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| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4290 | 7487-88-9 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
A small colorless crystal used as an anticonvulsant, a cathartic, and an electrolyte replenisher in the treatment of pre-eclampsia and eclampsia. It causes direct inhibition of action potentials in myometrial muscle cells. Excitation and contraction are uncoupled, which decreases the frequency and force of contractions. (From AMA Drug Evaluations Annual, 1992, p1083)
|
| Dose | Unit | Route |
|---|---|---|
| 7 | g | O |
| 3 | g | O |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 22, 2021 | PMDA | NIHON PHARMACEUTICAL CO., LTD. | |
| Oct. 6, 1981 | FDA | BAXTER HLTHCARE |
| 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 |
|---|---|---|---|---|---|---|
| Premature delivery | 444.04 | 9.30 | 316 | 73495 | 38446 | 90516190 |
| Macular degeneration | 379.33 | 9.30 | 285 | 73526 | 37685 | 90516951 |
| Premature baby | 232.32 | 9.30 | 180 | 73631 | 24897 | 90529739 |
| Pemphigus | 227.18 | 9.30 | 9 | 73802 | 326855 | 90227781 |
| Normal labour | 213.20 | 9.30 | 57 | 73754 | 560 | 90554076 |
| Synovitis | 205.07 | 9.30 | 17 | 73794 | 329735 | 90224901 |
| Hypermagnesaemia | 202.12 | 9.30 | 64 | 73747 | 1185 | 90553451 |
| Hand deformity | 190.74 | 9.30 | 13 | 73798 | 296349 | 90258287 |
| Systemic lupus erythematosus | 187.77 | 9.30 | 34 | 73777 | 361862 | 90192774 |
| Glossodynia | 178.71 | 9.30 | 25 | 73786 | 321754 | 90232882 |
| Exposure during pregnancy | 177.34 | 9.30 | 510 | 73301 | 237900 | 90316736 |
| Pericarditis | 162.37 | 9.30 | 16 | 73795 | 270135 | 90284501 |
| Contraindicated product administered | 161.96 | 9.30 | 32 | 73779 | 320107 | 90234529 |
| Delivery | 160.72 | 9.30 | 59 | 73752 | 1734 | 90552902 |
| Anti-cyclic citrullinated peptide antibody positive | 147.48 | 9.30 | 12 | 73799 | 236421 | 90318215 |
| Treatment failure | 146.34 | 9.30 | 34 | 73777 | 303894 | 90250742 |
| Pulmonary oedema | 144.06 | 9.30 | 213 | 73598 | 61867 | 90492769 |
| Wound | 141.76 | 9.30 | 36 | 73775 | 302944 | 90251692 |
| Arthropathy | 127.17 | 9.30 | 70 | 73741 | 366172 | 90188464 |
| Joint swelling | 121.08 | 9.30 | 139 | 73672 | 503161 | 90051475 |
| Paraesthesia oral | 121.05 | 9.30 | 139 | 73672 | 31520 | 90523116 |
| Low birth weight baby | 119.61 | 9.30 | 82 | 73729 | 9385 | 90545251 |
| Drug intolerance | 113.85 | 9.30 | 118 | 73693 | 447473 | 90107163 |
| Duodenal ulcer perforation | 110.04 | 9.30 | 23 | 73788 | 221265 | 90333371 |
| Helicobacter infection | 109.92 | 9.30 | 25 | 73786 | 226825 | 90327811 |
| Product use issue | 108.92 | 9.30 | 67 | 73744 | 329852 | 90224784 |
| Hepatic enzyme increased | 108.74 | 9.30 | 81 | 73730 | 360655 | 90193981 |
| Folliculitis | 108.55 | 9.30 | 18 | 73793 | 204335 | 90350301 |
| Rheumatoid factor positive | 106.23 | 9.30 | 9 | 73802 | 171641 | 90382995 |
| Diabetes insipidus | 103.11 | 9.30 | 51 | 73760 | 3161 | 90551475 |
| PCO2 increased | 102.34 | 9.30 | 39 | 73772 | 1274 | 90553362 |
| Lower respiratory tract infection | 99.13 | 9.30 | 40 | 73771 | 250619 | 90304017 |
| Chronic sinusitis | 95.23 | 9.30 | 107 | 73704 | 23695 | 90530941 |
| Completed suicide | 94.35 | 9.30 | 6 | 73805 | 145052 | 90409584 |
| Irritable bowel syndrome | 92.58 | 9.30 | 27 | 73784 | 207421 | 90347215 |
| Blood pH decreased | 92.31 | 9.30 | 44 | 73767 | 2514 | 90552122 |
| Therapeutic product effect decreased | 92.11 | 9.30 | 56 | 73755 | 277515 | 90277121 |
| Muscle injury | 90.68 | 9.30 | 17 | 73794 | 176637 | 90377999 |
| Maternal exposure during pregnancy | 87.70 | 9.30 | 547 | 73264 | 359516 | 90195120 |
| Procedural pain | 83.99 | 9.30 | 119 | 73692 | 33241 | 90521395 |
| Foetal exposure during pregnancy | 83.66 | 9.30 | 136 | 73675 | 42839 | 90511797 |
| Vaginal flatulence | 82.29 | 9.30 | 74 | 73737 | 12564 | 90542072 |
| Blood bicarbonate decreased | 78.38 | 9.30 | 42 | 73769 | 3077 | 90551559 |
| Discomfort | 78.34 | 9.30 | 65 | 73746 | 274270 | 90280366 |
| Hypersensitivity | 78.04 | 9.30 | 158 | 73653 | 454519 | 90100117 |
| Rheumatic fever | 78.02 | 9.30 | 15 | 73796 | 153106 | 90401530 |
| Female genital tract fistula | 77.84 | 9.30 | 84 | 73727 | 17784 | 90536852 |
| Radiculopathy | 77.14 | 9.30 | 85 | 73726 | 18420 | 90536216 |
| Rheumatoid arthritis | 76.92 | 9.30 | 110 | 73701 | 362504 | 90192132 |
| Impaired healing | 76.65 | 9.30 | 48 | 73763 | 234151 | 90320485 |
| Mitochondrial DNA mutation | 76.32 | 9.30 | 24 | 73787 | 434 | 90554202 |
| Proctitis | 74.08 | 9.30 | 76 | 73735 | 15183 | 90539453 |
| Postpartum haemorrhage | 73.76 | 9.30 | 37 | 73774 | 2364 | 90552272 |
| Alopecia | 72.84 | 9.30 | 187 | 73624 | 494884 | 90059752 |
| C-reactive protein abnormal | 72.84 | 9.30 | 9 | 73802 | 127420 | 90427216 |
| Blister | 72.09 | 9.30 | 61 | 73750 | 254937 | 90299699 |
| Sleep disorder due to general medical condition, insomnia type | 71.38 | 9.30 | 10 | 73801 | 128684 | 90425952 |
| Liver injury | 71.13 | 9.30 | 25 | 73786 | 170542 | 90384094 |
| Propofol infusion syndrome | 70.53 | 9.30 | 30 | 73781 | 1309 | 90553327 |
| Ill-defined disorder | 69.12 | 9.30 | 32 | 73779 | 184859 | 90369777 |
| Vaginal discharge | 68.64 | 9.30 | 82 | 73729 | 19382 | 90535254 |
| Unevaluable event | 68.12 | 9.30 | 143 | 73668 | 54705 | 90499931 |
| Joint range of motion decreased | 67.62 | 9.30 | 14 | 73797 | 135629 | 90419007 |
| Renal ischaemia | 67.50 | 9.30 | 24 | 73787 | 642 | 90553994 |
| Type 2 diabetes mellitus | 67.42 | 9.30 | 41 | 73770 | 203203 | 90351433 |
| Colitis | 65.41 | 9.30 | 163 | 73648 | 69779 | 90484857 |
| Intentional product use issue | 64.92 | 9.30 | 49 | 73762 | 216843 | 90337793 |
| Bursitis | 64.78 | 9.30 | 14 | 73797 | 131640 | 90422996 |
| Pre-eclampsia | 64.76 | 9.30 | 61 | 73750 | 10987 | 90543649 |
| Facet joint syndrome | 64.18 | 9.30 | 4 | 73807 | 98385 | 90456251 |
| Swollen joint count increased | 63.20 | 9.30 | 8 | 73803 | 111198 | 90443438 |
| Fibromyalgia | 62.51 | 9.30 | 46 | 73765 | 206223 | 90348413 |
| Anaemia | 61.86 | 9.30 | 495 | 73316 | 352307 | 90202329 |
| Swelling | 61.84 | 9.30 | 158 | 73653 | 418900 | 90135736 |
| Gastrointestinal disorder | 60.44 | 9.30 | 72 | 73739 | 256615 | 90298021 |
| General physical health deterioration | 60.39 | 9.30 | 124 | 73687 | 354991 | 90199645 |
| Diarrhoea | 59.90 | 9.30 | 1085 | 72726 | 938105 | 89616531 |
| Hypotension | 55.11 | 9.30 | 453 | 73358 | 324944 | 90229692 |
| Abdominal discomfort | 53.44 | 9.30 | 204 | 73607 | 477124 | 90077512 |
| Drug hypersensitivity | 53.29 | 9.30 | 196 | 73615 | 463413 | 90091223 |
| Deep vein thrombosis | 52.32 | 9.30 | 179 | 73632 | 91441 | 90463195 |
| PO2 increased | 50.38 | 9.30 | 21 | 73790 | 871 | 90553765 |
| Respiratory failure | 49.94 | 9.30 | 210 | 73601 | 118208 | 90436428 |
| Neonatal intestinal perforation | 49.84 | 9.30 | 10 | 73801 | 21 | 90554615 |
| Breast cancer stage III | 48.17 | 9.30 | 6 | 73805 | 84441 | 90470195 |
| Arthralgia | 47.87 | 9.30 | 405 | 73406 | 778117 | 89776519 |
| Constipation | 47.81 | 9.30 | 391 | 73420 | 280004 | 90274632 |
| Acute respiratory failure | 46.59 | 9.30 | 106 | 73705 | 42812 | 90511824 |
| Blood gases abnormal | 46.42 | 9.30 | 20 | 73791 | 901 | 90553735 |
| Mobility decreased | 45.69 | 9.30 | 84 | 73727 | 250650 | 90303986 |
| Blood magnesium decreased | 45.58 | 9.30 | 60 | 73751 | 15633 | 90539003 |
| Caesarean section | 44.90 | 9.30 | 65 | 73746 | 18512 | 90536124 |
| CSF oligoclonal band present | 44.76 | 9.30 | 16 | 73795 | 435 | 90554201 |
| Hypomagnesaemia | 44.44 | 9.30 | 93 | 73718 | 35495 | 90519141 |
| Musculoskeletal stiffness | 44.33 | 9.30 | 111 | 73700 | 296421 | 90258215 |
| Inflammation | 44.30 | 9.30 | 48 | 73763 | 178544 | 90376092 |
| Drug abuse | 44.27 | 9.30 | 7 | 73804 | 82340 | 90472296 |
| Lip dry | 43.47 | 9.30 | 14 | 73797 | 100941 | 90453695 |
| Wheezing | 43.16 | 9.30 | 80 | 73731 | 238000 | 90316636 |
| Obesity | 43.07 | 9.30 | 16 | 73795 | 105491 | 90449145 |
| Haematochezia | 42.65 | 9.30 | 141 | 73670 | 70772 | 90483864 |
| Neonatal respiratory distress syndrome | 41.89 | 9.30 | 28 | 73783 | 3073 | 90551563 |
| Blood magnesium increased | 41.83 | 9.30 | 29 | 73782 | 3379 | 90551257 |
| Product dose omission issue | 41.55 | 9.30 | 391 | 73420 | 291296 | 90263340 |
| Dehydration | 40.94 | 9.30 | 285 | 73526 | 194162 | 90360474 |
| Foetal death | 40.90 | 9.30 | 66 | 73745 | 20657 | 90533979 |
| Gene mutation | 40.79 | 9.30 | 24 | 73787 | 2106 | 90552530 |
| Oral candidiasis | 40.08 | 9.30 | 89 | 73722 | 35366 | 90519270 |
| Asthma | 39.93 | 9.30 | 86 | 73725 | 242074 | 90312562 |
| Neuropathy peripheral | 39.69 | 9.30 | 218 | 73593 | 136752 | 90417884 |
| Grip strength decreased | 39.57 | 9.30 | 13 | 73798 | 92563 | 90462073 |
| Rectal haemorrhage | 39.07 | 9.30 | 152 | 73659 | 82592 | 90472044 |
| Sepsis | 38.71 | 9.30 | 265 | 73546 | 179549 | 90375087 |
| Blood cholesterol increased | 38.50 | 9.30 | 69 | 73742 | 207943 | 90346693 |
| Hypocalcaemia | 37.79 | 9.30 | 97 | 73714 | 42271 | 90512365 |
| Sleep disorder | 37.28 | 9.30 | 65 | 73746 | 197965 | 90356671 |
| Encephalopathy | 37.04 | 9.30 | 102 | 73709 | 46342 | 90508294 |
| Nausea | 36.97 | 9.30 | 1173 | 72638 | 1109143 | 89445493 |
| Abdominal pain | 36.93 | 9.30 | 488 | 73323 | 395233 | 90159403 |
| Infection | 36.58 | 9.30 | 161 | 73650 | 361933 | 90192703 |
| C-reactive protein increased | 36.50 | 9.30 | 57 | 73754 | 181332 | 90373304 |
| Psoriatic arthropathy | 36.08 | 9.30 | 83 | 73728 | 228252 | 90326384 |
| Vaginal haemorrhage | 35.92 | 9.30 | 79 | 73732 | 31192 | 90523444 |
| Device expulsion | 35.84 | 9.30 | 93 | 73718 | 40793 | 90513843 |
| Peripheral venous disease | 35.49 | 9.30 | 12 | 73799 | 83909 | 90470727 |
| Pleocytosis | 35.34 | 9.30 | 17 | 73794 | 991 | 90553645 |
| Full blood count decreased | 35.23 | 9.30 | 76 | 73735 | 29613 | 90525023 |
| Cytokine release syndrome | 34.81 | 9.30 | 73 | 73738 | 27900 | 90526736 |
| COVID-19 | 34.03 | 9.30 | 53 | 73758 | 168790 | 90385846 |
| Infusion related reaction | 33.25 | 9.30 | 201 | 73610 | 416579 | 90138057 |
| Apgar score low | 32.49 | 9.30 | 17 | 73794 | 1186 | 90553450 |
| Chills | 32.36 | 9.30 | 201 | 73610 | 131780 | 90422856 |
| Hypoxia | 31.78 | 9.30 | 130 | 73681 | 72269 | 90482367 |
| Hypokalaemia | 31.72 | 9.30 | 199 | 73612 | 130917 | 90423719 |
| Urticaria thermal | 31.63 | 9.30 | 13 | 73798 | 520 | 90554116 |
| Premature labour | 31.16 | 9.30 | 46 | 73765 | 13330 | 90541306 |
| Airway peak pressure increased | 31.09 | 9.30 | 12 | 73799 | 406 | 90554230 |
| Epilepsy | 31.06 | 9.30 | 14 | 73797 | 82192 | 90472444 |
| Blood lactic acid increased | 30.98 | 9.30 | 37 | 73774 | 8741 | 90545895 |
| Frequent bowel movements | 30.56 | 9.30 | 109 | 73702 | 56826 | 90497810 |
| Haemoglobin decreased | 30.41 | 9.30 | 231 | 73580 | 161725 | 90392911 |
| Hypervolaemia | 30.26 | 9.30 | 76 | 73735 | 32681 | 90521955 |
| Platelet count decreased | 30.15 | 9.30 | 203 | 73608 | 136766 | 90417870 |
| Maternal exposure during delivery | 30.06 | 9.30 | 25 | 73786 | 3821 | 90550815 |
| Lung hyperinflation | 29.99 | 9.30 | 17 | 73794 | 1391 | 90553245 |
| Febrile neutropenia | 29.81 | 9.30 | 226 | 73585 | 158123 | 90396513 |
| Oxygen saturation abnormal | 29.69 | 9.30 | 26 | 73785 | 4262 | 90550374 |
| HELLP syndrome | 29.50 | 9.30 | 16 | 73795 | 1201 | 90553435 |
| Condition aggravated | 29.28 | 9.30 | 327 | 73484 | 595218 | 89959418 |
| Device dislocation | 29.04 | 9.30 | 73 | 73738 | 31409 | 90523227 |
| Foetal growth restriction | 29.02 | 9.30 | 37 | 73774 | 9343 | 90545293 |
| Neuromuscular blockade | 28.99 | 9.30 | 11 | 73800 | 355 | 90554281 |
| Deep vein thrombosis postoperative | 28.46 | 9.30 | 11 | 73800 | 70798 | 90483838 |
| Respiratory acidosis | 28.29 | 9.30 | 34 | 73777 | 8085 | 90546551 |
| Wound infection | 28.20 | 9.30 | 27 | 73784 | 106375 | 90448261 |
| Therapy cessation | 28.15 | 9.30 | 79 | 73732 | 36282 | 90518354 |
| Prescribed overdose | 28.00 | 9.30 | 23 | 73788 | 97602 | 90457034 |
| Myelosuppression | 27.82 | 9.30 | 5 | 73806 | 53586 | 90501050 |
| Pulmonary fibrosis | 27.66 | 9.30 | 28 | 73783 | 107475 | 90447161 |
| Atrial fibrillation | 27.62 | 9.30 | 195 | 73616 | 133416 | 90421220 |
| Feeling abnormal | 27.30 | 9.30 | 231 | 73580 | 167004 | 90387632 |
| Weight increased | 27.17 | 9.30 | 214 | 73597 | 417713 | 90136923 |
| Nasopharyngitis | 26.68 | 9.30 | 208 | 73603 | 406896 | 90147740 |
| Night sweats | 26.35 | 9.30 | 40 | 73771 | 128726 | 90425910 |
| Plasma cell myeloma | 26.19 | 9.30 | 83 | 73728 | 40745 | 90513891 |
| Adjustment disorder with depressed mood | 26.02 | 9.30 | 7 | 73804 | 56746 | 90497890 |
| Neuromuscular block prolonged | 25.95 | 9.30 | 12 | 73799 | 640 | 90553996 |
| Pleural effusion | 25.87 | 9.30 | 168 | 73643 | 111823 | 90442813 |
| Emotional distress | 25.82 | 9.30 | 77 | 73734 | 36585 | 90518051 |
| Skin discolouration | 25.66 | 9.30 | 87 | 73724 | 44228 | 90510408 |
| PO2 decreased | 25.61 | 9.30 | 16 | 73795 | 1565 | 90553071 |
| Foetal heart rate deceleration abnormality | 25.48 | 9.30 | 12 | 73799 | 667 | 90553969 |
| Stomatitis | 25.45 | 9.30 | 126 | 73685 | 274572 | 90280064 |
| Left ventricular dysfunction | 25.32 | 9.30 | 44 | 73767 | 14625 | 90540011 |
| Blood potassium decreased | 25.30 | 9.30 | 91 | 73720 | 47636 | 90507000 |
| Blepharospasm | 25.12 | 9.30 | 7 | 73804 | 55438 | 90499198 |
| Administration site erythema | 24.99 | 9.30 | 13 | 73798 | 896 | 90553740 |
| Craniotabes | 24.46 | 9.30 | 4 | 73807 | 0 | 90554636 |
| Osteoarthritis | 24.30 | 9.30 | 80 | 73731 | 195650 | 90358986 |
| Nail disorder | 24.03 | 9.30 | 9 | 73802 | 59058 | 90495578 |
| Suicide attempt | 23.90 | 9.30 | 16 | 73795 | 75383 | 90479253 |
| Acute pulmonary oedema | 23.85 | 9.30 | 34 | 73777 | 9546 | 90545090 |
| Dislocation of vertebra | 23.67 | 9.30 | 8 | 73803 | 55960 | 90498676 |
| Intentional overdose | 23.51 | 9.30 | 25 | 73786 | 93809 | 90460827 |
| Fall | 23.38 | 9.30 | 535 | 73276 | 481275 | 90073361 |
| Colitis ulcerative | 23.20 | 9.30 | 104 | 73707 | 60162 | 90494474 |
| Flatulence | 22.89 | 9.30 | 80 | 73731 | 41287 | 90513349 |
| Pelvic pain | 22.61 | 9.30 | 43 | 73768 | 15314 | 90539322 |
| Fear | 22.60 | 9.30 | 45 | 73766 | 16577 | 90538059 |
| Onychomadesis | 22.40 | 9.30 | 5 | 73806 | 45993 | 90508643 |
| Weight decreased | 22.37 | 9.30 | 434 | 73377 | 379476 | 90175160 |
| Status asthmaticus | 22.29 | 9.30 | 12 | 73799 | 887 | 90553749 |
| Neonatal gastrointestinal haemorrhage | 21.97 | 9.30 | 5 | 73806 | 23 | 90554613 |
| Red blood cell sedimentation rate increased | 21.84 | 9.30 | 21 | 73790 | 82574 | 90472062 |
| Toxicity to various agents | 21.81 | 9.30 | 141 | 73670 | 287705 | 90266931 |
| Lung disorder | 21.69 | 9.30 | 57 | 73754 | 149826 | 90404810 |
| Confusional state | 21.43 | 9.30 | 206 | 73605 | 385999 | 90168637 |
| Flushing | 21.20 | 9.30 | 134 | 73677 | 88357 | 90466279 |
| Blood calcium decreased | 20.88 | 9.30 | 63 | 73748 | 30119 | 90524517 |
| Neonatal disorder | 20.80 | 9.30 | 10 | 73801 | 582 | 90554054 |
| Adverse event | 20.79 | 9.30 | 40 | 73771 | 117378 | 90437258 |
| Back pain | 20.63 | 9.30 | 368 | 73443 | 316807 | 90237829 |
| Hyperkalaemia | 20.58 | 9.30 | 106 | 73705 | 64858 | 90489778 |
| Drug-induced liver injury | 20.53 | 9.30 | 26 | 73785 | 90292 | 90464344 |
| Torsade de pointes | 20.52 | 9.30 | 41 | 73770 | 15141 | 90539495 |
| Off label use | 20.46 | 9.30 | 714 | 73097 | 1101538 | 89453098 |
| Respiratory distress | 20.42 | 9.30 | 74 | 73737 | 38872 | 90515764 |
| Intentional product misuse | 20.16 | 9.30 | 26 | 73785 | 89578 | 90465058 |
| Hypercapnia | 20.12 | 9.30 | 26 | 73785 | 6651 | 90547985 |
| Lethargy | 19.99 | 9.30 | 103 | 73708 | 63036 | 90491600 |
| Coeliac disease | 19.53 | 9.30 | 6 | 73805 | 44604 | 90510032 |
| Mental status changes | 19.42 | 9.30 | 80 | 73731 | 44599 | 90510037 |
| Ventricular extrasystoles | 19.39 | 9.30 | 37 | 73774 | 13213 | 90541423 |
| Pneumonia | 19.30 | 9.30 | 667 | 73144 | 637392 | 89917244 |
| Schizencephaly | 19.12 | 9.30 | 8 | 73803 | 335 | 90554301 |
| Hypercholesterolaemia | 19.08 | 9.30 | 33 | 73778 | 100859 | 90453777 |
| Cerebral haemorrhage foetal | 19.01 | 9.30 | 8 | 73803 | 340 | 90554296 |
| Urticaria | 19.01 | 9.30 | 163 | 73648 | 312571 | 90242065 |
| Urinary tract infection | 18.62 | 9.30 | 351 | 73460 | 305281 | 90249355 |
| International normalised ratio increased | 18.47 | 9.30 | 82 | 73729 | 47234 | 90507402 |
| Sciatica | 18.42 | 9.30 | 34 | 73777 | 101348 | 90453288 |
| Pulmonary hypertension | 18.38 | 9.30 | 76 | 73735 | 42447 | 90512189 |
| Product use in unapproved indication | 18.38 | 9.30 | 180 | 73631 | 336056 | 90218580 |
| Nail bed tenderness | 18.37 | 9.30 | 8 | 73803 | 370 | 90554266 |
| Hip arthroplasty | 18.32 | 9.30 | 21 | 73790 | 76187 | 90478449 |
| Immune effector cell-associated neurotoxicity syndrome | 18.23 | 9.30 | 23 | 73788 | 5745 | 90548891 |
| Muscle spasms | 18.10 | 9.30 | 297 | 73514 | 251586 | 90303050 |
| Loss of personal independence in daily activities | 18.04 | 9.30 | 54 | 73757 | 136051 | 90418585 |
| Unresponsive to stimuli | 17.97 | 9.30 | 70 | 73741 | 38051 | 90516585 |
| Pulmonary embolism | 17.92 | 9.30 | 174 | 73637 | 130646 | 90423990 |
| Knee arthroplasty | 17.84 | 9.30 | 25 | 73786 | 83157 | 90471479 |
| Hypophagia | 17.77 | 9.30 | 67 | 73744 | 35870 | 90518766 |
| Autoimmune disorder | 17.54 | 9.30 | 22 | 73789 | 76722 | 90477914 |
| Haematocrit decreased | 17.48 | 9.30 | 74 | 73737 | 41758 | 90512878 |
| Electroencephalogram abnormal | 17.39 | 9.30 | 19 | 73792 | 4077 | 90550559 |
| Delayed fontanelle closure | 17.14 | 9.30 | 4 | 73807 | 21 | 90554615 |
| Cardiac arrest | 17.14 | 9.30 | 145 | 73666 | 104790 | 90449846 |
| X-ray abnormal | 16.75 | 9.30 | 8 | 73803 | 45416 | 90509220 |
| Endometritis | 16.61 | 9.30 | 11 | 73800 | 1189 | 90553447 |
| Transfusion | 16.60 | 9.30 | 41 | 73770 | 17447 | 90537189 |
| Hepatitis | 16.46 | 9.30 | 20 | 73791 | 70719 | 90483917 |
| Tachypnoea | 16.20 | 9.30 | 46 | 73765 | 21263 | 90533373 |
| Aspartate aminotransferase increased | 16.16 | 9.30 | 141 | 73670 | 102796 | 90451840 |
| Liver disorder | 16.15 | 9.30 | 48 | 73763 | 121221 | 90433415 |
| White blood cell count decreased | 15.94 | 9.30 | 207 | 73604 | 166902 | 90387734 |
| Infantile apnoea | 15.91 | 9.30 | 11 | 73800 | 1276 | 90553360 |
| Prescribed underdose | 15.64 | 9.30 | 23 | 73788 | 74996 | 90479640 |
| Blood albumin decreased | 15.53 | 9.30 | 39 | 73772 | 16764 | 90537872 |
| Failure to thrive | 15.53 | 9.30 | 26 | 73785 | 8385 | 90546251 |
| Hot flush | 15.46 | 9.30 | 92 | 73719 | 59396 | 90495240 |
| Immunodeficiency | 15.36 | 9.30 | 8 | 73803 | 43226 | 90511410 |
| Clonus | 15.20 | 9.30 | 21 | 73790 | 5729 | 90548907 |
| Finger deformity | 15.19 | 9.30 | 4 | 73807 | 32893 | 90521743 |
| Product compounding quality issue | 15.18 | 9.30 | 4 | 73807 | 37 | 90554599 |
| Peripheral swelling | 15.10 | 9.30 | 241 | 73570 | 412865 | 90141771 |
| Antinuclear antibody positive | 15.02 | 9.30 | 27 | 73784 | 9214 | 90545422 |
| Cardiac failure congestive | 14.88 | 9.30 | 134 | 73677 | 98560 | 90456076 |
| Nervousness | 14.82 | 9.30 | 61 | 73750 | 33995 | 90520641 |
| Arrhythmia | 14.78 | 9.30 | 71 | 73740 | 42261 | 90512375 |
| Drug tolerance decreased | 14.66 | 9.30 | 4 | 73807 | 32126 | 90522510 |
| Asthenia | 14.42 | 9.30 | 551 | 73260 | 533200 | 90021436 |
| Tremor | 14.30 | 9.30 | 189 | 73622 | 152984 | 90401652 |
| Dizziness | 14.23 | 9.30 | 601 | 73210 | 588683 | 89965953 |
| Hyporeflexia | 14.23 | 9.30 | 13 | 73798 | 2253 | 90552383 |
| Cystitis-like symptom | 14.19 | 9.30 | 3 | 73808 | 9 | 90554627 |
| Blood culture positive | 14.13 | 9.30 | 19 | 73792 | 5053 | 90549583 |
| Neonatal infection | 14.10 | 9.30 | 6 | 73805 | 262 | 90554374 |
| Patent ductus arteriosus | 14.10 | 9.30 | 18 | 73793 | 4551 | 90550085 |
| Product quality issue | 14.06 | 9.30 | 27 | 73784 | 79298 | 90475338 |
| Road traffic accident | 14.04 | 9.30 | 43 | 73768 | 107583 | 90447053 |
| Intestinal dilatation | 14.01 | 9.30 | 13 | 73798 | 2297 | 90552339 |
| Dyspnoea | 14.00 | 9.30 | 863 | 72948 | 880092 | 89674544 |
| Cyanosis | 13.83 | 9.30 | 41 | 73770 | 19414 | 90535222 |
| Food interaction | 13.77 | 9.30 | 10 | 73801 | 1254 | 90553382 |
| Overdose | 13.66 | 9.30 | 74 | 73737 | 157635 | 90397001 |
| Urine output decreased | 13.53 | 9.30 | 31 | 73780 | 12572 | 90542064 |
| Sleep disorder due to a general medical condition | 13.51 | 9.30 | 10 | 73801 | 44728 | 90509908 |
| Nasal congestion | 13.48 | 9.30 | 115 | 73696 | 83299 | 90471337 |
| Small intestinal obstruction | 13.47 | 9.30 | 43 | 73768 | 21191 | 90533445 |
| Electrocardiogram QT prolonged | 13.40 | 9.30 | 103 | 73708 | 72353 | 90482283 |
| Eclampsia | 13.34 | 9.30 | 7 | 73804 | 491 | 90554145 |
| Atelectasis | 13.33 | 9.30 | 47 | 73764 | 24362 | 90530274 |
| Seizure | 13.29 | 9.30 | 186 | 73625 | 152443 | 90402193 |
| Hypertension | 13.25 | 9.30 | 278 | 73533 | 457254 | 90097382 |
| Renal failure | 13.22 | 9.30 | 164 | 73647 | 130843 | 90423793 |
| Onychomycosis | 13.16 | 9.30 | 7 | 73804 | 37369 | 90517267 |
| Foetal distress syndrome | 13.16 | 9.30 | 11 | 73800 | 1694 | 90552942 |
| Pulmonary arterial hypertension | 13.09 | 9.30 | 49 | 73762 | 26138 | 90528498 |
| Therapeutic response decreased | 13.07 | 9.30 | 34 | 73777 | 89695 | 90464941 |
| Acute kidney injury | 12.90 | 9.30 | 347 | 73464 | 320040 | 90234596 |
| Vision blurred | 12.87 | 9.30 | 142 | 73669 | 110151 | 90444485 |
| Fallot's tetralogy | 12.84 | 9.30 | 4 | 73807 | 70 | 90554566 |
| Erythema | 12.84 | 9.30 | 260 | 73551 | 228986 | 90325650 |
| Lower limb fracture | 12.55 | 9.30 | 32 | 73779 | 84981 | 90469655 |
| Vitamin B6 increased | 12.53 | 9.30 | 4 | 73807 | 76 | 90554560 |
| Metabolic acidosis | 12.53 | 9.30 | 83 | 73728 | 55593 | 90499043 |
| C-reactive protein | 12.39 | 9.30 | 5 | 73806 | 31362 | 90523274 |
| Bone erosion | 12.33 | 9.30 | 15 | 73796 | 53006 | 90501630 |
| Bronchospasm | 12.29 | 9.30 | 41 | 73770 | 20668 | 90533968 |
| Bacteraemia | 12.23 | 9.30 | 43 | 73768 | 22257 | 90532379 |
| Anhedonia | 12.14 | 9.30 | 28 | 73783 | 11403 | 90543233 |
| Shock | 12.09 | 9.30 | 51 | 73760 | 28727 | 90525909 |
| Delirium | 12.04 | 9.30 | 44 | 73767 | 104315 | 90450321 |
| Device related sepsis | 11.92 | 9.30 | 17 | 73794 | 4776 | 90549860 |
| Diastolic hypotension | 11.90 | 9.30 | 4 | 73807 | 90 | 90554546 |
| Thrombosis | 11.85 | 9.30 | 101 | 73710 | 73150 | 90481486 |
| Taste disorder | 11.76 | 9.30 | 20 | 73791 | 61526 | 90493110 |
| Pancreatitis chronic | 11.75 | 9.30 | 13 | 73798 | 2830 | 90551806 |
| Laboratory test abnormal | 11.70 | 9.30 | 66 | 73745 | 41788 | 90512848 |
| Dizziness postural | 11.70 | 9.30 | 24 | 73787 | 9029 | 90545607 |
| Blood alkaline phosphatase increased | 11.64 | 9.30 | 73 | 73738 | 48006 | 90506630 |
| Dysgeusia | 11.62 | 9.30 | 78 | 73733 | 52482 | 90502154 |
| Septic shock | 11.55 | 9.30 | 112 | 73699 | 84048 | 90470588 |
| Encephalitis | 11.53 | 9.30 | 27 | 73784 | 11107 | 90543529 |
| Gait inability | 11.46 | 9.30 | 71 | 73740 | 146385 | 90408251 |
| Influenza like illness | 11.42 | 9.30 | 108 | 73703 | 80503 | 90474133 |
| Acute respiratory distress syndrome | 11.41 | 9.30 | 50 | 73761 | 28636 | 90526000 |
| Clostridium difficile infection | 11.38 | 9.30 | 59 | 73752 | 36186 | 90518450 |
| Hypoventilation neonatal | 11.36 | 9.30 | 3 | 73808 | 28 | 90554608 |
| Burkholderia test positive | 11.33 | 9.30 | 5 | 73806 | 239 | 90554397 |
| Cellulitis | 11.31 | 9.30 | 119 | 73692 | 91218 | 90463418 |
| Pulmonary valve incompetence | 11.25 | 9.30 | 10 | 73801 | 1671 | 90552965 |
| Respiratory rate decreased | 11.21 | 9.30 | 15 | 73796 | 3968 | 90550668 |
| Injection site bruising | 11.19 | 9.30 | 77 | 73734 | 52230 | 90502406 |
| Drug reaction with eosinophilia and systemic symptoms | 11.15 | 9.30 | 11 | 73800 | 42747 | 90511889 |
| Product complaint | 11.11 | 9.30 | 30 | 73781 | 13470 | 90541166 |
| Intentional self-injury | 11.07 | 9.30 | 5 | 73806 | 29329 | 90525307 |
| Peptic ulcer perforation | 11.04 | 9.30 | 6 | 73805 | 452 | 90554184 |
| Ureteric stenosis | 11.02 | 9.30 | 7 | 73804 | 705 | 90553931 |
| Anaphylactic shock | 11.01 | 9.30 | 6 | 73805 | 31611 | 90523025 |
| Injection site haemorrhage | 10.99 | 9.30 | 49 | 73762 | 28269 | 90526367 |
| Maternal drugs affecting foetus | 10.97 | 9.30 | 17 | 73794 | 5138 | 90549498 |
| Staphylococcal infection | 10.77 | 9.30 | 72 | 73739 | 48367 | 90506269 |
| Osmotic demyelination syndrome | 10.72 | 9.30 | 8 | 73803 | 1046 | 90553590 |
| Pain | 10.69 | 9.30 | 684 | 73127 | 995657 | 89558979 |
| Hypotonia neonatal | 10.57 | 9.30 | 9 | 73802 | 1421 | 90553215 |
| Plasma cell myeloma recurrent | 10.52 | 9.30 | 15 | 73796 | 4213 | 90550423 |
| Hip fracture | 10.50 | 9.30 | 54 | 73757 | 33023 | 90521613 |
| Pigmentation disorder | 10.47 | 9.30 | 18 | 73793 | 5931 | 90548705 |
| Prothrombin time prolonged | 10.45 | 9.30 | 24 | 73787 | 9748 | 90544888 |
| Aplastic anaemia | 10.44 | 9.30 | 29 | 73782 | 13240 | 90541396 |
| Vulvovaginal swelling | 10.30 | 9.30 | 7 | 73804 | 789 | 90553847 |
| Osteonecrosis of jaw | 10.27 | 9.30 | 10 | 73801 | 39093 | 90515543 |
| Vascular resistance systemic decreased | 10.26 | 9.30 | 4 | 73807 | 139 | 90554497 |
| Lupus vulgaris | 10.21 | 9.30 | 13 | 73798 | 45046 | 90509590 |
| Injury | 10.21 | 9.30 | 107 | 73704 | 197242 | 90357394 |
| Administration site swelling | 10.20 | 9.30 | 9 | 73802 | 1490 | 90553146 |
| Therapeutic response shortened | 10.16 | 9.30 | 3 | 73808 | 22876 | 90531760 |
| Tidal volume decreased | 10.12 | 9.30 | 3 | 73808 | 44 | 90554592 |
| Eye swelling | 10.05 | 9.30 | 49 | 73762 | 29337 | 90525299 |
| Disability | 10.04 | 9.30 | 11 | 73800 | 40734 | 90513902 |
| Cardiac pacemaker insertion | 10.04 | 9.30 | 15 | 73796 | 4392 | 90550244 |
| Laryngeal pain | 10.00 | 9.30 | 15 | 73796 | 4407 | 90550229 |
| Oedema peripheral | 10.00 | 9.30 | 278 | 73533 | 257637 | 90296999 |
| Small for dates baby | 9.95 | 9.30 | 16 | 73795 | 4991 | 90549645 |
| Stillbirth | 9.94 | 9.30 | 20 | 73791 | 7423 | 90547213 |
| Apnoea | 9.94 | 9.30 | 23 | 73788 | 9391 | 90545245 |
| Ventricular hypertrophy | 9.90 | 9.30 | 13 | 73798 | 3378 | 90551258 |
| Adverse reaction | 9.83 | 9.30 | 6 | 73805 | 29706 | 90524930 |
| Generalised oedema | 9.82 | 9.30 | 36 | 73775 | 19017 | 90535619 |
| Respiratory rate increased | 9.78 | 9.30 | 32 | 73779 | 15969 | 90538667 |
| Renal injury | 9.71 | 9.30 | 24 | 73787 | 10219 | 90544417 |
| Intestinal ischaemia | 9.70 | 9.30 | 22 | 73789 | 8861 | 90545775 |
| Right ventricular failure | 9.65 | 9.30 | 36 | 73775 | 19169 | 90535467 |
| Interstitial lung disease | 9.63 | 9.30 | 31 | 73780 | 76374 | 90478262 |
| Occult blood positive | 9.61 | 9.30 | 14 | 73797 | 4009 | 90550627 |
| Therapy partial responder | 9.59 | 9.30 | 3 | 73808 | 22040 | 90532596 |
| Coagulopathy | 9.58 | 9.30 | 41 | 73770 | 23248 | 90531388 |
| Therapy change | 9.53 | 9.30 | 21 | 73790 | 8301 | 90546335 |
| Blood pressure diastolic decreased | 9.48 | 9.30 | 5 | 73806 | 26821 | 90527815 |
| Hospice care | 9.47 | 9.30 | 23 | 73788 | 9681 | 90544955 |
| Leukocytosis | 9.42 | 9.30 | 50 | 73761 | 30940 | 90523696 |
| 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 |
|---|---|---|---|---|---|---|
| Premature baby | 145.99 | 10.89 | 146 | 42543 | 23007 | 42555639 |
| Off label use | 90.90 | 10.89 | 332 | 42357 | 638003 | 41940643 |
| Adrenal suppression | 84.49 | 10.89 | 33 | 42656 | 932 | 42577714 |
| Low birth weight baby | 80.36 | 10.89 | 72 | 42617 | 9883 | 42568763 |
| Drug abuse | 71.54 | 10.89 | 10 | 42679 | 104761 | 42473885 |
| Gingival disorder | 68.95 | 10.89 | 33 | 42656 | 1541 | 42577105 |
| Completed suicide | 59.67 | 10.89 | 12 | 42677 | 96453 | 42482193 |
| Product use in unapproved indication | 55.23 | 10.89 | 62 | 42627 | 184394 | 42394252 |
| Foetal exposure during pregnancy | 53.81 | 10.89 | 135 | 42554 | 47176 | 42531470 |
| Toxicity to various agents | 52.71 | 10.89 | 93 | 42596 | 229043 | 42349603 |
| Skin irritation | 42.72 | 10.89 | 45 | 42644 | 7529 | 42571117 |
| Cytokine release syndrome | 41.48 | 10.89 | 118 | 42571 | 44409 | 42534237 |
| Drug ineffective | 41.05 | 10.89 | 419 | 42270 | 629778 | 41948868 |
| Tachycardia foetal | 40.11 | 10.89 | 15 | 42674 | 375 | 42578271 |
| Intentional product misuse | 39.77 | 10.89 | 7 | 42682 | 61893 | 42516753 |
| Oral disorder | 37.25 | 10.89 | 34 | 42655 | 4778 | 42573868 |
| Plasma cell myeloma | 35.80 | 10.89 | 117 | 42572 | 47461 | 42531185 |
| Apgar score low | 35.61 | 10.89 | 18 | 42671 | 947 | 42577699 |
| Unevaluable event | 35.03 | 10.89 | 94 | 42595 | 34194 | 42544452 |
| Drug interaction | 34.46 | 10.89 | 144 | 42545 | 266855 | 42311791 |
| Pneumonia | 31.09 | 10.89 | 594 | 42095 | 421555 | 42157091 |
| Respiratory disorder | 30.51 | 10.89 | 68 | 42621 | 22017 | 42556629 |
| Blood potassium decreased | 28.43 | 10.89 | 63 | 42626 | 20321 | 42558325 |
| Diarrhoea | 28.20 | 10.89 | 631 | 42058 | 460218 | 42118428 |
| Hypermagnesaemia | 28.02 | 10.89 | 11 | 42678 | 315 | 42578331 |
| Foetal distress syndrome | 26.80 | 10.89 | 16 | 42673 | 1170 | 42577476 |
| Fatigue | 26.49 | 10.89 | 596 | 42093 | 435045 | 42143601 |
| Asthenia | 25.99 | 10.89 | 410 | 42279 | 280383 | 42298263 |
| General physical health deterioration | 24.54 | 10.89 | 74 | 42615 | 151172 | 42427474 |
| Dehydration | 24.49 | 10.89 | 233 | 42456 | 141534 | 42437112 |
| Small intestinal obstruction | 24.09 | 10.89 | 53 | 42636 | 17008 | 42561638 |
| Fall | 23.44 | 10.89 | 347 | 42342 | 234173 | 42344473 |
| Burkholderia test positive | 23.30 | 10.89 | 14 | 42675 | 1036 | 42577610 |
| Anhedonia | 22.89 | 10.89 | 33 | 42656 | 7607 | 42571039 |
| Immune effector cell-associated neurotoxicity syndrome | 22.89 | 10.89 | 37 | 42652 | 9424 | 42569222 |
| Laboratory test abnormal | 22.48 | 10.89 | 62 | 42627 | 22916 | 42555730 |
| Suicide attempt | 22.47 | 10.89 | 9 | 42680 | 46091 | 42532555 |
| Sepsis | 22.35 | 10.89 | 301 | 42388 | 199033 | 42379613 |
| Respiratory failure | 21.83 | 10.89 | 210 | 42479 | 127922 | 42450724 |
| Product use issue | 21.65 | 10.89 | 27 | 42662 | 76724 | 42501922 |
| Intentional product use issue | 21.63 | 10.89 | 24 | 42665 | 71809 | 42506837 |
| Injury | 21.62 | 10.89 | 60 | 42629 | 22256 | 42556390 |
| Fear | 21.42 | 10.89 | 39 | 42650 | 10926 | 42567720 |
| White blood cell count decreased | 21.37 | 10.89 | 186 | 42503 | 110210 | 42468436 |
| Myelosuppression | 21.25 | 10.89 | 7 | 42682 | 40454 | 42538192 |
| Intentional overdose | 20.65 | 10.89 | 13 | 42676 | 51443 | 42527203 |
| Mental status changes | 20.41 | 10.89 | 90 | 42599 | 42025 | 42536621 |
| Overdose | 18.92 | 10.89 | 49 | 42640 | 105215 | 42473431 |
| Full blood count decreased | 18.66 | 10.89 | 54 | 42635 | 20506 | 42558140 |
| Lip swelling | 18.23 | 10.89 | 51 | 42638 | 19002 | 42559644 |
| Constipation | 18.15 | 10.89 | 245 | 42444 | 162046 | 42416600 |
| Respiratory tract infection bacterial | 17.81 | 10.89 | 15 | 42674 | 1894 | 42576752 |
| Platelet count decreased | 17.08 | 10.89 | 213 | 42476 | 138368 | 42440278 |
| Bradycardia foetal | 17.03 | 10.89 | 8 | 42681 | 358 | 42578288 |
| Intraventricular haemorrhage neonatal | 16.91 | 10.89 | 8 | 42681 | 364 | 42578282 |
| Treatment failure | 16.67 | 10.89 | 23 | 42666 | 62601 | 42516045 |
| COVID-19 | 16.55 | 10.89 | 60 | 42629 | 115888 | 42462758 |
| Caesarean section | 16.54 | 10.89 | 15 | 42674 | 2091 | 42576555 |
| Complication of device removal | 16.48 | 10.89 | 5 | 42684 | 64 | 42578582 |
| Hypoxia | 16.45 | 10.89 | 123 | 42566 | 69663 | 42508983 |
| Foetal heart rate deceleration abnormality | 16.26 | 10.89 | 9 | 42680 | 570 | 42578076 |
| Back pain | 16.25 | 10.89 | 215 | 42474 | 141561 | 42437085 |
| Drug resistance | 16.19 | 10.89 | 7 | 42682 | 34241 | 42544405 |
| Pantoea agglomerans infection | 15.81 | 10.89 | 5 | 42684 | 74 | 42578572 |
| Adrenal insufficiency | 15.57 | 10.89 | 48 | 42641 | 18876 | 42559770 |
| Hepatic cytolysis | 15.27 | 10.89 | 4 | 42685 | 26840 | 42551806 |
| Renal injury | 14.97 | 10.89 | 36 | 42653 | 12244 | 42566402 |
| Acute respiratory failure | 14.47 | 10.89 | 77 | 42612 | 38781 | 42539865 |
| Product contamination | 14.06 | 10.89 | 10 | 42679 | 985 | 42577661 |
| Viral infection | 14.05 | 10.89 | 52 | 42637 | 22431 | 42556215 |
| Maternal drugs affecting foetus | 13.63 | 10.89 | 18 | 42671 | 3821 | 42574825 |
| Blood albumin decreased | 13.55 | 10.89 | 40 | 42649 | 15362 | 42563284 |
| Splenic vein thrombosis | 13.54 | 10.89 | 8 | 42681 | 574 | 42578072 |
| Patent ductus arteriosus | 13.44 | 10.89 | 17 | 42672 | 3459 | 42575187 |
| Electrocardiogram QT prolonged | 13.34 | 10.89 | 88 | 42601 | 47857 | 42530789 |
| Agranulocytosis | 13.33 | 10.89 | 7 | 42682 | 30605 | 42548041 |
| Drug intolerance | 13.28 | 10.89 | 39 | 42650 | 80385 | 42498261 |
| Blood magnesium decreased | 13.25 | 10.89 | 26 | 42663 | 7700 | 42570946 |
| Hypotension | 13.04 | 10.89 | 344 | 42345 | 257287 | 42321359 |
| Respiratory acidosis | 12.98 | 10.89 | 23 | 42666 | 6308 | 42572338 |
| Rheumatoid arthritis | 12.97 | 10.89 | 14 | 42675 | 42426 | 42536220 |
| Anorgasmia | 12.87 | 10.89 | 10 | 42679 | 1127 | 42577519 |
| Neonatal respiratory distress syndrome | 12.81 | 10.89 | 19 | 42670 | 4494 | 42574152 |
| Inappropriate schedule of product administration | 12.79 | 10.89 | 51 | 42638 | 95851 | 42482795 |
| Mixed dementia | 12.78 | 10.89 | 6 | 42683 | 268 | 42578378 |
| Torsade de pointes | 12.48 | 10.89 | 27 | 42662 | 8567 | 42570079 |
| Hypervolaemia | 12.43 | 10.89 | 51 | 42638 | 23074 | 42555572 |
| Drug-induced liver injury | 12.41 | 10.89 | 12 | 42677 | 38261 | 42540385 |
| Neonatal asphyxia | 12.28 | 10.89 | 7 | 42682 | 469 | 42578177 |
| Ureteric stenosis | 12.00 | 10.89 | 10 | 42679 | 1244 | 42577402 |
| Oesophagitis | 11.92 | 10.89 | 38 | 42651 | 15209 | 42563437 |
| Muscular weakness | 11.90 | 10.89 | 132 | 42557 | 83366 | 42495280 |
| Apnoea | 11.89 | 10.89 | 25 | 42664 | 7778 | 42570868 |
| Painful ejaculation | 11.82 | 10.89 | 5 | 42684 | 174 | 42578472 |
| Haemoglobin decreased | 11.68 | 10.89 | 192 | 42497 | 132279 | 42446367 |
| Diabetes mellitus | 11.55 | 10.89 | 27 | 42662 | 60060 | 42518586 |
| Transverse presentation | 11.39 | 10.89 | 4 | 42685 | 83 | 42578563 |
| Therapy partial responder | 11.36 | 10.89 | 3 | 42686 | 20018 | 42558628 |
| Behaviour disorder | 11.22 | 10.89 | 23 | 42666 | 7031 | 42571615 |
| Muscle spasms | 10.92 | 10.89 | 133 | 42556 | 85911 | 42492735 |
| 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 |
|---|---|---|---|---|---|---|
| Premature delivery | 292.23 | 9.49 | 226 | 92106 | 30406 | 110466561 |
| Synovitis | 184.71 | 9.49 | 11 | 92321 | 274081 | 110222886 |
| Exposure during pregnancy | 166.00 | 9.49 | 405 | 91927 | 167019 | 110329948 |
| Pemphigus | 146.44 | 9.49 | 8 | 92324 | 214562 | 110282405 |
| Hypermagnesaemia | 146.37 | 9.49 | 54 | 92278 | 1569 | 110495398 |
| Completed suicide | 143.45 | 9.49 | 17 | 92315 | 242364 | 110254603 |
| Hand deformity | 135.25 | 9.49 | 13 | 92319 | 218493 | 110278474 |
| Systemic lupus erythematosus | 125.79 | 9.49 | 29 | 92303 | 254309 | 110242658 |
| Macular degeneration | 125.24 | 9.49 | 120 | 92212 | 21539 | 110475428 |
| Helicobacter infection | 117.53 | 9.49 | 9 | 92323 | 181868 | 110315099 |
| Drug intolerance | 117.51 | 9.49 | 100 | 92232 | 406412 | 110090555 |
| Anti-cyclic citrullinated peptide antibody positive | 112.17 | 9.49 | 11 | 92321 | 181973 | 110314994 |
| Glossodynia | 108.42 | 9.49 | 26 | 92306 | 221978 | 110274989 |
| Contraindicated product administered | 106.68 | 9.49 | 37 | 92295 | 248230 | 110248737 |
| Pericarditis | 106.35 | 9.49 | 26 | 92306 | 219088 | 110277879 |
| Paraesthesia oral | 105.00 | 9.49 | 135 | 92197 | 33536 | 110463431 |
| Joint swelling | 103.12 | 9.49 | 131 | 92201 | 442714 | 110054253 |
| Product use in unapproved indication | 100.42 | 9.49 | 136 | 92196 | 447241 | 110049726 |
| Treatment failure | 99.04 | 9.49 | 54 | 92278 | 277180 | 110219787 |
| Drug abuse | 96.61 | 9.49 | 16 | 92316 | 177395 | 110319572 |
| Hepatic enzyme increased | 95.11 | 9.49 | 77 | 92255 | 320815 | 110176152 |
| Diabetes insipidus | 93.86 | 9.49 | 62 | 92270 | 6508 | 110490459 |
| Arthropathy | 90.30 | 9.49 | 65 | 92267 | 287457 | 110209510 |
| PCO2 increased | 89.17 | 9.49 | 40 | 92292 | 1937 | 110495030 |
| Procedural pain | 87.31 | 9.49 | 127 | 92205 | 35438 | 110461529 |
| Product use issue | 84.87 | 9.49 | 81 | 92251 | 311614 | 110185353 |
| Intentional product use issue | 84.67 | 9.49 | 51 | 92281 | 247855 | 110249112 |
| Chronic sinusitis | 83.65 | 9.49 | 104 | 92228 | 24980 | 110471987 |
| Vaginal flatulence | 81.27 | 9.49 | 73 | 92259 | 12071 | 110484896 |
| Folliculitis | 81.14 | 9.49 | 20 | 92312 | 167633 | 110329334 |
| Rheumatoid factor positive | 81.00 | 9.49 | 8 | 92324 | 131632 | 110365335 |
| Duodenal ulcer perforation | 80.73 | 9.49 | 24 | 92308 | 177676 | 110319291 |
| Cytokine release syndrome | 80.48 | 9.49 | 180 | 92152 | 70126 | 110426841 |
| C-reactive protein abnormal | 79.50 | 9.49 | 8 | 92324 | 129687 | 110367280 |
| Wound | 78.99 | 9.49 | 49 | 92283 | 234388 | 110262579 |
| Blood pH decreased | 78.94 | 9.49 | 49 | 92283 | 4620 | 110492347 |
| Female genital tract fistula | 77.99 | 9.49 | 82 | 92250 | 16437 | 110480530 |
| Radiculopathy | 77.40 | 9.49 | 88 | 92244 | 19248 | 110477719 |
| Unevaluable event | 76.22 | 9.49 | 159 | 92173 | 59068 | 110437899 |
| Lower respiratory tract infection | 74.98 | 9.49 | 56 | 92276 | 243050 | 110253917 |
| Mitochondrial DNA mutation | 74.82 | 9.49 | 24 | 92308 | 452 | 110496515 |
| Respiratory failure | 74.16 | 9.49 | 366 | 91966 | 214966 | 110282001 |
| Type 2 diabetes mellitus | 73.44 | 9.49 | 28 | 92304 | 177204 | 110319763 |
| General physical health deterioration | 72.65 | 9.49 | 154 | 92178 | 425141 | 110071826 |
| Pulmonary oedema | 71.09 | 9.49 | 215 | 92117 | 100444 | 110396523 |
| Vaginal discharge | 70.84 | 9.49 | 81 | 92251 | 17827 | 110479140 |
| Toxicity to various agents | 70.19 | 9.49 | 189 | 92143 | 480366 | 110016601 |
| Pre-eclampsia | 70.07 | 9.49 | 58 | 92274 | 8592 | 110488375 |
| Irritable bowel syndrome | 69.63 | 9.49 | 25 | 92307 | 164190 | 110332777 |
| Fibromyalgia | 69.17 | 9.49 | 28 | 92304 | 170881 | 110326086 |
| Muscle injury | 67.74 | 9.49 | 17 | 92315 | 140790 | 110356177 |
| Dehydration | 66.38 | 9.49 | 430 | 91902 | 279081 | 110217886 |
| Proctitis | 66.01 | 9.49 | 76 | 92256 | 16851 | 110480116 |
| Bursitis | 65.85 | 9.49 | 14 | 92318 | 129904 | 110367063 |
| Hypotension | 65.08 | 9.49 | 696 | 91636 | 523153 | 109973814 |
| Rheumatoid arthritis | 62.34 | 9.49 | 96 | 92236 | 299517 | 110197450 |
| Off label use | 61.58 | 9.49 | 883 | 91449 | 1499302 | 108997665 |
| Joint range of motion decreased | 60.00 | 9.49 | 14 | 92318 | 121818 | 110375149 |
| Acute respiratory failure | 59.13 | 9.49 | 167 | 92165 | 75093 | 110421874 |
| Rheumatic fever | 58.58 | 9.49 | 15 | 92317 | 122564 | 110374403 |
| Sepsis | 57.78 | 9.49 | 469 | 91863 | 326877 | 110170090 |
| Colitis | 57.34 | 9.49 | 202 | 92130 | 102121 | 110394846 |
| Gastrointestinal disorder | 56.86 | 9.49 | 71 | 92261 | 241881 | 110255086 |
| Propofol infusion syndrome | 56.40 | 9.49 | 32 | 92300 | 2557 | 110494410 |
| Blood bicarbonate decreased | 55.77 | 9.49 | 43 | 92289 | 5754 | 110491213 |
| Diarrhoea | 55.72 | 9.49 | 1293 | 91039 | 1138212 | 109358755 |
| Maternal exposure during pregnancy | 55.63 | 9.49 | 384 | 91948 | 254499 | 110242468 |
| Sleep disorder due to general medical condition, insomnia type | 54.34 | 9.49 | 11 | 92321 | 105632 | 110391335 |
| Hypoxia | 54.09 | 9.49 | 233 | 92099 | 129282 | 110367685 |
| Therapeutic product effect decreased | 53.04 | 9.49 | 76 | 92256 | 244240 | 110252727 |
| Blister | 52.11 | 9.49 | 68 | 92264 | 227308 | 110269659 |
| Intentional product misuse | 51.81 | 9.49 | 23 | 92309 | 132881 | 110364086 |
| Alopecia | 50.60 | 9.49 | 147 | 92185 | 364606 | 110132361 |
| Deep vein thrombosis | 50.46 | 9.49 | 241 | 92091 | 139646 | 110357321 |
| Hypomagnesaemia | 50.43 | 9.49 | 137 | 92195 | 60233 | 110436734 |
| Mental status changes | 49.49 | 9.49 | 158 | 92174 | 75964 | 110421003 |
| Impaired healing | 49.14 | 9.49 | 55 | 92277 | 196662 | 110300305 |
| Mobility decreased | 48.49 | 9.49 | 77 | 92255 | 237345 | 110259622 |
| Blood magnesium decreased | 48.49 | 9.49 | 71 | 92261 | 19925 | 110477042 |
| Hypervolaemia | 48.28 | 9.49 | 119 | 92213 | 49341 | 110447626 |
| Foetal death | 47.94 | 9.49 | 63 | 92269 | 15982 | 110480985 |
| Blood potassium decreased | 47.42 | 9.49 | 125 | 92207 | 53989 | 110442978 |
| Swollen joint count increased | 46.77 | 9.49 | 7 | 92325 | 83654 | 110413313 |
| Hypersensitivity | 46.31 | 9.49 | 177 | 92155 | 403821 | 110093146 |
| Pneumonia | 46.28 | 9.49 | 1006 | 91326 | 875708 | 109621259 |
| Inflammation | 46.14 | 9.49 | 56 | 92276 | 193182 | 110303785 |
| Fear | 45.94 | 9.49 | 75 | 92257 | 23118 | 110473849 |
| Plasma cell myeloma | 45.92 | 9.49 | 136 | 92196 | 62800 | 110434167 |
| Breast cancer stage III | 45.68 | 9.49 | 6 | 92326 | 79111 | 110417856 |
| Device expulsion | 44.59 | 9.49 | 87 | 92245 | 30804 | 110466163 |
| Myelosuppression | 44.21 | 9.49 | 12 | 92320 | 94328 | 110402639 |
| CSF oligoclonal band present | 43.66 | 9.49 | 16 | 92316 | 456 | 110496511 |
| Abdominal pain | 43.60 | 9.49 | 635 | 91697 | 512354 | 109984613 |
| Ill-defined disorder | 43.56 | 9.49 | 40 | 92292 | 156813 | 110340154 |
| Swelling | 43.40 | 9.49 | 149 | 92183 | 350892 | 110146075 |
| Lip dry | 42.82 | 9.49 | 15 | 92317 | 100068 | 110396899 |
| C-reactive protein increased | 42.34 | 9.49 | 73 | 92259 | 217846 | 110279121 |
| Liver injury | 42.20 | 9.49 | 38 | 92294 | 150375 | 110346592 |
| Arthralgia | 42.08 | 9.49 | 432 | 91900 | 779200 | 109717767 |
| Emotional distress | 41.77 | 9.49 | 106 | 92226 | 44741 | 110452226 |
| Epilepsy | 41.22 | 9.49 | 16 | 92316 | 100193 | 110396774 |
| Discomfort | 40.74 | 9.49 | 73 | 92259 | 214634 | 110282333 |
| Obesity | 40.57 | 9.49 | 22 | 92310 | 113329 | 110383638 |
| Constipation | 40.54 | 9.49 | 467 | 91865 | 357319 | 110139648 |
| Peripheral venous disease | 38.86 | 9.49 | 11 | 92321 | 84106 | 110412861 |
| PO2 increased | 38.70 | 9.49 | 21 | 92311 | 1538 | 110495429 |
| Blood gases abnormal | 38.54 | 9.49 | 20 | 92312 | 1338 | 110495629 |
| COVID-19 | 38.34 | 9.49 | 93 | 92239 | 244967 | 110252000 |
| Renal ischaemia | 38.32 | 9.49 | 24 | 92308 | 2299 | 110494668 |
| Hypokalaemia | 38.10 | 9.49 | 272 | 92060 | 182176 | 110314791 |
| Immune effector cell-associated neurotoxicity syndrome | 38.06 | 9.49 | 54 | 92278 | 14728 | 110482239 |
| Chills | 38.01 | 9.49 | 281 | 92051 | 190299 | 110306668 |
| Grip strength decreased | 37.94 | 9.49 | 10 | 92322 | 80164 | 110416803 |
| Vaginal haemorrhage | 37.89 | 9.49 | 72 | 92260 | 25002 | 110471965 |
| Product dose omission issue | 37.80 | 9.49 | 423 | 91909 | 321359 | 110175608 |
| Small intestinal obstruction | 37.45 | 9.49 | 83 | 92249 | 32130 | 110464837 |
| Haemoglobin decreased | 37.39 | 9.49 | 344 | 91988 | 248383 | 110248584 |
| Fall | 36.91 | 9.49 | 708 | 91624 | 602774 | 109894193 |
| Oral candidiasis | 36.81 | 9.49 | 101 | 92231 | 44659 | 110452308 |
| Respiratory acidosis | 36.32 | 9.49 | 51 | 92281 | 13775 | 110483192 |
| Anhedonia | 36.29 | 9.49 | 54 | 92278 | 15374 | 110481593 |
| Musculoskeletal stiffness | 35.79 | 9.49 | 117 | 92215 | 279705 | 110217262 |
| Osteoarthritis | 35.64 | 9.49 | 61 | 92271 | 182562 | 110314405 |
| Blood cholesterol increased | 34.90 | 9.49 | 63 | 92269 | 184722 | 110312245 |
| Asthma | 34.60 | 9.49 | 101 | 92231 | 250190 | 110246777 |
| Drug hypersensitivity | 34.29 | 9.49 | 230 | 92102 | 453860 | 110043107 |
| Torsade de pointes | 34.28 | 9.49 | 65 | 92267 | 22535 | 110474432 |
| Suicide attempt | 34.27 | 9.49 | 22 | 92310 | 103372 | 110393595 |
| Encephalopathy | 33.97 | 9.49 | 146 | 92186 | 80909 | 110416058 |
| Platelet count decreased | 33.77 | 9.49 | 317 | 92015 | 230126 | 110266841 |
| Caesarean section | 33.42 | 9.49 | 49 | 92283 | 13768 | 110483199 |
| Intentional overdose | 33.13 | 9.49 | 37 | 92295 | 132464 | 110364503 |
| Nausea | 33.07 | 9.49 | 1302 | 91030 | 1234388 | 109262579 |
| Anaemia | 32.82 | 9.49 | 640 | 91692 | 546446 | 109950521 |
| Electrocardiogram QT prolonged | 31.82 | 9.49 | 177 | 92155 | 108783 | 110388184 |
| Wheezing | 31.76 | 9.49 | 108 | 92224 | 255122 | 110241845 |
| Atrial fibrillation | 31.73 | 9.49 | 312 | 92020 | 229330 | 110267637 |
| Neuromuscular block prolonged | 31.52 | 9.49 | 17 | 92315 | 1230 | 110495737 |
| Urticaria thermal | 31.36 | 9.49 | 13 | 92319 | 518 | 110496449 |
| Hypocalcaemia | 30.74 | 9.49 | 122 | 92210 | 65244 | 110431723 |
| Hypercholesterolaemia | 30.56 | 9.49 | 19 | 92313 | 90818 | 110406149 |
| Premature labour | 30.53 | 9.49 | 38 | 92294 | 9134 | 110487833 |
| Administration site erythema | 30.23 | 9.49 | 12 | 92320 | 427 | 110496540 |
| Therapy cessation | 29.97 | 9.49 | 94 | 92238 | 44763 | 110452204 |
| Gene mutation | 29.90 | 9.49 | 24 | 92308 | 3405 | 110493562 |
| Hepatic cytolysis | 29.88 | 9.49 | 5 | 92327 | 55048 | 110441919 |
| Renal injury | 29.85 | 9.49 | 55 | 92277 | 18658 | 110478309 |
| Febrile neutropenia | 29.24 | 9.49 | 398 | 91934 | 316369 | 110180598 |
| Lung disorder | 29.22 | 9.49 | 67 | 92265 | 179980 | 110316987 |
| Nasopharyngitis | 29.15 | 9.49 | 201 | 92131 | 394160 | 110102807 |
| Pleocytosis | 28.91 | 9.49 | 18 | 92314 | 1706 | 110495261 |
| Sleep disorder | 28.30 | 9.49 | 79 | 92253 | 198565 | 110298402 |
| Rectal haemorrhage | 28.19 | 9.49 | 184 | 92148 | 119649 | 110377318 |
| Asthenia | 27.95 | 9.49 | 763 | 91569 | 688236 | 109808731 |
| Nail disorder | 27.85 | 9.49 | 7 | 92325 | 57928 | 110439039 |
| Blood magnesium increased | 27.61 | 9.49 | 24 | 92308 | 3799 | 110493168 |
| Abdominal discomfort | 27.52 | 9.49 | 204 | 92128 | 393654 | 110103313 |
| Psoriatic arthropathy | 27.48 | 9.49 | 79 | 92253 | 196682 | 110300285 |
| Drug-induced liver injury | 27.40 | 9.49 | 36 | 92296 | 120031 | 110376936 |
| Blood lactic acid increased | 27.15 | 9.49 | 48 | 92284 | 15773 | 110481194 |
| Lung hyperinflation | 27.01 | 9.49 | 19 | 92313 | 2210 | 110494757 |
| Drug interaction | 27 | 9.49 | 277 | 92055 | 499906 | 109997061 |
| Full blood count decreased | 26.96 | 9.49 | 73 | 92259 | 32026 | 110464941 |
| Oxygen saturation abnormal | 26.75 | 9.49 | 28 | 92304 | 5583 | 110491384 |
| Condition aggravated | 26.75 | 9.49 | 442 | 91890 | 734394 | 109762573 |
| Frequent bowel movements | 26.46 | 9.49 | 124 | 92208 | 71266 | 110425701 |
| Blood albumin decreased | 26.42 | 9.49 | 66 | 92266 | 27586 | 110469381 |
| Therapeutic response decreased | 26.33 | 9.49 | 25 | 92307 | 96474 | 110400493 |
| Status asthmaticus | 26.04 | 9.49 | 14 | 92318 | 1007 | 110495960 |
| Pleural effusion | 25.80 | 9.49 | 244 | 92088 | 177465 | 110319502 |
| Airway peak pressure increased | 25.79 | 9.49 | 12 | 92320 | 633 | 110496334 |
| Overdose | 25.76 | 9.49 | 104 | 92228 | 233690 | 110263277 |
| Blepharospasm | 25.66 | 9.49 | 7 | 92325 | 54844 | 110442123 |
| Device dislocation | 25.53 | 9.49 | 71 | 92261 | 31633 | 110465334 |
| Atelectasis | 25.52 | 9.49 | 78 | 92254 | 36634 | 110460333 |
| Pulmonary hypertension | 25.12 | 9.49 | 102 | 92230 | 55118 | 110441849 |
| Maternal exposure during delivery | 24.99 | 9.49 | 22 | 92310 | 3543 | 110493424 |
| Prescribed overdose | 24.71 | 9.49 | 22 | 92310 | 87559 | 110409408 |
| Hepatocellular injury | 24.57 | 9.49 | 6 | 92326 | 50636 | 110446331 |
| Electroencephalogram abnormal | 24.55 | 9.49 | 28 | 92304 | 6145 | 110490822 |
| Flushing | 24.14 | 9.49 | 160 | 92172 | 104576 | 110392391 |
| Night sweats | 24.13 | 9.49 | 47 | 92285 | 133936 | 110363031 |
| Cellulitis | 23.54 | 9.49 | 183 | 92149 | 125833 | 110371134 |
| Deep vein thrombosis postoperative | 23.52 | 9.49 | 10 | 92322 | 59281 | 110437686 |
| Aspartate aminotransferase increased | 23.42 | 9.49 | 220 | 92112 | 159716 | 110337251 |
| Haematocrit decreased | 23.17 | 9.49 | 113 | 92219 | 66004 | 110430963 |
| Failure to thrive | 23.06 | 9.49 | 41 | 92291 | 13533 | 110483434 |
| Liver disorder | 23.02 | 9.49 | 53 | 92279 | 142190 | 110354777 |
| Onychomadesis | 22.97 | 9.49 | 5 | 92327 | 45658 | 110451309 |
| Tachypnoea | 22.26 | 9.49 | 78 | 92254 | 39317 | 110457650 |
| Colitis ulcerative | 22.14 | 9.49 | 125 | 92207 | 77238 | 110419729 |
| Weight increased | 21.98 | 9.49 | 234 | 92098 | 419410 | 110077557 |
| Pulmonary fibrosis | 21.88 | 9.49 | 32 | 92300 | 102010 | 110394957 |
| Adjustment disorder with depressed mood | 21.69 | 9.49 | 5 | 92327 | 43878 | 110453089 |
| Unresponsive to stimuli | 21.63 | 9.49 | 108 | 92224 | 63682 | 110433285 |
| Dislocation of vertebra | 21.57 | 9.49 | 5 | 92327 | 43716 | 110453251 |
| Neuromuscular blockade | 21.24 | 9.49 | 11 | 92321 | 733 | 110496234 |
| Coeliac disease | 21.18 | 9.49 | 5 | 92327 | 43182 | 110453785 |
| Pantoea agglomerans infection | 21.02 | 9.49 | 7 | 92325 | 149 | 110496818 |
| Wound infection | 20.93 | 9.49 | 30 | 92302 | 96435 | 110400532 |
| Cardiac failure congestive | 20.77 | 9.49 | 205 | 92127 | 150795 | 110346172 |
| Sopor | 20.56 | 9.49 | 3 | 92329 | 36543 | 110460424 |
| Loss of personal independence in daily activities | 20.39 | 9.49 | 61 | 92271 | 149959 | 110347008 |
| Flatulence | 20.38 | 9.49 | 92 | 92240 | 52057 | 110444910 |
| Stomatitis | 20.32 | 9.49 | 137 | 92195 | 270105 | 110226862 |
| Urinary tract infection | 20.32 | 9.49 | 384 | 91948 | 325898 | 110171069 |
| Haematochezia | 20.07 | 9.49 | 165 | 92167 | 115359 | 110381608 |
| Onychomycosis | 19.84 | 9.49 | 4 | 92328 | 38527 | 110458440 |
| International normalised ratio increased | 19.66 | 9.49 | 132 | 92200 | 86640 | 110410327 |
| Dizziness | 19.62 | 9.49 | 740 | 91592 | 697453 | 109799514 |
| Metabolic encephalopathy | 19.56 | 9.49 | 34 | 92298 | 11026 | 110485941 |
| HELLP syndrome | 19.55 | 9.49 | 11 | 92321 | 865 | 110496102 |
| Transfusion | 19.49 | 9.49 | 56 | 92276 | 25416 | 110471551 |
| White blood cell count decreased | 19.46 | 9.49 | 284 | 92048 | 229106 | 110267861 |
| Red blood cell sedimentation rate increased | 19.43 | 9.49 | 22 | 92310 | 78280 | 110418687 |
| Infection | 19.36 | 9.49 | 201 | 92131 | 361999 | 110134968 |
| PO2 decreased | 19.26 | 9.49 | 18 | 92314 | 3130 | 110493837 |
| Pyrexia | 19.17 | 9.49 | 925 | 91407 | 897340 | 109599627 |
| Hospice care | 19.07 | 9.49 | 36 | 92296 | 12437 | 110484530 |
| Dyspnoea | 19.06 | 9.49 | 1117 | 91215 | 1105755 | 109391212 |
| Weight decreased | 18.86 | 9.49 | 518 | 91814 | 467539 | 110029428 |
| Infusion related reaction | 18.59 | 9.49 | 216 | 92116 | 380946 | 110116021 |
| Endometritis | 18.47 | 9.49 | 11 | 92321 | 963 | 110496004 |
| Pelvic pain | 18.44 | 9.49 | 41 | 92291 | 15901 | 110481066 |
| Bacteraemia | 18.26 | 9.49 | 77 | 92255 | 42313 | 110454654 |
| Nail bed tenderness | 18.06 | 9.49 | 8 | 92324 | 376 | 110496591 |
| Agranulocytosis | 18.05 | 9.49 | 15 | 92317 | 61745 | 110435222 |
| Feeling abnormal | 17.88 | 9.49 | 230 | 92102 | 180481 | 110316486 |
| Hypertension | 17.50 | 9.49 | 310 | 92022 | 509774 | 109987193 |
| Sleep disorder due to a general medical condition | 17.39 | 9.49 | 11 | 92321 | 52101 | 110444866 |
| Complication associated with device | 17.21 | 9.49 | 46 | 92286 | 20027 | 110476940 |
| Respiratory tract infection bacterial | 17.11 | 9.49 | 15 | 92317 | 2401 | 110494566 |
| Respiratory distress | 16.96 | 9.49 | 107 | 92225 | 68767 | 110428200 |
| Diabetes mellitus | 16.93 | 9.49 | 36 | 92296 | 99345 | 110397622 |
| Anxiety | 16.87 | 9.49 | 392 | 91940 | 344686 | 110152281 |
| Hyporeflexia | 16.76 | 9.49 | 19 | 92313 | 4141 | 110492826 |
| Renal failure | 16.72 | 9.49 | 274 | 92058 | 226300 | 110270667 |
| Coma | 16.69 | 9.49 | 47 | 92285 | 117822 | 110379145 |
| Autoimmune disorder | 16.68 | 9.49 | 18 | 92314 | 65465 | 110431502 |
| Small for dates baby | 16.66 | 9.49 | 9 | 92323 | 653 | 110496314 |
| Lethargy | 16.44 | 9.49 | 134 | 92198 | 93442 | 110403525 |
| Hypophagia | 16.38 | 9.49 | 87 | 92245 | 52539 | 110444428 |
| Product complaint | 16.24 | 9.49 | 36 | 92296 | 13936 | 110483031 |
| Back pain | 15.91 | 9.49 | 414 | 91918 | 370582 | 110126385 |
| Hepatitis | 15.86 | 9.49 | 32 | 92300 | 90022 | 110406945 |
| Cardiac arrest | 15.67 | 9.49 | 241 | 92091 | 196512 | 110300455 |
| Neuropathy peripheral | 15.61 | 9.49 | 223 | 92109 | 179054 | 110317913 |
| Sinus tachycardia | 15.56 | 9.49 | 76 | 92256 | 44417 | 110452550 |
| Taste disorder | 15.55 | 9.49 | 19 | 92313 | 65368 | 110431599 |
| Blood alkaline phosphatase increased | 15.53 | 9.49 | 107 | 92225 | 70828 | 110426139 |
| Urine output decreased | 15.50 | 9.49 | 44 | 92288 | 19832 | 110477135 |
| Drug reaction with eosinophilia and systemic symptoms | 15.48 | 9.49 | 28 | 92304 | 82067 | 110414900 |
| Adverse reaction | 15.39 | 9.49 | 3 | 92329 | 29591 | 110467376 |
| Anorgasmia | 15.38 | 9.49 | 12 | 92320 | 1634 | 110495333 |
| Dizziness postural | 15.16 | 9.49 | 36 | 92296 | 14573 | 110482394 |
| Painful ejaculation | 15.12 | 9.49 | 5 | 92327 | 104 | 110496863 |
| Therapy partial responder | 15.10 | 9.49 | 6 | 92326 | 37055 | 110459912 |
| Obstructive airways disorder | 15.05 | 9.49 | 10 | 92322 | 46139 | 110450828 |
| Cytomegalovirus infection | 14.97 | 9.49 | 14 | 92318 | 54430 | 110442537 |
| Product contamination microbial | 14.85 | 9.49 | 10 | 92322 | 1084 | 110495883 |
| Accidental exposure to product | 14.80 | 9.49 | 12 | 92320 | 49996 | 110446971 |
| Fatigue | 14.74 | 9.49 | 1192 | 91140 | 1214766 | 109282201 |
| Stillbirth | 14.73 | 9.49 | 18 | 92314 | 4246 | 110492721 |
| Antinuclear antibody positive | 14.69 | 9.49 | 27 | 92305 | 9141 | 110487826 |
| Pulmonary arterial hypertension | 14.68 | 9.49 | 60 | 92272 | 32508 | 110464459 |
| Bronchospasm | 14.67 | 9.49 | 57 | 92275 | 30182 | 110466785 |
| Vulvovaginal swelling | 14.51 | 9.49 | 8 | 92324 | 605 | 110496362 |
| Sciatica | 14.49 | 9.49 | 35 | 92297 | 92364 | 110404603 |
| Haemodynamic instability | 14.41 | 9.49 | 47 | 92285 | 22841 | 110474126 |
| Burkholderia test positive | 14.37 | 9.49 | 8 | 92324 | 616 | 110496351 |
| Vitamin B6 increased | 14.29 | 9.49 | 4 | 92328 | 46 | 110496921 |
| Multiple sclerosis relapse | 14.26 | 9.49 | 81 | 92251 | 50159 | 110446808 |
| Eczema | 14.23 | 9.49 | 24 | 92308 | 72269 | 110424698 |
| Laryngeal pain | 14.18 | 9.49 | 21 | 92311 | 5954 | 110491013 |
| Drug ineffective | 14.14 | 9.49 | 1086 | 91246 | 1519454 | 108977513 |
| Postpartum haemorrhage | 13.93 | 9.49 | 12 | 92320 | 1877 | 110495090 |
| Bone erosion | 13.88 | 9.49 | 11 | 92321 | 46360 | 110450607 |
| Blood culture positive | 13.84 | 9.49 | 26 | 92306 | 8950 | 110488017 |
| Blood calcium decreased | 13.83 | 9.49 | 63 | 92269 | 35782 | 110461185 |
| Incision site pain | 13.81 | 9.49 | 15 | 92317 | 3120 | 110493847 |
| Intentional self-injury | 13.78 | 9.49 | 7 | 92325 | 37422 | 110459545 |
| Hip fracture | 13.72 | 9.49 | 62 | 92270 | 35089 | 110461878 |
| Blood pressure fluctuation | 13.69 | 9.49 | 26 | 92306 | 74798 | 110422169 |
| Interstitial lung disease | 13.51 | 9.49 | 65 | 92267 | 139269 | 110357698 |
| Apnoea | 13.50 | 9.49 | 33 | 92299 | 13606 | 110483361 |
| Blood bilirubin increased | 13.46 | 9.49 | 109 | 92223 | 75863 | 110421104 |
| Mixed dementia | 13.44 | 9.49 | 6 | 92326 | 287 | 110496680 |
| Tachycardia | 13.17 | 9.49 | 264 | 92068 | 226381 | 110270586 |
| Dialysis | 13.00 | 9.49 | 41 | 92291 | 19578 | 110477389 |
| Seizure | 12.97 | 9.49 | 258 | 92074 | 220927 | 110276040 |
| Left ventricular dysfunction | 12.83 | 9.49 | 46 | 92286 | 23447 | 110473520 |
| X-ray abnormal | 12.78 | 9.49 | 8 | 92324 | 38109 | 110458858 |
| Dyspnoea exertional | 12.75 | 9.49 | 138 | 92194 | 103922 | 110393045 |
| Staphylococcal infection | 12.74 | 9.49 | 101 | 92231 | 69843 | 110427124 |
| Right ventricular failure | 12.65 | 9.49 | 49 | 92283 | 25905 | 110471062 |
| Influenza like illness | 12.63 | 9.49 | 121 | 92211 | 88291 | 110408676 |
| Skin discolouration | 12.58 | 9.49 | 77 | 92255 | 48969 | 110447998 |
| Tremor | 12.57 | 9.49 | 238 | 92094 | 201994 | 110294973 |
| Behaviour disorder | 12.53 | 9.49 | 26 | 92306 | 9621 | 110487346 |
| Hip arthroplasty | 12.46 | 9.49 | 17 | 92315 | 55796 | 110441171 |
| Osteonecrosis of jaw | 12.45 | 9.49 | 13 | 92319 | 48004 | 110448963 |
| Macroglossia | 12.26 | 9.49 | 10 | 92322 | 1451 | 110495516 |
| Cerebrovascular accident | 12.20 | 9.49 | 216 | 92116 | 181068 | 110315899 |
| Viral infection | 12.13 | 9.49 | 81 | 92251 | 53058 | 110443909 |
| Hypercapnia | 12.13 | 9.49 | 28 | 92304 | 11131 | 110485836 |
| Malnutrition | 12.10 | 9.49 | 50 | 92282 | 27229 | 110469738 |
| Ventricular extrasystoles | 12.08 | 9.49 | 44 | 92288 | 22597 | 110474370 |
| Decubitus ulcer | 11.98 | 9.49 | 38 | 92294 | 18198 | 110478769 |
| Pulmonary embolism | 11.86 | 9.49 | 248 | 92084 | 214226 | 110282741 |
| Blood pressure systolic increased | 11.82 | 9.49 | 33 | 92299 | 82958 | 110414009 |
| Septic shock | 11.80 | 9.49 | 191 | 92141 | 157337 | 110339630 |
| Gastrointestinal haemorrhage | 11.78 | 9.49 | 199 | 92133 | 165319 | 110331648 |
| Drug resistance | 11.77 | 9.49 | 18 | 92314 | 56356 | 110440611 |
| Pneumocystis jirovecii pneumonia | 11.74 | 9.49 | 11 | 92321 | 42724 | 110454243 |
| Acute pulmonary oedema | 11.71 | 9.49 | 36 | 92296 | 16960 | 110480007 |
| Lupus vulgaris | 11.52 | 9.49 | 7 | 92325 | 33876 | 110463091 |
| Knee arthroplasty | 11.51 | 9.49 | 23 | 92309 | 64925 | 110432042 |
| Ureteric stenosis | 11.48 | 9.49 | 10 | 92322 | 1587 | 110495380 |
| Dyspepsia | 11.28 | 9.49 | 223 | 92109 | 190742 | 110306225 |
| Impaired work ability | 11.23 | 9.49 | 4 | 92328 | 26415 | 110470552 |
| Rhabdomyolysis | 11.20 | 9.49 | 57 | 92275 | 120344 | 110376623 |
| Urticaria | 11.17 | 9.49 | 193 | 92139 | 318664 | 110178303 |
| Dysgeusia | 11.12 | 9.49 | 98 | 92234 | 69887 | 110427080 |
| Wound drainage | 11.10 | 9.49 | 9 | 92323 | 1295 | 110495672 |
| Road traffic accident | 11.07 | 9.49 | 49 | 92283 | 107349 | 110389618 |
| Testicular haemorrhage | 11.03 | 9.49 | 5 | 92327 | 248 | 110496719 |
| Adverse event | 11.00 | 9.49 | 50 | 92282 | 108759 | 110388208 |
| Negative pressure pulmonary oedema | 10.98 | 9.49 | 7 | 92325 | 692 | 110496275 |
| Splenic vein thrombosis | 10.95 | 9.49 | 8 | 92324 | 987 | 110495980 |
| Carbohydrate antigen 125 increased | 10.89 | 9.49 | 12 | 92320 | 2535 | 110494432 |
| Nervousness | 10.85 | 9.49 | 60 | 92272 | 36791 | 110460176 |
| Eosinophilia | 10.71 | 9.49 | 20 | 92312 | 57916 | 110439051 |
| C-reactive protein | 10.69 | 9.49 | 6 | 92326 | 30325 | 110466642 |
| Heparin-induced thrombocytopenia | 10.64 | 9.49 | 27 | 92305 | 11397 | 110485570 |
| Lupus-like syndrome | 10.63 | 9.49 | 11 | 92321 | 40781 | 110456186 |
| Foot deformity | 10.59 | 9.49 | 15 | 92317 | 48465 | 110448502 |
| Retinitis | 10.55 | 9.49 | 7 | 92325 | 32320 | 110464647 |
| Intestinal dilatation | 10.49 | 9.49 | 14 | 92318 | 3606 | 110493361 |
| Clostridium difficile infection | 10.46 | 9.49 | 77 | 92255 | 52052 | 110444915 |
| Muscle spasms | 10.40 | 9.49 | 305 | 92027 | 277852 | 110219115 |
| Drug tolerance decreased | 10.37 | 9.49 | 5 | 92327 | 27535 | 110469432 |
| Bradycardia foetal | 10.36 | 9.49 | 4 | 92328 | 132 | 110496835 |
| Prostatic pain | 10.24 | 9.49 | 5 | 92327 | 294 | 110496673 |
| Ear pain | 10.18 | 9.49 | 18 | 92314 | 53208 | 110443759 |
| Blood pressure diastolic decreased | 10.14 | 9.49 | 9 | 92323 | 35876 | 110461091 |
| Ventricular tachycardia | 10.11 | 9.49 | 74 | 92258 | 49935 | 110447032 |
| Aphasia | 10.10 | 9.49 | 84 | 92248 | 58913 | 110438054 |
| Product quality issue | 10.10 | 9.49 | 32 | 92300 | 77267 | 110419700 |
| Oesophagitis | 10.01 | 9.49 | 49 | 92283 | 28666 | 110468301 |
| Alanine aminotransferase increased | 10.00 | 9.49 | 212 | 92120 | 183561 | 110313406 |
| Liver function test increased | 9.99 | 9.49 | 39 | 92293 | 88509 | 110408458 |
| Sinusitis | 9.94 | 9.49 | 181 | 92151 | 296507 | 110200460 |
| Product contamination | 9.86 | 9.49 | 10 | 92322 | 1921 | 110495046 |
| Eye swelling | 9.85 | 9.49 | 54 | 92278 | 32994 | 110463973 |
| Pulse absent | 9.81 | 9.49 | 26 | 92306 | 11266 | 110485701 |
| Fluid retention | 9.74 | 9.49 | 121 | 92211 | 94186 | 110402781 |
| Finger deformity | 9.72 | 9.49 | 8 | 92324 | 33084 | 110463883 |
| Neoplasm progression | 9.72 | 9.49 | 25 | 92307 | 64570 | 110432397 |
| Biliary obstruction | 9.71 | 9.49 | 17 | 92315 | 5541 | 110491426 |
| Oedema peripheral | 9.60 | 9.49 | 350 | 91982 | 328310 | 110168657 |
| Computerised tomogram abnormal | 9.58 | 9.49 | 14 | 92318 | 3922 | 110493045 |
| 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 |
|---|---|---|---|---|---|---|
| Product preparation error | 39.23 | 23.98 | 11 | 111 | 102 | 113729 |
| Source | Code | Description |
|---|---|---|
| ATC | A06AD04 | ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Osmotically acting laxatives |
| ATC | A12CC02 | ALIMENTARY TRACT AND METABOLISM MINERAL SUPPLEMENTS OTHER MINERAL SUPPLEMENTS Magnesium |
| ATC | B05XA05 | BLOOD AND BLOOD FORMING ORGANS BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS I.V. SOLUTION ADDITIVES Electrolyte solutions |
| ATC | D11AX05 | DERMATOLOGICALS OTHER DERMATOLOGICAL PREPARATIONS OTHER DERMATOLOGICAL PREPARATIONS Other dermatologicals |
| ATC | V04CC02 | VARIOUS DIAGNOSTIC AGENTS OTHER DIAGNOSTIC AGENTS Tests for bile duct patency |
| MeSH PA | D000077264 | Calcium-Regulating Hormones and Agents |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D000777 | Anesthetics |
| MeSH PA | D000889 | Anti-Arrhythmia Agents |
| MeSH PA | D000927 | Anticonvulsants |
| MeSH PA | D002121 | Calcium Channel Blockers |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D002492 | Central Nervous System Depressants |
| MeSH PA | D012102 | Reproductive Control Agents |
| MeSH PA | D015149 | Tocolytic Agents |
| MeSH PA | D018689 | Sensory System Agents |
| MeSH PA | D049990 | Membrane Transport Modulators |
| CHEBI has role | CHEBI:50503 | laxative |
| CHEBI has role | CHEBI:75325 | cathartic |
| CHEBI has role | CHEBI:33287 | fertilizer |
| CHEBI has role | CHEBI:35480 | analgesic |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35623 | anticonvulsant |
| CHEBI has role | CHEBI:38070 | anti-arrhythmia drug |
| CHEBI has role | CHEBI:38215 | calcium channel blocker |
| CHEBI has role | CHEBI:38867 | anaesthetic |
| CHEBI has role | CHEBI:50247 | antidote |
| CHEBI has role | CHEBI:63726 | neuroprotective agent |
| CHEBI has role | CHEBI:65023 | anti-asthmatic agent |
| CHEBI has role | CHEBI:66993 | tocolytic agent |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Constipation | indication | 14760008 | DOID:2089 |
| Mild pre-eclampsia | indication | 41114007 | |
| Severe pre-eclampsia | indication | 46764007 | |
| Hypomagnesemia | indication | 190855004 | |
| Eclampsia in pregnancy | indication | 198992004 | |
| Incomplete passage of stool | indication | 249515001 | |
| Torsades de pointes | off-label use | 31722008 | |
| Atypical Ventricular Tachycardia | off-label use | ||
| Hypocalcemia | contraindication | 5291005 | |
| Hyperkalemia | contraindication | 14140009 | |
| Complete atrioventricular block | contraindication | 27885002 | |
| Dehydration | contraindication | 34095006 | |
| Gastrointestinal ulcer | contraindication | 40845000 | |
| Congenital myotonia, autosomal dominant form | contraindication | 57938005 | |
| Acute nephropathy | contraindication | 58574008 | |
| Hypermagnesemia | contraindication | 66978005 | |
| Appendicitis | contraindication | 74400008 | DOID:8337 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Gastrointestinal obstruction | contraindication | 126765001 | |
| Gastroparesis | contraindication | 235675006 | |
| Chronic diarrhea | contraindication | 236071009 | |
| Hyporeninemic hypoaldosteronism | contraindication | 236464008 | |
| Familial hyperkalemic periodic paralysis | contraindication | 304737009 | DOID:14451 |
| Severe dehydration | contraindication | 450316000 |
| Species | Use | Relation |
|---|---|---|
| Cattles | Used with sedative-relaxant and general anesthesia agents | Indication |
| Horses | Used with sedative-relaxant and general anesthesia agents | Indication |
| Product | Applicant | Ingredients |
|---|---|---|
| Chloropent | Zoetis Inc. | 3 |
None
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.225GM;0.188GM;1.479GM | SUTAB | AZURITY | N213135 | Nov. 10, 2020 | RX | TABLET | ORAL | 11033498 | Aug. 4, 2037 | GASTROINTESTINAL TABLETS INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY |
| 0.225GM;0.188GM;1.479GM | SUTAB | AZURITY | N213135 | Nov. 10, 2020 | RX | TABLET | ORAL | 11382864 | Aug. 4, 2037 | GASTROINTESTINAL TABLETS INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY |
| 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT | SUFLAVE | AZURITY | N215344 | June 15, 2023 | RX | FOR SOLUTION | ORAL | 12239659 | June 14, 2044 | GASTROINTESTINAL FLAVORED SOLUTION INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY |
| 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT | SUFLAVE | AZURITY | N215344 | June 15, 2023 | RX | FOR SOLUTION | ORAL | 12433914 | June 14, 2044 | GASTROINTESTINAL FLAVORED SOLUTION INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1GM/2ML (500MG/ML) | MAGNESIUM SULFATE | ASPIRO | A219777 | May 28, 2025 | RX | SOLUTION | INTRAMUSCULAR, INTRAVENOUS | Feb. 1, 2026 | COMPETITIVE GENERIC THERAPY |
| 25GM/50ML (500MG/ML) | MAGNESIUM SULFATE | ASPIRO | A219777 | May 28, 2025 | RX | SOLUTION | INTRAMUSCULAR, INTRAVENOUS | Feb. 1, 2026 | COMPETITIVE GENERIC THERAPY |
| 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT | SUFLAVE | AZURITY | N215344 | June 15, 2023 | RX | FOR SOLUTION | ORAL | June 15, 2026 | NEW PRODUCT |
| 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SUPREP BOWEL PREP KIT | AZURITY | N022372 | Aug. 5, 2010 | RX | SOLUTION | ORAL | Aug. 5, 2027 | FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
None
| ID | Source |
|---|---|
| 4019181 | VUID |
| N0000147424 | NUI |
| 10034-99-8 | SECONDARY_CAS_RN |
| 4000969 | VANDF |
| 4017468 | VANDF |
| 4017680 | VANDF |
| 4019181 | VANDF |
| C0024480 | UMLSCUI |
| CHEBI:32599 | CHEBI |
| CHEMBL3989857 | ChEMBL_ID |
| D008278 | MESH_DESCRIPTOR_UI |
| DB00653 | DRUGBANK_ID |
| 24083 | PUBCHEM_CID |
| 1053346 | RXNORM |
| 173828 | MMSL |
| 173829 | MMSL |
| 26390 | MMSL |
| 36335 | MMSL |
| 5017 | MMSL |
| 5259 | MMSL |
| 6287 | MMSL |
| 7114 | MMSL |
| d00468 | MMSL |
| 000789 | NDDF |
| 001184 | NDDF |
| 003022 | NDDF |
| 006708 | NDDF |
| 1269139001 | SNOMEDCT_US |
| 37400007 | SNOMEDCT_US |
| 387202002 | SNOMEDCT_US |
| 725797001 | SNOMEDCT_US |
| CHEMBL2021423 | ChEMBL_ID |
| SK47B8698T | UNII |
| SK47B8698T | INXIGHT DRUGS |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Magnesium Sulfate in Water | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0264-4204 | INJECTION, SOLUTION | 2 g | INTRAVENOUS | ANDA | 21 sections |
| Magnesium Sulfate in Water | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0264-4205 | INJECTION, SOLUTION | 4 g | INTRAVENOUS | ANDA | 21 sections |
| Magnesium Sulfate in Water | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0264-4206 | INJECTION, SOLUTION | 4 g | INTRAVENOUS | ANDA | 21 sections |
| Magnesium Sulfate in Dextrose | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0264-4400 | INJECTION, SOLUTION | 10 mg | INTRAVENOUS | ANDA | 26 sections |
| Magnesium Sulfate in Dextrose | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0264-4400 | INJECTION, SOLUTION | 10 mg | INTRAVENOUS | ANDA | 26 sections |
| TIS-U-SOL | HUMAN PRESCRIPTION DRUG LABEL | 5 | 0338-0190 | IRRIGANT | 20 mg | IRRIGATION | NDA | 5 sections |
| TIS-U-SOL | HUMAN PRESCRIPTION DRUG LABEL | 5 | 0338-0190 | IRRIGANT | 20 mg | IRRIGATION | NDA | 5 sections |
| Magnesium Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0338-1708 | INJECTION, SOLUTION | 2 g | INTRAVENOUS | ANDA | 20 sections |
| MAGNESIUM SULFATE IN DEXTROSE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0338-1709 | INJECTION, SOLUTION | 10 mg | INTRAVENOUS | ANDA | 23 sections |
| Magnesium Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0338-1715 | INJECTION, SOLUTION | 4 g | INTRAVENOUS | ANDA | 20 sections |
| Magnesium Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0338-1719 | INJECTION, SOLUTION | 4 g | INTRAVENOUS | ANDA | 20 sections |
| Magnesium Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0338-6353 | INJECTION, SOLUTION | 3 g | INTRAVENOUS | ANDA | 20 sections |
| Epsom Salt | HUMAN OTC DRUG LABEL | 1 | 0363-0395 | GRANULE | 1 g | ORAL | OTC Monograph Drug | 15 sections |
| Epsom Salt | HUMAN OTC DRUG LABEL | 1 | 0363-0942 | GRANULE, FOR SOLUTION | 1 g | ORAL | OTC Monograph Drug | 15 sections |
| Humco Epson Salt | HUMAN OTC DRUG LABEL | 1 | 0395-0807 | POWDER, FOR SOLUTION | 1000 mg | ORAL | OTC Monograph Drug | 10 sections |
| Magnesium Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9902 | INJECTION, SOLUTION | 500 mg | INTRAVENOUS | NDA | 12 sections |
| Magnesium Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9902 | INJECTION, SOLUTION | 500 mg | INTRAVENOUS | NDA | 12 sections |
| Magnesium Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9903 | INJECTION, SOLUTION | 500 mg | INTRAMUSCULAR | ANDA | 12 sections |
| Magnesium Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9903 | INJECTION, SOLUTION | 500 mg | INTRAMUSCULAR | ANDA | 12 sections |
| Magnesium Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9904 | INJECTION, SOLUTION | 500 mg | INTRAMUSCULAR | NDA | 12 sections |
| Magnesium Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9904 | INJECTION, SOLUTION | 500 mg | INTRAMUSCULAR | NDA | 12 sections |
| Magnesium Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1754 | INJECTION, SOLUTION | 500 mg | INTRAVENOUS | ANDA | 13 sections |
| Magnesium Sulfate in Water | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-2050 | INJECTION, SOLUTION | 20 g | INTRAVENOUS | NDA | 19 sections |
| Magnesium Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-2168 | INJECTION, SOLUTION | 500 mg | INTRAVENOUS | ANDA | 22 sections |
| Magnesium Sulfate in Water | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-3164 | INJECTION, SOLUTION | 40 g | INTRAVENOUS | NDA | 19 sections |
| Magnesium Sulfate in Water | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-4121 | INJECTION, SOLUTION | 4 g | INTRAVENOUS | NDA | 19 sections |
| Magnesium Sulfate in Water | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-5239 | INJECTION, SOLUTION | 2 g | INTRAVENOUS | NDA | 19 sections |
| Magnesium Sulfate in Dextrose | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-6727 | INJECTION, SOLUTION | 10 mg | INTRAVENOUS | NDA | 26 sections |
| Magnesium Sulfate in Water | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-6729 | INJECTION, SOLUTION | 40 mg | INTRAVENOUS | NDA | 19 sections |
| Magnesium Sulfate in Water | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-6730 | INJECTION, SOLUTION | 80 mg | INTRAVENOUS | NDA | 19 sections |