trimethoprim 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antimicrobials, dihydrofolate reductase (DHFR) inhibitors, trimethoprim analogues | 2755 | 738-70-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.40 | g | O |
| 0.40 | g | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 µM/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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 30, 1973 | FDA | MUTUAL PHARM |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Soft tissue disorder | 178.45 | 10.84 | 81 | 49266 | 4341 | 63435334 |
| Acute kidney injury | 160.23 | 10.84 | 509 | 48838 | 262906 | 63176769 |
| Drug ineffective | 122.82 | 10.84 | 411 | 48936 | 1044354 | 62395321 |
| Liver function test abnormal | 121.79 | 10.84 | 168 | 49179 | 48013 | 63391662 |
| Swelling face | 119.80 | 10.84 | 193 | 49154 | 63282 | 63376393 |
| Pre-engraftment immune reaction | 102.78 | 10.84 | 26 | 49321 | 212 | 63439463 |
| Leukopenia | 98.42 | 10.84 | 198 | 49149 | 77092 | 63362583 |
| Pneumonia viral | 96.75 | 10.84 | 66 | 49281 | 7856 | 63431819 |
| Hyperkalaemia | 94.45 | 10.84 | 159 | 49188 | 54044 | 63385631 |
| Pancytopenia | 93.46 | 10.84 | 222 | 49125 | 96711 | 63342964 |
| Pyrexia | 92.15 | 10.84 | 653 | 48694 | 469825 | 62969850 |
| Product dose omission issue | 86.37 | 10.84 | 37 | 49310 | 234276 | 63205399 |
| Stevens-Johnson syndrome | 83.49 | 10.84 | 100 | 49247 | 24850 | 63414825 |
| Hyponatraemia | 77.94 | 10.84 | 227 | 49120 | 111673 | 63328002 |
| Encephalitis viral | 77.15 | 10.84 | 34 | 49313 | 1698 | 63437977 |
| Completed suicide | 68.00 | 10.84 | 15 | 49332 | 145658 | 63294017 |
| Rash maculo-papular | 65.72 | 10.84 | 101 | 49246 | 31795 | 63407880 |
| Cytomegalovirus infection | 63.67 | 10.84 | 80 | 49267 | 20872 | 63418803 |
| Lip swelling | 63.49 | 10.84 | 98 | 49249 | 30965 | 63408710 |
| Injection site pain | 63.42 | 10.84 | 12 | 49335 | 129788 | 63309887 |
| Abdominal discomfort | 62.96 | 10.84 | 95 | 49252 | 320790 | 63118885 |
| Fatigue | 62.84 | 10.84 | 419 | 48928 | 887609 | 62552066 |
| Human herpesvirus 6 infection | 62.62 | 10.84 | 35 | 49312 | 2922 | 63436753 |
| Alopecia | 61.45 | 10.84 | 105 | 49242 | 337431 | 63102244 |
| Allergy to chemicals | 59.01 | 10.84 | 34 | 49313 | 3008 | 63436667 |
| Tenosynovitis stenosans | 58.42 | 10.84 | 35 | 49312 | 3329 | 63436346 |
| Ejection fraction decreased | 58.11 | 10.84 | 79 | 49268 | 22253 | 63417422 |
| Product use issue | 57.52 | 10.84 | 52 | 49295 | 220468 | 63219207 |
| Systemic lupus erythematosus | 56.02 | 10.84 | 48 | 49299 | 208870 | 63230805 |
| Synovial fluid analysis | 54.82 | 10.84 | 30 | 49317 | 2403 | 63437272 |
| International normalised ratio increased | 54.44 | 10.84 | 115 | 49232 | 46310 | 63393365 |
| Off label use | 53.98 | 10.84 | 306 | 49041 | 674156 | 62765519 |
| Scleritis | 51.97 | 10.84 | 36 | 49311 | 4392 | 63435283 |
| Toxic epidermal necrolysis | 50.48 | 10.84 | 79 | 49268 | 25255 | 63414420 |
| Kidney transplant rejection | 48.43 | 10.84 | 34 | 49313 | 4237 | 63435438 |
| Maternal exposure during pregnancy | 48.32 | 10.84 | 60 | 49287 | 220002 | 63219673 |
| Tenderness | 47.22 | 10.84 | 72 | 49275 | 22506 | 63417169 |
| Photophobia | 46.82 | 10.84 | 63 | 49284 | 17572 | 63422103 |
| Pleuritic pain | 46.25 | 10.84 | 43 | 49304 | 7986 | 63431689 |
| Conjunctivitis | 45.89 | 10.84 | 68 | 49279 | 20728 | 63418947 |
| Psoriasis | 44.75 | 10.84 | 7 | 49340 | 86950 | 63352725 |
| Death | 43.82 | 10.84 | 147 | 49200 | 374234 | 63065441 |
| Blood pressure increased | 43.72 | 10.84 | 37 | 49310 | 162025 | 63277650 |
| Hypophagia | 43.30 | 10.84 | 83 | 49264 | 31176 | 63408499 |
| Confusional state | 43.16 | 10.84 | 323 | 49024 | 236057 | 63203618 |
| Genital ulceration | 43.15 | 10.84 | 17 | 49330 | 638 | 63439037 |
| Mouth swelling | 43.04 | 10.84 | 33 | 49314 | 4707 | 63434968 |
| Deep vein thrombosis | 42.87 | 10.84 | 153 | 49194 | 83647 | 63356028 |
| Oral pain | 42.58 | 10.84 | 78 | 49269 | 28316 | 63411359 |
| Pemphigus | 42.56 | 10.84 | 48 | 49299 | 183678 | 63255997 |
| Macular degeneration | 41.77 | 10.84 | 71 | 49276 | 24305 | 63415370 |
| Swollen tongue | 41.73 | 10.84 | 87 | 49260 | 34713 | 63404962 |
| Urosepsis | 41.49 | 10.84 | 61 | 49286 | 18463 | 63421212 |
| Thrombocytopenia | 41.45 | 10.84 | 229 | 49118 | 150928 | 63288747 |
| Drug reaction with eosinophilia and systemic symptoms | 41.05 | 10.84 | 85 | 49262 | 33751 | 63405924 |
| Intentional overdose | 40.44 | 10.84 | 5 | 49342 | 74147 | 63365528 |
| Fear of eating | 39.89 | 10.84 | 14 | 49333 | 378 | 63439297 |
| Superinfection | 39.85 | 10.84 | 25 | 49322 | 2582 | 63437093 |
| Drug interaction | 39.54 | 10.84 | 309 | 49038 | 228822 | 63210853 |
| Renal failure | 38.31 | 10.84 | 187 | 49160 | 117465 | 63322210 |
| Genital pain | 37.98 | 10.84 | 14 | 49333 | 437 | 63439238 |
| Psoriatic arthropathy | 37.81 | 10.84 | 12 | 49335 | 91508 | 63348167 |
| Anaemia | 37.79 | 10.84 | 371 | 48976 | 293059 | 63146616 |
| Bone marrow failure | 37.21 | 10.84 | 75 | 49272 | 29215 | 63410460 |
| Pain | 36.97 | 10.84 | 383 | 48964 | 740245 | 62699430 |
| Crepitations | 36.86 | 10.84 | 38 | 49309 | 8002 | 63431673 |
| Glossodynia | 35.97 | 10.84 | 52 | 49295 | 178824 | 63260851 |
| Inappropriate schedule of product administration | 35.82 | 10.84 | 18 | 49329 | 103947 | 63335728 |
| Blood creatinine increased | 35.62 | 10.84 | 149 | 49198 | 87695 | 63351980 |
| Nasopharyngitis | 35.40 | 10.84 | 92 | 49255 | 254165 | 63185510 |
| Agranulocytosis | 35.13 | 10.84 | 67 | 49280 | 25067 | 63414608 |
| Abdominal pain | 34.89 | 10.84 | 365 | 48982 | 293091 | 63146584 |
| Intentional product use issue | 34.73 | 10.84 | 29 | 49318 | 127863 | 63311812 |
| Fibromyalgia | 34.66 | 10.84 | 139 | 49208 | 80281 | 63359394 |
| Oral candidiasis | 34.65 | 10.84 | 63 | 49284 | 22735 | 63416940 |
| Fall | 34.63 | 10.84 | 172 | 49175 | 392162 | 63047513 |
| Arthropathy | 34.20 | 10.84 | 83 | 49264 | 234709 | 63204966 |
| Injection site erythema | 34.20 | 10.84 | 11 | 49336 | 83163 | 63356512 |
| Cushingoid | 33.42 | 10.84 | 37 | 49310 | 8448 | 63431227 |
| Platelet count decreased | 32.54 | 10.84 | 177 | 49170 | 115945 | 63323730 |
| Injection site reaction | 31.78 | 10.84 | 4 | 49343 | 58520 | 63381155 |
| Pneumocystis jirovecii pneumonia | 31.30 | 10.84 | 51 | 49296 | 16863 | 63422812 |
| Atelectasis | 30.94 | 10.84 | 58 | 49289 | 21425 | 63418250 |
| Bacterial sepsis | 30.46 | 10.84 | 25 | 49322 | 3933 | 63435742 |
| COVID-19 | 30.28 | 10.84 | 26 | 49321 | 113077 | 63326598 |
| Deformity | 29.89 | 10.84 | 41 | 49306 | 11643 | 63428032 |
| Transplant rejection | 29.37 | 10.84 | 39 | 49308 | 10741 | 63428934 |
| Rash erythematous | 29.34 | 10.84 | 86 | 49261 | 42424 | 63397251 |
| Angioedema | 29.33 | 10.84 | 93 | 49254 | 47872 | 63391803 |
| Suicide attempt | 28.97 | 10.84 | 6 | 49341 | 60912 | 63378763 |
| Infusion related reaction | 28.97 | 10.84 | 96 | 49251 | 245425 | 63194250 |
| Complications of transplanted kidney | 28.68 | 10.84 | 20 | 49327 | 2466 | 63437209 |
| Documented hypersensitivity to administered product | 28.55 | 10.84 | 12 | 49335 | 533 | 63439142 |
| Neutropenic sepsis | 28.32 | 10.84 | 48 | 49299 | 16390 | 63423285 |
| Parkinsonian rest tremor | 28.11 | 10.84 | 8 | 49339 | 106 | 63439569 |
| HIV infection | 27.94 | 10.84 | 11 | 49336 | 412 | 63439263 |
| Drug abuse | 27.41 | 10.84 | 11 | 49336 | 72507 | 63367168 |
| Pulmonary toxicity | 26.98 | 10.84 | 35 | 49312 | 9420 | 63430255 |
| Discomfort | 26.95 | 10.84 | 56 | 49291 | 167318 | 63272357 |
| Herpes zoster | 26.79 | 10.84 | 131 | 49216 | 82331 | 63357344 |
| Excessive eye blinking | 26.70 | 10.84 | 15 | 49332 | 1265 | 63438410 |
| Arthralgia | 26.60 | 10.84 | 299 | 49048 | 569411 | 62870264 |
| Rash pruritic | 26.27 | 10.84 | 104 | 49243 | 59695 | 63379980 |
| Ureteric obstruction | 26.26 | 10.84 | 17 | 49330 | 1853 | 63437822 |
| Vaginal discharge | 26.18 | 10.84 | 34 | 49313 | 9164 | 63430511 |
| Cholecystitis chronic | 25.97 | 10.84 | 36 | 49311 | 10325 | 63429350 |
| Synovial cyst | 25.78 | 10.84 | 36 | 49311 | 10397 | 63429278 |
| Ocular hyperaemia | 25.75 | 10.84 | 59 | 49288 | 25085 | 63414590 |
| Muscle twitching | 25.75 | 10.84 | 51 | 49296 | 19617 | 63420058 |
| Blood pressure fluctuation | 25.56 | 10.84 | 3 | 49344 | 46314 | 63393361 |
| Infection | 25.33 | 10.84 | 281 | 49066 | 228892 | 63210783 |
| Treatment failure | 24.75 | 10.84 | 76 | 49271 | 198967 | 63240708 |
| Meningoencephalitis herpetic | 24.60 | 10.84 | 14 | 49333 | 1210 | 63438465 |
| Flank pain | 24.50 | 10.84 | 45 | 49302 | 16365 | 63423310 |
| Potentiating drug interaction | 24.46 | 10.84 | 23 | 49324 | 4333 | 63435342 |
| Wrong technique in product usage process | 24.32 | 10.84 | 9 | 49338 | 62331 | 63377344 |
| Vulvovaginal candidiasis | 24.32 | 10.84 | 20 | 49327 | 3155 | 63436520 |
| Feeling jittery | 24.24 | 10.84 | 40 | 49307 | 13363 | 63426312 |
| Bacterial test positive | 24.18 | 10.84 | 25 | 49322 | 5282 | 63434393 |
| Hepatic cytolysis | 23.96 | 10.84 | 43 | 49304 | 15364 | 63424311 |
| Rectal haemorrhage | 23.78 | 10.84 | 88 | 49259 | 48942 | 63390733 |
| Rheumatoid arthritis | 23.69 | 10.84 | 109 | 49238 | 253710 | 63185965 |
| Wound | 23.54 | 10.84 | 58 | 49289 | 163205 | 63276470 |
| Influenza | 23.47 | 10.84 | 30 | 49317 | 108692 | 63330983 |
| Mucosal inflammation | 23.41 | 10.84 | 85 | 49262 | 46843 | 63392832 |
| Toxicity to various agents | 23.18 | 10.84 | 106 | 49241 | 247144 | 63192531 |
| Rheumatoid factor positive | 23.08 | 10.84 | 19 | 49328 | 84387 | 63355288 |
| Contraindicated product administered | 23.07 | 10.84 | 89 | 49258 | 217559 | 63222116 |
| Seizure | 22.92 | 10.84 | 179 | 49168 | 132455 | 63307220 |
| Multiple organ dysfunction syndrome | 22.79 | 10.84 | 96 | 49251 | 56656 | 63383019 |
| Chronic sinusitis | 22.79 | 10.84 | 38 | 49309 | 12805 | 63426870 |
| Injection site bruising | 22.43 | 10.84 | 3 | 49344 | 41907 | 63397768 |
| Vomiting | 22.38 | 10.84 | 581 | 48766 | 559036 | 62880639 |
| Blindness cortical | 22.36 | 10.84 | 10 | 49337 | 517 | 63439158 |
| Pregnancy with injectable contraceptive | 22.26 | 10.84 | 7 | 49340 | 133 | 63439542 |
| Urinary tract infection | 22.13 | 10.84 | 308 | 49039 | 264376 | 63175299 |
| Eye pain | 21.95 | 10.84 | 67 | 49280 | 33787 | 63405888 |
| Antinuclear antibody positive | 21.88 | 10.84 | 29 | 49318 | 7970 | 63431705 |
| Red blood cell sedimentation rate increased | 21.61 | 10.84 | 4 | 49343 | 43978 | 63395697 |
| Cystitis noninfective | 21.59 | 10.84 | 12 | 49335 | 991 | 63438684 |
| Acquired immunodeficiency syndrome | 20.85 | 10.84 | 6 | 49341 | 83 | 63439592 |
| Hepatitis fulminant | 20.82 | 10.84 | 19 | 49328 | 3445 | 63436230 |
| Trimethylaminuria | 20.80 | 10.84 | 7 | 49340 | 166 | 63439509 |
| Renal tubular disorder | 20.76 | 10.84 | 17 | 49330 | 2665 | 63437010 |
| Deafness transitory | 20.76 | 10.84 | 15 | 49332 | 1955 | 63437720 |
| Blood sodium decreased | 20.65 | 10.84 | 53 | 49294 | 24199 | 63415476 |
| Clostridial infection | 20.57 | 10.84 | 21 | 49326 | 4371 | 63435304 |
| Body mass index decreased | 20.50 | 10.84 | 9 | 49338 | 445 | 63439230 |
| Pulmonary embolism | 20.45 | 10.84 | 158 | 49189 | 116526 | 63323149 |
| White blood cell count decreased | 20.44 | 10.84 | 181 | 49166 | 138923 | 63300752 |
| Weight increased | 20.39 | 10.84 | 119 | 49228 | 260673 | 63179002 |
| Effusion | 20.24 | 10.84 | 14 | 49333 | 1704 | 63437971 |
| Bronchopulmonary aspergillosis | 20.16 | 10.84 | 29 | 49318 | 8606 | 63431069 |
| Injection site swelling | 20.07 | 10.84 | 6 | 49341 | 47566 | 63392109 |
| Blood pressure systolic increased | 19.96 | 10.84 | 6 | 49341 | 47391 | 63392284 |
| Hospitalisation | 19.94 | 10.84 | 22 | 49325 | 85059 | 63354616 |
| Foaming at mouth | 19.89 | 10.84 | 12 | 49335 | 1156 | 63438519 |
| Palmar erythema | 19.88 | 10.84 | 14 | 49333 | 1753 | 63437922 |
| Cholelithiasis | 19.78 | 10.84 | 77 | 49270 | 43848 | 63395827 |
| Pseudomonas infection | 19.66 | 10.84 | 33 | 49314 | 11180 | 63428495 |
| Osteoporosis | 19.63 | 10.84 | 10 | 49337 | 57328 | 63382347 |
| Renal tubular necrosis | 19.56 | 10.84 | 34 | 49313 | 11844 | 63427831 |
| Soft tissue swelling | 19.19 | 10.84 | 12 | 49335 | 1232 | 63438443 |
| Blood cholesterol increased | 19.16 | 10.84 | 132 | 49215 | 93900 | 63345775 |
| Septic shock | 18.95 | 10.84 | 102 | 49245 | 66527 | 63373148 |
| Inappropriate antidiuretic hormone secretion | 18.94 | 10.84 | 39 | 49308 | 15423 | 63424252 |
| Intentional product misuse | 18.89 | 10.84 | 12 | 49335 | 60905 | 63378770 |
| Loss of personal independence in daily activities | 18.85 | 10.84 | 29 | 49318 | 97261 | 63342414 |
| Leukoencephalopathy | 18.70 | 10.84 | 20 | 49327 | 4393 | 63435282 |
| Tubulointerstitial nephritis | 18.53 | 10.84 | 45 | 49302 | 19858 | 63419817 |
| Aplasia pure red cell | 18.42 | 10.84 | 20 | 49327 | 4467 | 63435208 |
| Libido disorder | 18.42 | 10.84 | 5 | 49342 | 55 | 63439620 |
| Tenosynovitis | 18.33 | 10.84 | 36 | 49311 | 13759 | 63425916 |
| Hepatic enzyme increased | 18.22 | 10.84 | 88 | 49259 | 202240 | 63237435 |
| Fluid retention | 18.18 | 10.84 | 12 | 49335 | 59674 | 63380001 |
| Arthritis | 18.16 | 10.84 | 153 | 49194 | 115768 | 63323907 |
| Chemotherapeutic drug level increased | 18.13 | 10.84 | 6 | 49341 | 135 | 63439540 |
| Immune reconstitution inflammatory syndrome | 18.11 | 10.84 | 23 | 49324 | 6061 | 63433614 |
| Bone density decreased | 18.06 | 10.84 | 37 | 49310 | 14575 | 63425100 |
| Urine output decreased | 18.02 | 10.84 | 32 | 49315 | 11338 | 63428337 |
| Pericarditis | 17.99 | 10.84 | 48 | 49299 | 131531 | 63308144 |
| No adverse event | 17.88 | 10.84 | 5 | 49342 | 41400 | 63398275 |
| Haemoglobin decreased | 17.75 | 10.84 | 182 | 49165 | 145303 | 63294372 |
| Neutropenia | 17.72 | 10.84 | 211 | 49136 | 174794 | 63264881 |
| Dehydration | 17.54 | 10.84 | 209 | 49138 | 173145 | 63266530 |
| Device expulsion | 17.54 | 10.84 | 3 | 49344 | 34919 | 63404756 |
| Sinusitis | 17.41 | 10.84 | 104 | 49243 | 226549 | 63213126 |
| Breast cancer | 17.23 | 10.84 | 8 | 49339 | 48375 | 63391300 |
| Physical assault | 17.07 | 10.84 | 10 | 49337 | 913 | 63438762 |
| Hiccups | 16.98 | 10.84 | 14 | 49333 | 2217 | 63437458 |
| Angiodermatitis | 16.94 | 10.84 | 5 | 49342 | 76 | 63439599 |
| Dermatitis exfoliative | 16.83 | 10.84 | 21 | 49326 | 5438 | 63434237 |
| Lethargy | 16.79 | 10.84 | 87 | 49260 | 55920 | 63383755 |
| Mental status changes | 16.70 | 10.84 | 68 | 49279 | 39531 | 63400144 |
| Pseudomembranous colitis | 16.65 | 10.84 | 16 | 49331 | 3096 | 63436579 |
| Nasal congestion | 16.49 | 10.84 | 16 | 49331 | 65644 | 63374031 |
| Adverse event | 16.35 | 10.84 | 17 | 49330 | 67542 | 63372133 |
| Joint effusion | 16.34 | 10.84 | 39 | 49308 | 17021 | 63422654 |
| Cogwheel rigidity | 16.34 | 10.84 | 13 | 49334 | 1957 | 63437718 |
| Immunosuppressant drug level increased | 16.32 | 10.84 | 17 | 49330 | 3621 | 63436054 |
| Febrile bone marrow aplasia | 16.23 | 10.84 | 24 | 49323 | 7301 | 63432374 |
| Antinuclear antibody | 16.20 | 10.84 | 8 | 49339 | 518 | 63439157 |
| Gastrointestinal pain | 16.12 | 10.84 | 28 | 49319 | 9748 | 63429927 |
| Liver function test increased | 16.09 | 10.84 | 3 | 49344 | 32808 | 63406867 |
| Synovial disorder | 15.91 | 10.84 | 13 | 49334 | 2032 | 63437643 |
| Blood culture positive | 15.87 | 10.84 | 19 | 49328 | 4716 | 63434959 |
| Liver disorder | 15.82 | 10.84 | 83 | 49264 | 53604 | 63386071 |
| Purpura senile | 15.69 | 10.84 | 8 | 49339 | 555 | 63439120 |
| Meningitis aseptic | 15.59 | 10.84 | 19 | 49328 | 4804 | 63434871 |
| Left ventricular dysfunction | 15.59 | 10.84 | 31 | 49316 | 11957 | 63427718 |
| Tarsal tunnel syndrome | 15.54 | 10.84 | 8 | 49339 | 566 | 63439109 |
| Haemorrhoids | 15.46 | 10.84 | 45 | 49302 | 22105 | 63417570 |
| Migraine | 15.45 | 10.84 | 36 | 49311 | 103310 | 63336365 |
| Anti-cyclic citrullinated peptide antibody positive | 15.43 | 10.84 | 43 | 49304 | 116169 | 63323506 |
| Vestibular disorder | 15.32 | 10.84 | 11 | 49336 | 1420 | 63438255 |
| Proctitis | 15.31 | 10.84 | 20 | 49327 | 5421 | 63434254 |
| Paraesthesia oral | 15.29 | 10.84 | 41 | 49306 | 19215 | 63420460 |
| Blood alkaline phosphatase increased | 15.21 | 10.84 | 70 | 49277 | 42897 | 63396778 |
| Oliguria | 14.92 | 10.84 | 26 | 49321 | 9075 | 63430600 |
| Subdural haemorrhage | 14.77 | 10.84 | 15 | 49332 | 3103 | 63436572 |
| Acute respiratory distress syndrome | 14.72 | 10.84 | 46 | 49301 | 23488 | 63416187 |
| Impaired work ability | 14.68 | 10.84 | 38 | 49309 | 17437 | 63422238 |
| Jaundice | 14.60 | 10.84 | 53 | 49294 | 29198 | 63410477 |
| Lung transplant rejection | 14.45 | 10.84 | 9 | 49338 | 918 | 63438757 |
| Malaise | 14.37 | 10.84 | 424 | 48923 | 415530 | 63024145 |
| Procedural pain | 14.28 | 10.84 | 43 | 49304 | 21526 | 63418149 |
| Lung disorder | 14.25 | 10.84 | 90 | 49257 | 62171 | 63377504 |
| Hepatitis | 14.22 | 10.84 | 65 | 49282 | 39723 | 63399952 |
| Cushing's syndrome | 14.19 | 10.84 | 8 | 49339 | 679 | 63438996 |
| Vaginal flatulence | 14.09 | 10.84 | 15 | 49332 | 3278 | 63436397 |
| Hepatic failure | 14.07 | 10.84 | 60 | 49287 | 35596 | 63404079 |
| Citrobacter infection | 13.99 | 10.84 | 7 | 49340 | 466 | 63439209 |
| Pain in extremity | 13.89 | 10.84 | 178 | 49169 | 331308 | 63108367 |
| Genital burning sensation | 13.88 | 10.84 | 6 | 49341 | 286 | 63439389 |
| Tonsillar hypertrophy | 13.81 | 10.84 | 9 | 49338 | 992 | 63438683 |
| Alanine aminotransferase increased | 13.71 | 10.84 | 132 | 49215 | 103638 | 63336037 |
| Pustule | 13.64 | 10.84 | 11 | 49336 | 1688 | 63437987 |
| Asthma | 13.61 | 10.84 | 52 | 49295 | 127509 | 63312166 |
| Unevaluable event | 13.52 | 10.84 | 12 | 49335 | 51374 | 63388301 |
| Hypovolaemic shock | 13.19 | 10.84 | 20 | 49327 | 6221 | 63433454 |
| Hydronephrosis | 13.18 | 10.84 | 27 | 49320 | 10635 | 63429040 |
| Depression | 13.14 | 10.84 | 94 | 49253 | 196398 | 63243277 |
| Cataract | 13.09 | 10.84 | 15 | 49332 | 57038 | 63382637 |
| Herpes simplex viraemia | 13.07 | 10.84 | 6 | 49341 | 330 | 63439345 |
| Stress | 13.03 | 10.84 | 20 | 49327 | 67147 | 63372528 |
| Areflexia | 12.98 | 10.84 | 14 | 49333 | 3104 | 63436571 |
| Axillary vein thrombosis | 12.92 | 10.84 | 6 | 49341 | 339 | 63439336 |
| Altered visual depth perception | 12.85 | 10.84 | 6 | 49341 | 343 | 63439332 |
| Memory impairment | 12.81 | 10.84 | 40 | 49307 | 104218 | 63335457 |
| HIV wasting syndrome | 12.80 | 10.84 | 3 | 49344 | 17 | 63439658 |
| Dermatitis allergic | 12.79 | 10.84 | 33 | 49314 | 15115 | 63424560 |
| Muscle haemorrhage | 12.76 | 10.84 | 14 | 49333 | 3165 | 63436510 |
| Sepsis | 12.70 | 10.84 | 178 | 49169 | 152945 | 63286730 |
| Disseminated intravascular coagulation | 12.63 | 10.84 | 38 | 49309 | 19013 | 63420662 |
| Neutrophil count decreased | 12.58 | 10.84 | 81 | 49266 | 56325 | 63383350 |
| Hypoaesthesia | 12.54 | 10.84 | 78 | 49269 | 168315 | 63271360 |
| Mobility decreased | 12.54 | 10.84 | 50 | 49297 | 121109 | 63318566 |
| Aspartate aminotransferase increased | 12.50 | 10.84 | 116 | 49231 | 90161 | 63349514 |
| Porphyria acute | 12.49 | 10.84 | 9 | 49338 | 1168 | 63438507 |
| Dialysis | 12.42 | 10.84 | 26 | 49321 | 10401 | 63429274 |
| Escherichia test positive | 12.27 | 10.84 | 12 | 49335 | 2372 | 63437303 |
| Gait disturbance | 12.07 | 10.84 | 88 | 49259 | 183090 | 63256585 |
| Graft versus host disease | 11.98 | 10.84 | 20 | 49327 | 6743 | 63432932 |
| Lip ulceration | 11.85 | 10.84 | 11 | 49336 | 2039 | 63437636 |
| Ataxia | 11.71 | 10.84 | 32 | 49315 | 15163 | 63424512 |
| Nail infection | 11.70 | 10.84 | 12 | 49335 | 2511 | 63437164 |
| Plasma cell myeloma | 11.62 | 10.84 | 57 | 49290 | 35848 | 63403827 |
| Cytomegalovirus test positive | 11.61 | 10.84 | 13 | 49334 | 3005 | 63436670 |
| Renal tubular acidosis | 11.60 | 10.84 | 10 | 49337 | 1682 | 63437993 |
| Vaginal ulceration | 11.58 | 10.84 | 6 | 49341 | 430 | 63439245 |
| Pleural effusion | 11.55 | 10.84 | 117 | 49230 | 93093 | 63346582 |
| Abnormal loss of weight | 11.47 | 10.84 | 18 | 49329 | 5764 | 63433911 |
| Drug hypersensitivity | 11.35 | 10.84 | 319 | 49028 | 310368 | 63129307 |
| Intentional self-injury | 11.28 | 10.84 | 3 | 49344 | 25684 | 63413991 |
| Defaecation urgency | 11.21 | 10.84 | 15 | 49332 | 4160 | 63435515 |
| Hypersensitivity pneumonitis | 11.21 | 10.84 | 12 | 49335 | 2638 | 63437037 |
| Circulatory collapse | 11.16 | 10.84 | 40 | 49307 | 21898 | 63417777 |
| Eye irritation | 11.13 | 10.84 | 40 | 49307 | 21931 | 63417744 |
| Retinal detachment | 11.05 | 10.84 | 18 | 49329 | 5951 | 63433724 |
| Blood folate decreased | 11.03 | 10.84 | 7 | 49340 | 737 | 63438938 |
| Functional gastrointestinal disorder | 10.98 | 10.84 | 15 | 49332 | 4244 | 63435431 |
| Apraxia | 10.97 | 10.84 | 10 | 49337 | 1811 | 63437864 |
| Joint range of motion decreased | 10.87 | 10.84 | 52 | 49295 | 32376 | 63407299 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Off label use | 178.29 | 11.27 | 118 | 37687 | 419406 | 34499720 |
| Hyperkalaemia | 159.03 | 11.27 | 276 | 37529 | 69113 | 34850013 |
| Drug ineffective | 156.23 | 11.27 | 159 | 37646 | 456592 | 34462534 |
| Pyrexia | 154.26 | 11.27 | 739 | 37066 | 332274 | 34586852 |
| Acute kidney injury | 126.30 | 11.27 | 656 | 37149 | 304332 | 34614794 |
| Neutropenia | 110.14 | 11.27 | 396 | 37409 | 156382 | 34762744 |
| Death | 95.25 | 11.27 | 179 | 37626 | 397870 | 34521256 |
| Blood creatinine increased | 92.10 | 11.27 | 268 | 37537 | 94708 | 34824418 |
| Pancytopenia | 87.02 | 11.27 | 263 | 37542 | 94894 | 34824232 |
| Drug abuse | 86.98 | 11.27 | 5 | 37800 | 99091 | 34820035 |
| Stevens-Johnson syndrome | 86.90 | 11.27 | 104 | 37701 | 18535 | 34900591 |
| Immune reconstitution inflammatory syndrome | 85.60 | 11.27 | 73 | 37732 | 8686 | 34910440 |
| Cytomegalovirus infection | 81.88 | 11.27 | 120 | 37685 | 26015 | 34893111 |
| Completed suicide | 75.08 | 11.27 | 9 | 37796 | 98159 | 34820967 |
| Product dose omission issue | 70.42 | 11.27 | 21 | 37784 | 119690 | 34799436 |
| Transplant rejection | 66.14 | 11.27 | 68 | 37737 | 10243 | 34908883 |
| Product use in unapproved indication | 53.89 | 11.27 | 30 | 37775 | 117469 | 34801657 |
| Hepatic cytolysis | 53.48 | 11.27 | 72 | 37733 | 14424 | 34904702 |
| Product use issue | 53.07 | 11.27 | 4 | 37801 | 63212 | 34855914 |
| Kidney transplant rejection | 50.92 | 11.27 | 51 | 37754 | 7446 | 34911680 |
| Thrombocytopenia | 50.45 | 11.27 | 315 | 37490 | 155932 | 34763194 |
| Cellulitis enterococcal | 47.80 | 11.27 | 13 | 37792 | 100 | 34919026 |
| Agranulocytosis | 47.15 | 11.27 | 89 | 37716 | 23732 | 34895394 |
| Leukopenia | 45.91 | 11.27 | 161 | 37644 | 62695 | 34856431 |
| Fatigue | 45.17 | 11.27 | 227 | 37578 | 370426 | 34548700 |
| Renal tubular necrosis | 43.43 | 11.27 | 68 | 37737 | 15612 | 34903514 |
| Inappropriate schedule of product administration | 42.37 | 11.27 | 8 | 37797 | 62288 | 34856838 |
| Pneumocystis jirovecii pneumonia | 41.97 | 11.27 | 76 | 37729 | 19634 | 34899492 |
| Aspartate aminotransferase increased | 41.47 | 11.27 | 164 | 37641 | 67619 | 34851507 |
| Pre-engraftment immune reaction | 40.06 | 11.27 | 11 | 37794 | 88 | 34919038 |
| Haemodialysis | 39.93 | 11.27 | 53 | 37752 | 10473 | 34908653 |
| Alanine aminotransferase increased | 37.56 | 11.27 | 180 | 37625 | 80635 | 34838491 |
| Blood lactate dehydrogenase increased | 37.23 | 11.27 | 79 | 37726 | 22911 | 34896215 |
| Blood bilirubin increased | 36.99 | 11.27 | 108 | 37697 | 38188 | 34880938 |
| Hepatitis | 36.26 | 11.27 | 80 | 37725 | 23824 | 34895302 |
| Cholestasis | 36.25 | 11.27 | 86 | 37719 | 26862 | 34892264 |
| Lymphocyte count decreased | 35.79 | 11.27 | 77 | 37728 | 22545 | 34896581 |
| Anal inflammation | 34.51 | 11.27 | 20 | 37785 | 1280 | 34917846 |
| Blood urea increased | 33.62 | 11.27 | 90 | 37715 | 30274 | 34888852 |
| Weight increased | 33.18 | 11.27 | 31 | 37774 | 93002 | 34826124 |
| Toxicity to various agents | 32.26 | 11.27 | 110 | 37695 | 200252 | 34718874 |
| Osteoporotic fracture | 32.17 | 11.27 | 18 | 37787 | 1077 | 34918049 |
| Respiratory tract infection bacterial | 31.09 | 11.27 | 21 | 37784 | 1761 | 34917365 |
| Respiratory tract infection viral | 30.97 | 11.27 | 24 | 37781 | 2493 | 34916633 |
| SARS-CoV-2 test negative | 30.60 | 11.27 | 17 | 37788 | 1003 | 34918123 |
| Rash | 29.90 | 11.27 | 370 | 37435 | 222382 | 34696744 |
| Aplasia pure red cell | 29.87 | 11.27 | 35 | 37770 | 6097 | 34913029 |
| Platelet count decreased | 29.50 | 11.27 | 226 | 37579 | 119491 | 34799635 |
| Rash maculo-papular | 29.18 | 11.27 | 82 | 37723 | 28369 | 34890757 |
| Proctalgia | 28.43 | 11.27 | 33 | 37772 | 5690 | 34913436 |
| Plasma cell myeloma | 28.40 | 11.27 | 105 | 37700 | 41932 | 34877194 |
| Hospitalisation | 28.36 | 11.27 | 13 | 37792 | 56889 | 34862237 |
| Toxic skin eruption | 28.29 | 11.27 | 47 | 37758 | 11338 | 34907788 |
| Encephalitis viral | 27.88 | 11.27 | 17 | 37788 | 1195 | 34917931 |
| Liver transplant rejection | 27.82 | 11.27 | 21 | 37784 | 2098 | 34917028 |
| Fall | 27.74 | 11.27 | 119 | 37686 | 202766 | 34716360 |
| Dialysis | 27.49 | 11.27 | 46 | 37759 | 11162 | 34907964 |
| Blood alkaline phosphatase increased | 27.35 | 11.27 | 85 | 37720 | 31090 | 34888036 |
| Body temperature increased | 27.34 | 11.27 | 59 | 37746 | 17309 | 34901817 |
| Renal failure | 27.06 | 11.27 | 237 | 37568 | 130320 | 34788806 |
| HIV infection | 26.32 | 11.27 | 17 | 37788 | 1322 | 34917804 |
| Blood antidiuretic hormone increased | 26.31 | 11.27 | 7 | 37798 | 49 | 34919077 |
| Intestinal intraepithelial lymphocytes increased | 26.20 | 11.27 | 9 | 37796 | 161 | 34918965 |
| Cerebrovascular accident | 26.07 | 11.27 | 32 | 37773 | 84779 | 34834347 |
| Therapeutic product effect incomplete | 26.05 | 11.27 | 11 | 37794 | 50530 | 34868596 |
| Asthma | 25.95 | 11.27 | 7 | 37798 | 42649 | 34876477 |
| Liver function test abnormal | 25.68 | 11.27 | 83 | 37722 | 30991 | 34888135 |
| Hepatitis cholestatic | 25.62 | 11.27 | 37 | 37768 | 7910 | 34911216 |
| Drug reaction with eosinophilia and systemic symptoms | 25.34 | 11.27 | 86 | 37719 | 32926 | 34886200 |
| Acquired immunodeficiency syndrome | 25.33 | 11.27 | 12 | 37793 | 506 | 34918620 |
| Chills | 25.23 | 11.27 | 162 | 37643 | 80881 | 34838245 |
| Intentional overdose | 25.05 | 11.27 | 8 | 37797 | 43666 | 34875460 |
| Intentional product use issue | 25.00 | 11.27 | 17 | 37788 | 59799 | 34859327 |
| Pneumonia cytomegaloviral | 24.94 | 11.27 | 23 | 37782 | 3031 | 34916095 |
| Rash morbilliform | 24.73 | 11.27 | 23 | 37782 | 3064 | 34916062 |
| Kaposi's sarcoma | 24.55 | 11.27 | 14 | 37791 | 869 | 34918257 |
| Aspergillus infection | 24.51 | 11.27 | 46 | 37759 | 12208 | 34906918 |
| Jaundice | 24.42 | 11.27 | 83 | 37722 | 31799 | 34887327 |
| Proteus infection | 24.13 | 11.27 | 15 | 37790 | 1091 | 34918035 |
| Graft versus host disease | 24.10 | 11.27 | 42 | 37763 | 10527 | 34908599 |
| Bone marrow failure | 24.05 | 11.27 | 78 | 37727 | 29175 | 34889951 |
| Lymphocele | 23.69 | 11.27 | 16 | 37789 | 1341 | 34917785 |
| Blood potassium increased | 23.67 | 11.27 | 54 | 37751 | 16441 | 34902685 |
| Cryptitis | 23.32 | 11.27 | 9 | 37796 | 227 | 34918899 |
| Hepatomegaly | 23.30 | 11.27 | 41 | 37764 | 10355 | 34908771 |
| Tubulointerstitial nephritis | 22.95 | 11.27 | 62 | 37743 | 20962 | 34898164 |
| Culture urine positive | 22.90 | 11.27 | 15 | 37790 | 1195 | 34917931 |
| Injection site pain | 22.63 | 11.27 | 7 | 37798 | 38998 | 34880128 |
| Peripheral swelling | 22.37 | 11.27 | 30 | 37775 | 76511 | 34842615 |
| Hepatosplenomegaly | 22.34 | 11.27 | 25 | 37780 | 4144 | 34914982 |
| Renal papillary necrosis | 22.28 | 11.27 | 8 | 37797 | 164 | 34918962 |
| Nasopharyngitis | 21.93 | 11.27 | 26 | 37779 | 69942 | 34849184 |
| Intentional product misuse | 21.84 | 11.27 | 11 | 37794 | 45600 | 34873526 |
| Foetal exposure during pregnancy | 21.81 | 11.27 | 7 | 37798 | 38094 | 34881032 |
| SARS-CoV-2 antibody test positive | 21.28 | 11.27 | 10 | 37795 | 414 | 34918712 |
| Treatment failure | 21.28 | 11.27 | 12 | 37793 | 46685 | 34872441 |
| Leukaemia recurrent | 21.19 | 11.27 | 16 | 37789 | 1599 | 34917527 |
| Microvillous inclusion disease | 21.10 | 11.27 | 8 | 37797 | 192 | 34918934 |
| Drug intolerance | 21.06 | 11.27 | 20 | 37785 | 59550 | 34859576 |
| Neutrophil count decreased | 21.02 | 11.27 | 110 | 37695 | 50994 | 34868132 |
| Motion sickness | 20.99 | 11.27 | 8 | 37797 | 195 | 34918931 |
| Mental status changes | 20.79 | 11.27 | 89 | 37716 | 37994 | 34881132 |
| Therapeutic product effect decreased | 20.58 | 11.27 | 6 | 37799 | 34737 | 34884389 |
| Dyspnoea | 20.43 | 11.27 | 286 | 37519 | 376496 | 34542630 |
| White blood cell count decreased | 20.15 | 11.27 | 174 | 37631 | 95271 | 34823855 |
| Haemorrhoids | 20.12 | 11.27 | 47 | 37758 | 14528 | 34904598 |
| Dermatitis exfoliative | 20.08 | 11.27 | 30 | 37775 | 6609 | 34912517 |
| Probiotic therapy | 19.99 | 11.27 | 7 | 37798 | 133 | 34918993 |
| Wrong technique in product usage process | 19.92 | 11.27 | 7 | 37798 | 35979 | 34883147 |
| Gamma-glutamyltransferase increased | 19.73 | 11.27 | 73 | 37732 | 29158 | 34889968 |
| Human herpesvirus 6 infection | 19.63 | 11.27 | 17 | 37788 | 2064 | 34917062 |
| Clonal haematopoiesis | 19.23 | 11.27 | 6 | 37799 | 78 | 34919048 |
| Biopsy liver abnormal | 19.16 | 11.27 | 7 | 37798 | 151 | 34918975 |
| Joint swelling | 19.04 | 11.27 | 22 | 37783 | 59868 | 34859258 |
| Apoptosis | 18.52 | 11.27 | 9 | 37796 | 402 | 34918724 |
| Lung infiltration | 18.24 | 11.27 | 42 | 37763 | 12863 | 34906263 |
| Serum sickness | 18.18 | 11.27 | 16 | 37789 | 1984 | 34917142 |
| Ureteric obstruction | 17.99 | 11.27 | 13 | 37792 | 1215 | 34917911 |
| Biopsy | 17.64 | 11.27 | 8 | 37797 | 305 | 34918821 |
| Viral test positive | 17.29 | 11.27 | 7 | 37798 | 201 | 34918925 |
| Haemoglobin decreased | 17.20 | 11.27 | 203 | 37602 | 120569 | 34798557 |
| Rheumatoid arthritis | 17.17 | 11.27 | 10 | 37795 | 38228 | 34880898 |
| Myocardial infarction | 17.16 | 11.27 | 70 | 37735 | 121015 | 34798111 |
| Chronic lymphocytic leukaemia | 17.12 | 11.27 | 22 | 37783 | 4210 | 34914916 |
| Phlebitis | 17.06 | 11.27 | 21 | 37784 | 3849 | 34915277 |
| Renal tubular disorder | 17.03 | 11.27 | 23 | 37782 | 4620 | 34914506 |
| Dizziness | 16.90 | 11.27 | 153 | 37652 | 218368 | 34700758 |
| Escherichia urinary tract infection | 16.87 | 11.27 | 20 | 37785 | 3526 | 34915600 |
| Suicide attempt | 16.50 | 11.27 | 11 | 37794 | 39105 | 34880021 |
| Oesophageal candidiasis | 16.46 | 11.27 | 22 | 37783 | 4374 | 34914752 |
| Psoriasis | 16.26 | 11.27 | 11 | 37794 | 38801 | 34880325 |
| Syncope | 16.24 | 11.27 | 48 | 37757 | 91403 | 34827723 |
| Culture stool positive | 15.97 | 11.27 | 7 | 37798 | 246 | 34918880 |
| Enterovirus infection | 15.74 | 11.27 | 11 | 37794 | 975 | 34918151 |
| Idiopathic pneumonia syndrome | 15.53 | 11.27 | 7 | 37798 | 263 | 34918863 |
| Toxic epidermal necrolysis | 15.40 | 11.27 | 55 | 37750 | 21591 | 34897535 |
| Dehydration | 15.34 | 11.27 | 211 | 37594 | 129758 | 34789368 |
| Vomiting | 15.33 | 11.27 | 363 | 37442 | 247258 | 34671868 |
| Febrile neutropenia | 15.28 | 11.27 | 220 | 37585 | 136629 | 34782497 |
| Cytomegalovirus chorioretinitis | 15.06 | 11.27 | 19 | 37786 | 3570 | 34915556 |
| Erythema infectiosum | 15.03 | 11.27 | 6 | 37799 | 166 | 34918960 |
| Blood culture positive | 15.03 | 11.27 | 22 | 37783 | 4761 | 34914365 |
| Liver transplant | 14.97 | 11.27 | 16 | 37789 | 2518 | 34916608 |
| Parkinsonism hyperpyrexia syndrome | 14.85 | 11.27 | 5 | 37800 | 84 | 34919042 |
| Orbital haemorrhage | 14.79 | 11.27 | 4 | 37801 | 30 | 34919096 |
| Myositis | 14.61 | 11.27 | 37 | 37768 | 12033 | 34907093 |
| HIV wasting syndrome | 14.58 | 11.27 | 5 | 37800 | 89 | 34919037 |
| Photosensitivity reaction | 14.45 | 11.27 | 34 | 37771 | 10560 | 34908566 |
| Loss of personal independence in daily activities | 14.45 | 11.27 | 9 | 37796 | 33170 | 34885956 |
| Lymphadenopathy | 14.38 | 11.27 | 65 | 37740 | 28398 | 34890728 |
| Renal tubular acidosis | 14.34 | 11.27 | 15 | 37790 | 2304 | 34916822 |
| Drug ineffective for unapproved indication | 14.22 | 11.27 | 4 | 37801 | 23711 | 34895415 |
| Complications of transplanted kidney | 14.19 | 11.27 | 21 | 37784 | 4588 | 34914538 |
| Vena cava injury | 13.99 | 11.27 | 7 | 37798 | 333 | 34918793 |
| Light chain analysis decreased | 13.96 | 11.27 | 4 | 37801 | 38 | 34919088 |
| Lymphocytic infiltration | 13.86 | 11.27 | 9 | 37796 | 706 | 34918420 |
| Wound evisceration | 13.64 | 11.27 | 5 | 37800 | 109 | 34919017 |
| Acute graft versus host disease in skin | 13.63 | 11.27 | 22 | 37783 | 5179 | 34913947 |
| Peripheral motor neuropathy | 13.48 | 11.27 | 13 | 37792 | 1813 | 34917313 |
| Hepatic steatosis | 13.36 | 11.27 | 47 | 37758 | 18315 | 34900811 |
| Mycobacterium avium complex infection | 13.35 | 11.27 | 15 | 37790 | 2496 | 34916630 |
| Thrombotic microangiopathy | 13.30 | 11.27 | 33 | 37772 | 10597 | 34908529 |
| Hepatitis A antibody positive | 13.27 | 11.27 | 4 | 37801 | 46 | 34919080 |
| Sleep disorder | 13.25 | 11.27 | 9 | 37796 | 31679 | 34887447 |
| C-reactive protein increased | 13.23 | 11.27 | 102 | 37703 | 53996 | 34865130 |
| Cytomegalovirus test | 13.19 | 11.27 | 4 | 37801 | 47 | 34919079 |
| Stent removal | 12.88 | 11.27 | 3 | 37802 | 11 | 34919115 |
| Enterococcal infection | 12.84 | 11.27 | 30 | 37775 | 9276 | 34909850 |
| Transplant dysfunction | 12.70 | 11.27 | 15 | 37790 | 2634 | 34916492 |
| Cystic lymphangioma | 12.68 | 11.27 | 3 | 37802 | 12 | 34919114 |
| Optic neuropathy | 12.67 | 11.27 | 13 | 37792 | 1952 | 34917174 |
| Therapeutic product effect prolonged | 12.62 | 11.27 | 6 | 37799 | 255 | 34918871 |
| Cytomegalovirus viraemia | 12.57 | 11.27 | 26 | 37779 | 7404 | 34911722 |
| Hepatitis B antibody positive | 12.55 | 11.27 | 4 | 37801 | 56 | 34919070 |
| Immunosuppressant drug level increased | 12.45 | 11.27 | 23 | 37782 | 6032 | 34913094 |
| Malignant neoplasm progression | 12.40 | 11.27 | 51 | 37754 | 87995 | 34831131 |
| Blood calcium decreased | 12.30 | 11.27 | 31 | 37774 | 10053 | 34909073 |
| Wound infection | 12.25 | 11.27 | 25 | 37780 | 7054 | 34912072 |
| Laryngeal pain | 12.19 | 11.27 | 15 | 37790 | 2749 | 34916377 |
| Granulomatous rosacea | 12.11 | 11.27 | 5 | 37800 | 151 | 34918975 |
| Parvovirus infection | 12.11 | 11.27 | 7 | 37798 | 446 | 34918680 |
| Suprapubic pain | 12.08 | 11.27 | 7 | 37798 | 448 | 34918678 |
| Lymphopenia | 12.05 | 11.27 | 42 | 37763 | 16293 | 34902833 |
| Acute myocardial infarction | 12.03 | 11.27 | 25 | 37780 | 53694 | 34865432 |
| Heart rate decreased | 12.00 | 11.27 | 10 | 37795 | 31735 | 34887391 |
| Hepatitis C virus test | 11.95 | 11.27 | 4 | 37801 | 66 | 34919060 |
| Febrile bone marrow aplasia | 11.91 | 11.27 | 27 | 37778 | 8182 | 34910944 |
| Blood pressure increased | 11.82 | 11.27 | 52 | 37753 | 88050 | 34831076 |
| Product prescribing error | 11.79 | 11.27 | 5 | 37800 | 22922 | 34896204 |
| Sedation | 11.78 | 11.27 | 4 | 37801 | 21002 | 34898124 |
| Autoimmune haemolytic anaemia | 11.76 | 11.27 | 19 | 37786 | 4477 | 34914649 |
| Arthritis | 11.70 | 11.27 | 10 | 37795 | 31336 | 34887790 |
| Blood chloride increased | 11.69 | 11.27 | 15 | 37790 | 2866 | 34916260 |
| Granulomatosis with polyangiitis | 11.68 | 11.27 | 10 | 37795 | 1195 | 34917931 |
| Biliary sepsis | 11.65 | 11.27 | 8 | 37797 | 689 | 34918437 |
| Epidermal necrosis | 11.58 | 11.27 | 7 | 37798 | 484 | 34918642 |
| Rectal prolapse | 11.57 | 11.27 | 7 | 37798 | 485 | 34918641 |
| COVID-19 | 11.51 | 11.27 | 44 | 37761 | 77506 | 34841620 |
| Heart transplant rejection | 11.50 | 11.27 | 10 | 37795 | 1221 | 34917905 |
| Refusal of treatment by patient | 11.48 | 11.27 | 20 | 37785 | 5012 | 34914114 |
| Accident | 11.43 | 11.27 | 20 | 37785 | 5027 | 34914099 |
| Cytotoxic oedema | 11.40 | 11.27 | 5 | 37800 | 176 | 34918950 |
| Complications of transplant surgery | 11.34 | 11.27 | 7 | 37798 | 503 | 34918623 |
| Acute graft versus host disease in liver | 11.28 | 11.27 | 11 | 37794 | 1555 | 34917571 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Acute kidney injury | 246.16 | 10.31 | 1009 | 69558 | 518395 | 79155426 |
| Hyperkalaemia | 235.13 | 10.31 | 388 | 70179 | 114010 | 79559811 |
| Drug ineffective | 177.54 | 10.31 | 439 | 70128 | 1080474 | 78593347 |
| Pyrexia | 145.44 | 10.31 | 1062 | 69505 | 677647 | 78996174 |
| Pre-engraftment immune reaction | 141.25 | 10.31 | 37 | 70530 | 304 | 79673517 |
| Off label use | 139.87 | 10.31 | 380 | 70187 | 906835 | 78766986 |
| Completed suicide | 136.52 | 10.31 | 26 | 70541 | 245741 | 79428080 |
| Stevens-Johnson syndrome | 130.38 | 10.31 | 167 | 70400 | 38999 | 79634822 |
| Pancytopenia | 113.87 | 10.31 | 364 | 70203 | 165381 | 79508440 |
| Product dose omission issue | 111.26 | 10.31 | 40 | 70527 | 247497 | 79426324 |
| Death | 107.46 | 10.31 | 212 | 70355 | 566302 | 79107519 |
| Encephalitis viral | 106.64 | 10.31 | 50 | 70517 | 2529 | 79671292 |
| Swelling face | 103.55 | 10.31 | 208 | 70359 | 71004 | 79602817 |
| Drug abuse | 97.46 | 10.31 | 14 | 70553 | 162677 | 79511144 |
| Blood creatinine increased | 93.58 | 10.31 | 326 | 70241 | 154731 | 79519090 |
| Cytomegalovirus infection | 88.00 | 10.31 | 145 | 70422 | 42499 | 79631322 |
| Liver function test abnormal | 87.45 | 10.31 | 183 | 70384 | 64292 | 79609529 |
| Soft tissue disorder | 86.47 | 10.31 | 48 | 70519 | 3467 | 79670354 |
| Leukopenia | 79.18 | 10.31 | 255 | 70312 | 116258 | 79557563 |
| Injection site pain | 78.17 | 10.31 | 11 | 70556 | 129827 | 79543994 |
| Human herpesvirus 6 infection | 77.19 | 10.31 | 52 | 70515 | 5318 | 79668503 |
| Immune reconstitution inflammatory syndrome | 76.84 | 10.31 | 77 | 70490 | 13764 | 79660057 |
| Kidney transplant rejection | 76.10 | 10.31 | 67 | 70500 | 10179 | 79663642 |
| Fatigue | 72.47 | 10.31 | 504 | 70063 | 929223 | 78744598 |
| Transplant rejection | 69.65 | 10.31 | 86 | 70481 | 19351 | 79654470 |
| Product use issue | 67.62 | 10.31 | 52 | 70515 | 209770 | 79464051 |
| Hyponatraemia | 65.37 | 10.31 | 321 | 70246 | 177527 | 79496294 |
| Drug reaction with eosinophilia and systemic symptoms | 61.45 | 10.31 | 159 | 70408 | 64085 | 79609736 |
| Inappropriate schedule of product administration | 61.02 | 10.31 | 21 | 70546 | 133607 | 79540214 |
| Pneumonia viral | 60.37 | 10.31 | 56 | 70511 | 9102 | 79664719 |
| Neutropenia | 60.03 | 10.31 | 448 | 70119 | 287262 | 79386559 |
| Allergy to chemicals | 59.85 | 10.31 | 34 | 70533 | 2568 | 79671253 |
| Thrombocytopenia | 59.34 | 10.31 | 420 | 70147 | 264839 | 79408982 |
| Rash maculo-papular | 58.03 | 10.31 | 143 | 70424 | 55935 | 79617886 |
| Toxicity to various agents | 57.14 | 10.31 | 187 | 70380 | 421353 | 79252468 |
| Intentional overdose | 57.14 | 10.31 | 12 | 70555 | 105948 | 79567873 |
| Tenosynovitis stenosans | 57.10 | 10.31 | 35 | 70532 | 3043 | 79670778 |
| International normalised ratio increased | 54.47 | 10.31 | 182 | 70385 | 84539 | 79589282 |
| Synovial fluid analysis | 52.05 | 10.31 | 30 | 70537 | 2329 | 79671492 |
| Fall | 51.57 | 10.31 | 239 | 70328 | 487390 | 79186431 |
| Scleritis | 50.54 | 10.31 | 37 | 70530 | 4319 | 79669502 |
| Haemodialysis | 49.08 | 10.31 | 70 | 70497 | 18098 | 79655723 |
| Lip swelling | 48.49 | 10.31 | 110 | 70457 | 40801 | 79633020 |
| Renal failure | 47.75 | 10.31 | 323 | 70244 | 200645 | 79473176 |
| Wrong technique in product usage process | 47.55 | 10.31 | 5 | 70562 | 73870 | 79599951 |
| Nasopharyngitis | 47.16 | 10.31 | 96 | 70471 | 253785 | 79420036 |
| Psoriasis | 46.58 | 10.31 | 11 | 70556 | 89576 | 79584245 |
| Fear of eating | 46.39 | 10.31 | 17 | 70550 | 456 | 79673365 |
| Renal tubular necrosis | 46.18 | 10.31 | 81 | 70486 | 24958 | 79648863 |
| Rash | 45.40 | 10.31 | 741 | 69826 | 577617 | 79096204 |
| Blood pressure increased | 44.51 | 10.31 | 74 | 70493 | 211286 | 79462535 |
| Agranulocytosis | 42.60 | 10.31 | 111 | 70456 | 44919 | 79628902 |
| Toxic epidermal necrolysis | 42.28 | 10.31 | 110 | 70457 | 44471 | 79629350 |
| Platelet count decreased | 41.63 | 10.31 | 305 | 70262 | 194359 | 79479462 |
| Intentional product use issue | 41.47 | 10.31 | 44 | 70523 | 152068 | 79521753 |
| Pneumocystis jirovecii pneumonia | 41.45 | 10.31 | 90 | 70477 | 32418 | 79641403 |
| Genital ulceration | 41.43 | 10.31 | 20 | 70547 | 1080 | 79672741 |
| Photophobia | 41.27 | 10.31 | 69 | 70498 | 20459 | 79653362 |
| Ureteric obstruction | 40.72 | 10.31 | 27 | 70540 | 2689 | 79671132 |
| Intentional product misuse | 40.04 | 10.31 | 17 | 70550 | 95148 | 79578673 |
| Conjunctivitis | 39.64 | 10.31 | 77 | 70490 | 25638 | 79648183 |
| Urosepsis | 39.22 | 10.31 | 78 | 70489 | 26417 | 79647404 |
| Weight increased | 38.98 | 10.31 | 121 | 70446 | 277265 | 79396556 |
| Ejection fraction decreased | 38.81 | 10.31 | 91 | 70476 | 34486 | 79639335 |
| Tubulointerstitial nephritis | 37.98 | 10.31 | 96 | 70471 | 38139 | 79635682 |
| Mouth swelling | 37.96 | 10.31 | 36 | 70531 | 6015 | 79667806 |
| Tenderness | 37.93 | 10.31 | 72 | 70495 | 23570 | 79650251 |
| Alopecia | 37.65 | 10.31 | 94 | 70473 | 231261 | 79442560 |
| Haemorrhoids | 37.54 | 10.31 | 81 | 70486 | 29047 | 79644774 |
| Genital pain | 37.46 | 10.31 | 17 | 70550 | 797 | 79673024 |
| Blood urea increased | 37.02 | 10.31 | 111 | 70456 | 48679 | 79625142 |
| Pleuritic pain | 36.50 | 10.31 | 45 | 70522 | 10107 | 79663714 |
| Psoriatic arthropathy | 36.05 | 10.31 | 12 | 70555 | 77987 | 79595834 |
| Hepatitis | 35.18 | 10.31 | 119 | 70448 | 55608 | 79618213 |
| Suicide attempt | 34.60 | 10.31 | 15 | 70552 | 82917 | 79590904 |
| Hypophagia | 34.22 | 10.31 | 103 | 70464 | 45264 | 79628557 |
| Abdominal discomfort | 34.08 | 10.31 | 111 | 70456 | 250616 | 79423205 |
| Confusional state | 33.88 | 10.31 | 430 | 70137 | 317567 | 79356254 |
| Anal inflammation | 33.74 | 10.31 | 19 | 70548 | 1411 | 79672410 |
| Swollen tongue | 33.39 | 10.31 | 98 | 70469 | 42472 | 79631349 |
| Nasal congestion | 33.30 | 10.31 | 13 | 70554 | 76539 | 79597282 |
| Dialysis | 33.11 | 10.31 | 59 | 70508 | 18403 | 79655418 |
| Angioedema | 32.89 | 10.31 | 144 | 70423 | 75891 | 79597930 |
| Injection site erythema | 32.85 | 10.31 | 14 | 70553 | 78183 | 79595638 |
| Crepitations | 32.21 | 10.31 | 42 | 70525 | 9975 | 79663846 |
| Respiratory tract infection bacterial | 31.99 | 10.31 | 21 | 70546 | 2056 | 79671765 |
| Blood pressure systolic increased | 31.50 | 10.31 | 10 | 70557 | 66976 | 79606845 |
| Deafness transitory | 31.28 | 10.31 | 16 | 70551 | 979 | 79672842 |
| Rash pruritic | 30.49 | 10.31 | 135 | 70432 | 71494 | 79602327 |
| Jaundice | 30.29 | 10.31 | 110 | 70457 | 53239 | 79620582 |
| Rash erythematous | 30.20 | 10.31 | 116 | 70451 | 57653 | 79616168 |
| Deep vein thrombosis | 29.69 | 10.31 | 196 | 70371 | 120723 | 79553098 |
| Blood lactate dehydrogenase increased | 29.61 | 10.31 | 89 | 70478 | 39081 | 79634740 |
| Influenza | 29.54 | 10.31 | 43 | 70524 | 129563 | 79544258 |
| Bone marrow failure | 29.54 | 10.31 | 106 | 70461 | 51001 | 79622820 |
| Cushingoid | 29.09 | 10.31 | 39 | 70528 | 9513 | 79664308 |
| Deformity | 28.92 | 10.31 | 39 | 70528 | 9566 | 79664255 |
| Superinfection | 28.56 | 10.31 | 28 | 70539 | 4874 | 79668947 |
| Blood potassium increased | 28.55 | 10.31 | 73 | 70494 | 29202 | 79644619 |
| Cellulitis enterococcal | 28.09 | 10.31 | 7 | 70560 | 46 | 79673775 |
| Atelectasis | 27.97 | 10.31 | 77 | 70490 | 32180 | 79641641 |
| Meningoencephalitis herpetic | 27.97 | 10.31 | 19 | 70548 | 1970 | 79671851 |
| Blood alkaline phosphatase increased | 27.86 | 10.31 | 121 | 70446 | 63543 | 79610278 |
| Liver transplant rejection | 27.71 | 10.31 | 23 | 70544 | 3225 | 79670596 |
| Proctalgia | 27.70 | 10.31 | 39 | 70528 | 9962 | 79663859 |
| Oral pain | 27.67 | 10.31 | 76 | 70491 | 31722 | 79642099 |
| Intestinal intraepithelial lymphocytes increased | 27.47 | 10.31 | 9 | 70558 | 171 | 79673650 |
| Asthma | 26.88 | 10.31 | 49 | 70518 | 135046 | 79538775 |
| Hepatic cytolysis | 26.78 | 10.31 | 68 | 70499 | 27083 | 79646738 |
| Alanine aminotransferase increased | 26.76 | 10.31 | 240 | 70327 | 162330 | 79511491 |
| Clostridial infection | 26.71 | 10.31 | 29 | 70538 | 5685 | 79668136 |
| Blood culture positive | 26.57 | 10.31 | 35 | 70532 | 8394 | 79665427 |
| Haemoglobin decreased | 26.53 | 10.31 | 307 | 70260 | 221812 | 79452009 |
| SARS-CoV-2 test negative | 26.48 | 10.31 | 16 | 70551 | 1355 | 79672466 |
| Bronchopulmonary aspergillosis | 26.48 | 10.31 | 60 | 70507 | 22234 | 79651587 |
| Documented hypersensitivity to administered product | 26.26 | 10.31 | 14 | 70553 | 933 | 79672888 |
| Vulvovaginal candidiasis | 26.15 | 10.31 | 20 | 70547 | 2494 | 79671327 |
| Hospitalisation | 25.97 | 10.31 | 27 | 70540 | 94209 | 79579612 |
| Maternal exposure during pregnancy | 25.87 | 10.31 | 51 | 70516 | 136487 | 79537334 |
| Complications of transplanted kidney | 25.81 | 10.31 | 30 | 70537 | 6336 | 79667485 |
| Plasma cell myeloma | 25.47 | 10.31 | 104 | 70463 | 53155 | 79620666 |
| Mental status changes | 25.39 | 10.31 | 122 | 70445 | 66837 | 79606984 |
| Arthralgia | 25.34 | 10.31 | 355 | 70212 | 571448 | 79102373 |
| Liver transplant | 25.28 | 10.31 | 25 | 70542 | 4398 | 79669423 |
| Febrile bone marrow aplasia | 25.16 | 10.31 | 43 | 70524 | 12977 | 79660844 |
| Bacterial test positive | 25.15 | 10.31 | 32 | 70535 | 7417 | 79666404 |
| Vaginal discharge | 25.11 | 10.31 | 32 | 70535 | 7431 | 79666390 |
| Systemic lupus erythematosus | 24.95 | 10.31 | 43 | 70524 | 121106 | 79552715 |
| Liver function test increased | 24.82 | 10.31 | 3 | 70564 | 39770 | 79634051 |
| Infusion related reaction | 24.79 | 10.31 | 112 | 70455 | 230125 | 79443696 |
| Aspartate aminotransferase increased | 24.54 | 10.31 | 208 | 70359 | 138433 | 79535388 |
| Injection site pruritus | 24.48 | 10.31 | 4 | 70563 | 42279 | 79631542 |
| Loss of personal independence in daily activities | 24.41 | 10.31 | 33 | 70534 | 102547 | 79571274 |
| Aspergillus infection | 24.37 | 10.31 | 53 | 70514 | 19108 | 79654713 |
| Fluid retention | 24.18 | 10.31 | 16 | 70551 | 69793 | 79604028 |
| COVID-19 | 24.16 | 10.31 | 66 | 70501 | 157608 | 79516213 |
| Dermatitis exfoliative | 23.94 | 10.31 | 38 | 70529 | 10791 | 79663030 |
| Blood bilirubin increased | 23.91 | 10.31 | 119 | 70448 | 66113 | 79607708 |
| Hepatosplenomegaly | 23.61 | 10.31 | 28 | 70539 | 6041 | 79667780 |
| Pseudomonas infection | 23.44 | 10.31 | 55 | 70512 | 20848 | 79652973 |
| Culture urine positive | 23.39 | 10.31 | 24 | 70543 | 4411 | 79669410 |
| Serum sickness | 23.36 | 10.31 | 22 | 70545 | 3644 | 79670177 |
| Rash morbilliform | 23.31 | 10.31 | 28 | 70539 | 6122 | 79667699 |
| Synovial cyst | 23.19 | 10.31 | 36 | 70531 | 10029 | 79663792 |
| Pulmonary embolism | 23.13 | 10.31 | 243 | 70324 | 171411 | 79502410 |
| Oral candidiasis | 23.04 | 10.31 | 68 | 70499 | 29560 | 79644261 |
| Cryptitis | 23.04 | 10.31 | 9 | 70558 | 289 | 79673532 |
| Feeling jittery | 22.98 | 10.31 | 41 | 70526 | 12800 | 79661021 |
| Pregnancy with injectable contraceptive | 22.78 | 10.31 | 7 | 70560 | 107 | 79673714 |
| Injection site reaction | 22.71 | 10.31 | 10 | 70557 | 54775 | 79619046 |
| Pain | 22.41 | 10.31 | 464 | 70103 | 703338 | 78970483 |
| Arthropathy | 22.30 | 10.31 | 81 | 70486 | 177030 | 79496791 |
| Injection site swelling | 22.22 | 10.31 | 7 | 70560 | 47125 | 79626696 |
| Toxic skin eruption | 22.16 | 10.31 | 56 | 70511 | 22237 | 79651584 |
| Renal tubular disorder | 22.12 | 10.31 | 28 | 70539 | 6458 | 79667363 |
| Overdose | 22.06 | 10.31 | 86 | 70481 | 184120 | 79489701 |
| Vomiting | 21.85 | 10.31 | 756 | 69811 | 665072 | 79008749 |
| Product use in unapproved indication | 21.77 | 10.31 | 131 | 70436 | 250228 | 79423593 |
| Microvillous inclusion disease | 21.75 | 10.31 | 8 | 70559 | 217 | 79673604 |
| Red blood cell sedimentation rate increased | 21.35 | 10.31 | 7 | 70560 | 45935 | 79627886 |
| Apoptosis | 21.25 | 10.31 | 10 | 70557 | 510 | 79673311 |
| Lung infiltration | 21.18 | 10.31 | 56 | 70511 | 22856 | 79650965 |
| Excessive eye blinking | 20.99 | 10.31 | 15 | 70552 | 1686 | 79672135 |
| Blood sodium decreased | 20.97 | 10.31 | 71 | 70496 | 33184 | 79640637 |
| Therapeutic response decreased | 20.97 | 10.31 | 17 | 70550 | 66836 | 79606985 |
| Graft versus host disease | 20.77 | 10.31 | 43 | 70524 | 14983 | 79658838 |
| Meningitis aseptic | 20.66 | 10.31 | 28 | 70539 | 6900 | 79666921 |
| Blood antidiuretic hormone increased | 20.64 | 10.31 | 6 | 70561 | 75 | 79673746 |
| White blood cell count decreased | 20.62 | 10.31 | 256 | 70311 | 188032 | 79485789 |
| Respiratory tract infection viral | 20.59 | 10.31 | 22 | 70545 | 4237 | 79669584 |
| Hepatomegaly | 20.45 | 10.31 | 49 | 70518 | 18825 | 79654996 |
| Probiotic therapy | 20.45 | 10.31 | 7 | 70560 | 153 | 79673668 |
| Rheumatoid arthritis | 20.35 | 10.31 | 105 | 70462 | 208365 | 79465456 |
| Leukaemia recurrent | 20.32 | 10.31 | 18 | 70549 | 2756 | 79671065 |
| Viral test positive | 20.14 | 10.31 | 9 | 70558 | 407 | 79673414 |
| Fibromyalgia | 20.06 | 10.31 | 111 | 70456 | 64229 | 79609592 |
| Parkinsonian rest tremor | 20.02 | 10.31 | 8 | 70559 | 273 | 79673548 |
| Neutropenic sepsis | 19.99 | 10.31 | 61 | 70506 | 27003 | 79646818 |
| Flank pain | 19.89 | 10.31 | 50 | 70517 | 19794 | 79654027 |
| Renal papillary necrosis | 19.85 | 10.31 | 9 | 70558 | 421 | 79673400 |
| Urinary tract infection | 19.74 | 10.31 | 347 | 70220 | 274165 | 79399656 |
| Rhinorrhoea | 19.63 | 10.31 | 23 | 70544 | 76051 | 79597770 |
| Stress | 19.56 | 10.31 | 25 | 70542 | 79587 | 79594234 |
| Aplasia pure red cell | 19.51 | 10.31 | 29 | 70538 | 7781 | 79666040 |
| Liver disorder | 19.38 | 10.31 | 120 | 70447 | 72297 | 79601524 |
| Acquired immunodeficiency syndrome | 19.33 | 10.31 | 8 | 70559 | 299 | 79673522 |
| Antinuclear antibody positive | 19.28 | 10.31 | 29 | 70538 | 7861 | 79665960 |
| Cataract | 19.23 | 10.31 | 16 | 70551 | 62104 | 79611717 |
| Palmar erythema | 19.19 | 10.31 | 15 | 70552 | 1932 | 79671889 |
| Refusal of treatment by patient | 19.12 | 10.31 | 31 | 70536 | 8960 | 79664861 |
| Trimethylaminuria | 19.06 | 10.31 | 7 | 70560 | 189 | 79673632 |
| Body mass index decreased | 18.95 | 10.31 | 10 | 70557 | 653 | 79673168 |
| Cardiogenic shock | 18.43 | 10.31 | 7 | 70560 | 41907 | 79631914 |
| Cholestasis | 18.37 | 10.31 | 93 | 70474 | 52016 | 79621805 |
| Thrombotic microangiopathy | 18.34 | 10.31 | 49 | 70518 | 20120 | 79653701 |
| Gastrointestinal pain | 18.33 | 10.31 | 32 | 70535 | 9823 | 79663998 |
| Cytomegalovirus test | 18.21 | 10.31 | 5 | 70562 | 50 | 79673771 |
| Chronic lymphocytic leukaemia | 18.19 | 10.31 | 22 | 70545 | 4844 | 79668977 |
| Hepatitis fulminant | 18.19 | 10.31 | 27 | 70540 | 7235 | 79666586 |
| Pulmonary toxicity | 17.90 | 10.31 | 37 | 70530 | 12877 | 79660944 |
| Chronic obstructive pulmonary disease | 17.88 | 10.31 | 30 | 70537 | 85389 | 79588432 |
| Clostridium difficile infection | 17.82 | 10.31 | 80 | 70487 | 42605 | 79631216 |
| Colour blindness acquired | 17.80 | 10.31 | 6 | 70561 | 125 | 79673696 |
| Chronic sinusitis | 17.68 | 10.31 | 37 | 70530 | 12989 | 79660832 |
| Clostridium test positive | 17.63 | 10.31 | 25 | 70542 | 6429 | 79667392 |
| Ocular hyperaemia | 17.59 | 10.31 | 60 | 70507 | 28146 | 79645675 |
| Seizure | 17.46 | 10.31 | 249 | 70318 | 188585 | 79485236 |
| Foaming at mouth | 17.37 | 10.31 | 14 | 70553 | 1883 | 79671938 |
| Enterococcal infection | 17.34 | 10.31 | 41 | 70526 | 15619 | 79658202 |
| Erythema multiforme | 17.19 | 10.31 | 44 | 70523 | 17607 | 79656214 |
| Treatment failure | 17.13 | 10.31 | 85 | 70482 | 170401 | 79503420 |
| Biliary sepsis | 17.12 | 10.31 | 13 | 70554 | 1604 | 79672217 |
| Mucosal inflammation | 17.05 | 10.31 | 120 | 70447 | 75460 | 79598361 |
| Paraesthesia oral | 16.90 | 10.31 | 48 | 70519 | 20423 | 79653398 |
| Culture stool positive | 16.71 | 10.31 | 9 | 70558 | 612 | 79673209 |
| Lymphocele | 16.67 | 10.31 | 13 | 70554 | 1668 | 79672153 |
| Autoimmune haemolytic anaemia | 16.62 | 10.31 | 28 | 70539 | 8352 | 79665469 |
| HIV wasting syndrome | 16.61 | 10.31 | 5 | 70562 | 71 | 79673750 |
| Blood pressure fluctuation | 16.59 | 10.31 | 21 | 70546 | 67124 | 79606697 |
| Angiodermatitis | 16.42 | 10.31 | 5 | 70562 | 74 | 79673747 |
| Macular degeneration | 16.41 | 10.31 | 33 | 70534 | 11263 | 79662558 |
| HIV infection | 16.41 | 10.31 | 11 | 70556 | 1116 | 79672705 |
| Renal tubular acidosis | 16.30 | 10.31 | 18 | 70549 | 3596 | 79670225 |
| Osteonecrosis of jaw | 16.24 | 10.31 | 9 | 70558 | 43217 | 79630604 |
| Biopsy liver abnormal | 16.20 | 10.31 | 8 | 70559 | 454 | 79673367 |
| Antinuclear antibody | 16.12 | 10.31 | 8 | 70559 | 459 | 79673362 |
| Sinusitis | 16.11 | 10.31 | 104 | 70463 | 195397 | 79478424 |
| Rash macular | 15.91 | 10.31 | 59 | 70508 | 28840 | 79644981 |
| Dehydration | 15.84 | 10.31 | 308 | 70259 | 247879 | 79425942 |
| Pemphigus | 15.77 | 10.31 | 41 | 70526 | 99541 | 79574280 |
| Orbital haemorrhage | 15.71 | 10.31 | 4 | 70563 | 29 | 79673792 |
| Cholecystitis chronic | 15.68 | 10.31 | 30 | 70537 | 9876 | 79663945 |
| Inappropriate antidiuretic hormone secretion | 15.57 | 10.31 | 55 | 70512 | 26258 | 79647563 |
| Memory impairment | 15.49 | 10.31 | 49 | 70518 | 111685 | 79562136 |
| Effusion | 15.49 | 10.31 | 14 | 70553 | 2200 | 79671621 |
| Rectal haemorrhage | 15.41 | 10.31 | 118 | 70449 | 76182 | 79597639 |
| Eye pain | 15.37 | 10.31 | 70 | 70497 | 37508 | 79636313 |
| Abdominal pain | 15.27 | 10.31 | 452 | 70115 | 389117 | 79284704 |
| Blindness cortical | 15.25 | 10.31 | 10 | 70557 | 977 | 79672844 |
| Purpura senile | 15.16 | 10.31 | 8 | 70559 | 522 | 79673299 |
| Myocardial infarction | 15.15 | 10.31 | 98 | 70469 | 184031 | 79489790 |
| Vena cava injury | 15.10 | 10.31 | 7 | 70560 | 345 | 79673476 |
| Tarsal tunnel syndrome | 15.08 | 10.31 | 8 | 70559 | 528 | 79673293 |
| Complications of transplant surgery | 15.05 | 10.31 | 9 | 70558 | 748 | 79673073 |
| Chemotherapeutic drug level increased | 15.00 | 10.31 | 7 | 70560 | 350 | 79673471 |
| Granulomatous rosacea | 14.87 | 10.31 | 6 | 70561 | 210 | 79673611 |
| Erythema infectiosum | 14.84 | 10.31 | 6 | 70561 | 211 | 79673610 |
| Bone density decreased | 14.84 | 10.31 | 35 | 70532 | 13312 | 79660509 |
| Blood bilirubin unconjugated increased | 14.80 | 10.31 | 10 | 70557 | 1027 | 79672794 |
| Synovial disorder | 14.79 | 10.31 | 13 | 70554 | 1970 | 79671851 |
| Drug interaction | 14.75 | 10.31 | 476 | 70091 | 414707 | 79259114 |
| Cystitis noninfective | 14.69 | 10.31 | 11 | 70556 | 1329 | 79672492 |
| Drug dependence | 14.59 | 10.31 | 9 | 70558 | 40760 | 79633061 |
| Pain in extremity | 14.50 | 10.31 | 231 | 70336 | 364307 | 79309514 |
| Rheumatoid factor positive | 14.49 | 10.31 | 19 | 70548 | 59820 | 79614001 |
| Cardiac failure congestive | 14.30 | 10.31 | 71 | 70496 | 142331 | 79531490 |
| Pericarditis | 14.25 | 10.31 | 46 | 70521 | 104190 | 79569631 |
| Accidental exposure to product | 14.16 | 10.31 | 5 | 70562 | 31317 | 79642504 |
| Neuropathy peripheral | 14.15 | 10.31 | 189 | 70378 | 141116 | 79532705 |
| Unevaluable event | 14.13 | 10.31 | 17 | 70550 | 55568 | 79618253 |
| Lymphopenia | 14.08 | 10.31 | 59 | 70508 | 30498 | 79643323 |
| Hepatitis cholestatic | 13.98 | 10.31 | 35 | 70532 | 13817 | 79660004 |
| Myositis | 13.97 | 10.31 | 43 | 70524 | 19125 | 79654696 |
| Glossodynia | 13.85 | 10.31 | 46 | 70521 | 103291 | 79570530 |
| Therapy cessation | 13.85 | 10.31 | 8 | 70559 | 37554 | 79636267 |
| Device expulsion | 13.79 | 10.31 | 3 | 70564 | 25858 | 79647963 |
| Gastric disorder | 13.76 | 10.31 | 8 | 70559 | 37425 | 79636396 |
| Hepatic failure | 13.70 | 10.31 | 97 | 70470 | 61115 | 79612706 |
| Vaginal flatulence | 13.70 | 10.31 | 14 | 70553 | 2561 | 79671260 |
| Wound evisceration | 13.68 | 10.31 | 5 | 70562 | 133 | 79673688 |
| SARS-CoV-2 antibody test positive | 13.63 | 10.31 | 7 | 70560 | 432 | 79673389 |
| Limb discomfort | 13.61 | 10.31 | 6 | 70561 | 32844 | 79640977 |
| Soft tissue swelling | 13.58 | 10.31 | 11 | 70556 | 1490 | 79672331 |
| Malaise | 13.57 | 10.31 | 546 | 70021 | 489323 | 79184498 |
| Purpura | 13.49 | 10.31 | 43 | 70524 | 19484 | 79654337 |
| Pseudomembranous colitis | 13.49 | 10.31 | 20 | 70547 | 5354 | 79668467 |
| Gait disturbance | 13.48 | 10.31 | 118 | 70449 | 207388 | 79466433 |
| Proctitis | 13.44 | 10.31 | 22 | 70545 | 6410 | 79667411 |
| Lung transplant rejection | 13.39 | 10.31 | 11 | 70556 | 1520 | 79672301 |
| Vaginal ulceration | 13.39 | 10.31 | 6 | 70561 | 273 | 79673548 |
| Tenosynovitis | 13.36 | 10.31 | 37 | 70530 | 15517 | 79658304 |
| Cytomegalovirus test positive | 13.33 | 10.31 | 21 | 70546 | 5926 | 79667895 |
| Intentional self-injury | 13.30 | 10.31 | 6 | 70561 | 32413 | 79641408 |
| Autonomic neuropathy | 13.29 | 10.31 | 12 | 70555 | 1883 | 79671938 |
| Osteoporosis | 13.29 | 10.31 | 17 | 70550 | 54095 | 79619726 |
| Lymphocytic infiltration | 13.26 | 10.31 | 11 | 70556 | 1542 | 79672279 |
| Pneumonia cytomegaloviral | 13.21 | 10.31 | 19 | 70548 | 4950 | 79668871 |
| Bacterial sepsis | 13.19 | 10.31 | 25 | 70542 | 8173 | 79665648 |
| Muscle twitching | 13.16 | 10.31 | 50 | 70517 | 24714 | 79649107 |
| Hepatic enzyme increased | 13.15 | 10.31 | 101 | 70466 | 182509 | 79491312 |
| Abdominal wall haemorrhage | 13.15 | 10.31 | 8 | 70559 | 686 | 79673135 |
| Potentiating drug interaction | 13.10 | 10.31 | 26 | 70541 | 8793 | 79665028 |
| Enterovirus infection | 13.01 | 10.31 | 12 | 70555 | 1935 | 79671886 |
| Discomfort | 12.98 | 10.31 | 62 | 70505 | 125555 | 79548266 |
| Condition aggravated | 12.94 | 10.31 | 341 | 70226 | 500783 | 79173038 |
| Acne | 12.89 | 10.31 | 4 | 70563 | 27186 | 79646635 |
| Cushing's syndrome | 12.80 | 10.31 | 9 | 70558 | 986 | 79672835 |
| Body temperature increased | 12.77 | 10.31 | 75 | 70492 | 44345 | 79629476 |
| Joint effusion | 12.75 | 10.31 | 40 | 70527 | 17974 | 79655847 |
| Adverse event | 12.74 | 10.31 | 21 | 70546 | 60193 | 79613628 |
| Heart rate decreased | 12.69 | 10.31 | 27 | 70540 | 70289 | 79603532 |
| Eosinophilia | 12.68 | 10.31 | 76 | 70491 | 45269 | 79628552 |
| Dermatitis allergic | 12.59 | 10.31 | 40 | 70527 | 18090 | 79655731 |
| Febrile neutropenia | 12.55 | 10.31 | 280 | 70287 | 230719 | 79443102 |
| Genital burning sensation | 12.46 | 10.31 | 6 | 70561 | 322 | 79673499 |
| Tumour lysis syndrome | 12.45 | 10.31 | 48 | 70519 | 23891 | 79649930 |
| Prurigo | 12.32 | 10.31 | 10 | 70557 | 1359 | 79672462 |
| Osteoarthritis | 12.31 | 10.31 | 38 | 70529 | 87271 | 79586550 |
| Infection | 12.21 | 10.31 | 290 | 70277 | 241422 | 79432399 |
| Wound | 12.20 | 10.31 | 57 | 70510 | 116122 | 79557699 |
| Petechiae | 12.18 | 10.31 | 43 | 70524 | 20522 | 79653299 |
| Hepatitis C virus test | 12.16 | 10.31 | 4 | 70563 | 77 | 79673744 |
| Surgery | 12.05 | 10.31 | 7 | 70560 | 32759 | 79641062 |
| Flatulence | 12.04 | 10.31 | 12 | 70555 | 42712 | 79631109 |
| Sedation | 12.04 | 10.31 | 17 | 70550 | 51878 | 79621943 |
| Renal transplant | 12.04 | 10.31 | 13 | 70554 | 2534 | 79671287 |
| Limb reduction defect | 11.92 | 10.31 | 4 | 70563 | 82 | 79673739 |
| Lung neoplasm | 11.92 | 10.31 | 22 | 70545 | 7047 | 79666774 |
| Contraindicated product administered | 11.89 | 10.31 | 86 | 70481 | 157452 | 79516369 |
| Human herpesvirus 6 infection reactivation | 11.86 | 10.31 | 7 | 70560 | 568 | 79673253 |
| Anti-cyclic citrullinated peptide antibody positive | 11.85 | 10.31 | 36 | 70531 | 83107 | 79590714 |
| Tumour flare | 11.83 | 10.31 | 9 | 70558 | 1114 | 79672707 |
| Culture positive | 11.80 | 10.31 | 9 | 70558 | 1117 | 79672704 |
| Perinephric collection | 11.79 | 10.31 | 6 | 70561 | 363 | 79673458 |
| Sleep apnoea syndrome | 11.79 | 10.31 | 9 | 70558 | 36469 | 79637352 |
| Staphylococcal infection | 11.69 | 10.31 | 90 | 70477 | 58205 | 79615616 |
| Acute graft versus host disease | 11.67 | 10.31 | 27 | 70540 | 10140 | 79663681 |
| Hydronephrosis | 11.66 | 10.31 | 38 | 70529 | 17416 | 79656405 |
| Areflexia | 11.66 | 10.31 | 19 | 70548 | 5515 | 79668306 |
| Suicidal ideation | 11.65 | 10.31 | 32 | 70535 | 76308 | 79597513 |
| Idiopathic pneumonia syndrome | 11.63 | 10.31 | 7 | 70560 | 589 | 79673232 |
| Acute graft versus host disease in intestine | 11.55 | 10.31 | 16 | 70551 | 4025 | 79669796 |
| Cardio-respiratory arrest | 11.54 | 10.31 | 53 | 70514 | 108457 | 79565364 |
| Cholelithiasis | 11.52 | 10.31 | 83 | 70484 | 52581 | 79621240 |
| Immunosuppressant drug level increased | 11.51 | 10.31 | 25 | 70542 | 9002 | 79664819 |
| Product quality issue | 11.45 | 10.31 | 8 | 70559 | 33932 | 79639889 |
| Haematocrit decreased | 11.38 | 10.31 | 93 | 70474 | 61219 | 79612602 |
| Altered visual depth perception | 11.38 | 10.31 | 6 | 70561 | 391 | 79673430 |
| Hypovolaemia | 11.36 | 10.31 | 38 | 70529 | 17653 | 79656168 |
| Limb injury | 11.31 | 10.31 | 6 | 70561 | 29522 | 79644299 |
| Escherichia test positive | 11.30 | 10.31 | 14 | 70553 | 3161 | 79670660 |
| Blood chloride increased | 11.27 | 10.31 | 18 | 70549 | 5138 | 79668683 |
| Syncope | 11.23 | 10.31 | 103 | 70464 | 179346 | 79494475 |
| Lip ulceration | 11.22 | 10.31 | 12 | 70555 | 2313 | 79671508 |
| Drug hypersensitivity | 11.21 | 10.31 | 345 | 70222 | 298571 | 79375250 |
| Haemolytic anaemia | 11.20 | 10.31 | 38 | 70529 | 17782 | 79656039 |
| Loss of consciousness | 11.13 | 10.31 | 95 | 70472 | 167848 | 79505973 |
| Glioblastoma multiforme | 11.11 | 10.31 | 9 | 70558 | 1219 | 79672602 |
| Prostatitis | 11.07 | 10.31 | 16 | 70551 | 4186 | 79669635 |
| Cerebral toxoplasmosis | 11.06 | 10.31 | 12 | 70555 | 2350 | 79671471 |
| Motion sickness | 11.06 | 10.31 | 8 | 70559 | 917 | 79672904 |
| Multiple sclerosis relapse | 11.04 | 10.31 | 15 | 70552 | 46518 | 79627303 |
| Migraine | 11.02 | 10.31 | 40 | 70527 | 87453 | 79586368 |
| No adverse event | 11.00 | 10.31 | 10 | 70557 | 37182 | 79636639 |
| Pneumonia fungal | 10.98 | 10.31 | 28 | 70539 | 11182 | 79662639 |
| Nail infection | 10.91 | 10.31 | 12 | 70555 | 2387 | 79671434 |
| Food poisoning | 10.91 | 10.31 | 17 | 70550 | 4752 | 79669069 |
| Parkinsonism hyperpyrexia syndrome | 10.85 | 10.31 | 5 | 70562 | 243 | 79673578 |
| Hot flush | 10.83 | 10.31 | 20 | 70547 | 54857 | 79618964 |
| Hepatitis B antibody positive | 10.82 | 10.31 | 4 | 70563 | 110 | 79673711 |
| Hepatitis A antibody positive | 10.79 | 10.31 | 4 | 70563 | 111 | 79673710 |
| Apraxia | 10.78 | 10.31 | 13 | 70554 | 2854 | 79670967 |
| Pustule | 10.75 | 10.31 | 11 | 70556 | 2014 | 79671807 |
| Impaired work ability | 10.68 | 10.31 | 40 | 70527 | 19641 | 79654180 |
| Renal cyst haemorrhage | 10.67 | 10.31 | 7 | 70560 | 685 | 79673136 |
| Herpes simplex viraemia | 10.66 | 10.31 | 6 | 70561 | 445 | 79673376 |
| Candida infection | 10.65 | 10.31 | 64 | 70503 | 38150 | 79635671 |
| Drug intolerance | 10.62 | 10.31 | 167 | 70400 | 263952 | 79409869 |
| Chills | 10.61 | 10.31 | 200 | 70367 | 160034 | 79513787 |
| Acute febrile neutrophilic dermatosis | 10.58 | 10.31 | 15 | 70552 | 3857 | 79669964 |
| Suprapubic pain | 10.56 | 10.31 | 8 | 70559 | 984 | 79672837 |
| Tooth disorder | 10.54 | 10.31 | 5 | 70562 | 26228 | 79647593 |
| Pulmonary arterial hypertension | 10.52 | 10.31 | 6 | 70561 | 28360 | 79645461 |
| Bronchitis | 10.50 | 10.31 | 70 | 70497 | 130574 | 79543247 |
| Herpes simplex | 10.47 | 10.31 | 29 | 70538 | 12158 | 79661663 |
| Erosive duodenitis | 10.35 | 10.31 | 11 | 70556 | 2106 | 79671715 |
| Proteus infection | 10.34 | 10.31 | 11 | 70556 | 2107 | 79671714 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Acute otitis media | indication | 3110003 | |
| Haemophilus Influenzae Acute Otitis Media | indication | 19021002 | |
| 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 | ||
| 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 |
🐶 Veterinary Drug Use
| Species | Use | Relation |
|---|---|---|
| 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 |
🐶 Veterinary products
| Product | Applicant | Ingredients |
|---|---|---|
| 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 level | Dissociation constant | Type (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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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 | 4.84 | 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 | 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 | IC50 | 6.35 | CHEMBL | |||||
| Dihydrofolate reductase | Enzyme | IC50 | 7.04 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 | 29 sections |
| SULFATRIM | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-0854 | SUSPENSION | 40 mg | ORAL | NDA | 29 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 | 0527-5180 | 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 | 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 | 31 sections |
| Sulfamethoxazole and Trimethoprim | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0703-9503 | INJECTION, SOLUTION, CONCENTRATE | 16 mg | INTRAVENOUS | ANDA | 31 sections |
| Sulfamethoxazole and Trimethoprim | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0703-9503 | INJECTION, SOLUTION, CONCENTRATE | 16 mg | INTRAVENOUS | ANDA | 31 sections |
| Sulfamethoxazole and Trimethoprim | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0703-9514 | INJECTION, SOLUTION, CONCENTRATE | 16 mg | INTRAVENOUS | ANDA | 31 sections |
| Sulfamethoxazole and Trimethoprim | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0703-9514 | INJECTION, SOLUTION, CONCENTRATE | 16 mg | INTRAVENOUS | ANDA | 31 sections |
| Sulfamethoxazole and Trimethoprim | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0703-9514 | INJECTION, SOLUTION, CONCENTRATE | 16 mg | INTRAVENOUS | ANDA | 31 sections |
| Sulfamethoxazole and Trimethoprim | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0703-9514 | INJECTION, SOLUTION, CONCENTRATE | 16 mg | INTRAVENOUS | ANDA | 31 sections |
| Sulfamethoxazole and Trimethoprim | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0703-9514 | INJECTION, SOLUTION, CONCENTRATE | 16 mg | INTRAVENOUS | ANDA | 31 sections |
| Sulfamethoxazole and Trimethoprim | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0703-9514 | INJECTION, SOLUTION, CONCENTRATE | 16 mg | INTRAVENOUS | ANDA | 31 sections |
| Sulfamethoxazole and Trimethoprim | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0703-9526 | INJECTION, SOLUTION, CONCENTRATE | 16 mg | INTRAVENOUS | ANDA | 31 sections |
| Sulfamethoxazole and Trimethoprim | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0703-9526 | INJECTION, SOLUTION, CONCENTRATE | 16 mg | INTRAVENOUS | ANDA | 31 sections |
| Sulfamethoxazole and Trimethoprim | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0703-9526 | INJECTION, SOLUTION, CONCENTRATE | 16 mg | INTRAVENOUS | ANDA | 31 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 |