trimethoprim ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antibacterials, dihydrofolate reductase (DHFR) inhibitors, trimethoprim derivatives 2755 738-70-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • trimethoprim
  • trimethoprim sulfate
  • trimethoprim hydrochloride
  • trimethioprim
  • trimetoprim
  • trimopan
  • trimethoprim HCl
A pyrimidine inhibitor of dihydrofolate reductase, it is an antibacterial related to PYRIMETHAMINE. It is potentiated by SULFONAMIDES and the TRIMETHOPRIM, SULFAMETHOXAZOLE DRUG COMBINATION is the form most often used. It is sometimes used alone as an antimalarial. TRIMETHOPRIM RESISTANCE has been reported.
  • Molecular weight: 290.32
  • Formula: C14H18N4O3
  • CLOGP: 1.08
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 105.51
  • ALOGS: -2.67
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.40 g O
0.40 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1.37 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 70 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 15.75 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 98 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.50 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9.60 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
July 30, 1973 FDA MUTUAL PHARM

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
Drug ineffective 177.32 10.45 252 41481 819081 49744310
Soft tissue disorder 174.46 10.45 80 41653 4134 50559257
Acute kidney injury 174.21 10.45 496 41237 227562 50335829
Liver function test abnormal 123.42 10.45 167 41566 44172 50519219
Leukopenia 107.82 10.45 197 41536 67331 50496060
Pre-engraftment immune reaction 101.25 10.45 26 41707 212 50563179
Pneumonia viral 99.62 10.45 65 41668 6769 50556622
Pancytopenia 99.12 10.45 216 41517 83814 50479577
Off label use 93.41 10.45 155 41578 474271 50089120
Hyperkalaemia 93.38 10.45 153 41580 47936 50515455
Pyrexia 91.78 10.45 581 41152 379622 50183769
Stevens-Johnson syndrome 88.13 10.45 99 41634 21653 50541738
Encephalitis viral 77.86 10.45 34 41699 1563 50561828
Product dose omission issue 71.58 10.45 31 41702 183807 50379584
Hyponatraemia 71.14 10.45 207 41526 95932 50467459
Cytomegalovirus infection 68.10 10.45 79 41654 17883 50545508
Completed suicide 66.17 10.45 14 41719 131875 50431516
Lip swelling 65.54 10.45 91 41642 24645 50538746
Human herpesvirus 6 infection 64.82 10.45 35 41698 2571 50560820
Abdominal discomfort 64.11 10.45 58 41675 231583 50331808
Systemic lupus erythematosus 62.71 10.45 19 41714 140603 50422788
Swelling face 60.62 10.45 134 41599 52461 50510930
Fatigue 60.60 10.45 340 41393 707261 49856130
Alopecia 60.24 10.45 68 41665 244979 50318412
Toxic epidermal necrolysis 58.29 10.45 79 41654 20913 50542478
Injection site pain 55.25 10.45 12 41721 111012 50452379
International normalised ratio increased 54.38 10.45 114 41619 43038 50520353
Pemphigus 54.01 10.45 16 41717 120150 50443241
Product use issue 53.88 10.45 28 41705 149447 50413944
Infusion related reaction 53.77 10.45 37 41696 169520 50393871
Maternal exposure during pregnancy 50.48 10.45 35 41698 159743 50403648
Confusional state 49.66 10.45 292 41441 185636 50377755
Kidney transplant rejection 48.73 10.45 34 41699 3953 50559438
Rheumatoid arthritis 47.83 10.45 58 41675 202492 50360899
Thrombocytopenia 47.57 10.45 220 41513 127453 50435938
Mouth swelling 46.94 10.45 33 41700 3883 50559508
Fibromyalgia 46.73 10.45 110 41623 44868 50518523
Arthropathy 45.52 10.45 38 41695 157868 50405523
Rash maculo-papular 45.40 10.45 80 41653 26561 50536830
Superinfection 43.97 10.45 25 41708 2031 50561360
Nasopharyngitis 43.72 10.45 57 41676 192870 50370521
Glossodynia 42.61 10.45 21 41712 115548 50447843
Treatment failure 42.35 10.45 31 41702 137606 50425785
Pain 42.27 10.45 292 41441 578611 49984780
Drug reaction with eosinophilia and systemic symptoms 41.68 10.45 80 41653 28344 50535047
Drug interaction 41.32 10.45 294 41439 199327 50364064
Urosepsis 41.12 10.45 57 41676 15408 50547983
Fear of eating 41.03 10.45 14 41719 326 50563065
Renal failure 40.64 10.45 185 41548 106448 50456943
Death 40.12 10.45 136 41597 325243 50238148
Hepatic cytolysis 40.08 10.45 41 41692 8062 50555329
Blood creatinine increased 40.05 10.45 146 41587 76014 50487377
Agranulocytosis 40.01 10.45 67 41666 21354 50542037
Platelet count decreased 39.32 10.45 176 41557 100550 50462841
Anaemia 39.21 10.45 348 41385 252108 50311283
Ejection fraction decreased 38.77 10.45 61 41672 18459 50544932
Deep vein thrombosis 38.10 10.45 140 41593 73164 50490227
Intentional product use issue 36.89 10.45 9 41724 76909 50486482
Blood cholesterol increased 36.21 10.45 114 41619 55101 50508290
Hypophagia 35.80 10.45 74 41659 27654 50535737
Psoriasis 35.27 10.45 7 41726 68993 50494398
Intentional overdose 34.91 10.45 5 41728 62499 50500892
Rash erythematous 34.87 10.45 84 41649 34768 50528623
Pneumocystis jirovecii pneumonia 34.51 10.45 51 41682 14612 50548779
Drug intolerance 34.02 10.45 82 41651 219022 50344369
Blood pressure increased 33.71 10.45 36 41697 133096 50430295
Oral pain 32.55 10.45 67 41666 24966 50538425
Injection site erythema 31.84 10.45 11 41722 74925 50488466
Bone marrow failure 31.39 10.45 70 41663 27554 50535837
Discomfort 31.32 10.45 26 41707 108354 50455037
Bacterial sepsis 31.17 10.45 25 41708 3587 50559804
Transplant rejection 31.09 10.45 39 41694 9570 50553821
Contraindicated product administered 30.76 10.45 47 41686 148911 50414480
Injection site reaction 30.41 10.45 3 41730 50029 50513362
Complications of transplanted kidney 30.04 10.45 20 41713 2153 50561238
Tenderness 29.39 10.45 54 41679 18511 50544880
Wound 28.62 10.45 27 41706 105767 50457624
Herpes zoster 28.61 10.45 125 41608 70661 50492730
Documented hypersensitivity to administered product 28.57 10.45 12 41721 501 50562890
Muscle twitching 28.47 10.45 48 41685 15383 50548008
Parkinsonian rest tremor 28.30 10.45 8 41725 97 50563294
HIV infection 27.78 10.45 10 41723 274 50563117
Ureteric obstruction 27.50 10.45 17 41716 1611 50561780
Neutropenic sepsis 27.43 10.45 45 41688 14102 50549289
Cholecystitis chronic 26.25 10.45 36 41697 9633 50553758
Abdominal pain 26.23 10.45 304 41429 235924 50327467
Neutropenia 26.12 10.45 210 41523 147755 50415636
Vomiting 25.95 10.45 528 41205 460230 50103161
Photophobia 25.74 10.45 45 41688 14842 50548549
Meningoencephalitis herpetic 25.56 10.45 14 41719 1058 50562333
Arthralgia 25.15 10.45 236 41497 438466 50124925
Tubulointerstitial nephritis 25.04 10.45 45 41688 15166 50548225
Suicide attempt 24.91 10.45 6 41727 51726 50511665
Synovial fluid analysis 24.90 10.45 16 41717 1622 50561769
Fall 24.82 10.45 168 41565 334764 50228627
Blindness cortical 24.30 10.45 10 41723 396 50562995
Urinary tract infection 23.86 10.45 286 41447 223734 50339657
Wrong technique in product usage process 23.84 10.45 8 41725 55502 50507889
Pericarditis 23.84 10.45 18 41715 78671 50484720
Sinusitis 23.30 10.45 68 41665 170490 50392901
Conjunctivitis 23.13 10.45 45 41688 16100 50547291
Multiple organ dysfunction syndrome 22.76 10.45 92 41641 50245 50513146
Tenosynovitis stenosans 22.69 10.45 17 41716 2207 50561184
Inappropriate schedule of product administration 22.32 10.45 16 41717 71815 50491576
Pulmonary embolism 22.30 10.45 152 41581 101552 50461839
Hand deformity 22.27 10.45 30 41703 100169 50463222
Renal tubular necrosis 21.99 10.45 34 41699 10134 50553257
Pregnancy with injectable contraceptive 21.90 10.45 7 41726 132 50563259
Drug abuse 21.86 10.45 11 41722 59835 50503556
Hepatitis fulminant 21.84 10.45 19 41714 3049 50560342
Cholelithiasis 21.84 10.45 75 41658 37898 50525493
Weight increased 21.82 10.45 89 41644 201802 50361589
Infection 21.67 10.45 228 41505 172726 50390665
Anti-cyclic citrullinated peptide antibody positive 21.57 10.45 16 41717 70571 50492820
Body mass index decreased 21.53 10.45 9 41724 371 50563020
Dehydration 21.52 10.45 206 41527 152243 50411148
Renal tubular disorder 21.31 10.45 17 41716 2420 50560971
Pseudomonas infection 21.05 10.45 32 41701 9398 50553993
Septic shock 20.88 10.45 98 41635 57077 50506314
Acquired immunodeficiency syndrome 20.70 10.45 6 41727 80 50563311
Seizure 20.64 10.45 167 41566 117707 50445684
Inappropriate antidiuretic hormone secretion 20.52 10.45 38 41695 13105 50550286
Oral candidiasis 20.51 10.45 44 41689 16871 50546520
Cystitis noninfective 20.43 10.45 11 41722 803 50562588
Injection site bruising 20.39 10.45 3 41730 36765 50526626
Bronchopulmonary aspergillosis 20.21 10.45 28 41705 7564 50555827
Foaming at mouth 19.88 10.45 12 41721 1090 50562301
Vulvovaginal candidiasis 19.83 10.45 17 41716 2675 50560716
Blood pressure fluctuation 19.69 10.45 3 41730 35820 50527571
Clostridial infection 19.39 10.45 20 41713 3970 50559421
Porphyria acute 19.21 10.45 9 41724 488 50562903
Toxicity to various agents 19.21 10.45 100 41633 212399 50350992
Scleritis 19.07 10.45 18 41715 3209 50560182
Lethargy 18.99 10.45 86 41647 49346 50514045
Pleuritic pain 18.96 10.45 25 41708 6441 50556950
Immune reconstitution inflammatory syndrome 18.83 10.45 23 41710 5493 50557898
Hospitalisation 18.77 10.45 17 41716 67920 50495471
Urine output decreased 18.67 10.45 32 41701 10389 50553002
Soft tissue swelling 18.57 10.45 11 41722 965 50562426
Aplasia pure red cell 18.48 10.45 20 41713 4195 50559196
Bacterial test positive 18.28 10.45 21 41712 4702 50558689
Alanine aminotransferase increased 18.16 10.45 130 41603 88229 50475162
Libido disorder 18.13 10.45 5 41728 55 50563336
Effusion 18.04 10.45 13 41720 1590 50561801
Injection site swelling 17.97 10.45 6 41727 41767 50521624
COVID-19 17.93 10.45 8 41725 46654 50516737
Trimethylaminuria 17.90 10.45 6 41727 132 50563259
Febrile bone marrow aplasia 17.89 10.45 24 41709 6287 50557104
Immunosuppressant drug level increased 17.85 10.45 17 41716 3065 50560326
Chemotherapeutic drug level increased 17.78 10.45 6 41727 135 50563256
Influenza 17.76 10.45 29 41704 89509 50473882
Knee arthroplasty 17.57 10.45 4 41729 35842 50527549
Arthritis 17.48 10.45 127 41606 86594 50476797
Pruritus genital 17.24 10.45 9 41724 617 50562774
Breast cancer 17.04 10.45 7 41726 42883 50520508
Meningitis aseptic 16.99 10.45 19 41714 4133 50559258
Cogwheel rigidity 16.84 10.45 13 41720 1764 50561627
Dermatitis exfoliative 16.84 10.45 21 41712 5121 50558270
Pustule 16.67 10.45 11 41722 1167 50562224
Physical assault 16.67 10.45 10 41723 898 50562493
Angiodermatitis 16.65 10.45 5 41728 76 50563315
Potentiating drug interaction 16.54 10.45 18 41715 3798 50559593
Blood alkaline phosphatase increased 16.50 10.45 68 41665 37458 50525933
Blood culture positive 16.41 10.45 19 41714 4289 50559102
Musculoskeletal stiffness 16.28 10.45 53 41680 128428 50434963
Adverse drug reaction 16.26 10.45 13 41720 55209 50508182
Aspartate aminotransferase increased 16.17 10.45 115 41618 77883 50485508
Mental status changes 16.16 10.45 66 41667 36206 50527185
Neutrophil count decreased 16.16 10.45 78 41655 45948 50517443
Palmar erythema 16.06 10.45 12 41721 1551 50561840
Antinuclear antibody 16.05 10.45 8 41725 498 50562893
Vestibular disorder 15.92 10.45 11 41722 1258 50562133
Ill-defined disorder 15.92 10.45 13 41720 54641 50508750
Jaundice 15.90 10.45 53 41680 26376 50537015
Oliguria 15.74 10.45 26 41707 8190 50555201
Purpura senile 15.71 10.45 8 41725 521 50562870
Subdural haemorrhage 15.61 10.45 15 41718 2734 50560657
Sepsis 15.60 10.45 173 41560 132752 50430639
Tarsal tunnel syndrome 15.57 10.45 8 41725 531 50562860
Loss of personal independence in daily activities 15.54 10.45 21 41712 70029 50493362
Citrobacter infection 15.53 10.45 7 41726 347 50563044
Lung transplant rejection 15.51 10.45 9 41724 760 50562631
Pseudomembranous colitis 15.45 10.45 15 41718 2770 50560621
Allergy to chemicals 15.44 10.45 11 41722 1321 50562070
Hepatitis 15.44 10.45 59 41674 31394 50531997
Hepatic failure 15.39 10.45 60 41673 32223 50531168
Therapeutic product effect decreased 15.31 10.45 59 41674 135991 50427400
Hepatic enzyme increased 15.19 10.45 60 41673 137320 50426071
Acute respiratory distress syndrome 15.17 10.45 45 41688 21054 50542337
Hypovolaemic shock 15.12 10.45 20 41713 5168 50558223
Intentional product misuse 15.06 10.45 10 41723 46724 50516667
Hydronephrosis 15.00 10.45 26 41707 8515 50554876
Fluid retention 14.81 10.45 12 41721 50637 50512754
Adverse event 14.60 10.45 9 41724 43754 50519637
Device expulsion 14.57 10.45 3 41730 28819 50534572
Tonsillar hypertrophy 14.52 10.45 9 41724 857 50562534
Human herpesvirus 6 infection reactivation 14.43 10.45 5 41728 122 50563269
Genital burning sensation 14.41 10.45 6 41727 245 50563146
Pain in extremity 14.26 10.45 150 41583 272715 50290676
White blood cell count decreased 14.20 10.45 153 41580 116569 50446822
No adverse event 14.14 10.45 5 41728 33573 50529818
Rash pruritic 13.96 10.45 77 41656 47769 50515622
Headache 13.95 10.45 315 41418 506220 50057171
Osteoporosis 13.93 10.45 10 41723 44869 50518522
Genital ulceration 13.89 10.45 7 41726 446 50562945
Hip arthroplasty 13.75 10.45 4 41729 30425 50532966
Blood pressure systolic increased 13.74 10.45 6 41727 35443 50527948
Disseminated intravascular coagulation 13.73 10.45 38 41695 17097 50546294
Areflexia 13.63 10.45 14 41719 2766 50560625
Rash 13.41 10.45 463 41270 437008 50126383
Unevaluable event 13.37 10.45 11 41722 46055 50517336
Rectal haemorrhage 13.29 10.45 65 41668 38493 50524898
Blood sodium decreased 13.25 10.45 43 41690 21104 50542287
Plasma cell myeloma 13.17 10.45 56 41677 31266 50532125
Atelectasis 13.17 10.45 39 41694 18231 50545160
Dialysis 13.15 10.45 26 41707 9412 50553979
Haemorrhoids 13.10 10.45 40 41693 19013 50544378
Altered visual depth perception 13.08 10.45 6 41727 310 50563081
Red blood cell sedimentation rate increased 13.05 10.45 4 41729 29412 50533979
Muscle haemorrhage 12.90 10.45 14 41719 2944 50560447
Hiccups 12.85 10.45 11 41722 1728 50561663
Tremor 12.78 10.45 148 41585 114755 50448636
HIV wasting syndrome 12.78 10.45 3 41730 16 50563375
Nasal congestion 12.73 10.45 14 41719 51106 50512285
Axillary vein thrombosis 12.66 10.45 6 41727 334 50563057
Mucosal inflammation 12.66 10.45 66 41667 40076 50523315
Cytomegalovirus test positive 12.61 10.45 13 41720 2579 50560812
Condition aggravated 12.57 10.45 171 41562 296887 50266504
Lip ulceration 12.49 10.45 11 41722 1794 50561597
Ocular hyperaemia 12.48 10.45 41 41692 20251 50543140
Haemoglobin decreased 12.48 10.45 160 41573 127056 50436335
Graft versus host disease 12.48 10.45 20 41713 6146 50557245
Blood lactate dehydrogenase increased 12.46 10.45 40 41693 19522 50543869
Left ventricular dysfunction 12.36 10.45 27 41706 10479 50552912
Crepitations 12.35 10.45 20 41713 6199 50557192
Drug hypersensitivity 12.26 10.45 282 41451 250728 50312663
Vaginal ulceration 12.18 10.45 6 41727 364 50563027
Blood folate decreased 12.12 10.45 7 41726 586 50562805
Fluorosis 12.08 10.45 3 41730 21 50563370
Dermatitis allergic 12.02 10.45 30 41703 12690 50550701
Pleural effusion 11.95 10.45 111 41622 81343 50482048
Renal tubular acidosis 11.94 10.45 10 41723 1524 50561867
Hypersensitivity pneumonitis 11.94 10.45 12 41721 2310 50561081
Swollen tongue 11.90 10.45 51 41682 28579 50534812
Cushing's syndrome 11.54 10.45 7 41726 641 50562750
Excessive eye blinking 11.40 10.45 8 41725 938 50562453
Leukoencephalopathy 11.37 10.45 15 41718 3868 50559523
Petechiae 11.29 10.45 29 41704 12483 50550908
Clostridium difficile infection 11.10 10.45 46 41687 25393 50537998
Refusal of treatment by patient 11.07 10.45 17 41716 5036 50558355
Lung infiltration 11.03 10.45 30 41703 13363 50550028
Rash macular 11.02 10.45 38 41695 19239 50544152
Abscess rupture 10.94 10.45 5 41728 256 50563135
Liver transplant 10.93 10.45 11 41722 2121 50561270
Defaecation urgency 10.93 10.45 13 41720 3020 50560371
Resorption bone increased 10.92 10.45 8 41725 1003 50562388
Enterococcal infection 10.84 10.45 20 41713 6878 50556513
Unresponsive to stimuli 10.83 10.45 52 41681 30557 50532834
Product use in unapproved indication 10.74 10.45 54 41679 115765 50447626
Acute febrile neutrophilic dermatosis 10.65 10.45 12 41721 2630 50560761
Memory impairment 10.56 10.45 32 41701 79328 50484063
Asthma 10.53 10.45 38 41695 89299 50474092
Intentional self-injury 10.52 10.45 3 41730 23109 50540282
Arteritis 10.46 10.45 6 41727 496 50562895

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
Hyperkalaemia 154.42 11.18 272 35774 61120 29477361
Off label use 145.72 11.18 94 35952 300706 29237775
Drug ineffective 138.18 11.18 144 35902 363026 29175455
Pyrexia 137.77 11.18 702 35344 286920 29251561
Acute kidney injury 121.74 11.18 640 35406 264627 29273854
Death 98.02 11.18 167 35879 341917 29196564
Neutropenia 88.60 11.18 356 35690 131355 29407126
Stevens-Johnson syndrome 87.11 11.18 104 35942 16393 29522088
Blood creatinine increased 85.78 11.18 263 35783 84839 29453642
Immune reconstitution inflammatory syndrome 83.32 11.18 72 35974 7730 29530751
Pancytopenia 81.94 11.18 255 35791 82913 29455568
Cytomegalovirus infection 78.91 11.18 118 35928 23097 29515384
Completed suicide 78.61 11.18 9 36037 90237 29448244
Product dose omission issue 78.25 11.18 12 36034 96371 29442110
Hepatic cytolysis 77.17 11.18 71 35975 8276 29530205
Transplant rejection 65.75 11.18 68 35978 9144 29529337
Kidney transplant rejection 48.72 11.18 51 35995 6954 29531527
Agranulocytosis 48.33 11.18 88 35958 20252 29518229
Product use issue 47.74 11.18 4 36042 51440 29487041
Fatigue 45.07 11.18 216 35830 316605 29221876
Pneumocystis jirovecii pneumonia 42.95 11.18 75 35971 16704 29521777
Renal tubular necrosis 41.98 11.18 68 35978 14247 29524234
Leukopenia 41.74 11.18 155 35891 55048 29483433
Aspartate aminotransferase increased 41.30 11.18 163 35883 59562 29478919
Blood lactate dehydrogenase increased 40.53 11.18 79 35967 19130 29519351
Product use in unapproved indication 39.41 11.18 29 36017 86846 29451635
Pre-engraftment immune reaction 38.76 11.18 11 36035 88 29538393
Hepatitis 37.37 11.18 80 35966 20703 29517778
Cholestasis 37.34 11.18 86 35960 23376 29515105
Haemodialysis 37.30 11.18 53 35993 9901 29528580
Blood bilirubin increased 37.16 11.18 108 35938 33785 29504696
Alanine aminotransferase increased 37.10 11.18 178 35868 70766 29467715
Lymphocyte count decreased 36.77 11.18 76 35970 19195 29519286
Hospitalisation 36.68 11.18 6 36040 45982 29492499
Thrombocytopenia 36.46 11.18 285 35761 134538 29403943
Intentional product use issue 35.14 11.18 5 36041 42493 29495988
Inappropriate schedule of product administration 35.03 11.18 6 36040 44466 29494015
Osteoporotic fracture 31.84 11.18 18 36028 973 29537508
Blood urea increased 31.22 11.18 90 35956 28022 29510459
Rash maculo-papular 30.17 11.18 81 35965 24208 29514273
Rash 29.88 11.18 358 35688 189461 29349020
Toxicity to various agents 29.81 11.18 110 35936 173551 29364930
Aplasia pure red cell 29.61 11.18 35 36011 5456 29533025
Toxic skin eruption 29.50 11.18 47 35999 9710 29528771
Peripheral swelling 29.26 11.18 21 36025 63718 29474763
Cellulitis enterococcal 28.30 11.18 8 36038 63 29538418
Weight increased 28.29 11.18 31 36015 76636 29461845
Fall 28.00 11.18 116 35930 177062 29361419
Cerebrovascular accident 27.40 11.18 32 36014 76879 29461602
Encephalitis viral 27.08 11.18 17 36029 1115 29537366
Liver transplant rejection 26.91 11.18 21 36025 1953 29536528
HIV infection 26.42 11.18 17 36029 1164 29537317
Hepatitis cholestatic 26.27 11.18 37 36009 6856 29531625
Blood antidiuretic hormone increased 25.48 11.18 7 36039 49 29538432
Aspergillus infection 25.41 11.18 46 36000 10535 29527946
Dialysis 25.31 11.18 45 36001 10163 29528318
Tubulointerstitial nephritis 25.18 11.18 62 35984 17581 29520900
Pneumonia cytomegaloviral 25.15 11.18 23 36023 2659 29535822
Blood alkaline phosphatase increased 25.11 11.18 84 35962 28322 29510159
Drug reaction with eosinophilia and systemic symptoms 24.94 11.18 83 35963 27909 29510572
Intentional overdose 24.82 11.18 8 36038 38520 29499961
Rash morbilliform 24.60 11.18 22 36024 2471 29536010
Intentional product misuse 24.55 11.18 6 36040 34655 29503826
Therapeutic product effect incomplete 23.88 11.18 9 36037 39296 29499185
Blood potassium increased 23.63 11.18 54 35992 14597 29523884
Kaposi's sarcoma 23.31 11.18 14 36032 848 29537633
Graft versus host disease 23.30 11.18 42 36004 9586 29528895
Acquired immunodeficiency syndrome 23.08 11.18 11 36035 416 29538065
Liver function test abnormal 22.52 11.18 82 35964 28836 29509645
Renal failure 22.42 11.18 232 35814 118367 29420114
Hepatosplenomegaly 22.24 11.18 25 36021 3692 29534789
Lymphocele 22.24 11.18 16 36030 1316 29537165
Jaundice 21.91 11.18 82 35964 29214 29509267
Foetal exposure during pregnancy 21.87 11.18 7 36039 33860 29504621
Renal papillary necrosis 21.86 11.18 8 36038 153 29538328
Asthma 21.86 11.18 7 36039 33842 29504639
Culture urine positive 21.81 11.18 15 36031 1148 29537333
Bone marrow failure 21.51 11.18 78 35968 27371 29511110
Platelet count decreased 21.34 11.18 208 35838 104464 29434017
Neutrophil count decreased 21.11 11.18 107 35939 43460 29495021
Leukaemia recurrent 20.76 11.18 16 36030 1461 29537020
Motion sickness 20.61 11.18 8 36038 181 29538300
Hepatomegaly 20.49 11.18 39 36007 9278 29529203
Injection site pain 20.44 11.18 7 36039 32439 29506042
White blood cell count decreased 20.22 11.18 172 35874 83190 29455291
Nasopharyngitis 20.01 11.18 26 36020 59639 29478842
Human herpesvirus 6 infection 19.50 11.18 17 36029 1846 29536635
Wrong technique in product usage process 19.42 11.18 7 36039 31421 29507060
Mental status changes 19.24 11.18 89 35957 34838 29503643
Therapeutic product effect decreased 19.18 11.18 6 36040 29445 29509036
Dyspnoea 19.09 11.18 282 35764 326450 29212031
Myocardial infarction 18.81 11.18 70 35976 110226 29428255
Plasma cell myeloma 18.58 11.18 92 35954 37023 29501458
Treatment failure 18.54 11.18 11 36035 36928 29501553
Gamma-glutamyltransferase increased 18.49 11.18 73 35973 26664 29511817
Biopsy liver abnormal 18.48 11.18 7 36039 148 29538333
Joint swelling 18.38 11.18 20 36026 49610 29488871
Enterovirus infection 18.32 11.18 11 36035 666 29537815
Serum sickness 18.26 11.18 16 36030 1749 29536732
Dermatitis exfoliative 18.13 11.18 30 36016 6395 29532086
Lung infiltration 17.45 11.18 42 36004 11737 29526744
Drug intolerance 17.36 11.18 20 36026 48359 29490122
Ureteric obstruction 17.23 11.18 13 36033 1150 29537331
Chills 17.22 11.18 147 35899 71153 29467328
Syncope 17.12 11.18 47 35999 81324 29457157
Oesophageal candidiasis 16.82 11.18 22 36024 3799 29534682
Viral test positive 16.61 11.18 7 36039 197 29538284
Phlebitis 16.38 11.18 21 36025 3555 29534926
Toxic epidermal necrolysis 16.32 11.18 54 35992 18099 29520382
Culture stool positive 16.20 11.18 7 36039 210 29538271
Vena cava injury 16.17 11.18 7 36039 211 29538270
Chronic lymphocytic leukaemia 16.12 11.18 21 36025 3612 29534869
Renal tubular acidosis 16.01 11.18 15 36031 1788 29536693
Suicide attempt 15.96 11.18 11 36035 34099 29504382
Dizziness 15.96 11.18 151 35895 189533 29348948
Hepatic steatosis 15.78 11.18 47 35999 14899 29523582
SARS-CoV-2 antibody test positive 15.72 11.18 7 36039 226 29538255
Rheumatoid arthritis 15.54 11.18 10 36036 32142 29506339
Idiopathic pneumonia syndrome 15.35 11.18 7 36039 239 29538242
Cytomegalovirus chorioretinitis 14.81 11.18 19 36027 3219 29535262
Photosensitivity reaction 14.79 11.18 34 36012 9224 29529257
Complications of transplanted kidney 14.73 11.18 21 36025 3933 29534548
Rectal prolapse 14.71 11.18 7 36039 264 29538217
Lymphadenopathy 14.67 11.18 65 35981 24984 29513497
Erythema infectiosum 14.65 11.18 6 36040 157 29538324
Renal tubular disorder 14.60 11.18 22 36024 4330 29534151
Liver transplant 14.58 11.18 16 36030 2300 29536181
Parkinsonism hyperpyrexia syndrome 14.32 11.18 5 36041 83 29538398
Psoriasis 14.29 11.18 11 36035 32216 29506265
Lymphocytic infiltration 14.26 11.18 9 36037 596 29537885
HIV wasting syndrome 14.05 11.18 5 36041 88 29538393
Haemoglobin decreased 13.89 11.18 197 35849 108178 29430303
Cystic lymphangioma 13.85 11.18 3 36043 6 29538475
Blood culture positive 13.77 11.18 22 36024 4555 29533926
Lymphopenia 13.76 11.18 42 36004 13491 29524990
Dehydration 13.69 11.18 206 35840 114542 29423939
Light chain analysis decreased 13.68 11.18 4 36042 36 29538445
Acute graft versus host disease in skin 13.46 11.18 22 36024 4642 29533839
Proteus infection 13.45 11.18 10 36036 865 29537616
Wound evisceration 13.36 11.18 5 36041 102 29538379
Cytomegalovirus viraemia 13.34 11.18 26 36020 6294 29532187
Hepatitis A antibody positive 13.30 11.18 4 36042 40 29538441
Intraductal papillary mucinous neoplasm 13.20 11.18 7 36039 333 29538148
Peripheral motor neuropathy 13.18 11.18 13 36033 1652 29536829
Granulomatosis with polyangiitis 13.14 11.18 10 36036 896 29537585
Mycobacterium avium complex infection 13.13 11.18 15 36031 2254 29536227
Transplant dysfunction 13.13 11.18 15 36031 2255 29536226
Suprapubic pain 13.01 11.18 7 36039 343 29538138
Cytomegalovirus test 12.96 11.18 4 36042 44 29538437
Acute myocardial infarction 12.57 11.18 25 36021 48413 29490068
Stent removal 12.53 11.18 3 36043 11 29538470
Myositis 12.47 11.18 34 36012 10249 29528232
Rash papular 12.41 11.18 29 36017 7952 29530529
Therapeutic product effect prolonged 12.40 11.18 6 36040 235 29538246
Hepatitis B antibody positive 12.28 11.18 4 36042 53 29538428
Autoimmune haemolytic anaemia 12.27 11.18 19 36027 3829 29534652
Bronchopulmonary aspergillosis 12.26 11.18 38 36008 12306 29526175
Total lung capacity decreased 12.17 11.18 8 36038 568 29537913
Overdose 12.12 11.18 53 35993 79766 29458715
Biliary sepsis 12.12 11.18 8 36038 572 29537909
Renal cyst haemorrhage 12.06 11.18 7 36039 398 29538083
Abdominal wall haemorrhage 12.05 11.18 6 36040 250 29538231
Skin exfoliation 11.95 11.18 57 35989 22588 29515893
Immunosuppressant drug level increased 11.80 11.18 21 36025 4744 29533737
Granulomatous rosacea 11.76 11.18 5 36041 144 29538337
COVID-19 11.76 11.18 16 36030 35998 29502483
Febrile bone marrow aplasia 11.75 11.18 27 36019 7324 29531157
Enterococcal infection 11.74 11.18 29 36017 8239 29530242
Candida infection 11.70 11.18 43 36003 15182 29523299
Acute graft versus host disease in liver 11.63 11.18 11 36035 1327 29537154
Acquired haemophilia 11.56 11.18 9 36037 834 29537647
Hepatitis C virus test 11.48 11.18 4 36042 66 29538415
Laryngeal pain 11.45 11.18 15 36031 2593 29535888
Parvovirus infection 11.39 11.18 7 36039 442 29538039
Epidermal necrosis 11.28 11.18 7 36039 450 29538031
Blood pressure increased 11.21 11.18 49 35997 73754 29464727

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
Acute kidney injury 257.87 10.41 980 60967 448260 63988525
Hyperkalaemia 233.42 10.41 378 61569 100751 64336034
Drug ineffective 207.29 10.41 305 61642 839942 63596843
Off label use 176.96 10.41 209 61738 632597 63804188
Pyrexia 139.48 10.41 965 60982 557679 63879106
Pre-engraftment immune reaction 138.24 10.41 37 61910 304 64436481
Stevens-Johnson syndrome 137.37 10.41 167 61780 34082 64402703
Completed suicide 136.97 10.41 25 61922 224389 64212396
Pancytopenia 117.48 10.41 353 61594 142956 64293829
Product dose omission issue 107.99 10.41 27 61920 194720 64242065
Encephalitis viral 106.57 10.41 50 61897 2330 64434455
Death 103.84 10.41 191 61756 482514 63954271
Blood creatinine increased 94.37 10.41 316 61631 135466 64301319
Drug abuse 91.82 10.41 10 61937 132364 64304421
Cytomegalovirus infection 89.77 10.41 142 61805 37057 64399728
Liver function test abnormal 85.15 10.41 181 61766 59220 64377565
Soft tissue disorder 83.25 10.41 47 61900 3229 64433556
Leukopenia 81.62 10.41 248 61699 100994 64335791
Human herpesvirus 6 infection 80.09 10.41 52 61895 4602 64432183
Immune reconstitution inflammatory syndrome 76.44 10.41 76 61871 12394 64424391
Kidney transplant rejection 75.67 10.41 67 61880 9444 64427341
Fatigue 72.36 10.41 423 61524 748307 63688478
Product use issue 71.64 10.41 28 61919 151687 64285098
Transplant rejection 71.64 10.41 86 61861 17315 64419470
Injection site pain 71.05 10.41 11 61936 111397 64325388
Hyponatraemia 63.10 10.41 296 61651 148043 64288742
Drug reaction with eosinophilia and systemic symptoms 62.98 10.41 152 61795 54065 64382720
Pneumonia viral 60.04 10.41 54 61893 7768 64429017
Lip swelling 60.00 10.41 109 61838 31798 64404987
Neutropenia 56.58 10.41 409 61538 239215 64197570
Thrombocytopenia 55.17 10.41 386 61561 223415 64213370
Swelling face 53.47 10.41 151 61796 59015 64377770
Intentional product use issue 53.26 10.41 13 61934 95351 64341434
Nasopharyngitis 52.20 10.41 67 61880 196006 64240779
International normalised ratio increased 52.11 10.41 181 61766 78986 64357799
Rash 51.53 10.41 669 61278 457880 63978905
Intentional overdose 50.74 10.41 12 61935 89932 64346853
Hepatic cytolysis 50.71 10.41 65 61882 13984 64422801
Toxicity to various agents 49.45 10.41 181 61766 363332 64073453
Renal tubular necrosis 48.71 10.41 81 61866 22029 64414756
Haemodialysis 48.00 10.41 70 61877 17007 64419778
Renal failure 47.51 10.41 318 61629 181370 64255415
Agranulocytosis 47.46 10.41 110 61837 38119 64398666
Toxic epidermal necrolysis 47.31 10.41 108 61839 37058 64399727
Fear of eating 47.20 10.41 17 61930 398 64436387
Tubulointerstitial nephritis 46.39 10.41 96 61851 30813 64405972
Pneumocystis jirovecii pneumonia 45.26 10.41 89 61858 27545 64409240
Wrong technique in product usage process 44.81 10.41 5 61942 64969 64371816
Inappropriate schedule of product administration 43.60 10.41 17 61930 92269 64344516
Rash maculo-papular 43.45 10.41 121 61826 46905 64389880
Infusion related reaction 42.94 10.41 57 61890 164410 64272375
Fall 41.99 10.41 232 61715 416594 64020191
Ureteric obstruction 41.53 10.41 27 61920 2395 64434390
Rheumatoid arthritis 40.83 10.41 59 61888 164235 64272550
Mouth swelling 40.67 10.41 36 61911 5071 64431714
Intentional product misuse 40.09 10.41 10 61937 72285 64364500
Platelet count decreased 39.98 10.41 287 61660 167424 64269361
Blood urea increased 38.25 10.41 111 61836 44042 64392743
Confusional state 38.17 10.41 401 61546 260743 64176042
Hepatitis 37.97 10.41 113 61834 45469 64391316
Alopecia 37.83 10.41 63 61884 165627 64271158
Psoriasis 37.72 10.41 11 61936 71692 64365093
Urosepsis 37.21 10.41 72 61875 22022 64414763
Abdominal discomfort 36.60 10.41 75 61872 182247 64254538
Arthropathy 35.76 10.41 38 61909 120929 64315856
Weight increased 35.46 10.41 97 61850 213251 64223534
Blood lactate dehydrogenase increased 34.48 10.41 89 61858 32989 64403796
Rash erythematous 34.46 10.41 114 61833 48519 64388266
Drug intolerance 33.91 10.41 82 61865 187910 64248875
Hospitalisation 33.68 10.41 15 61932 75192 64361593
Dialysis 33.34 10.41 59 61888 16861 64419924
Blood pressure increased 32.94 10.41 73 61874 172479 64264306
Superinfection 32.16 10.41 28 61919 3858 64432927
Alanine aminotransferase increased 32.02 10.41 236 61711 138795 64297990
Injection site erythema 31.90 10.41 14 61933 70786 64365999
Pain 31.52 10.41 360 61587 553151 63883634
Treatment failure 30.98 10.41 40 61907 116776 64320009
Suicide attempt 30.51 10.41 15 61932 70992 64365793
Blood potassium increased 30.34 10.41 73 61874 25907 64410878
Jaundice 30.26 10.41 109 61838 48403 64388382
Aspartate aminotransferase increased 29.12 10.41 206 61741 119582 64317203
Meningoencephalitis herpetic 28.65 10.41 19 61928 1742 64435043
Bronchopulmonary aspergillosis 28.31 10.41 59 61888 19026 64417759
Systemic lupus erythematosus 28.25 10.41 20 61927 77592 64359193
Blood alkaline phosphatase increased 28.21 10.41 118 61829 56161 64380624
Nasal congestion 28.16 10.41 11 61936 59647 64377138
Complications of transplanted kidney 27.69 10.41 30 61917 5405 64431380
Liver transplant rejection 27.67 10.41 23 61924 2976 64433809
Blood bilirubin increased 27.56 10.41 119 61828 57434 64379351
Hypophagia 27.34 10.41 92 61855 39495 64397290
Febrile bone marrow aplasia 27.19 10.41 43 61904 11212 64425573
Documented hypersensitivity to administered product 26.64 10.41 14 61933 834 64435951
Plasma cell myeloma 26.63 10.41 101 61846 45974 64390811
Maternal exposure during pregnancy 26.30 10.41 32 61915 95852 64340933
Blood culture positive 26.22 10.41 35 61912 7833 64428952
Deep vein thrombosis 26.21 10.41 182 61765 105000 64331785
Ejection fraction decreased 25.67 10.41 73 61874 28634 64408151
Clostridial infection 25.63 10.41 28 61919 5091 64431694
Product use in unapproved indication 25.27 10.41 86 61861 176532 64260253
Liver transplant 25.19 10.41 25 61922 4067 64432718
Clostridium test positive 25.07 10.41 25 61922 4090 64432695
Aspergillus infection 24.73 10.41 51 61896 16328 64420457
Hepatosplenomegaly 24.65 10.41 28 61919 5315 64431470
Fibromyalgia 24.64 10.41 83 61864 35648 64401137
Toxic skin eruption 24.49 10.41 56 61891 19228 64417557
Mental status changes 24.49 10.41 120 61827 61042 64375743
Serum sickness 24.44 10.41 22 61925 3167 64433618
Bone marrow failure 24.39 10.41 101 61846 47851 64388934
Pseudomonas infection 23.91 10.41 53 61894 17830 64418955
Rash morbilliform 23.81 10.41 27 61920 5114 64431671
Blood pressure systolic increased 23.54 10.41 9 61938 49444 64387341
Injection site pruritus 23.51 10.41 4 61943 37822 64398963
Synovial fluid analysis 23.31 10.41 16 61931 1553 64435232
Culture urine positive 23.07 10.41 24 61923 4127 64432658
Meningitis aseptic 23.06 10.41 28 61919 5702 64431083
Pemphigus 22.95 10.41 15 61932 60686 64376099
Influenza 22.95 10.41 42 61905 106489 64330296
Dermatitis exfoliative 22.90 10.41 38 61909 10314 64426471
Asthma 22.87 10.41 35 61912 95190 64341595
Photophobia 22.84 10.41 51 61896 17242 64419543
Tenosynovitis stenosans 22.30 10.41 17 61930 1943 64434842
Pregnancy with injectable contraceptive 22.28 10.41 7 61940 106 64436679
Renal tubular disorder 22.08 10.41 28 61919 5959 64430826
Arthralgia 21.99 10.41 296 61651 441964 63994821
Overdose 21.95 10.41 79 61868 159487 64277298
Tenderness 21.74 10.41 54 61893 19548 64417237
Lung infiltration 21.56 10.41 56 61891 20833 64415952
Injection site reaction 21.38 10.41 9 61938 46655 64390130
Haemoglobin decreased 21.16 10.41 283 61664 194780 64242005
Vulvovaginal candidiasis 21.04 10.41 17 61930 2113 64434672
Fluid retention 20.87 10.41 16 61931 59590 64377195
Graft versus host disease 20.84 10.41 43 61904 13770 64423015
Neutropenic sepsis 20.63 10.41 59 61888 23213 64413572
Renal papillary necrosis 20.58 10.41 9 61938 355 64436430
Injection site swelling 20.58 10.41 7 61940 41346 64395439
Urinary tract infection 20.38 10.41 324 61623 231272 64205513
Vomiting 20.36 10.41 682 61265 550435 63886350
Body mass index decreased 20.31 10.41 10 61937 519 64436266
Contraindicated product administered 20.26 10.41 46 61901 107783 64329002
Therapeutic product effect decreased 20.25 10.41 51 61896 115300 64321485
Blood antidiuretic hormone increased 20.15 10.41 6 61941 75 64436710
Cholestasis 20.13 10.41 91 61856 44781 64392004
Leukaemia recurrent 20.09 10.41 18 61929 2576 64434209
Aplasia pure red cell 20.07 10.41 29 61918 6985 64429800
Scleritis 19.91 10.41 19 61928 2947 64433838
Rash pruritic 19.77 10.41 108 61839 57296 64379489
Viral test positive 19.77 10.41 9 61938 391 64436394
Bacterial test positive 19.64 10.41 28 61919 6662 64430123
Parkinsonian rest tremor 19.64 10.41 8 61939 264 64436521
Hepatitis fulminant 19.52 10.41 27 61920 6247 64430538
Cellulitis enterococcal 19.51 10.41 5 61942 34 64436751
Conjunctivitis 19.42 10.41 53 61894 20301 64416484
Hepatomegaly 19.24 10.41 47 61900 16835 64419950
Rash macular 19.04 10.41 58 61889 23627 64413158
Loss of personal independence in daily activities 19.01 10.41 25 61922 72429 64364356
Refusal of treatment by patient 18.97 10.41 31 61916 8308 64428477
Sinusitis 18.93 10.41 74 61873 145854 64290931
Dehydration 18.60 10.41 302 61645 216461 64220324
Autoimmune haemolytic anaemia 18.44 10.41 28 61919 7048 64429737
Glossodynia 18.37 10.41 21 61926 64675 64372110
Clostridium difficile infection 18.26 10.41 76 61871 36087 64400698
Erythema multiforme 18.20 10.41 44 61903 15657 64421128
Colour blindness acquired 17.98 10.41 6 61941 111 64436674
Renal tubular acidosis 17.97 10.41 18 61929 2961 64433824
Cytomegalovirus test 17.80 10.41 5 61942 50 64436735
Biliary sepsis 17.61 10.41 13 61934 1415 64435370
Acquired immunodeficiency syndrome 17.59 10.41 7 61940 217 64436568
Thrombotic microangiopathy 17.55 10.41 45 61902 16610 64420175
Vena cava injury 17.41 10.41 7 61940 223 64436562
Inappropriate antidiuretic hormone secretion 17.38 10.41 54 61893 22235 64414550
Oral pain 17.34 10.41 62 61885 27431 64409354
Enterococcal infection 17.32 10.41 40 61907 13826 64422959
Chronic lymphocytic leukaemia 17.23 10.41 21 61926 4294 64432491
SARS-CoV-2 antibody test positive 16.88 10.41 7 61940 242 64436543
Culture stool positive 16.85 10.41 9 61938 554 64436231
HIV wasting syndrome 16.61 10.41 5 61942 65 64436720
COVID-19 16.56 10.41 23 61924 65117 64371668
Knee arthroplasty 16.47 10.41 3 61944 26996 64409789
Neuropathy peripheral 16.45 10.41 179 61768 117346 64319439
Allergy to chemicals 16.42 10.41 11 61936 1026 64435759
Lymphopenia 16.30 10.41 58 61889 25599 64411186
White blood cell count decreased 16.29 10.41 227 61720 157610 64279175
Blindness cortical 16.28 10.41 10 61937 803 64435982
Myocardial infarction 16.27 10.41 93 61854 165728 64271057
Osteonecrosis of jaw 16.23 10.41 9 61938 39816 64396969
Abdominal wall haemorrhage 16.21 10.41 8 61939 417 64436368
Trimethylaminuria 16.11 10.41 6 61941 155 64436630
Pain in extremity 16.10 10.41 200 61747 302885 64133900
Angiodermatitis 16.02 10.41 5 61942 74 64436711
Lymphocele 16.01 10.41 13 61934 1628 64435157
Pericarditis 15.97 10.41 22 61925 62494 64374291
Haemorrhoids 15.89 10.41 55 61892 23946 64412839
Biopsy liver abnormal 15.88 10.41 8 61939 436 64436349
Therapeutic response decreased 15.86 10.41 16 61931 52172 64384613
Antinuclear antibody 15.78 10.41 8 61939 442 64436343
Wound 15.72 10.41 31 61916 76446 64360339
Muscle twitching 15.72 10.41 47 61900 18951 64417834
Human herpesvirus 6 infection reactivation 15.69 10.41 7 61940 290 64436495
Seizure 15.63 10.41 236 61711 166656 64270129
Palmar erythema 15.54 10.41 13 61934 1697 64435088
Eosinophilia 15.45 10.41 75 61872 38001 64398784
Foaming at mouth 15.41 10.41 13 61934 1716 64435069
Angioedema 15.41 10.41 107 61840 61714 64375071
Cholecystitis chronic 15.31 10.41 30 61917 9257 64427528
Anti-cyclic citrullinated peptide antibody positive 15.29 10.41 15 61932 49547 64387238
Cataract 15.26 10.41 16 61931 51246 64385539
Enterovirus infection 15.19 10.41 12 61935 1445 64435340
Blood bilirubin unconjugated increased 15.18 10.41 10 61937 907 64435878
Drug interaction 15.15 10.41 455 61492 361628 64075157
Atelectasis 15.12 10.41 59 61888 27207 64409578
Tarsal tunnel syndrome 14.91 10.41 8 61939 497 64436288
Purpura senile 14.82 10.41 8 61939 503 64436282
Porphyria acute 14.79 10.41 9 61938 711 64436074
Erythema infectiosum 14.78 10.41 6 61941 196 64436589
Unevaluable event 14.76 10.41 16 61931 50473 64386312
Cardiac failure congestive 14.62 10.41 70 61877 130510 64306275
Purpura 14.59 10.41 43 61904 17203 64419582
Granulomatous rosacea 14.59 10.41 6 61941 203 64436582
Complications of transplant surgery 14.57 10.41 9 61938 730 64436055
HIV infection 14.56 10.41 10 61937 972 64435813
Chemotherapeutic drug level increased 14.55 10.41 7 61940 345 64436440
Hepatic failure 14.48 10.41 97 61850 55297 64381488
Rhinorrhoea 14.43 10.41 22 61925 59947 64376838
Pleuritic pain 14.39 10.41 27 61920 8069 64428716
Cytomegalovirus test positive 14.33 10.41 21 61926 5123 64431662
Tumour lysis syndrome 14.15 10.41 46 61901 19394 64417391
Pulmonary embolism 14.11 10.41 208 61739 146148 64290637
Tumour flare 14.05 10.41 9 61938 778 64436007
Hepatitis cholestatic 14.02 10.41 34 61913 12121 64424664
Myositis 14.02 10.41 41 61906 16336 64420449
Staphylococcal infection 14.01 10.41 90 61857 50588 64386197
Pneumonia cytomegaloviral 14.00 10.41 19 61928 4320 64432465
Effusion 13.96 10.41 13 61934 1955 64434830
Lung transplant rejection 13.95 10.41 11 61936 1321 64435464
Autonomic neuropathy 13.87 10.41 12 61935 1640 64435145
Vaginal ulceration 13.79 10.41 6 61941 234 64436551
Pustule 13.71 10.41 11 61936 1354 64435431
Cardiogenic shock 13.70 10.41 7 61940 32420 64404365
Wound evisceration 13.61 10.41 5 61942 124 64436661
Chronic obstructive pulmonary disease 13.60 10.41 30 61917 71018 64365767
Candida infection 13.56 10.41 63 61884 31356 64405429
Soft tissue swelling 13.52 10.41 10 61937 1092 64435693
Cystitis noninfective 13.49 10.41 10 61937 1096 64435689
Lymphocytic infiltration 13.44 10.41 11 61936 1393 64435392
Bacterial sepsis 13.42 10.41 25 61922 7432 64429353
Blood sodium decreased 13.38 10.41 60 61887 29422 64407363
Dermatitis allergic 13.10 10.41 38 61909 15071 64421714
Condition aggravated 12.98 10.41 266 61681 372160 64064625
Stress 12.91 10.41 24 61923 60510 64376275
Genital burning sensation 12.86 10.41 6 61941 276 64436509
Limb discomfort 12.84 10.41 5 61942 27170 64409615
Cerebral toxoplasmosis 12.83 10.41 12 61935 1814 64434971
Red blood cell sedimentation rate increased 12.82 10.41 7 61940 31228 64405557
Renal cyst haemorrhage 12.75 10.41 7 61940 455 64436330
Memory impairment 12.74 10.41 41 61906 85641 64351144
Osteoarthritis 12.74 10.41 26 61921 63310 64373475
Hydronephrosis 12.70 10.41 36 61911 14089 64422696
Cholelithiasis 12.69 10.41 81 61866 45425 64391360
Intentional self-injury 12.68 10.41 6 61941 29038 64407747
Pneumonia fungal 12.65 10.41 27 61920 8850 64427935
Limb reduction defect 12.64 10.41 4 61943 62 64436723
Prurigo 12.64 10.41 10 61937 1207 64435578
Petechiae 12.61 10.41 43 61904 18583 64418202
Discomfort 12.52 10.41 38 61909 80840 64355945
Renal transplant 12.50 10.41 13 61934 2235 64434550
Lung neoplasm 12.44 10.41 22 61925 6283 64430502
Bacterial infection 12.26 10.41 52 61895 24898 64411887
Drug hypersensitivity 12.24 10.41 307 61640 237508 64199277
Acute graft versus host disease 12.23 10.41 27 61920 9057 64427728
Accidental exposure to product 12.21 10.41 5 61942 26359 64410426
Pseudomembranous colitis 12.18 10.41 19 61928 4897 64431888
Haematocrit decreased 12.13 10.41 92 61855 54563 64382222
Perinephric collection 12.08 10.41 6 61941 317 64436468
Multiple sclerosis relapse 12.06 10.41 13 61934 41122 64395663
Surgery 12.05 10.41 6 61941 28207 64408578
Suicidal ideation 12.00 10.41 29 61918 66513 64370272
Prostatitis 11.95 10.41 16 61931 3590 64433195
Acute graft versus host disease in intestine 11.94 10.41 16 61931 3593 64433192
Areflexia 11.92 10.41 19 61928 4988 64431797
Lip ulceration 11.90 10.41 12 61935 1989 64434796
Oral candidiasis 11.89 10.41 49 61898 23163 64413622
Headache 11.89 10.41 403 61544 529064 63907721
Abdominal pain 11.86 10.41 388 61559 311987 64124798
Pruritus genital 11.85 10.41 9 61938 1023 64435762
Hepatitis C virus test 11.84 10.41 4 61943 77 64436708
Sleep apnoea syndrome 11.79 10.41 7 61940 29825 64406960
Tremor 11.78 10.41 204 61743 148026 64288759
Hip arthroplasty 11.74 10.41 3 61944 21348 64415437
Motion sickness 11.71 10.41 8 61939 770 64436015
Haemolytic anaemia 11.70 10.41 38 61909 16015 64420770
Idiopathic pneumonia syndrome 11.63 10.41 7 61940 542 64436243
Culture positive 11.62 10.41 9 61938 1053 64435732
Hand deformity 11.61 10.41 27 61920 62744 64374041
Drug dependence 11.58 10.41 9 61938 33303 64403482
Device expulsion 11.57 10.41 3 61944 21133 64415652
Cardio-respiratory arrest 11.45 10.41 52 61895 98341 64338444
Pulmonary arterial hypertension 11.45 10.41 5 61942 25362 64411423
Immunosuppressant drug level increased 11.43 10.41 23 61924 7236 64429549
Pancreatitis 11.41 10.41 97 61850 59510 64377275
Acute febrile neutrophilic dermatosis 11.39 10.41 15 61932 3314 64433471
Gastric disorder 11.33 10.41 7 61940 29190 64407595
Acne 11.32 10.41 4 61943 23077 64413708
Altered visual depth perception 11.25 10.41 6 61941 368 64436417
Crepitations 11.20 10.41 24 61923 7891 64428894
Rash papular 11.14 10.41 39 61908 17074 64419711
Blood chloride increased 11.12 10.41 18 61929 4785 64432000
Intraductal papillary mucinous neoplasm 11.09 10.41 7 61940 590 64436195
Bone marrow oedema 10.99 10.41 9 61938 1141 64435644
Hepatitis A antibody positive 10.97 10.41 4 61943 97 64436688
Pharyngeal cancer 10.97 10.41 3 61944 27 64436758
Hepatitis B antibody positive 10.94 10.41 4 61943 98 64436687
Splenomegaly 10.90 10.41 40 61907 17921 64418864
Swollen tongue 10.87 10.41 64 61883 34890 64401895
Mycobacterium avium complex infection 10.85 10.41 16 61931 3924 64432861
Liver disorder 10.84 10.41 88 61859 53263 64383522
Parkinsonism hyperpyrexia syndrome 10.82 10.41 5 61942 225 64436560
Suprapubic pain 10.81 10.41 8 61939 874 64435911
Therapeutic product effect incomplete 10.71 10.41 57 61890 103425 64333360
Hypovolaemia 10.70 10.41 36 61911 15450 64421335
Blood pressure fluctuation 10.68 10.41 21 61926 51850 64384935
Hepatic enzyme increased 10.64 10.41 77 61870 129866 64306919
Photosensitivity reaction 10.63 10.41 40 61907 18133 64418652
Herpes simplex 10.62 10.41 28 61919 10508 64426277
Genital ulceration 10.61 10.41 7 61940 636 64436149
Sepsis 10.60 10.41 293 61654 230048 64206737
Feeling abnormal 10.54 10.41 80 61867 133522 64303263
Abdominal tenderness 10.52 10.41 26 61921 9379 64427406
Infection 10.52 10.41 242 61705 184638 64252147
Graft complication 10.49 10.41 7 61940 649 64436136
Product quality issue 10.43 10.41 8 61939 29791 64406994

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01EA01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
SULFONAMIDES AND TRIMETHOPRIM
Trimethoprim and derivatives
ATC J01EE01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
SULFONAMIDES AND TRIMETHOPRIM
Combinations of sulfonamides and trimethoprim, incl. derivatives
ATC J01EE02 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
SULFONAMIDES AND TRIMETHOPRIM
Combinations of sulfonamides and trimethoprim, incl. derivatives
ATC J01EE03 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
SULFONAMIDES AND TRIMETHOPRIM
Combinations of sulfonamides and trimethoprim, incl. derivatives
ATC J01EE04 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
SULFONAMIDES AND TRIMETHOPRIM
Combinations of sulfonamides and trimethoprim, incl. derivatives
ATC J01EE05 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
SULFONAMIDES AND TRIMETHOPRIM
Combinations of sulfonamides and trimethoprim, incl. derivatives
ATC J01EE07 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
SULFONAMIDES AND TRIMETHOPRIM
Combinations of sulfonamides and trimethoprim, incl. derivatives
ATC J04AM08 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIMYCOBACTERIALS
DRUGS FOR TREATMENT OF TUBERCULOSIS
Combinations of drugs for treatment of tuberculosis
FDA MoA N0000000191 Dihydrofolate Reductase Inhibitors
FDA EPC N0000175489 Dihydrofolate Reductase Inhibitor Antibacterial
MeSH PA D018726 Anti-Dyskinesia Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000892 Anti-Infective Agents, Urinary
MeSH PA D000962 Antimalarials
MeSH PA D000977 Antiparasitic Agents
MeSH PA D000981 Antiprotozoal Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D065687 Cytochrome P-450 CYP2C8 Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D005493 Folic Acid Antagonists
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
FDA MoA N0000187061 Organic Cation Transporter 2 Inhibitors
FDA MoA N0000187062 Cytochrome P450 2C8 Inhibitors
CHEBI has role CHEBI:35498 diuretics
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:50683 dihydrofolic acid reductase inhibitors
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug

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

DiseaseRelationSNOMED_IDDOID
Acute otitis media indication 3110003
Shigellosis indication 36188001
Klebsiella cystitis indication 60867007
Urinary tract infectious disease indication 68566005
Blepharoconjunctivitis indication 68659002 DOID:2456
Bacterial conjunctivitis indication 128350005 DOID:9700
Escherichia coli urinary tract infection indication 301011002
Proteus urinary tract infection indication 301012009
Bacterial urinary infection indication 312124009
Infective otitis media indication 312218008
Pneumocystosis jiroveci pneumonia indication 415125002 DOID:11339
Acute exacerbation of chronic bronchitis indication 425748003
Morganella Morganii Urinary Tract Infection indication
Staphylococcus Aureus Urinary Tract Infection indication
Haemophilus Influenzae Acute Otitis Media indication
Pneumocystis Carinii Pneumonia Prevention indication
Haemophilus Influenzae Chronic Bronchitis indication
Streptococcus Pneumoniae Chronic Bronchitis indication
Typhoid fever off-label use 4834000 DOID:13258
Infection of skin AND/OR subcutaneous tissue off-label use 19824006
Pertussis off-label use 27836007
Granuloma inguinale off-label use 28867007 DOID:9113
Nocardiosis off-label use 29227009 DOID:2312
Listeria meningitis off-label use 31568009 DOID:11572
Sinusitis off-label use 36971009
Whipple's disease off-label use 41545003 DOID:8476
Bacterial pneumonia off-label use 53084003 DOID:874
Paracoccidioidomycosis off-label use 59925007 DOID:12662
Cholera off-label use 63650001 DOID:1498
Brucellosis off-label use 75702008 DOID:11077
Paratyphoid fever off-label use 85904008 DOID:3055
Chlamydial infection off-label use 105629000
Infection of bone off-label use 111253001
Meningococcus carrier off-label use 170486006
Lymphogranuloma venereum off-label use 186946009 DOID:13819
Chancroid off-label use 266143009 DOID:13778
Diverticulitis of gastrointestinal tract off-label use 271366000
Bacterial endocarditis off-label use 301183007
Toxoplasmosis associated with acquired immunodeficiency syndrome off-label use 421666009
Toxoplasmosis Prevention off-label use
Postexposure Plague Prophylaxis off-label use
Chronic Bacterial Prostatitis off-label use
Diabetic Foot Infection off-label use
Third trimester pregnancy contraindication 41587001
Megaloblastic anemia due to folate deficiency contraindication 85649008 DOID:14026
Kidney disease contraindication 90708001 DOID:557
Anemia due to enzyme deficiency contraindication 111577008
Deficiency of glucose-6-phosphate dehydrogenase contraindication 124134002 DOID:2862
Folic acid deficiency contraindication 190633005
Disease of liver contraindication 235856003 DOID:409
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Pseudomembranous enterocolitis contraindication 397683000
Porphyria contraindication 418470004




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Dogs Systemic antibacterial action against sensitive organisms to surgery Indication
Dogs Systemic antibacterial action against sensitive organisms to debridement Indication
Dogs Control of bacterial infection during the treatment of acute urinary tract infections Indication
Dogs Control of bacterial infection during the treatment of acute bacterial complications of distemper Indication
Dogs Control of bacterial infection during the treatment of acute respiratory tract infections Indication
Dogs Control of bacterial infection during the treatment of acute alimentary tract infections Indication
Dogs Control of bacterial infection during the treatment of wound infections Indication
Dogs Control of bacterial infection during the treatment of abscesses Indication
Horses Systemic antibacterial action against sensitive organisms during treatment of acute strangles Indication
Horses Systemic antibacterial action against sensitive organisms during treatment of respiratory tract infections Indication
Horses Systemic antibacterial action against sensitive organisms during treatment of acute urogenital infections Indication
Horses Systemic antibacterial action against sensitive organisms during treatment of wound infections Indication
Horses Systemic antibacterial action against sensitive organisms during treatment of abscesses Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Tribrissen 120 Tablets, Tribrissen 30 Tablets, Tribrissen 480 Tablets, Tribrissen 960 Tablets Intervet Inc. 2
Tribrissen 24% Injection Intervet Inc. 2
Tribrissen 48% Injection Intervet Inc. 2
Di-Trim Tablets Zoetis Inc. 2
Tribrissen 400 Oral Paste Intervet Inc. 2
Di-Trim 24% Zoetis Inc. 2
Di-Trim 48% Injection Zoetis Inc. 2
Di-Trim 400 Paste Zoetis Inc. 2
Tribrissen 60 Oral Suspension Intervet Inc. 2
EQUISUL-SDT Aurora Pharmaceutical Inc. 2
Uniprim Powder Neogen Corp. 2
Tucoprim Powder Zoetis Inc. 2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.01 Basic
pKa2 0.6 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
Dihydrofolate reductase Enzyme Ki 8 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.25 CHEMBL
Dihydrofolate reductase Enzyme INHIBITOR IC50 5.57 CHEMBL CHEMBL
Bifunctional dihydrofolate reductase-thymidylate synthase Enzyme IC50 8.14 CHEMBL
Dihydrofolate reductase Enzyme Ki 6.82 CHEMBL
Bifunctional dihydrofolate reductase-thymidylate synthase Enzyme IC50 6.92 CHEMBL
Bifunctional dihydrofolate reductase-thymidylate synthase Enzyme Ki 7.99 CHEMBL
Dihydrofolate reductase Enzyme Ki 6.30 CHEMBL
Dihydrofolate reductase Enzyme Ki 6.88 CHEMBL
Dihydrofolate reductase Enzyme IC50 4.92 CHEMBL
Bifunctional dihydrofolate reductase-thymidylate synthase Enzyme Ki 6.92 WOMBAT-PK
Dihydrofolate reductase Enzyme IC50 8.66 CHEMBL
Dihydrofolate reductase Enzyme IC50 6.72 CHEMBL
Dihydrofolate reductase Enzyme Ki 8.89 CHEMBL
Bifunctional dihydrofolate reductase-thymidylate synthase Enzyme Ki 6 WOMBAT-PK
Dihydrofolate reductase Enzyme Ki 8.92 CHEMBL
Bifunctional dihydrofolate reductase-thymidylate synthase Enzyme Ki 8 WOMBAT-PK
Dihydrofolate reductase Enzyme IC50 6.35 CHEMBL
Dihydrofolate reductase Enzyme IC50 6.35 CHEMBL
Dihydrofolate reductase Enzyme IC50 4.06 CHEMBL
Dihydrofolate reductase Enzyme Ki 4.62 CHEMBL
Bifunctional dihydrofolate reductase-thymidylate synthase Enzyme IC50 5.40 CHEMBL
Dihydrofolate reductase type 1 Enzyme IC50 6.30 CHEMBL
Dihydrofolate reductase Enzyme Ki 8.08 CHEMBL
Dihydrofolate reductase Enzyme IC50 4.38 CHEMBL
Dihydrofolate reductase Enzyme Ki 4.84 CHEMBL
Dihydrofolate reductase Enzyme IC50 7.04 CHEMBL

External reference:

IDSource
4017735 VUID
N0000146103 NUI
D00145 KEGG_DRUG
56585-33-2 SECONDARY_CAS_RN
60834-30-2 SECONDARY_CAS_RN
4017735 VANDF
4019528 VANDF
C0041041 UMLSCUI
CHEBI:45924 CHEBI
TOP PDB_CHEM_ID
CHEMBL22 ChEMBL_ID
DB00440 DRUGBANK_ID
CHEMBL2110367 ChEMBL_ID
CHEMBL1201080 ChEMBL_ID
D014295 MESH_DESCRIPTOR_UI
5578 PUBCHEM_CID
10931 IUPHAR_LIGAND_ID
1047 INN_ID
AN164J8Y0X UNII
10829 RXNORM
3055 MMSL
5633 MMSL
5634 MMSL
d00123 MMSL
002873 NDDF
008281 NDDF
32792001 SNOMEDCT_US
387179001 SNOMEDCT_US
412323009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Polytrim HUMAN PRESCRIPTION DRUG LABEL 2 0023-7824 SOLUTION/ DROPS 1 mg OPHTHALMIC NDA 19 sections
Polytrim HUMAN PRESCRIPTION DRUG LABEL 2 0023-7824 SOLUTION/ DROPS 1 mg OPHTHALMIC NDA 19 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0121-0853 SUSPENSION 40 mg ORAL NDA 28 sections
SULFATRIM HUMAN PRESCRIPTION DRUG LABEL 2 0121-0854 SUSPENSION 40 mg ORAL NDA 28 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0121-4793 SUSPENSION 40 mg ORAL ANDA 28 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0440-2406 TABLET 160 mg ORAL ANDA 13 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0527-5180 SUSPENSION 40 mg ORAL ANDA 21 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0527-5181 SUSPENSION 40 mg ORAL ANDA 21 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0615-8121 TABLET 160 mg ORAL ANDA 26 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0703-9503 INJECTION, SOLUTION, CONCENTRATE 16 mg INTRAVENOUS ANDA 22 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0703-9514 INJECTION, SOLUTION, CONCENTRATE 16 mg INTRAVENOUS ANDA 22 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0703-9514 INJECTION, SOLUTION, CONCENTRATE 16 mg INTRAVENOUS ANDA 22 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0703-9526 INJECTION, SOLUTION, CONCENTRATE 16 mg INTRAVENOUS ANDA 22 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 0904-2725 TABLET 160 mg ORAL ANDA 13 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 10544-053 TABLET 160 mg ORAL ANDA 26 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 10544-092 TABLET 160 mg ORAL ANDA 25 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 10544-525 TABLET 160 mg ORAL ANDA 13 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 10544-926 TABLET 160 mg ORAL ANDA 13 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 10544-940 TABLET 160 mg ORAL ANDA 27 sections
Sulfamethoxazole and Trimethoprim DS HUMAN PRESCRIPTION DRUG LABEL 2 12634-177 TABLET 160 mg ORAL ANDA 21 sections
SULFAMETHOXAZOLE and TRIMETHOPRIM HUMAN PRESCRIPTION DRUG LABEL 2 12634-779 SUSPENSION 40 mg ORAL ANDA 21 sections
Primsol HUMAN PRESCRIPTION DRUG LABEL 1 13551-501 SOLUTION 50 mg ORAL NDA 25 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 16590-210 TABLET 160 mg ORAL ANDA 29 sections
Polymyxin B Sulfate and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 16590-233 SOLUTION 1 mg OPHTHALMIC ANDA 17 sections
POLYMYXIN B SULFATE AND TRIMETHOPRIM HUMAN PRESCRIPTION DRUG LABEL 2 17478-703 SOLUTION 1 mg OPHTHALMIC ANDA 19 sections
POLYMYXIN B SULFATE AND TRIMETHOPRIM HUMAN PRESCRIPTION DRUG LABEL 2 17478-703 SOLUTION 1 mg OPHTHALMIC ANDA 19 sections
SULFATRIM HUMAN PRESCRIPTION DRUG LABEL 2 17856-0007 SUSPENSION 40 mg ORAL NDA 21 sections
Sulfamethoxazole and Trimethoprim Human Prescription Drug Label 2 17856-0496 SUSPENSION 40 mg ORAL ANDA 26 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 17856-0823 SUSPENSION 40 mg ORAL ANDA 20 sections
Sulfamethoxazole and Trimethoprim HUMAN PRESCRIPTION DRUG LABEL 2 17856-5181 SUSPENSION 40 mg ORAL ANDA 21 sections