 206 51255 334726 50218937
Oesophageal dilatation 31.15 11.95 12 51449 321 50553342
Exposure during pregnancy 30.88 11.95 47 51414 120968 50432695
Pre-existing condition improved 30.70 11.95 37 51424 7060 50546603
Acquired haemophilia 30.65 11.95 16 51445 887 50552776
Deformity 30.50 11.95 39 51422 7901 50545762
Respiratory tract congestion 30.37 11.95 53 51408 14146 50539517
Impaired healing 29.70 11.95 17 51444 69769 50483894
Circumstance or information capable of leading to device use error 29.68 11.95 9 51452 113 50553550
Nasal mucosal disorder 29.37 11.95 12 51449 376 50553287
Burning sensation 29.08 11.95 107 51354 45339 50508324
Ejection fraction abnormal 28.72 11.95 15 51446 832 50552831
Enthesopathy 28.69 11.95 36 51425 7157 50546506
Headache 28.61 11.95 695 50766 505840 50047823
Nasopharyngitis 28.60 11.95 311 51150 192616 50361047
Adrenal suppression 28.31 11.95 15 51446 857 50552806
Exostosis 28.25 11.95 46 51415 11607 50542056
Product odour abnormal 28.00 11.95 16 51445 1061 50552602
Dysphonia 27.83 11.95 95 51366 38797 50514866
Rales 27.82 11.95 42 51419 9936 50543727
Bronchitis 27.60 11.95 191 51270 103968 50449695
Haemoglobin decreased 27.38 11.95 55 51406 127161 50426502
Product availability issue 26.98 11.95 20 51441 2068 50551595
Platelet count decreased 26.79 11.95 38 51423 100688 50452975
Expired product administered 26.52 11.95 30 51431 5352 50548311
Neutrophil count decreased 26.52 11.95 7 51454 46019 50507644
Pain 26.15 11.95 423 51038 578480 49975183
Pulmonary function test decreased 26.03 11.95 24 51437 3364 50550299
Tenosynovitis 26.01 11.95 42 51419 10523 50543140
Febrile neutropenia 25.82 11.95 37 51424 97630 50456033
Hepatic enzyme increased 25.80 11.95 64 51397 137316 50416347
Decreased appetite 25.68 11.95 111 51350 200812 50352851
Eczema 25.39 11.95 65 51396 22637 50531026
Total lung capacity decreased 25.32 11.95 16 51445 1275 50552388
Arthropathy 24.90 11.95 80 51381 157826 50395837
Upper respiratory tract infection 24.54 11.95 132 51329 65766 50487897
Croup infectious 24.32 11.95 11 51450 444 50553219
Vital capacity decreased 24.32 11.95 14 51447 942 50552721
Cardiac disorder 24.07 11.95 97 51364 42882 50510781
Lactic acidosis 23.65 11.95 3 51458 33352 50520311
Sarcoidosis 23.10 11.95 27 51434 4990 50548673
CFTR gene mutation 23.08 11.95 7 51454 88 50553575
Diaphragmatic rupture 23.05 11.95 9 51452 250 50553413
Bradycardia 23.02 11.95 19 51442 64407 50489256
Cardiac failure 23.01 11.95 26 51435 76014 50477649
Female sterilisation 23.00 11.95 11 51450 505 50553158
Septic shock 22.84 11.95 15 51446 57160 50496503
Diarrhoea 22.74 11.95 442 51019 588034 49965629
Sepsis 22.63 11.95 65 51396 132860 50420803
Dyspnoea exertional 22.13 11.95 107 51354 51126 50502537
Seizure 22.06 11.95 55 51406 117819 50435844
Osteoarthritis 21.97 11.95 132 51329 68474 50485189
Loss of personal independence in daily activities 21.94 11.95 134 51327 69916 50483747
Disease progression 21.89 11.95 40 51421 95826 50457837
Inappropriate schedule of product administration 21.62 11.95 136 51325 71695 50481968
Mucosal inflammation 21.49 11.95 7 51454 40135 50513528
Palpitations 21.43 11.95 167 51294 94339 50459324
Anosmia 21.25 11.95 23 51438 3908 50549755
Product dosage form issue 21.24 11.95 5 51456 21 50553642
Folliculitis 20.72 11.95 7 51454 39218 50514445
Lung perforation 20.68 11.95 6 51455 64 50553599
Respiratory arrest 20.57 11.95 3 51458 30006 50523657
Renal failure 20.55 11.95 49 51412 106584 50447079
Electrocardiogram QT prolonged 20.20 11.95 14 51447 51872 50501791
Gastrointestinal haemorrhage 20.16 11.95 27 51434 73294 50480369
Suicide attempt 20.09 11.95 14 51447 51718 50501945
Therapeutic product effect decreased 20.03 11.95 71 51390 135979 50417684
Throat irritation 20.02 11.95 72 51389 30167 50523496
Product leakage 19.71 11.95 10 51451 522 50553141
Therapy non-responder 19.56 11.95 14 51447 51008 50502655
Hippocampal sclerosis 19.53 11.95 6 51455 79 50553584
Nasal dryness 19.45 11.95 21 51440 3558 50550105
Respiratory tract infection 19.33 11.95 74 51387 31943 50521720
Skin burning sensation 19.21 11.95 36 51425 10149 50543514
Adiposis dolorosa 19.00 11.95 8 51453 271 50553392
Depressed level of consciousness 18.96 11.95 15 51446 51938 50501725
Sinus congestion 18.84 11.95 43 51418 13928 50539735
Interstitial lung disease 18.61 11.95 16 51445 53160 50500503
Painful respiration 18.59 11.95 17 51444 2358 50551305
Irritable bowel syndrome 18.59 11.95 15 51446 51426 50502237
Seasonal allergy 18.51 11.95 44 51417 14632 50539031
Ureteral disorder 18.46 11.95 8 51453 291 50553372
Hepatic failure 18.43 11.95 5 51456 32278 50521385
Genital rash 18.18 11.95 9 51452 446 50553217
Exposure via skin contact 18.04 11.95 7 51454 191 50553472
Epistaxis 17.96 11.95 119 51342 63835 50489828
Red blood cell sedimentation rate increased 17.87 11.95 4 51457 29412 50524251
Procedural anxiety 17.69 11.95 10 51451 650 50553013
Focal segmental glomerulosclerosis 17.68 11.95 13 51448 1328 50552335
International normalised ratio increased 17.67 11.95 11 51450 43141 50510522
Dystrophic calcification 17.59 11.95 6 51455 112 50553551
Hypothyroidism 17.52 11.95 75 51386 34050 50519613
Erythema marginatum 17.15 11.95 4 51457 16 50553647
Haemoptysis 17.02 11.95 61 51400 25512 50528151
Purpura senile 16.89 11.95 9 51452 520 50553143
Temporal lobe epilepsy 16.83 11.95 8 51453 362 50553301
Tarsal tunnel syndrome 16.74 11.95 9 51452 530 50553133
Fibromyalgia 16.68 11.95 90 51371 44888 50508775
Secretion discharge 16.51 11.95 33 51428 9758 50543905
Blood immunoglobulin E decreased 16.33 11.95 5 51456 65 50553598
Knee arthroplasty 16.33 11.95 8 51453 35838 50517825
Obstruction 16.31 11.95 15 51446 2096 50551567
Anxiety 16.14 11.95 262 51199 177344 50376319
Allergic sinusitis 16.13 11.95 9 51452 570 50553093
Product quality control issue 16.10 11.95 4 51457 22 50553641
Hypothalamic pituitary adrenal axis suppression 16.07 11.95 6 51455 147 50553516
White blood cell count decreased 15.82 11.95 63 51398 116659 50437004
Product administration error 15.78 11.95 50 51411 19649 50534014
Type 2 diabetes mellitus 15.73 11.95 73 51388 34302 50519361
Nasal oedema 15.57 11.95 10 51451 820 50552843
Hyperaesthesia 15.56 11.95 29 51432 8144 50545519
Tongue pruritus 15.38 11.95 8 51453 440 50553223
Cardiac failure congestive 15.30 11.95 40 51421 84342 50469321
Product administered to patient of inappropriate age 15.30 11.95 16 51445 2614 50551049
Urticaria 15.28 11.95 200 51261 129361 50424302
Eosinophil count abnormal 15.20 11.95 8 51453 451 50553212
Drug reaction with eosinophilia and systemic symptoms 15.14 11.95 5 51456 28419 50525244
Hip arthroplasty 15.11 11.95 6 51455 30423 50523240
Blister 15.10 11.95 41 51420 85377 50468286
Post-traumatic stress disorder 14.77 11.95 20 51441 4283 50549380
Periodic limb movement disorder 14.72 11.95 6 51455 187 50553476
Encephalopathy 14.65 11.95 8 51453 33703 50519960
Glaucoma 14.62 11.95 42 51419 15644 50538019
Pregnancy 14.41 11.95 6 51455 29571 50524092
Rash 14.40 11.95 337 51124 437134 50116529
Dermatitis atopic 14.39 11.95 18 51443 3568 50550095
Depressive symptom 14.36 11.95 17 51444 3183 50550480
Urinary tract infection 14.36 11.95 152 51309 223868 50329795
Intentional self-injury 14.33 11.95 3 51458 23109 50530554
Hypokalaemia 14.27 11.95 44 51417 87948 50465715
Haematocrit decreased 14.21 11.95 9 51452 34967 50518696
Pulmonary eosinophilia 14.15 11.95 6 51455 207 50553456
Exposure to fungus 14.07 11.95 5 51456 106 50553557
Bursitis 14.06 11.95 52 51409 22083 50531580
Mesenteric haemorrhage 13.84 11.95 4 51457 42 50553621
Hypocalcaemia 13.79 11.95 5 51456 26811 50526852
Pulmonary mass 13.65 11.95 46 51415 18659 50535004
Diaphragmatic paralysis 13.64 11.95 8 51453 557 50553106
Ascites 13.54 11.95 10 51451 35851 50517812
Fractional exhaled nitric oxide increased 13.53 11.95 3 51458 9 50553654
Skin atrophy 13.48 11.95 19 51442 4226 50549437
Sneezing 13.48 11.95 38 51423 14006 50539657
Peritoneal perforation 13.45 11.95 5 51456 121 50553542
Bronchitis chronic 13.28 11.95 18 51443 3859 50549804
Menopause 13.26 11.95 14 51447 2313 50551350
C-reactive protein increased 13.24 11.95 30 51431 66444 50487219
Paranasal sinus inflammation 13.05 11.95 7 51454 410 50553253
Cerebral infarction 13 11.95 3 51458 21601 50532062
Lower respiratory tract congestion 12.96 11.95 13 51448 2023 50551640
Lichenification 12.94 11.95 7 51454 417 50553246
Exercise tolerance decreased 12.86 11.95 20 51441 4854 50548809
Incorrect route of product administration 12.83 11.95 45 51416 18621 50535042
Breath sounds abnormal 12.82 11.95 26 51435 7766 50545897
Intentional product use issue 12.80 11.95 38 51423 76880 50476783
Flail chest 12.66 11.95 4 51457 58 50553605
Skin wrinkling 12.64 11.95 9 51452 874 50552789
Hypoglycaemia 12.55 11.95 22 51439 53559 50500104
Cystic fibrosis 12.50 11.95 15 51446 2849 50550814
Asthenia 12.46 11.95 239 51222 318803 50234860
Unresponsive to stimuli 12.26 11.95 8 51453 30601 50523062
Metastases to lymph nodes 12.23 11.95 24 51437 7000 50546663
Hospitalisation 12.20 11.95 114 51347 67823 50485840
Pneumonia 12.14 11.95 485 50976 377916 50175747

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
Product quality issue 2545.49 14.05 794 21957 15101 29536675
No adverse event 2090.63 14.05 700 22051 16778 29534998
Poor quality device used 1484.22 14.05 289 22462 531 29551245
Product dose omission issue 1018.62 14.05 728 22023 95655 29456121
Product container issue 412.20 14.05 95 22656 502 29551274
Asthma 405.37 14.05 277 22474 33572 29518204
Device malfunction 320.54 14.05 148 22603 8359 29543417
Circumstance or information capable of leading to medication error 284.73 14.05 86 22665 1438 29550338
Wheezing 264.87 14.05 213 22538 33027 29518749
Dyspnoea 128.50 14.05 543 22208 326189 29225587
Cough 126.66 14.05 292 22459 126435 29425341
Nasal polyps 113.84 14.05 45 22706 1724 29550052
Nasal congestion 113.47 14.05 103 22648 18776 29533000
Obstructive airways disorder 112.71 14.05 82 22669 10934 29540842
Infective pulmonary exacerbation of cystic fibrosis 101.53 14.05 62 22689 6174 29545602
Chest discomfort 96.62 14.05 146 22605 45837 29505939
Sinusitis 77.79 14.05 113 22638 34237 29517539
Full blood count abnormal 75.09 14.05 74 22677 14939 29536837
Chronic sinusitis 71.45 14.05 32 22719 1679 29550097
Toxicity to various agents 70.40 14.05 23 22728 173638 29378138
Poor quality product administered 66.71 14.05 30 22721 1589 29550187
Steroid withdrawal syndrome 65.62 14.05 18 22733 209 29551567
Incorrect dose administered 64.02 14.05 101 22650 32883 29518893
Productive cough 61.06 14.05 96 22655 31163 29520613
Sleep disorder due to a general medical condition 60.95 14.05 35 22716 3111 29548665
Upper-airway cough syndrome 59.76 14.05 34 22717 2969 29548807
Acute kidney injury 59.57 14.05 70 22681 265197 29286579
Nasal discomfort 58.17 14.05 25 22726 1187 29550589
Death 55.99 14.05 112 22639 341972 29209804
Completed suicide 54.10 14.05 4 22747 90242 29461534
Rhinitis perennial 52.58 14.05 15 22736 203 29551573
Painful respiration 49.16 14.05 22 22729 1152 29550624
Fractional exhaled nitric oxide increased 48.50 14.05 16 22735 360 29551416
Drug abuse 46.60 14.05 4 22747 79879 29471897
Underdose 45.90 14.05 51 22700 11818 29539958
Neutropenia 45.86 14.05 22 22729 131689 29420087
Product taste abnormal 45.06 14.05 20 22731 1027 29550749
Forced expiratory volume decreased 43.32 14.05 27 22724 2786 29548990
Thrombocytopenia 43.28 14.05 25 22726 134798 29416978
Chest injury 42.00 14.05 21 22730 1412 29550364
Walking aid user 41.40 14.05 21 22730 1456 29550320
Oropharyngeal discomfort 40.55 14.05 25 22726 2531 29549245
Nasopharyngitis 40.39 14.05 119 22632 59546 29492230
Bronchopulmonary aspergillosis allergic 39.83 14.05 15 22736 503 29551273
Dyspnoea exertional 39.56 14.05 87 22664 36403 29515373
Adrenal suppression 39.44 14.05 15 22736 517 29551259
Pleural thickening 39.18 14.05 13 22738 298 29551478
Pulmonary function test decreased 38.12 14.05 29 22722 4134 29547642
Anaemia 38 14.05 60 22691 200891 29350885
Nasal disorder 36.00 14.05 19 22732 1430 29550346
Anosmia 35.52 14.05 21 22730 1970 29549806
Hypersomnia 34.54 14.05 42 22709 10712 29541064
Bronchial obstruction 33.88 14.05 18 22733 1373 29550403
Renal failure 32.69 14.05 26 22725 118573 29433203
Bronchial wall thickening 32.56 14.05 16 22735 1036 29550740
Middle insomnia 32.05 14.05 30 22721 5678 29546098
Secretion discharge 31.41 14.05 26 22725 4184 29547592
Hypersensitivity 30.68 14.05 100 22651 52803 29498973
Myocardial infarction 30.62 14.05 24 22727 110272 29441504
Adjustment disorder 30.32 14.05 15 22736 986 29550790
Respiratory tract congestion 30.27 14.05 28 22723 5221 29546555
Sleep apnoea syndrome 30.21 14.05 51 22700 17548 29534228
Plantar fasciitis 29.59 14.05 16 22735 1265 29550511
Hyperkalaemia 28.89 14.05 6 22745 61386 29490390
Nasal oedema 27.86 14.05 10 22741 292 29551484
Tongue dry 27.65 14.05 9 22742 194 29551582
Platelet count decreased 27.54 14.05 24 22727 104648 29447128
Sensation of foreign body 27.11 14.05 17 22734 1773 29550003
Hot flush 26.74 14.05 44 22707 14826 29536950
Central obesity 26.71 14.05 11 22740 469 29551307
Aortic aneurysm 26.27 14.05 28 22723 6192 29545584
Product availability issue 26.05 14.05 14 22737 1093 29550683
Skin plaque 25.53 14.05 22 22729 3740 29548036
Myoglobin blood increased 25.42 14.05 17 22734 1978 29549798
Oral candidiasis 25.31 14.05 36 22715 10686 29541090
Sinus polyp 25.28 14.05 8 22743 157 29551619
Increased viscosity of upper respiratory secretion 25.08 14.05 7 22744 87 29551689
Sputum discoloured 25.03 14.05 28 22723 6535 29545241
Off label use 24.96 14.05 133 22618 300667 29251109
Temperature intolerance 23.82 14.05 19 22732 2902 29548874
Cardio-respiratory arrest 23.69 14.05 5 22746 50596 29501180
Dry skin 23.50 14.05 54 22697 23253 29528523
Eosinophilic granulomatosis with polyangiitis 23.12 14.05 14 22737 1372 29550404
Sitting disability 23.06 14.05 7 22744 119 29551657
Chorioretinopathy 22.84 14.05 14 22737 1402 29550374
Bronchiolitis 22.63 14.05 18 22733 2737 29549039
Cystic fibrosis 22.17 14.05 14 22737 1478 29550298
Feeling cold 21.90 14.05 31 22720 9160 29542616
Rhinorrhoea 21.85 14.05 50 22701 21469 29530307
Incorrect dose administered by product 21.59 14.05 5 22746 27 29551749
Leukopenia 21.14 14.05 8 22743 55195 29496581
Rhinitis 21.05 14.05 22 22729 4756 29547020
Eczema 21.04 14.05 38 22713 13788 29537988
Growth retardation 20.99 14.05 14 22737 1622 29550154
Wrong technique in device usage process 20.83 14.05 12 22739 1073 29550703
Pancytopenia 20.77 14.05 20 22731 83148 29468628
Influenza 20.63 14.05 75 22676 41806 29509970
Ear infection 20.32 14.05 28 22723 8072 29543704
Maple syrup disease 20.30 14.05 4 22747 8 29551768
Hepatic function abnormal 20.29 14.05 3 22748 39256 29512520
Device dislocation 20.22 14.05 21 22730 4506 29547270
Dyspnoea at rest 20.21 14.05 18 22733 3196 29548580
Cockroach allergy 20.01 14.05 5 22746 39 29551737
Throat irritation 20.01 14.05 29 22722 8756 29543020
Dust allergy 19.95 14.05 9 22742 480 29551296
Dysphonia 19.93 14.05 45 22706 19151 29532625
Multiple organ dysfunction syndrome 19.81 14.05 12 22739 63104 29488672
Dermatitis atopic 19.31 14.05 15 22736 2204 29549572
Therapeutic product effect incomplete 19.03 14.05 70 22681 39235 29512541
Bronchitis 18.99 14.05 67 22684 36801 29514975
Bradycardia 18.56 14.05 14 22737 65615 29486161
Exostosis 18.51 14.05 18 22733 3571 29548205
Polyp 18.48 14.05 17 22734 3148 29548628
Blood creatinine increased 18.45 14.05 23 22728 85079 29466697
Bronchiectasis 18.41 14.05 24 22727 6561 29545215
Skin atrophy 17.94 14.05 13 22738 1721 29550055
Sepsis 17.53 14.05 54 22697 142628 29409148
Cardiac arrest 16.67 14.05 25 22726 85566 29466210
Skin weeping 16.62 14.05 6 22745 178 29551598
Seasonal allergy 16.50 14.05 20 22731 5082 29546694
Hyperleukocytosis 16.33 14.05 12 22739 1623 29550153
Brain natriuretic peptide increased 16.05 14.05 18 22733 4212 29547564
Disease progression 15.88 14.05 24 22727 81892 29469884
Sneezing 15.42 14.05 18 22733 4396 29547380
Aspartate aminotransferase increased 15.33 14.05 14 22737 59711 29492065
Confusional state 15.28 14.05 49 22702 127828 29423948
Somnolence 15.07 14.05 31 22720 93924 29457852
Clumsiness 14.92 14.05 11 22740 1495 29550281
Obesity 14.87 14.05 27 22724 9836 29541940
Encephalopathy 14.67 14.05 3 22748 31040 29520736
Stress 14.65 14.05 43 22708 21447 29530329
Coma 14.64 14.05 6 22745 39444 29512332
Allergy to animal 14.61 14.05 6 22745 254 29551522
Snoring 14.43 14.05 14 22737 2770 29549006
Hypotension 14.43 14.05 89 22662 194265 29357511
Drug interaction 14.33 14.05 91 22660 197294 29354482
Expired product administered 14.32 14.05 14 22737 2797 29548979
Pharyngeal paraesthesia 14.25 14.05 7 22744 453 29551323
Ear disorder 14.21 14.05 10 22741 1264 29550512
Swollen tongue 14.15 14.05 30 22721 12236 29539540
Lactic acidosis 14.13 14.05 3 22748 30244 29521532
Hypoacusis 14.08 14.05 33 22718 14390 29537386
Loss of consciousness 14.06 14.05 22 22729 74034 29477742

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
Poor quality device used 2050.53 11.33 450 55833 1557 64440892
Product quality issue 1917.58 11.33 784 55499 29015 64413434
Asthma 789.59 11.33 658 55625 94567 64347882
No adverse event 719.80 11.33 394 55889 28167 64414282
Product dose omission issue 572.68 11.33 774 55509 193973 64248476
Wheezing 455.06 11.33 449 55834 80130 64362319
Device malfunction 451.73 11.33 246 56037 17387 64425062
Gastrooesophageal reflux disease 337.68 11.33 389 55894 82754 64359695
Circumstance or information capable of leading to medication error 325.45 11.33 119 56164 3221 64439228
Cough 263.78 11.33 715 55568 301433 64141016
Product container issue 260.73 11.33 74 56209 857 64441592
Sputum discoloured 223.77 11.33 158 56125 17698 64424751
Productive cough 208.54 11.33 287 55996 72916 64369533
Infective pulmonary exacerbation of cystic fibrosis 205.04 11.33 128 56155 11668 64430781
Ejection fraction 204.07 11.33 66 56217 1220 64441229
Dyspnoea 196.42 11.33 1181 55102 717493 63724956
Sleep disorder due to a general medical condition 194.68 11.33 109 56174 8125 64434324
Toxicity to various agents 190.97 11.33 42 56241 363471 64078978
Nasal congestion 185.32 11.33 244 56039 59414 64383035
Completed suicide 176.59 11.33 4 56279 224410 64218039
Nasal polyps 175.13 11.33 78 56205 3551 64438898
Rhinitis allergic 167.07 11.33 98 56185 7980 64434469
Pleural thickening 162.80 11.33 68 56215 2642 64439807
Polycystic ovaries 153.15 11.33 61 56222 2094 64440355
Sensitisation 151.48 11.33 57 56226 1674 64440775
Steroid withdrawal syndrome 148.04 11.33 44 56239 606 64441843
Presbyacusis 142.66 11.33 61 56222 2514 64439935
Full blood count abnormal 140.94 11.33 151 56132 29606 64412843
Chest discomfort 136.15 11.33 308 55975 115798 64326651
Obstructive airways disorder 134.04 11.33 131 56152 23054 64419395
Acute kidney injury 124.78 11.33 125 56158 449115 63993334
Pneumonia aspiration 119.71 11.33 198 56085 59073 64383376
Pleural fibrosis 119.17 11.33 62 56221 3988 64438461
Blood magnesium increased 105.33 11.33 53 56230 3178 64439271
Blood test abnormal 104.01 11.33 88 56195 12855 64429594
Deafness neurosensory 95.50 11.33 63 56220 6311 64436138
Drug abuse 94.92 11.33 5 56278 132369 64310080
Sleep apnoea syndrome 86.45 11.33 118 56165 29714 64412735
Neutropenia 84.96 11.33 52 56231 239572 64202877
Epigastric discomfort 84.69 11.33 60 56223 6751 64435698
Death 82.86 11.33 187 56096 482518 63959931
Thrombocytopenia 81.55 11.33 47 56236 223754 64218695
Forced expiratory volume decreased 79.68 11.33 58 56225 6809 64435640
Therapeutic product effect incomplete 79.29 11.33 234 56049 103248 64339201
Cyst 79.12 11.33 73 56210 11954 64430495
Sinusitis 77.08 11.33 291 55992 145637 64296812
Synovitis 73.45 11.33 3 56280 99087 64343362
Anaemia 73.16 11.33 137 56146 378543 64063906
Headache 71.76 11.33 741 55542 528726 63913723
Bone cyst 71.50 11.33 36 56247 2161 64440288
Nasopharyngitis 66.22 11.33 342 55941 195731 64246718
Bronchopulmonary aspergillosis allergic 66.11 11.33 31 56252 1591 64440858
Product taste abnormal 65.71 11.33 33 56250 1970 64440479
Dry eye 64.10 11.33 101 56182 28918 64413531
Bronchiectasis 63.87 11.33 70 56213 14070 64428379
Middle insomnia 62.11 11.33 66 56217 12811 64429638
Osteopenia 61.80 11.33 72 56211 15468 64426981
Upper-airway cough syndrome 61.15 11.33 55 56228 8715 64433734
Overdose 58.83 11.33 33 56250 159533 64282916
Sleep disorder 58.70 11.33 148 56135 59561 64382888
Eosinophilic granulomatosis with polyangiitis 57.06 11.33 34 56249 2848 64439601
Skin weeping 56.25 11.33 21 56262 603 64441846
Osteosclerosis 56.01 11.33 36 56247 3450 64438999
Cardio-respiratory arrest 54.41 11.33 10 56273 98383 64344066
Hyperkalaemia 54.40 11.33 11 56272 101118 64341331
Rhinorrhoea 54.17 11.33 144 56139 59825 64382624
Drug interaction 53.72 11.33 151 56132 361932 64080517
Asthenopia 53.62 11.33 29 56254 2018 64440431
Off label use 53.27 11.33 329 55954 632477 63809972
Adrenal suppression 52.97 11.33 25 56258 1302 64441147
Cardiac arrest 52.43 11.33 35 56248 154029 64288420
Bronchial obstruction 52.27 11.33 30 56253 2344 64440105
Pulmonary function test decreased 52.06 11.33 44 56239 6417 64436032
Wrong technique in device usage process 51.92 11.33 32 56251 2850 64439599
Incorrect dose administered 49.99 11.33 141 56142 60624 64381825
Bronchitis 49.46 11.33 207 56076 108536 64333913
Nephrectomy 48.34 11.33 24 56259 1398 64441051
Pancytopenia 48.17 11.33 33 56250 143276 64299173
Oropharyngeal pain 47.54 11.33 178 56105 88689 64353760
Asthma-chronic obstructive pulmonary disease overlap syndrome 47.40 11.33 22 56261 1103 64441346
Leukopenia 46.80 11.33 15 56268 101227 64341222
Total lung capacity increased 46.72 11.33 19 56264 689 64441760
Carpal tunnel syndrome 46.44 11.33 63 56220 15765 64426684
Exostosis 45.49 11.33 53 56230 11385 64431064
Rhinitis perennial 45.45 11.33 14 56269 219 64442230
Chronic sinusitis 44.94 11.33 40 56243 6252 64436197
Platelet count decreased 43.82 11.33 49 56234 167662 64274787
Loss of personal independence in daily activities 43.75 11.33 151 56132 72303 64370146
Multiple organ dysfunction syndrome 43.50 11.33 17 56266 101396 64341053
Nasal oedema 43.36 11.33 20 56263 988 64441461
Hand deformity 43.09 11.33 3 56280 62768 64379681
Eczema 43.06 11.33 86 56197 29634 64412815
Systemic lupus erythematosus 42.67 11.33 8 56275 77604 64364845
Respiratory tract congestion 42.45 11.33 61 56222 16104 64426345
Intentional overdose 42.15 11.33 13 56270 89931 64352518
Metabolic acidosis 41.94 11.33 6 56277 70952 64371497
Anosmia 41.72 11.33 33 56250 4384 64438065
Respiration abnormal 40.90 11.33 38 56245 6277 64436172
Nasal mucosal disorder 40.26 11.33 14 56269 326 64442123
Hypotension 39.80 11.33 184 56099 380790 64061659
Hypersensitivity 39.46 11.33 300 55983 196152 64246297
Confusional state 39.37 11.33 108 56175 261036 64181413
Renal failure 39.37 11.33 61 56222 181627 64260822
Heart sounds 39.16 11.33 16 56267 587 64441862
Bradycardia 38.70 11.33 28 56255 118191 64324258
Rhinitis 38.08 11.33 47 56236 10718 64431731
Nasal discomfort 38.04 11.33 31 56252 4297 64438152
Painful respiration 37.98 11.33 27 56256 3054 64439395
Prolonged expiration 37.51 11.33 17 56266 806 64441643
Dyspnoea exertional 37.22 11.33 145 56138 73585 64368864
Deformity 37.17 11.33 36 56247 6261 64436188
Incorrect dose administered by product 36.97 11.33 11 56272 152 64442297
Poor quality product administered 36.95 11.33 27 56256 3188 64439261
Coma 36.92 11.33 163 56120 87452 64354997
Lactic acidosis 36.75 11.33 5 56278 61405 64381044
General physical health deterioration 35.13 11.33 79 56204 204346 64238103
Respiratory arrest 35.05 11.33 3 56280 52982 64389467
Sinus disorder 34.81 11.33 57 56226 16851 64425598
Dust allergy 33.52 11.33 17 56266 1036 64441413
Contraindicated product administered 33.43 11.33 27 56256 107802 64334647
Septic shock 33.19 11.33 26 56257 105411 64337038
Increased viscosity of upper respiratory secretion 32.70 11.33 11 56272 231 64442218
Sepsis 31.98 11.33 99 56184 230242 64212207
Influenza 31.97 11.33 180 56103 106351 64336098
Bronchial wall thickening 31.40 11.33 20 56263 1887 64440562
Cystic fibrosis 31.04 11.33 25 56258 3409 64439040
Bone marrow failure 30.95 11.33 3 56280 47949 64394500
Glossodynia 30.95 11.33 9 56274 64687 64377762
Underdose 30.76 11.33 69 56214 25760 64416689
Urticaria 30.71 11.33 227 56056 147090 64295359
Blood potassium increased 30.49 11.33 69 56214 25911 64416538
Burning sensation 30.41 11.33 104 56179 49560 64392889
Skin plaque 29.98 11.33 38 56245 8902 64433547
Hepatic failure 29.84 11.33 6 56277 55388 64387061
Palpitations 29.69 11.33 174 56109 104314 64338135
Croup infectious 29.56 11.33 13 56270 574 64441875
Skin lesion 29.36 11.33 84 56199 36398 64406051
Skin burning sensation 29.36 11.33 41 56242 10542 64431907
Product administered to patient of inappropriate age 28.48 11.33 27 56256 4574 64437875
Nasal disorder 28.22 11.33 22 56261 2862 64439587
Febrile neutropenia 27.23 11.33 79 56204 187578 64254871
Throat irritation 26.99 11.33 76 56207 32635 64409814
Chest injury 26.98 11.33 20 56263 2413 64440036
Neutrophil count decreased 26.98 11.33 17 56266 77179 64365270
International normalised ratio increased 26.90 11.33 18 56265 79149 64363300
Disease progression 26.64 11.33 52 56231 141628 64300821
Haemoglobin decreased 26.26 11.33 85 56198 194978 64247471
Seasonal allergy 26.15 11.33 41 56242 11685 64430764
Dry skin 26.13 11.33 101 56182 51060 64391389
Temperature intolerance 25.97 11.33 34 56249 8221 64434228
Pericarditis 25.96 11.33 11 56272 62505 64379944
Seizure 25.90 11.33 68 56215 166824 64275625
Rales 25.67 11.33 47 56236 15182 64427267
Swelling face 25.62 11.33 111 56172 59055 64383394
Diaphragmatic rupture 25.39 11.33 9 56274 222 64442227
Osteoarthritis 25.30 11.33 116 56167 63220 64379229
Skin atrophy 25.13 11.33 26 56257 4894 64437555
Encephalopathy 24.99 11.33 10 56273 58809 64383640
Cardiac disorder 24.39 11.33 105 56178 55711 64386738
Acquired haemophilia 24.24 11.33 16 56267 1604 64440845
Hyponatraemia 24.13 11.33 59 56224 148280 64294169
Hepatic function abnormal 24.12 11.33 13 56270 64300 64378149
Interstitial lung disease 23.97 11.33 30 56253 97702 64344747
Vomiting 23.90 11.33 338 55945 550779 63891670
Swollen tongue 23.90 11.33 76 56207 34878 64407571
Ejection fraction abnormal 23.71 11.33 15 56268 1398 64441051
Condition aggravated 23.40 11.33 210 56073 372216 64070233
Total lung capacity decreased 23.35 11.33 16 56267 1706 64440743
Breast cancer 23.34 11.33 67 56216 29081 64413368
Type 2 diabetes mellitus 23.29 11.33 74 56209 33946 64408503
Shock 23.15 11.33 3 56280 38237 64404212
Dehydration 23.01 11.33 104 56179 216659 64225790
Fibromyalgia 22.91 11.33 76 56207 35655 64406794
Hypersomnia 22.73 11.33 52 56231 19665 64422784
Product availability issue 22.59 11.33 17 56266 2099 64440350
Cytomegalovirus infection 22.32 11.33 3 56280 37196 64405253
Sneezing 21.93 11.33 44 56239 15207 64427242
Enthesopathy 21.91 11.33 34 56249 9604 64432845
Secretion discharge 21.54 11.33 38 56245 11926 64430523
Lung perforation 21.34 11.33 6 56277 67 64442382
Ascites 21.19 11.33 14 56269 61987 64380462
Helicobacter infection 20.99 11.33 4 56279 38358 64404091
Central obesity 20.88 11.33 14 56269 1441 64441008
Dermatitis atopic 20.73 11.33 21 56262 3855 64438594
Sitting disability 20.72 11.33 7 56276 149 64442300
Altered state of consciousness 20.63 11.33 4 56279 37898 64404551
CFTR gene mutation 20.57 11.33 6 56277 77 64442372
Aortic aneurysm 20.50 11.33 29 56254 7545 64434904
Sinus congestion 20.38 11.33 43 56240 15396 64427053
Mucosal inflammation 20.24 11.33 15 56268 62569 64379880
Adiposis dolorosa 20.18 11.33 8 56275 271 64442178
Cockroach allergy 20.10 11.33 6 56277 84 64442365
Oropharyngeal discomfort 20.02 11.33 24 56259 5311 64437138
Somnolence 19.89 11.33 268 56015 203377 64239072
Therapy non-responder 19.80 11.33 17 56266 65882 64376567
Maple syrup disease 19.79 11.33 4 56279 8 64442441
Cardiac failure 19.73 11.33 55 56228 132318 64310131
Gastrointestinal haemorrhage 19.70 11.33 55 56228 132257 64310192
Rhabdomyolysis 19.66 11.33 31 56252 91695 64350754
Blood immunoglobulin E decreased 19.65 11.33 6 56277 91 64442358
Circulatory collapse 19.59 11.33 3 56280 33729 64408720
Suicide attempt 19.36 11.33 20 56263 70987 64371462
Procedural anxiety 19.28 11.33 10 56273 639 64441810
Genital rash 19.18 11.33 11 56272 858 64441591
Maternal exposure during pregnancy 19.08 11.33 34 56249 95850 64346599
Sarcoidosis 18.85 11.33 25 56258 6121 64436328
Hepatocellular injury 18.71 11.33 8 56275 45227 64397222
Hospitalisation 18.68 11.33 121 56162 75086 64367363
C-reactive protein increased 18.57 11.33 34 56249 94875 64347574
Drug resistance 18.49 11.33 4 56279 35098 64407351
Respiratory tract infection 18.41 11.33 73 56210 37334 64405115
Hypomagnesaemia 18.25 11.33 5 56278 37371 64405078
Dystrophic calcification 18.01 11.33 6 56277 122 64442327
Depressed level of consciousness 17.95 11.33 27 56256 81409 64361040
Electrocardiogram QT prolonged 17.85 11.33 26 56257 79422 64363027
Expired product administered 17.82 11.33 24 56259 5963 64436486
Skin wrinkling 17.76 11.33 11 56272 988 64441461
Erythema marginatum 17.76 11.33 4 56279 16 64442433
Drug reaction with eosinophilia and systemic symptoms 17.53 11.33 13 56270 54204 64388245
Delirium 17.22 11.33 21 56262 69173 64373276
Bursitis 16.83 11.33 49 56234 21436 64421013
Feeling cold 16.66 11.33 52 56231 23626 64418823
Lung opacity 16.51 11.33 17 56266 3182 64439267
Blood pressure increased 16.40 11.33 226 56057 172326 64270123
Depressed mood 16.29 11.33 75 56208 40937 64401512
Cardiac murmur 16.20 11.33 33 56250 11530 64430919
Cardiac failure congestive 16.14 11.33 59 56224 130521 64311928
Hypothyroidism 16.08 11.33 74 56209 40383 64402066
Intentional self-injury 15.95 11.33 3 56280 29041 64413408
Tongue pruritus 15.89 11.33 8 56275 480 64441969
Cerebral infarction 15.83 11.33 8 56275 41036 64401413
Tarsal tunnel syndrome 15.63 11.33 8 56275 497 64441952
Ureteral disorder 15.63 11.33 8 56275 497 64441952
Anxiety 15.60 11.33 256 56027 202393 64240056
Purpura senile 15.54 11.33 8 56275 503 64441946
Fall 15.54 11.33 263 56020 416563 64025886
Arrhythmia 15.49 11.33 14 56269 52930 64389519
Growth retardation 15.47 11.33 12 56271 1549 64440900
Walking aid user 15.47 11.33 23 56260 6258 64436191
Oral candidiasis 15.44 11.33 50 56233 23162 64419287
Coronary artery disease 15.40 11.33 18 56265 60415 64382034
Orthostatic hypotension 15.38 11.33 11 56272 46727 64395722
Dyspnoea at rest 15.34 11.33 23 56260 6306 64436143
Tongue dry 15.26 11.33 10 56273 990 64441459
Nasal dryness 15.14 11.33 17 56266 3509 64438940
Hypokalaemia 15.12 11.33 55 56228 121848 64320601
Infusion related reaction 15.10 11.33 83 56200 164384 64278065
Dysphonia 15.00 11.33 80 56203 46302 64396147
Lower respiratory tract infection 14.97 11.33 137 56146 94477 64347972
Skin fragility 14.73 11.33 9 56274 789 64441660
Neurotoxicity 14.69 11.33 3 56280 27401 64415048
Adrenal insufficiency 14.57 11.33 48 56235 22439 64420010
Tenosynovitis 14.53 11.33 32 56251 11801 64430648
Myocardial infarction 14.51 11.33 85 56198 165736 64276713
Dermatitis allergic 14.37 11.33 37 56246 15072 64427377
Nasal discharge discolouration 14.24 11.33 12 56271 1742 64440707
Cholestasis 14.20 11.33 11 56272 44861 64397588
Burns third degree 14.19 11.33 7 56276 402 64442047
Exposure during pregnancy 14.17 11.33 29 56254 77646 64364803
Bronchial irritation 14.12 11.33 4 56279 46 64442403
Rash macular 13.97 11.33 49 56234 23636 64418813
Hearing disability 13.96 11.33 4 56279 48 64442401
Chorioretinopathy 13.80 11.33 13 56270 2184 64440265
Blood bilirubin increased 13.76 11.33 18 56265 57535 64384914
White blood cell count decreased 13.76 11.33 81 56202 157756 64284693
Pruritus 13.63 11.33 363 55920 312037 64130412
Aphonia 13.61 11.33 26 56257 8671 64433778
Stress 13.60 11.33 95 56188 60439 64382010
Lacrimation increased 13.57 11.33 41 56242 18305 64424144
Skin exfoliation 13.56 11.33 76 56207 44809 64397640
Sinus polyp 13.47 11.33 7 56276 449 64442000
Impaired healing 13.38 11.33 20 56263 60453 64381996
Migraine 13.29 11.33 97 56186 62580 64379869
Hypothalamic pituitary adrenal axis suppression 13.17 11.33 6 56277 288 64442161
Lichenification 13.17 11.33 8 56275 694 64441755
Allergic sinusitis 13.16 11.33 7 56276 471 64441978
Eye pruritus 13.09 11.33 32 56251 12627 64429822
Loss of consciousness 13.01 11.33 76 56207 148289 64294160
Acute myeloid leukaemia 12.81 11.33 4 56279 27459 64414990
Diarrhoea 12.70 11.33 509 55774 722195 63720254
Drug level increased 12.70 11.33 7 56276 34189 64408260
Coagulopathy 12.65 11.33 6 56277 31914 64410535
Ear infection 12.60 11.33 47 56236 23357 64419092
Bone hypertrophy 12.58 11.33 6 56277 320 64442129
Peritoneal perforation 12.57 11.33 5 56278 171 64442278
Hot flush 12.48 11.33 76 56207 46159 64396290
Menopause 12.48 11.33 11 56272 1697 64440752
Occupational exposure to dust 12.46 11.33 3 56280 17 64442432
Flail chest 12.41 11.33 4 56279 73 64442376
Choking 12.38 11.33 28 56255 10510 64431939
Mesenteric haemorrhage 12.26 11.33 4 56279 76 64442373
Lower respiratory tract congestion 12.24 11.33 14 56269 2947 64439502
Red blood cell sedimentation rate increased 12.18 11.33 6 56277 31229 64411220
Haematocrit decreased 12.16 11.33 18 56265 54637 64387812
Periarthritis 12.10 11.33 13 56270 2554 64439895
Exposure to allergen 12.02 11.33 5 56278 192 64442257
Wound 11.98 11.33 31 56252 76446 64366003
Pulmonary eosinophilia 11.87 11.33 7 56276 575 64441874
Depressive symptom 11.85 11.33 17 56266 4479 64437970
Increased upper airway secretion 11.84 11.33 15 56268 3512 64438937
Upper respiratory tract infection 11.82 11.33 106 56177 72679 64369770
Chronic obstructive pulmonary disease 11.81 11.33 104 56179 70944 64371505
Polyp 11.76 11.33 21 56262 6652 64435797
Product odour abnormal 11.73 11.33 9 56274 1144 64441305
Respiratory depression 11.70 11.33 3 56280 23440 64419009
Clumsiness 11.60 11.33 13 56270 2678 64439771
Neutropenic sepsis 11.57 11.33 3 56280 23269 64419180
Swelling 11.56 11.33 87 56196 160131 64282318
Bronchiolitis 11.46 11.33 15 56268 3626 64438823
Viral infection 11.46 11.33 62 56221 36078 64406371
Adjustment disorder 11.39 11.33 13 56270 2732 64439717
Forced expiratory volume abnormal 11.35 11.33 4 56279 97 64442352

FDA Adverse Event Reporting System (Pediatric)

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
Small for dates baby 18.00 14.89 7 3 2737 81931

Pharmacologic Action:

SourceCodeDescription
ATC D07AC13 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, potent (group III)
ATC D07XC03 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, OTHER COMBINATIONS
Corticosteroids, potent, other combinations
ATC R01AD09 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R01AD59 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R03AK09 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK14 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AL12 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03BA07 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
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D003879 Dermatologic Agents
CHEBI has role CHEBI:35472 anti-inflammatory drugs
CHEBI has role CHEBI:50177 dermatologic agent
CHEBI has role CHEBI:50857 anti-allergic drugs

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Atopic dermatitis indication 24079001 DOID:3310
Contact dermatitis indication 40275004 DOID:2773
Seborrheic dermatitis indication 50563003 DOID:8741
Lichen simplex chronicus indication 53891004
Allergic rhinitis indication 61582004
Granuloma annulare indication 65508009 DOID:3777
Pruritus ani indication 90446007
Asthma indication 195967001 DOID:2841
Discoid lupus erythematosus indication 200938002
Plaque psoriasis indication 200965009
Scalp psoriasis indication 238608008
Non-allergic asthma indication 266361008 DOID:9360
Pruritus of genital organs indication 267802000
Eruption of skin indication 271807003 DOID:0050486
Allergic asthma indication 389145006 DOID:9415
Primary cutaneous T-cell lymphoma indication 400122007
Asthma management indication 406162001
Allergic Rhinitis Prevention indication
Chronic Non-Allergic Rhinitis indication
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
Asthenia contraindication 13791008
Measles contraindication 14189004 DOID:8622
Disease caused by parasite contraindication 17322007
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Immunosuppression contraindication 38013005
Hypertensive disorder contraindication 38341003 DOID:10763
Varicella contraindication 38907003 DOID:8659
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Skin ulcer contraindication 46742003
Osteoporosis contraindication 64859006 DOID:11476
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Perforation of nasal septum contraindication 80142000
Bacterial infectious disease contraindication 87628006
Operation on nose contraindication 88733004
Thyrotoxicosis contraindication 90739004 DOID:7997
Fissure in skin contraindication 95321009
Bilateral cataracts contraindication 95722004
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Ophthalmic herpes simplex contraindication 186542001
Disease of liver contraindication 235856003 DOID:409
Telangiectasia disorder contraindication 247479008
Exacerbation of asthma contraindication 281239006
Varicella-zoster virus infection contraindication 309465005
Osteopenia contraindication 312894000
Skin irritation contraindication 367466007
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Denuded skin contraindication 418242004
Congenital long QT syndrome contraindication 442917000
Nasal Septal Ulcers contraindication
Untreated Fungal Infection contraindication
Nasal Trauma contraindication
Nasal Candidiasis contraindication
Uncontrolled Bacterial Infections contraindication




🐶 Veterinary Drug Use

SpeciesUseRelation
Dogs Otitis externa Indication

🐶 Veterinary products

ProductApplicantIngredients
Mometamax Otic Suspension Intervet Inc. 3
Posatex Otic Suspension Intervet Inc. 3
CLARO Elanco US Inc. 3
Mometavet Med-Pharmex Inc. 3

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
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 7662141 March 12, 2024 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 7713255 March 12, 2024 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 7951130 March 12, 2024 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 7951131 March 12, 2024 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 7951133 March 12, 2024 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 8109918 March 12, 2024 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 9585681 April 4, 2026 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 7544192 Nov. 29, 2026 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 8025635 June 12, 2027 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 10357640 Oct. 3, 2031 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10016443 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10517880 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10548907 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10646500 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10758550 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE TO A PEDIATRIC PATIENT
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 10765686 Sept. 4, 2034 METHOD OF DELIVERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE TO A NASAL AIRWAY
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 9078923 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL 9750754 Sept. 4, 2034 TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
1.35MG SINUVA INTERSECT ENT INC N209310 Dec. 8, 2017 RX IMPLANT IMPLANTATION 10232152 Nov. 24, 2034 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.005MG/INH;0.05MG/INH DULERA ORGANON N022518 Aug. 12, 2019 RX AEROSOL, METERED INHALATION Aug. 12, 2022 NEW STRENGTH
0.05MG/INH ASMANEX HFA ORGANON N205641 Aug. 12, 2019 RX AEROSOL, METERED INHALATION Aug. 12, 2022 NEW STRENGTH
0.005MG/INH;0.05MG/INH DULERA ORGANON N022518 Aug. 12, 2019 RX AEROSOL, METERED INHALATION Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
0.05MG/INH ASMANEX HFA ORGANON N205641 Aug. 12, 2019 RX AEROSOL, METERED INHALATION Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
0.025MG/SPRAY;0.665MG/SPRAY RYALTRIS GLENMARK SPECIALTY N211746 Jan. 13, 2022 RX SPRAY, METERED NASAL Jan. 13, 2025 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST Ki 9.15 CHEMBL CHEMBL
Multidrug resistance protein 1 Transporter IC50 6.13 WOMBAT-PK
Progesterone receptor Nuclear hormone receptor EC50 9.90 WOMBAT-PK

External reference:

IDSource
4019844 VUID
N0000147931 NUI
D00690 KEGG_DRUG
4019367 VANDF
4019844 VANDF
4021125 VANDF
C0066700 UMLSCUI
CHEBI:47564 CHEBI
CHEBI:6970 CHEBI
MOF PDB_CHEM_ID
CHEMBL1161 ChEMBL_ID
D000068656 MESH_DESCRIPTOR_UI
DB14512 DRUGBANK_ID
9029 IUPHAR_LIGAND_ID
141646-00-6 SECONDARY_CAS_RN
105102-22-5 SECONDARY_CAS_RN
04201GDN4R UNII
441336 PUBCHEM_CID
441335 PUBCHEM_CID
DB00764 DRUGBANK_ID
108118 RXNORM
11404 MMSL
239640 MMSL
5129 MMSL
5130 MMSL
d05262 MMSL
002205 NDDF
395802006 SNOMEDCT_US
395803001 SNOMEDCT_US
395990009 SNOMEDCT_US
75203002 SNOMEDCT_US
C0360564 UMLSCUI
6030 INN_ID
8HR4QJ6DW8 UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dulera HUMAN PRESCRIPTION DRUG LABEL 2 0085-4610 AEROSOL 200 ug RESPIRATORY (INHALATION) NDA 29 sections
Dulera HUMAN PRESCRIPTION DRUG LABEL 2 0085-7206 AEROSOL 100 ug RESPIRATORY (INHALATION) NDA 29 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0270 CREAM 1 mg TOPICAL ANDA 28 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0271 OINTMENT 1 mg TOPICAL ANDA 28 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0272 SOLUTION 1 mg TOPICAL ANDA 29 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0634 CREAM 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0634 CREAM 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0635 OINTMENT 1 mg TOPICAL ANDA 24 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0701 SOLUTION 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0726 CREAM 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0726 CREAM 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0727 OINTMENT 1 mg TOPICAL ANDA 24 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0727 OINTMENT 1 mg TOPICAL ANDA 24 sections
Sinuva HUMAN PRESCRIPTION DRUG LABEL 1 10599-003 IMPLANT 1350 ug INTRASINAL NDA 29 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 13668-527 OINTMENT 1 mg TOPICAL ANDA 26 sections
MOMETASONE FUROATE HUMAN PRESCRIPTION DRUG LABEL 1 16590-993 CREAM 1 mg TOPICAL ANDA 10 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 16714-974 CREAM 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 21695-786 CREAM 1 mg TOPICAL ANDA 13 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 42254-175 OINTMENT 1 mg TOPICAL ANDA 13 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 45802-118 SOLUTION 1 mg TOPICAL ANDA 27 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 45802-119 OINTMENT 1 mg TOPICAL ANDA 29 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 45802-257 CREAM 1 mg TOPICAL ANDA 29 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 50090-1026 OINTMENT 1 mg TOPICAL ANDA 26 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 50090-1633 OINTMENT 1 mg TOPICAL ANDA 26 sections
Dulera HUMAN PRESCRIPTION DRUG LABEL 2 50090-1916 AEROSOL 200 ug RESPIRATORY (INHALATION) NDA 29 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 50090-2179 CREAM 1 mg TOPICAL ANDA 25 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 50090-2991 CREAM 1 mg TOPICAL ANDA 25 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 51672-1305 SOLUTION 1 mg TOPICAL ANDA 29 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 51672-1305 SOLUTION 1 mg TOPICAL ANDA 29 sections
Mometasone Furoate HUMAN PRESCRIPTION DRUG LABEL 1 51672-1311 OINTMENT 1 mg TOPICAL ANDA 29 sections