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

Stem definitionDrug idCAS RN
prednisone and prednisolone derivatives 1770 53-36-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • methylprednisolone acetate
  • depo-methylprednisolone
  • medrol acetate
Methylprednisolone derivative that is used as an anti-inflammatory agent for the treatment of ALLERGY and ALLERGIC RHINITIS; ASTHMA; and BURSITIS; and for the treatment of ADRENAL INSUFFICIENCY.
  • Molecular weight: 416.51
  • Formula: C24H32O6
  • CLOGP: 2.28
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 100.90
  • ALOGS: -4.33
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
S (Water solubility) 0.12 mg/mL Bocci G, Oprea TI, Benet LZ
BA (Bioavailability) 82 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 2.216 Moderate 0.78
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.535 Moderate 0.78
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 54.702 10^-6 cm/s Moderate 0.78
dh-clint Dog hepatocyte intrinsic clearance 40.644 uL/min/10^6 cells Moderate 0.78
dppb Dog plasma protein binding (% unbound) 20.110 % Moderate 0.78
fcs-ppb Fetal calf serum protein binding (% unbound) 34.680 % Moderate 0.78
herg hERG pIC50 4.472 pIC50 Moderate 0.78
hh-clint Human hepatocyte intrinsic clearance 43.053 uL/min/10^6 cells Moderate 0.78
hlm-clint Human liver microsomal intrinsic clearance 89.331 uL/min/mg protein Moderate 0.78
hppb Human plasma protein binding (% unbound) 14.600 % Moderate 0.78
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 5.970 Moderate 0.78
mh-clint Mouse hepatocyte intrinsic clearance 172.187 Moderate 0.78
mppb Mouse plasma protein binding (% unbound) 19.280 Moderate 0.78
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 13.868 Moderate 0.78
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 29.900 % Moderate 0.78
rh-clint Rat hepatocyte intrinsic clearance 191.426 uL/min/10^6 cells Moderate 0.78
rh-fuinc Rat hepatocyte fraction unbound in incubation 74.520 % Moderate 0.78
rppb Rat plasma protein binding (% unbound) 19.750 % Moderate 0.78
solubility-dd Solubility at pH 7.4 in DMSO 241.546 uM Moderate 0.78

Approvals:

DateAgencyCompanyOrphan
May 27, 1959 FDA PHARMACIA AND UPJOHN

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
Food allergy 752.44 17.46 329 45288 25149 90557681
Temperature regulation disorder 682.77 17.46 262 45355 14317 90568513
Immunodeficiency 622.99 17.46 342 45275 42892 90539938
Rheumatoid arthritis 491.72 17.46 747 44870 361867 90220963
Rash erythematous 433.78 17.46 316 45301 64788 90518042
Coeliac disease 414.67 17.46 266 45351 44344 90538486
Upper respiratory tract infection 404.39 17.46 405 45212 127913 90454917
Bursitis 323.30 17.46 364 45253 131290 90451540
Gangrene 321.69 17.46 148 45469 12728 90570102
Arterial occlusive disease 320.19 17.46 146 45471 12300 90570530
Hyperhidrosis 314.67 17.46 365 45252 135940 90446890
Neurologic neglect syndrome 293.12 17.46 124 45493 8723 90574107
Foetal death 290.28 17.46 161 45456 20562 90562268
Carotid artery thrombosis 286.56 17.46 123 45494 8969 90573861
Adjustment disorder 263.54 17.46 118 45499 9524 90573306
Fluid retention 257.25 17.46 267 45350 87824 90495006
Personality disorder 252.62 17.46 124 45493 12320 90570510
Synovial cyst 247.25 17.46 120 45497 11632 90571198
Sensory loss 246.53 17.46 138 45479 17937 90564893
Psoriasis 236.80 17.46 330 45287 147424 90435406
Prescribed overdose 234.59 17.46 267 45350 97358 90485472
Hemiplegia 222.09 17.46 124 45493 16036 90566794
Coordination abnormal 217.53 17.46 135 45482 21221 90561609
Skin haemorrhage 212.34 17.46 133 45484 21247 90561583
Affect lability 211.86 17.46 125 45492 17938 90564892
Motor dysfunction 204.62 17.46 125 45492 19105 90563725
Intentional product misuse 198.41 17.46 235 45382 89369 90493461
Tenderness 196.24 17.46 138 45479 26730 90556100
Angina pectoris 188.71 17.46 157 45460 39003 90543827
Cataract 183.11 17.46 203 45414 71889 90510941
Sinus congestion 180.00 17.46 132 45485 27292 90555538
Pulmonary toxicity 176.45 17.46 95 45522 11436 90571394
Sneezing 172.13 17.46 133 45484 29736 90553094
Crepitations 167.21 17.46 84 45533 8768 90574062
Treatment failure 165.11 17.46 427 45190 303501 90279329
Respiratory tract congestion 164.42 17.46 125 45492 27285 90555545
Tenosynovitis 163.51 17.46 98 45519 14469 90568361
Tenosynovitis stenosans 160.17 17.46 64 45553 3889 90578941
Sinus disorder 157.51 17.46 134 45483 34313 90548517
Joint swelling 156.62 17.46 582 45035 502718 90080112
Hemiparesis 156.28 17.46 129 45488 31690 90551140
Synovial fluid analysis 154.98 17.46 57 45560 2761 90580069
Eating disorder 153.10 17.46 121 45496 27952 90554878
Pain 151.68 17.46 936 44681 995405 89587425
Arthritis 147.10 17.46 285 45332 167030 90415800
Overdose 145.25 17.46 274 45343 157435 90425395
Erythema 144.45 17.46 341 45276 228905 90353925
Muscle spasticity 140.61 17.46 127 45490 35195 90547635
Bone density decreased 140.58 17.46 95 45522 17250 90565580
Scleritis 139.97 17.46 63 45554 5145 90577685
Allergy to chemicals 139.11 17.46 57 45560 3697 90579133
Joint effusion 134.17 17.46 97 45520 19613 90563217
Asthma 133.26 17.46 342 45275 241818 90341012
Muscular weakness 121.13 17.46 299 45318 206367 90376463
Aphasia 119.95 17.46 127 45490 42685 90540145
Product use issue 116.54 17.46 398 45219 329521 90253309
Dry eye 115.28 17.46 144 45473 57787 90525043
Spinal stenosis 112.37 17.46 83 45534 17341 90565489
Hepatic enzyme increased 107.74 17.46 412 45205 360324 90222506
Exposure during pregnancy 101.77 17.46 307 45310 238103 90344727
Rheumatoid nodule 101.62 17.46 83 45534 20083 90562747
Pleuritic pain 101.16 17.46 64 45553 10397 90572433
Dysarthria 99.84 17.46 130 45487 54352 90528478
Cushingoid 96.55 17.46 62 45555 10333 90572497
Back pain 95.28 17.46 363 45254 316812 90266018
Death 95.07 17.46 56 45561 456495 90126335
Antinuclear antibody positive 93.03 17.46 58 45559 9183 90573647
Skin exfoliation 91.69 17.46 140 45477 67773 90515057
Anaemia 90.98 17.46 32 45585 352770 90230060
Drug interaction 90.91 17.46 15 45602 276438 90306392
Toxicity to various agents 89.52 17.46 18 45599 287828 90295002
Dysphagia 84.05 17.46 179 45438 112099 90470731
Cystitis 83.75 17.46 133 45484 66585 90516245
Rheumatoid lung 83.60 17.46 41 45576 4062 90578768
Blood folate decreased 78.10 17.46 30 45587 1640 90581190
Acute kidney injury 77.69 17.46 32 45585 320355 90262475
Alopecia 77.48 17.46 81 45536 494990 90087840
Dyspnoea 77.07 17.46 210 45407 880745 89702085
Feeling jittery 76.89 17.46 63 45554 15308 90567522
Conjunctivitis 76.18 17.46 80 45537 26626 90556204
Contraindicated product administered 74.61 17.46 339 45278 319800 90263030
Photophobia 74.07 17.46 71 45546 21198 90561632
Influenza like illness 71.61 17.46 138 45479 80473 90502357
Impaired work ability 70.13 17.46 66 45551 19260 90563570
Deformity 69.68 17.46 54 45563 12116 90570714
Thrombocytopenia 68.58 17.46 246 45371 208479 90374351
Neutropenia 67.99 17.46 15 45602 224889 90357941
Product dose omission issue 67.75 17.46 31 45586 291656 90291174
Drug hypersensitivity 67.23 17.46 431 45186 463178 90119652
Rash maculo-papular 66.32 17.46 92 45525 40841 90541989
Drug intolerance 65.44 17.46 417 45200 447174 90135656
Chest pain 65.38 17.46 40 45577 319605 90263225
Flank pain 64.74 17.46 63 45554 19159 90563671
Rhinorrhoea 64.02 17.46 139 45478 88177 90494653
Palpitations 62.98 17.46 181 45436 136547 90446283
Headache 61.71 17.46 684 44933 862062 89720768
Atelectasis 60.67 17.46 68 45549 24341 90558489
Meningitis fungal 58.75 17.46 13 45604 91 90582739
Decreased appetite 58.43 17.46 62 45555 376478 90206352
Viral upper respiratory tract infection 57.64 17.46 42 45575 8592 90574238
Rotator cuff repair 57.53 17.46 27 45590 2427 90580403
Somnolence 57.33 17.46 17 45600 209067 90373763
Fibromyalgia 55.35 17.46 228 45389 206041 90376789
Disease progression 54.94 17.46 7 45610 156608 90426222
Decreased immune responsiveness 54.90 17.46 41 45576 8707 90574123
Hypotension 53.42 17.46 51 45566 325346 90257484
Hypersensitivity 53.09 17.46 401 45216 454276 90128554
Ulcer 51.92 17.46 73 45544 32809 90550021
Dehydration 51.19 17.46 17 45600 194430 90388400
Oedema peripheral 50.37 17.46 34 45583 257881 90324949
Diarrhoea 48.64 17.46 276 45341 938914 89643916
Febrile neutropenia 46.97 17.46 11 45606 158338 90424492
Chest discomfort 46.20 17.46 164 45453 138201 90444629
Musculoskeletal pain 45.70 17.46 189 45428 171062 90411768
Oedema 45.40 17.46 22 45595 200273 90382557
Nodule 44.76 17.46 61 45556 26625 90556205
Constipation 44.53 17.46 267 45350 280128 90302702
Product contamination 43.94 17.46 18 45599 1166 90581664
Ocular hyperaemia 43.26 17.46 68 45549 33730 90549100
Synovial disorder 43.03 17.46 24 45593 3094 90579736
Influenza 42.23 17.46 160 45457 139104 90443726
Joint range of motion decreased 41.27 17.46 156 45461 135487 90447343
Abdominal discomfort 40.70 17.46 115 45502 477213 90105617
Joint noise 40.55 17.46 28 45589 5262 90577568
Glossodynia 40.54 17.46 62 45555 321717 90261113
Blood pressure increased 40.18 17.46 201 45416 197016 90385814
Injection site pain 39.48 17.46 19 45598 173680 90409150
Bone density abnormal 39.21 17.46 25 45592 4115 90578715
Musculoskeletal stiffness 38.87 17.46 269 45348 296263 90286567
Cardiac failure congestive 38.28 17.46 3 45614 98691 90484139
Arthritis bacterial 38.26 17.46 31 45586 7414 90575416
Neoplasm malignant 37.72 17.46 64 45553 33816 90549014
Lip and/or oral cavity cancer 37.60 17.46 15 45602 907 90581923
Eye irritation 37.59 17.46 64 45553 33914 90548916
Renal failure 37.11 17.46 10 45607 130997 90451833
Swollen joint count increased 36.60 17.46 6 45611 111200 90471630
Hypertension 36.42 17.46 371 45246 457161 90125669
Sleep disorder due to general medical condition, insomnia type 36.13 17.46 10 45607 128684 90454146
Infusion related reaction 36.11 17.46 344 45273 416436 90166394
Red blood cell sedimentation rate decreased 35.75 17.46 15 45602 1033 90581797
Rash pruritic 35.13 17.46 106 45511 82108 90500722
Cerebrovascular accident 35.06 17.46 139 45478 123394 90459436
Urinary tract infection 34.68 17.46 63 45554 305569 90277261
Grip strength decreased 34.64 17.46 114 45503 92462 90490368
Vaginal haematoma 34.22 17.46 9 45608 139 90582691
Renal impairment 34.01 17.46 6 45611 105415 90477415
Amnesia 33.26 17.46 7 45610 108498 90474332
Pruritus 32.55 17.46 151 45466 541374 90041456
Eye pain 32.55 17.46 70 45547 44098 90538732
Chills 32.26 17.46 13 45604 131968 90450862
Weight decreased 32.02 17.46 92 45525 379818 90203012
Onychomadesis 31.74 17.46 71 45546 45927 90536903
Drug abuse 30.59 17.46 3 45614 82344 90500486
Parapsoriasis 30.46 17.46 8 45609 123 90582707
Aspartate aminotransferase increased 28.89 17.46 8 45609 102929 90479901
Sepsis 28.54 17.46 29 45588 179785 90403045
Rheumatoid factor positive 28.03 17.46 27 45590 171623 90411207
Insomnia 27.92 17.46 81 45536 333393 90249437
Middle lobe syndrome 27.77 17.46 6 45611 37 90582793
Tremor 27.54 17.46 22 45595 153151 90429679
Thyroid atrophy 27.48 17.46 9 45608 307 90582523
Stomatitis 27.42 17.46 61 45556 274637 90308193
Hepatic enzyme decreased 27.06 17.46 12 45605 946 90581884
Vomiting 26.24 17.46 262 45355 788031 89794799
Seizure 26.12 17.46 23 45594 152606 90430224
Pulmonary fibrosis 25.61 17.46 11 45606 107492 90475338
Connective tissue inflammation 25.59 17.46 6 45611 56 90582774
Tachycardia 25.52 17.46 25 45592 157648 90425182
Injection site erythema 25.24 17.46 9 45608 98493 90484337
C-reactive protein increased 25.20 17.46 167 45450 181222 90401608
Alanine aminotransferase abnormal 24.57 17.46 21 45596 5405 90577425
Delirium 24.35 17.46 11 45606 104348 90478482
Malaise 24.29 17.46 422 45195 585564 89997266
Gait disturbance 24.27 17.46 60 45557 260436 90322394
Pemphigus 24.13 17.46 84 45533 326780 90256050
Onychomycosis 23.91 17.46 56 45561 37320 90545510
Depressed level of consciousness 23.79 17.46 4 45613 72780 90510050
Coma 23.72 17.46 4 45613 72628 90510202
Productive cough 23.56 17.46 5 45612 77058 90505772
Gastrointestinal haemorrhage 23.55 17.46 8 45609 90240 90492590
Irritable bowel syndrome 23.31 17.46 43 45574 207405 90375425
Epistaxis 23.18 17.46 7 45610 85118 90497712
Abdominal pain upper 22.90 17.46 88 45529 332586 90250244
Hepatic enzyme 22.82 17.46 20 45597 5324 90577506
Dry skin 22.65 17.46 8 45609 88065 90494765
Bradycardia 22.64 17.46 7 45610 83840 90498990
Colitis 22.52 17.46 4 45613 69938 90512892
Dry mouth 22.36 17.46 164 45453 183895 90398935
Systemic lupus erythematosus 22.26 17.46 100 45517 361796 90221034
Off label use 21.98 17.46 717 44900 1101535 89481295
Cardiac failure 21.95 17.46 14 45603 109482 90473348
Cardio-respiratory arrest 21.71 17.46 3 45614 63137 90519693
Post cholecystectomy syndrome 21.60 17.46 10 45607 871 90581959
Pleural effusion 21.53 17.46 15 45602 111976 90470854
Infection 21.31 17.46 277 45340 361817 90221013
Prescribed underdose 20.73 17.46 6 45611 75013 90507817
Product quality issue 20.71 17.46 87 45530 79238 90503592
Fatigue 20.32 17.46 740 44877 1153283 89429547
Hyperkalaemia 20.30 17.46 4 45613 64960 90517870
Osteoarthritis 20.24 17.46 168 45449 195562 90387268
Discomfort 19.91 17.46 71 45546 274264 90308566
Dyspnoea exertional 19.58 17.46 6 45611 72282 90510548
Interstitial lung disease 19.33 17.46 83 45534 76322 90506508
Paraplegia 19.23 17.46 15 45602 3397 90579433
Bone pain 18.99 17.46 4 45613 61979 90520851
Mandibular mass 18.90 17.46 6 45611 185 90582645
Alanine aminotransferase increased 18.87 17.46 19 45598 118319 90464511
Hallucination 18.74 17.46 5 45612 65954 90516876
Arachnoiditis 18.70 17.46 8 45609 578 90582252
Loss of consciousness 18.64 17.46 26 45591 140212 90442618
Diverticulum oesophageal 18.63 17.46 6 45611 194 90582636
Pancytopenia 18.40 17.46 20 45597 120243 90462587
Red blood cell count decreased 18.16 17.46 58 45559 46293 90536537
Thalassaemia minor 17.95 17.46 4 45613 29 90582801
Hip arthroplasty 17.83 17.46 8 45609 76200 90506630
Carpal tunnel syndrome 17.71 17.46 38 45579 23890 90558940
Pyrexia 17.64 17.46 446 45171 660039 89922791
Finger deformity 17.57 17.46 46 45571 32851 90549979

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
Joint swelling 192.10 17.85 121 6121 67901 42547192
Musculoskeletal stiffness 158.61 17.85 101 6141 57664 42557429
Vitamin D deficiency 109.26 17.85 42 6200 8031 42607062
Arthralgia 106.43 17.85 140 6102 205098 42409995
C-reactive protein decreased 83.76 17.85 25 6217 2211 42612882
Synovitis 79.87 17.85 41 6201 15526 42599567
Gastrointestinal disorder 66.73 17.85 55 6187 46598 42568495
Dental caries 57.63 17.85 23 6219 4849 42610244
Drug ineffective 56.08 17.85 210 6032 629987 41985106
Drug intolerance 51.30 17.85 61 6181 80363 42534730
Rash vesicular 51.20 17.85 19 6223 3294 42611799
Muscle strain 48.62 17.85 20 6222 4557 42610536
Colitis 46.84 17.85 45 6197 46527 42568566
Cutaneous symptom 46.31 17.85 11 6231 402 42614691
Diabetes mellitus inadequate control 44.85 17.85 28 6214 15362 42599731
Off label use 44.21 17.85 197 6045 638138 41976955
Peripheral swelling 44.15 17.85 60 6182 90210 42524883
Drug hypersensitivity 42.58 17.85 62 6180 99327 42515766
Febrile bone marrow aplasia 41.46 17.85 23 6219 10158 42604935
Spinal pain 41.07 17.85 20 6222 6762 42608331
Rheumatoid arthritis 40.78 17.85 40 6202 42400 42572693
Haematochezia 40.03 17.85 46 6196 58390 42556703
Arthritis bacterial 37.64 17.85 18 6224 5850 42609243
Pain 36.70 17.85 98 6144 244750 42370343
Meningitis tuberculous 36.22 17.85 10 6232 669 42614424
Incorrect route of product administration 35.44 17.85 29 6213 24276 42590817
Meningitis 34.78 17.85 17 6225 5792 42609301
Sacroiliitis 32.96 17.85 12 6230 1970 42613123
Drug ineffective for unapproved indication 31.04 17.85 36 6206 46127 42568966
Myocardial oedema 29.54 17.85 7 6235 253 42614840
Chorioretinopathy 28.21 17.85 10 6232 1521 42613572
Pain in extremity 27.46 17.85 65 6177 150539 42464554
Psoriasis 26.34 17.85 34 6208 48570 42566523
Pulmonary mass 24.96 17.85 20 6222 16245 42598848
Joint range of motion decreased 24.87 17.85 15 6227 7738 42607355
Paralysis 23.60 17.85 14 6228 7006 42608087
Herpes simplex 23.46 17.85 14 6228 7081 42608012
Toxicity to various agents 23.39 17.85 3 6239 229133 42385960
Death 23.21 17.85 21 6221 471164 42143929
Haemolytic anaemia 23.20 17.85 17 6225 12110 42602983
Joint effusion 23.13 17.85 13 6229 5884 42609209
Psoriatic arthropathy 22.98 17.85 23 6219 24944 42590149
Wrong product administered 22.47 17.85 13 6229 6213 42608880
Mycobacterium kansasii infection 22.30 17.85 6 6236 364 42614729
Haemophilus bacteraemia 22.06 17.85 5 6237 148 42614945
Meningioma malignant 21.55 17.85 4 6238 42 42615051
Condition aggravated 21.38 17.85 85 6157 260669 42354424
Meningitis fungal 20.47 17.85 5 6237 206 42614887
Pulmonary fibrosis 19.95 17.85 22 6220 26659 42588434
Enthesopathy 19.91 17.85 11 6231 4817 42610276
Blood pressure fluctuation 19.80 17.85 22 6220 26886 42588207
Injection site infection 19.41 17.85 7 6235 1119 42613974
Arthritis infective 18.72 17.85 10 6232 4096 42610997
Ankylosing spondylitis 18.47 17.85 12 6230 7044 42608049
Weight increased 17.94 17.85 45 6197 107938 42507155

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
Temperature regulation disorder 656.54 16.92 235 46554 12591 110529919
Rheumatoid arthritis 602.48 16.92 686 46103 298927 110243583
Food allergy 555.75 16.92 235 46554 19713 110522797
Coeliac disease 451.94 16.92 261 46528 42926 110499584
Immunodeficiency 442.13 16.92 248 46541 38590 110503920
Bursitis 361.28 16.92 354 46435 129564 110412946
Arterial occlusive disease 324.92 16.92 149 46640 15159 110527351
Gangrene 321.79 16.92 151 46638 16190 110526320
Neurologic neglect syndrome 318.37 16.92 127 46662 9171 110533339
Carotid artery thrombosis 310.51 16.92 126 46663 9512 110532998
Adjustment disorder 280.22 16.92 121 46668 10674 110531836
Personality disorder 278.90 16.92 127 46662 12710 110529800
Foetal death 278.62 16.92 136 46653 15909 110526601
Psoriasis 278.08 16.92 319 46470 139674 110402836
Upper respiratory tract infection 274.00 16.92 307 46482 131021 110411489
Rash erythematous 273.43 16.92 247 46542 81585 110460925
Sensory loss 266.05 16.92 145 46644 21312 110521198
Affect lability 234.00 16.92 127 46662 18510 110524000
Fluid retention 227.36 16.92 238 46551 94069 110448441
Coordination abnormal 220.95 16.92 136 46653 25092 110517418
Skin haemorrhage 220.40 16.92 135 46654 24692 110517818
Pain 220.25 16.92 891 45898 954064 109588446
Motor dysfunction 219.96 16.92 134 46655 24272 110518238
Hemiplegia 215.42 16.92 129 46660 22653 110519857
Joint swelling 215.00 16.92 535 46254 442310 110100200
Synovial cyst 204.82 16.92 99 46690 11331 110531179
Tenderness 201.74 16.92 136 46653 29301 110513209
Sneezing 198.49 16.92 139 46650 31845 110510665
Cataract 197.70 16.92 204 46585 79281 110463229
Sinus congestion 192.82 16.92 134 46655 30325 110512185
Sinus disorder 191.00 16.92 137 46652 32591 110509919
Treatment failure 181.19 16.92 377 46412 276857 110265653
Arthritis 180.09 16.92 283 46506 167303 110375207
Respiratory tract congestion 177.40 16.92 128 46661 30729 110511781
Eating disorder 170.58 16.92 125 46664 30733 110511777
Muscle spasticity 164.39 16.92 130 46659 35785 110506725
Tenosynovitis stenosans 161.93 16.92 60 46729 3543 110538967
Angina pectoris 158.73 16.92 162 46627 62133 110480377
Synovial fluid analysis 155.77 16.92 54 46735 2627 110539883
Contraindicated product administered 147.64 16.92 325 46464 247942 110294568
Hyperhidrosis 146.82 16.92 275 46514 187023 110355487
Hemiparesis 145.56 16.92 132 46657 43771 110498739
Prescribed overdose 144.95 16.92 182 46607 87399 110455111
Joint effusion 141.84 16.92 96 46693 20809 110521701
Tenosynovitis 140.59 16.92 87 46702 16196 110526314
Acute kidney injury 138.67 16.92 48 46741 635382 109907128
Scleritis 138.19 16.92 60 46729 5360 110537150
Toxicity to various agents 135.00 16.92 21 46768 480534 110061976
Drug hypersensitivity 133.64 16.92 459 46330 453631 110088879
Erythema 127.64 16.92 339 46450 291108 110251402
Drug interaction 125.34 16.92 29 46760 500154 110042356
Pulmonary toxicity 124.01 16.92 83 46706 17663 110524847
Drug intolerance 122.29 16.92 414 46375 406098 110136412
Bone density decreased 121.74 16.92 79 46710 15963 110526547
Death 121.10 16.92 73 46716 698796 109843714
Spinal stenosis 120.99 16.92 84 46705 18972 110523538
Aphasia 117.97 16.92 135 46654 58862 110483648
Crepitations 111.99 16.92 65 46724 10770 110531740
Muscular weakness 111.81 16.92 292 46497 248176 110294334
Musculoskeletal stiffness 107.19 16.92 310 46479 279512 110262998
Anaemia 105.20 16.92 50 46739 547036 109995474
Product use issue 104.99 16.92 330 46459 311365 110231145
Cystitis 102.58 16.92 133 46656 65903 110476607
Back pain 98.75 16.92 363 46426 370633 110171877
Allergy to chemicals 98.69 16.92 41 46748 3284 110539226
Antinuclear antibody positive 94.76 16.92 55 46734 9113 110533397
Dry eye 93.98 16.92 117 46672 55676 110486834
Cushingoid 92.14 16.92 59 46730 11653 110530857
Skin exfoliation 89.92 16.92 145 46644 87506 110455004
Hepatic enzyme increased 89.64 16.92 319 46470 320573 110221937
Fibromyalgia 89.63 16.92 213 46576 170696 110371814
Neutropenia 87.52 16.92 25 46764 374595 110167915
Rheumatoid lung 82.34 16.92 39 46750 4265 110538245
Influenza like illness 82.29 16.92 140 46649 88272 110454238
Feeling jittery 82.17 16.92 60 46729 14662 110527848
Asthma 80.59 16.92 261 46528 250030 110292480
Pleuritic pain 79.44 16.92 61 46728 16079 110526431
Dysarthria 78.02 16.92 133 46656 83988 110458522
Dyspnoea 77.55 16.92 227 46562 1106645 109435865
Rhinorrhoea 76.99 16.92 148 46641 102518 110439992
Dysphagia 74.74 16.92 186 46603 153414 110389096
Blood folate decreased 73.40 16.92 30 46759 2305 110540205
Somnolence 72.97 16.92 18 46771 297431 110245079
Rheumatoid nodule 71.17 16.92 63 46726 20233 110522277
Hypotension 70.06 16.92 71 46718 523778 110018732
Disease progression 67.71 16.92 11 46778 244023 110298487
Photophobia 67.41 16.92 68 46721 25703 110516807
Palpitations 67.40 16.92 183 46606 159029 110383481
Conjunctivitis 66.99 16.92 77 46712 33715 110508795
Dehydration 64.62 16.92 19 46770 279492 110263018
Febrile neutropenia 62.30 16.92 28 46761 316739 110225771
Intentional product misuse 61.58 16.92 158 46631 132746 110409764
Decreased immune responsiveness 60.17 16.92 42 46747 9564 110532946
Joint range of motion decreased 59.75 16.92 148 46641 121684 110420826
Drug abuse 59.39 16.92 4 46785 177407 110365103
Headache 59.05 16.92 601 46188 881776 109660734
Flank pain 58.62 16.92 60 46729 23070 110519440
Grip strength decreased 58.18 16.92 114 46675 80060 110462450
C-reactive protein decreased 57.62 16.92 27 46762 2882 110539628
Rotator cuff repair 57.49 16.92 25 46764 2241 110540269
Impaired work ability 57.15 16.92 63 46726 26356 110516154
Arthritis bacterial 55.68 16.92 42 46747 10778 110531732
Viral upper respiratory tract infection 55.61 16.92 41 46748 10167 110532343
Product dose omission issue 55.08 16.92 34 46755 321748 110220762
Synovial disorder 53.73 16.92 26 46763 2981 110539529
Decreased appetite 53.44 16.92 74 46715 475772 110066738
Oedema peripheral 53.18 16.92 37 46752 328623 110213887
Deformity 51.32 16.92 39 46750 10121 110532389
Diarrhoea 50.95 16.92 279 46510 1139226 109403284
Chest discomfort 50.35 16.92 175 46614 173673 110368837
Meningitis fungal 50.28 16.92 14 46775 325 110542185
Blood pressure increased 49.07 16.92 228 46561 258145 110284365
Vitamin D deficiency 48.61 16.92 49 46740 18503 110524007
Influenza 47.92 16.92 169 46620 168932 110373578
Neoplasm malignant 47.36 16.92 68 46721 37075 110505435
Bone density abnormal 47.33 16.92 26 46763 3877 110538633
Ulcer 46.51 16.92 73 46716 43043 110499467
Osteoarthritis 45.44 16.92 175 46614 182448 110360062
Atelectasis 45.04 16.92 66 46723 36646 110505864
Musculoskeletal pain 44.41 16.92 174 46615 182849 110359661
Cardiac failure congestive 43.73 16.92 6 46783 150994 110391516
Renal failure 43.04 16.92 21 46768 226553 110315957
Gastrointestinal disorder 42.67 16.92 209 46580 241743 110300767
Eye irritation 42.29 16.92 61 46728 33391 110509119
Onychomadesis 42.07 16.92 72 46717 45591 110496919
Product contamination 41.61 16.92 19 46770 1912 110540598
Hypersensitivity 41.58 16.92 303 46486 403695 110138815
Renal impairment 41.42 16.92 14 46775 188431 110354079
Joint noise 40.68 16.92 26 46763 5117 110537393
Ocular hyperaemia 40.29 16.92 65 46724 39221 110503289
Tremor 39.55 16.92 18 46771 202214 110340296
Chest pain 38.86 16.92 62 46727 376313 110166197
Hyperkalaemia 37.93 16.92 6 46783 135790 110406720
Fatigue 37.28 16.92 721 46068 1215237 109327273
Product quality issue 36.94 16.92 93 46696 77206 110465304
Exposure during pregnancy 36.51 16.92 154 46635 167270 110375240
Lip and/or oral cavity cancer 36.42 16.92 15 46774 1175 110541335
Nodule 36.24 16.92 56 46733 32575 110509935
Constipation 36.04 16.92 267 46522 357519 110184991
Vaginal haematoma 35.84 16.92 9 46780 138 110542372
Seizure 35.63 16.92 25 46764 221160 110321350
Red blood cell sedimentation rate decreased 34.77 16.92 15 46774 1319 110541191
Tachycardia 34.72 16.92 27 46762 226618 110315892
Pancytopenia 34.69 16.92 23 46766 209590 110332920
Urinary tract infection 34.39 16.92 53 46736 326229 110216281
Rhabdomyolysis 34.36 16.92 5 46784 120396 110422114
Overdose 33.69 16.92 191 46598 233603 110308907
Gastrointestinal haemorrhage 33.52 16.92 14 46775 165504 110377006
Hypoxia 33.42 16.92 7 46782 129508 110413002
Ankylosing spondylitis 33.37 16.92 37 46752 15575 110526935
Aspartate aminotransferase increased 33.25 16.92 13 46776 159923 110382587
Synovitis 33.18 16.92 214 46575 273878 110268632
Electrocardiogram QT prolonged 32.34 16.92 4 46785 108956 110433554
Oedema 32.18 16.92 25 46764 209951 110332559
Blood creatinine increased 31.73 16.92 19 46770 182870 110359640
Spinal pain 31.45 16.92 39 46750 18476 110524034
Metabolic acidosis 31.29 16.92 3 46786 99741 110442769
Rash maculo-papular 31.07 16.92 85 46704 74137 110468373
Cardiac failure 30.49 16.92 21 46768 187605 110354905
Cardio-respiratory arrest 30.43 16.92 6 46783 115830 110426680
Eye pain 30.18 16.92 66 46723 50033 110492477
Bradycardia 30.16 16.92 14 46775 155503 110387007
Chills 30.09 16.92 22 46767 190558 110351952
Onychomycosis 29.43 16.92 56 46733 38475 110504035
Thyroid atrophy 29.28 16.92 9 46780 298 110542212
Myocardial infarction 29.27 16.92 23 46766 192060 110350450
Myelosuppression 29.16 16.92 3 46786 94337 110448173
Meningitis 29.01 16.92 30 46759 11672 110530838
Middle lobe syndrome 28.95 16.92 6 46783 36 110542474
Hepatic enzyme 28.72 16.92 21 46768 5142 110537368
Dry mouth 28.57 16.92 163 46626 199785 110342725
Hepatic enzyme decreased 28.54 16.92 12 46777 990 110541520
Hypoglycaemia 28.50 16.92 7 46782 116097 110426413
Facet joint syndrome 28.48 16.92 98 46691 96730 110445780
Malaise 28.42 16.92 420 46369 671399 109871111
Cardiac arrest 28.21 16.92 25 46764 196728 110345782
Coma 27.25 16.92 8 46781 117861 110424649
Sepsis 26.73 16.92 62 46727 327284 110215226
Blepharospasm 26.21 16.92 66 46723 54785 110487725
Ascites 26.14 16.92 4 46785 92804 110449706
Productive cough 25.98 16.92 8 46781 114297 110428213
Peripheral swelling 25.39 16.92 272 46517 403762 110138748
Rash pruritic 25.22 16.92 95 46694 97974 110444536
Hallucination 25.13 16.92 6 46783 101426 110441084
Infusion related reaction 25.08 16.92 259 46530 380903 110161607
Sacroiliitis 24.90 16.92 19 46770 4959 110537551
Epistaxis 24.88 16.92 12 46777 130360 110412150
Haematuria 24.75 16.92 3 46786 83002 110459508
Sinusitis 24.19 16.92 211 46578 296477 110246033
Alopecia 23.85 16.92 77 46712 364676 110177834
Febrile bone marrow aplasia 23.78 16.92 33 46756 17432 110525078
Insomnia 23.67 16.92 76 46713 360514 110181996
Post cholecystectomy syndrome 23.59 16.92 10 46779 842 110541668
Amnesia 22.87 16.92 8 46781 105400 110437110
Injection site infection 22.75 16.92 14 46775 2579 110539931
Finger deformity 22.73 16.92 46 46743 33046 110509464
Loss of consciousness 22.54 16.92 30 46759 196276 110346234
Weight decreased 22.28 16.92 112 46677 467945 110074565
Delirium 22.09 16.92 15 46774 135010 110407500
COVID-19 22.01 16.92 44 46745 245016 110297494
Osteopenia 21.76 16.92 36 46753 22173 110520337
Injection site pain 21.66 16.92 26 46763 177896 110364614
Cerebrovascular accident 21.59 16.92 141 46648 181143 110361367
Back injury 21.58 16.92 56 46733 47343 110495167
Pulmonary embolism 21.49 16.92 36 46753 214438 110328072
Sleep disorder due to general medical condition, insomnia type 21.29 16.92 9 46780 105634 110436876
Paraplegia 21.25 16.92 19 46770 6181 110536329
Deep vein thrombosis 21.00 16.92 17 46772 139870 110402640
Blood creatine phosphokinase increased 20.93 16.92 3 46786 73074 110469436
Acute myocardial infarction 20.66 16.92 5 46784 83772 110458738
Lethargy 20.47 16.92 7 46782 93569 110448941
Dry skin 20.40 16.92 10 46779 107643 110434867
Alanine aminotransferase increased 20.18 16.92 29 46760 183744 110358766
Oxygen saturation decreased 20.13 16.92 22 46767 156960 110385550
Blood glucose increased 20.01 16.92 16 46773 132480 110410030
Product label confusion 19.90 16.92 35 46754 22642 110519868
International normalised ratio increased 19.85 16.92 6 46783 86766 110455744
Blood bilirubin increased 19.82 16.92 4 46785 75968 110466542
Meningitis tuberculous 19.72 16.92 10 46779 1268 110541242
Conjunctival ulcer 19.65 16.92 5 46784 81 110542429
Syncope 19.38 16.92 35 46754 202501 110340009
Diverticulum oesophageal 19.28 16.92 6 46783 207 110542303
Chorioretinopathy 19.14 16.92 12 46777 2283 110540227
Hyponatraemia 18.76 16.92 40 46749 217613 110324897
Haemophilus bacteraemia 18.55 16.92 6 46783 235 110542275
Mandibular mass 18.50 16.92 6 46783 237 110542273
Drug ineffective 18.41 16.92 802 45987 1519738 109022772
Orthostatic hypotension 18.33 16.92 3 46786 66246 110476264
Thalassaemia minor 18.30 16.92 4 46785 32 110542478
Injection site joint swelling 18.19 16.92 4 46785 33 110542477
Hypertension 18.18 16.92 310 46479 509774 110032736
Quality of life decreased 18.15 16.92 26 46763 14143 110528367
Frequent bowel movements 18.13 16.92 4 46785 71386 110471124
Incorrect route of product administration 18.11 16.92 64 46725 63997 110478513
Alanine aminotransferase abnormal 18.04 16.92 21 46768 9313 110533197
Crystal arthropathy 18.02 16.92 6 46783 258 110542252
Vitamin B12 increased 17.79 16.92 11 46778 2044 110540466
Vomiting 17.69 16.92 275 46514 910400 109632110
Multiple organ dysfunction syndrome 17.60 16.92 23 46766 151687 110390823
Benign neoplasm 17.47 16.92 9 46780 1179 110541331
Breast cancer stage III 17.41 16.92 73 46716 79044 110463466
Hepatic function abnormal 17.37 16.92 8 46781 89287 110453223
Pain in extremity 17.34 16.92 296 46493 486822 110055688
Pruritus 17.27 16.92 160 46629 581400 109961110
C-reactive protein increased 17.24 16.92 154 46635 217765 110324745
Hepatic failure 17.15 16.92 4 46785 68735 110473775
Abdominal pain 17.08 16.92 137 46652 512852 110029658
Swollen joint count increased 17.06 16.92 7 46782 83654 110458856

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
FDA EPC N0000175576 Corticosteroid
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000932 Antiemetics
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D018696 Neuroprotective Agents
MeSH PA D020011 Protective Agents
CHEBI has role CHEBI:35472 anti-inflammatory drug
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:35845 gout suppressant
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:75835 anti-anaemic agent

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

DiseaseRelationSNOMED_IDDOID
Atopic dermatitis indication 24079001 DOID:3310
Erythema multiforme indication 36715001
Contact dermatitis indication 40275004 DOID:2773
Humoral hypercalcemia of malignancy indication 47709007
Pemphigus indication 65172003 DOID:9182
Transfusion reaction due to serum protein reaction indication 72284000
Dermatitis herpetiformis indication 111196000 DOID:8505
Mycosis fungoides indication 118618005
Congenital adrenal hyperplasia indication 237751000
Seasonal allergic rhinitis indication 367498001
Adrenal cortical hypofunction indication 386584007 DOID:10493
Perennial allergic rhinitis indication 446096008
Transfusion Reaction Urticaria indication
Exfoliative Erythroderma indication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

ProductApplicantIngredients
Depo-Medrol Zoetis Inc. 1
Methylprednisolone Acetate Inj. Cronus Pharma Specialities India Private Limited 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.63 acidic
pKa2 13.35 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
4018070 VUID
N0000179565 NUI
D00979 KEGG_DRUG
4018068 VANDF
4018070 VANDF
C0600901 UMLSCUI
CHEBI:6889 CHEBI
CHEMBL1364144 ChEMBL_ID
D000077555 MESH_DESCRIPTOR_UI
5877 PUBCHEM_CID
43502P7F0P UNII
155323 RXNORM
1041 MMSL
4853 MMSL
5093 MMSL
5094 MMSL
d00293 MMSL
002160 NDDF
002161 NDDF
116593003 SNOMEDCT_US
27242001 SNOMEDCT_US
80959009 SNOMEDCT_US
C0025815 UMLSCUI
DB00959 DRUGBANK_ID
6741 PUBCHEM_CID
732 INN_ID
D008775 MESH_DESCRIPTOR_UI
CHEBI:6888 CHEBI
43502P7F0P INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Depo-Medrol HUMAN PRESCRIPTION DRUG LABEL 1 0009-0274 INJECTION, SUSPENSION 20 mg INTRAMUSCULAR NDA 22 sections
Depo-Medrol HUMAN PRESCRIPTION DRUG LABEL 1 0009-0280 INJECTION, SUSPENSION 40 mg INTRAMUSCULAR NDA 22 sections
Depo-Medrol HUMAN PRESCRIPTION DRUG LABEL 1 0009-0306 INJECTION, SUSPENSION 80 mg INTRAMUSCULAR NDA 22 sections
Depo-Medrol HUMAN PRESCRIPTION DRUG LABEL 1 0009-3073 INJECTION, SUSPENSION 40 mg INTRAMUSCULAR NDA 22 sections
Depo-Medrol HUMAN PRESCRIPTION DRUG LABEL 1 0009-3073 INJECTION, SUSPENSION 40 mg INTRAMUSCULAR NDA 22 sections
Depo-Medrol HUMAN PRESCRIPTION DRUG LABEL 1 0009-3073 INJECTION, SUSPENSION 40 mg INTRAMUSCULAR NDA 22 sections
Depo-Medrol HUMAN PRESCRIPTION DRUG LABEL 1 0009-3475 INJECTION, SUSPENSION 80 mg INTRAMUSCULAR NDA 22 sections
Depo-Medrol HUMAN PRESCRIPTION DRUG LABEL 1 0009-3475 INJECTION, SUSPENSION 80 mg INTRAMUSCULAR NDA 22 sections
Depo-Medrol HUMAN PRESCRIPTION DRUG LABEL 1 0009-3475 INJECTION, SUSPENSION 80 mg INTRAMUSCULAR NDA 22 sections
METHYLPREDNISOLONE ACETATE Human Prescription Drug Label 1 0781-3516 INJECTION, SUSPENSION 80 mg INTRAMUSCULAR ANDA 20 sections
METHYLPREDNISOLONE ACETATE Human Prescription Drug Label 1 0781-3522 INJECTION, SUSPENSION 40 mg INTRAMUSCULAR ANDA 20 sections
Methylprednisolone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 21695-849 INJECTION, SUSPENSION 40 mg INTRA-ARTICULAR ANDA 17 sections
Methylprednisolone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 21695-850 INJECTION, SUSPENSION 80 mg INTRA-ARTICULAR ANDA 17 sections
Depo-Medrol HUMAN PRESCRIPTION DRUG LABEL 1 21695-952 INJECTION, SUSPENSION 40 mg INTRAMUSCULAR NDA 22 sections
methylprednisolone acetate HUMAN PRESCRIPTION DRUG LABEL 1 25021-820 INJECTION, SUSPENSION 40 mg INTRA-ARTICULAR ANDA 21 sections
methylprednisolone acetate HUMAN PRESCRIPTION DRUG LABEL 1 25021-821 INJECTION, SUSPENSION 80 mg INTRA-ARTICULAR ANDA 21 sections
METHYLPREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 42023-238 INJECTION, SUSPENSION 40 mg INTRA-ARTICULAR ANDA 18 sections
METHYLPREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 42023-239 INJECTION, SUSPENSION 40 mg INTRA-ARTICULAR ANDA 18 sections
Methylprednisolone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 42023-240 INJECTION, SUSPENSION 80 mg INTRA-ARTERIAL ANDA 18 sections
Depo-Medrol HUMAN PRESCRIPTION DRUG LABEL 1 50090-0312 INJECTION, SUSPENSION 40 mg INTRAMUSCULAR NDA 21 sections
DEPO-MEDROL HUMAN PRESCRIPTION DRUG LABEL 1 50090-0436 INJECTION, SUSPENSION 80 mg INTRAMUSCULAR NDA 21 sections
DEPO-MEDROL HUMAN PRESCRIPTION DRUG LABEL 1 50090-0436 INJECTION, SUSPENSION 80 mg INTRAMUSCULAR NDA 21 sections
DEPO-MEDROL HUMAN PRESCRIPTION DRUG LABEL 1 50090-0556 INJECTION, SUSPENSION 40 mg INTRAMUSCULAR NDA 21 sections
DEPO-MEDROL HUMAN PRESCRIPTION DRUG LABEL 1 50090-1823 INJECTION, SUSPENSION 80 mg INTRAMUSCULAR NDA 21 sections
DEPO-MEDROL HUMAN PRESCRIPTION DRUG LABEL 1 50090-2098 INJECTION, SUSPENSION 40 mg INTRAMUSCULAR NDA 21 sections
DEPO-MEDROL HUMAN PRESCRIPTION DRUG LABEL 1 50090-2098 INJECTION, SUSPENSION 40 mg INTRAMUSCULAR NDA 21 sections
Methylprednisolone acetate HUMAN PRESCRIPTION DRUG LABEL 1 50090-5894 INJECTION, SUSPENSION 40 mg INTRA-ARTICULAR ANDA 18 sections
Methylprednisolone acetate HUMAN PRESCRIPTION DRUG LABEL 1 50090-5894 INJECTION, SUSPENSION 40 mg INTRA-ARTICULAR ANDA 18 sections
Methylprednisolone acetate HUMAN PRESCRIPTION DRUG LABEL 1 50090-6024 INJECTION, SUSPENSION 80 mg INTRA-ARTICULAR ANDA 18 sections
METHYLPREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 51662-1429 INJECTION, SUSPENSION 40 mg INTRA-ARTICULAR ANDA 12 sections