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

Stem definitionDrug idCAS RN
N-methylated xanthine derivatives 2620 58-55-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • aminophyllin
  • aminophylline
  • theophylline
  • 1,3-Dimethylxanthine
  • armophylline
  • cetraphylline
  • chronophyllin
  • duraphyllin
  • elixophyllin
  • elixophylline
  • etheophyl
  • lanophyllin
  • pseudotheophylline
  • theophyllin
  • throphylline
  • xanthium
  • theophylline anhydrous
  • aminophylline dihydrate
  • theophylline sodium glycinate
  • theophylline monohydrate
A plant genus of the family ASTERACEAE. The name "prickly burweed" is sometimes used but causes confusion with AMSINCKIA.
  • Molecular weight: 180.17
  • Formula: C7H8N4O2
  • CLOGP: -0.03
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 1
  • TPSA: 69.30
  • ALOGS: -0.80
  • ROTB: 0
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.40 g O
0.40 g P
0.40 g R
0.60 g O
0.60 g P
0.60 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 8.30 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 18 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 48.12 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.51 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.86 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.61 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 7.20 hours Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 96 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,ALK,AURKA,AURKB,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,CHEK1,CSF1R,DDR1,DYRK1B,EIF2AK3,ERBB2,FLT3,GRK2,GRK3,GSK3B,IGF1R,ITK,JAK1,JAK2,MAP3K21,MAP3K7,MAP4K1,MAPK12,MAPK7,MAPK9,MARK4,MET,MTOR,NTRK2,PDK1,PDK2,PDPK1,PIK3CB,PIK3CD,PIM2,PLK1,PRKCD,PRKDC,PTK2,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1 53
kinase-selectivity-class AXL,CDK9,GRK2,IRAK1,MAPK12,MAPK7,MARK4,MET,PDK1,PRKDC,STK33,TEK 12
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
April 19, 1940 FDA GD SEARLE LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 1599.84 16.02 1071 35657 241089 90350630
Wheezing 1130.21 16.02 862 35866 237218 90354501
Oedema 760.76 16.02 637 36091 199658 90392061
Dyspnoea 698.58 16.02 1261 35467 879694 89712025
Nasal oedema 636.45 16.02 193 36535 6391 90585328
Respiratory tract infection 619.59 16.02 352 36376 58726 90532993
Pneumonia 600.96 16.02 987 35741 637072 89954647
Drug hypersensitivity 480.42 16.02 750 35978 462859 90128860
Vomiting 363.69 16.02 907 35821 787386 89804333
Cough 358.30 16.02 580 36148 368382 90223337
Chest pain 221.54 16.02 434 36294 319211 90272508
Productive cough 208.61 16.02 203 36525 76860 90514859
Chronic obstructive pulmonary disease 191.49 16.02 190 36538 73639 90518080
Rales 186.72 16.02 102 36626 15725 90575994
Pulmonary pain 171.50 16.02 68 36660 5046 90586673
Malaise 166.30 16.02 568 36160 585418 90006301
Sputum discoloured 160.21 16.02 101 36627 20290 90571429
Multiple drug therapy 144.51 16.02 66 36662 6943 90584776
Alopecia 137.30 16.02 19 36709 495052 90096667
Amyloid arthropathy 135.97 16.02 43 36685 1637 90590082
Systemic lupus erythematosus 132.28 16.02 3 36725 361893 90229826
Bronchial neoplasm 123.36 16.02 31 36697 499 90591220
Sinus tachycardia 121.03 16.02 97 36631 28416 90563303
Breath sounds abnormal 117.84 16.02 75 36653 15311 90576408
Bronchial haemorrhage 116.94 16.02 31 36697 622 90591097
Forced expiratory volume decreased 114.45 16.02 53 36675 5755 90585964
Nasal turbinate hypertrophy 110.83 16.02 32 36696 889 90590830
Obstructive airways disorder 109.79 16.02 88 36640 25781 90565938
Chest discomfort 104.37 16.02 195 36533 138170 90453549
Exercise tolerance decreased 104.10 16.02 54 36674 7497 90584222
Endometrial ablation 103.00 16.02 31 36697 998 90590721
Prolonged expiration 101.01 16.02 32 36696 1225 90590494
Heart sounds 99.76 16.02 31 36697 1113 90590606
Hepatic enzyme increased 99.59 16.02 14 36714 360722 90230997
Blood pressure inadequately controlled 98.92 16.02 49 36679 6175 90585544
Treatment failure 96.28 16.02 7 36721 303921 90287798
Nasal congestion 95.77 16.02 142 36586 83272 90508447
Bronchial disorder 94.42 16.02 32 36696 1518 90590201
Joint swelling 92.83 16.02 44 36684 503256 90088463
Depressed mood 92.70 16.02 108 36620 50114 90541605
Synovitis 90.54 16.02 13 36715 329739 90261980
Rheumatoid arthritis 89.31 16.02 19 36709 362595 90229124
Rhonchi 87.46 16.02 36 36692 2942 90588777
Contraindicated product administered 82.56 16.02 15 36713 320124 90271595
Fatigue 81.85 16.02 221 36507 1153802 89437917
Infusion related reaction 80.65 16.02 34 36694 416746 90174973
Toxicity to various agents 80.43 16.02 278 36450 287568 90304151
Psoriatic arthropathy 76.08 16.02 4 36724 228331 90363388
Impaired healing 75.30 16.02 5 36723 234194 90357525
Swelling 70.78 16.02 41 36687 419017 90172702
Stomatitis 70.54 16.02 13 36715 274685 90317034
Hypercapnia 70.46 16.02 40 36688 6637 90585082
Bronchial obstruction 69.26 16.02 26 36702 1663 90590056
Therapeutic product effect decreased 67.40 16.02 15 36713 277556 90314163
Discomfort 66.26 16.02 15 36713 274320 90317399
Diabetes mellitus inadequate control 65.67 16.02 57 36671 18627 90573092
Creatinine renal clearance increased 64.83 16.02 30 36698 3251 90588468
Status asthmaticus 64.51 16.02 21 36707 878 90590841
Bronchitis chronic 62.76 16.02 33 36695 4710 90587009
Rhinitis 61.51 16.02 48 36680 13524 90578195
Occupational asthma 59.60 16.02 14 36714 167 90591552
Depressive symptom 59.41 16.02 33 36695 5252 90586467
Muscle injury 59.14 16.02 3 36725 176651 90415068
Respiration abnormal 58.95 16.02 38 36690 7925 90583794
Dyspnoea exertional 58.41 16.02 105 36623 72183 90519536
Drug interaction 58.19 16.02 244 36484 276209 90315510
Granuloma 57.17 16.02 34 36694 6151 90585568
Fibromyalgia 56.90 16.02 8 36720 206261 90385458
Neurosensory hypoacusis 56.45 16.02 14 36714 213 90591506
Diarrhoea 56.35 16.02 194 36534 938996 89652723
Intentional product use issue 56.24 16.02 10 36718 216882 90374837
Rash 55.87 16.02 153 36575 795947 89795772
Overdose 55.54 16.02 165 36563 157544 90434175
Eosinophil count increased 52.33 16.02 43 36685 13038 90578681
Myopathy 51.10 16.02 43 36685 13475 90578244
Liver injury 51.05 16.02 5 36723 170562 90421157
Drug intolerance 50.91 16.02 64 36664 447527 90144192
Sinus pain 50.80 16.02 30 36698 5359 90586360
Eosinophilic granulomatosis with polyangiitis 49.57 16.02 23 36705 2507 90589212
Bronchospasm 49.45 16.02 51 36677 20658 90571061
Respiratory rate increased 48.68 16.02 45 36683 15956 90575763
Musculoskeletal stiffness 48.65 16.02 30 36698 296502 90295217
Sleep disorder due to a general medical condition 48.25 16.02 74 36654 44664 90547055
Middle insomnia 46.92 16.02 45 36683 16706 90575013
Depressed level of consciousness 46.84 16.02 96 36632 72688 90519031
Drug ineffective 46.49 16.02 350 36378 1383948 89207771
Gastrointestinal disorder 46.40 16.02 23 36705 256664 90335055
Cognitive disorder 46.40 16.02 93 36635 69314 90522405
Abdominal discomfort 45.70 16.02 77 36651 477251 90114468
Analgesic therapy 45.41 16.02 15 36713 657 90591062
Affective disorder 45.27 16.02 32 36696 7761 90583958
Renal function test abnormal 45.22 16.02 31 36697 7160 90584559
Lower respiratory tract infection 44.99 16.02 211 36517 250448 90341271
Ill-defined disorder 44.85 16.02 10 36718 184881 90406838
Oesophageal dilatation 44.72 16.02 14 36714 515 90591204
Sedation complication 44.62 16.02 44 36684 16900 90574819
Congestive cardiomyopathy 44.59 16.02 31 36697 7323 90584396
Off label use 44.31 16.02 264 36464 1101988 89489731
Creatinine renal clearance decreased 44.15 16.02 46 36682 18853 90572866
Antacid therapy 43.71 16.02 15 36713 739 90590980
Arteriosclerosis coronary artery 43.60 16.02 34 36694 9569 90582150
Appendicolith 43.58 16.02 15 36713 746 90590973
Appetite disorder 42.91 16.02 33 36695 9100 90582619
Drug therapy 42.68 16.02 15 36713 794 90590925
Anticoagulant therapy 42.54 16.02 15 36713 802 90590917
Respiratory acidosis 41.83 16.02 31 36697 8088 90583631
Bursitis 41.75 16.02 3 36725 131651 90460068
Inflammation 40.70 16.02 11 36717 178581 90413138
Night sweats 40.65 16.02 3 36725 128763 90462956
Oligoarthritis 39.67 16.02 13 36715 555 90591164
Airway peak pressure increased 39.30 16.02 12 36716 406 90591313
PCO2 increased 38.99 16.02 16 36712 1297 90590422
Drug abuse 38.86 16.02 96 36632 82251 90509468
Memory impairment 38.25 16.02 16 36712 197228 90394491
Arthropathy 37.96 16.02 56 36672 366186 90225533
Lung hyperinflation 37.91 16.02 16 36712 1392 90590327
Female sterilisation 37.32 16.02 13 36715 670 90591049
Decreased bronchial secretion 37.05 16.02 8 36720 63 90591656
Diabetes mellitus 36.47 16.02 81 36647 64794 90526925
Lipohypertrophy 36.32 16.02 13 36715 726 90590993
Arthralgia 35.88 16.02 178 36550 778344 89813375
Increased viscosity of bronchial secretion 35.83 16.02 11 36717 379 90591340
Febrile neutropenia 35.62 16.02 10 36718 158339 90433380
Neutropenia 35.18 16.02 24 36704 224880 90366839
Respiratory tract inflammation 34.65 16.02 12 36716 608 90591111
Vital capacity decreased 33.98 16.02 16 36712 1803 90589916
Rhinorrhoea 33.58 16.02 95 36633 88221 90503498
Influenza 33.33 16.02 128 36600 139136 90452583
Osteoarthritis 33.22 16.02 19 36709 195711 90396008
PO2 decreased 32.94 16.02 15 36713 1566 90590153
Adrenal suppression 32.38 16.02 13 36715 996 90590723
Eosinophilia 31.90 16.02 48 36680 28485 90563234
Respiratory failure 31.82 16.02 113 36615 118305 90473414
Painful respiration 31.63 16.02 18 36710 3000 90588719
Blister 31.61 16.02 34 36694 254964 90336755
Pruritus 31.61 16.02 113 36615 541412 90050307
Orthostatic hypotension 31.56 16.02 59 36669 41768 90549951
Increased bronchial secretion 31.42 16.02 16 36712 2137 90589582
Hypoventilation 31.35 16.02 22 36706 5274 90586445
Emphysema 30.96 16.02 31 36697 12124 90579595
Product use issue 30.83 16.02 54 36674 329865 90261854
Asthmatic crisis 30.24 16.02 15 36713 1895 90589824
Eye paraesthesia 29.79 16.02 8 36720 169 90591550
Joint range of motion decreased 29.71 16.02 9 36719 135634 90456085
Drug dependence 29.52 16.02 47 36681 29280 90562439
Blood cholesterol increased 28.96 16.02 25 36703 207987 90383732
Left ventricular failure 28.86 16.02 23 36705 6677 90585042
Blood pH decreased 28.83 16.02 16 36712 2542 90589177
Dyspnoea at rest 28.59 16.02 20 36708 4771 90586948
Lung opacity 28.56 16.02 22 36706 6080 90585639
Blood bicarbonate decreased 28.45 16.02 17 36711 3102 90588617
Viral infection 28.28 16.02 56 36672 41358 90550361
Acute respiratory failure 28.07 16.02 57 36671 42861 90548858
Ligament pain 27.82 16.02 8 36720 219 90591500
Infective exacerbation of chronic obstructive airways disease 27.54 16.02 13 36715 1473 90590246
Adverse event 27.19 16.02 7 36721 117411 90474308
Blood calcium decreased 27.18 16.02 46 36682 30136 90561583
Full blood count abnormal 26.84 16.02 51 36677 36546 90555173
Breast neoplasm 26.78 16.02 13 36715 1567 90590152
Urinary tract discomfort 26.70 16.02 11 36717 901 90590818
Hyperventilation 26.67 16.02 22 36706 6706 90585013
Pleural rub 26.33 16.02 6 36722 62 90591657
Glossitis 26.26 16.02 17 36711 3570 90588149
Heart rate increased 25.57 16.02 102 36626 112800 90478919
Type 2 diabetes mellitus 25.29 16.02 27 36701 203217 90388502
Pulmonary congestion 25.09 16.02 35 36693 19398 90572321
Oxygen saturation decreased 25.06 16.02 98 36630 107385 90484334
Peripheral swelling 24.89 16.02 85 36643 413021 90178698
Paranasal sinus hypersecretion 24.86 16.02 18 36710 4533 90587186
Drug level increased 24.59 16.02 42 36686 27720 90563999
Myocardial ischaemia 24.31 16.02 29 36699 13785 90577934
Flail chest 24.21 16.02 6 36722 91 90591628
Stress urinary incontinence 24.03 16.02 14 36714 2438 90589281
Bronchitis 24.03 16.02 124 36604 152803 90438916
Alveolar osteitis 24.00 16.02 11 36717 1166 90590553
Respiratory disorder 23.93 16.02 69 36659 64747 90526972
Ankle fracture 23.82 16.02 35 36693 20335 90571384
Lung perforation 23.79 16.02 6 36722 98 90591621
Pulmonary fibrosis 23.79 16.02 7 36721 107496 90484223
Spleen congestion 23.46 16.02 6 36722 104 90591615
Seizure 23.46 16.02 123 36605 152506 90439213
Wound infection 23.41 16.02 7 36721 106395 90485324
Hyperphosphataemia 23.34 16.02 16 36712 3695 90588024
Drug level above therapeutic 23.04 16.02 19 36709 5790 90585929
Calculus urinary 22.99 16.02 12 36716 1686 90590033
Tunnel vision 22.97 16.02 12 36716 1689 90590030
Dyspepsia 22.84 16.02 28 36700 198132 90393587
Disease progression 22.81 16.02 18 36710 156597 90435122
Urogenital haemorrhage 22.30 16.02 7 36721 260 90591459
Live birth 21.96 16.02 3 36725 79104 90512615
Kyphosis 21.83 16.02 14 36714 2894 90588825
Stress cardiomyopathy 21.81 16.02 27 36701 13328 90578391
Maternal exposure during pregnancy 21.75 16.02 74 36654 359989 90231730
Stevens-Johnson syndrome 21.62 16.02 41 36687 29335 90562384
Aortic stenosis 21.60 16.02 19 36709 6317 90585402
Confusional state 21.58 16.02 82 36646 386123 90205596
Thrombocytopenia 21.52 16.02 32 36696 208693 90383026
Crepitations 21.49 16.02 22 36706 8830 90582889
Sputum abnormal 21.49 16.02 9 36719 768 90590951
Haemoptysis 21.49 16.02 44 36684 33276 90558443
Respiratory symptom 21.38 16.02 16 36712 4236 90587483
Thoracic operation 21.34 16.02 6 36722 151 90591568
Pain in extremity 21.28 16.02 102 36626 450427 90141292
Presbyacusis 21.25 16.02 14 36714 3028 90588691
Musculoskeletal pain 21.03 16.02 23 36705 171228 90420491
Angina pectoris 21.01 16.02 48 36680 39112 90552607
Treatment noncompliance 21.00 16.02 57 36671 51670 90540049
Hip arthroplasty 20.90 16.02 3 36725 76205 90515514
Infection 20.81 16.02 76 36652 362018 90229701
Completed suicide 20.72 16.02 17 36711 145041 90446678
Tremor 20.56 16.02 119 36609 153054 90438665
Antasthmatic drug level above therapeutic 20.43 16.02 3 36725 0 90591719
Medication error 20.40 16.02 78 36650 84574 90507145
Oesophagogastroduodenoscopy 20.37 16.02 6 36722 179 90591540
Abdominal pain upper 20.34 16.02 68 36660 332606 90259113
Pertussis 20.15 16.02 9 36719 898 90590821
Bladder pain 20.11 16.02 13 36715 2724 90588995
Toxic epidermal necrolysis 19.86 16.02 42 36686 32486 90559233
Macrocytosis 19.68 16.02 13 36715 2825 90588894
Stress 19.62 16.02 75 36653 81320 90510399
Therapy non-responder 19.55 16.02 16 36712 136688 90455031
Headache 19.50 16.02 240 36488 862506 89729213
General physical health deterioration 19.45 16.02 76 36652 355039 90236680
Animal scratch 19.41 16.02 11 36717 1819 90589900
Injection site hypoaesthesia 19.40 16.02 8 36720 657 90591062
Joint stiffness 19.37 16.02 4 36724 78038 90513681
Glaucoma 19.18 16.02 32 36696 20723 90570996
Polymyalgia rheumatica 19.16 16.02 16 36712 4961 90586758
Latent tuberculosis 19.12 16.02 13 36715 2963 90588756
Blood phosphorus increased 18.98 16.02 15 36713 4303 90587416
Staphylococcus test positive 18.90 16.02 15 36713 4330 90587389
White blood cell count decreased 18.85 16.02 24 36704 167085 90424634
Blood immunoglobulin E increased 18.66 16.02 15 36713 4410 90587309
Status epilepticus 18.66 16.02 30 36698 18844 90572875
Respiratory tract congestion 18.64 16.02 37 36691 27373 90564346
Bronchopulmonary aspergillosis allergic 18.56 16.02 14 36714 3752 90587967
Rhabdomyolysis 18.38 16.02 54 36674 51202 90540517
Gout 18.33 16.02 28 36700 16831 90574888
Allergic cough 18.28 16.02 9 36719 1119 90590600
Accidental death 18.26 16.02 11 36717 2037 90589682
Cyanosis 17.98 16.02 30 36698 19425 90572294
Breast conserving surgery 17.86 16.02 9 36719 1176 90590543
Paraesthesia 17.57 16.02 48 36680 250278 90341441
Oropharyngeal candidiasis 17.55 16.02 9 36719 1219 90590500
COVID-19 17.29 16.02 26 36702 168817 90422902
Flank pain 16.92 16.02 29 36699 19193 90572526
Neck pain 16.72 16.02 13 36715 113950 90477769
Blood lactic acid increased 16.39 16.02 19 36709 8759 90582960
Liver function test increased 16.26 16.02 7 36721 84848 90506871
Supraventricular tachycardia 16.19 16.02 26 36702 16310 90575409
Atrial fibrillation 16.14 16.02 101 36627 133510 90458209

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 575.52 14.53 371 21341 61943 42537680
Wheezing 292.48 14.53 234 21478 54547 42545076
Chronic obstructive pulmonary disease 291.89 14.53 248 21464 62866 42536757
Obstructive airways disorder 174.61 14.53 125 21587 24634 42574989
Dyspnoea 167.47 14.53 549 21163 442072 42157551
Right atrial hypertrophy 166.03 14.53 44 21668 693 42598930
Full blood count abnormal 147.42 14.53 122 21590 29754 42569869
Bronchial secretion retention 144.23 14.53 47 21665 1560 42598063
Bronchial wall thickening 139.39 14.53 44 21668 1316 42598307
Right ventricular hypertrophy 133.68 14.53 44 21668 1508 42598115
Pulmonary function test abnormal 116.98 14.53 46 21666 2648 42596975
Productive cough 115.82 14.53 137 21575 51430 42548193
Aortic valve stenosis 111.71 14.53 46 21666 2986 42596637
Forced expiratory volume decreased 110.91 14.53 61 21651 7569 42592054
Obstruction 110.68 14.53 46 21666 3057 42596566
Chest X-ray abnormal 106.38 14.53 50 21662 4458 42595165
Therapeutic product effect incomplete 101.37 14.53 151 21561 70788 42528835
Adulterated product 100.68 14.53 30 21682 736 42598887
Gastrooesophageal reflux disease 87.14 14.53 111 21601 44912 42554711
Diastolic dysfunction 85.76 14.53 50 21662 6933 42592690
Gout 80.96 14.53 85 21627 27970 42571653
Sputum discoloured 80.36 14.53 55 21657 10077 42589546
Intervertebral disc degeneration 78.14 14.53 48 21664 7319 42592304
Loss of personal independence in daily activities 76.87 14.53 110 21602 49706 42549917
Radiation inflammation 71.71 14.53 25 21687 1023 42598600
Vital capacity decreased 71.23 14.53 21 21691 496 42599127
Foetal malformation 70.70 14.53 17 21695 176 42599447
Sleep disorder due to a general medical condition 69.32 14.53 63 21649 17390 42582233
Adjustment disorder 65.68 14.53 25 21687 1317 42598306
Cough 64.21 14.53 218 21494 177885 42421738
Pulmonary pain 61.75 14.53 25 21687 1553 42598070
Osteoporosis 59.58 14.53 54 21658 14852 42584771
Benign prostatic hyperplasia 59.34 14.53 63 21649 20989 42578634
Rhinitis perennial 54.82 14.53 14 21698 189 42599434
Sleep disorder therapy 53.66 14.53 37 21675 6857 42592766
Bronchiectasis 52.70 14.53 55 21657 17964 42581659
Ventricular fibrillation 51.65 14.53 70 21642 30053 42569570
Chest discomfort 49.79 14.53 104 21608 63512 42536111
Febrile neutropenia 48.56 14.53 17 21695 185686 42413937
Accidental death 48.56 14.53 26 21686 3057 42596566
Analgesic therapy 46.10 14.53 33 21679 6491 42593132
Mental disability 45.85 14.53 10 21702 64 42599559
Emphysema 45.59 14.53 42 21670 11793 42587830
Trisomy 18 45.54 14.53 17 21695 848 42598775
Neutropenia 44.57 14.53 23 21689 199408 42400215
Sleep apnoea syndrome 44.53 14.53 55 21657 21553 42578070
Respiratory failure 44.51 14.53 155 21557 127977 42471646
Forced vital capacity decreased 44.17 14.53 17 21695 923 42598700
Off label use 43.54 14.53 173 21539 638162 41961461
Eosinophil count increased 43.02 14.53 39 21673 10724 42588899
Lower respiratory tract infection 42.85 14.53 76 21636 41130 42558493
Drug therapy 42.18 14.53 31 21681 6349 42593274
Lung diffusion disorder 42.12 14.53 11 21701 163 42599460
Atrial fibrillation 41.86 14.53 161 21551 139432 42460191
Diarrhoea 41.74 14.53 110 21602 460739 42138884
Hypoacusis 39.18 14.53 48 21664 18654 42580969
Pulmonary function test decreased 38.23 14.53 28 21684 5704 42593919
Appendicolith 37.44 14.53 40 21672 13416 42586207
Hyperphosphataemia 36.79 14.53 39 21673 12965 42586658
Inguinal hernia repair 35.53 14.53 11 21701 308 42599315
Hypercapnia 35.33 14.53 26 21686 5335 42594288
Hypophosphataemia 34.88 14.53 48 21664 20897 42578726
Iron deficiency 34.58 14.53 35 21677 11026 42588597
Blood phosphorus increased 34.44 14.53 37 21675 12488 42587135
Incorrect route of product administration 33.61 14.53 51 21661 24254 42575369
Fungal disease carrier 32.82 14.53 11 21701 399 42599224
Pancytopenia 32.12 14.53 10 21702 117733 42481890
Hypercholesterolaemia 31.94 14.53 36 21676 12813 42586810
Bronchial obstruction 31.28 14.53 16 21696 1713 42597910
Supraventricular tachycardia 31.24 14.53 35 21677 12373 42587250
Genital ulceration 31.07 14.53 13 21699 878 42598745
Genital pain 30.81 14.53 13 21699 897 42598726
Acute kidney injury 30.74 14.53 91 21621 367246 42232377
Oropharyngeal candidiasis 30.55 14.53 13 21699 916 42598707
Ocular discomfort 30.09 14.53 19 21693 3038 42596585
Myasthenia gravis 29.96 14.53 39 21673 16098 42583525
Seasonal allergy 29.89 14.53 28 21684 8027 42591596
Eosinophilic bronchitis 29.24 14.53 9 21703 247 42599376
Pain 29.15 14.53 50 21662 244798 42354825
Lung opacity 29.10 14.53 24 21688 5813 42593810
Anxiety 28.64 14.53 128 21584 118432 42481191
Appendicitis 28.15 14.53 43 21669 20570 42579053
Aortic stenosis 27.94 14.53 28 21684 8717 42590906
Total lung capacity decreased 27.41 14.53 19 21693 3551 42596072
Thrombocytopenia 27.40 14.53 34 21678 190245 42409378
Blood uric acid increased 26.45 14.53 36 21676 15511 42584112
Lung neoplasm malignant 26.22 14.53 40 21672 19107 42580516
Arthralgia 26.22 14.53 40 21672 205198 42394425
Tachycardia foetal 25.52 14.53 9 21703 381 42599242
Intentional product misuse 25.14 14.53 79 21633 61821 42537802
Wolff-Parkinson-White syndrome 25.00 14.53 8 21704 250 42599373
Antacid therapy 24.79 14.53 20 21692 4697 42594926
Foetal distress syndrome 24.47 14.53 12 21700 1174 42598449
Tachycardia 24.31 14.53 109 21603 100978 42498645
Dyspnoea exertional 24.16 14.53 68 21644 50080 42549543
Schizophrenia 23.60 14.53 28 21684 10522 42589101
Obesity 23.42 14.53 35 21677 16424 42583199
Pneumonia 23.30 14.53 322 21390 421827 42177796
Fatigue 23.14 14.53 129 21583 435512 42164111
Blood immunoglobulin E increased 22.59 14.53 17 21695 3608 42596015
Blood cholesterol increased 22.42 14.53 45 21667 26696 42572927
Cardiac failure congestive 21.87 14.53 94 21618 85508 42514115
Dermatitis allergic 21.48 14.53 24 21688 8459 42591164
Toxicity to various agents 21.42 14.53 194 21518 228942 42370681
Back pain 20.75 14.53 25 21687 141751 42457872
Conduction disorder 20.75 14.53 14 21698 2504 42597119
Food poisoning 19.84 14.53 14 21698 2692 42596931
Eosinophilic pneumonia chronic 19.77 14.53 7 21705 300 42599323
Hypoxia 19.68 14.53 79 21633 69707 42529916
Perfume sensitivity 19.66 14.53 6 21706 160 42599463
Pulmonary artery dilatation 19.44 14.53 7 21705 315 42599308
Status asthmaticus 19.36 14.53 7 21705 319 42599304
Ulcer 19.28 14.53 32 21680 16409 42583214
Anticoagulant therapy 19.25 14.53 17 21695 4518 42595105
Lung hyperinflation 19.12 14.53 10 21702 1121 42598502
Breath sounds abnormal 19.07 14.53 27 21685 12066 42587557
Bronchopulmonary aspergillosis allergic 19.04 14.53 17 21695 4581 42595042
Deep vein thrombosis 18.51 14.53 8 21704 76949 42522674
Abdominal distension 18.49 14.53 79 21633 71656 42527967
Blood calcium increased 18.19 14.53 22 21690 8432 42591191
Sputum increased 17.88 14.53 14 21698 3149 42596474
End stage renal disease 17.80 14.53 31 21681 16527 42583096
Bacterial infection 17.76 14.53 42 21670 27837 42571786
Gastrointestinal pain 17.65 14.53 16 21696 4399 42595224
Activated partial thromboplastin time prolonged 17.39 14.53 30 21682 15873 42583750
Drug level increased 17.27 14.53 40 21672 26160 42573463
Tachyarrhythmia 17.21 14.53 15 21697 3917 42595706
Post streptococcal glomerulonephritis 17.12 14.53 5 21707 114 42599509
Supraventricular extrasystoles 16.97 14.53 15 21697 3991 42595632
Dizziness exertional 16.75 14.53 6 21706 266 42599357
Circulatory collapse 16.59 14.53 37 21675 23599 42576024
Lipid metabolism disorder 16.49 14.53 7 21705 490 42599133
Intentional product use issue 16.45 14.53 8 21704 71825 42527798
Knee arthroplasty 15.95 14.53 21 21691 8760 42590863
Neuropathy peripheral 15.95 14.53 17 21695 101836 42497787
Sudden infant death syndrome 15.80 14.53 6 21706 314 42599309
Ventricular extrasystoles 15.62 14.53 26 21686 13364 42586259
Rhinitis allergic 15.51 14.53 14 21698 3828 42595795
Glaucoma 15.41 14.53 20 21692 8228 42591395
Dry mouth 15.37 14.53 50 21662 39829 42559794
Carbon dioxide increased 15.33 14.53 9 21703 1263 42598360
Reversible airways obstruction 15.19 14.53 7 21705 596 42599027
Infusion related reaction 15.14 14.53 6 21706 60800 42538823
Sideroblastic anaemia 15 14.53 6 21706 361 42599262
Lung neoplasm 14.96 14.53 15 21697 4673 42594950
Somnambulism 14.89 14.53 13 21699 3402 42596221
Headache 14.89 14.53 67 21645 239302 42360321
Electrocardiogram repolarisation abnormality 14.69 14.53 8 21704 973 42598650
Depressed mood 14.65 14.53 35 21677 23349 42576274
Neuralgia 14.60 14.53 37 21675 25610 42574013

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 1918.89 13.43 1299 52140 248992 110286868
Wheezing 1276.51 13.43 1025 52414 254205 110281655
Dyspnoea 737.17 13.43 1634 51805 1105238 109430622
Oedema 667.13 13.43 653 52786 209323 110326537
Nasal oedema 595.64 13.43 193 53246 6646 110529214
Respiratory tract infection 516.39 13.43 359 53080 71258 110464602
Pneumonia 506.51 13.43 1226 52213 875488 109660372
Drug hypersensitivity 427.82 13.43 777 52662 453313 110082547
Chronic obstructive pulmonary disease 426.10 13.43 381 53058 108777 110427083
Cough 360.94 13.43 730 52709 460911 110074949
Vomiting 279.86 13.43 1019 52420 909656 109626204
Productive cough 268.56 13.43 303 53136 114002 110421858
Obstructive airways disorder 228.96 13.43 185 53254 45964 110489896
Pulmonary pain 224.80 13.43 92 53347 6201 110529659
Forced expiratory volume decreased 192.96 13.43 104 53335 13072 110522788
Sputum discoloured 184.86 13.43 133 53306 27812 110508048
Rales 157.40 13.43 115 53324 24624 110511236
Right atrial hypertrophy 156.58 13.43 41 53398 650 110535210
Chest pain 147.58 13.43 458 52981 375917 110159943
Amyloid arthropathy 128.53 13.43 43 53396 1637 110534223
Malaise 125.51 13.43 648 52791 671171 109864689
Full blood count abnormal 125.49 13.43 145 53294 55907 110479953
Multiple drug therapy 125.07 13.43 66 53373 7948 110527912
Alopecia 124.54 13.43 15 53424 364738 110171122
Right ventricular hypertrophy 119.71 13.43 41 53398 1678 110534182
Bronchial neoplasm 117.60 13.43 31 53408 505 110535355
Bronchial wall thickening 111.54 13.43 46 53393 3161 110532699
Sinus tachycardia 111.38 13.43 122 53317 44371 110491489
Breath sounds abnormal 109.69 13.43 94 53345 25310 110510550
Obstruction 109.01 13.43 54 53385 5698 110530162
Systemic lupus erythematosus 108.90 13.43 3 53436 254335 110281525
Chest discomfort 108.00 13.43 251 53188 173597 110362263
Adulterated product 106.29 13.43 34 53405 1121 110534739
Nasal turbinate hypertrophy 103.67 13.43 31 53408 813 110535047
Hepatic enzyme increased 100.66 13.43 17 53422 320875 110214985
Sleep disorder due to a general medical condition 100.55 13.43 125 53314 51987 110483873
Endometrial ablation 100.12 13.43 31 53408 917 110534943
Gout 99.86 13.43 105 53334 36461 110499399
Depressed mood 97.30 13.43 133 53306 60676 110475184
Heart sounds 94.42 13.43 31 53408 1112 110534748
Pulmonary function test abnormal 91.97 13.43 46 53393 4954 110530906
Diarrhoea 91.86 13.43 266 53173 1139239 109396621
Bronchial secretion retention 91.76 13.43 46 53393 4978 110530882
Nasal congestion 90.62 13.43 167 53272 98115 110437745
Glossodynia 90.22 13.43 4 53435 222000 110313860
Hypercapnia 89.98 13.43 60 53379 11099 110524761
Toxicity to various agents 89.91 13.43 464 52975 480091 110055769
Bronchial obstruction 89.88 13.43 39 53400 3040 110532820
Aortic valve stenosis 89.85 13.43 49 53390 6301 110529559
Synovitis 89.41 13.43 13 53426 274079 110261781
Blood pressure inadequately controlled 89.31 13.43 52 53387 7581 110528279
Pericarditis 88.87 13.43 4 53435 219110 110316750
Bronchial haemorrhage 88.54 13.43 31 53408 1356 110534504
Infusion related reaction 88.00 13.43 37 53402 381125 110154735
Rheumatoid arthritis 87.34 13.43 19 53420 299594 110236266
Fatigue 86.69 13.43 300 53139 1215658 109320202
Prolonged expiration 85.13 13.43 31 53408 1521 110534339
Febrile neutropenia 84.76 13.43 24 53415 316743 110219117
Rhonchi 84.39 13.43 42 53397 4476 110531384
Analgesic therapy 83.58 13.43 49 53390 7235 110528625
Eosinophil count increased 83.04 13.43 74 53365 20984 110514876
Neutropenia 82.35 13.43 39 53400 374581 110161279
Joint swelling 81.82 13.43 57 53382 442788 110093072
Psoriatic arthropathy 81.79 13.43 3 53436 196758 110339102
Stomatitis 79.05 13.43 17 53422 270225 110265635
Exercise tolerance decreased 78.81 13.43 57 53382 12010 110523850
Impaired healing 78.46 13.43 4 53435 196713 110339147
Drug therapy 78.31 13.43 47 53392 7244 110528616
Treatment failure 76.05 13.43 20 53419 277214 110258646
Off label use 76.01 13.43 421 53018 1499764 109036096
Intentional product use issue 75.84 13.43 14 53425 247892 110287968
Wound 74.44 13.43 12 53427 234425 110301435
Bronchial disorder 74.04 13.43 33 53406 2743 110533117
Radiation inflammation 72.99 13.43 25 53414 1023 110534837
Helicobacter infection 71.59 13.43 4 53435 181873 110353987
Creatinine renal clearance increased 71.58 13.43 35 53404 3590 110532270
Status asthmaticus 69.73 13.43 24 53415 997 110534863
Sleep disorder therapy 69.65 13.43 44 53395 7427 110528433
Chest X-ray abnormal 69.32 13.43 46 53393 8441 110527419
Appendicolith 68.26 13.43 56 53383 14199 110521661
Therapeutic product effect decreased 68.21 13.43 17 53422 244299 110291561
Emphysema 67.35 13.43 64 53375 19692 110516168
Accidental death 66.33 13.43 37 53402 4972 110530888
Benign prostatic hyperplasia 63.94 13.43 60 53379 18174 110517686
Hyperphosphataemia 61.50 13.43 56 53383 16325 110519535
Fibromyalgia 60.91 13.43 6 53433 170903 110364957
Lower respiratory tract infection 60.29 13.43 255 53184 242851 110293009
Loss of personal independence in daily activities 59.07 13.43 183 53256 149837 110386023
Duodenal ulcer perforation 58.94 13.43 8 53431 177692 110358168
Respiration abnormal 58.79 13.43 44 53395 9765 110526095
Ventricular fibrillation 58.15 13.43 85 53354 41228 110494632
Antacid therapy 57.99 13.43 35 53404 5449 110530411
Atrial fibrillation 57.04 13.43 241 53198 229401 110306459
Overdose 56.25 13.43 243 53196 233551 110302309
Respiratory failure 55.84 13.43 229 53210 215103 110320757
Blood phosphorus increased 55.83 13.43 53 53386 16287 110519573
Diastolic dysfunction 55.80 13.43 47 53392 12357 110523503
Dyspnoea exertional 55.78 13.43 142 53297 103918 110431942
Bronchiectasis 55.64 13.43 78 53361 36415 110499445
Drug interaction 55.19 13.43 422 53017 499761 110036099
Rhinitis perennial 53.58 13.43 14 53425 220 110535640
Mental disability 53.46 13.43 14 53425 222 110535638
Rhinitis 53.28 13.43 60 53379 22485 110513375
Sleep apnoea syndrome 52.32 13.43 80 53359 40367 110495493
Aortic stenosis 51.70 13.43 46 53393 13013 110522847
Lung hyperinflation 51.57 13.43 24 53415 2205 110533655
Bronchospasm 51.20 13.43 68 53371 30171 110505689
Anticoagulant therapy 51.04 13.43 32 53407 5329 110530531
Rash 50.94 13.43 214 53225 820750 109715110
Gastrointestinal disorder 50.42 13.43 27 53412 241925 110293935
Arthralgia 50.38 13.43 200 53239 779432 109756428
Night sweats 49.64 13.43 4 53435 133979 110401881
Bursitis 47.80 13.43 4 53435 129914 110405946
Ill-defined disorder 47.66 13.43 9 53430 156844 110379016
Neurosensory hypoacusis 47.59 13.43 13 53426 244 110535616
Oropharyngeal candidiasis 47.45 13.43 22 53417 2004 110533856
Diabetes mellitus 46.55 13.43 129 53310 99252 110436608
Thrombocytopenia 45.69 13.43 61 53378 348824 110187036
Respiratory rate increased 44.94 13.43 58 53381 25025 110510835
Intentional product misuse 44.11 13.43 153 53286 132751 110403109
Blood uric acid increased 43.71 13.43 53 53386 21476 110514384
Sinus pain 43.56 13.43 30 53409 5849 110530011
Diabetes mellitus inadequate control 42.98 13.43 62 53377 29713 110506147
Seasonal allergy 42.42 13.43 50 53389 19672 110516188
Depressive symptom 42.28 13.43 34 53405 8380 110527480
Hypoacusis 41.90 13.43 67 53372 35124 110500736
Osteoarthritis 41.68 13.43 18 53421 182605 110353255
Supraventricular tachycardia 41.47 13.43 55 53384 24367 110511493
Hypoventilation 41.34 13.43 33 53406 8048 110527812
Irritable bowel syndrome 41.10 13.43 14 53425 164201 110371659
Pruritus 40.92 13.43 144 53295 581416 109954444
Appendicitis 40.69 13.43 59 53380 28405 110507455
Renal function test abnormal 40.45 13.43 34 53405 8912 110526948
Acute kidney injury 40.39 13.43 164 53275 635266 109900594
Therapeutic product effect incomplete 40.30 13.43 214 53225 223591 110312269
Hypophosphataemia 39.27 13.43 63 53376 33119 110502741
Intervertebral disc degeneration 39.15 13.43 46 53393 18039 110517821
PCO2 increased 38.77 13.43 19 53420 1958 110533902
Granuloma 38.71 13.43 34 53405 9456 110526404
Respiratory acidosis 38.28 13.43 40 53399 13786 110522074
Appetite disorder 37.86 13.43 34 53405 9735 110526125
Lung diffusion disorder 36.99 13.43 11 53428 283 110535577
Creatinine renal clearance decreased 36.84 13.43 49 53390 21766 110514094
Middle insomnia 36.10 13.43 47 53392 20455 110515405
Headache 36.07 13.43 264 53175 882113 109653747
Bronchopulmonary aspergillosis allergic 36.01 13.43 31 53408 8395 110527465
Forced vital capacity decreased 35.87 13.43 18 53421 1952 110533908
Airway peak pressure increased 35.81 13.43 13 53426 632 110535228
Congestive cardiomyopathy 35.60 13.43 39 53400 14180 110521680
Decreased bronchial secretion 35.43 13.43 8 53431 65 110535795
Drug level increased 35.37 13.43 74 53365 47645 110488215
Contraindicated product administered 35.01 13.43 41 53398 248226 110287634
Joint range of motion decreased 34.93 13.43 8 53431 121824 110414036
Bacterial infection 34.84 13.43 72 53367 45964 110489896
Pancytopenia 34.83 13.43 30 53409 209583 110326277
End stage renal disease 34.39 13.43 47 53392 21426 110514434
Myasthenia gravis 34.32 13.43 47 53392 21464 110514396
Inguinal hernia repair 34.12 13.43 11 53428 372 110535488
Liver injury 34.04 13.43 15 53424 150398 110385462
Affective disorder 33.80 13.43 34 53405 11207 110524653
Product use issue 33.66 13.43 62 53377 311633 110224227
Oligoarthritis 33.39 13.43 13 53426 768 110535092
Eosinophilic granulomatosis with polyangiitis 33.38 13.43 33 53406 10653 110525207
Pulmonary function test decreased 33.17 13.43 30 53409 8670 110527190
Tachycardia 33.12 13.43 205 53234 226440 110309420
Sedation complication 32.62 13.43 44 53395 19811 110516049
Increased viscosity of bronchial secretion 32.47 13.43 12 53427 614 110535246
Vital capacity decreased 32.14 13.43 17 53422 2056 110533804
Drug ineffective 32.02 13.43 530 52909 1520010 109015850
Iron deficiency 31.97 13.43 42 53397 18434 110517426
Activated partial thromboplastin time prolonged 31.44 13.43 46 53393 22322 110513538
Fungal disease carrier 31.42 13.43 11 53428 481 110535379
Respiratory disorder 30.84 13.43 90 53349 71292 110464568
PO2 decreased 30.50 13.43 19 53420 3129 110532731
Myopathy 30.37 13.43 48 53391 24912 110510948
Blood pH decreased 30.36 13.43 22 53417 4647 110531213
Drug abuse 30.15 13.43 167 53272 177244 110358616
Total lung capacity decreased 30.05 13.43 26 53413 7088 110528772
Rhinorrhoea 29.67 13.43 113 53326 102553 110433307
Swelling 29.58 13.43 80 53359 350961 110184899
Musculoskeletal pain 29.44 13.43 27 53412 182996 110352864
Blood immunoglobulin E increased 28.92 13.43 26 53413 7456 110528404
Asthmatic crisis 28.85 13.43 16 53423 2126 110533734
Medication error 28.84 13.43 114 53325 105252 110430608
Cognitive disorder 28.39 13.43 100 53339 87411 110448449
Pulmonary congestion 27.75 13.43 52 53387 30914 110504946
Confusional state 27.28 13.43 125 53314 468555 110067305
Stress 27.26 13.43 112 53327 105236 110430624
Psoriasis 27.19 13.43 17 53422 139976 110395884
Lipohypertrophy 26.96 13.43 12 53427 994 110534866
Toxic epidermal necrolysis 26.92 13.43 74 53365 56653 110479207
Blood calcium increased 26.67 13.43 38 53401 18002 110517858
Influenza 26.64 13.43 156 53283 168945 110366915
Sciatica 26.62 13.43 6 53433 92393 110443467
Respiratory tract inflammation 26.55 13.43 12 53427 1031 110534829
Antasthmatic drug level above therapeutic 26.54 13.43 4 53435 0 110535860
Paraesthesia 26.44 13.43 59 53380 276462 110259398
Breast neoplasm 26.38 13.43 12 53427 1046 110534814
Wound infection 26.36 13.43 7 53432 96458 110439402
Eosinophilic pneumonia chronic 26.25 13.43 10 53429 557 110535303
Genital pain 26.10 13.43 13 53426 1387 110534473
Disease progression 25.94 13.43 49 53390 243985 110291875
Eosinophilic bronchitis 25.93 13.43 10 53429 576 110535284
Dry skin 25.55 13.43 10 53429 107643 110428217
Ligament pain 25.54 13.43 8 53431 246 110535614
Cyanosis 25.49 13.43 49 53390 29692 110506168
Type 2 diabetes mellitus 25.27 13.43 29 53410 177203 110358657
Pleural rub 25.02 13.43 6 53433 65 110535795
Neuropathy peripheral 24.85 13.43 30 53409 179247 110356613
Discomfort 24.72 13.43 41 53398 214666 110321194
Septic shock 24.44 13.43 24 53415 157504 110378356
White blood cell count decreased 24.43 13.43 46 53393 229344 110306516
Lung opacity 24.17 13.43 29 53410 11623 110524237
Urinary tract discomfort 24.07 13.43 11 53428 969 110534891
Infection 23.92 13.43 92 53347 362108 110173752
Myelosuppression 23.68 13.43 8 53431 94332 110441528
Generalised tonic-clonic seizure 23.67 13.43 69 53370 54611 110481249
Seizure 23.44 13.43 185 53254 221000 110314860
Memory impairment 23.24 13.43 37 53402 196907 110338953
Blood test abnormal 23.20 13.43 46 53393 28508 110507352
Stevens-Johnson syndrome 23.07 13.43 62 53377 46839 110489021
Alveolar osteitis 23.01 13.43 11 53428 1074 110534786
Kyphosis 23.00 13.43 16 53423 3171 110532689
Arrhythmia 22.99 13.43 80 53359 69495 110466365
Leukopenia 22.71 13.43 23 53416 148768 110387092
Flail chest 22.69 13.43 6 53433 99 110535761
Musculoskeletal stiffness 22.65 13.43 65 53374 279757 110256103
Neck pain 22.50 13.43 16 53423 123114 110412746
Arteriosclerosis coronary artery 22.28 13.43 42 53397 25076 110510784
Bronchitis 22.28 13.43 141 53298 156891 110378969
Heart rate increased 22.21 13.43 132 53307 143702 110392158
Blister 22.16 13.43 48 53391 227328 110308532
Blood bicarbonate decreased 22.12 13.43 20 53419 5777 110530083
Increased bronchial secretion 22.09 13.43 17 53422 3931 110531929
Osteoporosis 22.03 13.43 92 53347 87060 110448800
Genital ulceration 21.91 13.43 13 53426 1962 110533898
Paranasal sinus hypersecretion 21.76 13.43 18 53421 4616 110531244
Supraventricular extrasystoles 21.71 13.43 23 53416 8050 110527810
Myocardial ischaemia 21.69 13.43 43 53396 26641 110509219
Wolff-Parkinson-White syndrome 21.67 13.43 8 53431 408 110535452
Lung perforation 21.47 13.43 6 53433 123 110535737
Hyperlipidaemia 21.40 13.43 51 53388 35797 110500063
Electrocardiogram ST segment depression 21.15 13.43 19 53420 5442 110530418
Status epilepticus 21.15 13.43 47 53392 31524 110504336
Haematochezia 21.13 13.43 15 53424 115509 110420351
Asthenia 21.08 13.43 222 53217 688777 109847083
Dyspnoea at rest 21.08 13.43 23 53416 8323 110527537
Adrenal suppression 21.03 13.43 12 53427 1684 110534176
Adjustment disorder 20.98 13.43 26 53413 10769 110525091
Cushingoid 20.85 13.43 27 53412 11685 110524175
Colitis 20.47 13.43 12 53427 102311 110433549
Abdominal pain upper 20.37 13.43 93 53346 349018 110186842
Blood calcium decreased 20.34 13.43 50 53389 35795 110500065
Hepatic cirrhosis 20.28 13.43 4 53435 67622 110468238
Joint stiffness 20.12 13.43 4 53435 67239 110468621
Ankle fracture 19.94 13.43 35 53404 19784 110516076
Frequent bowel movements 19.85 13.43 5 53434 71385 110464475
Nasal polyps 19.80 13.43 28 53411 13172 110522688
Platelet count decreased 19.79 13.43 52 53387 230391 110305469
Respiratory tract congestion 19.63 13.43 45 53394 30812 110505048
Eye paraesthesia 19.36 13.43 6 53433 178 110535682
Tunnel vision 19.11 13.43 12 53427 2003 110533857
Clonic convulsion 19.11 13.43 11 53428 1569 110534291
Neoplasm progression 19.00 13.43 4 53435 64591 110471269
Dyspepsia 18.87 13.43 40 53399 190925 110344935
Bronchitis chronic 18.76 13.43 17 53422 4923 110530937
Breast conserving surgery 18.64 13.43 9 53430 898 110534962
Injection site reaction 18.46 13.43 10 53429 89060 110446800
Peripheral swelling 18.39 13.43 117 53322 403917 110131943
COVID-19 18.35 13.43 59 53380 245001 110290859
Left ventricular failure 18.35 13.43 25 53414 11364 110524496
Nail disorder 18.30 13.43 3 53436 57932 110477928
Hypoaesthesia 18.15 13.43 84 53355 314139 110221721
Hyperventilation 18.12 13.43 22 53417 8925 110526935
Drug level above therapeutic 18.01 13.43 25 53414 11563 110524297
Tachyarrhythmia 17.86 13.43 21 53418 8240 110527620
Inflammation 17.85 13.43 42 53397 193196 110342664
Gastric atony 17.83 13.43 3 53436 3 110535857
Crepitations 17.78 13.43 24 53415 10811 110525049
Deep vein thrombosis 17.75 13.43 25 53414 139862 110395998
Injection site hypoaesthesia 17.75 13.43 8 53431 683 110535177
Presbyacusis 17.69 13.43 13 53426 2806 110533054
Allergic cough 17.51 13.43 9 53430 1026 110534834
Animal scratch 17.46 13.43 11 53428 1848 110534012
Oesophagogastroduodenoscopy 17.28 13.43 6 53433 256 110535604
Post streptococcal glomerulonephritis 17.22 13.43 5 53434 118 110535742
Acute respiratory failure 17.14 13.43 77 53362 75183 110460677
Perfume sensitivity 17.07 13.43 9 53430 1082 110534778
Abdominal discomfort 16.94 13.43 116 53323 393742 110142118
Lung neoplasm malignant 16.91 13.43 45 53394 33797 110502063
Thoracic operation 16.91 13.43 6 53433 273 110535587
Urticaria 16.83 13.43 88 53351 318769 110217091
Dementia 16.73 13.43 43 53396 31630 110504230
Tonic convulsion 16.69 13.43 13 53426 3061 110532799
Eosinophilic pneumonia 16.68 13.43 19 53420 7208 110528652
Viral infection 16.61 13.43 60 53379 53079 110482781
Sputum increased 16.57 13.43 17 53422 5734 110530126
Calculus urinary 16.40 13.43 13 53426 3139 110532721
Hypokalaemia 16.35 13.43 147 53292 182301 110353559
Nausea 16.25 13.43 464 52975 1235226 109300634
Eosinophilia 16.11 13.43 63 53376 57873 110477987
Hepatitis 16.07 13.43 12 53427 90042 110445818
Stress cardiomyopathy 16.02 13.43 28 53411 15778 110520082
Road traffic accident 15.94 13.43 17 53422 107381 110428479
Clostridium difficile infection 15.81 13.43 3 53436 52126 110483734
Nasal septum deviation 15.78 13.43 11 53428 2187 110533673
Pertussis 15.63 13.43 9 53430 1284 110534576
Sudden infant death syndrome 15.60 13.43 6 53433 343 110535517
Bladder pain 15.53 13.43 12 53427 2793 110533067
Ventricular extrasystoles 15.50 13.43 34 53405 22607 110513253
Decreased appetite 15.50 13.43 151 53288 475695 110060165
Conduction disorder 15.49 13.43 14 53425 4041 110531819
Maternal exposure during pregnancy 15.40 13.43 67 53372 254816 110281044
Alanine aminotransferase increased 15.38 13.43 42 53397 183731 110352129
Hip arthroplasty 15.34 13.43 4 53435 55809 110480051
Orthostatic hypotension 15.25 13.43 68 53371 66181 110469679
Blood potassium decreased 15.17 13.43 59 53380 54055 110481805
Pulmonary mass 15.13 13.43 46 53393 37255 110498605
Bronchitis bacterial 15.11 13.43 10 53429 1826 110534034
Sputum abnormal 15.05 13.43 9 53430 1377 110534483
Multiple sclerosis relapse 15.01 13.43 3 53436 50237 110485623
Lipid metabolism disorder 15.00 13.43 7 53432 647 110535213
Pulmonary artery dilatation 14.94 13.43 7 53432 653 110535207
Anaemia 14.86 13.43 181 53258 546905 109988955
Cardiogenic shock 14.86 13.43 61 53378 57277 110478583
Lower limb fracture 14.84 13.43 9 53430 75339 110460521
Death 14.82 13.43 243 53196 698626 109837234
Cytomegalovirus infection 14.78 13.43 4 53435 54440 110481420
Plasma cell myeloma 14.68 13.43 6 53433 62930 110472930
Drug reaction with eosinophilia and systemic symptoms 14.57 13.43 11 53428 82084 110453776
Ventricular arrhythmia 14.55 13.43 21 53418 10066 110525794
Drug ineffective for unapproved indication 14.47 13.43 17 53422 102821 110433039
Ventricular tachycardia 14.41 13.43 55 53384 49954 110485906
Foot deformity 14.27 13.43 3 53436 48477 110487383
Arthropathy 14.26 13.43 81 53358 287441 110248419
Pulmonary fibrosis 14.22 13.43 17 53422 102025 110433835
Sideroblastic anaemia 14.14 13.43 6 53433 443 110535417
Nasal discharge discolouration 14.13 13.43 12 53427 3189 110532671
Urinary tract infection 14.07 13.43 96 53343 326186 110209674
C-reactive protein increased 13.96 13.43 56 53383 217863 110317997
Therapy non-responder 13.89 13.43 35 53404 157272 110378588
Macrocytosis 13.79 13.43 12 53427 3295 110532565
Migraine 13.79 13.43 40 53399 171612 110364248
Latent tuberculosis 13.78 13.43 13 53426 3964 110531896
Product use in unapproved indication 13.72 13.43 144 53295 447233 110088627
Blood bilirubin increased 13.71 13.43 10 53429 75962 110459898
Depressed level of consciousness 13.63 13.43 97 53342 112181 110423679
Burns third degree 13.60 13.43 6 53433 487 110535373
Hypoxia 13.53 13.43 108 53331 129407 110406453

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R03DA04 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Xanthines
ATC R03DA05 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Xanthines
ATC R03DA54 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Xanthines
ATC R03DA55 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Xanthines
ATC R03DA74 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Xanthines
ATC R03DB04 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Xanthines and adrenergics
ATC R03DB05 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Xanthines and adrenergics
FDA CS M0023046 Xanthines
CHEBI has role CHEBI:35523 bronchodilator agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:38147 cardiotonic drug
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:231911 renoprotective agent
MeSH PA D001993 Bronchodilator Agents
MeSH PA D002316 Cardiotonic Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D010726 Phosphodiesterase Inhibitors
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D019141 Respiratory System Agents
MeSH PA D020011 Protective Agents
MeSH PA D058915 Purinergic P1 Receptor Antagonists
MeSH PA D014665 Vasodilator Agents
FDA EPC N0000175790 Methylxanthine
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:49103 drug metabolite
CHEBI has role CHEBI:49167 anti-asthmatic drug
CHEBI has role CHEBI:50218 EC 3.1.4.* (phosphoric diester hydrolase) inhibitor
CHEBI has role CHEBI:50846 immunomodulator
CHEBI has role CHEBI:51371 muscle relaxant
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:71232 adenosine receptor antagonist
CHEBI has role CHEBI:76946 fungal metabolite
CHEBI has role CHEBI:85234 human blood serum metabolite

Related Drugs by ATC class:

R03DA Xanthines 9 drugs
acefyllinebamifyllinebufyllinecholine theophyllinatediprophyllinedoxofyllineetamiphyllineproxyphyllinetheobromine
R03DB Xanthines and adrenergics 4 drugs
choline theophyllinatediprophyllineetamiphyllineproxyphylline

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

DiseaseRelationSNOMED_IDDOID
Bronchospasm indication 4386001
Disorder of lung indication 19829001 DOID:850
Bronchitis indication 32398004 DOID:6132
Pulmonary emphysema indication 87433001
Asthma indication 195967001 DOID:2841
Asthma night-time symptoms indication 395022009
Asthma management indication 406162001
Acute exacerbation of asthma indication 708038006
Asthma-chronic obstructive pulmonary disease overlap syndrome indication 10692761000119107
COPD Associated with Chronic Bronchitis indication
Chronic Obstructive Pulmonary Disease with Bronchospasms indication
Apnea in the newborn off-label use 13094009
Neonatal Mixed Apnea off-label use
Goiter contraindication 3716002 DOID:12176
Tachyarrhythmia contraindication 6285003
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Hyperammonemia contraindication 9360008
Peptic ulcer contraindication 13200003 DOID:750
Hepatic encephalopathy contraindication 13920009 DOID:13413
Hyperkalemia contraindication 14140009
Pulmonary edema contraindication 19242006 DOID:11396
Hashimoto thyroiditis contraindication 21983002
Myocardial infarction contraindication 22298006 DOID:5844
Acute tuberculosis contraindication 25629007
Shock contraindication 27942005
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Acute hepatitis contraindication 37871000
Hypertensive disorder contraindication 38341003 DOID:10763
Hypothyroidism contraindication 40930008 DOID:1459
Third trimester pregnancy contraindication 41587001
Conduction disorder of the heart contraindication 44808001
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Multiple organ failure contraindication 57653000
Hepatic failure contraindication 59927004
Poisoning by phenobarbital contraindication 64921004
Substance abuse contraindication 66214007
Psychotic disorder contraindication 69322001
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Sleep apnea contraindication 73430006 DOID:0050847
Chronic idiopathic constipation contraindication 82934008
Cor pulmonale contraindication 83291003 DOID:8515
Open-angle glaucoma contraindication 84494001 DOID:1067
Kidney disease contraindication 90708001 DOID:557
Dermatitis herpetiformis contraindication 111196000 DOID:8505
Seizure disorder contraindication 128613002
Cystic fibrosis contraindication 190905008 DOID:1485
Angina pectoris contraindication 194828000
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Sepsis syndrome contraindication 238150007
Hypocomplementemic urticarial vasculitis contraindication 239945009
Benign prostatic hyperplasia contraindication 266569009
Dyspnea contraindication 267036007
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Continuous fever contraindication 271751000
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Smoking cessation assistance contraindication 384742004
Angle-closure glaucoma contraindication 392291006 DOID:13550
Breastfeeding (mother) contraindication 413712001
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Porphyria contraindication 418470004
Hypertensive urgency contraindication 443482000
Smokes tobacco daily contraindication 449868002
Severe Hypoxemia contraindication
Theophylline Toxicity contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.46 acidic
pKa2 3.01 Basic

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
cGMP-inhibited 3',5'-cyclic phosphodiesterase A Enzyme INHIBITOR Ki 3.85 WOMBAT-PK CHEMBL
cAMP-specific 3',5'-cyclic phosphodiesterase 4A Enzyme INHIBITOR Ki 4.11 WOMBAT-PK CHEMBL
Adenosine receptor A1 GPCR ANTAGONIST Ki 9.22 CHEMBL CHEMBL
Adenosine receptor A2b GPCR ANTAGONIST Ki 5.57 CHEMBL CHEMBL
Adenosine receptor A2a GPCR ANTAGONIST Ki 9.22 CHEMBL CHEMBL
Transmembrane domain-containing protein TMIGD3 Membrane other Ki 4.06 CHEMBL
Adenosine receptor A3 GPCR ANTAGONIST Ki 7.85 CHEMBL
Alkaline phosphatase, tissue-nonspecific isozyme Enzyme Ki 4.09 CHEMBL
Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform Kinase IC50 4.12 CHEMBL
Adenosine receptor A2a GPCR Ki 5.17 CHEMBL
Uncharacterized protein Enzyme Ki 4.11 CHEMBL
Adenosine receptor A3 GPCR Ki 4.07 CHEMBL
Adenosine receptor A1 GPCR Ki 5.42 CHEMBL
Adenosine receptor A1 GPCR Ki 5.01 CHEMBL
Adenosine A2 receptor GPCR Ki 5.88 CHEMBL
Adenosine A2b receptor GPCR Ki 4.82 CHEMBL
Adenosine receptor GPCR Ki 4.70 CHEMBL
Heart phosphodiesterase Enzyme IC50 4.04 CHEMBL
Adenosine A2a receptor GPCR Ki 4.89 CHEMBL
Adenosine receptor A2b GPCR ANTAGONIST Ki 5.25 IUPHAR
Adenosine receptor A1 GPCR Ki 6.15 CHEMBL

External reference:

IDSource
4018056 VUID
N0000146397 NUI
D00227 KEGG_DRUG
317-34-0 SECONDARY_CAS_RN
5897-66-5 SECONDARY_CAS_RN
4018055 VANDF
4018056 VANDF
4018129 VANDF
4018130 VANDF
4018132 VANDF
C0039771 UMLSCUI
CHEBI:28177 CHEBI
TEP PDB_CHEM_ID
CHEMBL1355736 ChEMBL_ID
DB00277 DRUGBANK_ID
CHEMBL1370561 ChEMBL_ID
CHEMBL190 ChEMBL_ID
CHEMBL1200578 ChEMBL_ID
D013806 MESH_DESCRIPTOR_UI
2153 PUBCHEM_CID
413 IUPHAR_LIGAND_ID
8000-10-0 SECONDARY_CAS_RN
C137DTR5RG UNII
DB01223 DRUGBANK_ID
10438 RXNORM
2086 MMSL
3058 MMSL
4172 MMSL
4173 MMSL
4175 MMSL
5563 MMSL
5564 MMSL
674 MMSL
72114 MMSL
72147 MMSL
d00142 MMSL
d00758 MMSL
000602 NDDF
000603 NDDF
000607 NDDF
000608 NDDF
111131008 SNOMEDCT_US
372810006 SNOMEDCT_US
373508009 SNOMEDCT_US
387431001 SNOMEDCT_US
45940009 SNOMEDCT_US
517701000202103 SNOMEDCT_US
55867006 SNOMEDCT_US
66493003 SNOMEDCT_US
D000628 MESH_DESCRIPTOR_UI
D031210 MESH_DESCRIPTOR_UI
376 INN_ID
5967-84-0 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
THEOPHYLLINE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0820 SOLUTION 80 mg ORAL ANDA 25 sections
THEOPHYLLINE HUMAN PRESCRIPTION DRUG LABEL 1 0121-4820 SOLUTION 80 mg ORAL ANDA 25 sections
Aminophylline HUMAN PRESCRIPTION DRUG LABEL 1 0404-9813 INJECTION, SOLUTION 25 mg INTRAVENOUS ANDA 12 sections
Aminophylline HUMAN PRESCRIPTION DRUG LABEL 1 0404-9813 INJECTION, SOLUTION 25 mg INTRAVENOUS ANDA 12 sections
Aminophylline HUMAN PRESCRIPTION DRUG LABEL 1 0404-9814 INJECTION, SOLUTION 25 mg INTRAVENOUS ANDA 12 sections
Aminophylline HUMAN PRESCRIPTION DRUG LABEL 1 0404-9814 INJECTION, SOLUTION 25 mg INTRAVENOUS ANDA 12 sections
Aminophylline HUMAN PRESCRIPTION DRUG LABEL 1 0409-5921 INJECTION, SOLUTION 25 mg INTRAVENOUS ANDA 22 sections
Aminophylline HUMAN PRESCRIPTION DRUG LABEL 1 0409-5922 INJECTION, SOLUTION 25 mg INTRAVENOUS ANDA 22 sections
Theophylline HUMAN PRESCRIPTION DRUG LABEL 1 0480-3309 TABLET, EXTENDED RELEASE 450 mg ORAL ANDA 22 sections
Theophylline HUMAN PRESCRIPTION DRUG LABEL 1 0480-3310 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 22 sections
Theophylline HUMAN PRESCRIPTION DRUG LABEL 1 10135-604 SOLUTION 80 mg ORAL ANDA 22 sections
Theophylline HUMAN PRESCRIPTION DRUG LABEL 1 17856-0038 SOLUTION 80 mg ORAL ANDA 13 sections
ELIXOPHYLLIN Human Prescription Drug Label 1 17856-0644 LIQUID 80 mg ORAL ANDA 21 sections
Theophylline HUMAN PRESCRIPTION DRUG LABEL 1 23155-741 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 12 sections
Theophylline HUMAN PRESCRIPTION DRUG LABEL 1 23155-742 TABLET, EXTENDED RELEASE 450 mg ORAL ANDA 12 sections
Theophylline Human Prescription Drug Label 1 27241-272 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 20 sections
Theophylline Human Prescription Drug Label 1 27241-273 TABLET, EXTENDED RELEASE 450 mg ORAL ANDA 20 sections
Theophylline HUMAN PRESCRIPTION DRUG LABEL 1 27808-033 SOLUTION 80 mg ORAL ANDA 13 sections
Theophylline(Anhydrous) HUMAN PRESCRIPTION DRUG LABEL 1 29033-001 TABLET, EXTENDED RELEASE 400 mg ORAL ANDA 22 sections
Theophylline(Anhydrous) HUMAN PRESCRIPTION DRUG LABEL 1 29033-002 TABLET, EXTENDED RELEASE 600 mg ORAL ANDA 22 sections
Theophylline Human Prescription Drug Label 1 29033-057 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 21 sections
Theophylline Human Prescription Drug Label 1 29033-058 TABLET, EXTENDED RELEASE 200 mg ORAL ANDA 21 sections
Theophylline Human Prescription Drug Label 1 29033-059 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 21 sections
Theophylline Human Prescription Drug Label 1 29033-060 TABLET, EXTENDED RELEASE 450 mg ORAL ANDA 21 sections
Theophylline HUMAN PRESCRIPTION DRUG LABEL 1 31722-077 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 19 sections
Theophylline HUMAN PRESCRIPTION DRUG LABEL 1 31722-078 TABLET, EXTENDED RELEASE 450 mg ORAL ANDA 19 sections
Theophylline HUMAN PRESCRIPTION DRUG LABEL 1 42291-922 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 12 sections
Theophylline Human Prescription Drug Label 1 46708-025 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 21 sections
Theophylline Human Prescription Drug Label 1 46708-026 TABLET, EXTENDED RELEASE 450 mg ORAL ANDA 21 sections
Theophylline(Anhydrous) HUMAN PRESCRIPTION DRUG LABEL 1 51407-318 TABLET, EXTENDED RELEASE 400 mg ORAL ANDA 22 sections