| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5368 | None |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Botulinum toxin type A (Clostridium botulinum neurotoxin) blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within the nerve endings, thereby leading to denervation of the muscle and a flaccid paralysis.
|
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 27, 2019 | EMA | Evolus Pharma Limited | |
| Dec. 20, 2019 | PMDA | GlaxoSmithKline K.K. |
| 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 | 22639.14 | 18.99 | 14864 | 71125 | 1029901 | 62373132 |
| Product preparation error | 10598.38 | 18.99 | 2284 | 83705 | 3808 | 63399225 |
| Therapeutic response decreased | 7341.80 | 18.99 | 2849 | 83140 | 58676 | 63344357 |
| Multiple use of single-use product | 5593.14 | 18.99 | 1061 | 84928 | 431 | 63402602 |
| Eyelid ptosis | 5556.71 | 18.99 | 1399 | 84590 | 5868 | 63397165 |
| Off label use | 5001.78 | 18.99 | 5275 | 80714 | 669187 | 62733846 |
| Wrong technique in product usage process | 4496.50 | 18.99 | 2019 | 83970 | 60321 | 63342712 |
| Injection site pain | 2818.14 | 18.99 | 1901 | 84088 | 127899 | 63275134 |
| Facial paresis | 1564.12 | 18.99 | 441 | 85548 | 3057 | 63399976 |
| Brow ptosis | 1223.71 | 18.99 | 231 | 85758 | 84 | 63402949 |
| Product preparation issue | 1200.71 | 18.99 | 293 | 85696 | 1039 | 63401994 |
| Injection site swelling | 1063.04 | 18.99 | 711 | 85278 | 46861 | 63356172 |
| Poor quality product administered | 1061.55 | 18.99 | 319 | 85670 | 2837 | 63400196 |
| Drug ineffective for unapproved indication | 870.66 | 18.99 | 554 | 85435 | 33509 | 63369524 |
| Swelling face | 764.96 | 18.99 | 656 | 85333 | 62819 | 63340214 |
| Dysphagia | 761.63 | 18.99 | 758 | 85231 | 87827 | 63315206 |
| Therapeutic response shortened | 725.97 | 18.99 | 344 | 85645 | 11544 | 63391489 |
| Product storage error | 705.54 | 18.99 | 363 | 85626 | 14593 | 63388440 |
| Eye swelling | 658.80 | 18.99 | 408 | 85581 | 23510 | 63379523 |
| Botulism | 578.94 | 18.99 | 115 | 85874 | 89 | 63402944 |
| Muscular weakness | 565.30 | 18.99 | 760 | 85229 | 121593 | 63281440 |
| Eyelid oedema | 499.00 | 18.99 | 256 | 85733 | 10223 | 63392810 |
| Vision blurred | 463.09 | 18.99 | 596 | 85393 | 91328 | 63311705 |
| Facial asymmetry | 417.24 | 18.99 | 114 | 85875 | 691 | 63402342 |
| Facial paralysis | 397.96 | 18.99 | 244 | 85745 | 13797 | 63389236 |
| Diarrhoea | 347.85 | 18.99 | 277 | 85712 | 715089 | 62687944 |
| Diplopia | 326.53 | 18.99 | 265 | 85724 | 23463 | 63379570 |
| Neuromuscular toxicity | 325.31 | 18.99 | 68 | 85921 | 87 | 63402946 |
| Arthralgia | 322.99 | 18.99 | 186 | 85803 | 569524 | 62833509 |
| Neck pain | 318.89 | 18.99 | 430 | 85559 | 68888 | 63334145 |
| Anaemia | 315.50 | 18.99 | 21 | 85968 | 293409 | 63109624 |
| Headache | 314.60 | 18.99 | 1685 | 84304 | 631556 | 62771477 |
| Injection site rash | 312.88 | 18.99 | 235 | 85754 | 18574 | 63384459 |
| Migraine | 311.19 | 18.99 | 526 | 85463 | 102820 | 63300213 |
| Joint swelling | 283.35 | 18.99 | 51 | 85938 | 327615 | 63075418 |
| Acute kidney injury | 276.94 | 18.99 | 21 | 85968 | 263394 | 63139639 |
| Influenza like illness | 266.33 | 18.99 | 387 | 85602 | 66437 | 63336596 |
| Pneumonia | 260.25 | 18.99 | 148 | 85841 | 456619 | 62946414 |
| Skin tightness | 248.54 | 18.99 | 120 | 85869 | 4196 | 63398837 |
| Periorbital swelling | 246.67 | 18.99 | 106 | 85883 | 2812 | 63400221 |
| Incorrect route of product administration | 244.98 | 18.99 | 240 | 85749 | 27212 | 63375821 |
| Injection site erythema | 243.27 | 18.99 | 418 | 85571 | 82756 | 63320277 |
| Abdominal discomfort | 235.74 | 18.99 | 71 | 85918 | 320814 | 63082219 |
| Product quality issue | 233.45 | 18.99 | 265 | 85724 | 35600 | 63367433 |
| Blepharospasm | 233.18 | 18.99 | 128 | 85861 | 5868 | 63397165 |
| Contraindicated product administered | 229.73 | 18.99 | 17 | 85972 | 217631 | 63185402 |
| Arthropathy | 227.40 | 18.99 | 26 | 85963 | 234766 | 63168267 |
| Infusion related reaction | 223.82 | 18.99 | 33 | 85956 | 245488 | 63157545 |
| Facial pain | 219.28 | 18.99 | 151 | 85838 | 10410 | 63392623 |
| Toxicity to various agents | 219.11 | 18.99 | 36 | 85953 | 247214 | 63155819 |
| Synovitis | 214.48 | 18.99 | 9 | 85980 | 186909 | 63216124 |
| Pemphigus | 213.68 | 18.99 | 8 | 85981 | 183718 | 63219315 |
| Rheumatoid arthritis | 211.91 | 18.99 | 43 | 85946 | 253776 | 63149257 |
| Injection site mass | 210.72 | 18.99 | 186 | 85803 | 18470 | 63384563 |
| Systemic lupus erythematosus | 210.37 | 18.99 | 20 | 85969 | 208898 | 63194135 |
| Neutropenia | 209.28 | 18.99 | 6 | 85983 | 174999 | 63228034 |
| Hepatic enzyme increased | 202.06 | 18.99 | 20 | 85969 | 202308 | 63200725 |
| Maternal exposure during pregnancy | 195.05 | 18.99 | 32 | 85957 | 220030 | 63183003 |
| Thrombocytopenia | 189.29 | 18.99 | 3 | 85986 | 151154 | 63251879 |
| Lagophthalmos | 185.28 | 18.99 | 51 | 85938 | 319 | 63402714 |
| Drug interaction | 184.75 | 18.99 | 42 | 85947 | 229089 | 63173944 |
| Hypotension | 183.33 | 18.99 | 70 | 85919 | 272534 | 63130499 |
| Eyelid sensory disorder | 181.22 | 18.99 | 39 | 85950 | 63 | 63402970 |
| Glossodynia | 180.40 | 18.99 | 17 | 85972 | 178859 | 63224174 |
| Hand deformity | 178.62 | 18.99 | 9 | 85980 | 159448 | 63243585 |
| Product administered at inappropriate site | 176.64 | 18.99 | 86 | 85903 | 3063 | 63399970 |
| Hypoaesthesia | 175.38 | 18.99 | 564 | 85425 | 167829 | 63235204 |
| General physical health deterioration | 172.54 | 18.99 | 32 | 85957 | 201370 | 63201663 |
| Injection site nodule | 171.94 | 18.99 | 90 | 85899 | 3745 | 63399288 |
| Completed suicide | 170.55 | 18.99 | 6 | 85983 | 145667 | 63257366 |
| Drug hypersensitivity | 165.12 | 18.99 | 109 | 85880 | 310578 | 63092455 |
| Swelling of eyelid | 161.59 | 18.99 | 81 | 85908 | 3075 | 63399958 |
| Wound | 158.21 | 18.99 | 18 | 85971 | 163245 | 63239788 |
| Dysphonia | 157.52 | 18.99 | 253 | 85736 | 47361 | 63355672 |
| Peripheral swelling | 155.81 | 18.99 | 83 | 85906 | 265859 | 63137174 |
| Fall | 155.08 | 18.99 | 182 | 85807 | 392152 | 63010881 |
| Condition aggravated | 151.18 | 18.99 | 194 | 85795 | 402023 | 63001010 |
| Oedema peripheral | 148.29 | 18.99 | 37 | 85952 | 189474 | 63213559 |
| Sepsis | 148.08 | 18.99 | 17 | 85972 | 153106 | 63249927 |
| Pericarditis | 145.55 | 18.99 | 8 | 85981 | 131571 | 63271462 |
| Drug effect less than expected | 144.89 | 18.99 | 62 | 85927 | 1627 | 63401406 |
| Infection | 142.56 | 18.99 | 66 | 85923 | 229107 | 63173926 |
| Abdominal pain | 137.83 | 18.99 | 117 | 85872 | 293339 | 63109694 |
| Nasopharyngitis | 136.68 | 18.99 | 88 | 85901 | 254169 | 63148864 |
| Pyrexia | 135.30 | 18.99 | 271 | 85718 | 470207 | 62932826 |
| Product distribution issue | 134.89 | 18.99 | 56 | 85933 | 1360 | 63401673 |
| Muscle twitching | 134.24 | 18.99 | 149 | 85840 | 19519 | 63383514 |
| Disease progression | 128.30 | 18.99 | 10 | 85979 | 122748 | 63280285 |
| Death | 125.32 | 18.99 | 196 | 85793 | 374185 | 63028848 |
| Haemoglobin decreased | 124.82 | 18.99 | 23 | 85966 | 145462 | 63257571 |
| Renal failure | 124.61 | 18.99 | 9 | 85980 | 117643 | 63285390 |
| Anti-cyclic citrullinated peptide antibody positive | 122.77 | 18.99 | 9 | 85980 | 116203 | 63286830 |
| Asthenopia | 122.66 | 18.99 | 61 | 85928 | 2276 | 63400757 |
| Alopecia | 120.47 | 18.99 | 169 | 85820 | 337367 | 63065666 |
| Fatigue | 119.93 | 18.99 | 710 | 85279 | 887318 | 62515715 |
| Injection site urticaria | 119.91 | 18.99 | 120 | 85869 | 13953 | 63389080 |
| Periorbital oedema | 119.72 | 18.99 | 82 | 85907 | 5602 | 63397431 |
| Treatment failure | 119.69 | 18.99 | 60 | 85929 | 198983 | 63204050 |
| Confusional state | 117.53 | 18.99 | 89 | 85900 | 236291 | 63166742 |
| Muscle tightness | 117.43 | 18.99 | 110 | 85879 | 11790 | 63391243 |
| Head discomfort | 117.27 | 18.99 | 116 | 85873 | 13299 | 63389734 |
| Facial discomfort | 113.27 | 18.99 | 26 | 85963 | 65 | 63402968 |
| Injection site bruising | 112.58 | 18.99 | 203 | 85786 | 41707 | 63361326 |
| Platelet count decreased | 111.99 | 18.99 | 13 | 85976 | 116109 | 63286924 |
| Hyponatraemia | 111.82 | 18.99 | 11 | 85978 | 111889 | 63291144 |
| Weight increased | 111.77 | 18.99 | 113 | 85876 | 260679 | 63142354 |
| Pain in extremity | 111.43 | 18.99 | 173 | 85816 | 331313 | 63071720 |
| Stomatitis | 110.62 | 18.99 | 26 | 85963 | 138699 | 63264334 |
| Lower respiratory tract infection | 107.09 | 18.99 | 24 | 85965 | 132283 | 63270750 |
| Decreased appetite | 106.19 | 18.99 | 110 | 85879 | 250942 | 63152091 |
| Eye pain | 105.34 | 18.99 | 175 | 85814 | 33679 | 63369354 |
| Incorrect dose administered | 104.68 | 18.99 | 243 | 85746 | 59725 | 63343308 |
| Hypertension | 104.53 | 18.99 | 135 | 85854 | 279168 | 63123865 |
| Hypokalaemia | 104.26 | 18.99 | 10 | 85979 | 103794 | 63299239 |
| Lacrimation increased | 104.08 | 18.99 | 134 | 85855 | 20497 | 63382536 |
| Injection site paraesthesia | 103.10 | 18.99 | 36 | 85953 | 534 | 63402499 |
| Helicobacter infection | 101.50 | 18.99 | 6 | 85983 | 92779 | 63310254 |
| Rheumatoid factor positive | 100.47 | 18.99 | 3 | 85986 | 84403 | 63318630 |
| Impaired healing | 100.08 | 18.99 | 11 | 85978 | 102531 | 63300502 |
| Hypoaesthesia oral | 99.92 | 18.99 | 105 | 85884 | 12928 | 63390105 |
| Pleural effusion | 99.08 | 18.99 | 7 | 85982 | 93203 | 63309830 |
| Dry eye | 98.91 | 18.99 | 189 | 85800 | 40572 | 63362461 |
| Renal impairment | 98.87 | 18.99 | 5 | 85984 | 88350 | 63314683 |
| Injection site oedema | 98.44 | 18.99 | 45 | 85944 | 1387 | 63401646 |
| Blood creatinine increased | 98.20 | 18.99 | 5 | 85984 | 87839 | 63315194 |
| Burning sensation | 97.75 | 18.99 | 223 | 85766 | 54184 | 63348849 |
| Overdose | 96.64 | 18.99 | 359 | 85630 | 114719 | 63288314 |
| Gastrointestinal disorder | 96.30 | 18.99 | 29 | 85960 | 131210 | 63271823 |
| Gastrointestinal haemorrhage | 96.21 | 18.99 | 3 | 85986 | 81173 | 63321860 |
| Vomiting | 94.88 | 18.99 | 413 | 85576 | 559204 | 62843829 |
| Atrial fibrillation | 94.70 | 18.99 | 21 | 85968 | 116615 | 63286418 |
| Duodenal ulcer perforation | 94.31 | 18.99 | 6 | 85983 | 87203 | 63315830 |
| Paraesthesia | 93.68 | 18.99 | 441 | 85548 | 156525 | 63246508 |
| White blood cell count decreased | 92.96 | 18.99 | 36 | 85953 | 139068 | 63263965 |
| Alanine aminotransferase increased | 92.08 | 18.99 | 15 | 85974 | 103755 | 63299278 |
| Aspartate aminotransferase increased | 89.86 | 18.99 | 9 | 85980 | 90268 | 63312765 |
| Speech disorder | 88.44 | 18.99 | 180 | 85809 | 40449 | 63362584 |
| Cardiac failure | 88.44 | 18.99 | 9 | 85980 | 89133 | 63313900 |
| Cough | 88.03 | 18.99 | 164 | 85825 | 292579 | 63110454 |
| Product dose omission issue | 87.91 | 18.99 | 113 | 85876 | 234200 | 63168833 |
| Inappropriate schedule of product administration | 86.17 | 18.99 | 323 | 85666 | 103642 | 63299391 |
| Pulmonary embolism | 85.21 | 18.99 | 26 | 85963 | 116658 | 63286375 |
| Cardiac failure congestive | 85.13 | 18.99 | 12 | 85977 | 92421 | 63310612 |
| Injection site hypoaesthesia | 84.59 | 18.99 | 30 | 85959 | 467 | 63402566 |
| Dehydration | 82.69 | 18.99 | 68 | 85921 | 173286 | 63229747 |
| Facial spasm | 81.61 | 18.99 | 32 | 85957 | 667 | 63402366 |
| Bronchitis | 80.76 | 18.99 | 34 | 85955 | 124901 | 63278132 |
| Intentional overdose | 80.48 | 18.99 | 5 | 85984 | 74147 | 63328886 |
| Neuropathy peripheral | 80.04 | 18.99 | 27 | 85962 | 113640 | 63289393 |
| Sinusitis | 78.30 | 18.99 | 116 | 85873 | 226537 | 63176496 |
| Lid sulcus deepened | 76.44 | 18.99 | 19 | 85970 | 74 | 63402959 |
| Drug abuse | 75.50 | 18.99 | 6 | 85983 | 72512 | 63330521 |
| Exposure during pregnancy | 75.45 | 18.99 | 60 | 85929 | 155487 | 63247546 |
| Blister | 75.23 | 18.99 | 41 | 85948 | 129773 | 63273260 |
| Cardiac arrest | 74.45 | 18.99 | 17 | 85972 | 92528 | 63310505 |
| Product packaging issue | 73.90 | 18.99 | 35 | 85954 | 1171 | 63401862 |
| Myocardial infarction | 73.41 | 18.99 | 22 | 85967 | 99871 | 63303162 |
| Injection site discomfort | 72.89 | 18.99 | 56 | 85933 | 4574 | 63398459 |
| Neovascularisation | 72.54 | 18.99 | 34 | 85955 | 1111 | 63401922 |
| Back pain | 71.69 | 18.99 | 157 | 85832 | 263988 | 63139045 |
| Folliculitis | 70.01 | 18.99 | 7 | 85982 | 70310 | 63332723 |
| Psoriatic arthropathy | 69.38 | 18.99 | 19 | 85970 | 91501 | 63311532 |
| Leukopenia | 68.95 | 18.99 | 11 | 85978 | 77279 | 63325754 |
| Blood cholesterol increased | 68.57 | 18.99 | 21 | 85968 | 94011 | 63309022 |
| Pain | 67.93 | 18.99 | 659 | 85330 | 739969 | 62663064 |
| Product use issue | 67.62 | 18.99 | 122 | 85867 | 220398 | 63182635 |
| Ophthalmoplegia | 67.47 | 18.99 | 35 | 85954 | 1429 | 63401604 |
| Deep vein thrombosis | 66.21 | 18.99 | 16 | 85973 | 83784 | 63319249 |
| Blood glucose increased | 66.16 | 18.99 | 16 | 85973 | 83740 | 63319293 |
| Coma | 65.16 | 18.99 | 6 | 85983 | 64358 | 63338675 |
| Paralysis | 64.13 | 18.99 | 73 | 85916 | 9827 | 63393206 |
| Injection site pruritus | 64.10 | 18.99 | 169 | 85820 | 44947 | 63358086 |
| Urinary tract infection | 63.37 | 18.99 | 168 | 85821 | 264516 | 63138517 |
| Respiratory failure | 62.25 | 18.99 | 30 | 85959 | 101828 | 63301205 |
| Hypoxia | 62.09 | 18.99 | 5 | 85984 | 59787 | 63343246 |
| Type 2 diabetes mellitus | 61.94 | 18.99 | 7 | 85982 | 63861 | 63339172 |
| Injection site granuloma | 61.87 | 18.99 | 14 | 85975 | 32 | 63403001 |
| Injection site indentation | 61.66 | 18.99 | 19 | 85970 | 185 | 63402848 |
| Product reconstitution quality issue | 61.06 | 18.99 | 15 | 85974 | 55 | 63402978 |
| C-reactive protein increased | 60.83 | 18.99 | 26 | 85963 | 94681 | 63308352 |
| Irritable bowel syndrome | 60.82 | 18.99 | 18 | 85971 | 82394 | 63320639 |
| Suicide attempt | 60.81 | 18.99 | 6 | 85983 | 60912 | 63342121 |
| Mastication disorder | 60.68 | 18.99 | 37 | 85952 | 2069 | 63400964 |
| Nausea | 60.44 | 18.99 | 806 | 85183 | 853665 | 62549368 |
| Product temperature excursion issue | 60.42 | 18.99 | 19 | 85970 | 199 | 63402834 |
| Eyelid pain | 60.17 | 18.99 | 21 | 85968 | 311 | 63402722 |
| Ill-defined disorder | 60.08 | 18.99 | 18 | 85971 | 81737 | 63321296 |
| Suspected product quality issue | 59.83 | 18.99 | 19 | 85970 | 206 | 63402827 |
| Hypoglycaemia | 59.74 | 18.99 | 6 | 85983 | 60059 | 63342974 |
| Patient dissatisfaction with treatment | 59.27 | 18.99 | 16 | 85973 | 92 | 63402941 |
| Photophobia | 58.70 | 18.99 | 94 | 85895 | 17541 | 63385492 |
| Taste disorder | 58.61 | 18.99 | 82 | 85907 | 13580 | 63389453 |
| Mobility decreased | 58.41 | 18.99 | 47 | 85942 | 121112 | 63281921 |
| Septic shock | 58.28 | 18.99 | 10 | 85979 | 66619 | 63336414 |
| Neutrophil count decreased | 57.79 | 18.99 | 5 | 85984 | 56401 | 63346632 |
| Ocular discomfort | 57.63 | 18.99 | 47 | 85942 | 4186 | 63398847 |
| Oxygen saturation decreased | 55.82 | 18.99 | 25 | 85964 | 88560 | 63314473 |
| Multiple organ dysfunction syndrome | 55.59 | 18.99 | 6 | 85983 | 56746 | 63346287 |
| Erythema of eyelid | 55.42 | 18.99 | 36 | 85953 | 2250 | 63400783 |
| Liver injury | 55.39 | 18.99 | 8 | 85981 | 60512 | 63342521 |
| Skin wrinkling | 55.18 | 18.99 | 28 | 85961 | 1091 | 63401942 |
| Injection site haemorrhage | 54.43 | 18.99 | 109 | 85880 | 24205 | 63378828 |
| Abnormal sensation in eye | 53.68 | 18.99 | 32 | 85957 | 1717 | 63401316 |
| Chronic obstructive pulmonary disease | 53.55 | 18.99 | 10 | 85979 | 62676 | 63340357 |
| Pulmonary oedema | 53.25 | 18.99 | 6 | 85983 | 54867 | 63348166 |
| Liver function test abnormal | 53.04 | 18.99 | 3 | 85986 | 48178 | 63354855 |
| Constipation | 52.90 | 18.99 | 144 | 85845 | 224799 | 63178234 |
| Throat tightness | 52.67 | 18.99 | 109 | 85880 | 24778 | 63378255 |
| Bradycardia | 52.23 | 18.99 | 17 | 85972 | 73210 | 63329823 |
| Drug intolerance | 52.03 | 18.99 | 228 | 85761 | 308433 | 63094600 |
| Electrocardiogram QT prolonged | 51.92 | 18.99 | 9 | 85980 | 59521 | 63343512 |
| Haematochezia | 51.59 | 18.99 | 6 | 85983 | 53538 | 63349495 |
| Mucosal inflammation | 51.42 | 18.99 | 3 | 85986 | 46925 | 63356108 |
| Intentional product misuse | 51.06 | 18.99 | 190 | 85799 | 60727 | 63342306 |
| Skin indentation | 50.93 | 18.99 | 12 | 85977 | 35 | 63402998 |
| International normalised ratio increased | 50.77 | 18.99 | 3 | 85986 | 46422 | 63356611 |
| Muscle injury | 50.60 | 18.99 | 13 | 85976 | 65332 | 63337701 |
| Accidental exposure to product | 48.85 | 18.99 | 112 | 85877 | 27293 | 63375740 |
| Lip disorder | 47.95 | 18.99 | 28 | 85961 | 1446 | 63401587 |
| Wheezing | 47.45 | 18.99 | 36 | 85953 | 95559 | 63307474 |
| Urticaria | 47.26 | 18.99 | 385 | 85604 | 165417 | 63237616 |
| Injury | 47.21 | 18.99 | 20 | 85969 | 73227 | 63329806 |
| Osteoporosis | 47.19 | 18.99 | 10 | 85979 | 57328 | 63345705 |
| Liver disorder | 47.08 | 18.99 | 8 | 85981 | 53679 | 63349354 |
| Strabismus | 47.08 | 18.99 | 31 | 85958 | 1983 | 63401050 |
| Injection site inflammation | 46.78 | 18.99 | 40 | 85949 | 3803 | 63399230 |
| Eye discharge | 46.75 | 18.99 | 49 | 85940 | 6014 | 63397019 |
| Cardio-respiratory arrest | 46.29 | 18.99 | 12 | 85977 | 59947 | 63343086 |
| Muscle atrophy | 45.79 | 18.99 | 52 | 85937 | 6981 | 63396052 |
| Knee arthroplasty | 45.55 | 18.99 | 9 | 85980 | 54197 | 63348836 |
| Delirium | 45.51 | 18.99 | 7 | 85982 | 50534 | 63352499 |
| Lip swelling | 44.77 | 18.99 | 117 | 85872 | 30946 | 63372087 |
| Endometriosis | 44.65 | 18.99 | 45 | 85944 | 5275 | 63397758 |
| Nerve injury | 44.62 | 18.99 | 61 | 85928 | 9885 | 63393148 |
| Oedema | 44.45 | 18.99 | 40 | 85949 | 97582 | 63305451 |
| Hip arthroplasty | 44.30 | 18.99 | 6 | 85983 | 47640 | 63355393 |
| Fluid retention | 44.11 | 18.99 | 13 | 85976 | 59673 | 63343360 |
| Ocular hyperaemia | 43.98 | 18.99 | 102 | 85887 | 25042 | 63377991 |
| Vertigo | 43.86 | 18.99 | 179 | 85810 | 59708 | 63343325 |
| Abdominal distension | 43.78 | 18.99 | 32 | 85957 | 86583 | 63316450 |
| Osteoarthritis | 43.49 | 18.99 | 39 | 85950 | 95304 | 63307729 |
| Lung disorder | 43.45 | 18.99 | 15 | 85974 | 62246 | 63340787 |
| Arthritis | 43.33 | 18.99 | 56 | 85933 | 115865 | 63287168 |
| Chest pain | 43.11 | 18.99 | 149 | 85840 | 215810 | 63187223 |
| Manufacturing product shipping issue | 43.07 | 18.99 | 12 | 85977 | 79 | 63402954 |
| Blood pressure systolic increased | 41.70 | 18.99 | 7 | 85982 | 47390 | 63355643 |
| Colitis | 40.90 | 18.99 | 8 | 85981 | 48520 | 63354513 |
| Choking | 40.46 | 18.99 | 58 | 85931 | 9821 | 63393212 |
| Blood pressure increased | 40.18 | 18.99 | 101 | 85888 | 161961 | 63241072 |
| Epilepsy | 40.10 | 18.99 | 103 | 85886 | 26962 | 63376071 |
| Muscle contractions involuntary | 40.02 | 18.99 | 30 | 85959 | 2362 | 63400671 |
| Thrombosis | 39.67 | 18.99 | 19 | 85970 | 64736 | 63338297 |
| Central nervous system function test abnormal | 39.65 | 18.99 | 9 | 85980 | 21 | 63403012 |
| Madarosis | 39.42 | 18.99 | 33 | 85956 | 3048 | 63399985 |
| Pregnancy | 38.82 | 18.99 | 124 | 85865 | 36712 | 63366321 |
| Red blood cell count decreased | 38.07 | 18.99 | 5 | 85984 | 40640 | 63362393 |
| Diabetes mellitus | 38.00 | 18.99 | 14 | 85975 | 55796 | 63347237 |
| Epistaxis | 37.90 | 18.99 | 26 | 85963 | 72699 | 63330334 |
| Red blood cell sedimentation rate increased | 37.60 | 18.99 | 7 | 85982 | 43975 | 63359058 |
| Pancreatitis | 37.52 | 18.99 | 10 | 85979 | 49045 | 63353988 |
| Rectal haemorrhage | 37.49 | 18.99 | 10 | 85979 | 49020 | 63354013 |
| Plasma cell myeloma | 37.29 | 18.99 | 3 | 85986 | 35902 | 63367131 |
| Pulmonary fibrosis | 37.04 | 18.99 | 5 | 85984 | 39804 | 63363229 |
| Hepatitis | 37.02 | 18.99 | 5 | 85984 | 39783 | 63363250 |
| White blood cell count increased | 36.95 | 18.99 | 10 | 85979 | 48551 | 63354482 |
| Post-traumatic neck syndrome | 36.91 | 18.99 | 27 | 85962 | 2047 | 63400986 |
| Fibromyalgia | 36.55 | 18.99 | 33 | 85956 | 80387 | 63322646 |
| Pneumonitis | 36.42 | 18.99 | 3 | 85986 | 35219 | 63367814 |
| Eye irritation | 36.11 | 18.99 | 87 | 85902 | 21884 | 63381149 |
| Cataract | 36.10 | 18.99 | 16 | 85973 | 57037 | 63345996 |
| Drug specific antibody | 36.02 | 18.99 | 28 | 85961 | 2327 | 63400706 |
| Rhabdomyolysis | 35.49 | 18.99 | 8 | 85981 | 43943 | 63359090 |
| Erythema | 35.43 | 18.99 | 379 | 85610 | 175372 | 63227661 |
| Eyelid disorder | 35.03 | 18.99 | 25 | 85964 | 1824 | 63401209 |
| Femur fracture | 34.94 | 18.99 | 7 | 85982 | 41749 | 63361284 |
| Dermatochalasis | 34.92 | 18.99 | 7 | 85982 | 6 | 63403027 |
| Gamma-glutamyltransferase increased | 34.91 | 18.99 | 3 | 85986 | 34028 | 63369005 |
| Libido increased | 34.63 | 18.99 | 22 | 85967 | 1323 | 63401710 |
| Hypoaesthesia eye | 34.59 | 18.99 | 14 | 85975 | 318 | 63402715 |
| Agitation | 34.42 | 18.99 | 19 | 85970 | 59738 | 63343295 |
| Hepatic failure | 34.34 | 18.99 | 4 | 85985 | 35652 | 63367381 |
| Blood alkaline phosphatase increased | 34.33 | 18.99 | 8 | 85981 | 42959 | 63360074 |
| Eyelid function disorder | 34.17 | 18.99 | 13 | 85976 | 249 | 63402784 |
| Treatment noncompliance | 34.00 | 18.99 | 5 | 85984 | 37320 | 63365713 |
| Depressed level of consciousness | 33.97 | 18.99 | 21 | 85968 | 62057 | 63340976 |
| Malaise | 33.93 | 18.99 | 380 | 85609 | 415574 | 62987459 |
| Blood bilirubin increased | 33.77 | 18.99 | 5 | 85984 | 37135 | 63365898 |
| Dyspnoea exertional | 33.56 | 18.99 | 20 | 85969 | 60282 | 63342751 |
| Hospitalisation | 32.94 | 18.99 | 40 | 85949 | 85041 | 63317992 |
| Rash | 32.94 | 18.99 | 548 | 85441 | 560323 | 62842710 |
| Soft tissue injury | 32.83 | 18.99 | 23 | 85966 | 1629 | 63401404 |
| Paradoxical drug reaction | 32.81 | 18.99 | 34 | 85955 | 4118 | 63398915 |
| Visual impairment | 32.64 | 18.99 | 211 | 85778 | 84235 | 63318798 |
| Adverse drug reaction | 32.46 | 18.99 | 36 | 85953 | 79678 | 63323355 |
| Cutis laxa | 32.28 | 18.99 | 11 | 85978 | 151 | 63402882 |
| Haematocrit decreased | 32.09 | 18.99 | 7 | 85982 | 39333 | 63363700 |
| Full blood count abnormal | 31.98 | 18.99 | 3 | 85986 | 31714 | 63371319 |
| Eye pruritus | 31.84 | 18.99 | 75 | 85914 | 18596 | 63384437 |
| Tension headache | 31.51 | 18.99 | 37 | 85952 | 5149 | 63397884 |
| Encephalopathy | 31.24 | 18.99 | 7 | 85982 | 38613 | 63364420 |
| Application site acne | 31.21 | 18.99 | 6 | 85983 | 3 | 63403030 |
| Eyelid thickening | 31.11 | 18.99 | 9 | 85980 | 69 | 63402964 |
| Injection site anaesthesia | 31.08 | 18.99 | 8 | 85981 | 37 | 63402996 |
| Feeling abnormal | 30.84 | 18.99 | 322 | 85667 | 148070 | 63254963 |
| Liver function test increased | 30.82 | 18.99 | 4 | 85985 | 32807 | 63370226 |
| Skin ulcer | 30.68 | 18.99 | 10 | 85979 | 43035 | 63359998 |
| Vitreous floaters | 30.48 | 18.99 | 39 | 85950 | 5927 | 63397106 |
| Mental status changes | 30.42 | 18.99 | 8 | 85981 | 39591 | 63363442 |
| Hostility | 30.26 | 18.99 | 23 | 85966 | 1849 | 63401184 |
| Urinary retention | 30.12 | 18.99 | 100 | 85889 | 30201 | 63372832 |
| Dysarthria | 29.96 | 18.99 | 126 | 85863 | 42585 | 63360448 |
| Rash maculo-papular | 29.69 | 18.99 | 4 | 85985 | 31892 | 63371141 |
| Vascular malformation | 29.50 | 18.99 | 13 | 85976 | 367 | 63402666 |
| Hypocalcaemia | 29.47 | 18.99 | 4 | 85985 | 31709 | 63371324 |
| Drooling | 29.36 | 18.99 | 31 | 85958 | 3837 | 63399196 |
| Skin disorder | 29.00 | 18.99 | 97 | 85892 | 29410 | 63373623 |
| Sleep disorder | 28.86 | 18.99 | 41 | 85948 | 81525 | 63321508 |
| Muscle spasms | 28.84 | 18.99 | 331 | 85658 | 155819 | 63247214 |
| Flatulence | 28.66 | 18.99 | 6 | 85983 | 34696 | 63368337 |
| Diverticulitis | 28.53 | 18.99 | 9 | 85980 | 39548 | 63363485 |
| Vestibular migraine | 28.29 | 18.99 | 11 | 85978 | 224 | 63402809 |
| Eye contusion | 28.24 | 18.99 | 23 | 85966 | 2044 | 63400989 |
| Intranasal hypoaesthesia | 28.03 | 18.99 | 5 | 85984 | 0 | 63403033 |
| Injection site hypersensitivity | 27.95 | 18.99 | 23 | 85966 | 2074 | 63400959 |
| Injection site pallor | 27.92 | 18.99 | 8 | 85981 | 59 | 63402974 |
| Swollen tongue | 27.88 | 18.99 | 107 | 85882 | 34693 | 63368340 |
| Gastric disorder | 27.87 | 18.99 | 8 | 85981 | 37361 | 63365672 |
| Injection site scab | 27.84 | 18.99 | 13 | 85976 | 421 | 63402612 |
| Hypervolaemia | 27.84 | 18.99 | 3 | 85986 | 28410 | 63374623 |
| Haemorrhage | 27.77 | 18.99 | 25 | 85964 | 60997 | 63342036 |
| Dyspnoea | 27.52 | 18.99 | 684 | 85305 | 660629 | 62742404 |
| Weight decreased | 27.51 | 18.99 | 241 | 85748 | 276557 | 63126476 |
| Angina pectoris | 27.46 | 18.99 | 4 | 85985 | 30074 | 63372959 |
| Pericardial effusion | 27.44 | 18.99 | 4 | 85985 | 30054 | 63372979 |
| Sensation of foreign body | 27.42 | 18.99 | 33 | 85956 | 4712 | 63398321 |
| Prescribed overdose | 27.35 | 18.99 | 105 | 85884 | 34048 | 63368985 |
| Torticollis | 27.29 | 18.99 | 22 | 85967 | 1927 | 63401106 |
| Foot deformity | 27.14 | 18.99 | 3 | 85986 | 27850 | 63375183 |
| Diaphragmatic rupture | 27.13 | 18.99 | 11 | 85978 | 251 | 63402782 |
| Medication error | 26.83 | 18.99 | 19 | 85970 | 52265 | 63350768 |
| Mouth ulceration | 26.64 | 18.99 | 6 | 85983 | 32978 | 63370055 |
| Somnolence | 26.56 | 18.99 | 138 | 85851 | 178547 | 63224486 |
| Injection site haematoma | 26.36 | 18.99 | 39 | 85950 | 6793 | 63396240 |
| Muscle hypertrophy | 26.23 | 18.99 | 8 | 85981 | 75 | 63402958 |
| Occupational exposure to product | 26.06 | 18.99 | 22 | 85967 | 2056 | 63400977 |
| Hepatic steatosis | 25.87 | 18.99 | 4 | 85985 | 28765 | 63374268 |
| Haemoptysis | 25.81 | 18.99 | 4 | 85985 | 28722 | 63374311 |
| Blood pressure decreased | 25.78 | 18.99 | 30 | 85959 | 64992 | 63338041 |
| Blepharochalasis | 25.68 | 18.99 | 5 | 85984 | 3 | 63403030 |
| Injection site deformation | 25.68 | 18.99 | 5 | 85984 | 3 | 63403030 |
| Eyelid contusion | 25.68 | 18.99 | 5 | 85984 | 3 | 63403030 |
| Haematemesis | 25.65 | 18.99 | 5 | 85984 | 30407 | 63372626 |
| Paranasal cyst | 25.52 | 18.99 | 12 | 85977 | 395 | 63402638 |
| Localised infection | 25.41 | 18.99 | 5 | 85984 | 30205 | 63372828 |
| Cellulitis | 25.40 | 18.99 | 45 | 85944 | 81913 | 63321120 |
| Tachycardia | 25.30 | 18.99 | 79 | 85910 | 118077 | 63284956 |
| Eyelids pruritus | 25.30 | 18.99 | 17 | 85972 | 1125 | 63401908 |
| Pharyngeal hypoaesthesia | 25.28 | 18.99 | 11 | 85978 | 301 | 63402732 |
| Injection site discolouration | 24.98 | 18.99 | 41 | 85948 | 7807 | 63395226 |
| Sternal fracture | 24.51 | 18.99 | 22 | 85967 | 2232 | 63400801 |
| Product quality control issue | 24.42 | 18.99 | 6 | 85983 | 22 | 63403011 |
| Jaundice | 24.28 | 18.99 | 5 | 85984 | 29246 | 63373787 |
| Psoriasis | 24.12 | 18.99 | 51 | 85938 | 86906 | 63316127 |
| Trismus | 24.07 | 18.99 | 28 | 85961 | 3857 | 63399176 |
| Pancreatitis acute | 23.92 | 18.99 | 4 | 85985 | 27162 | 63375871 |
| Cholelithiasis | 23.84 | 18.99 | 15 | 85974 | 43910 | 63359123 |
| Mass | 23.61 | 18.99 | 56 | 85933 | 13944 | 63389089 |
| Blood pressure fluctuation | 23.55 | 18.99 | 17 | 85972 | 46300 | 63356733 |
| Face lift | 23.26 | 18.99 | 5 | 85984 | 8 | 63403025 |
| Productive cough | 23.14 | 18.99 | 31 | 85958 | 63177 | 63339856 |
| Loss of personal independence in daily activities | 23.05 | 18.99 | 62 | 85927 | 97228 | 63305805 |
| Injection site atrophy | 23.01 | 18.99 | 13 | 85976 | 630 | 63402403 |
| Vocal cord paralysis | 22.98 | 18.99 | 21 | 85968 | 2180 | 63400853 |
| Product prescribing error | 22.87 | 18.99 | 4 | 85985 | 26285 | 63376748 |
| Upper respiratory tract infection | 22.85 | 18.99 | 48 | 85941 | 81999 | 63321034 |
| Injection site vesicles | 22.85 | 18.99 | 24 | 85965 | 2953 | 63400080 |
| Macular degeneration | 22.83 | 18.99 | 3 | 85986 | 24373 | 63378660 |
| Dry mouth | 22.81 | 18.99 | 182 | 85807 | 77681 | 63325352 |
| Gastritis | 22.76 | 18.99 | 11 | 85978 | 37292 | 63365741 |
| Sinus tachycardia | 22.69 | 18.99 | 3 | 85986 | 24265 | 63378768 |
| Joint injury | 22.67 | 18.99 | 6 | 85983 | 29566 | 63373467 |
| Ulcer | 22.65 | 18.99 | 4 | 85985 | 26103 | 63376930 |
| Panic attack | 22.47 | 18.99 | 74 | 85915 | 22257 | 63380776 |
| Application site papules | 22.46 | 18.99 | 7 | 85982 | 71 | 63402962 |
| Mephisto sign | 22.42 | 18.99 | 4 | 85985 | 0 | 63403033 |
| Gastric ulcer | 22.41 | 18.99 | 3 | 85986 | 24034 | 63378999 |
| Intestinal obstruction | 22.34 | 18.99 | 7 | 85982 | 30892 | 63372141 |
| Hallucination | 22.05 | 18.99 | 25 | 85964 | 54792 | 63348241 |
| Tinnitus | 21.87 | 18.99 | 101 | 85888 | 35527 | 63367506 |
| Shock | 21.70 | 18.99 | 3 | 85986 | 23460 | 63379573 |
| Gait disturbance | 21.68 | 18.99 | 152 | 85837 | 183026 | 63220007 |
| Muscle disorder | 21.57 | 18.99 | 30 | 85959 | 4939 | 63398094 |
| Hypothyroidism | 21.22 | 18.99 | 16 | 85973 | 42616 | 63360417 |
| Injection site infection | 21.19 | 18.99 | 19 | 85970 | 1924 | 63401109 |
| Sciatica | 21.13 | 18.99 | 10 | 85979 | 34314 | 63368719 |
| Product contamination | 21.00 | 18.99 | 13 | 85976 | 747 | 63402286 |
| Disease recurrence | 20.90 | 18.99 | 6 | 85983 | 28024 | 63375009 |
| Eosinophilia | 20.84 | 18.99 | 3 | 85986 | 22753 | 63380280 |
| Bone pain | 20.82 | 18.99 | 26 | 85963 | 54615 | 63348418 |
| Product supply issue | 20.82 | 18.99 | 18 | 85971 | 1737 | 63401296 |
| Drug dependence | 20.70 | 18.99 | 4 | 85985 | 24479 | 63378554 |
| Pulmonary mass | 20.64 | 18.99 | 3 | 85986 | 22593 | 63380440 |
| Myasthenic syndrome | 20.52 | 18.99 | 9 | 85980 | 251 | 63402782 |
| Osteomyelitis | 20.48 | 18.99 | 5 | 85984 | 26015 | 63377018 |
| Blood sodium decreased | 20.43 | 18.99 | 4 | 85985 | 24248 | 63378785 |
| Eye movement disorder | 20.40 | 18.99 | 30 | 85959 | 5198 | 63397835 |
| Lower limb fracture | 20.39 | 18.99 | 4 | 85985 | 24217 | 63378816 |
| Leukocytosis | 20.38 | 18.99 | 5 | 85984 | 25930 | 63377103 |
| Acute myocardial infarction | 20.33 | 18.99 | 9 | 85980 | 32115 | 63370918 |
| Vaginal haemorrhage | 20.28 | 18.99 | 6 | 85983 | 27481 | 63375552 |
| Residual urine volume increased | 20.20 | 18.99 | 6 | 85983 | 51 | 63402982 |
| Device dislocation | 20.12 | 18.99 | 5 | 85984 | 25700 | 63377333 |
| Cerebral infarction | 20.00 | 18.99 | 4 | 85985 | 23889 | 63379144 |
| Serotonin syndrome | 19.86 | 18.99 | 7 | 85982 | 28675 | 63374358 |
| Hyperacusis | 19.83 | 18.99 | 19 | 85970 | 2094 | 63400939 |
| Product lot number issue | 19.63 | 18.99 | 8 | 85981 | 185 | 63402848 |
| Ear discomfort | 19.59 | 18.99 | 37 | 85952 | 7869 | 63395164 |
| Acute respiratory distress syndrome | 19.58 | 18.99 | 4 | 85985 | 23530 | 63379503 |
| Altered state of consciousness | 19.57 | 18.99 | 5 | 85984 | 25225 | 63377808 |
| Blood potassium decreased | 19.39 | 18.99 | 17 | 85972 | 42009 | 63361024 |
| Tooth disorder | 19.28 | 18.99 | 7 | 85982 | 28150 | 63374883 |
| Skin laxity | 19.27 | 18.99 | 5 | 85984 | 24 | 63403009 |
| Neuralgic amyotrophy | 19.27 | 18.99 | 5 | 85984 | 24 | 63403009 |
| Sensory disturbance | 19.19 | 18.99 | 51 | 85938 | 13621 | 63389412 |
| Unresponsive to stimuli | 19.12 | 18.99 | 11 | 85978 | 33805 | 63369228 |
| Blood calcium decreased | 19.11 | 18.99 | 6 | 85983 | 26445 | 63376588 |
| Basal cell carcinoma | 19.09 | 18.99 | 7 | 85982 | 27984 | 63375049 |
| 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 | 2370.95 | 25.65 | 1568 | 9791 | 455183 | 34490389 |
| Product preparation error | 1009.17 | 25.65 | 216 | 11143 | 2101 | 34943471 |
| Off label use | 920.71 | 25.65 | 879 | 10480 | 418645 | 34526927 |
| Therapeutic response decreased | 662.44 | 25.65 | 275 | 11084 | 29038 | 34916534 |
| Multiple use of single-use product | 539.82 | 25.65 | 93 | 11266 | 226 | 34945346 |
| Injection site pain | 416.73 | 25.65 | 218 | 11141 | 38787 | 34906785 |
| Eyelid ptosis | 385.82 | 25.65 | 121 | 11238 | 5645 | 34939927 |
| Wrong technique in product usage process | 369.74 | 25.65 | 196 | 11163 | 35790 | 34909782 |
| Dysphagia | 254.49 | 25.65 | 189 | 11170 | 62192 | 34883380 |
| Muscular weakness | 199.68 | 25.65 | 175 | 11184 | 72722 | 34872850 |
| Migraine | 187.17 | 25.65 | 98 | 11261 | 17380 | 34928192 |
| Product storage error | 136.51 | 25.65 | 62 | 11297 | 8060 | 34937512 |
| Nightmare | 121.58 | 25.65 | 69 | 11290 | 14322 | 34931250 |
| Head discomfort | 118.17 | 25.65 | 46 | 11313 | 4070 | 34941502 |
| Product preparation issue | 116.06 | 25.65 | 27 | 11332 | 391 | 34945181 |
| Botulism | 115.67 | 25.65 | 23 | 11336 | 148 | 34945424 |
| Neck pain | 108.06 | 25.65 | 79 | 11280 | 25270 | 34920302 |
| Poor quality product administered | 102.84 | 25.65 | 34 | 11325 | 1873 | 34943699 |
| Sedation | 97.62 | 25.65 | 69 | 11290 | 20937 | 34924635 |
| Nephrolithiasis | 97.59 | 25.65 | 80 | 11279 | 30253 | 34915319 |
| Neuromuscular toxicity | 93.46 | 25.65 | 17 | 11342 | 62 | 34945510 |
| Headache | 89.06 | 25.65 | 199 | 11160 | 200436 | 34745136 |
| Injection site swelling | 80.83 | 25.65 | 49 | 11310 | 11478 | 34934094 |
| Product used for unknown indication | 75.71 | 25.65 | 23 | 11336 | 960 | 34944612 |
| Brow ptosis | 63.29 | 25.65 | 9 | 11350 | 0 | 34945572 |
| Facial paresis | 63.26 | 25.65 | 27 | 11332 | 3022 | 34942550 |
| Acute kidney injury | 62.11 | 25.65 | 12 | 11347 | 304976 | 34640596 |
| Hyperhidrosis | 56.84 | 25.65 | 94 | 11265 | 75598 | 34869974 |
| Residual urine volume increased | 56.26 | 25.65 | 8 | 11351 | 0 | 34945572 |
| Anaemia | 54.82 | 25.65 | 6 | 11353 | 233329 | 34712243 |
| Drug ineffective for unapproved indication | 49.42 | 25.65 | 49 | 11310 | 23666 | 34921906 |
| Therapeutic response shortened | 48.14 | 25.65 | 30 | 11329 | 7374 | 34938198 |
| Toxicity to various agents | 38.44 | 25.65 | 9 | 11350 | 200353 | 34745219 |
| Drug interaction | 38.08 | 25.65 | 13 | 11346 | 225933 | 34719639 |
| Injection site rash | 38.01 | 25.65 | 21 | 11338 | 4132 | 34941440 |
| Diplopia | 37.33 | 25.65 | 36 | 11323 | 16807 | 34928765 |
| Urinary retention | 37.02 | 25.65 | 52 | 11307 | 36236 | 34909336 |
| Therapeutic product effect decreased | 35.76 | 25.65 | 50 | 11309 | 34693 | 34910879 |
| Diarrhoea | 35.41 | 25.65 | 45 | 11314 | 389867 | 34555705 |
| Product distribution issue | 32.23 | 25.65 | 11 | 11348 | 668 | 34944904 |
| Thrombocytopenia | 32.05 | 25.65 | 6 | 11353 | 156241 | 34789331 |
| Epilepsy | 30.06 | 25.65 | 36 | 11323 | 21459 | 34924113 |
| Injection site oedema | 29.43 | 25.65 | 8 | 11351 | 223 | 34945349 |
| Aspiration | 28.80 | 25.65 | 27 | 11332 | 12167 | 34933405 |
| Eyelid oedema | 26.53 | 25.65 | 18 | 11341 | 5106 | 34940466 |
| Product quality issue | 26.26 | 25.65 | 30 | 11329 | 17005 | 34928567 |
| 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 | 9413.60 | 19.17 | 7068 | 52551 | 1073845 | 78610924 |
| Product preparation error | 6008.35 | 19.17 | 1278 | 58341 | 4515 | 79680254 |
| Eyelid ptosis | 3436.27 | 19.17 | 921 | 58698 | 10123 | 79674646 |
| Off label use | 2971.80 | 19.17 | 3489 | 56130 | 903726 | 78781043 |
| Therapeutic response decreased | 2842.70 | 19.17 | 1252 | 58367 | 65601 | 79619168 |
| Multiple use of single-use product | 2383.87 | 19.17 | 437 | 59182 | 487 | 79684282 |
| Wrong technique in product usage process | 2183.19 | 19.17 | 1076 | 58543 | 72799 | 79611970 |
| Injection site pain | 1937.60 | 19.17 | 1205 | 58414 | 128633 | 79556136 |
| Facial paresis | 892.65 | 19.17 | 277 | 59342 | 5249 | 79679520 |
| Brow ptosis | 786.52 | 19.17 | 137 | 59482 | 80 | 79684689 |
| Dysphagia | 715.75 | 19.17 | 648 | 58971 | 121488 | 79563281 |
| Injection site swelling | 674.76 | 19.17 | 427 | 59192 | 46705 | 79638064 |
| Drug ineffective for unapproved indication | 608.53 | 19.17 | 413 | 59206 | 50825 | 79633944 |
| Product preparation issue | 604.86 | 19.17 | 152 | 59467 | 1258 | 79683511 |
| Swelling face | 599.60 | 19.17 | 466 | 59153 | 70746 | 79614023 |
| Poor quality product administered | 564.72 | 19.17 | 177 | 59442 | 3468 | 79681301 |
| Muscular weakness | 557.96 | 19.17 | 643 | 58976 | 160086 | 79524683 |
| Migraine | 541.54 | 19.17 | 479 | 59140 | 87014 | 79597755 |
| Botulism | 489.72 | 19.17 | 101 | 59518 | 290 | 79684479 |
| Headache | 485.03 | 19.17 | 1319 | 58300 | 652453 | 79032316 |
| Therapeutic response shortened | 467.17 | 19.17 | 231 | 59388 | 15632 | 79669137 |
| Eye swelling | 455.92 | 19.17 | 270 | 59349 | 26198 | 79658571 |
| Product storage error | 418.46 | 19.17 | 216 | 59403 | 16010 | 79668759 |
| Vision blurred | 403.57 | 19.17 | 445 | 59174 | 105453 | 79579316 |
| Neck pain | 368.30 | 19.17 | 362 | 59257 | 75055 | 79609714 |
| Eyelid oedema | 358.13 | 19.17 | 184 | 59435 | 13503 | 79671266 |
| Neuromuscular toxicity | 331.44 | 19.17 | 67 | 59552 | 168 | 79684601 |
| Acute kidney injury | 295.86 | 19.17 | 25 | 59594 | 519379 | 79165390 |
| Anaemia | 257.30 | 19.17 | 20 | 59599 | 444995 | 79239774 |
| Diplopia | 247.27 | 19.17 | 203 | 59416 | 33263 | 79651506 |
| Facial asymmetry | 238.32 | 19.17 | 65 | 59554 | 761 | 79684008 |
| Influenza like illness | 235.24 | 19.17 | 279 | 59340 | 71428 | 79613341 |
| Incorrect route of product administration | 229.47 | 19.17 | 198 | 59421 | 34731 | 79650038 |
| Injection site rash | 225.63 | 19.17 | 150 | 59469 | 17804 | 79666965 |
| Facial paralysis | 208.46 | 19.17 | 152 | 59467 | 20920 | 79663849 |
| Toxicity to various agents | 208.36 | 19.17 | 33 | 59586 | 421507 | 79263262 |
| Head discomfort | 201.41 | 19.17 | 129 | 59490 | 14373 | 79670396 |
| Injection site erythema | 194.33 | 19.17 | 265 | 59354 | 77932 | 79606837 |
| Hypoaesthesia | 193.17 | 19.17 | 419 | 59200 | 178933 | 79505836 |
| Neutropenia | 187.99 | 19.17 | 6 | 59613 | 287704 | 79397065 |
| Drug interaction | 187.02 | 19.17 | 41 | 59578 | 415142 | 79269627 |
| Blepharospasm | 186.60 | 19.17 | 90 | 59529 | 5761 | 79679008 |
| Product quality issue | 177.00 | 19.17 | 169 | 59450 | 33771 | 79650998 |
| Pneumonia | 173.25 | 19.17 | 144 | 59475 | 660102 | 79024667 |
| Skin tightness | 170.26 | 19.17 | 83 | 59536 | 5439 | 79679330 |
| Facial pain | 166.92 | 19.17 | 108 | 59511 | 12242 | 79672527 |
| Completed suicide | 164.70 | 19.17 | 4 | 59615 | 245763 | 79439006 |
| Diarrhoea | 162.82 | 19.17 | 255 | 59364 | 880234 | 78804535 |
| Thrombocytopenia | 161.78 | 19.17 | 9 | 59610 | 265250 | 79419519 |
| Injection site mass | 160.86 | 19.17 | 128 | 59491 | 20056 | 79664713 |
| Periorbital swelling | 151.55 | 19.17 | 63 | 59556 | 2833 | 79681936 |
| Hypotension | 151.39 | 19.17 | 70 | 59549 | 440247 | 79244522 |
| Injection site nodule | 147.97 | 19.17 | 67 | 59552 | 3713 | 79681056 |
| Dysphonia | 144.71 | 19.17 | 195 | 59424 | 56677 | 79628092 |
| Paraesthesia | 131.92 | 19.17 | 358 | 59261 | 175965 | 79508804 |
| Arthralgia | 125.31 | 19.17 | 146 | 59473 | 571657 | 79113112 |
| Muscle tightness | 125.11 | 19.17 | 92 | 59527 | 12822 | 79671947 |
| Lagophthalmos | 123.81 | 19.17 | 34 | 59585 | 409 | 79684360 |
| General physical health deterioration | 120.21 | 19.17 | 29 | 59590 | 275209 | 79409560 |
| Eyelid sensory disorder | 118.49 | 19.17 | 24 | 59595 | 61 | 79684708 |
| Asthenopia | 117.65 | 19.17 | 50 | 59569 | 2377 | 79682392 |
| Injection site bruising | 117.37 | 19.17 | 149 | 59470 | 40853 | 79643916 |
| Sepsis | 114.55 | 19.17 | 30 | 59589 | 269398 | 79415371 |
| Renal failure | 110.65 | 19.17 | 11 | 59608 | 200957 | 79483812 |
| Pancytopenia | 109.88 | 19.17 | 3 | 59616 | 165742 | 79519027 |
| Joint swelling | 108.64 | 19.17 | 40 | 59579 | 288606 | 79396163 |
| Muscle twitching | 102.82 | 19.17 | 109 | 59510 | 24655 | 79660114 |
| Dry eye | 102.23 | 19.17 | 132 | 59487 | 36799 | 79647970 |
| Injection site urticaria | 101.47 | 19.17 | 81 | 59538 | 12745 | 79672024 |
| Renal impairment | 97.27 | 19.17 | 5 | 59614 | 157778 | 79526991 |
| Oedema peripheral | 96.56 | 19.17 | 34 | 59585 | 252254 | 79432515 |
| Product distribution issue | 96.49 | 19.17 | 37 | 59582 | 1343 | 79683426 |
| Haemoglobin decreased | 95.81 | 19.17 | 24 | 59595 | 222095 | 79462674 |
| Eye pain | 95.81 | 19.17 | 129 | 59490 | 37449 | 79647320 |
| Platelet count decreased | 94.35 | 19.17 | 16 | 59603 | 194648 | 79490121 |
| Infusion related reaction | 93.46 | 19.17 | 28 | 59591 | 230209 | 79454560 |
| Blood creatinine increased | 92.26 | 19.17 | 6 | 59613 | 155051 | 79529718 |
| Disease progression | 91.95 | 19.17 | 14 | 59605 | 184348 | 79500421 |
| Swelling of eyelid | 90.43 | 19.17 | 48 | 59571 | 3763 | 79681006 |
| Atrial fibrillation | 90.09 | 19.17 | 19 | 59600 | 197867 | 79486902 |
| Neovascularisation | 89.28 | 19.17 | 34 | 59585 | 1211 | 79683558 |
| Product administered at inappropriate site | 88.64 | 19.17 | 48 | 59571 | 3917 | 79680852 |
| Hypoaesthesia oral | 88.57 | 19.17 | 78 | 59541 | 14046 | 79670723 |
| Hepatic enzyme increased | 88.52 | 19.17 | 15 | 59604 | 182595 | 79502174 |
| Drug effect less than expected | 88.16 | 19.17 | 39 | 59580 | 2045 | 79682724 |
| Synovitis | 86.34 | 19.17 | 7 | 59612 | 150727 | 79534042 |
| Hyponatraemia | 85.35 | 19.17 | 15 | 59604 | 177833 | 79506936 |
| Pyrexia | 83.89 | 19.17 | 246 | 59373 | 678463 | 79006306 |
| Injection site paraesthesia | 83.69 | 19.17 | 27 | 59592 | 582 | 79684187 |
| Gastrointestinal haemorrhage | 81.53 | 19.17 | 8 | 59611 | 147711 | 79537058 |
| Burning sensation | 80.94 | 19.17 | 152 | 59467 | 58480 | 79626289 |
| Periorbital oedema | 79.46 | 19.17 | 59 | 59560 | 8343 | 79676426 |
| Cardiac failure | 78.97 | 19.17 | 11 | 59608 | 154831 | 79529938 |
| Drug abuse | 77.46 | 19.17 | 14 | 59605 | 162677 | 79522092 |
| Arthropathy | 76.63 | 19.17 | 19 | 59600 | 177092 | 79507677 |
| Speech disorder | 76.22 | 19.17 | 142 | 59477 | 54303 | 79630466 |
| Cardiac failure congestive | 75.31 | 19.17 | 9 | 59610 | 142393 | 79542376 |
| Pleural effusion | 74.83 | 19.17 | 10 | 59609 | 145252 | 79539517 |
| Prescribed overdose | 74.53 | 19.17 | 115 | 59504 | 37768 | 79647001 |
| Cardiac arrest | 73.42 | 19.17 | 19 | 59600 | 172077 | 79512692 |
| Alanine aminotransferase increased | 73.19 | 19.17 | 16 | 59603 | 162554 | 79522215 |
| Product packaging issue | 71.94 | 19.17 | 29 | 59590 | 1204 | 79683565 |
| Injection site discomfort | 71.84 | 19.17 | 46 | 59573 | 5120 | 79679649 |
| Hypokalaemia | 71.67 | 19.17 | 11 | 59608 | 144029 | 79540740 |
| Condition aggravated | 71.47 | 19.17 | 169 | 59450 | 500955 | 79183814 |
| Abdominal pain | 69.65 | 19.17 | 115 | 59504 | 389454 | 79295315 |
| Injection site haemorrhage | 68.50 | 19.17 | 94 | 59525 | 27776 | 79656993 |
| Myocardial infarction | 68.43 | 19.17 | 26 | 59593 | 184103 | 79500666 |
| Fall | 68.30 | 19.17 | 166 | 59453 | 487463 | 79197306 |
| Contraindicated product administered | 67.96 | 19.17 | 17 | 59602 | 157521 | 79527248 |
| Infection | 67.91 | 19.17 | 49 | 59570 | 241663 | 79443106 |
| Confusional state | 66.55 | 19.17 | 84 | 59535 | 317913 | 79366856 |
| Aspartate aminotransferase increased | 65.85 | 19.17 | 12 | 59607 | 138629 | 79546140 |
| Decreased appetite | 64.11 | 19.17 | 98 | 59521 | 342320 | 79342449 |
| Endometriosis | 62.03 | 19.17 | 37 | 59582 | 3631 | 79681138 |
| Facial discomfort | 61.88 | 19.17 | 15 | 59604 | 105 | 79684664 |
| Rheumatoid arthritis | 61.57 | 19.17 | 40 | 59579 | 208430 | 79476339 |
| Abdominal discomfort | 61.55 | 19.17 | 58 | 59561 | 250669 | 79434100 |
| Dehydration | 61.41 | 19.17 | 57 | 59562 | 248130 | 79436639 |
| Muscle spasms | 61.26 | 19.17 | 276 | 59343 | 174454 | 79510315 |
| Intentional overdose | 60.45 | 19.17 | 5 | 59614 | 105955 | 79578814 |
| Nightmare | 60.24 | 19.17 | 85 | 59534 | 25776 | 79658993 |
| Injection site pruritus | 60.08 | 19.17 | 111 | 59508 | 42172 | 79642597 |
| Feeling abnormal | 60.01 | 19.17 | 257 | 59362 | 158942 | 79525827 |
| Injection site oedema | 59.10 | 19.17 | 26 | 59593 | 1345 | 79683424 |
| Lacrimation increased | 57.04 | 19.17 | 77 | 59542 | 22400 | 79662369 |
| Ophthalmoplegia | 56.19 | 19.17 | 32 | 59587 | 2880 | 79681889 |
| Neuropathy peripheral | 55.85 | 19.17 | 18 | 59601 | 141287 | 79543482 |
| White blood cell count decreased | 55.77 | 19.17 | 36 | 59583 | 188252 | 79496517 |
| Throat tightness | 55.29 | 19.17 | 85 | 59534 | 27822 | 79656947 |
| Pulmonary embolism | 54.81 | 19.17 | 30 | 59589 | 171624 | 79513145 |
| Hand deformity | 53.89 | 19.17 | 7 | 59612 | 103912 | 79580857 |
| Multiple organ dysfunction syndrome | 53.79 | 19.17 | 12 | 59607 | 120234 | 79564535 |
| Leukopenia | 53.40 | 19.17 | 11 | 59608 | 116502 | 79568267 |
| Pemphigus | 53.38 | 19.17 | 6 | 59613 | 99576 | 79585193 |
| Photophobia | 53.13 | 19.17 | 71 | 59548 | 20457 | 79664312 |
| Post-traumatic neck syndrome | 51.46 | 19.17 | 27 | 59592 | 2067 | 79682702 |
| Drug hypersensitivity | 50.87 | 19.17 | 91 | 59528 | 298825 | 79385944 |
| Weight increased | 50.37 | 19.17 | 81 | 59538 | 277305 | 79407464 |
| Mastication disorder | 50.18 | 19.17 | 29 | 59590 | 2684 | 79682085 |
| Hypertension | 50.08 | 19.17 | 108 | 59511 | 330884 | 79353885 |
| Suicide attempt | 49.95 | 19.17 | 3 | 59616 | 82929 | 79601840 |
| Urticaria | 49.59 | 19.17 | 271 | 59348 | 184930 | 79499839 |
| Pericarditis | 49.54 | 19.17 | 9 | 59610 | 104227 | 79580542 |
| Maternal exposure during pregnancy | 49.54 | 19.17 | 20 | 59599 | 136518 | 79548251 |
| Strabismus | 49.45 | 19.17 | 28 | 59591 | 2493 | 79682276 |
| Ocular discomfort | 49.39 | 19.17 | 36 | 59583 | 4947 | 79679822 |
| Epilepsy | 49.18 | 19.17 | 100 | 59519 | 40760 | 79644009 |
| Erythema of eyelid | 48.94 | 19.17 | 28 | 59591 | 2542 | 79682227 |
| Systemic lupus erythematosus | 48.65 | 19.17 | 15 | 59604 | 121134 | 79563635 |
| Drug specific antibody | 48.36 | 19.17 | 28 | 59591 | 2600 | 79682169 |
| International normalised ratio increased | 48.32 | 19.17 | 4 | 59615 | 84717 | 79600052 |
| Overdose | 47.62 | 19.17 | 267 | 59352 | 183939 | 79500830 |
| Neutrophil count decreased | 47.14 | 19.17 | 7 | 59612 | 93952 | 79590817 |
| Rhabdomyolysis | 46.72 | 19.17 | 10 | 59609 | 103121 | 79581648 |
| Stomatitis | 46.34 | 19.17 | 26 | 59593 | 146731 | 79538038 |
| Peripheral swelling | 45.94 | 19.17 | 82 | 59537 | 269535 | 79415234 |
| Bradycardia | 45.79 | 19.17 | 22 | 59597 | 135535 | 79549234 |
| Hypoglycaemia | 45.72 | 19.17 | 10 | 59609 | 101584 | 79583185 |
| Wound | 45.56 | 19.17 | 15 | 59604 | 116164 | 79568605 |
| Coma | 45.10 | 19.17 | 10 | 59609 | 100639 | 79584130 |
| Central nervous system function test abnormal | 44.98 | 19.17 | 9 | 59610 | 21 | 79684748 |
| Hypoxia | 44.79 | 19.17 | 11 | 59608 | 103232 | 79581537 |
| Product reconstitution quality issue | 44.63 | 19.17 | 13 | 59606 | 196 | 79684573 |
| Metabolic acidosis | 44.16 | 19.17 | 5 | 59614 | 82524 | 79602245 |
| Death | 44.15 | 19.17 | 246 | 59373 | 566268 | 79118501 |
| Product used for unknown indication | 44.00 | 19.17 | 22 | 59597 | 1522 | 79683247 |
| Soft tissue injury | 43.87 | 19.17 | 23 | 59596 | 1758 | 79683011 |
| Manufacturing product shipping issue | 43.66 | 19.17 | 11 | 59608 | 92 | 79684677 |
| Vertigo | 43.57 | 19.17 | 132 | 59487 | 68950 | 79615819 |
| Pulmonary oedema | 43.31 | 19.17 | 7 | 59612 | 88247 | 79596522 |
| Eye discharge | 43.29 | 19.17 | 36 | 59583 | 5998 | 79678771 |
| Blood glucose increased | 43.10 | 19.17 | 16 | 59603 | 114959 | 79569810 |
| Accidental exposure to product | 42.96 | 19.17 | 81 | 59538 | 31241 | 79653528 |
| Septic shock | 42.92 | 19.17 | 19 | 59600 | 122782 | 79561987 |
| Taste disorder | 42.91 | 19.17 | 56 | 59563 | 15767 | 79669002 |
| Injection site granuloma | 42.58 | 19.17 | 10 | 59609 | 60 | 79684709 |
| Patient dissatisfaction with treatment | 41.63 | 19.17 | 12 | 59607 | 174 | 79684595 |
| Visual impairment | 41.30 | 19.17 | 157 | 59462 | 91974 | 79592795 |
| Facial spasm | 40.90 | 19.17 | 17 | 59602 | 764 | 79684005 |
| Nasopharyngitis | 40.79 | 19.17 | 80 | 59539 | 253801 | 79430968 |
| Haematochezia | 40.73 | 19.17 | 8 | 59611 | 87637 | 79597132 |
| Electrocardiogram QT prolonged | 40.46 | 19.17 | 9 | 59610 | 90377 | 79594392 |
| Hepatic function abnormal | 40.22 | 19.17 | 4 | 59615 | 73103 | 79611666 |
| Ocular hyperaemia | 40.01 | 19.17 | 74 | 59545 | 28132 | 79656637 |
| Anti-cyclic citrullinated peptide antibody positive | 39.90 | 19.17 | 7 | 59612 | 83136 | 79601633 |
| Eye irritation | 39.58 | 19.17 | 62 | 59557 | 20619 | 79664150 |
| Injection site hypoaesthesia | 39.52 | 19.17 | 15 | 59604 | 529 | 79684240 |
| Choking | 39.50 | 19.17 | 47 | 59572 | 12054 | 79672715 |
| Paralysis | 39.47 | 19.17 | 49 | 59570 | 13128 | 79671641 |
| Abnormal sensation in eye | 39.33 | 19.17 | 22 | 59597 | 1913 | 79682856 |
| Skin indentation | 39.31 | 19.17 | 8 | 59611 | 21 | 79684748 |
| Lower respiratory tract infection | 39.23 | 19.17 | 24 | 59595 | 129196 | 79555573 |
| Dermatochalasis | 39.07 | 19.17 | 7 | 59612 | 6 | 79684763 |
| Cough | 38.92 | 19.17 | 142 | 59477 | 366647 | 79318122 |
| Agitation | 38.88 | 19.17 | 13 | 59606 | 99702 | 79585067 |
| Libido increased | 38.64 | 19.17 | 22 | 59597 | 1979 | 79682790 |
| Lid sulcus deepened | 38.59 | 19.17 | 11 | 59608 | 153 | 79684616 |
| Nerve injury | 38.38 | 19.17 | 41 | 59578 | 9351 | 79675418 |
| Hostility | 38.28 | 19.17 | 23 | 59596 | 2287 | 79682482 |
| Paradoxical drug reaction | 37.87 | 19.17 | 36 | 59583 | 7149 | 79677620 |
| Eyelid pain | 37.75 | 19.17 | 13 | 59606 | 345 | 79684424 |
| Rectal haemorrhage | 37.55 | 19.17 | 6 | 59613 | 76294 | 79608475 |
| Deep vein thrombosis | 37.35 | 19.17 | 22 | 59597 | 120897 | 79563872 |
| Injection site indentation | 36.87 | 19.17 | 11 | 59608 | 181 | 79684588 |
| Swollen tongue | 36.46 | 19.17 | 91 | 59528 | 42479 | 79642290 |
| C-reactive protein increased | 36.42 | 19.17 | 26 | 59593 | 129001 | 79555768 |
| Vascular malformation | 36.40 | 19.17 | 13 | 59606 | 385 | 79684384 |
| Dry mouth | 36.21 | 19.17 | 146 | 59473 | 87873 | 79596896 |
| Cardio-respiratory arrest | 36.06 | 19.17 | 18 | 59601 | 108492 | 79576277 |
| Colitis | 35.55 | 19.17 | 6 | 59613 | 73301 | 79611468 |
| Drug-induced liver injury | 35.39 | 19.17 | 4 | 59615 | 66113 | 79618656 |
| Injection site haematoma | 35.05 | 19.17 | 29 | 59590 | 4798 | 79679971 |
| Liver disorder | 34.96 | 19.17 | 6 | 59613 | 72411 | 79612358 |
| Impaired healing | 34.93 | 19.17 | 11 | 59608 | 87644 | 79597125 |
| Diaphragmatic rupture | 34.87 | 19.17 | 11 | 59608 | 220 | 79684549 |
| Delirium | 34.85 | 19.17 | 10 | 59609 | 84617 | 79600152 |
| Eyelid contusion | 34.77 | 19.17 | 6 | 59613 | 3 | 79684766 |
| Glossodynia | 34.55 | 19.17 | 17 | 59602 | 103320 | 79581449 |
| Product temperature excursion issue | 33.88 | 19.17 | 11 | 59608 | 242 | 79684527 |
| Sternal fracture | 33.88 | 19.17 | 22 | 59597 | 2508 | 79682261 |
| Vitreous floaters | 33.84 | 19.17 | 34 | 59585 | 7222 | 79677547 |
| Skin wrinkling | 33.56 | 19.17 | 17 | 59602 | 1209 | 79683560 |
| Chronic obstructive pulmonary disease | 33.54 | 19.17 | 11 | 59608 | 85408 | 79599361 |
| Epistaxis | 33.45 | 19.17 | 21 | 59598 | 111494 | 79573275 |
| Injection site inflammation | 33.36 | 19.17 | 26 | 59593 | 3950 | 79680819 |
| Vomiting | 33.20 | 19.17 | 328 | 59291 | 665500 | 79019269 |
| Helicobacter infection | 33.16 | 19.17 | 6 | 59613 | 69698 | 79615071 |
| Application site acne | 33.04 | 19.17 | 6 | 59613 | 6 | 79684763 |
| Lip disorder | 32.71 | 19.17 | 18 | 59601 | 1516 | 79683253 |
| Lip swelling | 32.49 | 19.17 | 85 | 59534 | 40826 | 79643943 |
| Bronchitis | 32.30 | 19.17 | 30 | 59589 | 130614 | 79554155 |
| Madarosis | 31.83 | 19.17 | 22 | 59597 | 2780 | 79681989 |
| Dysarthria | 31.77 | 19.17 | 117 | 59502 | 67505 | 79617264 |
| Suspected product quality issue | 31.45 | 19.17 | 11 | 59608 | 306 | 79684463 |
| Blood pressure systolic increased | 31.37 | 19.17 | 6 | 59613 | 66980 | 79617789 |
| Paranasal cyst | 31.10 | 19.17 | 12 | 59607 | 443 | 79684326 |
| Rash maculo-papular | 31.03 | 19.17 | 3 | 59616 | 56075 | 79628694 |
| Thrombosis | 31.02 | 19.17 | 12 | 59607 | 84088 | 79600681 |
| Duodenal ulcer perforation | 30.86 | 19.17 | 6 | 59613 | 66205 | 79618564 |
| Gastrointestinal disorder | 30.28 | 19.17 | 28 | 59591 | 122177 | 79562592 |
| Muscle spasticity | 30.03 | 19.17 | 56 | 59563 | 21419 | 79663350 |
| Respiratory failure | 29.93 | 19.17 | 56 | 59563 | 180855 | 79503914 |
| Fluid retention | 29.20 | 19.17 | 8 | 59611 | 69801 | 79614968 |
| Dizziness | 29.20 | 19.17 | 554 | 59065 | 525887 | 79158882 |
| Oxygen saturation decreased | 29.20 | 19.17 | 32 | 59587 | 129015 | 79555754 |
| Plasma cell myeloma | 29.07 | 19.17 | 3 | 59616 | 53256 | 79631513 |
| Blood bilirubin increased | 28.84 | 19.17 | 7 | 59612 | 66225 | 79618544 |
| Product dose omission issue | 28.84 | 19.17 | 92 | 59527 | 247445 | 79437324 |
| Treatment noncompliance | 28.39 | 19.17 | 3 | 59616 | 52265 | 79632504 |
| Hepatitis | 28.30 | 19.17 | 4 | 59615 | 55723 | 79629046 |
| Transaminases increased | 28.03 | 19.17 | 3 | 59616 | 51740 | 79633029 |
| Liver function test abnormal | 27.71 | 19.17 | 7 | 59612 | 64468 | 79620301 |
| Eye contusion | 27.50 | 19.17 | 19 | 59600 | 2400 | 79682369 |
| Lung disorder | 27.31 | 19.17 | 13 | 59606 | 80544 | 79604225 |
| Blood alkaline phosphatase increased | 27.19 | 19.17 | 7 | 59612 | 63657 | 79621112 |
| Acute myocardial infarction | 26.79 | 19.17 | 12 | 59607 | 77024 | 79607745 |
| Oedema | 26.67 | 19.17 | 30 | 59589 | 119550 | 79565219 |
| Muscle atrophy | 26.28 | 19.17 | 37 | 59582 | 11195 | 79673574 |
| Haemoptysis | 26.25 | 19.17 | 5 | 59614 | 55994 | 79628775 |
| Unresponsive to stimuli | 26.11 | 19.17 | 5 | 59614 | 55783 | 79628986 |
| Encephalopathy | 25.90 | 19.17 | 9 | 59610 | 67388 | 79617381 |
| Psoriatic arthropathy | 25.82 | 19.17 | 13 | 59606 | 77986 | 79606783 |
| Angina pectoris | 25.61 | 19.17 | 4 | 59615 | 51728 | 79633041 |
| Eye pruritus | 25.53 | 19.17 | 51 | 59568 | 20519 | 79664250 |
| Cerebral haemorrhage | 25.30 | 19.17 | 6 | 59613 | 57667 | 79627102 |
| Tension headache | 25.19 | 19.17 | 29 | 59590 | 7182 | 79677587 |
| Product quality control issue | 25.19 | 19.17 | 5 | 59614 | 11 | 79684758 |
| Haematuria | 25.10 | 19.17 | 10 | 59609 | 68826 | 79615943 |
| Osteoporosis | 25.01 | 19.17 | 5 | 59614 | 54107 | 79630662 |
| Pancreatitis | 24.94 | 19.17 | 10 | 59609 | 68565 | 79616204 |
| Pain in extremity | 24.83 | 19.17 | 165 | 59454 | 364373 | 79320396 |
| Intranasal hypoaesthesia | 24.80 | 19.17 | 4 | 59615 | 0 | 79684769 |
| Jaundice | 24.51 | 19.17 | 5 | 59614 | 53344 | 79631425 |
| Drooling | 24.42 | 19.17 | 26 | 59593 | 5908 | 79678861 |
| Depressed level of consciousness | 24.12 | 19.17 | 22 | 59597 | 96630 | 79588139 |
| Mental status changes | 23.97 | 19.17 | 10 | 59609 | 66949 | 79617820 |
| Arrhythmia | 23.86 | 19.17 | 8 | 59611 | 61264 | 79623505 |
| Haematemesis | 23.80 | 19.17 | 5 | 59614 | 52259 | 79632510 |
| Blood urea increased | 23.64 | 19.17 | 4 | 59615 | 48786 | 79635983 |
| Eyelid disorder | 23.58 | 19.17 | 16 | 59603 | 1962 | 79682807 |
| Gamma-glutamyltransferase increased | 23.38 | 19.17 | 6 | 59613 | 54674 | 79630095 |
| Red blood cell count decreased | 23.30 | 19.17 | 7 | 59612 | 57506 | 79627263 |
| Diabetes mellitus | 23.18 | 19.17 | 15 | 59604 | 78375 | 79606394 |
| Wheezing | 23.16 | 19.17 | 32 | 59587 | 116632 | 79568137 |
| Torticollis | 23.11 | 19.17 | 17 | 59602 | 2370 | 79682399 |
| Type 2 diabetes mellitus | 23.06 | 19.17 | 7 | 59612 | 57115 | 79627654 |
| Skin ulcer | 23.04 | 19.17 | 6 | 59613 | 54144 | 79630625 |
| Exposure during pregnancy | 22.96 | 19.17 | 25 | 59594 | 101107 | 79583662 |
| Sedation | 22.89 | 19.17 | 88 | 59531 | 51807 | 79632962 |
| Ear discomfort | 22.69 | 19.17 | 30 | 59589 | 8553 | 79676216 |
| Injection site scab | 22.64 | 19.17 | 9 | 59610 | 360 | 79684409 |
| Eyelids pruritus | 22.60 | 19.17 | 12 | 59607 | 941 | 79683828 |
| Sinusitis | 22.53 | 19.17 | 73 | 59546 | 195428 | 79489341 |
| White blood cell count increased | 22.46 | 19.17 | 14 | 59605 | 74619 | 79610150 |
| Procedural anxiety | 22.08 | 19.17 | 11 | 59608 | 755 | 79684014 |
| Pancreatitis acute | 22.08 | 19.17 | 5 | 59614 | 49599 | 79635170 |
| Product contamination | 22.06 | 19.17 | 13 | 59606 | 1247 | 79683522 |
| Folliculitis | 21.97 | 19.17 | 7 | 59612 | 55373 | 79629396 |
| Cutis laxa | 21.96 | 19.17 | 7 | 59612 | 145 | 79684624 |
| Pericardial effusion | 21.95 | 19.17 | 4 | 59615 | 46233 | 79638536 |
| Hypervolaemia | 21.83 | 19.17 | 3 | 59616 | 42687 | 79642082 |
| Clostridium difficile infection | 21.83 | 19.17 | 3 | 59616 | 42682 | 79642087 |
| Abdominal distension | 21.64 | 19.17 | 35 | 59584 | 119615 | 79565154 |
| Vestibular migraine | 21.61 | 19.17 | 7 | 59612 | 153 | 79684616 |
| Dyspnoea exertional | 21.51 | 19.17 | 20 | 59599 | 87053 | 79597716 |
| Cardiogenic shock | 21.30 | 19.17 | 3 | 59616 | 41911 | 79642858 |
| Haemorrhage | 21.27 | 19.17 | 22 | 59597 | 91096 | 79593673 |
| Eye movement disorder | 21.18 | 19.17 | 28 | 59591 | 7983 | 79676786 |
| Cataract | 21.10 | 19.17 | 10 | 59609 | 62110 | 79622659 |
| Aggression | 21.02 | 19.17 | 6 | 59613 | 50952 | 79633817 |
| Product prescribing error | 21.01 | 19.17 | 4 | 59615 | 44809 | 79639960 |
| Liver injury | 21.01 | 19.17 | 8 | 59611 | 56606 | 79628163 |
| Panic attack | 20.98 | 19.17 | 52 | 59567 | 24164 | 79660605 |
| Erythema | 20.89 | 19.17 | 257 | 59362 | 223033 | 79461736 |
| Tachycardia | 20.74 | 19.17 | 66 | 59553 | 177702 | 79507067 |
| Blister | 20.63 | 19.17 | 36 | 59583 | 119440 | 79565329 |
| Haematocrit decreased | 20.62 | 19.17 | 10 | 59609 | 61302 | 79623467 |
| Pulmonary fibrosis | 20.55 | 19.17 | 4 | 59615 | 44108 | 79640661 |
| Medication error | 20.48 | 19.17 | 13 | 59606 | 68629 | 79616140 |
| Product lot number issue | 20.46 | 19.17 | 7 | 59612 | 182 | 79684587 |
| Full blood count abnormal | 20.33 | 19.17 | 3 | 59616 | 40471 | 79644298 |
| Glossopharyngeal nerve disorder | 20.27 | 19.17 | 5 | 59614 | 38 | 79684731 |
| Eyelid function disorder | 20.15 | 19.17 | 8 | 59611 | 319 | 79684450 |
| Leukocytosis | 20.12 | 19.17 | 4 | 59615 | 43451 | 79641318 |
| Injury | 20.11 | 19.17 | 17 | 59602 | 77479 | 79607290 |
| Knee arthroplasty | 19.98 | 19.17 | 4 | 59615 | 43244 | 79641525 |
| Blood cholesterol increased | 19.79 | 19.17 | 20 | 59599 | 83700 | 79601069 |
| Chest pain | 19.61 | 19.17 | 127 | 59492 | 282177 | 79402592 |
| COVID-19 | 19.50 | 19.17 | 57 | 59562 | 157617 | 79527152 |
| Anxiety | 19.49 | 19.17 | 277 | 59342 | 248235 | 79436534 |
| Sensory disturbance | 19.46 | 19.17 | 38 | 59581 | 15039 | 79669730 |
| Head deformity | 19.42 | 19.17 | 5 | 59614 | 46 | 79684723 |
| Tinnitus | 19.41 | 19.17 | 75 | 59544 | 44258 | 79640511 |
| Atrioventricular septal defect | 19.26 | 19.17 | 6 | 59613 | 115 | 79684654 |
| Injection site discolouration | 19.19 | 19.17 | 26 | 59593 | 7588 | 79677181 |
None
| Source | Code | Description |
|---|---|---|
| MeSH PA | D065087 | Acetylcholine Release Inhibitors |
| MeSH PA | D018678 | Cholinergic Agents |
| MeSH PA | D049990 | Membrane Transport Modulators |
| MeSH PA | D009465 | Neuromuscular Agents |
| MeSH PA | D009498 | Neurotoxins |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D009676 | Noxae |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| FDA PE | N0000175731 | Neuromuscular Blockade |
| FDA MoA | N0000175770 | Acetylcholine Release Inhibitors |
| FDA EPC | N0000175771 | Acetylcholine Release Inhibitor |
| FDA EPC | N0000193962 | Neuromuscular Blocker |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Rhytidectomy of glabellar frown lines | indication | 14667004 | |
| Urge urinary incontinence | indication | 87557004 | |
| Urinary frequency | indication | 162116003 | |
| Lower limb spasticity | indication | 394679006 | |
| Upper limb spasticity | indication | 394680009 | |
| Neurogenic bladder | indication | 398064005 | |
| Overactive bladder | indication | 786457000 |
None
None
None
None
None
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Synaptosomal-associated protein 25 | Cytosolic other | BLOCKER | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE |
| ID | Source |
|---|---|
| CHEBI:3160 | CHEBI |
| CHEMBL4297862 | ChEMBL_ID |
| D00783 | KEGG_DRUG |
| C545476 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB00083 | DRUGBANK_ID |
| 013287 | NDDF |
| 108890005 | SNOMEDCT_US |
| 427412002 | SNOMEDCT_US |
| 703368006 | SNOMEDCT_US |
| 772950004 | SNOMEDCT_US |
| 4020561 | VANDF |
| 4030130 | VANDF |
| C0006050 | UMLSCUI |
| CHEMBL2108035 | ChEMBL_ID |
| 93384-43-1 | SECONDARY_CAS_RN |
| 1000104 | RXNORM |
| 27317 | MMSL |
| 4295 | MMSL |
| d01227 | MMSL |
| d07669 | MMSL |
| E211KPY694 | UNII |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| BOTOX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-1145 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 [USPU] | INTRADERMAL | BLA | 32 sections |
| BOTOX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-1145 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 [USPU] | INTRADERMAL | BLA | 32 sections |
| BOTOX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-1145 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 [USPU] | INTRADERMAL | BLA | 32 sections |
| BOTOX Cosmetic | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-3919 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 50 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| BOTOX Cosmetic | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-3919 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 50 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| BOTOX Cosmetic | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-3919 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 50 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| BOTOX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-3921 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 [USPU] | INTRADERMAL | BLA | 32 sections |
| BOTOX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-3921 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 [USPU] | INTRADERMAL | BLA | 32 sections |
| BOTOX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-3921 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 [USPU] | INTRADERMAL | BLA | 32 sections |
| BOTOX Cosmetic | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-9232 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| BOTOX Cosmetic | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-9232 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| BOTOX Cosmetic | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-9232 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| Xeomin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0259-1605 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 50 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| Xeomin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0259-1605 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 50 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| Xeomin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0259-1610 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| Xeomin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0259-1610 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| Xeomin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0259-1620 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| Xeomin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0259-1620 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| Xeomin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0259-4110 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| Xeomin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0259-4110 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| Xeomin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0259-4150 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 50 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| Xeomin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0259-4150 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 50 [USPU] | INTRAMUSCULAR | BLA | 31 sections |
| Dysport | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0299-5962 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 300 U | INTRAMUSCULAR | BLA | 33 sections |
| Dysport | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0299-5962 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 300 U | INTRAMUSCULAR | BLA | 33 sections |
| Dysport | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0299-5962 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 300 U | INTRAMUSCULAR | BLA | 33 sections |
| Dysport | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-0500 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500 U | INTRAMUSCULAR | BLA | 31 sections |
| Dysport | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-0500 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500 U | INTRAMUSCULAR | BLA | 31 sections |
| Dysport | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-0530 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 300 U | INTRAMUSCULAR | BLA | 31 sections |
| Dysport | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-0530 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 300 U | INTRAMUSCULAR | BLA | 31 sections |
| Xeomin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 46783-160 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 [USPU] | INTRAMUSCULAR | BLA | 31 sections |