famotidine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| histamine-H2-receptor antagonists, cimetidine derivatives | 1129 | 76824-35-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion. Computer-aided, structure-based, virtual screening of libraries of compounds against SARS-CoV-2 proteins suggested potential for famotidine to interact with viral proteases in-volved in coronavirus replication. HOWEVER, there is no clinical trial evidence supporting efficacy or safety for treatment of COVID-19.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 40 | mg | O |
| 40 | mg | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 67 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 1.98 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 42 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 1.20 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 6.60 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.84 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 2.80 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 1 mg/mL | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 15, 1986 | FDA | VALEANT PHARMS NORTH |
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 |
|---|---|---|---|---|---|---|
| Drug ineffective | 440.09 | 9.41 | 1044 | 139050 | 1043721 | 62305207 |
| Pemphigus | 388.27 | 9.41 | 3 | 140091 | 183723 | 63165205 |
| Contraindicated product administered | 388.11 | 9.41 | 23 | 140071 | 217625 | 63131303 |
| Synovitis | 377.51 | 9.41 | 7 | 140087 | 186911 | 63162017 |
| Drug intolerance | 320.65 | 9.41 | 140 | 139954 | 308521 | 63040407 |
| Hand deformity | 310.28 | 9.41 | 9 | 140085 | 159448 | 63189480 |
| Systemic lupus erythematosus | 289.65 | 9.41 | 55 | 140039 | 208863 | 63140065 |
| Glossodynia | 282.78 | 9.41 | 32 | 140062 | 178844 | 63170084 |
| Joint swelling | 269.57 | 9.41 | 198 | 139896 | 327468 | 63021460 |
| Arthropathy | 264.29 | 9.41 | 94 | 140000 | 234698 | 63114230 |
| Treatment failure | 260.28 | 9.41 | 60 | 140034 | 198983 | 63149945 |
| Therapeutic product effect decreased | 245.22 | 9.41 | 62 | 140032 | 193125 | 63155803 |
| Pericarditis | 214.44 | 9.41 | 21 | 140073 | 131558 | 63217370 |
| Rheumatoid arthritis | 195.21 | 9.41 | 164 | 139930 | 253655 | 63095273 |
| Wound | 191.24 | 9.41 | 61 | 140033 | 163202 | 63185726 |
| Duodenal ulcer perforation | 169.31 | 9.41 | 5 | 140089 | 87204 | 63261724 |
| Helicobacter infection | 161.71 | 9.41 | 11 | 140083 | 92774 | 63256154 |
| Lower respiratory tract infection | 140.41 | 9.41 | 58 | 140036 | 132249 | 63216679 |
| Hepatic enzyme increased | 136.47 | 9.41 | 147 | 139947 | 202181 | 63146747 |
| Hepatic function abnormal | 135.18 | 9.41 | 271 | 139823 | 36871 | 63312057 |
| Alopecia | 134.10 | 9.41 | 346 | 139748 | 337190 | 63011738 |
| Pneumonia aspiration | 132.94 | 9.41 | 258 | 139836 | 34282 | 63314646 |
| Maternal exposure during pregnancy | 131.31 | 9.41 | 176 | 139918 | 219886 | 63129042 |
| Gastrooesophageal reflux disease | 128.22 | 9.41 | 483 | 139611 | 95156 | 63253772 |
| Platelet count decreased | 127.42 | 9.41 | 551 | 139543 | 115571 | 63233357 |
| White blood cell count decreased | 126.73 | 9.41 | 625 | 139469 | 138479 | 63210449 |
| Muscle injury | 125.92 | 9.41 | 4 | 140090 | 65341 | 63283587 |
| General physical health deterioration | 125.39 | 9.41 | 156 | 139938 | 201246 | 63147682 |
| Swelling | 122.32 | 9.41 | 266 | 139828 | 275112 | 63073816 |
| Product use issue | 116.36 | 9.41 | 192 | 139902 | 220328 | 63128600 |
| Folliculitis | 115.12 | 9.41 | 11 | 140083 | 70306 | 63278622 |
| Musculoskeletal stiffness | 109.76 | 9.41 | 148 | 139946 | 184470 | 63164458 |
| Discomfort | 108.04 | 9.41 | 126 | 139968 | 167248 | 63181680 |
| Chronic kidney disease | 100.98 | 9.41 | 273 | 139821 | 45125 | 63303803 |
| Abdominal discomfort | 96.39 | 9.41 | 373 | 139721 | 320512 | 63028416 |
| Drug abuse | 94.43 | 9.41 | 22 | 140072 | 72496 | 63276432 |
| Toxicity to various agents | 93.91 | 9.41 | 259 | 139835 | 246991 | 63101937 |
| Off label use | 92.32 | 9.41 | 998 | 139096 | 673464 | 62675464 |
| Mobility decreased | 86.22 | 9.41 | 84 | 140010 | 121075 | 63227853 |
| C-reactive protein abnormal | 84.81 | 9.41 | 4 | 140090 | 46092 | 63302836 |
| Flushing | 83.64 | 9.41 | 358 | 139736 | 74729 | 63274199 |
| Aspartate aminotransferase increased | 82.44 | 9.41 | 406 | 139688 | 89871 | 63259057 |
| Psoriatic arthropathy | 78.13 | 9.41 | 53 | 140041 | 91467 | 63257461 |
| Therapeutic product effect incomplete | 75.58 | 9.41 | 99 | 139995 | 124957 | 63223971 |
| Disseminated intravascular coagulation | 75.37 | 9.41 | 144 | 139950 | 18907 | 63330021 |
| Anaphylactic reaction | 69.68 | 9.41 | 310 | 139784 | 65790 | 63283138 |
| Liver injury | 68.39 | 9.41 | 24 | 140070 | 60496 | 63288432 |
| Arthralgia | 68.17 | 9.41 | 868 | 139226 | 568842 | 62780086 |
| Neutrophil count decreased | 65.97 | 9.41 | 273 | 139821 | 56133 | 63292795 |
| Impaired healing | 65.28 | 9.41 | 78 | 140016 | 102464 | 63246464 |
| Dehydration | 65.08 | 9.41 | 626 | 139468 | 172728 | 63176200 |
| Ill-defined disorder | 62.54 | 9.41 | 53 | 140041 | 81702 | 63267226 |
| Chest discomfort | 61.70 | 9.41 | 435 | 139659 | 109534 | 63239394 |
| Drug hypersensitivity | 60.51 | 9.41 | 419 | 139675 | 310268 | 63038660 |
| Pain | 60.01 | 9.41 | 1214 | 138880 | 739414 | 62609514 |
| Alanine aminotransferase increased | 59.70 | 9.41 | 413 | 139681 | 103357 | 63245571 |
| Mast cell activation syndrome | 58.71 | 9.41 | 31 | 140063 | 794 | 63348134 |
| Urinary tract infection | 54.79 | 9.41 | 854 | 139240 | 263830 | 63085098 |
| Irritable bowel syndrome | 54.27 | 9.41 | 61 | 140033 | 82351 | 63266577 |
| Cholecystitis chronic | 53.49 | 9.41 | 88 | 140006 | 10273 | 63338655 |
| Blister | 53.04 | 9.41 | 131 | 139963 | 129683 | 63219245 |
| Knee arthroplasty | 52.45 | 9.41 | 27 | 140067 | 54179 | 63294749 |
| Blood lactate dehydrogenase increased | 52.39 | 9.41 | 140 | 139954 | 22976 | 63325952 |
| Fibromyalgia | 51.36 | 9.41 | 61 | 140033 | 80359 | 63268569 |
| Diarrhoea | 49.88 | 9.41 | 1989 | 138105 | 713377 | 62635551 |
| Interstitial lung disease | 49.27 | 9.41 | 268 | 139826 | 61640 | 63287288 |
| Febrile neutropenia | 49.10 | 9.41 | 437 | 139657 | 118012 | 63230916 |
| Red blood cell sedimentation rate increased | 48.75 | 9.41 | 18 | 140076 | 43964 | 63304964 |
| COVID-19 | 48.29 | 9.41 | 420 | 139674 | 112683 | 63236245 |
| Hip arthroplasty | 47.21 | 9.41 | 23 | 140071 | 47623 | 63301305 |
| Angioedema | 45.41 | 9.41 | 218 | 139876 | 47747 | 63301181 |
| Intentional product use issue | 43.44 | 9.41 | 141 | 139953 | 127751 | 63221177 |
| Lip swelling | 41.69 | 9.41 | 157 | 139937 | 30906 | 63318022 |
| Nausea | 40.59 | 9.41 | 2287 | 137807 | 852184 | 62496744 |
| Upper respiratory tract inflammation | 40.56 | 9.41 | 38 | 140056 | 2485 | 63346443 |
| Mental status changes | 40.43 | 9.41 | 184 | 139910 | 39415 | 63309513 |
| Constipation | 39.61 | 9.41 | 707 | 139387 | 224236 | 63124692 |
| Dermatitis atopic | 39.08 | 9.41 | 74 | 140020 | 9650 | 63339278 |
| Hepatocellular injury | 38.34 | 9.41 | 7 | 140087 | 27374 | 63321554 |
| Loss of personal independence in daily activities | 38.33 | 9.41 | 100 | 139994 | 97190 | 63251738 |
| Enterocolitis | 38.24 | 9.41 | 65 | 140029 | 7793 | 63341135 |
| Type 2 diabetes mellitus | 38.12 | 9.41 | 51 | 140043 | 63817 | 63285111 |
| Decreased appetite | 38.02 | 9.41 | 771 | 139323 | 250281 | 63098647 |
| Throat tightness | 37.83 | 9.41 | 131 | 139963 | 24756 | 63324172 |
| Cerebral infarction | 36.52 | 9.41 | 126 | 139968 | 23767 | 63325161 |
| Butterfly rash | 35.03 | 9.41 | 30 | 140064 | 1743 | 63347185 |
| Sopor | 34.90 | 9.41 | 4 | 140090 | 22160 | 63326768 |
| Illness | 34.83 | 9.41 | 206 | 139888 | 48853 | 63300075 |
| Urticaria | 34.66 | 9.41 | 536 | 139558 | 165266 | 63183662 |
| Gastrointestinal disorder | 34.13 | 9.41 | 161 | 139933 | 131078 | 63217850 |
| Blood cholesterol increased | 33.81 | 9.41 | 101 | 139993 | 93931 | 63254997 |
| Exposure during pregnancy | 33.69 | 9.41 | 203 | 139891 | 155344 | 63193584 |
| Somnolence | 32.29 | 9.41 | 564 | 139530 | 178121 | 63170807 |
| Plasma cell myeloma | 31.71 | 9.41 | 160 | 139934 | 35745 | 63313183 |
| Torsade de pointes | 31.41 | 9.41 | 82 | 140012 | 13269 | 63335659 |
| Acute respiratory failure | 30.68 | 9.41 | 154 | 139940 | 34331 | 63314597 |
| Infective pulmonary exacerbation of cystic fibrosis | 30.49 | 9.41 | 63 | 140031 | 8754 | 63340174 |
| Neuropathy peripheral | 30.43 | 9.41 | 384 | 139710 | 113283 | 63235645 |
| Periorbital oedema | 30.32 | 9.41 | 49 | 140045 | 5635 | 63343293 |
| Gallbladder disorder | 30.24 | 9.41 | 101 | 139993 | 18741 | 63330187 |
| Medication error | 29.95 | 9.41 | 43 | 140051 | 52241 | 63296687 |
| Therapy non-responder | 29.91 | 9.41 | 78 | 140016 | 75823 | 63273105 |
| Arthritis | 28.53 | 9.41 | 145 | 139949 | 115776 | 63233152 |
| Hereditary angioedema | 28.50 | 9.41 | 56 | 140038 | 7506 | 63341422 |
| Haemorrhage subcutaneous | 28.41 | 9.41 | 34 | 140060 | 2949 | 63345979 |
| Throat irritation | 27.97 | 9.41 | 160 | 139934 | 37487 | 63311441 |
| Drug tolerance decreased | 27.90 | 9.41 | 3 | 140091 | 17470 | 63331458 |
| Musculoskeletal pain | 27.81 | 9.41 | 107 | 139987 | 92170 | 63256758 |
| Dizziness | 27.68 | 9.41 | 1186 | 138908 | 428739 | 62920189 |
| Condition aggravated | 27.65 | 9.41 | 676 | 139418 | 401541 | 62947387 |
| Completed suicide | 27.56 | 9.41 | 198 | 139896 | 145475 | 63203453 |
| Rheumatoid nodule | 27.25 | 9.41 | 3 | 140091 | 17152 | 63331776 |
| Pneumonia | 27.21 | 9.41 | 1250 | 138844 | 455517 | 62893411 |
| Osteoarthritis | 27.18 | 9.41 | 113 | 139981 | 95230 | 63253698 |
| Product dose omission issue | 27.14 | 9.41 | 693 | 139401 | 233620 | 63115308 |
| Hypoxia | 27.07 | 9.41 | 225 | 139869 | 59567 | 63289361 |
| Inflammation | 27.04 | 9.41 | 92 | 140002 | 82181 | 63266747 |
| Weight fluctuation | 26.99 | 9.41 | 64 | 140030 | 9755 | 63339173 |
| Contusion | 26.92 | 9.41 | 207 | 139887 | 149837 | 63199091 |
| Gastritis | 26.71 | 9.41 | 157 | 139937 | 37146 | 63311782 |
| Sepsis | 26.48 | 9.41 | 480 | 139614 | 152643 | 63196285 |
| Liver disorder | 25.91 | 9.41 | 205 | 139889 | 53482 | 63295446 |
| Aplastic anaemia | 25.91 | 9.41 | 62 | 140032 | 9507 | 63339421 |
| Blood alkaline phosphatase increased | 25.88 | 9.41 | 173 | 139921 | 42794 | 63306134 |
| Emotional distress | 25.28 | 9.41 | 140 | 139954 | 32409 | 63316519 |
| Seasonal allergy | 24.96 | 9.41 | 102 | 139992 | 20848 | 63328080 |
| Pulmonary fibrosis | 24.57 | 9.41 | 31 | 140063 | 39778 | 63309150 |
| Overdose | 24.48 | 9.41 | 151 | 139943 | 114927 | 63234001 |
| Dyspnoea | 24.48 | 9.41 | 1733 | 138361 | 659580 | 62689348 |
| Infection | 24.47 | 9.41 | 357 | 139737 | 228816 | 63120112 |
| Back pain | 24.39 | 9.41 | 759 | 139335 | 263386 | 63085542 |
| Blood magnesium decreased | 24.14 | 9.41 | 74 | 140020 | 13124 | 63335804 |
| Disease progression | 23.81 | 9.41 | 392 | 139702 | 122366 | 63226562 |
| Hepatotoxicity | 23.75 | 9.41 | 28 | 140066 | 37013 | 63311915 |
| Blood potassium decreased | 23.41 | 9.41 | 166 | 139928 | 41860 | 63307068 |
| Hospice care | 23.23 | 9.41 | 53 | 140041 | 7879 | 63341049 |
| Hypersensitivity | 22.90 | 9.41 | 482 | 139612 | 292203 | 63056725 |
| Cholecystitis acute | 22.88 | 9.41 | 54 | 140040 | 8206 | 63340722 |
| Drug resistance | 22.82 | 9.41 | 11 | 140083 | 22922 | 63326006 |
| Vaccination site reaction | 22.37 | 9.41 | 9 | 140085 | 120 | 63348808 |
| Anaemia | 22.24 | 9.41 | 824 | 139270 | 292606 | 63056322 |
| Renal injury | 22.23 | 9.41 | 58 | 140036 | 9381 | 63339547 |
| Lymphocyte stimulation test positive | 22.19 | 9.41 | 14 | 140080 | 505 | 63348423 |
| Cough | 22.18 | 9.41 | 822 | 139272 | 291921 | 63057007 |
| Abdominal distension | 22.08 | 9.41 | 290 | 139804 | 86325 | 63262603 |
| Ventricular tachycardia | 22.03 | 9.41 | 95 | 139999 | 19884 | 63329044 |
| Blood pressure diastolic abnormal | 21.98 | 9.41 | 3 | 140091 | 14539 | 63334389 |
| Prescribed overdose | 21.70 | 9.41 | 26 | 140068 | 34127 | 63314801 |
| Dopamine transporter scintigraphy abnormal | 21.35 | 9.41 | 8 | 140086 | 87 | 63348841 |
| Joint range of motion decreased | 21.35 | 9.41 | 24 | 140070 | 32404 | 63316524 |
| Hypervolaemia | 21.27 | 9.41 | 121 | 139973 | 28292 | 63320636 |
| End stage renal disease | 21.03 | 9.41 | 46 | 140048 | 6647 | 63342281 |
| Full blood count decreased | 20.93 | 9.41 | 113 | 139981 | 25911 | 63323017 |
| Pyrexia | 20.63 | 9.41 | 1251 | 138843 | 469227 | 62879701 |
| Coma | 20.57 | 9.41 | 225 | 139869 | 64139 | 63284789 |
| Tenosynovitis | 20.49 | 9.41 | 3 | 140091 | 13792 | 63335136 |
| Erythema multiforme | 20.48 | 9.41 | 59 | 140035 | 10110 | 63338818 |
| Blood pressure fluctuation | 20.30 | 9.41 | 45 | 140049 | 46272 | 63302656 |
| Blood bilirubin increased | 20.28 | 9.41 | 146 | 139948 | 36994 | 63311934 |
| Cystoid macular oedema | 20.25 | 9.41 | 21 | 140073 | 1554 | 63347374 |
| Drug eruption | 20.05 | 9.41 | 120 | 139974 | 28574 | 63320354 |
| Palmar erythema | 19.97 | 9.41 | 22 | 140072 | 1745 | 63347183 |
| Hypokalaemia | 19.95 | 9.41 | 331 | 139763 | 103473 | 63245455 |
| Cystitis noninfective | 19.87 | 9.41 | 17 | 140077 | 986 | 63347942 |
| Weight increased | 19.66 | 9.41 | 432 | 139662 | 260360 | 63088568 |
| Feeling abnormal | 19.62 | 9.41 | 447 | 139647 | 147945 | 63200983 |
| Foetal exposure during pregnancy | 19.61 | 9.41 | 25 | 140069 | 31937 | 63316991 |
| Hypoalbuminaemia | 19.58 | 9.41 | 64 | 140030 | 11741 | 63337187 |
| Biliary dyskinesia | 19.54 | 9.41 | 27 | 140067 | 2702 | 63346226 |
| White blood cell count increased | 19.51 | 9.41 | 178 | 139916 | 48383 | 63300545 |
| Chills | 19.45 | 9.41 | 355 | 139739 | 113023 | 63235905 |
| Peripheral swelling | 19.35 | 9.41 | 443 | 139651 | 265499 | 63083429 |
| Live birth | 19.13 | 9.41 | 17 | 140077 | 25613 | 63323315 |
| Total lung capacity abnormal | 19.11 | 9.41 | 7 | 140087 | 71 | 63348857 |
| Premature baby | 19.08 | 9.41 | 11 | 140083 | 20724 | 63328204 |
| Ileus | 18.59 | 9.41 | 73 | 140021 | 14652 | 63334276 |
| Swelling face | 18.53 | 9.41 | 218 | 139876 | 63257 | 63285671 |
| Laboratory test abnormal | 18.46 | 9.41 | 112 | 139982 | 26800 | 63322128 |
| Anaphylactoid reaction | 18.39 | 9.41 | 31 | 140063 | 3692 | 63345236 |
| Joint stiffness | 18.09 | 9.41 | 41 | 140053 | 41828 | 63307100 |
| Chest pain | 17.72 | 9.41 | 612 | 139482 | 215347 | 63133581 |
| Acquired haemophilia | 17.49 | 9.41 | 16 | 140078 | 1015 | 63347913 |
| Basophil count decreased | 17.32 | 9.41 | 8 | 140086 | 152 | 63348776 |
| Infusion related reaction | 17.29 | 9.41 | 411 | 139683 | 245110 | 63103818 |
| Bacteriuria | 17.20 | 9.41 | 16 | 140078 | 1037 | 63347891 |
| Rebound acid hypersecretion | 16.93 | 9.41 | 10 | 140084 | 320 | 63348608 |
| Respiratory alkalosis | 16.81 | 9.41 | 25 | 140069 | 2676 | 63346252 |
| Cytomegalovirus enterocolitis | 16.55 | 9.41 | 13 | 140081 | 668 | 63348260 |
| Asteatosis | 16.55 | 9.41 | 6 | 140088 | 59 | 63348869 |
| Device difficult to use | 16.42 | 9.41 | 4 | 140090 | 12792 | 63336136 |
| Therapeutic response decreased | 16.27 | 9.41 | 75 | 140019 | 61450 | 63287478 |
| Haematocrit decreased | 16.21 | 9.41 | 145 | 139949 | 39195 | 63309733 |
| Device expulsion | 16.08 | 9.41 | 33 | 140061 | 34889 | 63314039 |
| Lupus hepatitis | 16.07 | 9.41 | 5 | 140089 | 29 | 63348899 |
| Lip dry | 16.05 | 9.41 | 7 | 140087 | 15463 | 63333465 |
| Lymphocyte count decreased | 15.98 | 9.41 | 118 | 139976 | 30139 | 63318789 |
| Eye haematoma | 15.95 | 9.41 | 6 | 140088 | 66 | 63348862 |
| Hepatic cytolysis | 15.94 | 9.41 | 7 | 140087 | 15400 | 63333528 |
| Nasopharyngitis | 15.93 | 9.41 | 433 | 139661 | 253824 | 63095104 |
| Joint dislocation | 15.89 | 9.41 | 11 | 140083 | 18789 | 63330139 |
| Red blood cell count decreased | 15.83 | 9.41 | 148 | 139946 | 40497 | 63308431 |
| Heart rate increased | 15.79 | 9.41 | 294 | 139800 | 93944 | 63254984 |
| Panniculitis | 15.75 | 9.41 | 3 | 140091 | 11382 | 63337546 |
| Cytokine release syndrome | 15.73 | 9.41 | 68 | 140026 | 14246 | 63334682 |
| Gastrointestinal haemorrhage | 15.65 | 9.41 | 259 | 139835 | 80917 | 63268011 |
| Blood pressure systolic increased | 15.57 | 9.41 | 53 | 140041 | 47344 | 63301584 |
| Reflux gastritis | 15.49 | 9.41 | 16 | 140078 | 1179 | 63347749 |
| Vomiting | 15.40 | 9.41 | 1434 | 138660 | 558183 | 62790745 |
| Protein total decreased | 15.40 | 9.41 | 38 | 140056 | 5939 | 63342989 |
| Anxiety | 15.31 | 9.41 | 606 | 139488 | 216935 | 63131993 |
| Sleep disorder due to a general medical condition | 15.27 | 9.41 | 4 | 140090 | 12184 | 63336744 |
| Grip strength decreased | 15.22 | 9.41 | 16 | 140078 | 22271 | 63326657 |
| Facet joint syndrome | 15.18 | 9.41 | 4 | 140090 | 12134 | 63336794 |
| Blood urea increased | 15.16 | 9.41 | 105 | 139989 | 26274 | 63322654 |
| Impaired work ability | 15.07 | 9.41 | 10 | 140084 | 17465 | 63331463 |
| Small intestinal obstruction | 15 | 9.41 | 80 | 140014 | 18257 | 63330671 |
| Palpitations | 15.00 | 9.41 | 340 | 139754 | 112430 | 63236498 |
| Congenital neuropathy | 14.96 | 9.41 | 4 | 140090 | 12 | 63348916 |
| Gallbladder injury | 14.85 | 9.41 | 17 | 140077 | 1406 | 63347522 |
| Atrioventricular block complete | 14.85 | 9.41 | 46 | 140048 | 8205 | 63340723 |
| Infusion site erythema | 14.82 | 9.41 | 58 | 140036 | 11621 | 63337307 |
| Hyperuricaemia | 14.76 | 9.41 | 35 | 140059 | 5335 | 63343593 |
| Blood pressure decreased | 14.65 | 9.41 | 213 | 139881 | 64809 | 63284119 |
| Bursitis | 14.64 | 9.41 | 38 | 140056 | 37003 | 63311925 |
| Deep vein thrombosis | 14.58 | 9.41 | 263 | 139831 | 83537 | 63265391 |
| Infusion site swelling | 14.48 | 9.41 | 51 | 140043 | 9719 | 63339209 |
| Blindness transient | 14.44 | 9.41 | 28 | 140066 | 3716 | 63345212 |
| Amino acid level decreased | 14.38 | 9.41 | 5 | 140089 | 43 | 63348885 |
| Pulmonary hypertension | 14.37 | 9.41 | 135 | 139959 | 36988 | 63311940 |
| Carbohydrate antigen 15-3 | 14.34 | 9.41 | 6 | 140088 | 89 | 63348839 |
| Carcinoembryonic antigen | 14.16 | 9.41 | 6 | 140088 | 92 | 63348836 |
| Oropharyngeal discomfort | 14.15 | 9.41 | 34 | 140060 | 5226 | 63343702 |
| Burkholderia test positive | 14.10 | 9.41 | 8 | 140086 | 237 | 63348691 |
| Macular degeneration | 14.01 | 9.41 | 20 | 140074 | 24356 | 63324572 |
| Breast cancer stage III | 13.82 | 9.41 | 3 | 140091 | 10383 | 63338545 |
| Pharyngeal swelling | 13.72 | 9.41 | 38 | 140056 | 6366 | 63342562 |
| Bone pain | 13.53 | 9.41 | 182 | 139912 | 54459 | 63294469 |
| Anhedonia | 13.53 | 9.41 | 54 | 140040 | 10920 | 63338008 |
| Granulocytopenia | 13.51 | 9.41 | 35 | 140059 | 5637 | 63343291 |
| Skin exfoliation | 13.46 | 9.41 | 150 | 139944 | 42952 | 63305976 |
| Infusion site pain | 13.40 | 9.41 | 73 | 140021 | 16796 | 63332132 |
| Breast adenoma | 13.37 | 9.41 | 5 | 140089 | 54 | 63348874 |
| Status asthmaticus | 13.36 | 9.41 | 13 | 140081 | 891 | 63348037 |
| Adverse drug reaction | 13.35 | 9.41 | 112 | 139982 | 79602 | 63269326 |
| Cholelithiasis | 13.33 | 9.41 | 152 | 139942 | 43773 | 63305155 |
| Sedation complication | 13.20 | 9.41 | 7 | 140087 | 13815 | 63335113 |
| Blood albumin decreased | 13.18 | 9.41 | 66 | 140028 | 14700 | 63334228 |
| Adverse event | 13.17 | 9.41 | 91 | 140003 | 67468 | 63281460 |
| Hyperlipidaemia | 13.14 | 9.41 | 81 | 140013 | 19490 | 63329438 |
| Haemoglobin decreased | 13.13 | 9.41 | 417 | 139677 | 145068 | 63203860 |
| Therapy interrupted | 13.05 | 9.41 | 119 | 139975 | 32336 | 63316592 |
| Pleural effusion | 13.02 | 9.41 | 283 | 139811 | 92927 | 63256001 |
| Rhinovirus infection | 12.97 | 9.41 | 30 | 140064 | 4499 | 63344429 |
| Intentional self-injury | 12.94 | 9.41 | 23 | 140071 | 25664 | 63323264 |
| Oropharyngeal spasm | 12.90 | 9.41 | 8 | 140086 | 280 | 63348648 |
| Respiratory failure | 12.89 | 9.41 | 305 | 139789 | 101553 | 63247375 |
| Cholinergic syndrome | 12.83 | 9.41 | 10 | 140084 | 508 | 63348420 |
| Head discomfort | 12.71 | 9.41 | 61 | 140033 | 13354 | 63335574 |
| Mite allergy | 12.70 | 9.41 | 11 | 140083 | 649 | 63348279 |
| Drug clearance decreased | 12.66 | 9.41 | 16 | 140078 | 1468 | 63347460 |
| Putamen haemorrhage | 12.63 | 9.41 | 7 | 140087 | 198 | 63348730 |
| Haemolytic anaemia | 12.62 | 9.41 | 50 | 140044 | 10075 | 63338853 |
| Feeling hot | 12.58 | 9.41 | 168 | 139926 | 50186 | 63298742 |
| Hypoparathyroidism | 12.44 | 9.41 | 11 | 140083 | 667 | 63348261 |
| Chronic spontaneous urticaria | 12.38 | 9.41 | 14 | 140080 | 1143 | 63347785 |
| Pyuria | 12.32 | 9.41 | 18 | 140076 | 1896 | 63347032 |
| Extrapyramidal disorder | 12.29 | 9.41 | 7 | 140087 | 13277 | 63335651 |
| Cranial nerve disorder | 12.22 | 9.41 | 10 | 140084 | 545 | 63348383 |
| Ovarian cancer recurrent | 12.08 | 9.41 | 13 | 140081 | 1004 | 63347924 |
| Dermatitis acneiform | 12.08 | 9.41 | 31 | 140063 | 4965 | 63343963 |
| Ammonia decreased | 12.07 | 9.41 | 3 | 140091 | 6 | 63348922 |
| Lethargy | 12.05 | 9.41 | 182 | 139912 | 55825 | 63293103 |
| Coronary artery dissection | 12.01 | 9.41 | 12 | 140082 | 850 | 63348078 |
| Urinary retention postoperative | 11.96 | 9.41 | 5 | 140089 | 74 | 63348854 |
| Creatinine renal clearance decreased | 11.95 | 9.41 | 11 | 140083 | 16297 | 63332631 |
| Spondylolisthesis | 11.91 | 9.41 | 25 | 140069 | 3511 | 63345417 |
| Poikiloderma | 11.91 | 9.41 | 7 | 140087 | 222 | 63348706 |
| Intentional product misuse | 11.90 | 9.41 | 82 | 140012 | 60835 | 63288093 |
| Haematotoxicity | 11.90 | 9.41 | 3 | 140091 | 9373 | 63339555 |
| Blood creatine phosphokinase MB increased | 11.81 | 9.41 | 14 | 140080 | 1202 | 63347726 |
| Xanthogranuloma | 11.76 | 9.41 | 3 | 140091 | 7 | 63348921 |
| Swollen tongue | 11.75 | 9.41 | 123 | 139971 | 34677 | 63314251 |
| Reversible cerebral vasoconstriction syndrome | 11.65 | 9.41 | 21 | 140073 | 2637 | 63346291 |
| COVID-19 pneumonia | 11.63 | 9.41 | 62 | 140032 | 14147 | 63334781 |
| Renal failure | 11.63 | 9.41 | 341 | 139753 | 117311 | 63231617 |
| Respiratory syncytial virus infection | 11.60 | 9.41 | 38 | 140056 | 6980 | 63341948 |
| Thrombosis | 11.54 | 9.41 | 204 | 139890 | 64551 | 63284377 |
| Foot deformity | 11.45 | 9.41 | 28 | 140066 | 27825 | 63321103 |
| Altered state of consciousness | 11.45 | 9.41 | 95 | 139999 | 25135 | 63323793 |
| Ovarian cancer | 11.39 | 9.41 | 34 | 140060 | 5942 | 63342986 |
| Dizziness postural | 11.36 | 9.41 | 39 | 140055 | 7337 | 63341591 |
| Pneumothorax | 11.36 | 9.41 | 68 | 140026 | 16193 | 63332735 |
| Dysgeusia | 11.32 | 9.41 | 155 | 139939 | 46555 | 63302373 |
| Osteoporosis | 11.29 | 9.41 | 77 | 140017 | 57261 | 63291667 |
| Pityriasis lichenoides et varioliformis acuta | 11.25 | 9.41 | 4 | 140090 | 37 | 63348891 |
| Brain natriuretic peptide increased | 11.24 | 9.41 | 31 | 140063 | 5182 | 63343746 |
| Dry skin | 11.15 | 9.41 | 182 | 139912 | 56705 | 63292223 |
| Blood pressure systolic abnormal | 11.09 | 9.41 | 8 | 140086 | 13378 | 63335550 |
| Asthma | 11.09 | 9.41 | 364 | 139730 | 127197 | 63221731 |
| Pleural neoplasm | 11.06 | 9.41 | 8 | 140086 | 363 | 63348565 |
| Infusion related hypersensitivity reaction | 10.87 | 9.41 | 7 | 140087 | 262 | 63348666 |
| Injection site reaction | 10.84 | 9.41 | 80 | 140014 | 58444 | 63290484 |
| Hypophagia | 10.79 | 9.41 | 111 | 139983 | 31148 | 63317780 |
| Atopy | 10.77 | 9.41 | 7 | 140087 | 266 | 63348662 |
| Vascular resistance systemic decreased | 10.73 | 9.41 | 5 | 140089 | 97 | 63348831 |
| Flashback | 10.72 | 9.41 | 6 | 140088 | 173 | 63348755 |
| Disability | 10.59 | 9.41 | 15 | 140079 | 18332 | 63330596 |
| Blindness cortical | 10.58 | 9.41 | 9 | 140085 | 518 | 63348410 |
| Drug dependence | 10.55 | 9.41 | 24 | 140070 | 24459 | 63324469 |
| Cellulitis | 10.55 | 9.41 | 246 | 139848 | 81712 | 63267216 |
| Muscle spasticity | 10.55 | 9.41 | 20 | 140074 | 21774 | 63327154 |
| Red blood cell schistocytes present | 10.54 | 9.41 | 7 | 140087 | 276 | 63348652 |
| Epistaxis | 10.54 | 9.41 | 222 | 139872 | 72503 | 63276425 |
| Heliotrope rash | 10.48 | 9.41 | 6 | 140088 | 181 | 63348747 |
| Pneumonia bacterial | 10.43 | 9.41 | 45 | 140049 | 9420 | 63339508 |
| Night sweats | 10.40 | 9.41 | 64 | 140030 | 48750 | 63300178 |
| Restless arm syndrome | 10.40 | 9.41 | 4 | 140090 | 47 | 63348881 |
| Enterovirus infection | 10.39 | 9.41 | 12 | 140082 | 1002 | 63347926 |
| Neurological examination abnormal | 10.39 | 9.41 | 7 | 140087 | 283 | 63348645 |
| Dyspepsia | 10.31 | 9.41 | 297 | 139797 | 101899 | 63247029 |
| Cholestasis | 10.30 | 9.41 | 32 | 140062 | 29402 | 63319526 |
| Ingrowing nail | 10.29 | 9.41 | 19 | 140075 | 2430 | 63346498 |
| Infusion site pruritus | 10.27 | 9.41 | 33 | 140061 | 6002 | 63342926 |
| Neuroleptic malignant syndrome | 10.26 | 9.41 | 7 | 140087 | 12049 | 63336879 |
| Allergic transfusion reaction | 10.25 | 9.41 | 4 | 140090 | 49 | 63348879 |
| Reticulocyte percentage increased | 10.18 | 9.41 | 3 | 140091 | 14 | 63348914 |
| Tremor | 10.16 | 9.41 | 372 | 139722 | 131867 | 63217061 |
| Device related infection | 10.04 | 9.41 | 87 | 140007 | 23305 | 63325623 |
| Mean arterial pressure increased | 10.01 | 9.41 | 3 | 140091 | 15 | 63348913 |
| Therapeutic hypothermia | 10.01 | 9.41 | 3 | 140091 | 15 | 63348913 |
| Dysphagia | 9.94 | 9.41 | 261 | 139833 | 88324 | 63260604 |
| Shock | 9.93 | 9.41 | 87 | 140007 | 23376 | 63325552 |
| Bacterial test positive | 9.93 | 9.41 | 30 | 140064 | 5277 | 63343651 |
| Polyarthritis | 9.89 | 9.41 | 5 | 140089 | 10141 | 63338787 |
| Oesophagogastric fundoplasty | 9.88 | 9.41 | 5 | 140089 | 117 | 63348811 |
| Myocarditis infectious | 9.85 | 9.41 | 3 | 140091 | 16 | 63348912 |
| Cerebrovascular accident | 9.84 | 9.41 | 310 | 139784 | 107714 | 63241214 |
| Renal impairment | 9.83 | 9.41 | 260 | 139834 | 88095 | 63260833 |
| Multiple allergies | 9.82 | 9.41 | 58 | 140036 | 13744 | 63335184 |
| Tinea pedis | 9.82 | 9.41 | 14 | 140080 | 1442 | 63347486 |
| Atelectasis | 9.80 | 9.41 | 81 | 140013 | 21402 | 63327526 |
| Hyperglycaemia | 9.77 | 9.41 | 138 | 139956 | 41729 | 63307199 |
| Stress cardiomyopathy | 9.71 | 9.41 | 44 | 140050 | 9406 | 63339522 |
| Hypergeusia | 9.70 | 9.41 | 3 | 140091 | 17 | 63348911 |
| Intraductal papillary breast neoplasm | 9.70 | 9.41 | 3 | 140091 | 17 | 63348911 |
| Colitis ischaemic | 9.65 | 9.41 | 48 | 140046 | 10660 | 63338268 |
| Benign vulval neoplasm | 9.64 | 9.41 | 4 | 140090 | 58 | 63348870 |
| Oropharyngeal swelling | 9.61 | 9.41 | 11 | 140083 | 910 | 63348018 |
| Diabetic retinal oedema | 9.53 | 9.41 | 7 | 140087 | 325 | 63348603 |
| Gastrostomy tube site complication | 9.52 | 9.41 | 4 | 140090 | 60 | 63348868 |
| Subarachnoid haemorrhage | 9.51 | 9.41 | 59 | 140035 | 14224 | 63334704 |
| Ear swelling | 9.49 | 9.41 | 14 | 140080 | 1487 | 63347441 |
| Anaplastic astrocytoma | 9.46 | 9.41 | 4 | 140090 | 61 | 63348867 |
| Injection site bruising | 9.43 | 9.41 | 54 | 140040 | 41856 | 63307072 |
| SARS-CoV-2 test positive | 9.42 | 9.41 | 39 | 140055 | 8017 | 63340911 |
| Pyelonephritis acute | 9.42 | 9.41 | 27 | 140067 | 4614 | 63344314 |
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 |
|---|---|---|---|---|---|---|
| Drug ineffective | 182.09 | 10.01 | 609 | 91574 | 456142 | 34408606 |
| Drug abuse | 177.95 | 10.01 | 25 | 92158 | 99071 | 34765677 |
| Hepatic function abnormal | 160.84 | 10.01 | 359 | 91824 | 44004 | 34820744 |
| Toxicity to various agents | 127.02 | 10.01 | 208 | 91975 | 200154 | 34664594 |
| Off label use | 112.31 | 10.01 | 649 | 91534 | 418875 | 34445873 |
| Alanine aminotransferase increased | 109.70 | 10.01 | 463 | 91720 | 80352 | 34784396 |
| Aspartate aminotransferase increased | 109.41 | 10.01 | 410 | 91773 | 67373 | 34797375 |
| Platelet count decreased | 97.58 | 10.01 | 594 | 91589 | 119123 | 34745625 |
| Completed suicide | 89.91 | 10.01 | 76 | 92107 | 98092 | 34766656 |
| Liver disorder | 85.61 | 10.01 | 235 | 91948 | 32762 | 34831986 |
| Disseminated intravascular coagulation | 79.53 | 10.01 | 177 | 92006 | 21639 | 34843109 |
| General physical health deterioration | 76.75 | 10.01 | 138 | 92045 | 128131 | 34736617 |
| White blood cell count decreased | 67.51 | 10.01 | 457 | 91726 | 94988 | 34769760 |
| Neutrophil count decreased | 62.59 | 10.01 | 284 | 91899 | 50820 | 34813928 |
| Aplastic anaemia | 53.83 | 10.01 | 94 | 92089 | 9622 | 34855126 |
| Drug interaction | 48.40 | 10.01 | 373 | 91810 | 225573 | 34639175 |
| Treatment failure | 44.16 | 10.01 | 35 | 92148 | 46662 | 34818086 |
| Blood lactate dehydrogenase increased | 43.87 | 10.01 | 147 | 92036 | 22843 | 34841905 |
| Drug resistance | 43.23 | 10.01 | 8 | 92175 | 25919 | 34838829 |
| Infusion related reaction | 42.98 | 10.01 | 263 | 91920 | 52794 | 34811954 |
| Upper respiratory tract inflammation | 42.68 | 10.01 | 36 | 92147 | 1708 | 34863040 |
| Chronic kidney disease | 41.80 | 10.01 | 217 | 91966 | 40993 | 34823755 |
| Pneumonia | 39.96 | 10.01 | 1244 | 90939 | 361383 | 34503365 |
| Interstitial lung disease | 39.42 | 10.01 | 301 | 91882 | 64981 | 34799767 |
| Overdose | 36.96 | 10.01 | 120 | 92063 | 90939 | 34773809 |
| Blood alkaline phosphatase increased | 36.49 | 10.01 | 171 | 92012 | 31004 | 34833744 |
| Febrile neutropenia | 35.51 | 10.01 | 532 | 91651 | 136317 | 34728431 |
| Pyrexia | 35.50 | 10.01 | 1138 | 91045 | 331875 | 34532873 |
| Drug intolerance | 34.78 | 10.01 | 65 | 92118 | 59505 | 34805243 |
| Therapeutic product effect incomplete | 34.30 | 10.01 | 50 | 92133 | 50491 | 34814257 |
| Cerebral infarction | 33.92 | 10.01 | 153 | 92030 | 27302 | 34837446 |
| Lymphocyte stimulation test positive | 33.80 | 10.01 | 22 | 92161 | 698 | 34864050 |
| Rheumatoid arthritis | 33.30 | 10.01 | 31 | 92152 | 38207 | 34826541 |
| Product use in unapproved indication | 32.73 | 10.01 | 179 | 92004 | 117320 | 34747428 |
| Intentional product use issue | 32.56 | 10.01 | 68 | 92115 | 59748 | 34805000 |
| Intentional product misuse | 31.07 | 10.01 | 45 | 92138 | 45566 | 34819182 |
| Pneumonitis | 28.11 | 10.01 | 169 | 92014 | 33709 | 34831039 |
| Enterocolitis | 27.99 | 10.01 | 64 | 92119 | 7962 | 34856786 |
| Decreased appetite | 27.63 | 10.01 | 603 | 91580 | 165789 | 34698959 |
| Foetal exposure during pregnancy | 26.53 | 10.01 | 37 | 92146 | 38064 | 34826684 |
| Blood bilirubin increased | 26.22 | 10.01 | 182 | 92001 | 38114 | 34826634 |
| Blood creatine phosphokinase MB increased | 25.36 | 10.01 | 28 | 92155 | 1858 | 34862890 |
| Acute respiratory failure | 24.84 | 10.01 | 153 | 92030 | 30775 | 34833973 |
| Pneumonia bacterial | 24.52 | 10.01 | 78 | 92105 | 11794 | 34852954 |
| Blood urea increased | 24.26 | 10.01 | 150 | 92033 | 30214 | 34834534 |
| Infective pulmonary exacerbation of cystic fibrosis | 23.46 | 10.01 | 54 | 92129 | 6747 | 34858001 |
| Hypoxia | 22.86 | 10.01 | 234 | 91949 | 54861 | 34809887 |
| Rash | 22.83 | 10.01 | 758 | 91425 | 221994 | 34642754 |
| Burkholderia test positive | 22.77 | 10.01 | 20 | 92163 | 1003 | 34863745 |
| Constipation | 21.96 | 10.01 | 494 | 91689 | 136488 | 34728260 |
| Cytokine release syndrome | 21.51 | 10.01 | 118 | 92065 | 22759 | 34841989 |
| Erythema multiforme | 20.85 | 10.01 | 60 | 92123 | 8589 | 34856159 |
| Anaphylactic reaction | 20.65 | 10.01 | 151 | 92032 | 32150 | 34832598 |
| Urticaria | 20.46 | 10.01 | 253 | 91930 | 62124 | 34802624 |
| Cardiogenic shock | 20.45 | 10.01 | 24 | 92159 | 26594 | 34838154 |
| Contraindicated product administered | 20.43 | 10.01 | 16 | 92167 | 21465 | 34843283 |
| Plasma cell myeloma | 20.12 | 10.01 | 184 | 91999 | 41853 | 34822895 |
| Musculoskeletal stiffness | 20.00 | 10.01 | 60 | 92123 | 46620 | 34818128 |
| Arthropathy | 19.89 | 10.01 | 25 | 92158 | 26882 | 34837866 |
| Pneumonia aspiration | 19.85 | 10.01 | 183 | 92000 | 41720 | 34823028 |
| Haematocrit decreased | 19.69 | 10.01 | 149 | 92034 | 32067 | 34832681 |
| Joint swelling | 19.69 | 10.01 | 86 | 92097 | 59804 | 34804944 |
| Stomatitis | 19.30 | 10.01 | 184 | 91999 | 42330 | 34822418 |
| Blood pressure ambulatory increased | 19.04 | 10.01 | 7 | 92176 | 59 | 34864689 |
| Blood albumin decreased | 18.57 | 10.01 | 78 | 92105 | 13494 | 34851254 |
| Respiratory failure | 18.49 | 10.01 | 395 | 91788 | 108177 | 34756571 |
| Intentional overdose | 18.10 | 10.01 | 57 | 92126 | 43617 | 34821131 |
| Pharyngeal dystonia | 17.99 | 10.01 | 7 | 92176 | 70 | 34864678 |
| Hiccups | 17.95 | 10.01 | 63 | 92120 | 10019 | 34854729 |
| Prohormone brain natriuretic peptide increased | 17.48 | 10.01 | 7 | 92176 | 76 | 34864672 |
| Hypoalbuminaemia | 16.68 | 10.01 | 70 | 92113 | 12104 | 34852644 |
| End stage renal disease | 16.32 | 10.01 | 56 | 92127 | 8805 | 34855943 |
| White blood cell count increased | 16.22 | 10.01 | 173 | 92010 | 40978 | 34823770 |
| Lactic acidosis | 16.15 | 10.01 | 43 | 92140 | 34729 | 34830019 |
| Psychotic disorder | 15.80 | 10.01 | 25 | 92158 | 24427 | 34840321 |
| Catheter site haemorrhage | 15.69 | 10.01 | 24 | 92159 | 2200 | 34862548 |
| Flushing | 15.56 | 10.01 | 142 | 92041 | 32278 | 34832470 |
| Drug dependence | 15.42 | 10.01 | 25 | 92158 | 24192 | 34840556 |
| PO2 increased | 15.28 | 10.01 | 13 | 92170 | 624 | 34864124 |
| Blood pressure fluctuation | 15.22 | 10.01 | 27 | 92156 | 25222 | 34839526 |
| Cholangitis acute | 15.20 | 10.01 | 15 | 92168 | 873 | 34863875 |
| Inappropriate schedule of product administration | 15.16 | 10.01 | 99 | 92084 | 62197 | 34802551 |
| Cardiac autonomic neuropathy | 15.16 | 10.01 | 6 | 92177 | 63 | 34864685 |
| Pneumonia staphylococcal | 15.14 | 10.01 | 28 | 92155 | 2996 | 34861752 |
| Wound secretion | 15.04 | 10.01 | 26 | 92157 | 2639 | 34862109 |
| Glossectomy | 14.82 | 10.01 | 3 | 92180 | 0 | 34864748 |
| Blood pressure decreased | 14.82 | 10.01 | 204 | 91979 | 51311 | 34813437 |
| Ventricular tachycardia | 14.63 | 10.01 | 120 | 92063 | 26459 | 34838289 |
| Gastrointestinal mucosal necrosis | 14.59 | 10.01 | 8 | 92175 | 184 | 34864564 |
| Torsade de pointes | 14.56 | 10.01 | 47 | 92136 | 7162 | 34857586 |
| Platelet transfusion | 14.52 | 10.01 | 19 | 92164 | 1507 | 34863241 |
| Eczema asteatotic | 14.36 | 10.01 | 9 | 92174 | 267 | 34864481 |
| Frequent bowel movements | 14.21 | 10.01 | 8 | 92175 | 12779 | 34851969 |
| Visual evoked potentials abnormal | 14.16 | 10.01 | 6 | 92177 | 76 | 34864672 |
| Sepsis | 14.14 | 10.01 | 555 | 91628 | 166006 | 34698742 |
| Conduction disorder | 13.81 | 10.01 | 22 | 92161 | 2088 | 34862660 |
| Blood pressure systolic increased | 13.43 | 10.01 | 25 | 92158 | 22927 | 34841821 |
| Cystic fibrosis | 13.29 | 10.01 | 19 | 92164 | 1639 | 34863109 |
| Spasmodic dysphonia | 13.24 | 10.01 | 8 | 92175 | 222 | 34864526 |
| Hepatocellular injury | 13.17 | 10.01 | 24 | 92159 | 22187 | 34842561 |
| Burkholderia infection | 13.13 | 10.01 | 6 | 92177 | 92 | 34864656 |
| Polyneuropathy | 13.06 | 10.01 | 12 | 92171 | 14884 | 34849864 |
| Coma | 13.03 | 10.01 | 69 | 92114 | 45609 | 34819139 |
| Stevens-Johnson syndrome | 13.00 | 10.01 | 89 | 92094 | 18550 | 34846198 |
| Convulsive threshold lowered | 12.95 | 10.01 | 11 | 92172 | 527 | 34864221 |
| Hepatotoxicity | 12.93 | 10.01 | 23 | 92160 | 21462 | 34843286 |
| Haematotoxicity | 12.69 | 10.01 | 3 | 92180 | 8191 | 34856557 |
| Amino acid level increased | 12.66 | 10.01 | 10 | 92173 | 432 | 34864316 |
| Weight increased | 12.64 | 10.01 | 171 | 92012 | 92862 | 34771886 |
| Mast cell activation syndrome | 12.63 | 10.01 | 8 | 92175 | 242 | 34864506 |
| Anal erosion | 12.33 | 10.01 | 4 | 92179 | 22 | 34864726 |
| Sputum retention | 12.27 | 10.01 | 10 | 92173 | 452 | 34864296 |
| Therapy partial responder | 12.24 | 10.01 | 5 | 92178 | 9611 | 34855137 |
| Supine hypertension | 12.22 | 10.01 | 9 | 92174 | 350 | 34864398 |
| Renal impairment | 12.18 | 10.01 | 331 | 91852 | 94182 | 34770566 |
| Hypertensive crisis | 12.07 | 10.01 | 4 | 92179 | 8747 | 34856001 |
| CADASIL | 12.07 | 10.01 | 6 | 92177 | 112 | 34864636 |
| Gamma-glutamyltransferase increased | 12.04 | 10.01 | 124 | 92059 | 29107 | 34835641 |
| Hospice care | 12.04 | 10.01 | 43 | 92140 | 6897 | 34857851 |
| Human ehrlichiosis | 11.93 | 10.01 | 9 | 92174 | 363 | 34864385 |
| Loss of personal independence in daily activities | 11.93 | 10.01 | 46 | 92137 | 33133 | 34831615 |
| Disease prodromal stage | 11.91 | 10.01 | 4 | 92179 | 25 | 34864723 |
| Protein total decreased | 11.80 | 10.01 | 35 | 92148 | 5095 | 34859653 |
| Convulsions local | 11.77 | 10.01 | 4 | 92179 | 26 | 34864722 |
| Pulmonary fibrosis | 11.71 | 10.01 | 19 | 92164 | 18377 | 34846371 |
| Hyperuricaemia | 11.61 | 10.01 | 47 | 92136 | 7996 | 34856752 |
| Aggression | 11.59 | 10.01 | 58 | 92125 | 38906 | 34825842 |
| Cerebral microangiopathy | 11.56 | 10.01 | 7 | 92176 | 195 | 34864553 |
| Post procedural haematoma | 11.52 | 10.01 | 17 | 92166 | 1509 | 34863239 |
| Substance abuse | 11.44 | 10.01 | 3 | 92180 | 7638 | 34857110 |
| Suicide attempt | 11.20 | 10.01 | 59 | 92124 | 39057 | 34825691 |
| Jaundice hepatocellular | 11.04 | 10.01 | 5 | 92178 | 75 | 34864673 |
| Progressive multifocal leukoencephalopathy | 11.01 | 10.01 | 6 | 92177 | 9758 | 34854990 |
| Gastric perforation | 10.98 | 10.01 | 22 | 92161 | 2498 | 34862250 |
| Oral pruritus | 10.88 | 10.01 | 8 | 92175 | 310 | 34864438 |
| Sputum culture positive | 10.83 | 10.01 | 18 | 92165 | 1770 | 34862978 |
| Magnetic resonance imaging spinal abnormal | 10.82 | 10.01 | 6 | 92177 | 141 | 34864607 |
| Eosinophil count increased | 10.75 | 10.01 | 48 | 92135 | 8524 | 34856224 |
| Lower respiratory tract infection | 10.66 | 10.01 | 45 | 92138 | 31592 | 34833156 |
| Product use issue | 10.58 | 10.01 | 111 | 92072 | 63105 | 34801643 |
| Blood creatinine increased | 10.43 | 10.01 | 326 | 91857 | 94650 | 34770098 |
| Ventricular flutter | 10.37 | 10.01 | 5 | 92178 | 87 | 34864661 |
| Post procedural complication | 10.21 | 10.01 | 58 | 92125 | 11330 | 34853418 |
| Oral dysaesthesia | 10.17 | 10.01 | 5 | 92178 | 91 | 34864657 |
| Laboratory test abnormal | 10.13 | 10.01 | 90 | 92093 | 20301 | 34844447 |
| Extravasation | 10.10 | 10.01 | 18 | 92165 | 1872 | 34862876 |
| Lipid metabolism disorder | 10.08 | 10.01 | 8 | 92175 | 348 | 34864400 |
| Arthralgia | 10.07 | 10.01 | 357 | 91826 | 169684 | 34695064 |
| Troponin I increased | 10.04 | 10.01 | 22 | 92161 | 2660 | 34862088 |
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 |
|---|---|---|---|---|---|---|
| Drug ineffective | 416.71 | 9.28 | 1225 | 184797 | 1079688 | 78478678 |
| Synovitis | 283.42 | 9.28 | 17 | 186005 | 150717 | 79407649 |
| Hepatic function abnormal | 262.61 | 9.28 | 548 | 185474 | 72559 | 79485807 |
| Drug intolerance | 257.63 | 9.28 | 148 | 185874 | 263971 | 79294395 |
| Contraindicated product administered | 248.15 | 9.28 | 36 | 185986 | 157502 | 79400864 |
| Drug abuse | 247.58 | 9.28 | 41 | 185981 | 162650 | 79395716 |
| Joint swelling | 236.06 | 9.28 | 196 | 185826 | 288450 | 79269916 |
| Pemphigus | 212.19 | 9.28 | 4 | 186018 | 99578 | 79458788 |
| Arthropathy | 210.49 | 9.28 | 75 | 185947 | 177036 | 79381330 |
| Platelet count decreased | 206.00 | 9.28 | 950 | 185072 | 193714 | 79364652 |
| Treatment failure | 201.23 | 9.28 | 73 | 185949 | 170413 | 79387953 |
| Hand deformity | 200.68 | 9.28 | 10 | 186012 | 103909 | 79454457 |
| Off label use | 187.57 | 9.28 | 1294 | 184728 | 905921 | 78652445 |
| Toxicity to various agents | 187.09 | 9.28 | 444 | 185578 | 421096 | 79137270 |
| Rheumatoid arthritis | 183.82 | 9.28 | 131 | 185891 | 208339 | 79350027 |
| Therapeutic product effect decreased | 182.12 | 9.28 | 77 | 185945 | 163786 | 79394580 |
| Aspartate aminotransferase increased | 176.87 | 9.28 | 716 | 185306 | 137925 | 79420441 |
| General physical health deterioration | 165.34 | 9.28 | 241 | 185781 | 274997 | 79283369 |
| Alanine aminotransferase increased | 156.41 | 9.28 | 772 | 185250 | 161798 | 79396568 |
| White blood cell count decreased | 148.23 | 9.28 | 846 | 185176 | 187442 | 79370924 |
| Systemic lupus erythematosus | 132.89 | 9.28 | 58 | 185964 | 121091 | 79437275 |
| Glossodynia | 129.32 | 9.28 | 40 | 185982 | 103297 | 79455069 |
| Pericarditis | 129.28 | 9.28 | 41 | 185981 | 104195 | 79454171 |
| Disseminated intravascular coagulation | 129.04 | 9.28 | 269 | 185753 | 35573 | 79522793 |
| Duodenal ulcer perforation | 122.83 | 9.28 | 8 | 186014 | 66203 | 79492163 |
| Pneumonia aspiration | 115.93 | 9.28 | 382 | 185640 | 66585 | 79491781 |
| Lower respiratory tract infection | 111.52 | 9.28 | 83 | 185939 | 129137 | 79429229 |
| Helicobacter infection | 107.27 | 9.28 | 17 | 186005 | 69687 | 79488679 |
| Cytokine release syndrome | 105.70 | 9.28 | 249 | 185773 | 35749 | 79522617 |
| Neutrophil count decreased | 101.09 | 9.28 | 461 | 185561 | 93498 | 79464868 |
| Completed suicide | 98.00 | 9.28 | 273 | 185749 | 245494 | 79312872 |
| Flushing | 97.90 | 9.28 | 437 | 185585 | 87831 | 79470535 |
| Musculoskeletal stiffness | 95.76 | 9.28 | 163 | 185859 | 174845 | 79383521 |
| C-reactive protein abnormal | 95.50 | 9.28 | 4 | 186018 | 48363 | 79510003 |
| Wound | 94.73 | 9.28 | 79 | 185943 | 116100 | 79442266 |
| Liver disorder | 93.89 | 9.28 | 376 | 185646 | 72041 | 79486325 |
| Gastrooesophageal reflux disease | 93.85 | 9.28 | 486 | 185536 | 103760 | 79454606 |
| Mobility decreased | 92.52 | 9.28 | 89 | 185933 | 122086 | 79436280 |
| Therapeutic product effect incomplete | 92.07 | 9.28 | 117 | 185905 | 141528 | 79416838 |
| Muscle injury | 89.68 | 9.28 | 6 | 186016 | 48555 | 79509811 |
| Blood lactate dehydrogenase increased | 88.08 | 9.28 | 245 | 185777 | 38925 | 79519441 |
| Sleep disorder due to general medical condition, insomnia type | 88.06 | 9.28 | 3 | 186019 | 43553 | 79514813 |
| Arthralgia | 85.52 | 9.28 | 887 | 185135 | 570916 | 78987450 |
| Febrile neutropenia | 84.01 | 9.28 | 866 | 185156 | 230133 | 79328233 |
| Aplastic anaemia | 82.30 | 9.28 | 149 | 185873 | 17756 | 79540610 |
| Psoriatic arthropathy | 81.41 | 9.28 | 40 | 185982 | 77959 | 79480407 |
| Folliculitis | 79.80 | 9.28 | 16 | 186006 | 55364 | 79503002 |
| Interstitial lung disease | 78.96 | 9.28 | 491 | 185531 | 112109 | 79446257 |
| Product use issue | 77.88 | 9.28 | 241 | 185781 | 209581 | 79348785 |
| Type I hypersensitivity | 74.69 | 9.28 | 70 | 185952 | 4328 | 79554038 |
| Upper respiratory tract inflammation | 71.96 | 9.28 | 66 | 185956 | 3969 | 79554397 |
| Discomfort | 71.49 | 9.28 | 114 | 185908 | 125503 | 79432863 |
| Cerebral infarction | 68.12 | 9.28 | 248 | 185774 | 45428 | 79512938 |
| Chronic kidney disease | 67.77 | 9.28 | 320 | 185702 | 65834 | 79492532 |
| Anaphylactic reaction | 66.30 | 9.28 | 377 | 185645 | 83366 | 79475000 |
| Intentional product use issue | 65.92 | 9.28 | 162 | 185860 | 151950 | 79406416 |
| Enterocolitis | 63.22 | 9.28 | 118 | 185904 | 14394 | 79543972 |
| Drug hypersensitivity | 63.07 | 9.28 | 423 | 185599 | 298493 | 79259873 |
| Red blood cell sedimentation rate increased | 62.70 | 9.28 | 15 | 186007 | 45927 | 79512439 |
| Hepatic enzyme increased | 62.06 | 9.28 | 218 | 185804 | 182392 | 79375974 |
| Irritable bowel syndrome | 61.87 | 9.28 | 34 | 185988 | 62207 | 79496159 |
| Sopor | 61.19 | 9.28 | 4 | 186018 | 33006 | 79525360 |
| Decreased appetite | 60.02 | 9.28 | 1127 | 184895 | 341291 | 79217075 |
| Alopecia | 58.52 | 9.28 | 309 | 185713 | 231046 | 79327320 |
| Pneumonia | 58.33 | 9.28 | 1981 | 184041 | 658265 | 78900101 |
| Lymphocyte stimulation test positive | 58.07 | 9.28 | 35 | 185987 | 1098 | 79557268 |
| Drug resistance | 57.18 | 9.28 | 14 | 186008 | 42199 | 79516167 |
| Blood alkaline phosphatase increased | 56.72 | 9.28 | 296 | 185726 | 63368 | 79494998 |
| Acute respiratory failure | 56.66 | 9.28 | 282 | 185740 | 59259 | 79499107 |
| Maternal exposure during pregnancy | 56.39 | 9.28 | 149 | 185873 | 136389 | 79421977 |
| Fibromyalgia | 55.92 | 9.28 | 41 | 185981 | 64299 | 79494067 |
| Overdose | 54.20 | 9.28 | 233 | 185789 | 183973 | 79374393 |
| Chest discomfort | 50.36 | 9.28 | 518 | 185504 | 137526 | 79420840 |
| Pyrexia | 49.88 | 9.28 | 1995 | 184027 | 676714 | 78881652 |
| Blood bilirubin increased | 49.71 | 9.28 | 294 | 185728 | 65938 | 79492428 |
| Swelling | 49.62 | 9.28 | 299 | 185723 | 216412 | 79341954 |
| Hypoxia | 49.58 | 9.28 | 411 | 185611 | 102832 | 79455534 |
| Cholecystitis chronic | 47.53 | 9.28 | 84 | 185938 | 9822 | 79548544 |
| Infective pulmonary exacerbation of cystic fibrosis | 46.89 | 9.28 | 97 | 185925 | 12754 | 79545612 |
| Dehydration | 46.66 | 9.28 | 826 | 185196 | 247361 | 79311005 |
| Impaired healing | 45.79 | 9.28 | 84 | 185938 | 87571 | 79470795 |
| Hepatic cytolysis | 43.21 | 9.28 | 6 | 186016 | 27145 | 79531221 |
| Sepsis | 43.19 | 9.28 | 875 | 185147 | 268553 | 79289813 |
| Blood pressure fluctuation | 43.06 | 9.28 | 56 | 185966 | 67089 | 79491277 |
| Knee arthroplasty | 42.44 | 9.28 | 24 | 185998 | 43224 | 79515142 |
| Hepatocellular injury | 40.49 | 9.28 | 31 | 185991 | 47562 | 79510804 |
| Weight increased | 39.85 | 9.28 | 434 | 185588 | 276952 | 79281414 |
| Erythema multiforme | 39.28 | 9.28 | 110 | 185912 | 17541 | 79540825 |
| Arthritis | 39.11 | 9.28 | 137 | 185885 | 114743 | 79443623 |
| Urticaria | 39.04 | 9.28 | 628 | 185394 | 184573 | 79373793 |
| Mast cell activation syndrome | 38.87 | 9.28 | 23 | 185999 | 697 | 79557669 |
| Ill-defined disorder | 38.21 | 9.28 | 59 | 185963 | 65816 | 79492550 |
| Loss of personal independence in daily activities | 37.91 | 9.28 | 118 | 185904 | 102462 | 79455904 |
| Plasma cell myeloma | 37.79 | 9.28 | 233 | 185789 | 53026 | 79505340 |
| Mental status changes | 37.36 | 9.28 | 276 | 185746 | 66683 | 79491683 |
| Blood creatine phosphokinase MB increased | 37.10 | 9.28 | 39 | 185983 | 2772 | 79555594 |
| Torsade de pointes | 36.90 | 9.28 | 114 | 185908 | 19198 | 79539168 |
| Liver injury | 36.53 | 9.28 | 47 | 185975 | 56567 | 79501799 |
| Pain | 36.11 | 9.28 | 1311 | 184711 | 702491 | 78855875 |
| Blister | 35.82 | 9.28 | 150 | 185872 | 119326 | 79439040 |
| Drug interaction | 35.79 | 9.28 | 718 | 185304 | 414465 | 79143901 |
| Pneumonitis | 35.76 | 9.28 | 254 | 185768 | 60606 | 79497760 |
| Blood pressure systolic increased | 35.15 | 9.28 | 64 | 185958 | 66922 | 79491444 |
| Butterfly rash | 34.74 | 9.28 | 30 | 185992 | 1666 | 79556700 |
| White blood cell count increased | 34.71 | 9.28 | 295 | 185727 | 74338 | 79484028 |
| Blood urea increased | 34.33 | 9.28 | 213 | 185809 | 48577 | 79509789 |
| Pneumonia bacterial | 34.09 | 9.28 | 111 | 185911 | 19220 | 79539146 |
| Urinary tract infection | 33.81 | 9.28 | 859 | 185163 | 273653 | 79284713 |
| Drug eruption | 33.59 | 9.28 | 196 | 185826 | 43739 | 79514627 |
| Hip arthroplasty | 33.46 | 9.28 | 21 | 186001 | 35735 | 79522631 |
| Gastrointestinal disorder | 33.28 | 9.28 | 159 | 185863 | 122046 | 79436320 |
| Medication error | 33.06 | 9.28 | 69 | 185953 | 68573 | 79489793 |
| Intentional product misuse | 32.72 | 9.28 | 113 | 185909 | 95052 | 79463314 |
| Constipation | 32.34 | 9.28 | 877 | 185145 | 282173 | 79276193 |
| Lip swelling | 32.25 | 9.28 | 184 | 185838 | 40727 | 79517639 |
| Haematocrit decreased | 31.56 | 9.28 | 248 | 185774 | 61064 | 79497302 |
| Throat tightness | 30.80 | 9.28 | 138 | 185884 | 27769 | 79530597 |
| Blood albumin decreased | 30.71 | 9.28 | 125 | 185897 | 24118 | 79534248 |
| Protein total decreased | 30.14 | 9.28 | 66 | 185956 | 9026 | 79549340 |
| Abdominal discomfort | 29.31 | 9.28 | 410 | 185612 | 250317 | 79308049 |
| Chills | 28.93 | 9.28 | 530 | 185492 | 159704 | 79398662 |
| Ventricular tachycardia | 28.84 | 9.28 | 182 | 185840 | 41753 | 79516613 |
| Hospice care | 28.78 | 9.28 | 70 | 185952 | 10254 | 79548112 |
| Respiratory failure | 28.46 | 9.28 | 586 | 185436 | 180325 | 79378041 |
| Musculoskeletal pain | 27.97 | 9.28 | 133 | 185889 | 102221 | 79456145 |
| Hepatotoxicity | 27.91 | 9.28 | 48 | 185974 | 51304 | 79507062 |
| Periorbital oedema | 27.86 | 9.28 | 61 | 185961 | 8341 | 79550025 |
| Pulmonary fibrosis | 27.06 | 9.28 | 38 | 185984 | 44074 | 79514292 |
| Peripheral swelling | 26.72 | 9.28 | 455 | 185567 | 269162 | 79289204 |
| Angioedema | 26.62 | 9.28 | 283 | 185739 | 75752 | 79482614 |
| COVID-19 | 26.22 | 9.28 | 515 | 185507 | 157159 | 79401207 |
| Condition aggravated | 26.21 | 9.28 | 931 | 185091 | 500193 | 79058173 |
| Haemorrhage subcutaneous | 26.00 | 9.28 | 43 | 185979 | 4766 | 79553600 |
| Dermatitis atopic | 25.74 | 9.28 | 66 | 185956 | 9990 | 79548376 |
| Granulocytopenia | 25.20 | 9.28 | 71 | 185951 | 11360 | 79547006 |
| Therapy non-responder | 25.19 | 9.28 | 120 | 185902 | 92185 | 79466181 |
| Contusion | 25.02 | 9.28 | 224 | 185798 | 148552 | 79409814 |
| Blood pressure diastolic abnormal | 24.80 | 9.28 | 7 | 186015 | 19195 | 79539171 |
| Renal impairment | 24.78 | 9.28 | 511 | 185511 | 157272 | 79401094 |
| Swelling face | 24.44 | 9.28 | 264 | 185758 | 70948 | 79487418 |
| Emotional distress | 24.17 | 9.28 | 168 | 185854 | 39801 | 79518565 |
| Blood creatinine increased | 23.97 | 9.28 | 501 | 185521 | 154556 | 79403810 |
| Hypoalbuminaemia | 23.27 | 9.28 | 105 | 185917 | 21192 | 79537174 |
| Hyperuricaemia | 22.87 | 9.28 | 70 | 185952 | 11729 | 79546637 |
| Polyneuropathy | 22.85 | 9.28 | 14 | 186008 | 24137 | 79534229 |
| Blood magnesium decreased | 22.41 | 9.28 | 87 | 185935 | 16425 | 79541941 |
| Throat irritation | 22.40 | 9.28 | 168 | 185854 | 40778 | 79517588 |
| Burkholderia test positive | 22.32 | 9.28 | 15 | 186007 | 570 | 79557796 |
| End stage renal disease | 22.30 | 9.28 | 71 | 185951 | 12149 | 79546217 |
| Vaccination site reaction | 21.88 | 9.28 | 9 | 186013 | 120 | 79558246 |
| Nasopharyngitis | 21.86 | 9.28 | 439 | 185583 | 253442 | 79304924 |
| Intentional overdose | 21.79 | 9.28 | 151 | 185871 | 105809 | 79452557 |
| Blood cholesterol increased | 21.60 | 9.28 | 111 | 185911 | 83609 | 79474757 |
| Diarrhoea | 21.44 | 9.28 | 2356 | 183666 | 878133 | 78680233 |
| Tenosynovitis | 21.38 | 9.28 | 5 | 186017 | 15549 | 79542817 |
| Exposure during pregnancy | 20.85 | 9.28 | 144 | 185878 | 100988 | 79457378 |
| Infection | 20.80 | 9.28 | 418 | 185604 | 241294 | 79317072 |
| Nausea | 20.47 | 9.28 | 2540 | 183482 | 954656 | 78603710 |
| Gallbladder disorder | 20.13 | 9.28 | 94 | 185928 | 19246 | 79539120 |
| Pleural effusion | 20.11 | 9.28 | 462 | 185560 | 144800 | 79413566 |
| Cholecystitis acute | 20.02 | 9.28 | 73 | 185949 | 13378 | 79544988 |
| Haemoglobin decreased | 19.90 | 9.28 | 668 | 185354 | 221451 | 79336915 |
| Gastritis | 19.89 | 9.28 | 185 | 185837 | 47808 | 79510558 |
| Asteatosis | 19.77 | 9.28 | 8 | 186014 | 102 | 79558264 |
| Joint stiffness | 19.70 | 9.28 | 41 | 185981 | 40789 | 79517577 |
| Drug dependence | 19.61 | 9.28 | 41 | 185981 | 40728 | 79517638 |
| Inflammation | 19.57 | 9.28 | 133 | 185889 | 93620 | 79464746 |
| Blood pressure ambulatory increased | 19.47 | 9.28 | 7 | 186015 | 63 | 79558303 |
| Blood pressure systolic abnormal | 19.31 | 9.28 | 8 | 186014 | 17239 | 79541127 |
| Osteoarthritis | 19.17 | 9.28 | 122 | 185900 | 87187 | 79471179 |
| Poisoning deliberate | 19.13 | 9.28 | 10 | 186012 | 18818 | 79539548 |
| Joint range of motion decreased | 19.12 | 9.28 | 30 | 185992 | 33252 | 79525114 |
| Grip strength decreased | 18.92 | 9.28 | 14 | 186008 | 21855 | 79536511 |
| Renal injury | 18.90 | 9.28 | 84 | 185938 | 16843 | 79541523 |
| Palmar erythema | 18.85 | 9.28 | 23 | 185999 | 1924 | 79556442 |
| Stevens-Johnson syndrome | 18.84 | 9.28 | 156 | 185866 | 39010 | 79519356 |
| Therapeutic response decreased | 18.78 | 9.28 | 86 | 185936 | 66767 | 79491599 |
| Biliary dyskinesia | 18.34 | 9.28 | 26 | 185996 | 2519 | 79555847 |
| Prescribed overdose | 18.31 | 9.28 | 38 | 185984 | 37845 | 79520521 |
| Blood potassium decreased | 18.14 | 9.28 | 177 | 185845 | 46335 | 79512031 |
| Osteoporosis | 18.10 | 9.28 | 65 | 185957 | 54047 | 79504319 |
| Psychotic disorder | 18.00 | 9.28 | 44 | 185978 | 41358 | 79517008 |
| Non-cardiac chest pain | 17.99 | 9.28 | 56 | 185966 | 9468 | 79548898 |
| Sedation complication | 17.98 | 9.28 | 7 | 186015 | 15662 | 79542704 |
| Blood pressure decreased | 17.94 | 9.28 | 329 | 185693 | 99137 | 79459229 |
| Small intestinal obstruction | 17.91 | 9.28 | 117 | 185905 | 27155 | 79531211 |
| Hypervolaemia | 17.91 | 9.28 | 165 | 185857 | 42525 | 79515841 |
| Impaired work ability | 17.81 | 9.28 | 12 | 186010 | 19669 | 79538697 |
| Extrapyramidal disorder | 17.77 | 9.28 | 16 | 186006 | 22663 | 79535703 |
| Haematotoxicity | 17.70 | 9.28 | 7 | 186015 | 15512 | 79542854 |
| Disease progression | 17.42 | 9.28 | 558 | 185464 | 183804 | 79374562 |
| Heart rate decreased | 17.16 | 9.28 | 95 | 185927 | 70221 | 79488145 |
| Gamma-glutamyltransferase increased | 17.08 | 9.28 | 199 | 185823 | 54481 | 79503885 |
| Weight fluctuation | 17.07 | 9.28 | 63 | 185959 | 11612 | 79546754 |
| Platelet transfusion | 16.98 | 9.28 | 24 | 185998 | 2318 | 79556048 |
| Pain in extremity | 16.88 | 9.28 | 687 | 185335 | 363851 | 79194515 |
| Basal cell carcinoma | 16.82 | 9.28 | 39 | 185983 | 37336 | 79521030 |
| Foot deformity | 16.57 | 9.28 | 19 | 186003 | 24055 | 79534311 |
| Cholestasis | 16.51 | 9.28 | 64 | 185958 | 52045 | 79506321 |
| Deep vein thrombosis | 16.25 | 9.28 | 383 | 185639 | 120536 | 79437830 |
| Ventricular flutter | 16.22 | 9.28 | 7 | 186015 | 106 | 79558260 |
| Blindness transient | 16.21 | 9.28 | 35 | 185987 | 4741 | 79553625 |
| Red blood cell count decreased | 16.09 | 9.28 | 205 | 185817 | 57308 | 79501058 |
| Product use in unapproved indication | 15.99 | 9.28 | 453 | 185569 | 249906 | 79308460 |
| Autoimmune hepatitis | 15.92 | 9.28 | 62 | 185960 | 11721 | 79546645 |
| Hypertensive crisis | 15.87 | 9.28 | 15 | 186007 | 20755 | 79537611 |
| Chest pain | 15.87 | 9.28 | 808 | 185214 | 281496 | 79276870 |
| Laboratory test abnormal | 15.86 | 9.28 | 116 | 185906 | 27932 | 79530434 |
| Musculoskeletal disorder | 15.79 | 9.28 | 16 | 186006 | 21432 | 79536934 |
| Cardiac autonomic neuropathy | 15.79 | 9.28 | 6 | 186016 | 64 | 79558302 |
| Hereditary angioedema | 15.76 | 9.28 | 37 | 185985 | 5298 | 79553068 |
| Ileus | 15.75 | 9.28 | 110 | 185912 | 26101 | 79532265 |
| Bursitis | 15.65 | 9.28 | 38 | 185984 | 35806 | 79522560 |
| Injection site pain | 15.63 | 9.28 | 211 | 185811 | 129627 | 79428739 |
| Pneumothorax | 15.37 | 9.28 | 116 | 185906 | 28207 | 79530159 |
| Device difficult to use | 15.33 | 9.28 | 6 | 186016 | 13379 | 79544987 |
| Tumour lysis syndrome | 15.30 | 9.28 | 102 | 185920 | 23837 | 79534529 |
| Dyspnoea | 15.28 | 9.28 | 2250 | 183772 | 854775 | 78703591 |
| Balance disorder | 15.27 | 9.28 | 152 | 185870 | 98705 | 79459661 |
| Rhinovirus infection | 15.24 | 9.28 | 47 | 185975 | 7906 | 79550460 |
| Therapy partial responder | 15.23 | 9.28 | 11 | 186011 | 17386 | 79540980 |
| Glossectomy | 15.19 | 9.28 | 3 | 186019 | 0 | 79558366 |
| Lymphocyte count decreased | 15.17 | 9.28 | 173 | 185849 | 47116 | 79511250 |
| Pharyngeal swelling | 15.15 | 9.28 | 46 | 185976 | 7673 | 79550693 |
| Tubulointerstitial nephritis | 15.15 | 9.28 | 146 | 185876 | 38089 | 79520277 |
| Cystic fibrosis | 15.00 | 9.28 | 30 | 185992 | 3850 | 79554516 |
| Back pain | 14.99 | 9.28 | 860 | 185162 | 303320 | 79255046 |
| Basophil count decreased | 14.94 | 9.28 | 9 | 186013 | 282 | 79558084 |
| Post procedural complication | 14.91 | 9.28 | 101 | 185921 | 23728 | 79534638 |
| Circulatory collapse | 14.87 | 9.28 | 42 | 185980 | 37626 | 79520740 |
| Renal disorder | 14.87 | 9.28 | 157 | 185865 | 41948 | 79516418 |
| Status asthmaticus | 14.83 | 9.28 | 15 | 186007 | 1019 | 79557347 |
| Facet joint syndrome | 14.82 | 9.28 | 4 | 186018 | 11298 | 79547068 |
| Frequent bowel movements | 14.81 | 9.28 | 29 | 185993 | 29510 | 79528856 |
| Neuroleptic malignant syndrome | 14.76 | 9.28 | 26 | 185996 | 27533 | 79530833 |
| Cholangitis acute | 14.68 | 9.28 | 18 | 186004 | 1514 | 79556852 |
| Therapy cessation | 14.67 | 9.28 | 143 | 185879 | 37419 | 79520947 |
| Dysphagia | 14.66 | 9.28 | 381 | 185641 | 121755 | 79436611 |
| Drug tolerance decreased | 14.57 | 9.28 | 6 | 186016 | 12972 | 79545394 |
| Congenital neuropathy | 14.50 | 9.28 | 4 | 186018 | 13 | 79558353 |
| Gallbladder injury | 14.46 | 9.28 | 16 | 186006 | 1205 | 79557161 |
| Lethargy | 14.35 | 9.28 | 268 | 185754 | 81024 | 79477342 |
| Anaphylactoid reaction | 14.31 | 9.28 | 36 | 185986 | 5386 | 79552980 |
| Gastrointestinal mucosal necrosis | 14.15 | 9.28 | 8 | 186014 | 222 | 79558144 |
| Type 2 diabetes mellitus | 14.03 | 9.28 | 77 | 185945 | 57045 | 79501321 |
| Bacteriuria | 13.94 | 9.28 | 16 | 186006 | 1255 | 79557111 |
| Cystoid macular oedema | 13.93 | 9.28 | 20 | 186002 | 1960 | 79556406 |
| Sleep disorder due to a general medical condition | 13.90 | 9.28 | 8 | 186014 | 14269 | 79544097 |
| Respiratory distress | 13.88 | 9.28 | 202 | 185820 | 58137 | 79500229 |
| Haemodialysis | 13.85 | 9.28 | 81 | 185941 | 18087 | 79540279 |
| Carcinoembryonic antigen | 13.83 | 9.28 | 6 | 186016 | 92 | 79558274 |
| Breast cancer stage III | 13.82 | 9.28 | 3 | 186019 | 9823 | 79548543 |
| Swollen tongue | 13.77 | 9.28 | 156 | 185866 | 42414 | 79515952 |
| Fibrin D dimer increased | 13.76 | 9.28 | 48 | 185974 | 8606 | 79549760 |
| Carbohydrate antigen 15-3 | 13.66 | 9.28 | 6 | 186016 | 95 | 79558271 |
| Peritonitis | 13.66 | 9.28 | 112 | 185910 | 27924 | 79530442 |
| Post procedural haematoma | 13.42 | 9.28 | 22 | 186000 | 2420 | 79555946 |
| Anaplastic astrocytoma | 13.42 | 9.28 | 7 | 186015 | 165 | 79558201 |
| Cystitis noninfective | 13.25 | 9.28 | 16 | 186006 | 1324 | 79557042 |
| Hypophagia | 13.24 | 9.28 | 163 | 185859 | 45204 | 79513162 |
| Cholecystitis | 13.22 | 9.28 | 93 | 185929 | 22119 | 79536247 |
| Sciatica | 13.15 | 9.28 | 37 | 185985 | 33185 | 79525181 |
| Heparin-induced thrombocytopenia | 13.13 | 9.28 | 51 | 185971 | 9631 | 79548735 |
| Anaemia | 13.13 | 9.28 | 1207 | 184815 | 443808 | 79114558 |
| Breast adenoma | 13.10 | 9.28 | 5 | 186017 | 54 | 79558312 |
| Illness | 13.10 | 9.28 | 166 | 185856 | 46345 | 79512021 |
| Dermatitis acneiform | 13.03 | 9.28 | 52 | 185970 | 9941 | 79548425 |
| Full blood count decreased | 12.99 | 9.28 | 107 | 185915 | 26712 | 79531654 |
| Infusion site erythema | 12.97 | 9.28 | 50 | 185972 | 9410 | 79548956 |
| Eosinophil count increased | 12.87 | 9.28 | 76 | 185946 | 17029 | 79541337 |
| Gastrointestinal haemorrhage | 12.65 | 9.28 | 442 | 185580 | 147277 | 79411089 |
| Milk allergy | 12.62 | 9.28 | 6 | 186016 | 115 | 79558251 |
| Ammonia decreased | 12.53 | 9.28 | 4 | 186018 | 24 | 79558342 |
| Adverse drug reaction | 12.50 | 9.28 | 97 | 185925 | 66295 | 79492071 |
| Catheter site haemorrhage | 12.50 | 9.28 | 33 | 185989 | 5084 | 79553282 |
| Cholinergic syndrome | 12.46 | 9.28 | 14 | 186008 | 1073 | 79557293 |
| Seasonal allergy | 12.42 | 9.28 | 73 | 185949 | 16333 | 79542033 |
| Cholelithiasis | 12.39 | 9.28 | 182 | 185840 | 52482 | 79505884 |
| Ischaemic stroke | 12.31 | 9.28 | 38 | 185984 | 33093 | 79525273 |
| Intentional self-injury | 12.18 | 9.28 | 37 | 185985 | 32382 | 79525984 |
| Brain natriuretic peptide increased | 12.17 | 9.28 | 47 | 185975 | 8853 | 79549513 |
| Amylase increased | 12.05 | 9.28 | 55 | 185967 | 11154 | 79547212 |
| Malignant neoplasm progression | 11.92 | 9.28 | 408 | 185614 | 135582 | 79422784 |
| Administration site inflammation | 11.91 | 9.28 | 3 | 186019 | 6 | 79558360 |
| Supine hypertension | 11.86 | 9.28 | 9 | 186013 | 415 | 79557951 |
| Chronic gastritis | 11.79 | 9.28 | 28 | 185994 | 4040 | 79554326 |
| Blood pressure diastolic decreased | 11.70 | 9.28 | 34 | 185988 | 30182 | 79528184 |
| Catatonia | 11.67 | 9.28 | 3 | 186019 | 8753 | 79549613 |
| Toxic epidermal necrolysis | 11.67 | 9.28 | 157 | 185865 | 44424 | 79513942 |
| Live birth | 11.64 | 9.28 | 16 | 186006 | 18728 | 79539638 |
| Post procedural haemorrhage | 11.62 | 9.28 | 63 | 185959 | 13681 | 79544685 |
| Acquired haemophilia | 11.58 | 9.28 | 18 | 186004 | 1893 | 79556473 |
| Drug use disorder | 11.46 | 9.28 | 3 | 186019 | 8648 | 79549718 |
| Suicide attempt | 11.40 | 9.28 | 131 | 185891 | 82801 | 79475565 |
| Total lung capacity abnormal | 11.35 | 9.28 | 7 | 186015 | 229 | 79558137 |
| Night sweats | 11.33 | 9.28 | 73 | 185949 | 52022 | 79506344 |
| Pregnancy | 11.31 | 9.28 | 29 | 185993 | 26822 | 79531544 |
| Lymphatic disorder | 11.28 | 9.28 | 8 | 186014 | 332 | 79558034 |
| Product dose omission issue | 11.27 | 9.28 | 695 | 185327 | 246842 | 79311524 |
| Disability | 11.26 | 9.28 | 14 | 186008 | 17106 | 79541260 |
| Dizziness | 11.20 | 9.28 | 1397 | 184625 | 525044 | 79033322 |
| Cardiogenic shock | 11.14 | 9.28 | 55 | 185967 | 41859 | 79516507 |
| Hypokalaemia | 11.12 | 9.28 | 426 | 185596 | 143614 | 79414752 |
| Chronic spontaneous urticaria | 11.11 | 9.28 | 14 | 186008 | 1210 | 79557156 |
| Cellulitis | 11.07 | 9.28 | 333 | 185689 | 108727 | 79449639 |
| Gastrointestinal oedema | 11.04 | 9.28 | 21 | 186001 | 2597 | 79555769 |
| Joint dislocation | 10.99 | 9.28 | 14 | 186008 | 16925 | 79541441 |
| Gastric perforation | 10.86 | 9.28 | 27 | 185995 | 4010 | 79554356 |
| Haemorrhagic diathesis | 10.79 | 9.28 | 35 | 185987 | 6049 | 79552317 |
| Eye haematoma | 10.76 | 9.28 | 6 | 186016 | 162 | 79558204 |
| Pleural neoplasm | 10.72 | 9.28 | 8 | 186014 | 360 | 79558006 |
| Intercepted medication error | 10.71 | 9.28 | 12 | 186010 | 917 | 79557449 |
| Metabolic encephalopathy | 10.68 | 9.28 | 46 | 185976 | 9101 | 79549265 |
| Drug-induced liver injury | 10.66 | 9.28 | 215 | 185807 | 65902 | 79492464 |
| Cognitive disorder | 10.59 | 9.28 | 108 | 185914 | 69818 | 79488548 |
| Hepatitis cholestatic | 10.59 | 9.28 | 10 | 186012 | 13842 | 79544524 |
| Cranial nerve disorder | 10.57 | 9.28 | 13 | 186009 | 1097 | 79557269 |
| Blood pressure diastolic increased | 10.54 | 9.28 | 11 | 186011 | 14531 | 79543835 |
| Hyperlipidaemia | 10.52 | 9.28 | 100 | 185922 | 25993 | 79532373 |
| Paronychia | 10.48 | 9.28 | 41 | 185981 | 7767 | 79550599 |
| Heart transplant | 10.48 | 9.28 | 15 | 186007 | 1466 | 79556900 |
| Pneumonia staphylococcal | 10.48 | 9.28 | 30 | 185992 | 4844 | 79553522 |
| Urine osmolarity decreased | 10.42 | 9.28 | 5 | 186017 | 98 | 79558268 |
| Foetal heart rate abnormal | 10.41 | 9.28 | 8 | 186014 | 376 | 79557990 |
| Lung disorder | 10.40 | 9.28 | 129 | 185893 | 80428 | 79477938 |
| Nephrogenic anaemia | 10.39 | 9.28 | 26 | 185996 | 3876 | 79554490 |
| Cardiac arrest | 10.37 | 9.28 | 496 | 185526 | 171600 | 79386766 |
| Breast cancer female | 10.36 | 9.28 | 7 | 186015 | 11454 | 79546912 |
| Putamen haemorrhage | 10.30 | 9.28 | 9 | 186013 | 508 | 79557858 |
| Psoriasis | 10.28 | 9.28 | 147 | 185875 | 89440 | 79468926 |
| Pityriasis lichenoides et varioliformis acuta | 10.26 | 9.28 | 4 | 186018 | 46 | 79558320 |
| Coronary artery dissection | 10.25 | 9.28 | 13 | 186009 | 1131 | 79557235 |
| Haemolytic anaemia | 10.25 | 9.28 | 74 | 185948 | 17746 | 79540620 |
| Rash | 10.23 | 9.28 | 1518 | 184504 | 576840 | 78981526 |
| Pathogen resistance | 10.22 | 9.28 | 11 | 186011 | 14331 | 79544035 |
| Infusion related hypersensitivity reaction | 10.18 | 9.28 | 8 | 186014 | 389 | 79557977 |
| Coeliac disease | 10.17 | 9.28 | 7 | 186015 | 11344 | 79547022 |
| Prohormone brain natriuretic peptide increased | 10.17 | 9.28 | 7 | 186015 | 277 | 79558089 |
| Altered state of consciousness | 10.14 | 9.28 | 151 | 185871 | 43671 | 79514695 |
| Lactic acidosis | 10.12 | 9.28 | 110 | 185912 | 70249 | 79488117 |
| Oropharyngeal swelling | 10.12 | 9.28 | 14 | 186008 | 1326 | 79557040 |
| Pruritus | 10.11 | 9.28 | 1060 | 184962 | 393588 | 79164778 |
| Pharyngeal dystonia | 10.10 | 9.28 | 4 | 186018 | 48 | 79558318 |
| Restless arm syndrome | 10.10 | 9.28 | 4 | 186018 | 48 | 79558318 |
| Substance abuse | 10.10 | 9.28 | 6 | 186016 | 10520 | 79547846 |
| Palmar-plantar erythrodysaesthesia syndrome | 10.09 | 9.28 | 120 | 185902 | 33014 | 79525352 |
| Hypersomnia | 10.08 | 9.28 | 90 | 185932 | 22996 | 79535370 |
| Cancer pain | 10.06 | 9.28 | 31 | 185991 | 5214 | 79553152 |
| VIIth nerve injury | 10.05 | 9.28 | 6 | 186016 | 185 | 79558181 |
| Mucocutaneous rash | 10.03 | 9.28 | 4 | 186018 | 49 | 79558317 |
| Anal erosion | 10.03 | 9.28 | 4 | 186018 | 49 | 79558317 |
| Troponin I increased | 10.03 | 9.28 | 29 | 185993 | 4709 | 79553657 |
| Ulcer | 10.02 | 9.28 | 36 | 185986 | 29936 | 79528430 |
| Abdominal distension | 9.99 | 9.28 | 357 | 185665 | 119293 | 79439073 |
| Atelectasis | 9.90 | 9.28 | 117 | 185905 | 32140 | 79526226 |
| Sputum culture positive | 9.87 | 9.28 | 25 | 185997 | 3756 | 79554610 |
| Lower limb fracture | 9.83 | 9.28 | 25 | 185997 | 23190 | 79535176 |
| Cytomegalovirus infection reactivation | 9.83 | 9.28 | 4 | 186018 | 8712 | 79549654 |
| Cerebral haemorrhage | 9.79 | 9.28 | 189 | 185833 | 57484 | 79500882 |
| Schizophrenia | 9.77 | 9.28 | 13 | 186009 | 15427 | 79542939 |
| Mean arterial pressure increased | 9.75 | 9.28 | 4 | 186018 | 53 | 79558313 |
| Heliotrope rash | 9.74 | 9.28 | 6 | 186016 | 196 | 79558170 |
| Flashback | 9.74 | 9.28 | 7 | 186015 | 297 | 79558069 |
| PO2 increased | 9.68 | 9.28 | 15 | 186007 | 1573 | 79556793 |
| Injection site bruising | 9.67 | 9.28 | 56 | 185966 | 40946 | 79517420 |
| Iron deficiency anaemia | 9.67 | 9.28 | 97 | 185925 | 25575 | 79532791 |
| Product prescribing error | 9.64 | 9.28 | 63 | 185959 | 44750 | 79513616 |
| Tinea pedis | 9.60 | 9.28 | 19 | 186003 | 2421 | 79555945 |
| Hypergeusia | 9.54 | 9.28 | 3 | 186019 | 17 | 79558349 |
| Unresponsive to stimuli | 9.53 | 9.28 | 183 | 185839 | 55605 | 79502761 |
| Autoimmune disorder | 9.52 | 9.28 | 15 | 186007 | 16597 | 79541769 |
| Conduction disorder | 9.51 | 9.28 | 23 | 185999 | 3356 | 79555010 |
| COVID-19 pneumonia | 9.46 | 9.28 | 106 | 185916 | 28743 | 79529623 |
| PCO2 decreased | 9.46 | 9.28 | 22 | 186000 | 3132 | 79555234 |
| Carotid artery stenosis | 9.43 | 9.28 | 43 | 185979 | 8715 | 79549651 |
| Benign vulval neoplasm | 9.42 | 9.28 | 4 | 186018 | 58 | 79558308 |
| Infusion site pain | 9.42 | 9.28 | 61 | 185961 | 14115 | 79544251 |
| Lymphocyte percentage increased | 9.42 | 9.28 | 10 | 186012 | 719 | 79557647 |
| Tuberculosis | 9.41 | 9.28 | 13 | 186009 | 15185 | 79543181 |
| Surfactant protein increased | 9.39 | 9.28 | 3 | 186019 | 18 | 79558348 |
| Human chorionic gonadotropin decreased | 9.39 | 9.28 | 3 | 186019 | 18 | 79558348 |
| Blood creatine phosphokinase increased | 9.39 | 9.28 | 211 | 185811 | 65879 | 79492487 |
| Mucormycosis | 9.37 | 9.28 | 4 | 186018 | 8465 | 79549901 |
| Respiratory depression | 9.37 | 9.28 | 33 | 185989 | 27597 | 79530769 |
| Pulmonary hypertension | 9.37 | 9.28 | 161 | 185861 | 47919 | 79510447 |
| Gastroenteritis | 9.33 | 9.28 | 121 | 185901 | 33961 | 79524405 |
| Dyslalia | 9.32 | 9.28 | 12 | 186010 | 1060 | 79557306 |
| Small intestinal haemorrhage | 9.32 | 9.28 | 26 | 185996 | 4137 | 79554229 |
| Pancreatic enlargement | 9.29 | 9.28 | 6 | 186016 | 213 | 79558153 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A02BA03 | ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) H2-receptor antagonists |
| ATC | A02BA53 | ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) H2-receptor antagonists |
| FDA MoA | N0000000151 | Histamine H2 Receptor Antagonists |
| CHEBI has role | CHEBI:37961 | H2 receptor antagonists |
| CHEBI has role | CHEBI:49201 | anti-ulcer drugs |
| CHEBI has role | CHEBI:50183 | P450 inhibitors |
| FDA EPC | N0000175784 | Histamine-2 Receptor Antagonist |
| MeSH PA | D000897 | Anti-Ulcer Agents |
| MeSH PA | D005765 | Gastrointestinal Agents |
| MeSH PA | D018494 | Histamine Agents |
| MeSH PA | D006633 | Histamine Antagonists |
| MeSH PA | D006635 | Histamine H2 Antagonists |
| MeSH PA | D018377 | Neurotransmitter Agents |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Heartburn | indication | 16331000 | |
| Erosive esophagitis | indication | 40719004 | |
| Duodenal ulcer disease | indication | 51868009 | DOID:1724 |
| Zollinger-Ellison syndrome | indication | 53132006 | DOID:0050782 |
| Peptic reflux disease | indication | 57643001 | |
| Indigestion | indication | 162031009 | |
| Gastroesophageal reflux disease | indication | 235595009 | DOID:8534 |
| Gastric ulcer | indication | 397825006 | DOID:10808 |
| Dyspepsia Prevention | indication | ||
| Maintenance of Healing Duodenal Ulcer | indication | ||
| Heartburn Prevention | indication | ||
| Upper gastrointestinal hemorrhage | off-label use | 37372002 | |
| Prevention of Stress Ulcer | off-label use | ||
| Constipation | contraindication | 14760008 | DOID:2089 |
| Sarcoidosis | contraindication | 31541009 | DOID:11335 |
| Dehydration | contraindication | 34095006 | |
| Diarrhea | contraindication | 62315008 | |
| Hypercalcemia | contraindication | 66931009 | DOID:12678 |
| Hyperparathyroidism | contraindication | 66999008 | DOID:13543 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Kidney stone | contraindication | 95570007 | |
| Impaired renal function disorder | contraindication | 197663003 | |
| Osteolysis | contraindication | 203522001 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Malignant tumor of stomach | contraindication | 363349007 | DOID:10534 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.84 | acidic |
| pKa2 | 12.0 | acidic |
| pKa3 | 6.97 | Basic |
| pKa4 | 6.37 | Basic |
| pKa5 | 2.56 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 26.6MG;800MG | DUEXIS | HORIZON | N022519 | April 23, 2011 | RX | TABLET | ORAL | 8067451 | July 18, 2026 | RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS |
| 26.6MG;800MG | DUEXIS | HORIZON | N022519 | April 23, 2011 | RX | TABLET | ORAL | 8501228 | July 18, 2026 | RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Histamine H2 receptor | GPCR | ANTAGONIST | Kd | 7.93 | WOMBAT-PK | CHEMBL | |||
| Carbonic anhydrase 2 | Enzyme | Ki | 7.24 | CHEMBL | |||||
| Carbonic anhydrase 1 | Enzyme | Ki | 6.04 | CHEMBL | |||||
| Carbonic anhydrase 4 | Enzyme | Ki | 6.03 | CHEMBL | |||||
| Carbonic anhydrase 9 | Enzyme | Ki | 6.90 | CHEMBL | |||||
| Carbonic anhydrase 12 | Enzyme | Ki | 7.34 | CHEMBL | |||||
| Carbonic anhydrase 5A, mitochondrial | Enzyme | Ki | 5.84 | CHEMBL | |||||
| Carbonic anhydrase 5B, mitochondrial | Enzyme | Ki | 5.27 | CHEMBL | |||||
| Carbonic anhydrase 7 | Enzyme | Ki | 8.52 | CHEMBL | |||||
| Carbonic anhydrase 6 | Enzyme | Ki | 7.01 | CHEMBL | |||||
| Carbonic anhydrase 14 | Enzyme | Ki | 6.17 | CHEMBL | |||||
| Carbonic anhydrase 13 | Enzyme | Ki | 6.77 | CHEMBL | |||||
| Solute carrier family 22 member 2 | Transporter | IC50 | 4.44 | CHEMBL | |||||
| Multidrug and toxin extrusion protein 1 | Transporter | IC50 | 6.12 | CHEMBL | |||||
| Multidrug and toxin extrusion protein 2 | Transporter | IC50 | 4.44 | CHEMBL | |||||
| Heat shock protein HSP 90-alpha | Cytosolic other | IC50 | 5.30 | WOMBAT-PK | |||||
| Solute carrier family 22 member 3 | Transporter | IC50 | 4.97 | CHEMBL | |||||
| Histamine H2 receptor | GPCR | Kd | 7 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4017970 | VUID |
| N0000146320 | NUI |
| D00318 | KEGG_DRUG |
| 4017970 | VANDF |
| C0015620 | UMLSCUI |
| CHEBI:4975 | CHEBI |
| FO9 | PDB_CHEM_ID |
| CHEMBL902 | ChEMBL_ID |
| DB00927 | DRUGBANK_ID |
| D015738 | MESH_DESCRIPTOR_UI |
| 5702160 | PUBCHEM_CID |
| 7074 | IUPHAR_LIGAND_ID |
| 5217 | INN_ID |
| 5QZO15J2Z8 | UNII |
| 4278 | RXNORM |
| 41331 | MMSL |
| 4713 | MMSL |
| d00141 | MMSL |
| 003417 | NDDF |
| 387211002 | SNOMEDCT_US |
| 39128000 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Ibuprofen and famotidine | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-8107 | TABLET, FILM COATED | 26.60 mg | ORAL | ANDA | 28 sections |
| Good Sense Dual Action Complete | HUMAN OTC DRUG LABEL | 3 | 0113-0032 | TABLET, CHEWABLE | 10 mg | ORAL | ANDA | 15 sections |
| Good Sense Dual Action Complete | HUMAN OTC DRUG LABEL | 3 | 0113-0032 | TABLET, CHEWABLE | 10 mg | ORAL | ANDA | 15 sections |
| good sense acid reducer | HUMAN OTC DRUG LABEL | 1 | 0113-0141 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 15 sections |
| Good Sense Acid Reducer | HUMAN OTC DRUG LABEL | 1 | 0113-0194 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 15 sections |
| Good Sense Acid Reducer | HUMAN OTC DRUG LABEL | 1 | 0113-0194 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 15 sections |
| injoy heartburn relief | HUMAN OTC DRUG LABEL | 3 | 0113-6023 | TABLET, CHEWABLE | 10 mg | ORAL | ANDA | 15 sections |
| basic care acid reducer | HUMAN OTC DRUG LABEL | 1 | 0113-7141 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 15 sections |
| Basic Care famotidine | HUMAN OTC DRUG LABEL | 1 | 0113-7194 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 14 sections |
| basic care dual action complete | HUMAN OTC DRUG LABEL | 3 | 0113-7321 | TABLET, CHEWABLE | 10 mg | ORAL | ANDA | 15 sections |
| Famotidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0172-5728 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 25 sections |
| Famotidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0172-5729 | TABLET, FILM COATED | 40 mg | ORAL | ANDA | 25 sections |
| Pepcid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0187-4420 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 25 sections |
| Pepcid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0187-4420 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 25 sections |
| Pepcid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0187-4440 | TABLET, FILM COATED | 40 mg | ORAL | ANDA | 25 sections |
| Pepcid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0187-4440 | TABLET, FILM COATED | 40 mg | ORAL | ANDA | 25 sections |
| Famotidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0338-5197 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | ANDA | 22 sections |
| Famotidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0338-5197 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | ANDA | 22 sections |
| Acid ControllerOriginal Strength | HUMAN OTC DRUG LABEL | 1 | 0363-0141 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 15 sections |
| Acid ControllerOriginal Strength | HUMAN OTC DRUG LABEL | 1 | 0363-0141 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 15 sections |
| Acid Reducer Complete | HUMAN OTC DRUG LABEL | 3 | 0363-0511 | TABLET, CHEWABLE | 10 mg | ORAL | ANDA | 15 sections |
| Acid Reducer Complete | HUMAN OTC DRUG LABEL | 3 | 0363-0511 | TABLET, CHEWABLE | 10 mg | ORAL | ANDA | 15 sections |
| Acid Controller | HUMAN OTC DRUG LABEL | 1 | 0363-0701 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 15 sections |
| Acid Controller | HUMAN OTC DRUG LABEL | 1 | 0363-0701 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 15 sections |
| Acid Reducer Complete | HUMAN OTC DRUG LABEL | 3 | 0363-0713 | TABLET, CHEWABLE | 10 mg | ORAL | ANDA | 15 sections |
| Acid Reducer Complete | HUMAN OTC DRUG LABEL | 3 | 0363-0713 | TABLET, CHEWABLE | 10 mg | ORAL | ANDA | 15 sections |
| acid controller | HUMAN OTC DRUG LABEL | 1 | 0363-1203 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 15 sections |
| Famotidine | Human OTC Drug Label | 1 | 0363-1899 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 16 sections |
| Famotidine | Human OTC Drug Label | 1 | 0363-1899 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 16 sections |
| Famotidine | Human OTC Drug Label | 1 | 0363-4400 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 16 sections |