dimethyl fumarate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4757 | 624-49-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A fumarate derivative that is used as a DERMATOLOGIC AGENT in the treatment of PSORIASIS and SKIN DISEASES. It also may be used as an IMMUNOSUPPRESSIVE AGENT in the treatment of MULTIPLE SCLEROSIS.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.48 | g | O |
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 30, 2014 | EMA | BIOGEN NETHERLANDS B.V. | |
| March 27, 2013 | FDA | BIOGEN IDEC INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Flushing | 4908.91 | 13.63 | 1991 | 53320 | 73096 | 63360615 |
| Multiple sclerosis relapse | 3712.75 | 13.63 | 1443 | 53868 | 47035 | 63386676 |
| Prescribed underdose | 687.09 | 13.63 | 387 | 54924 | 29302 | 63404409 |
| Lymphopenia | 638.15 | 13.63 | 314 | 54997 | 18013 | 63415698 |
| Lymphocyte count decreased | 511.03 | 13.63 | 322 | 54989 | 29935 | 63403776 |
| Abdominal pain upper | 367.01 | 13.63 | 650 | 54661 | 205794 | 63227917 |
| Central nervous system lesion | 366.51 | 13.63 | 181 | 55130 | 10454 | 63423257 |
| Hot flush | 356.07 | 13.63 | 320 | 54991 | 50839 | 63382872 |
| Fall | 341.82 | 13.63 | 926 | 54385 | 391408 | 63042303 |
| General symptom | 334.21 | 13.63 | 116 | 55195 | 2692 | 63431019 |
| Gastrointestinal disorder | 322.75 | 13.63 | 479 | 54832 | 130760 | 63302951 |
| Intentional underdose | 284.26 | 13.63 | 93 | 55218 | 1789 | 63431922 |
| Memory impairment | 269.94 | 13.63 | 390 | 54921 | 103868 | 63329843 |
| Underdose | 251.06 | 13.63 | 201 | 55110 | 27255 | 63406456 |
| Abortion spontaneous | 240.97 | 13.63 | 249 | 55062 | 46946 | 63386765 |
| Diarrhoea | 230.08 | 13.63 | 1226 | 54085 | 714140 | 62719571 |
| Off label use | 223.75 | 13.63 | 158 | 55153 | 674304 | 62759407 |
| Gait disturbance | 215.78 | 13.63 | 486 | 54825 | 182692 | 63251019 |
| Gastric disorder | 214.31 | 13.63 | 210 | 55101 | 37159 | 63396552 |
| Magnetic resonance imaging abnormal | 204.45 | 13.63 | 83 | 55228 | 3002 | 63430709 |
| Balance disorder | 201.43 | 13.63 | 304 | 55007 | 84118 | 63349593 |
| Seizure | 187.37 | 13.63 | 379 | 54932 | 132255 | 63301456 |
| Nausea | 180.06 | 13.63 | 1314 | 53997 | 853157 | 62580554 |
| Pruritus | 175.44 | 13.63 | 700 | 54611 | 360753 | 63072958 |
| Infusion related reaction | 173.64 | 13.63 | 10 | 55301 | 245511 | 63188200 |
| Toxicity to various agents | 169.13 | 13.63 | 12 | 55299 | 247238 | 63186473 |
| Rheumatoid arthritis | 168.88 | 13.63 | 14 | 55297 | 253805 | 63179906 |
| Multiple sclerosis | 162.69 | 13.63 | 149 | 55162 | 24223 | 63409488 |
| Breast cancer | 160.07 | 13.63 | 204 | 55107 | 48179 | 63385532 |
| Vomiting | 158.64 | 13.63 | 928 | 54383 | 558689 | 62875022 |
| Loss of control of legs | 152.08 | 13.63 | 54 | 55257 | 1342 | 63432369 |
| Lymphocyte count abnormal | 148.24 | 13.63 | 45 | 55266 | 670 | 63433041 |
| Burning sensation | 147.25 | 13.63 | 208 | 55103 | 54199 | 63379512 |
| Product use issue | 144.40 | 13.63 | 13 | 55298 | 220507 | 63213204 |
| Urinary tract infection | 142.49 | 13.63 | 530 | 54781 | 264154 | 63169557 |
| Optic neuritis | 135.42 | 13.63 | 87 | 55224 | 8348 | 63425363 |
| Hypoaesthesia | 134.65 | 13.63 | 386 | 54925 | 168007 | 63265704 |
| Invasive ductal breast carcinoma | 132.51 | 13.63 | 80 | 55231 | 6878 | 63426833 |
| Glossodynia | 127.32 | 13.63 | 7 | 55304 | 178869 | 63254842 |
| Pemphigus | 125.36 | 13.63 | 9 | 55302 | 183717 | 63249994 |
| Hand deformity | 120.89 | 13.63 | 4 | 55307 | 159453 | 63274258 |
| Condition aggravated | 113.49 | 13.63 | 110 | 55201 | 402107 | 63031604 |
| Drug hypersensitivity | 113.33 | 13.63 | 65 | 55246 | 310622 | 63123089 |
| Joint swelling | 111.96 | 13.63 | 74 | 55237 | 327592 | 63106119 |
| Muscular weakness | 110.18 | 13.63 | 293 | 55018 | 122060 | 63311651 |
| Acute kidney injury | 109.86 | 13.63 | 46 | 55265 | 263369 | 63170342 |
| Paraesthesia | 107.71 | 13.63 | 341 | 54970 | 156625 | 63277086 |
| Contraindicated product administered | 106.39 | 13.63 | 29 | 55282 | 217619 | 63216092 |
| Maternal exposure during pregnancy | 106.34 | 13.63 | 426 | 54885 | 219636 | 63214075 |
| Systemic lupus erythematosus | 105.63 | 13.63 | 26 | 55285 | 208892 | 63224819 |
| Arthralgia | 102.18 | 13.63 | 215 | 55096 | 569495 | 62864216 |
| White blood cell count decreased | 101.73 | 13.63 | 309 | 55002 | 138795 | 63294916 |
| Cognitive disorder | 99.17 | 13.63 | 176 | 55135 | 55639 | 63378072 |
| Product dose omission issue | 95.71 | 13.63 | 431 | 54880 | 233882 | 63199829 |
| Dyspnoea | 95.63 | 13.63 | 279 | 55032 | 661034 | 62772677 |
| Drug interaction | 95.55 | 13.63 | 40 | 55271 | 229091 | 63204620 |
| Adverse reaction | 91.75 | 13.63 | 74 | 55237 | 10129 | 63423582 |
| Wound | 89.26 | 13.63 | 17 | 55294 | 163246 | 63270465 |
| Chromaturia | 88.53 | 13.63 | 90 | 55221 | 16627 | 63417084 |
| Arthropathy | 87.19 | 13.63 | 48 | 55263 | 234744 | 63198967 |
| Synovitis | 85.71 | 13.63 | 28 | 55283 | 186890 | 63246821 |
| Secondary progressive multiple sclerosis | 83.07 | 13.63 | 35 | 55276 | 1392 | 63432319 |
| Urticaria | 80.06 | 13.63 | 321 | 54990 | 165481 | 63268230 |
| Injection site pain | 76.54 | 13.63 | 11 | 55300 | 129789 | 63303922 |
| Completed suicide | 75.84 | 13.63 | 17 | 55294 | 145656 | 63288055 |
| Exposure during pregnancy | 75.48 | 13.63 | 21 | 55290 | 155526 | 63278185 |
| Product use in unapproved indication | 73.46 | 13.63 | 32 | 55279 | 179048 | 63254663 |
| Gait inability | 73.09 | 13.63 | 150 | 55161 | 52809 | 63380902 |
| Anaemia | 72.98 | 13.63 | 89 | 55222 | 293341 | 63140370 |
| Discomfort | 71.74 | 13.63 | 28 | 55283 | 167346 | 63266365 |
| Peroneal nerve palsy | 70.60 | 13.63 | 47 | 55264 | 4788 | 63428923 |
| Anti-cyclic citrullinated peptide antibody positive | 70.54 | 13.63 | 9 | 55302 | 116203 | 63317508 |
| Hypotension | 69.58 | 13.63 | 81 | 55230 | 272523 | 63161188 |
| Stress | 67.81 | 13.63 | 168 | 55143 | 66999 | 63366712 |
| Feeling hot | 67.58 | 13.63 | 141 | 55170 | 50213 | 63383498 |
| Malignant melanoma | 67.29 | 13.63 | 65 | 55246 | 11291 | 63422420 |
| Musculoskeletal disorder | 66.60 | 13.63 | 86 | 55225 | 20558 | 63413153 |
| Progressive multiple sclerosis | 62.32 | 13.63 | 27 | 55284 | 1151 | 63432560 |
| Herpes zoster | 61.95 | 13.63 | 185 | 55126 | 82277 | 63351434 |
| Paternal exposure before pregnancy | 61.93 | 13.63 | 13 | 55298 | 34 | 63433677 |
| Swelling | 61.87 | 13.63 | 90 | 55221 | 275288 | 63158423 |
| Yellow skin | 61.73 | 13.63 | 33 | 55278 | 2247 | 63431464 |
| Hemianaesthesia | 61.60 | 13.63 | 20 | 55291 | 375 | 63433336 |
| Rheumatoid factor positive | 60.98 | 13.63 | 3 | 55308 | 84403 | 63349308 |
| Progressive multifocal leukoencephalopathy | 60.05 | 13.63 | 65 | 55246 | 12906 | 63420805 |
| Oedema peripheral | 59.18 | 13.63 | 47 | 55264 | 189464 | 63244247 |
| Malignant neoplasm progression | 59.07 | 13.63 | 3 | 55308 | 82118 | 63351593 |
| Trigeminal neuralgia | 58.23 | 13.63 | 37 | 55274 | 3482 | 63430229 |
| Therapeutic product effect decreased | 57.74 | 13.63 | 50 | 55261 | 193137 | 63240574 |
| Injection site erythema | 56.92 | 13.63 | 4 | 55307 | 83170 | 63350541 |
| Caesarean section | 56.59 | 13.63 | 72 | 55239 | 16960 | 63416751 |
| Cough | 56.17 | 13.63 | 106 | 55205 | 292637 | 63141074 |
| Abdominal pain | 55.96 | 13.63 | 442 | 54869 | 293014 | 63140697 |
| Pancytopenia | 55.35 | 13.63 | 9 | 55302 | 96924 | 63336787 |
| Pericarditis | 54.76 | 13.63 | 23 | 55288 | 131556 | 63302155 |
| Muscle spasticity | 54.08 | 13.63 | 80 | 55231 | 21714 | 63411997 |
| Muscle spasms | 54.07 | 13.63 | 274 | 55037 | 155876 | 63277835 |
| Loss of personal independence in daily activities | 53.44 | 13.63 | 10 | 55301 | 97280 | 63336431 |
| Thrombocytopenia | 51.74 | 13.63 | 34 | 55277 | 151123 | 63282588 |
| Oxygen saturation decreased | 51.09 | 13.63 | 8 | 55303 | 88577 | 63345134 |
| JC polyomavirus test positive | 50.85 | 13.63 | 25 | 55286 | 1428 | 63432283 |
| Temperature intolerance | 50.66 | 13.63 | 50 | 55261 | 8914 | 63424797 |
| Blood creatinine increased | 50.51 | 13.63 | 8 | 55303 | 87836 | 63345875 |
| Relapsing-remitting multiple sclerosis | 50.11 | 13.63 | 19 | 55292 | 571 | 63433140 |
| Duodenal ulcer perforation | 50.01 | 13.63 | 8 | 55303 | 87201 | 63346510 |
| Blindness unilateral | 49.32 | 13.63 | 42 | 55269 | 6199 | 63427512 |
| Stomatitis | 49.13 | 13.63 | 30 | 55281 | 138695 | 63295016 |
| Neutropenia | 49.09 | 13.63 | 48 | 55263 | 174957 | 63258754 |
| CD4 lymphocytes decreased | 48.30 | 13.63 | 24 | 55287 | 1403 | 63432308 |
| Haemoglobin decreased | 48.09 | 13.63 | 34 | 55277 | 145451 | 63288260 |
| Wheezing | 48.08 | 13.63 | 12 | 55299 | 95583 | 63338128 |
| Hyponatraemia | 47.47 | 13.63 | 19 | 55292 | 111881 | 63321830 |
| Decreased immune responsiveness | 47.18 | 13.63 | 37 | 55274 | 4864 | 63428847 |
| Dyspepsia | 47.01 | 13.63 | 195 | 55116 | 102001 | 63331710 |
| Agraphia | 46.88 | 13.63 | 10 | 55301 | 29 | 63433682 |
| Abdominal discomfort | 46.47 | 13.63 | 455 | 54856 | 320430 | 63113281 |
| Abdominal distension | 46.09 | 13.63 | 173 | 55138 | 86442 | 63347269 |
| Helicobacter infection | 45.99 | 13.63 | 12 | 55299 | 92773 | 63340938 |
| Skin burning sensation | 45.77 | 13.63 | 56 | 55255 | 12678 | 63421033 |
| Sensory disturbance | 45.74 | 13.63 | 58 | 55253 | 13614 | 63420097 |
| General physical health deterioration | 45.04 | 13.63 | 66 | 55245 | 201336 | 63232375 |
| Product dose omission in error | 44.03 | 13.63 | 43 | 55268 | 7569 | 63426142 |
| Papillary thyroid cancer | 43.11 | 13.63 | 26 | 55285 | 2230 | 63431481 |
| Ocular icterus | 42.73 | 13.63 | 31 | 55280 | 3625 | 63430086 |
| Renal impairment | 42.71 | 13.63 | 12 | 55299 | 88343 | 63345368 |
| Nasal congestion | 42.59 | 13.63 | 4 | 55307 | 65656 | 63368055 |
| Hip fracture | 41.27 | 13.63 | 84 | 55227 | 29390 | 63404321 |
| Drug abuse | 40.81 | 13.63 | 7 | 55304 | 72511 | 63361200 |
| Productive cough | 40.60 | 13.63 | 4 | 55307 | 63204 | 63370507 |
| Disease progression | 40.16 | 13.63 | 29 | 55282 | 122729 | 63310982 |
| Sinusitis | 40.09 | 13.63 | 86 | 55225 | 226567 | 63207144 |
| Erythema | 39.88 | 13.63 | 276 | 55035 | 175475 | 63258236 |
| Band sensation | 39.72 | 13.63 | 18 | 55293 | 855 | 63432856 |
| Impaired self-care | 39.53 | 13.63 | 23 | 55288 | 1847 | 63431864 |
| Pleural effusion | 37.66 | 13.63 | 17 | 55294 | 93193 | 63340518 |
| Depression | 37.42 | 13.63 | 296 | 55015 | 196196 | 63237515 |
| Micturition urgency | 37.39 | 13.63 | 44 | 55267 | 9567 | 63424144 |
| Ophthalmic herpes zoster | 37.33 | 13.63 | 23 | 55288 | 2050 | 63431661 |
| C-reactive protein increased | 37.14 | 13.63 | 18 | 55293 | 94689 | 63339022 |
| Hemiparesis | 37.02 | 13.63 | 70 | 55241 | 23212 | 63410499 |
| Dehydration | 36.86 | 13.63 | 268 | 55043 | 173086 | 63260625 |
| Major depression | 36.80 | 13.63 | 40 | 55271 | 7978 | 63425733 |
| Hyperkalaemia | 35.97 | 13.63 | 3 | 55308 | 54200 | 63379511 |
| Relapsing multiple sclerosis | 35.22 | 13.63 | 11 | 55300 | 181 | 63433530 |
| Drug intolerance | 35.06 | 13.63 | 417 | 54894 | 308244 | 63125467 |
| Uterine leiomyosarcoma | 34.65 | 13.63 | 7 | 55304 | 14 | 63433697 |
| Pain | 34.15 | 13.63 | 448 | 54863 | 740180 | 62693531 |
| Dyspnoea exertional | 33.54 | 13.63 | 6 | 55305 | 60296 | 63373415 |
| Oedema | 33.34 | 13.63 | 22 | 55289 | 97600 | 63336111 |
| Hypertension | 33.22 | 13.63 | 128 | 55183 | 279175 | 63154536 |
| Paraparesis | 33.18 | 13.63 | 22 | 55289 | 2226 | 63431485 |
| Flatulence | 33.13 | 13.63 | 85 | 55226 | 34617 | 63399094 |
| Thyroid cancer | 33.02 | 13.63 | 32 | 55279 | 5579 | 63428132 |
| Prolonged labour | 33.01 | 13.63 | 14 | 55297 | 566 | 63433145 |
| Ankle fracture | 32.59 | 13.63 | 57 | 55254 | 17798 | 63415913 |
| Head injury | 32.50 | 13.63 | 73 | 55238 | 27323 | 63406388 |
| Motor dysfunction | 31.88 | 13.63 | 43 | 55268 | 10718 | 63422993 |
| Mental disorder | 31.80 | 13.63 | 70 | 55241 | 25849 | 63407862 |
| Blindness | 31.76 | 13.63 | 63 | 55248 | 21636 | 63412075 |
| Myelitis | 31.64 | 13.63 | 18 | 55293 | 1385 | 63432326 |
| Hypoglycaemia | 31.27 | 13.63 | 7 | 55304 | 60058 | 63373653 |
| Hypoxia | 31.06 | 13.63 | 7 | 55304 | 59785 | 63373926 |
| Ataxia | 31.04 | 13.63 | 51 | 55260 | 15144 | 63418567 |
| Depressed level of consciousness | 30.81 | 13.63 | 8 | 55303 | 62070 | 63371641 |
| Mobility decreased | 30.31 | 13.63 | 195 | 55116 | 120964 | 63312747 |
| Intraductal proliferative breast lesion | 30.02 | 13.63 | 23 | 55288 | 2922 | 63430789 |
| Urosepsis | 29.83 | 13.63 | 56 | 55255 | 18468 | 63415243 |
| Visual impairment | 29.77 | 13.63 | 149 | 55162 | 84297 | 63349414 |
| International normalised ratio increased | 29.65 | 13.63 | 3 | 55308 | 46422 | 63387289 |
| Blood pressure fluctuation | 29.57 | 13.63 | 3 | 55308 | 46314 | 63387397 |
| Therapy cessation | 29.49 | 13.63 | 75 | 55236 | 30382 | 63403329 |
| Cervix carcinoma | 29.39 | 13.63 | 23 | 55288 | 3014 | 63430697 |
| Appendicitis | 29.27 | 13.63 | 36 | 55275 | 8193 | 63425518 |
| Cardio-respiratory arrest | 29.24 | 13.63 | 8 | 55303 | 59951 | 63373760 |
| Fibromyalgia | 29.01 | 13.63 | 17 | 55294 | 80403 | 63353308 |
| Multiple organ dysfunction syndrome | 28.77 | 13.63 | 7 | 55304 | 56745 | 63376966 |
| CD8 lymphocytes decreased | 28.22 | 13.63 | 9 | 55302 | 159 | 63433552 |
| Hysterectomy | 28.21 | 13.63 | 38 | 55273 | 9461 | 63424250 |
| Hypokalaemia | 27.36 | 13.63 | 30 | 55281 | 103774 | 63329937 |
| Death | 27.33 | 13.63 | 468 | 54843 | 373913 | 63059798 |
| Breast cancer female | 27.01 | 13.63 | 45 | 55266 | 13514 | 63420197 |
| C-reactive protein abnormal | 26.94 | 13.63 | 4 | 55307 | 46092 | 63387619 |
| Bladder disorder | 26.89 | 13.63 | 36 | 55275 | 8910 | 63424801 |
| Cardiac failure | 26.70 | 13.63 | 23 | 55288 | 89119 | 63344592 |
| Coronavirus infection | 26.31 | 13.63 | 25 | 55286 | 4253 | 63429458 |
| Wrong technique in product usage process | 25.76 | 13.63 | 11 | 55300 | 62329 | 63371382 |
| Blood pressure systolic increased | 25.75 | 13.63 | 5 | 55306 | 47392 | 63386319 |
| Electrocardiogram QT prolonged | 25.42 | 13.63 | 10 | 55301 | 59520 | 63374191 |
| Myelitis transverse | 25.32 | 13.63 | 15 | 55296 | 1245 | 63432466 |
| Neoplasm malignant | 25.32 | 13.63 | 70 | 55241 | 29791 | 63403920 |
| Pyrexia | 25.29 | 13.63 | 275 | 55036 | 470203 | 62963508 |
| Lower respiratory tract infection | 25.26 | 13.63 | 48 | 55263 | 132259 | 63301452 |
| Ascites | 25.08 | 13.63 | 3 | 55308 | 40725 | 63392986 |
| Lower limb fracture | 24.87 | 13.63 | 61 | 55250 | 24160 | 63409551 |
| Neuropathy peripheral | 24.66 | 13.63 | 38 | 55273 | 113629 | 63320082 |
| Dysstasia | 24.66 | 13.63 | 56 | 55255 | 21110 | 63412601 |
| Asthenia | 24.64 | 13.63 | 470 | 54841 | 383134 | 63050577 |
| Herpes zoster meningomyelitis | 24.19 | 13.63 | 4 | 55307 | 0 | 63433711 |
| Folliculitis | 23.80 | 13.63 | 16 | 55295 | 70301 | 63363410 |
| Asthma | 23.72 | 13.63 | 47 | 55264 | 127514 | 63306197 |
| Eosinophilic cellulitis | 23.72 | 13.63 | 6 | 55305 | 43 | 63433668 |
| Influenza like illness | 23.62 | 13.63 | 118 | 55193 | 66706 | 63367005 |
| Feeding disorder | 23.54 | 13.63 | 42 | 55269 | 13320 | 63420391 |
| Hypersensitivity | 23.23 | 13.63 | 371 | 54940 | 292314 | 63141397 |
| Gallbladder operation | 23.23 | 13.63 | 18 | 55293 | 2325 | 63431386 |
| Lactic acidosis | 23.14 | 13.63 | 3 | 55308 | 38284 | 63395427 |
| Gastrointestinal haemorrhage | 23.05 | 13.63 | 22 | 55289 | 81154 | 63352557 |
| Injury | 23.05 | 13.63 | 18 | 55293 | 73229 | 63360482 |
| Gastrointestinal pain | 22.99 | 13.63 | 35 | 55276 | 9741 | 63423970 |
| Liver injury | 22.98 | 13.63 | 12 | 55299 | 60508 | 63373203 |
| Weight increased | 22.53 | 13.63 | 134 | 55177 | 260658 | 63173053 |
| Accident | 22.45 | 13.63 | 27 | 55284 | 6005 | 63427706 |
| Glioblastoma | 22.34 | 13.63 | 12 | 55299 | 825 | 63432886 |
| Urinary incontinence | 22.32 | 13.63 | 70 | 55241 | 31944 | 63401767 |
| Blister | 22.32 | 13.63 | 50 | 55261 | 129764 | 63303947 |
| Cervical spinal stenosis | 21.97 | 13.63 | 17 | 55294 | 2191 | 63431520 |
| Muscle tightness | 21.73 | 13.63 | 38 | 55273 | 11862 | 63421849 |
| Concussion | 21.60 | 13.63 | 33 | 55278 | 9211 | 63424500 |
| Invasive lobular breast carcinoma | 21.59 | 13.63 | 12 | 55299 | 883 | 63432828 |
| Injection site bruising | 21.58 | 13.63 | 5 | 55306 | 41905 | 63391806 |
| Diplopia | 21.50 | 13.63 | 57 | 55254 | 23671 | 63410040 |
| Hepatic enzyme increased | 21.39 | 13.63 | 97 | 55214 | 202231 | 63231480 |
| Sedation | 21.28 | 13.63 | 4 | 55307 | 38805 | 63394906 |
| Decubitus ulcer | 21.07 | 13.63 | 35 | 55276 | 10485 | 63423226 |
| Psoriasis | 20.92 | 13.63 | 27 | 55284 | 86930 | 63346781 |
| Tachycardia | 20.73 | 13.63 | 45 | 55266 | 118111 | 63315600 |
| Miliaria | 20.51 | 13.63 | 13 | 55298 | 1218 | 63432493 |
| Renal failure | 20.48 | 13.63 | 45 | 55266 | 117607 | 63316104 |
| Sleep disorder due to general medical condition, insomnia type | 20.35 | 13.63 | 10 | 55301 | 52207 | 63381504 |
| Gastric bypass | 20.32 | 13.63 | 15 | 55296 | 1802 | 63431909 |
| Pancreatic failure | 20.31 | 13.63 | 12 | 55299 | 991 | 63432720 |
| Respiratory failure | 20.29 | 13.63 | 36 | 55275 | 101822 | 63331889 |
| COVID-19 | 20.22 | 13.63 | 168 | 55143 | 112935 | 63320776 |
| Cervical dysplasia | 20.18 | 13.63 | 19 | 55292 | 3195 | 63430516 |
| Bradycardia | 19.48 | 13.63 | 21 | 55290 | 73206 | 63360505 |
| Psoriatic arthropathy | 19.47 | 13.63 | 31 | 55280 | 91489 | 63342222 |
| Rhabdomyolysis | 19.40 | 13.63 | 7 | 55304 | 43944 | 63389767 |
| Muscle injury | 19.40 | 13.63 | 17 | 55294 | 65328 | 63368383 |
| Road traffic accident | 19.33 | 13.63 | 73 | 55238 | 36559 | 63397152 |
| Peripheral swelling | 19.27 | 13.63 | 144 | 55167 | 265798 | 63167913 |
| T-lymphocyte count decreased | 19.23 | 13.63 | 8 | 55303 | 308 | 63433403 |
| Therapy interrupted | 19.09 | 13.63 | 67 | 55244 | 32388 | 63401323 |
| Blood cholesterol increased | 18.94 | 13.63 | 33 | 55278 | 93999 | 63339712 |
| Musculoskeletal pain | 18.94 | 13.63 | 32 | 55279 | 92245 | 63341466 |
| Meningioma | 18.92 | 13.63 | 20 | 55291 | 3865 | 63429846 |
| Primary progressive multiple sclerosis | 18.71 | 13.63 | 6 | 55305 | 108 | 63433603 |
| Upper limb fracture | 18.66 | 13.63 | 47 | 55264 | 18921 | 63414790 |
| Noninfectious myelitis | 18.65 | 13.63 | 4 | 55307 | 12 | 63433699 |
| Facial spasm | 18.60 | 13.63 | 10 | 55301 | 689 | 63433022 |
| Pneumonitis | 18.54 | 13.63 | 4 | 55307 | 35218 | 63398493 |
| Nephrolithiasis | 18.43 | 13.63 | 79 | 55232 | 41905 | 63391806 |
| Inflammation | 18.33 | 13.63 | 27 | 55284 | 82246 | 63351465 |
| Dysphagia | 18.26 | 13.63 | 136 | 55175 | 88449 | 63345262 |
| Herpes simplex encephalitis | 18.25 | 13.63 | 8 | 55303 | 351 | 63433360 |
| Foetal heart rate increased | 18.14 | 13.63 | 3 | 55308 | 0 | 63433711 |
| Abortion | 18.11 | 13.63 | 16 | 55295 | 2480 | 63431231 |
| Limb discomfort | 18.05 | 13.63 | 62 | 55249 | 29654 | 63404057 |
| Needle fatigue | 18.02 | 13.63 | 6 | 55305 | 122 | 63433589 |
| Pulmonary hypertension | 18.01 | 13.63 | 5 | 55306 | 37118 | 63396593 |
| Appendicitis perforated | 18.01 | 13.63 | 14 | 55297 | 1816 | 63431895 |
| Feeling abnormal | 17.93 | 13.63 | 203 | 55108 | 148189 | 63285522 |
| Tibia fracture | 17.57 | 13.63 | 22 | 55289 | 5098 | 63428613 |
| Human papilloma virus test positive | 17.50 | 13.63 | 9 | 55302 | 566 | 63433145 |
| Impaired healing | 17.22 | 13.63 | 40 | 55271 | 102502 | 63331209 |
| Expanded disability status scale score increased | 17.19 | 13.63 | 9 | 55302 | 587 | 63433124 |
| Bronchitis | 17.02 | 13.63 | 54 | 55257 | 124881 | 63308830 |
| Hepatic failure | 16.94 | 13.63 | 5 | 55306 | 35651 | 63398060 |
| Gait spastic | 16.65 | 13.63 | 7 | 55304 | 277 | 63433434 |
| Genital hypoaesthesia | 16.57 | 13.63 | 4 | 55307 | 23 | 63433688 |
| Dermatitis allergic | 16.46 | 13.63 | 39 | 55272 | 15109 | 63418602 |
| Injection site reaction | 16.45 | 13.63 | 16 | 55295 | 58508 | 63375203 |
| Skin warm | 16.40 | 13.63 | 22 | 55289 | 5454 | 63428257 |
| Blood pressure increased | 16.35 | 13.63 | 79 | 55232 | 161983 | 63271728 |
| Hyperglycaemia | 16.34 | 13.63 | 8 | 55303 | 41859 | 63391852 |
| Medication error | 16.26 | 13.63 | 13 | 55298 | 52271 | 63381440 |
| Cholestasis | 16.21 | 13.63 | 3 | 55308 | 29431 | 63404280 |
| Overdose | 16.20 | 13.63 | 49 | 55262 | 115029 | 63318682 |
| Hepatotoxicity | 16.18 | 13.63 | 6 | 55305 | 37035 | 63396676 |
| Malignant neoplasm of unknown primary site | 16.17 | 13.63 | 7 | 55304 | 298 | 63433413 |
| Neurogenic bladder | 16.15 | 13.63 | 17 | 55294 | 3268 | 63430443 |
| Lymphocyte percentage abnormal | 16.02 | 13.63 | 4 | 55307 | 27 | 63433684 |
| Nasal sinus cancer | 16.02 | 13.63 | 4 | 55307 | 27 | 63433684 |
| Mental impairment | 16.00 | 13.63 | 37 | 55274 | 14114 | 63419597 |
| Accidental exposure to product by child | 15.99 | 13.63 | 11 | 55300 | 1182 | 63432529 |
| Anal incontinence | 15.91 | 13.63 | 36 | 55275 | 13540 | 63420171 |
| Hypocalcaemia | 15.90 | 13.63 | 4 | 55307 | 31709 | 63402002 |
| Uterine cancer | 15.71 | 13.63 | 20 | 55291 | 4713 | 63428998 |
| Therapeutic product effect incomplete | 15.70 | 13.63 | 56 | 55255 | 125000 | 63308711 |
| Cardiac arrest | 15.62 | 13.63 | 36 | 55275 | 92509 | 63341202 |
| Drug reaction with eosinophilia and systemic symptoms | 15.61 | 13.63 | 5 | 55306 | 33831 | 63399880 |
| Metabolic acidosis | 15.59 | 13.63 | 10 | 55301 | 45059 | 63388652 |
| Intentional product use issue | 15.58 | 13.63 | 58 | 55253 | 127834 | 63305877 |
| Pulmonary oedema | 15.43 | 13.63 | 15 | 55296 | 54858 | 63378853 |
| Hypervolaemia | 15.43 | 13.63 | 3 | 55308 | 28410 | 63405301 |
| Squamous cell carcinoma of the vulva | 15.43 | 13.63 | 4 | 55307 | 32 | 63433679 |
| Osteoarthritis | 15.36 | 13.63 | 38 | 55273 | 95305 | 63338406 |
| Vertigo | 15.35 | 13.63 | 97 | 55214 | 59790 | 63373921 |
| Somnolence | 15.32 | 13.63 | 92 | 55219 | 178593 | 63255118 |
| Bipolar disorder | 15.30 | 13.63 | 26 | 55285 | 7934 | 63425777 |
| Partial seizures | 15.30 | 13.63 | 22 | 55289 | 5820 | 63427891 |
| Paraplegia | 15.28 | 13.63 | 15 | 55296 | 2657 | 63431054 |
| Hospitalisation | 15.26 | 13.63 | 32 | 55279 | 85049 | 63348662 |
| Adenocarcinoma of the cervix | 15.13 | 13.63 | 6 | 55305 | 204 | 63433507 |
| Nasopharyngitis | 15.12 | 13.63 | 145 | 55166 | 254112 | 63179599 |
| Incorrect dose administered | 15.07 | 13.63 | 18 | 55293 | 59950 | 63373761 |
| Mouth ulceration | 15.00 | 13.63 | 5 | 55306 | 32979 | 63400732 |
| Pyramidal tract syndrome | 15.00 | 13.63 | 7 | 55304 | 356 | 63433355 |
| Melaena | 14.90 | 13.63 | 4 | 55307 | 30361 | 63403350 |
| Joint stiffness | 14.89 | 13.63 | 9 | 55302 | 41860 | 63391851 |
| Protein S increased | 14.85 | 13.63 | 3 | 55308 | 6 | 63433705 |
| Premature delivery | 14.84 | 13.63 | 4 | 55307 | 30277 | 63403434 |
| Inappropriate schedule of product administration | 14.83 | 13.63 | 44 | 55267 | 103921 | 63329790 |
| Cardiac failure congestive | 14.77 | 13.63 | 37 | 55274 | 92396 | 63341315 |
| Platelet count decreased | 14.58 | 13.63 | 52 | 55259 | 116070 | 63317641 |
| Speech disorder | 14.53 | 13.63 | 72 | 55239 | 40557 | 63393154 |
| Decreased interest | 14.53 | 13.63 | 16 | 55295 | 3238 | 63430473 |
| Chronic kidney disease | 14.48 | 13.63 | 11 | 55300 | 45387 | 63388324 |
| Alopecia | 14.27 | 13.63 | 390 | 54921 | 337146 | 63096565 |
| Epistaxis | 14.21 | 13.63 | 26 | 55285 | 72699 | 63361012 |
| Malignant melanoma stage I | 14.20 | 13.63 | 4 | 55307 | 45 | 63433666 |
| Bone pain | 14.17 | 13.63 | 16 | 55295 | 54625 | 63379086 |
| Appendicectomy | 14.08 | 13.63 | 15 | 55296 | 2924 | 63430787 |
| Foetal heart rate abnormal | 13.90 | 13.63 | 8 | 55303 | 629 | 63433082 |
| Macular oedema | 13.85 | 13.63 | 17 | 55294 | 3860 | 63429851 |
| Pneumonia | 13.85 | 13.63 | 298 | 55013 | 456469 | 62977242 |
| Musculoskeletal stiffness | 13.83 | 13.63 | 99 | 55212 | 184519 | 63249192 |
| Aphasia | 13.65 | 13.63 | 61 | 55250 | 32939 | 63400772 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Multiple sclerosis relapse | 1760.54 | 20.86 | 494 | 13600 | 12639 | 34930198 |
| Flushing | 1151.70 | 20.86 | 447 | 13647 | 31973 | 34910864 |
| Prescribed underdose | 232.99 | 20.86 | 99 | 13995 | 8834 | 34934003 |
| Central nervous system lesion | 214.07 | 20.86 | 85 | 14009 | 6378 | 34936459 |
| Lymphopenia | 195.46 | 20.86 | 106 | 13988 | 16229 | 34926608 |
| Lymphocyte count decreased | 178.39 | 20.86 | 112 | 13982 | 22510 | 34920327 |
| Relapsing-remitting multiple sclerosis | 174.86 | 20.86 | 47 | 14047 | 1003 | 34941834 |
| Balance disorder | 170.80 | 20.86 | 137 | 13957 | 40517 | 34902320 |
| Fall | 170.74 | 20.86 | 298 | 13796 | 202587 | 34740250 |
| Memory impairment | 163.16 | 20.86 | 137 | 13957 | 43181 | 34899656 |
| Muscle spasticity | 142.78 | 20.86 | 62 | 14032 | 5826 | 34937011 |
| Gait spastic | 136.23 | 20.86 | 39 | 14055 | 1057 | 34941780 |
| Needle fatigue | 130.67 | 20.86 | 36 | 14058 | 845 | 34941992 |
| General symptom | 130.55 | 20.86 | 36 | 14058 | 848 | 34941989 |
| Gait disturbance | 122.72 | 20.86 | 161 | 13933 | 84979 | 34857858 |
| Hypertonic bladder | 111.88 | 20.86 | 38 | 14056 | 1826 | 34941011 |
| Gastric disorder | 111.82 | 20.86 | 67 | 14027 | 12374 | 34930463 |
| Multiple sclerosis | 107.96 | 20.86 | 53 | 14041 | 6592 | 34936245 |
| Urinary tract infection | 98.61 | 20.86 | 144 | 13950 | 83937 | 34858900 |
| Monoparesis | 96 | 20.86 | 36 | 14058 | 2310 | 34940527 |
| Abdominal discomfort | 93.76 | 20.86 | 118 | 13976 | 59717 | 34883120 |
| Ataxia | 85.77 | 20.86 | 59 | 14035 | 13794 | 34929043 |
| Acute kidney injury | 81.19 | 20.86 | 13 | 14081 | 304975 | 34637862 |
| Hypoaesthesia | 79.01 | 20.86 | 110 | 13984 | 61334 | 34881503 |
| Gastrointestinal disorder | 78.65 | 20.86 | 82 | 14012 | 33866 | 34908971 |
| Hot flush | 73.90 | 20.86 | 60 | 14034 | 18006 | 34924831 |
| Micturition urgency | 71.55 | 20.86 | 40 | 14054 | 6485 | 34936352 |
| Product dose omission issue | 68.72 | 20.86 | 150 | 13944 | 119561 | 34823276 |
| Toxicity to various agents | 68.12 | 20.86 | 3 | 14091 | 200359 | 34742478 |
| Loss of control of legs | 64.60 | 20.86 | 20 | 14074 | 713 | 34942124 |
| Magnetic resonance imaging abnormal | 62.66 | 20.86 | 24 | 14070 | 1632 | 34941205 |
| Abdominal pain upper | 62.39 | 20.86 | 107 | 13987 | 71383 | 34871454 |
| Anaemia | 59.71 | 20.86 | 11 | 14083 | 233324 | 34709513 |
| Mobility decreased | 59.66 | 20.86 | 67 | 14027 | 30061 | 34912776 |
| Movement disorder | 59.43 | 20.86 | 45 | 14049 | 12203 | 34930634 |
| Underdose | 56.85 | 20.86 | 46 | 14048 | 13734 | 34929103 |
| Muscular weakness | 55.75 | 20.86 | 103 | 13991 | 72794 | 34870043 |
| Progressive multiple sclerosis | 54.27 | 20.86 | 14 | 14080 | 253 | 34942584 |
| Intentional underdose | 53.75 | 20.86 | 17 | 14077 | 651 | 34942186 |
| Paraesthesia | 53.31 | 20.86 | 94 | 14000 | 64078 | 34878759 |
| CD8 lymphocytes decreased | 52.40 | 20.86 | 11 | 14083 | 75 | 34942762 |
| Seizure | 51.95 | 20.86 | 124 | 13970 | 104733 | 34838104 |
| Pollakiuria | 51.90 | 20.86 | 51 | 14043 | 19623 | 34923214 |
| Cognitive disorder | 47.15 | 20.86 | 58 | 14036 | 28635 | 34914202 |
| Off label use | 46.35 | 20.86 | 61 | 14033 | 419463 | 34523374 |
| Nocturia | 46.22 | 20.86 | 36 | 14058 | 10174 | 34932663 |
| Hypotension | 46.03 | 20.86 | 16 | 14078 | 221633 | 34721204 |
| Dysarthria | 45.76 | 20.86 | 63 | 14031 | 34719 | 34908118 |
| Herpes zoster | 44.80 | 20.86 | 62 | 14032 | 34337 | 34908500 |
| Musculoskeletal disorder | 42.16 | 20.86 | 28 | 14066 | 6176 | 34936661 |
| Gait inability | 40.81 | 20.86 | 46 | 14048 | 20712 | 34922125 |
| Lymphocyte count abnormal | 40.50 | 20.86 | 16 | 14078 | 1182 | 34941655 |
| Adverse reaction | 39.96 | 20.86 | 21 | 14073 | 3010 | 34939827 |
| T-lymphocyte count decreased | 37.66 | 20.86 | 10 | 14084 | 203 | 34942634 |
| Erectile dysfunction | 37.65 | 20.86 | 44 | 14050 | 20593 | 34922244 |
| Thrombocytopenia | 36.59 | 20.86 | 9 | 14085 | 156238 | 34786599 |
| Neutropenia | 33.07 | 20.86 | 11 | 14083 | 156767 | 34786070 |
| Road traffic accident | 31.49 | 20.86 | 37 | 14057 | 17413 | 34925424 |
| Optic neuritis | 31.46 | 20.86 | 19 | 14075 | 3555 | 34939282 |
| Haemoglobin decreased | 30.20 | 20.86 | 6 | 14088 | 120766 | 34822071 |
| Progressive multifocal leukoencephalopathy | 28.94 | 20.86 | 27 | 14067 | 9737 | 34933100 |
| Dyspnoea | 28.70 | 20.86 | 69 | 14025 | 376713 | 34566124 |
| Congenital supraventricular tachycardia | 28.59 | 20.86 | 5 | 14089 | 10 | 34942827 |
| Renal impairment | 27.52 | 20.86 | 3 | 14091 | 94510 | 34848327 |
| Secondary progressive multiple sclerosis | 27.52 | 20.86 | 9 | 14085 | 384 | 34942453 |
| Oedema peripheral | 25.98 | 20.86 | 8 | 14086 | 119804 | 34823033 |
| Anxiety | 25.45 | 20.86 | 93 | 14001 | 99335 | 34843502 |
| Treatment failure | 25.02 | 20.86 | 57 | 14037 | 46640 | 34896197 |
| Testicular seminoma (pure) stage I | 24.81 | 20.86 | 5 | 14089 | 27 | 34942810 |
| Drug intolerance | 24.80 | 20.86 | 66 | 14028 | 59504 | 34883333 |
| Hemiparesis | 24.48 | 20.86 | 31 | 14063 | 15747 | 34927090 |
| Insomnia | 23.96 | 20.86 | 94 | 14000 | 103813 | 34839024 |
| Hemianaesthesia | 23.88 | 20.86 | 6 | 14088 | 97 | 34942740 |
| Trigeminal neuralgia | 23.60 | 20.86 | 11 | 14083 | 1218 | 34941619 |
| Diarrhoea | 23.49 | 20.86 | 250 | 13844 | 389662 | 34553175 |
| Chromaturia | 23.28 | 20.86 | 29 | 14065 | 14491 | 34928346 |
| Band sensation | 23.02 | 20.86 | 6 | 14088 | 113 | 34942724 |
| Urosepsis | 22.86 | 20.86 | 27 | 14067 | 12772 | 34930065 |
| Pleural effusion | 22.73 | 20.86 | 3 | 14091 | 81543 | 34861294 |
| Product dose omission in error | 22.40 | 20.86 | 13 | 14081 | 2261 | 34940576 |
| Congenital coronary artery malformation | 21.28 | 20.86 | 5 | 14089 | 60 | 34942777 |
| Feeling hot | 20.96 | 20.86 | 32 | 14062 | 19340 | 34923497 |
| Nausea | 20.95 | 20.86 | 219 | 13875 | 339689 | 34603148 |
| Multiple organ dysfunction syndrome | 20.90 | 20.86 | 3 | 14091 | 76563 | 34866274 |
| Hyponatraemia | 20.89 | 20.86 | 4 | 14090 | 82687 | 34860150 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Flushing | 4276.12 | 15.09 | 1715 | 47718 | 86553 | 79608402 |
| Multiple sclerosis relapse | 3954.59 | 15.09 | 1367 | 48066 | 45166 | 79649789 |
| Prescribed underdose | 747.05 | 15.09 | 365 | 49068 | 29149 | 79665806 |
| Lymphopenia | 658.87 | 15.09 | 339 | 49094 | 30218 | 79664737 |
| Lymphocyte count decreased | 448.89 | 15.09 | 309 | 49124 | 46980 | 79647975 |
| Central nervous system lesion | 432.68 | 15.09 | 196 | 49237 | 13172 | 79681783 |
| Abdominal pain upper | 429.85 | 15.09 | 607 | 48826 | 223212 | 79471743 |
| Fall | 403.43 | 15.09 | 914 | 48519 | 486715 | 79208240 |
| Hot flush | 344.84 | 15.09 | 280 | 49153 | 54597 | 79640358 |
| General symptom | 280.05 | 15.09 | 91 | 49342 | 2443 | 79692512 |
| Intentional underdose | 270.19 | 15.09 | 87 | 49346 | 2267 | 79692688 |
| Underdose | 246.77 | 15.09 | 187 | 49246 | 32964 | 79661991 |
| Memory impairment | 230.48 | 15.09 | 314 | 49119 | 111420 | 79583535 |
| Gait disturbance | 227.04 | 15.09 | 437 | 48996 | 207069 | 79487886 |
| Diarrhoea | 226.29 | 15.09 | 1109 | 48324 | 879380 | 78815575 |
| Balance disorder | 219.48 | 15.09 | 288 | 49145 | 98569 | 79596386 |
| Toxicity to various agents | 219.32 | 15.09 | 10 | 49423 | 421530 | 79273425 |
| Nausea | 206.85 | 15.09 | 1149 | 48284 | 956047 | 78738908 |
| Abortion spontaneous | 196.86 | 15.09 | 156 | 49277 | 29351 | 79665604 |
| Off label use | 195.43 | 15.09 | 166 | 49267 | 907049 | 78787906 |
| Multiple sclerosis | 193.60 | 15.09 | 138 | 49295 | 22144 | 79672811 |
| Acute kidney injury | 179.60 | 15.09 | 50 | 49383 | 519354 | 79175601 |
| Pruritus | 178.82 | 15.09 | 594 | 48839 | 394054 | 79300901 |
| Gastric disorder | 178.16 | 15.09 | 163 | 49270 | 37270 | 79657685 |
| Urinary tract infection | 176.54 | 15.09 | 468 | 48965 | 274044 | 79420911 |
| Hypoaesthesia | 171.27 | 15.09 | 357 | 49076 | 178995 | 79515960 |
| Loss of control of legs | 171.19 | 15.09 | 59 | 49374 | 1906 | 79693049 |
| Vomiting | 165.78 | 15.09 | 832 | 48601 | 664996 | 79029959 |
| Gastrointestinal disorder | 160.91 | 15.09 | 279 | 49154 | 121926 | 79573029 |
| Relapsing-remitting multiple sclerosis | 157.56 | 15.09 | 52 | 49381 | 1467 | 79693488 |
| Drug interaction | 155.06 | 15.09 | 34 | 49399 | 415149 | 79279806 |
| Product dose omission issue | 143.13 | 15.09 | 406 | 49027 | 247131 | 79447824 |
| Muscle spasticity | 139.95 | 15.09 | 112 | 49321 | 21363 | 79673592 |
| Invasive ductal breast carcinoma | 137.47 | 15.09 | 69 | 49364 | 5823 | 79689132 |
| Magnetic resonance imaging abnormal | 135.44 | 15.09 | 58 | 49375 | 3401 | 79691554 |
| Maternal exposure during pregnancy | 131.70 | 15.09 | 273 | 49160 | 136265 | 79558690 |
| Burning sensation | 130.34 | 15.09 | 171 | 49262 | 58461 | 79636494 |
| Gait spastic | 128.27 | 15.09 | 42 | 49391 | 1155 | 79693800 |
| Needle fatigue | 127.13 | 15.09 | 39 | 49394 | 863 | 79694092 |
| Seizure | 125.40 | 15.09 | 326 | 49107 | 188508 | 79506447 |
| Optic neuritis | 121.62 | 15.09 | 75 | 49358 | 9445 | 79685510 |
| Condition aggravated | 121.30 | 15.09 | 81 | 49352 | 501043 | 79193912 |
| Breast cancer | 119.38 | 15.09 | 125 | 49308 | 33656 | 79661299 |
| Paraesthesia | 114.61 | 15.09 | 302 | 49131 | 176021 | 79518934 |
| Abdominal discomfort | 107.68 | 15.09 | 371 | 49062 | 250356 | 79444599 |
| Anaemia | 107.57 | 15.09 | 72 | 49361 | 444943 | 79250012 |
| Hypotension | 106.76 | 15.09 | 71 | 49362 | 440246 | 79254709 |
| Infusion related reaction | 98.75 | 15.09 | 13 | 49420 | 230224 | 79464731 |
| Rheumatoid arthritis | 96.40 | 15.09 | 9 | 49424 | 208461 | 79486494 |
| Herpes zoster | 93.12 | 15.09 | 189 | 49244 | 92894 | 79602061 |
| Micturition urgency | 91.16 | 15.09 | 70 | 49363 | 12571 | 79682384 |
| White blood cell count decreased | 89.14 | 15.09 | 288 | 49145 | 188000 | 79506955 |
| Drug hypersensitivity | 87.31 | 15.09 | 38 | 49395 | 298878 | 79396077 |
| Completed suicide | 86.03 | 15.09 | 23 | 49410 | 245744 | 79449211 |
| Pancytopenia | 85.86 | 15.09 | 4 | 49429 | 165741 | 79529214 |
| Lymphocyte count abnormal | 85.66 | 15.09 | 33 | 49400 | 1470 | 79693485 |
| Urticaria | 85.61 | 15.09 | 281 | 49152 | 184920 | 79510035 |
| Muscular weakness | 85.46 | 15.09 | 256 | 49177 | 160473 | 79534482 |
| Product use issue | 85.00 | 15.09 | 14 | 49419 | 209808 | 79485147 |
| Hypertonic bladder | 80.20 | 15.09 | 43 | 49390 | 4158 | 79690797 |
| Blood creatinine increased | 79.49 | 15.09 | 4 | 49429 | 155053 | 79539902 |
| Dyspnoea | 79.22 | 15.09 | 270 | 49163 | 856755 | 78838200 |
| Gait inability | 76.81 | 15.09 | 134 | 49299 | 58783 | 79636172 |
| Thrombocytopenia | 73.92 | 15.09 | 36 | 49397 | 265223 | 79429732 |
| Neutropenia | 71.56 | 15.09 | 45 | 49388 | 287665 | 79407290 |
| Malignant neoplasm progression | 71.36 | 15.09 | 3 | 49430 | 135987 | 79558968 |
| Monoparesis | 70.02 | 15.09 | 37 | 49396 | 3474 | 79691481 |
| Feeling hot | 69.12 | 15.09 | 129 | 49304 | 59605 | 79635350 |
| Progressive multifocal leukoencephalopathy | 68.82 | 15.09 | 74 | 49359 | 20526 | 79674429 |
| Hemianaesthesia | 68.69 | 15.09 | 21 | 49412 | 459 | 79694496 |
| Ataxia | 68.40 | 15.09 | 81 | 49352 | 24958 | 79669997 |
| Dyspepsia | 67.37 | 15.09 | 183 | 49250 | 108504 | 79586451 |
| Secondary progressive multiple sclerosis | 66.75 | 15.09 | 27 | 49406 | 1370 | 79693585 |
| Haemoglobin decreased | 63.64 | 15.09 | 29 | 49404 | 222090 | 79472865 |
| Drug abuse | 63.39 | 15.09 | 12 | 49421 | 162679 | 79532276 |
| Oedema peripheral | 63.37 | 15.09 | 39 | 49394 | 252249 | 79442706 |
| Progressive multiple sclerosis | 63.28 | 15.09 | 25 | 49408 | 1192 | 79693763 |
| Musculoskeletal disorder | 62.96 | 15.09 | 72 | 49361 | 21376 | 79673579 |
| Renal impairment | 62.85 | 15.09 | 11 | 49422 | 157772 | 79537183 |
| General physical health deterioration | 59.40 | 15.09 | 50 | 49383 | 275188 | 79419767 |
| Caesarean section | 58.48 | 15.09 | 54 | 49379 | 12481 | 79682474 |
| Injection site pain | 56.45 | 15.09 | 7 | 49426 | 129831 | 79565124 |
| Hyponatraemia | 56.19 | 15.09 | 20 | 49413 | 177828 | 79517127 |
| Oxygen saturation decreased | 56.00 | 15.09 | 7 | 49426 | 129040 | 79565915 |
| Hyperkalaemia | 55.46 | 15.09 | 4 | 49429 | 114394 | 79580561 |
| Hip fracture | 55.27 | 15.09 | 81 | 49352 | 30680 | 79664275 |
| Abdominal pain | 54.81 | 15.09 | 421 | 49012 | 389148 | 79305807 |
| Pollakiuria | 54.10 | 15.09 | 89 | 49344 | 37228 | 79657727 |
| Skin burning sensation | 53.98 | 15.09 | 53 | 49380 | 13219 | 79681736 |
| Multiple organ dysfunction syndrome | 53.47 | 15.09 | 6 | 49427 | 120240 | 79574715 |
| Mobility decreased | 53.42 | 15.09 | 182 | 49251 | 121993 | 79572962 |
| Product use in unapproved indication | 53.38 | 15.09 | 46 | 49387 | 250313 | 79444642 |
| Cough | 53.23 | 15.09 | 91 | 49342 | 366698 | 79328257 |
| Disease progression | 52.91 | 15.09 | 24 | 49409 | 184338 | 79510617 |
| Trigeminal neuralgia | 52.74 | 15.09 | 31 | 49402 | 3578 | 79691377 |
| CD8 lymphocytes decreased | 52.66 | 15.09 | 15 | 49418 | 254 | 79694701 |
| Decreased immune responsiveness | 52.42 | 15.09 | 36 | 49397 | 5439 | 79689516 |
| Muscle spasms | 51.67 | 15.09 | 230 | 49203 | 174500 | 79520455 |
| Ankle fracture | 49.86 | 15.09 | 57 | 49376 | 16912 | 79678043 |
| Hand deformity | 49.34 | 15.09 | 4 | 49429 | 103915 | 79591040 |
| Stress | 48.28 | 15.09 | 133 | 49300 | 79479 | 79615476 |
| Arthralgia | 47.52 | 15.09 | 188 | 49245 | 571615 | 79123340 |
| Band sensation | 47.42 | 15.09 | 18 | 49415 | 770 | 79694185 |
| Glossodynia | 46.34 | 15.09 | 5 | 49428 | 103332 | 79591623 |
| CD4 lymphocytes decreased | 44.85 | 15.09 | 25 | 49408 | 2609 | 79692346 |
| Peroneal nerve palsy | 44.75 | 15.09 | 34 | 49399 | 6008 | 79688947 |
| Malignant melanoma | 44.14 | 15.09 | 50 | 49383 | 14691 | 79680264 |
| JC polyomavirus test positive | 44.08 | 15.09 | 21 | 49412 | 1581 | 79693374 |
| Alopecia | 43.77 | 15.09 | 269 | 49164 | 231086 | 79463869 |
| Hypersensitivity | 42.94 | 15.09 | 294 | 49139 | 261945 | 79433010 |
| T-lymphocyte count decreased | 41.66 | 15.09 | 15 | 49418 | 552 | 79694403 |
| Sensory disturbance | 41.55 | 15.09 | 49 | 49384 | 15028 | 79679927 |
| Pleural effusion | 41.54 | 15.09 | 19 | 49414 | 145243 | 79549712 |
| Gastrointestinal haemorrhage | 41.19 | 15.09 | 20 | 49413 | 147699 | 79547256 |
| Loss of personal independence in daily activities | 41.18 | 15.09 | 7 | 49426 | 102573 | 79592382 |
| Cognitive disorder | 40.60 | 15.09 | 115 | 49318 | 69811 | 79625144 |
| Prolonged labour | 40.56 | 15.09 | 14 | 49419 | 454 | 79694501 |
| Joint swelling | 39.71 | 15.09 | 74 | 49359 | 288572 | 79406383 |
| Product dose omission in error | 39.17 | 15.09 | 35 | 49398 | 7753 | 79687202 |
| International normalised ratio increased | 38.24 | 15.09 | 4 | 49429 | 84717 | 79610238 |
| Cardiac failure | 37.40 | 15.09 | 25 | 49408 | 154817 | 79540138 |
| Rhabdomyolysis | 37.32 | 15.09 | 9 | 49424 | 103122 | 79591833 |
| Papillary thyroid cancer | 37.23 | 15.09 | 22 | 49411 | 2564 | 79692391 |
| Flatulence | 37.19 | 15.09 | 82 | 49351 | 42642 | 79652313 |
| Road traffic accident | 37.10 | 15.09 | 83 | 49350 | 43581 | 79651374 |
| Wheezing | 37.05 | 15.09 | 13 | 49420 | 116651 | 79578304 |
| Ophthalmic herpes zoster | 36.47 | 15.09 | 22 | 49411 | 2662 | 79692293 |
| Renal failure | 35.91 | 15.09 | 43 | 49390 | 200925 | 79494030 |
| Productive cough | 35.51 | 15.09 | 6 | 49427 | 88325 | 79606630 |
| Hypoxia | 35.47 | 15.09 | 10 | 49423 | 103233 | 79591722 |
| Pemphigus | 35.43 | 15.09 | 9 | 49424 | 99573 | 79595382 |
| Head injury | 35.14 | 15.09 | 74 | 49359 | 37295 | 79657660 |
| Wound | 35.12 | 15.09 | 14 | 49419 | 116165 | 79578790 |
| Abdominal distension | 34.97 | 15.09 | 157 | 49276 | 119493 | 79575462 |
| Arthropathy | 34.83 | 15.09 | 35 | 49398 | 177076 | 79517879 |
| Dyspnoea exertional | 34.82 | 15.09 | 6 | 49427 | 87067 | 79607888 |
| Contraindicated product administered | 34.73 | 15.09 | 28 | 49405 | 157510 | 79537445 |
| Injection site erythema | 34.52 | 15.09 | 4 | 49429 | 78193 | 79616762 |
| Urosepsis | 34.18 | 15.09 | 60 | 49373 | 26435 | 79668520 |
| Headache | 33.86 | 15.09 | 581 | 48852 | 653191 | 79041764 |
| Myelitis | 33.53 | 15.09 | 20 | 49413 | 2371 | 79692584 |
| Ascites | 33.02 | 15.09 | 4 | 49429 | 75558 | 79619397 |
| Cardio-respiratory arrest | 32.93 | 15.09 | 13 | 49420 | 108497 | 79586458 |
| Hypoglycaemia | 32.81 | 15.09 | 11 | 49422 | 101583 | 79593372 |
| Intraductal proliferative breast lesion | 32.77 | 15.09 | 20 | 49413 | 2471 | 79692484 |
| Uterine leiomyosarcoma | 32.44 | 15.09 | 6 | 49427 | 10 | 79694945 |
| Respiratory failure | 32.01 | 15.09 | 39 | 49394 | 180872 | 79514083 |
| Thyroid cancer | 31.91 | 15.09 | 27 | 49406 | 5561 | 79689394 |
| Paraparesis | 31.75 | 15.09 | 23 | 49410 | 3780 | 79691175 |
| Synovitis | 31.74 | 15.09 | 28 | 49405 | 150706 | 79544249 |
| Platelet count decreased | 31.34 | 15.09 | 45 | 49388 | 194619 | 79500336 |
| Nasal congestion | 31.22 | 15.09 | 5 | 49428 | 76547 | 79618408 |
| Exposure during pregnancy | 30.88 | 15.09 | 12 | 49421 | 101120 | 79593835 |
| Oedema | 30.68 | 15.09 | 18 | 49415 | 119562 | 79575393 |
| Blood pressure systolic increased | 30.66 | 15.09 | 3 | 49430 | 66983 | 79627972 |
| Electrocardiogram QT prolonged | 30.59 | 15.09 | 9 | 49424 | 90377 | 79604578 |
| Depressed level of consciousness | 30.29 | 15.09 | 11 | 49422 | 96641 | 79598314 |
| Agraphia | 30.06 | 15.09 | 7 | 49426 | 50 | 79694905 |
| Stomatitis | 30.02 | 15.09 | 28 | 49405 | 146729 | 79548226 |
| Dehydration | 29.86 | 15.09 | 259 | 49174 | 247928 | 79447027 |
| Dysstasia | 29.72 | 15.09 | 58 | 49375 | 27688 | 79667267 |
| C-reactive protein increased | 29.62 | 15.09 | 22 | 49411 | 129005 | 79565950 |
| Decubitus ulcer | 29.18 | 15.09 | 42 | 49391 | 15645 | 79679310 |
| Chromaturia | 29.03 | 15.09 | 55 | 49378 | 25691 | 79669264 |
| Hemiparesis | 28.52 | 15.09 | 64 | 49369 | 33669 | 79661286 |
| Visual impairment | 28.52 | 15.09 | 123 | 49310 | 92008 | 79602947 |
| Erythema | 28.44 | 15.09 | 236 | 49197 | 223054 | 79471901 |
| Invasive lobular breast carcinoma | 28.09 | 15.09 | 12 | 49421 | 699 | 79694256 |
| Major depression | 27.81 | 15.09 | 31 | 49402 | 8949 | 79686006 |
| Systemic lupus erythematosus | 27.37 | 15.09 | 21 | 49412 | 121128 | 79573827 |
| Pyrexia | 27.33 | 15.09 | 279 | 49154 | 678430 | 79016525 |
| Dysarthria | 27.18 | 15.09 | 98 | 49335 | 67524 | 79627431 |
| Anti-cyclic citrullinated peptide antibody positive | 26.85 | 15.09 | 9 | 49424 | 83134 | 79611821 |
| Discomfort | 26.85 | 15.09 | 23 | 49410 | 125594 | 79569361 |
| Rheumatoid factor positive | 26.56 | 15.09 | 3 | 49430 | 59836 | 79635119 |
| Cardiac arrest | 26.52 | 15.09 | 41 | 49392 | 172055 | 79522900 |
| Cystitis | 26.13 | 15.09 | 82 | 49351 | 52650 | 79642305 |
| Decreased interest | 25.62 | 15.09 | 20 | 49413 | 3677 | 79691278 |
| Bladder disorder | 25.61 | 15.09 | 30 | 49403 | 9135 | 79685820 |
| Eosinophilic cellulitis | 25.55 | 15.09 | 7 | 49426 | 102 | 79694853 |
| Gastrointestinal pain | 25.47 | 15.09 | 31 | 49402 | 9824 | 79685131 |
| Erectile dysfunction | 25.45 | 15.09 | 38 | 49395 | 14626 | 79680329 |
| Depression | 25.43 | 15.09 | 225 | 49208 | 216565 | 79478390 |
| Motor dysfunction | 25.32 | 15.09 | 38 | 49395 | 14695 | 79680260 |
| Death | 25.28 | 15.09 | 492 | 48941 | 566022 | 79128933 |
| Insomnia | 25.03 | 15.09 | 247 | 49186 | 244923 | 79450032 |
| Metabolic acidosis | 24.85 | 15.09 | 10 | 49423 | 82519 | 79612436 |
| Pneumonitis | 24.76 | 15.09 | 4 | 49429 | 60856 | 79634099 |
| Muscle tightness | 24.65 | 15.09 | 35 | 49398 | 12879 | 79682076 |
| Nocturia | 24.53 | 15.09 | 36 | 49397 | 13645 | 79681310 |
| Septic shock | 24.45 | 15.09 | 24 | 49409 | 122777 | 79572178 |
| Cervix carcinoma | 24.42 | 15.09 | 16 | 49417 | 2237 | 79692718 |
| Therapeutic product effect decreased | 24.34 | 15.09 | 40 | 49393 | 163823 | 79531132 |
| Lower limb fracture | 24.22 | 15.09 | 48 | 49385 | 23167 | 79671788 |
| Feeding disorder | 23.87 | 15.09 | 39 | 49394 | 16215 | 79678740 |
| Gallbladder operation | 23.60 | 15.09 | 15 | 49418 | 1990 | 79692965 |
| Therapy non-responder | 23.53 | 15.09 | 14 | 49419 | 92291 | 79602664 |
| Hypokalaemia | 23.47 | 15.09 | 33 | 49400 | 144007 | 79550948 |
| Pulmonary oedema | 23.04 | 15.09 | 13 | 49420 | 88241 | 79606714 |
| Cardiac failure congestive | 22.84 | 15.09 | 33 | 49400 | 142369 | 79552586 |
| Somnolence | 22.83 | 15.09 | 74 | 49359 | 238907 | 79456048 |
| Tachycardia | 22.35 | 15.09 | 48 | 49385 | 177720 | 79517235 |
| Product administered to patient of inappropriate age | 22.25 | 15.09 | 22 | 49411 | 5531 | 79689424 |
| Overdose | 22.12 | 15.09 | 51 | 49382 | 184155 | 79510800 |
| Hyperglycaemia | 22.05 | 15.09 | 8 | 49425 | 70327 | 79624628 |
| Asthenia | 21.67 | 15.09 | 441 | 48992 | 511248 | 79183707 |
| Chronic kidney disease | 21.65 | 15.09 | 7 | 49426 | 66147 | 79628808 |
| Neutrophil count decreased | 21.59 | 15.09 | 16 | 49417 | 93943 | 79601012 |
| Cervical spinal stenosis | 21.38 | 15.09 | 15 | 49418 | 2344 | 79692611 |
| Pericarditis | 21.18 | 15.09 | 20 | 49413 | 104216 | 79590739 |
| Movement disorder | 21.15 | 15.09 | 50 | 49383 | 27209 | 79667746 |
| Temperature intolerance | 21.08 | 15.09 | 28 | 49405 | 9677 | 79685278 |
| Tibia fracture | 21.04 | 15.09 | 21 | 49412 | 5340 | 79689615 |
| Limb discomfort | 21.03 | 15.09 | 56 | 49377 | 32794 | 79662161 |
| Glioblastoma | 21.00 | 15.09 | 13 | 49420 | 1647 | 79693308 |
| Hypocalcaemia | 20.95 | 15.09 | 3 | 49430 | 49921 | 79645034 |
| Hepatic failure | 20.89 | 15.09 | 6 | 49427 | 61206 | 79633749 |
| Epistaxis | 20.84 | 15.09 | 23 | 49410 | 111492 | 79583463 |
| Drug reaction with eosinophilia and systemic symptoms | 20.67 | 15.09 | 7 | 49426 | 64237 | 79630718 |
| Accidental exposure to product by child | 20.65 | 15.09 | 16 | 49417 | 2910 | 79692045 |
| Inappropriate schedule of product administration | 20.43 | 15.09 | 32 | 49401 | 133596 | 79561359 |
| Abortion | 20.31 | 15.09 | 12 | 49421 | 1398 | 79693557 |
| Cervical dysplasia | 20.20 | 15.09 | 14 | 49419 | 2147 | 79692808 |
| Sedation | 19.84 | 15.09 | 4 | 49429 | 51891 | 79643064 |
| Treatment failure | 19.83 | 15.09 | 48 | 49385 | 170438 | 79524517 |
| Hypertension | 19.83 | 15.09 | 122 | 49311 | 330870 | 79364085 |
| Koebner phenomenon | 19.80 | 15.09 | 5 | 49428 | 52 | 79694903 |
| Gastroenteritis viral | 19.76 | 15.09 | 46 | 49387 | 24785 | 79670170 |
| Neuropathy peripheral | 19.61 | 15.09 | 36 | 49397 | 141269 | 79553686 |
| Relapsing multiple sclerosis | 19.42 | 15.09 | 6 | 49427 | 136 | 79694819 |
| Lung cancer metastatic | 19.35 | 15.09 | 17 | 49416 | 3682 | 79691273 |
| Depressed mood | 19.26 | 15.09 | 70 | 49363 | 48410 | 79646545 |
| Expanded disability status scale score increased | 19.22 | 15.09 | 9 | 49424 | 652 | 79694303 |
| Anti-myelin-associated glycoprotein antibodies positive | 19.16 | 15.09 | 3 | 49430 | 0 | 79694955 |
| Helicobacter duodenitis | 19.16 | 15.09 | 3 | 49430 | 0 | 79694955 |
| Therapy cessation | 19.15 | 15.09 | 59 | 49374 | 37503 | 79657452 |
| Miliaria | 19.01 | 15.09 | 12 | 49421 | 1574 | 79693381 |
| Malignant melanoma stage I | 18.98 | 15.09 | 6 | 49427 | 147 | 79694808 |
| Pancreatic failure | 18.72 | 15.09 | 12 | 49421 | 1616 | 79693339 |
| Delirium | 18.69 | 15.09 | 15 | 49418 | 84612 | 79610343 |
| Dizziness | 18.57 | 15.09 | 442 | 48991 | 525999 | 79168956 |
| Gastric bypass | 18.55 | 15.09 | 11 | 49422 | 1290 | 79693665 |
| Concussion | 18.50 | 15.09 | 26 | 49407 | 9477 | 79685478 |
| Blood pressure increased | 18.46 | 15.09 | 68 | 49365 | 211292 | 79483663 |
| Accident | 18.45 | 15.09 | 25 | 49408 | 8806 | 79686149 |
| Duodenal ulcer perforation | 18.40 | 15.09 | 9 | 49424 | 66202 | 79628753 |
| Hysterectomy | 18.31 | 15.09 | 21 | 49412 | 6251 | 79688704 |
| Noninfectious myelitis | 18.23 | 15.09 | 4 | 49429 | 21 | 79694934 |
| Haemoptysis | 18.19 | 15.09 | 6 | 49427 | 55993 | 79638962 |
| Agitation | 18.16 | 15.09 | 21 | 49412 | 99694 | 79595261 |
| Product prescribing error | 18.11 | 15.09 | 3 | 49430 | 44810 | 79650145 |
| Vision blurred | 18.06 | 15.09 | 120 | 49313 | 105778 | 79589177 |
| C-reactive protein abnormal | 17.93 | 15.09 | 4 | 49429 | 48363 | 79646592 |
| Testicular seminoma (pure) stage I | 17.92 | 15.09 | 4 | 49429 | 23 | 79694932 |
| Pulmonary hypertension | 17.78 | 15.09 | 4 | 49429 | 48076 | 79646879 |
| COVID-19 | 17.64 | 15.09 | 162 | 49271 | 157512 | 79537443 |
| Fibromyalgia | 17.50 | 15.09 | 9 | 49424 | 64331 | 79630624 |
| Adverse reaction | 17.42 | 15.09 | 25 | 49408 | 9289 | 79685666 |
| Impaired self-care | 17.38 | 15.09 | 14 | 49419 | 2693 | 79692262 |
| Upper limb fracture | 17.38 | 15.09 | 36 | 49397 | 17931 | 79677024 |
| Herpes zoster meningomyelitis | 17.37 | 15.09 | 4 | 49429 | 27 | 79694928 |
| Respiratory arrest | 17.28 | 15.09 | 7 | 49426 | 57543 | 79637412 |
| Dermatitis allergic | 17.16 | 15.09 | 36 | 49397 | 18094 | 79676861 |
| Testicular neoplasm | 17.08 | 15.09 | 3 | 49430 | 3 | 79694952 |
| Hospitalisation | 16.99 | 15.09 | 20 | 49413 | 94216 | 79600739 |
| Pyramidal tract syndrome | 16.96 | 15.09 | 8 | 49425 | 589 | 79694366 |
| Blindness unilateral | 16.93 | 15.09 | 23 | 49410 | 8123 | 79686832 |
| Blood creatine phosphokinase increased | 16.88 | 15.09 | 10 | 49423 | 66080 | 79628875 |
| Myelitis transverse | 16.77 | 15.09 | 12 | 49421 | 1935 | 79693020 |
| Haematuria | 16.77 | 15.09 | 11 | 49422 | 68825 | 79626130 |
| Mental disorder | 16.74 | 15.09 | 50 | 49383 | 31252 | 79663703 |
| Tumefactive multiple sclerosis | 16.63 | 15.09 | 5 | 49428 | 103 | 79694852 |
| Red blood cell sedimentation rate increased | 16.63 | 15.09 | 4 | 49429 | 45938 | 79649017 |
| Vitamin D decreased | 16.59 | 15.09 | 25 | 49408 | 9700 | 79685255 |
| Cardiogenic shock | 16.51 | 15.09 | 3 | 49430 | 41911 | 79653044 |
| Unintentional use for unapproved indication | 16.38 | 15.09 | 6 | 49427 | 232 | 79694723 |
| Lymphocyte percentage abnormal | 16.36 | 15.09 | 4 | 49429 | 36 | 79694919 |
| Fatigue | 16.34 | 15.09 | 718 | 48715 | 929009 | 78765946 |
| Heavy menstrual bleeding | 15.88 | 15.09 | 30 | 49403 | 13981 | 79680974 |
| Squamous cell carcinoma of the vulva | 15.87 | 15.09 | 3 | 49430 | 6 | 79694949 |
| Melaena | 15.85 | 15.09 | 9 | 49424 | 60881 | 79634074 |
| Asthma | 15.74 | 15.09 | 38 | 49395 | 135057 | 79559898 |
| Acute respiratory distress syndrome | 15.64 | 15.09 | 4 | 49429 | 44063 | 79650892 |
| Diplopia | 15.63 | 15.09 | 51 | 49382 | 33415 | 79661540 |
| Neurogenic bladder | 15.62 | 15.09 | 16 | 49417 | 4196 | 79690759 |
| Herpes zoster oticus | 15.60 | 15.09 | 7 | 49426 | 459 | 79694496 |
| Urinary incontinence | 15.35 | 15.09 | 58 | 49375 | 40851 | 79654104 |
| Coronavirus infection | 15.32 | 15.09 | 21 | 49412 | 7476 | 79687479 |
| Coronary artery disease | 15.24 | 15.09 | 11 | 49422 | 65463 | 79629492 |
| Incorrect dose administered | 15.22 | 15.09 | 15 | 49418 | 76615 | 79618340 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L04AX07 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Other immunosuppressants |
| MeSH PA | D003879 | Dermatologic Agents |
| MeSH PA | D007155 | Immunologic Factors |
| MeSH PA | D007166 | Immunosuppressive Agents |
| MeSH PA | D011838 | Radiation-Sensitizing Agents |
| CHEBI has role | CHEBI:76924 | plant metabolites |
| CHEBI has role | CHEBI:77746 | Homo sapiens metabolite |
| CHEBI has role | CHEBI:50748 | antipsoriatic drug |
| CHEBI has role | CHEBI:50846 | Immunologic factor |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Plaque psoriasis | indication | 200965009 | |
| Relapsing remitting multiple sclerosis | indication | 426373005 | DOID:2378 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 120MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 8399514 | Feb. 7, 2028 | METHOD OF TREATING MULTIPLE SCLEROSIS |
| 240MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 8399514 | Feb. 7, 2028 | METHOD OF TREATING MULTIPLE SCLEROSIS |
| 120MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10391160 | March 13, 2035 | METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE |
| 120MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10555993 | March 13, 2035 | METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE |
| 120MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10994003 | March 13, 2035 | METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE |
| 240MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10391160 | March 13, 2035 | METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE |
| 240MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10555993 | March 13, 2035 | METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE |
| 240MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10994003 | March 13, 2035 | METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE |
| 120MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10959972 | Nov. 16, 2035 | METHOD OF TREATING MULTIPLE SCLEROSIS |
| 120MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 11007166 | Nov. 16, 2035 | METHOD OF TREATING MULTIPLE SCLEROSIS |
| 120MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 11007167 | Nov. 16, 2035 | METHOD OF TREATING MULTIPLE SCLEROSIS |
| 120MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 11129806 | Nov. 16, 2035 | METHOD OF TREATING MULTIPLE SCLEROSIS |
| 120MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 11246850 | Nov. 16, 2035 | METHOD OF TREATING MULTIPLE SCLEROSIS |
| 240MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10959972 | Nov. 16, 2035 | METHOD OF TREATING MULTIPLE SCLEROSIS |
| 240MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 11007166 | Nov. 16, 2035 | METHOD OF TREATING MULTIPLE SCLEROSIS |
| 240MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 11007167 | Nov. 16, 2035 | METHOD OF TREATING MULTIPLE SCLEROSIS |
| 240MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 11129806 | Nov. 16, 2035 | METHOD OF TREATING MULTIPLE SCLEROSIS |
| 240MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 11246850 | Nov. 16, 2035 | METHOD OF TREATING MULTIPLE SCLEROSIS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 120MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | Feb. 5, 2023 | INFORMATION ADDED TO THE LABELING DESCRIBING A RANDOMIZED, OPEN-LABEL STUDY THAT EXAMINED THE CONCOMITANT USE OF DIMETHYL FUMARATE AND SEVERAL NON-LIVE VACCINES IN ADULTS 27-55 YEARS OF AGE WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS |
| 240MG | TECFIDERA | BIOGEN INC | N204063 | March 27, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | Feb. 5, 2023 | INFORMATION ADDED TO THE LABELING DESCRIBING A RANDOMIZED, OPEN-LABEL STUDY THAT EXAMINED THE CONCOMITANT USE OF DIMETHYL FUMARATE AND SEVERAL NON-LIVE VACCINES IN ADULTS 27-55 YEARS OF AGE WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Kelch-like ECH-associated protein 1 | Cytosolic other | INHIBITOR | CHEMBL | CHEMBL | |||||
| Hydroxycarboxylic acid receptor 2 | GPCR | Ki | 6.74 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| FO2303MNI2 | UNII |
| D03846 | KEGG_DRUG |
| 4032290 | VUID |
| N0000186952 | NUI |
| 4032290 | VANDF |
| C0058218 | UMLSCUI |
| CHEBI:76004 | CHEBI |
| 9HB | PDB_CHEM_ID |
| CHEMBL2107333 | ChEMBL_ID |
| 637568 | PUBCHEM_CID |
| DB08908 | DRUGBANK_ID |
| CHEMBL589586 | ChEMBL_ID |
| D000069462 | MESH_DESCRIPTOR_UI |
| 7045 | IUPHAR_LIGAND_ID |
| 1373478 | RXNORM |
| 200501 | MMSL |
| 29369 | MMSL |
| 337937 | MMSL |
| d08079 | MMSL |
| 009199 | NDDF |
| 724035008 | SNOMEDCT_US |
| 764365009 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-9218 | CAPSULE | 120 mg | ORAL | NDA | 26 sections |
| dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-9218 | CAPSULE | 120 mg | ORAL | NDA | 26 sections |
| dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-9219 | CAPSULE | 240 mg | ORAL | NDA | 26 sections |
| dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-9219 | CAPSULE | 240 mg | ORAL | NDA | 26 sections |
| Dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0396 | CAPSULE, DELAYED RELEASE | 120 mg | ORAL | ANDA | 28 sections |
| Dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0396 | CAPSULE, DELAYED RELEASE | 120 mg | ORAL | ANDA | 28 sections |
| Dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0396 | CAPSULE, DELAYED RELEASE | 120 mg | ORAL | ANDA | 28 sections |
| Dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0399 | CAPSULE, DELAYED RELEASE | 240 mg | ORAL | ANDA | 28 sections |
| Dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0399 | CAPSULE, DELAYED RELEASE | 240 mg | ORAL | ANDA | 28 sections |
| Dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0399 | CAPSULE, DELAYED RELEASE | 240 mg | ORAL | ANDA | 28 sections |
| DIMETHYL FUMARATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-416 | CAPSULE, DELAYED RELEASE | 120 mg | ORAL | ANDA | 26 sections |
| DIMETHYL FUMARATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-416 | CAPSULE, DELAYED RELEASE | 120 mg | ORAL | ANDA | 26 sections |
| DIMETHYL FUMARATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-417 | CAPSULE, DELAYED RELEASE | 240 mg | ORAL | ANDA | 26 sections |
| DIMETHYL FUMARATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-417 | CAPSULE, DELAYED RELEASE | 240 mg | ORAL | ANDA | 26 sections |
| dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24979-127 | CAPSULE, DELAYED RELEASE | 120 mg | ORAL | ANDA | 18 sections |
| dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24979-127 | CAPSULE, DELAYED RELEASE | 120 mg | ORAL | ANDA | 18 sections |
| dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24979-127 | CAPSULE, DELAYED RELEASE | 120 mg | ORAL | ANDA | 18 sections |
| dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24979-128 | CAPSULE, DELAYED RELEASE | 240 mg | ORAL | ANDA | 18 sections |
| dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24979-128 | CAPSULE, DELAYED RELEASE | 240 mg | ORAL | ANDA | 18 sections |
| dimethyl fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24979-128 | CAPSULE, DELAYED RELEASE | 240 mg | ORAL | ANDA | 18 sections |
| Dimethyl Fumarate | Human Prescription Drug Label | 1 | 31722-657 | CAPSULE, DELAYED RELEASE | 120 mg | ORAL | ANDA | 26 sections |
| Dimethyl Fumarate | Human Prescription Drug Label | 1 | 31722-657 | CAPSULE, DELAYED RELEASE | 120 mg | ORAL | ANDA | 26 sections |
| Dimethyl Fumarate | Human Prescription Drug Label | 1 | 31722-658 | CAPSULE, DELAYED RELEASE | 240 mg | ORAL | ANDA | 26 sections |
| Dimethyl Fumarate | Human Prescription Drug Label | 1 | 31722-658 | CAPSULE, DELAYED RELEASE | 240 mg | ORAL | ANDA | 26 sections |
| DIMETHYL FUMARATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43547-024 | CAPSULE, DELAYED RELEASE | 120 mg | ORAL | ANDA | 25 sections |
| DIMETHYL FUMARATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43547-025 | CAPSULE, DELAYED RELEASE | 240 mg | ORAL | ANDA | 25 sections |
| Dimethyl Fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-429 | CAPSULE, DELAYED RELEASE | 120 mg | ORAL | ANDA | 25 sections |
| Dimethyl Fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-429 | CAPSULE, DELAYED RELEASE | 120 mg | ORAL | ANDA | 25 sections |
| Dimethyl Fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-430 | CAPSULE, DELAYED RELEASE | 240 mg | ORAL | ANDA | 25 sections |
| Dimethyl Fumarate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-430 | CAPSULE, DELAYED RELEASE | 240 mg | ORAL | ANDA | 25 sections |