amantadine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| adamantane derivatives | 144 | 768-94-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An antiviral that is used in the prophylactic or symptomatic treatment of influenza A. It is also used as an antiparkinsonian agent, to treat extrapyramidal reactions, and for postherpetic neuralgia. The mechanisms of its effects in movement disorders are not well understood but probably reflect an increase in synthesis and release of dopamine, with perhaps some inhibition of dopamine uptake.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.20 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 50 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 85 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 37.78 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 90 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 6.60 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 4.80 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.33 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 16 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 14, 1968 | FDA | ENDO PHARMS |
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 |
|---|---|---|---|---|---|---|
| Dyskinesia | 447.99 | 14.03 | 208 | 18312 | 31794 | 63438708 |
| Hallucination | 397.76 | 14.03 | 229 | 18291 | 54588 | 63415914 |
| Multiple sclerosis relapse | 292.78 | 14.03 | 180 | 18340 | 48298 | 63422204 |
| Hallucination, visual | 228.87 | 14.03 | 112 | 18408 | 19186 | 63451316 |
| Fall | 218.49 | 14.03 | 401 | 18119 | 391933 | 63078569 |
| On and off phenomenon | 177.45 | 14.03 | 50 | 18470 | 1785 | 63468717 |
| Stoma site discharge | 174.98 | 14.03 | 48 | 18472 | 1550 | 63468952 |
| Freezing phenomenon | 171.34 | 14.03 | 45 | 18475 | 1227 | 63469275 |
| Multiple sclerosis | 166.44 | 14.03 | 98 | 18422 | 24274 | 63446228 |
| Tremor | 155.35 | 14.03 | 192 | 18328 | 132047 | 63338455 |
| Gait disturbance | 137.07 | 14.03 | 214 | 18306 | 182964 | 63287538 |
| Dystonia | 136.83 | 14.03 | 71 | 18449 | 13748 | 63456754 |
| Bradykinesia | 133.50 | 14.03 | 52 | 18468 | 5136 | 63465366 |
| Neuroleptic malignant syndrome | 116.66 | 14.03 | 61 | 18459 | 11995 | 63458507 |
| Psychotic disorder | 112.29 | 14.03 | 78 | 18442 | 25634 | 63444868 |
| Stoma site erythema | 111.66 | 14.03 | 32 | 18488 | 1215 | 63469287 |
| Muscle rigidity | 110.74 | 14.03 | 58 | 18462 | 11442 | 63459060 |
| Balance disorder | 107.89 | 14.03 | 128 | 18392 | 84294 | 63386208 |
| Therapeutic response shortened | 103.33 | 14.03 | 56 | 18464 | 11832 | 63458670 |
| Corneal oedema | 93.22 | 14.03 | 29 | 18491 | 1464 | 63469038 |
| Urinary tract infection | 89.18 | 14.03 | 221 | 18299 | 264463 | 63206039 |
| Hyperkinesia | 85.39 | 14.03 | 28 | 18492 | 1676 | 63468826 |
| Seizure | 76.45 | 14.03 | 138 | 18382 | 132496 | 63338006 |
| Akinesia | 75.11 | 14.03 | 25 | 18495 | 1568 | 63468934 |
| Parkinsonism hyperpyrexia syndrome | 72.31 | 14.03 | 15 | 18505 | 138 | 63470364 |
| Stoma site pain | 68.91 | 14.03 | 21 | 18499 | 989 | 63469513 |
| Delusion | 65.85 | 14.03 | 42 | 18478 | 11975 | 63458527 |
| Dysphagia | 65.43 | 14.03 | 103 | 18417 | 88482 | 63382020 |
| Acute psychosis | 63.87 | 14.03 | 25 | 18495 | 2500 | 63468002 |
| Hallucinations, mixed | 63.19 | 14.03 | 30 | 18490 | 4799 | 63465703 |
| Speech disorder | 62.74 | 14.03 | 68 | 18452 | 40561 | 63429941 |
| Diarrhoea | 61.65 | 14.03 | 71 | 18449 | 715295 | 62755207 |
| Livedo reticularis | 61.24 | 14.03 | 24 | 18496 | 2408 | 63468094 |
| Joint swelling | 58.87 | 14.03 | 12 | 18508 | 327654 | 63142848 |
| Impulse-control disorder | 56.35 | 14.03 | 17 | 18503 | 773 | 63469729 |
| Infusion related reaction | 56.20 | 14.03 | 4 | 18516 | 245517 | 63224985 |
| Hypokinesia | 55.56 | 14.03 | 40 | 18480 | 13896 | 63456606 |
| Delirium | 53.87 | 14.03 | 70 | 18450 | 50471 | 63420031 |
| Abnormal dreams | 53.30 | 14.03 | 35 | 18485 | 10481 | 63460021 |
| Rheumatoid arthritis | 53.09 | 14.03 | 6 | 18514 | 253813 | 63216689 |
| Rash | 52.34 | 14.03 | 52 | 18468 | 560819 | 62909683 |
| Myoclonus | 50.93 | 14.03 | 40 | 18480 | 15828 | 63454674 |
| Stoma site inflammation | 45.70 | 14.03 | 13 | 18507 | 480 | 63470022 |
| Orthostatic hypotension | 41.55 | 14.03 | 52 | 18468 | 36108 | 63434394 |
| Stoma site hypergranulation | 41.49 | 14.03 | 11 | 18509 | 311 | 63470191 |
| Abdominal discomfort | 39.89 | 14.03 | 22 | 18498 | 320863 | 63149639 |
| Stoma site reaction | 39.09 | 14.03 | 10 | 18510 | 245 | 63470257 |
| Agitation | 38.04 | 14.03 | 65 | 18455 | 59692 | 63410810 |
| Therapeutic product effect variable | 37.74 | 14.03 | 14 | 18506 | 1209 | 63469293 |
| Dopamine dysregulation syndrome | 37.35 | 14.03 | 9 | 18511 | 171 | 63470331 |
| Stoma site extravasation | 36.68 | 14.03 | 10 | 18510 | 315 | 63470187 |
| Treatment failure | 36.32 | 14.03 | 7 | 18513 | 199036 | 63271466 |
| Drug hypersensitivity | 36.21 | 14.03 | 23 | 18497 | 310664 | 63159838 |
| Drug intolerance | 35.77 | 14.03 | 23 | 18497 | 308638 | 63161864 |
| Arthropathy | 35.68 | 14.03 | 12 | 18508 | 234780 | 63235722 |
| Glossodynia | 35.51 | 14.03 | 5 | 18515 | 178871 | 63291631 |
| Dysstasia | 35.45 | 14.03 | 37 | 18483 | 21129 | 63449373 |
| Stoma site infection | 35.34 | 14.03 | 12 | 18508 | 800 | 63469702 |
| Corneal decompensation | 35.32 | 14.03 | 7 | 18513 | 50 | 63470452 |
| Relapsing-remitting multiple sclerosis | 34.91 | 14.03 | 11 | 18509 | 579 | 63469923 |
| Paratonia | 33.61 | 14.03 | 6 | 18514 | 22 | 63470480 |
| Systemic lupus erythematosus | 32.94 | 14.03 | 10 | 18510 | 208908 | 63261594 |
| Arthralgia | 32.55 | 14.03 | 74 | 18446 | 569636 | 62900866 |
| Rapid eye movement sleep behaviour disorder | 32.05 | 14.03 | 9 | 18511 | 317 | 63470185 |
| Cognitive disorder | 32.01 | 14.03 | 58 | 18462 | 55757 | 63414745 |
| Dementia | 31.74 | 14.03 | 33 | 18487 | 18761 | 63451741 |
| Wound | 31.40 | 14.03 | 5 | 18515 | 163258 | 63307244 |
| Nightmare | 31.16 | 14.03 | 33 | 18487 | 19161 | 63451341 |
| Psychotic symptom | 31.03 | 14.03 | 13 | 18507 | 1548 | 63468954 |
| Cerebral atrophy | 31.01 | 14.03 | 19 | 18501 | 5047 | 63465455 |
| Parkinsonism | 30.69 | 14.03 | 25 | 18495 | 10414 | 63460088 |
| Disorientation | 30.68 | 14.03 | 47 | 18473 | 39405 | 63431097 |
| Alopecia | 30.62 | 14.03 | 32 | 18488 | 337504 | 63132998 |
| Parkinson's disease | 30.59 | 14.03 | 12 | 18508 | 1207 | 63469295 |
| Gait inability | 30.33 | 14.03 | 55 | 18465 | 52904 | 63417598 |
| Muscle spasticity | 29.39 | 14.03 | 34 | 18486 | 21760 | 63448742 |
| Posture abnormal | 29.03 | 14.03 | 14 | 18506 | 2318 | 63468184 |
| Memory impairment | 28.83 | 14.03 | 81 | 18439 | 104177 | 63366325 |
| Abnormal behaviour | 28.18 | 14.03 | 33 | 18487 | 21393 | 63449109 |
| Parkinsonian gait | 27.92 | 14.03 | 9 | 18511 | 510 | 63469992 |
| Progressive multifocal leukoencephalopathy | 27.91 | 14.03 | 26 | 18494 | 12945 | 63457557 |
| Depression | 26.84 | 14.03 | 121 | 18399 | 196371 | 63274131 |
| Neutropenia | 26.48 | 14.03 | 9 | 18511 | 174996 | 63295506 |
| Device dislocation | 26.44 | 14.03 | 35 | 18485 | 25670 | 63444832 |
| Swelling | 26.23 | 14.03 | 25 | 18495 | 275353 | 63195149 |
| Sleep talking | 25.68 | 14.03 | 10 | 18510 | 986 | 63469516 |
| Lower respiratory tract infection | 25.56 | 14.03 | 4 | 18516 | 132303 | 63338199 |
| Stoma site odour | 25.31 | 14.03 | 5 | 18515 | 35 | 63470467 |
| Pneumonia aspiration | 25.25 | 14.03 | 40 | 18480 | 34500 | 63436002 |
| Stoma site haemorrhage | 24.98 | 14.03 | 10 | 18510 | 1061 | 63469441 |
| Muscular weakness | 24.52 | 14.03 | 85 | 18435 | 122268 | 63348234 |
| Confusional state | 24.10 | 14.03 | 134 | 18386 | 236246 | 63234256 |
| Lymphopenia | 23.72 | 14.03 | 28 | 18492 | 18299 | 63452203 |
| Urinary incontinence | 23.30 | 14.03 | 37 | 18483 | 31977 | 63438525 |
| Gastrointestinal complication associated with device | 23.28 | 14.03 | 4 | 18516 | 11 | 63470491 |
| Stomatitis | 23.05 | 14.03 | 6 | 18514 | 138719 | 63331783 |
| Device occlusion | 22.37 | 14.03 | 18 | 18502 | 7369 | 63463133 |
| Somnolence | 22.16 | 14.03 | 107 | 18413 | 178578 | 63291924 |
| Motor dysfunction | 22.06 | 14.03 | 21 | 18499 | 10740 | 63459762 |
| Nasopharyngitis | 22.05 | 14.03 | 25 | 18495 | 254232 | 63216270 |
| Extrapyramidal disorder | 21.85 | 14.03 | 23 | 18497 | 13261 | 63457241 |
| Choking | 21.64 | 14.03 | 20 | 18500 | 9859 | 63460643 |
| Device kink | 21.61 | 14.03 | 11 | 18509 | 2043 | 63468459 |
| Tongue biting | 21.61 | 14.03 | 10 | 18510 | 1510 | 63468992 |
| Movement disorder | 21.52 | 14.03 | 29 | 18491 | 21632 | 63448870 |
| Discomfort | 21.47 | 14.03 | 11 | 18509 | 167363 | 63303139 |
| Prescribed underdose | 21.18 | 14.03 | 34 | 18486 | 29655 | 63440847 |
| Stridor | 21.07 | 14.03 | 13 | 18507 | 3497 | 63467005 |
| Chorea | 20.97 | 14.03 | 10 | 18510 | 1614 | 63468888 |
| Mutism | 20.94 | 14.03 | 10 | 18510 | 1620 | 63468882 |
| Compulsive shopping | 20.92 | 14.03 | 8 | 18512 | 751 | 63469751 |
| Pain | 20.73 | 14.03 | 129 | 18391 | 740499 | 62730003 |
| Central nervous system lesion | 20.38 | 14.03 | 20 | 18500 | 10615 | 63459887 |
| Resting tremor | 20.29 | 14.03 | 8 | 18512 | 815 | 63469687 |
| Vitamin B6 deficiency | 20.14 | 14.03 | 5 | 18515 | 108 | 63470394 |
| Sinusitis | 19.96 | 14.03 | 22 | 18498 | 226631 | 63243871 |
| Nausea | 19.92 | 14.03 | 157 | 18363 | 854314 | 62616188 |
| Febrile neutropenia | 19.91 | 14.03 | 5 | 18515 | 118444 | 63352058 |
| Hypernatraemia | 19.84 | 14.03 | 17 | 18503 | 7592 | 63462910 |
| Aggression | 19.70 | 14.03 | 29 | 18491 | 23469 | 63447033 |
| Encephalopathy | 19.49 | 14.03 | 38 | 18482 | 38582 | 63431920 |
| Device issue | 19.43 | 14.03 | 29 | 18491 | 23752 | 63446750 |
| Lymphocyte count decreased | 19.36 | 14.03 | 33 | 18487 | 30224 | 63440278 |
| Camptocormia | 19.28 | 14.03 | 6 | 18514 | 303 | 63470199 |
| Secondary progressive multiple sclerosis | 19.08 | 14.03 | 9 | 18511 | 1418 | 63469084 |
| Blister | 19.08 | 14.03 | 7 | 18513 | 129807 | 63340695 |
| Off label use | 18.59 | 14.03 | 118 | 18402 | 674344 | 62796158 |
| Tardive dyskinesia | 18.21 | 14.03 | 17 | 18503 | 8485 | 63462017 |
| Hyporesponsive to stimuli | 18.02 | 14.03 | 8 | 18512 | 1096 | 63469406 |
| Generalised tonic-clonic seizure | 17.72 | 14.03 | 31 | 18489 | 28985 | 63441517 |
| Compulsive hoarding | 17.68 | 14.03 | 4 | 18516 | 57 | 63470445 |
| Maternal exposure during pregnancy | 17.63 | 14.03 | 23 | 18497 | 220039 | 63250463 |
| Hepatic enzyme increased | 17.42 | 14.03 | 20 | 18500 | 202308 | 63268194 |
| Hip fracture | 17.37 | 14.03 | 31 | 18489 | 29443 | 63441059 |
| Progressive supranuclear palsy | 17.37 | 14.03 | 4 | 18516 | 62 | 63470440 |
| Nocturia | 16.90 | 14.03 | 16 | 18504 | 8125 | 63462377 |
| Fibroma | 16.74 | 14.03 | 7 | 18513 | 830 | 63469672 |
| Immune reconstitution inflammatory syndrome | 16.70 | 14.03 | 14 | 18506 | 6070 | 63464432 |
| Stoma site irritation | 16.62 | 14.03 | 5 | 18515 | 225 | 63470277 |
| Dyspnoea | 16.57 | 14.03 | 119 | 18401 | 661194 | 62809308 |
| Nystagmus | 16.43 | 14.03 | 14 | 18506 | 6206 | 63464296 |
| Loss of consciousness | 16.30 | 14.03 | 73 | 18447 | 118048 | 63352454 |
| Stoma site candida | 16.22 | 14.03 | 3 | 18517 | 14 | 63470488 |
| Muscle spasms | 16.22 | 14.03 | 89 | 18431 | 156061 | 63314441 |
| Hypersexuality | 16.20 | 14.03 | 6 | 18514 | 516 | 63469986 |
| Asthenia | 16.18 | 14.03 | 177 | 18343 | 383427 | 63087075 |
| Abdominal wall wound | 16.04 | 14.03 | 4 | 18516 | 88 | 63470414 |
| Autonomic nervous system imbalance | 15.81 | 14.03 | 10 | 18510 | 2808 | 63467694 |
| Urosepsis | 15.73 | 14.03 | 23 | 18497 | 18501 | 63452001 |
| Mental impairment | 15.69 | 14.03 | 20 | 18500 | 14131 | 63456371 |
| Hyperthermia | 15.32 | 14.03 | 16 | 18504 | 9140 | 63461362 |
| Corneal endotheliitis | 15.32 | 14.03 | 3 | 18517 | 20 | 63470482 |
| Fractured coccyx | 15.15 | 14.03 | 7 | 18513 | 1052 | 63469450 |
| Peroneal nerve palsy | 15.11 | 14.03 | 12 | 18508 | 4823 | 63465679 |
| Exposure during pregnancy | 14.94 | 14.03 | 14 | 18506 | 155533 | 63314969 |
| Device leakage | 14.84 | 14.03 | 14 | 18506 | 7082 | 63463420 |
| Product use issue | 14.81 | 14.03 | 26 | 18494 | 220494 | 63250008 |
| Dementia with Lewy bodies | 14.73 | 14.03 | 5 | 18515 | 333 | 63470169 |
| Malnutrition | 14.47 | 14.03 | 20 | 18500 | 15278 | 63455224 |
| Progressive multiple sclerosis | 14.44 | 14.03 | 7 | 18513 | 1171 | 63469331 |
| Withdrawal syndrome | 14.40 | 14.03 | 23 | 18497 | 19974 | 63450528 |
| Psychiatric symptom | 14.29 | 14.03 | 12 | 18508 | 5211 | 63465291 |
| Corneal disorder | 14.26 | 14.03 | 8 | 18512 | 1806 | 63468696 |
| Serotonin syndrome | 14.20 | 14.03 | 28 | 18492 | 28654 | 63441848 |
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 |
|---|---|---|---|---|---|---|
| Hallucination | 517.38 | 15.75 | 300 | 14166 | 51198 | 34891267 |
| Dyskinesia | 415.51 | 15.75 | 197 | 14269 | 22216 | 34920249 |
| On and off phenomenon | 335.84 | 15.75 | 95 | 14371 | 2402 | 34940063 |
| Hallucination, visual | 256.91 | 15.75 | 132 | 14334 | 17659 | 34924806 |
| Dopamine dysregulation syndrome | 179.87 | 15.75 | 41 | 14425 | 415 | 34942050 |
| Fall | 178.04 | 15.75 | 308 | 14158 | 202577 | 34739888 |
| Freezing phenomenon | 177.76 | 15.75 | 52 | 14414 | 1484 | 34940981 |
| Bradykinesia | 113.23 | 15.75 | 47 | 14419 | 3846 | 34938619 |
| Delusion | 111.81 | 15.75 | 68 | 14398 | 12567 | 34929898 |
| Muscle rigidity | 109.83 | 15.75 | 63 | 14403 | 10455 | 34932010 |
| Stoma site discharge | 101.50 | 15.75 | 32 | 14434 | 1181 | 34941284 |
| Gait disturbance | 100.09 | 15.75 | 148 | 14318 | 84992 | 34857473 |
| Hypersexuality | 98.93 | 15.75 | 33 | 14433 | 1460 | 34941005 |
| Tremor | 96.27 | 15.75 | 143 | 14323 | 82444 | 34860021 |
| Gambling disorder | 95.50 | 15.75 | 33 | 14433 | 1627 | 34940838 |
| Impulse-control disorder | 87.17 | 15.75 | 29 | 14437 | 1272 | 34941193 |
| Stoma site erythema | 86.16 | 15.75 | 26 | 14440 | 827 | 34941638 |
| Balance disorder | 81.33 | 15.75 | 92 | 14374 | 40562 | 34901903 |
| Neuroleptic malignant syndrome | 77.14 | 15.75 | 62 | 14404 | 17872 | 34924593 |
| Agitation | 75.04 | 15.75 | 105 | 14361 | 57294 | 34885171 |
| Confusional state | 73.45 | 15.75 | 175 | 14291 | 143985 | 34798480 |
| Multiple sclerosis | 69.89 | 15.75 | 40 | 14426 | 6605 | 34935860 |
| Multiple sclerosis relapse | 68.70 | 15.75 | 51 | 14415 | 13082 | 34929383 |
| Device dislocation | 66.75 | 15.75 | 38 | 14428 | 6211 | 34936254 |
| Illusion | 65.81 | 15.75 | 21 | 14445 | 806 | 34941659 |
| Hyperkinesia | 64.04 | 15.75 | 25 | 14441 | 1743 | 34940722 |
| Serotonin syndrome | 63.46 | 15.75 | 58 | 14408 | 19875 | 34922590 |
| Stoma site pain | 61.22 | 15.75 | 19 | 14447 | 665 | 34941800 |
| Dystonia | 60.99 | 15.75 | 44 | 14422 | 10801 | 34931664 |
| Parkinsonism hyperpyrexia syndrome | 57.48 | 15.75 | 12 | 14454 | 77 | 34942388 |
| Aggression | 53.48 | 15.75 | 73 | 14393 | 38891 | 34903574 |
| Corneal oedema | 52.12 | 15.75 | 20 | 14446 | 1331 | 34941134 |
| Hypersomnia | 51.45 | 15.75 | 42 | 14424 | 12365 | 34930100 |
| Speech disorder | 51.12 | 15.75 | 58 | 14408 | 25628 | 34916837 |
| Therapeutic product effect variable | 46.68 | 15.75 | 22 | 14444 | 2434 | 34940031 |
| Psychotic disorder | 46.61 | 15.75 | 54 | 14412 | 24398 | 34918067 |
| Embedded device | 46.33 | 15.75 | 13 | 14453 | 318 | 34942147 |
| Stoma site infection | 46.19 | 15.75 | 16 | 14450 | 794 | 34941671 |
| Parkinsonism | 45.71 | 15.75 | 33 | 14433 | 8105 | 34934360 |
| Abnormal behaviour | 45.70 | 15.75 | 54 | 14412 | 24915 | 34917550 |
| Abnormal dreams | 45.49 | 15.75 | 32 | 14434 | 7546 | 34934919 |
| Diarrhoea | 45.42 | 15.75 | 57 | 14409 | 389855 | 34552610 |
| Stoma site inflammation | 45.19 | 15.75 | 14 | 14452 | 487 | 34941978 |
| Febrile neutropenia | 44.92 | 15.75 | 3 | 14463 | 136846 | 34805619 |
| Memory impairment | 40.67 | 15.75 | 68 | 14398 | 43250 | 34899215 |
| Mobility decreased | 40.66 | 15.75 | 56 | 14410 | 30072 | 34912393 |
| Somnolence | 40.32 | 15.75 | 119 | 14347 | 110997 | 34831468 |
| Akinesia | 36.76 | 15.75 | 18 | 14448 | 2166 | 34940299 |
| Cognitive disorder | 36.73 | 15.75 | 52 | 14414 | 28641 | 34913824 |
| Dysphagia | 36.40 | 15.75 | 80 | 14386 | 62301 | 34880164 |
| Neutropenia | 36.28 | 15.75 | 10 | 14456 | 156768 | 34785697 |
| Compulsive shopping | 35.22 | 15.75 | 11 | 14455 | 393 | 34942072 |
| Reduced facial expression | 34.54 | 15.75 | 14 | 14452 | 1077 | 34941388 |
| Paranoia | 34.33 | 15.75 | 33 | 14433 | 12035 | 34930430 |
| Dementia | 34.31 | 15.75 | 35 | 14431 | 13713 | 34928752 |
| Parkinson's disease | 34.15 | 15.75 | 15 | 14451 | 1409 | 34941056 |
| Gambling | 33.02 | 15.75 | 9 | 14457 | 197 | 34942268 |
| Anticholinergic syndrome | 32.50 | 15.75 | 14 | 14452 | 1255 | 34941210 |
| Delirium | 32.25 | 15.75 | 62 | 14404 | 43929 | 34898536 |
| Fibroma | 31.48 | 15.75 | 10 | 14456 | 378 | 34942087 |
| Device connection issue | 30.96 | 15.75 | 10 | 14456 | 399 | 34942066 |
| Pneumonia aspiration | 30.65 | 15.75 | 59 | 14407 | 41844 | 34900621 |
| Posture abnormal | 30.52 | 15.75 | 16 | 14450 | 2223 | 34940242 |
| Choking | 29.69 | 15.75 | 21 | 14445 | 4994 | 34937471 |
| Rapid eye movements sleep abnormal | 29.15 | 15.75 | 8 | 14458 | 180 | 34942285 |
| Hallucination, tactile | 28.94 | 15.75 | 9 | 14457 | 317 | 34942148 |
| Myoclonus | 28.87 | 15.75 | 33 | 14433 | 14692 | 34927773 |
| Middle insomnia | 28.14 | 15.75 | 23 | 14443 | 6779 | 34935686 |
| Sensory disturbance | 27.93 | 15.75 | 22 | 14444 | 6155 | 34936310 |
| Motor dysfunction | 27.64 | 15.75 | 23 | 14443 | 6951 | 34935514 |
| Nocturia | 27.32 | 15.75 | 27 | 14439 | 10183 | 34932282 |
| Stoma site reaction | 27.08 | 15.75 | 8 | 14458 | 236 | 34942229 |
| Deep brain stimulation | 26.33 | 15.75 | 5 | 14461 | 18 | 34942447 |
| Anaemia | 26.17 | 15.75 | 35 | 14431 | 233300 | 34709165 |
| Male sexual dysfunction | 25.67 | 15.75 | 8 | 14458 | 284 | 34942181 |
| Intentional medical device removal by patient | 25.12 | 15.75 | 8 | 14458 | 305 | 34942160 |
| Saccadic eye movement | 24.92 | 15.75 | 7 | 14459 | 172 | 34942293 |
| Nightmare | 24.48 | 15.75 | 30 | 14436 | 14361 | 34928104 |
| Therapeutic response shortened | 24.45 | 15.75 | 22 | 14444 | 7382 | 34935083 |
| Insomnia | 24.20 | 15.75 | 96 | 14370 | 103811 | 34838654 |
| Stoma site extravasation | 23.73 | 15.75 | 6 | 14460 | 97 | 34942368 |
| Thrombocytopenia | 23.72 | 15.75 | 18 | 14448 | 156229 | 34786236 |
| Somatic delusion | 23.67 | 15.75 | 6 | 14460 | 98 | 34942367 |
| Platelet count decreased | 23.59 | 15.75 | 10 | 14456 | 119707 | 34822758 |
| Autonomic nervous system imbalance | 23.25 | 15.75 | 14 | 14452 | 2537 | 34939928 |
| Urinary tract infection | 23.17 | 15.75 | 82 | 14384 | 83999 | 34858466 |
| Persecutory delusion | 23.10 | 15.75 | 14 | 14452 | 2566 | 34939899 |
| Musculoskeletal stiffness | 22.97 | 15.75 | 56 | 14410 | 46624 | 34895841 |
| Bedridden | 22.78 | 15.75 | 16 | 14450 | 3762 | 34938703 |
| Device kink | 22.63 | 15.75 | 8 | 14458 | 422 | 34942043 |
| Hallucinations, mixed | 22.57 | 15.75 | 14 | 14452 | 2675 | 34939790 |
| Rash | 22.44 | 15.75 | 36 | 14430 | 222716 | 34719749 |
| Progressive supranuclear palsy | 22.17 | 15.75 | 5 | 14461 | 48 | 34942417 |
| Disturbance in attention | 22.07 | 15.75 | 39 | 14427 | 25906 | 34916559 |
| Dysstasia | 21.69 | 15.75 | 26 | 14440 | 12169 | 34930296 |
| Anxiety | 21.67 | 15.75 | 90 | 14376 | 99338 | 34843127 |
| Malignant neoplasm progression | 21.54 | 15.75 | 5 | 14461 | 88041 | 34854424 |
| Feeling abnormal | 21.28 | 15.75 | 66 | 14400 | 63169 | 34879296 |
| Parkinsonian gait | 21.05 | 15.75 | 8 | 14458 | 518 | 34941947 |
| Device issue | 21.03 | 15.75 | 23 | 14443 | 9754 | 34932711 |
| Sleep talking | 20.82 | 15.75 | 8 | 14458 | 534 | 34941931 |
| Acute kidney injury | 20.28 | 15.75 | 62 | 14404 | 304926 | 34637539 |
| Movement disorder | 19.98 | 15.75 | 25 | 14441 | 12223 | 34930242 |
| Mydriasis | 19.11 | 15.75 | 19 | 14447 | 7218 | 34935247 |
| Soft tissue mass | 18.97 | 15.75 | 9 | 14457 | 1010 | 34941455 |
| Hyperkalaemia | 18.96 | 15.75 | 3 | 14463 | 69386 | 34873079 |
| Disorientation | 18.71 | 15.75 | 42 | 14424 | 33146 | 34909319 |
| Sepsis | 18.64 | 15.75 | 25 | 14441 | 166536 | 34775929 |
| Facial paresis | 18.59 | 15.75 | 13 | 14453 | 3036 | 34939429 |
| Band neutrophil percentage increased | 18.50 | 15.75 | 5 | 14461 | 106 | 34942359 |
| Depression | 18.19 | 15.75 | 84 | 14382 | 97014 | 34845451 |
| Tic | 18.00 | 15.75 | 11 | 14455 | 2047 | 34940418 |
| Stoma site odour | 17.87 | 15.75 | 4 | 14462 | 37 | 34942428 |
| Sexually inappropriate behaviour | 17.70 | 15.75 | 7 | 14459 | 505 | 34941960 |
| Underdose | 17.67 | 15.75 | 25 | 14441 | 13755 | 34928710 |
| Nasal discomfort | 17.65 | 15.75 | 10 | 14456 | 1618 | 34940847 |
| Cerebral hypoperfusion | 17.54 | 15.75 | 7 | 14459 | 517 | 34941948 |
| Prescribed underdose | 17.47 | 15.75 | 20 | 14446 | 8913 | 34933552 |
| Tension | 17.44 | 15.75 | 11 | 14455 | 2164 | 34940301 |
| Micturition disorder | 17.11 | 15.75 | 11 | 14455 | 2237 | 34940228 |
| Postural reflex impairment | 17.08 | 15.75 | 3 | 14463 | 6 | 34942459 |
| Stoma site induration | 16.85 | 15.75 | 4 | 14462 | 49 | 34942416 |
| Corneal opacity | 16.78 | 15.75 | 7 | 14459 | 579 | 34941886 |
| Depressed mood | 16.38 | 15.75 | 29 | 14437 | 19288 | 34923177 |
| Neuropathy peripheral | 16.33 | 15.75 | 7 | 14459 | 83256 | 34859209 |
| Intentional underdose | 15.90 | 15.75 | 7 | 14459 | 661 | 34941804 |
| Pelvic fracture | 15.78 | 15.75 | 11 | 14455 | 2556 | 34939909 |
| Resting tremor | 15.76 | 15.75 | 7 | 14459 | 675 | 34941790 |
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 |
|---|---|---|---|---|---|---|
| Dyskinesia | 716.07 | 13.40 | 335 | 26917 | 44438 | 79672698 |
| Hallucination | 674.73 | 13.40 | 399 | 26853 | 85346 | 79631790 |
| On and off phenomenon | 415.65 | 13.40 | 114 | 27138 | 3126 | 79714010 |
| Hallucination, visual | 414.81 | 13.40 | 209 | 27043 | 32520 | 79684616 |
| Fall | 318.24 | 13.40 | 584 | 26668 | 487045 | 79230091 |
| Freezing phenomenon | 257.85 | 13.40 | 70 | 27182 | 1844 | 79715292 |
| Multiple sclerosis relapse | 256.28 | 13.40 | 173 | 27079 | 46360 | 79670776 |
| Dopamine dysregulation syndrome | 198.99 | 13.40 | 44 | 27208 | 473 | 79716663 |
| Stoma site discharge | 190.29 | 13.40 | 57 | 27195 | 2152 | 79714984 |
| Tremor | 188.38 | 13.40 | 260 | 26992 | 169823 | 79547313 |
| Neuroleptic malignant syndrome | 174.91 | 13.40 | 112 | 27140 | 27447 | 79689689 |
| Bradykinesia | 172.52 | 13.40 | 74 | 27178 | 7969 | 79709167 |
| Gait disturbance | 168.03 | 13.40 | 274 | 26978 | 207232 | 79509904 |
| Dystonia | 163.81 | 13.40 | 98 | 27154 | 21301 | 79695835 |
| Muscle rigidity | 159.89 | 13.40 | 94 | 27158 | 19788 | 79697348 |
| Multiple sclerosis | 155.05 | 13.40 | 96 | 27156 | 22186 | 79694950 |
| Psychotic disorder | 150.90 | 13.40 | 120 | 27132 | 41282 | 79675854 |
| Corneal oedema | 148.05 | 13.40 | 49 | 27203 | 2571 | 79714565 |
| Impulse-control disorder | 140.89 | 13.40 | 43 | 27209 | 1731 | 79715405 |
| Balance disorder | 135.59 | 13.40 | 168 | 27084 | 98689 | 79618447 |
| Parkinsonism hyperpyrexia syndrome | 128.72 | 13.40 | 27 | 27225 | 221 | 79716915 |
| Hyperkinesia | 126.54 | 13.40 | 44 | 27208 | 2685 | 79714451 |
| Delusion | 124.65 | 13.40 | 81 | 27171 | 20342 | 79696794 |
| Stoma site erythema | 120.32 | 13.40 | 38 | 27214 | 1715 | 79715421 |
| Therapeutic response shortened | 112.02 | 13.40 | 69 | 27183 | 15794 | 79701342 |
| Agitation | 105.14 | 13.40 | 149 | 27103 | 99566 | 79617570 |
| Gambling disorder | 99.11 | 13.40 | 34 | 27218 | 1992 | 79715144 |
| Stoma site pain | 97.57 | 13.40 | 31 | 27221 | 1427 | 79715709 |
| Hypersexuality | 97.25 | 13.40 | 32 | 27220 | 1648 | 79715488 |
| Akinesia | 82.84 | 13.40 | 34 | 27218 | 3278 | 79713858 |
| Urinary tract infection | 80.60 | 13.40 | 241 | 27011 | 274271 | 79442865 |
| Dysphagia | 77.50 | 13.40 | 145 | 27107 | 121991 | 79595145 |
| Serotonin syndrome | 77.47 | 13.40 | 86 | 27166 | 44941 | 79672195 |
| Delirium | 76.99 | 13.40 | 118 | 27134 | 84509 | 79632627 |
| Abnormal dreams | 76.43 | 13.40 | 48 | 27204 | 11364 | 79705772 |
| Diarrhoea | 75.93 | 13.40 | 115 | 27137 | 880374 | 78836762 |
| Speech disorder | 73.75 | 13.40 | 92 | 27160 | 54353 | 79662783 |
| Myoclonus | 73.73 | 13.40 | 67 | 27185 | 27593 | 79689543 |
| Hallucinations, mixed | 70.02 | 13.40 | 38 | 27214 | 6861 | 79710275 |
| Therapeutic product effect variable | 69.19 | 13.40 | 26 | 27226 | 1983 | 79715153 |
| Confusional state | 69.01 | 13.40 | 252 | 27000 | 317745 | 79399391 |
| Stoma site infection | 68.52 | 13.40 | 24 | 27228 | 1496 | 79715640 |
| Seizure | 67.37 | 13.40 | 178 | 27074 | 188656 | 79528480 |
| Acute psychosis | 62.78 | 13.40 | 30 | 27222 | 4150 | 79712986 |
| Parkinsonism | 62.40 | 13.40 | 49 | 27203 | 16535 | 79700601 |
| Abnormal behaviour | 61.68 | 13.40 | 69 | 27183 | 36352 | 79680784 |
| Illusion | 61.66 | 13.40 | 23 | 27229 | 1718 | 79715418 |
| Aggression | 61.00 | 13.40 | 81 | 27171 | 50877 | 79666259 |
| Rheumatoid arthritis | 58.83 | 13.40 | 3 | 27249 | 208467 | 79508669 |
| Dementia | 56.64 | 13.40 | 55 | 27197 | 24604 | 79692532 |
| Febrile neutropenia | 55.08 | 13.40 | 7 | 27245 | 230992 | 79486144 |
| Infusion related reaction | 54.84 | 13.40 | 7 | 27245 | 230230 | 79486906 |
| Joint swelling | 53.67 | 13.40 | 16 | 27236 | 288630 | 79428506 |
| Hypokinesia | 52.43 | 13.40 | 47 | 27205 | 19013 | 79698123 |
| Device dislocation | 52.42 | 13.40 | 54 | 27198 | 25916 | 79691220 |
| Stoma site extravasation | 52.22 | 13.40 | 14 | 27238 | 351 | 79716785 |
| Neutropenia | 51.61 | 13.40 | 17 | 27235 | 287693 | 79429443 |
| Rash | 51.23 | 13.40 | 74 | 27178 | 578284 | 79138852 |
| Pneumonia aspiration | 50.81 | 13.40 | 86 | 27166 | 66881 | 79650255 |
| Compulsive shopping | 49.08 | 13.40 | 16 | 27236 | 800 | 79716336 |
| Stoma site inflammation | 47.40 | 13.40 | 15 | 27237 | 681 | 79716455 |
| Livedo reticularis | 45.57 | 13.40 | 24 | 27228 | 4079 | 79713057 |
| Cognitive disorder | 45.56 | 13.40 | 84 | 27168 | 69842 | 79647294 |
| Parkinson's disease | 44.69 | 13.40 | 18 | 27234 | 1653 | 79715483 |
| Hypersomnia | 43.02 | 13.40 | 46 | 27206 | 23040 | 79694096 |
| Drug hypersensitivity | 42.07 | 13.40 | 25 | 27227 | 298891 | 79418245 |
| Stoma site odour | 42.04 | 13.40 | 9 | 27243 | 82 | 79717054 |
| Somnolence | 40.97 | 13.40 | 176 | 27076 | 238805 | 79478331 |
| Rapid eye movement sleep behaviour disorder | 40.03 | 13.40 | 12 | 27240 | 454 | 79716682 |
| Dysstasia | 39.36 | 13.40 | 48 | 27204 | 27698 | 79689438 |
| Disorientation | 39.13 | 13.40 | 74 | 27178 | 62702 | 79654434 |
| Progressive supranuclear palsy | 38.99 | 13.40 | 9 | 27243 | 119 | 79717017 |
| Autonomic nervous system imbalance | 37.50 | 13.40 | 22 | 27230 | 4608 | 79712528 |
| Arthralgia | 37.42 | 13.40 | 88 | 27164 | 571715 | 79145421 |
| Pancytopenia | 37.22 | 13.40 | 6 | 27246 | 165739 | 79551397 |
| Sleep talking | 37.07 | 13.40 | 14 | 27238 | 1082 | 79716054 |
| Rapid eye movements sleep abnormal | 36.63 | 13.40 | 10 | 27242 | 269 | 79716867 |
| Stoma site hypergranulation | 36.25 | 13.40 | 11 | 27241 | 434 | 79716702 |
| Resting tremor | 35.96 | 13.40 | 15 | 27237 | 1506 | 79715630 |
| Choking | 35.60 | 13.40 | 31 | 27221 | 12070 | 79705066 |
| Nightmare | 35.49 | 13.40 | 44 | 27208 | 25817 | 79691319 |
| Memory impairment | 33.57 | 13.40 | 99 | 27153 | 111635 | 79605501 |
| Orthostatic hypotension | 33.52 | 13.40 | 65 | 27187 | 56099 | 79661037 |
| Drug intolerance | 33.24 | 13.40 | 25 | 27227 | 264094 | 79453042 |
| Nausea | 33.15 | 13.40 | 192 | 27060 | 957004 | 78760132 |
| Cerebral atrophy | 32.86 | 13.40 | 25 | 27227 | 8050 | 79709086 |
| Deep brain stimulation | 32.68 | 13.40 | 7 | 27245 | 64 | 79717072 |
| Paratonia | 32.66 | 13.40 | 6 | 27246 | 22 | 79717114 |
| Prescribed underdose | 32.41 | 13.40 | 45 | 27207 | 29469 | 79687667 |
| Hyperthermia | 31.96 | 13.40 | 35 | 27217 | 18002 | 79699134 |
| Parkinsonian gait | 31.67 | 13.40 | 12 | 27240 | 936 | 79716200 |
| Stomatitis | 31.45 | 13.40 | 6 | 27246 | 146751 | 79570385 |
| Gait inability | 31.35 | 13.40 | 65 | 27187 | 58852 | 79658284 |
| Drug withdrawal syndrome | 30.98 | 13.40 | 48 | 27204 | 34670 | 79682466 |
| Arthropathy | 30.81 | 13.40 | 11 | 27241 | 177100 | 79540036 |
| Psychotic symptom | 30.59 | 13.40 | 16 | 27236 | 2681 | 79714455 |
| Motor dysfunction | 30.39 | 13.40 | 31 | 27221 | 14702 | 79702434 |
| Posture abnormal | 30.34 | 13.40 | 18 | 27234 | 3848 | 79713288 |
| Reduced facial expression | 30.22 | 13.40 | 16 | 27236 | 2749 | 79714387 |
| Paranoia | 29.83 | 13.40 | 35 | 27217 | 19397 | 79697739 |
| Dyspnoea | 29.07 | 13.40 | 173 | 27079 | 856852 | 78860284 |
| Male sexual dysfunction | 28.89 | 13.40 | 8 | 27244 | 227 | 79716909 |
| Stoma site reaction | 28.65 | 13.40 | 9 | 27243 | 399 | 79716737 |
| Nocturia | 28.61 | 13.40 | 29 | 27223 | 13652 | 79703484 |
| Postural reflex impairment | 28.51 | 13.40 | 5 | 27247 | 13 | 79717123 |
| Anxiety | 28.31 | 13.40 | 163 | 27089 | 248349 | 79468787 |
| Middle insomnia | 28.16 | 13.40 | 31 | 27221 | 16038 | 79701098 |
| Insomnia | 28.05 | 13.40 | 161 | 27091 | 245009 | 79472127 |
| Sensory disturbance | 28.02 | 13.40 | 30 | 27222 | 15047 | 79702089 |
| Swelling | 27.93 | 13.40 | 20 | 27232 | 216691 | 79500445 |
| Platelet count decreased | 27.77 | 13.40 | 16 | 27236 | 194648 | 79522488 |
| Treatment failure | 27.34 | 13.40 | 12 | 27240 | 170474 | 79546662 |
| Gambling | 26.96 | 13.40 | 8 | 27244 | 292 | 79716844 |
| Mutism | 26.70 | 13.40 | 14 | 27238 | 2358 | 79714778 |
| Withdrawal syndrome | 26.62 | 13.40 | 39 | 27213 | 26815 | 79690321 |
| Saccadic eye movement | 26.44 | 13.40 | 7 | 27245 | 167 | 79716969 |
| Malignant neoplasm progression | 26.25 | 13.40 | 7 | 27245 | 135983 | 79581153 |
| Relapsing-remitting multiple sclerosis | 26.21 | 13.40 | 12 | 27240 | 1507 | 79715629 |
| Abdominal discomfort | 25.33 | 13.40 | 29 | 27223 | 250698 | 79466438 |
| Depressed mood | 25.22 | 13.40 | 53 | 27199 | 48427 | 79668709 |
| Movement disorder | 24.76 | 13.40 | 38 | 27214 | 27221 | 79689915 |
| Stereotypy | 24.65 | 13.40 | 10 | 27242 | 935 | 79716201 |
| Device occlusion | 24.54 | 13.40 | 25 | 27227 | 11841 | 79705295 |
| Persecutory delusion | 24.05 | 13.40 | 17 | 27235 | 4892 | 79712244 |
| Secondary progressive multiple sclerosis | 23.99 | 13.40 | 11 | 27241 | 1386 | 79715750 |
| Anticholinergic syndrome | 23.70 | 13.40 | 15 | 27237 | 3596 | 79713540 |
| Device connection issue | 23.65 | 13.40 | 10 | 27242 | 1038 | 79716098 |
| Device issue | 23.52 | 13.40 | 37 | 27215 | 27071 | 79690065 |
| Death | 23.46 | 13.40 | 296 | 26956 | 566218 | 79150918 |
| Encephalopathy | 23.45 | 13.40 | 63 | 27189 | 67334 | 79649802 |
| Camptocormia | 23.13 | 13.40 | 8 | 27244 | 480 | 79716656 |
| Alopecia | 23.10 | 13.40 | 27 | 27225 | 231328 | 79485808 |
| Stoma site induration | 23.03 | 13.40 | 5 | 27247 | 49 | 79717087 |
| Depression | 22.63 | 13.40 | 139 | 27113 | 216651 | 79500485 |
| Glossodynia | 22.62 | 13.40 | 4 | 27248 | 103333 | 79613803 |
| Extrapyramidal disorder | 22.57 | 13.40 | 33 | 27219 | 22646 | 79694490 |
| Mobility decreased | 22.48 | 13.40 | 92 | 27160 | 122083 | 79595053 |
| Stoma site oedema | 22.11 | 13.40 | 5 | 27247 | 60 | 79717076 |
| Corneal decompensation | 22.03 | 13.40 | 5 | 27247 | 61 | 79717075 |
| Nasopharyngitis | 21.92 | 13.40 | 33 | 27219 | 253848 | 79463288 |
| Pain | 21.80 | 13.40 | 146 | 27106 | 703656 | 79013480 |
| Urinary incontinence | 21.60 | 13.40 | 45 | 27207 | 40864 | 79676272 |
| Urticaria | 21.46 | 13.40 | 19 | 27233 | 185182 | 79531954 |
| Hip fracture | 21.36 | 13.40 | 38 | 27214 | 30723 | 79686413 |
| Pruritus | 21.08 | 13.40 | 67 | 27185 | 394581 | 79322555 |
| Mental status changes | 20.75 | 13.40 | 60 | 27192 | 66899 | 79650237 |
| Delusion of grandeur | 20.66 | 13.40 | 10 | 27242 | 1422 | 79715714 |
| Headache | 20.56 | 13.40 | 135 | 27117 | 653637 | 79063499 |
| Somatic delusion | 20.12 | 13.40 | 8 | 27244 | 710 | 79716426 |
| Discomfort | 19.89 | 13.40 | 9 | 27243 | 125608 | 79591528 |
| Embedded device | 19.84 | 13.40 | 13 | 27239 | 3306 | 79713830 |
| Vomiting | 19.69 | 13.40 | 140 | 27112 | 665688 | 79051448 |
| Neuropathy peripheral | 19.61 | 13.40 | 12 | 27240 | 141293 | 79575843 |
| Muscle spasticity | 19.59 | 13.40 | 30 | 27222 | 21445 | 79695691 |
| Generalised tonic-clonic seizure | 19.44 | 13.40 | 45 | 27207 | 43865 | 79673271 |
| Underdose | 19.33 | 13.40 | 38 | 27214 | 33113 | 79684023 |
| Hallucination, auditory | 19.01 | 13.40 | 29 | 27223 | 20664 | 79696472 |
| Anaemia | 18.91 | 13.40 | 83 | 27169 | 444932 | 79272204 |
| Decubitus ulcer | 18.86 | 13.40 | 25 | 27227 | 15662 | 79701474 |
| Corneal disorder | 18.85 | 13.40 | 11 | 27241 | 2280 | 79714856 |
| Thrombocytopenia | 18.81 | 13.40 | 39 | 27213 | 265220 | 79451916 |
| Systemic lupus erythematosus | 18.69 | 13.40 | 9 | 27243 | 121140 | 79595996 |
| Soft tissue mass | 18.60 | 13.40 | 9 | 27243 | 1279 | 79715857 |
| Sexually inappropriate behaviour | 18.57 | 13.40 | 7 | 27245 | 538 | 79716598 |
| Blood creatine phosphokinase increased | 18.37 | 13.40 | 57 | 27195 | 66033 | 79651103 |
| Intentional product use issue | 18.37 | 13.40 | 15 | 27237 | 152097 | 79565039 |
| Disturbance in attention | 18.19 | 13.40 | 48 | 27204 | 50753 | 79666383 |
| Device kink | 18.02 | 13.40 | 10 | 27242 | 1885 | 79715251 |
| Tardive dyskinesia | 17.84 | 13.40 | 20 | 27232 | 10551 | 79706585 |
| Hallucination, tactile | 17.82 | 13.40 | 7 | 27245 | 602 | 79716534 |
| Progressive multifocal leukoencephalopathy | 17.71 | 13.40 | 28 | 27224 | 20572 | 79696564 |
| Neuroprosthesis implantation | 17.65 | 13.40 | 3 | 27249 | 6 | 79717130 |
| Hypernatraemia | 17.33 | 13.40 | 23 | 27229 | 14428 | 79702708 |
| Head injury | 17.32 | 13.40 | 39 | 27213 | 37330 | 79679806 |
| Intentional medical device removal by patient | 17.02 | 13.40 | 6 | 27246 | 381 | 79716755 |
| Blister | 16.78 | 13.40 | 10 | 27242 | 119466 | 79597670 |
| Psychiatric symptom | 16.73 | 13.40 | 16 | 27236 | 7019 | 79710117 |
| Mental impairment | 16.53 | 13.40 | 26 | 27226 | 19010 | 79698126 |
| Compulsive hoarding | 16.33 | 13.40 | 4 | 27248 | 69 | 79717067 |
| Constipation | 16.33 | 13.40 | 158 | 27094 | 282892 | 79434244 |
| Sinusitis | 16.30 | 13.40 | 26 | 27226 | 195475 | 79521661 |
| Musculoskeletal stiffness | 16.28 | 13.40 | 109 | 27143 | 174899 | 79542237 |
| Stridor | 16.10 | 13.40 | 14 | 27238 | 5439 | 79711697 |
| Intentional underdose | 16.01 | 13.40 | 10 | 27242 | 2344 | 79714792 |
| Stoma site candida | 15.93 | 13.40 | 3 | 27249 | 13 | 79717123 |
| Hypersensitivity | 15.83 | 13.40 | 42 | 27210 | 262197 | 79454939 |
| Chorea | 15.77 | 13.40 | 10 | 27242 | 2407 | 79714729 |
| Bedridden | 15.69 | 13.40 | 20 | 27232 | 12059 | 79705077 |
| Dementia with Lewy bodies | 15.60 | 13.40 | 7 | 27245 | 839 | 79716297 |
| Incoherent | 15.53 | 13.40 | 16 | 27236 | 7676 | 79709460 |
| Saliva altered | 15.52 | 13.40 | 6 | 27246 | 494 | 79716642 |
| Muscular weakness | 15.49 | 13.40 | 101 | 27151 | 160628 | 79556508 |
| Ataxia | 14.96 | 13.40 | 29 | 27223 | 25010 | 79692126 |
| Dysarthria | 14.96 | 13.40 | 54 | 27198 | 67568 | 79649568 |
| Cardiac failure congestive | 14.89 | 13.40 | 16 | 27236 | 142386 | 79574750 |
| Urinary hesitation | 14.76 | 13.40 | 12 | 27240 | 4254 | 79712882 |
| Wheezing | 14.72 | 13.40 | 11 | 27241 | 116653 | 79600483 |
| Incontinence | 14.66 | 13.40 | 21 | 27231 | 14143 | 79702993 |
| Cough | 14.62 | 13.40 | 70 | 27182 | 366719 | 79350417 |
| Injection site necrosis | 14.61 | 13.40 | 8 | 27244 | 1470 | 79715666 |
| Mania | 14.58 | 13.40 | 24 | 27228 | 18236 | 79698900 |
| Leukocytosis | 14.50 | 13.40 | 40 | 27212 | 43415 | 79673721 |
| Volvulus | 14.44 | 13.40 | 10 | 27242 | 2786 | 79714350 |
| Tongue biting | 14.40 | 13.40 | 9 | 27243 | 2112 | 79715024 |
| Periphlebitis | 14.36 | 13.40 | 3 | 27249 | 24 | 79717112 |
| Asthenia | 14.33 | 13.40 | 250 | 27002 | 511439 | 79205697 |
| Therapeutic response unexpected | 14.31 | 13.40 | 25 | 27227 | 19921 | 79697215 |
| Aspiration | 14.12 | 13.40 | 25 | 27227 | 20133 | 79697003 |
| Impulsive behaviour | 14.11 | 13.40 | 10 | 27242 | 2890 | 79714246 |
| Oromandibular dystonia | 14.11 | 13.40 | 7 | 27245 | 1051 | 79716085 |
| Lower respiratory tract infection | 14.09 | 13.40 | 14 | 27238 | 129206 | 79587930 |
| Abdominal pain | 14.03 | 13.40 | 77 | 27175 | 389492 | 79327644 |
| Vitamin B6 deficiency | 13.84 | 13.40 | 5 | 27247 | 341 | 79716795 |
| Feeding disorder | 13.84 | 13.40 | 22 | 27230 | 16232 | 79700904 |
| Hypotension | 13.77 | 13.40 | 91 | 27161 | 440226 | 79276910 |
| Chest pain | 13.65 | 13.40 | 50 | 27202 | 282254 | 79434882 |
| Screaming | 13.47 | 13.40 | 11 | 27241 | 3922 | 79713214 |
| Torticollis | 13.43 | 13.40 | 9 | 27243 | 2378 | 79714758 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N04BB01 | NERVOUS SYSTEM ANTI-PARKINSON DRUGS DOPAMINERGIC AGENTS Adamantane derivatives |
| FDA MoA | N0000175542 | M2 Protein Inhibitors |
| FDA EPC | N0000175543 | Influenza A M2 Protein Inhibitor |
| CHEBI has role | CHEBI:36044 | antiviral drugs |
| CHEBI has role | CHEBI:48407 | antiparkinson agent |
| CHEBI has role | CHEBI:48560 | dopaminergic agents |
| CHEBI has role | CHEBI:60643 | N-methyl-D-aspartate receptor antagonists |
| CHEBI has role | CHEBI:22587 | antiviral agents |
| CHEBI has role | CHEBI:51065 | Dopamine receptor agonist |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D018712 | Analgesics, Non-Narcotic |
| MeSH PA | D018726 | Anti-Dyskinesia Agents |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000978 | Antiparkinson Agents |
| MeSH PA | D000998 | Antiviral Agents |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D015259 | Dopamine Agents |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D018689 | Sensory System Agents |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Postencephalitic parkinsonism | indication | 19972008 | DOID:14332 |
| Parkinsonism | indication | 32798002 | |
| Parkinson's disease | indication | 49049000 | DOID:14330 |
| Extrapyramidal disease | indication | 76349003 | |
| Influenza due to Influenza A virus | indication | 442438000 | |
| Arteriosclerotic Parkinsonism | indication | ||
| Influenza A Prevention | indication | ||
| Jakob-Creutzfeldt disease | off-label use | 792004 | DOID:11949 |
| Cognitive impairment following traumatic brain injury | off-label use | 127295002 | |
| Arousal post traumatic brain injury | off-label use | 127295002 | |
| Cognitive Impairment following Traumatic Brain Injury | off-label use | ||
| Fatigue due to Multiple Sclerosis | off-label use | ||
| Suicidal thoughts | contraindication | 6471006 | |
| Orthostatic hypotension | contraindication | 28651003 | |
| Eczema | contraindication | 43116000 | |
| Chronic heart failure | contraindication | 48447003 | |
| Substance abuse | contraindication | 66214007 | |
| Psychotic disorder | contraindication | 69322001 | |
| Epilepsy | contraindication | 84757009 | DOID:1826 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Edema | contraindication | 267038008 | |
| Malignant melanoma | contraindication | 372244006 | |
| Angle-closure glaucoma | contraindication | 392291006 | DOID:13550 |
| Psychiatric Disturbance | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.4 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8895615 | Nov. 23, 2025 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8895616 | Nov. 23, 2025 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8895617 | Nov. 23, 2025 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8895615 | Nov. 23, 2025 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8895616 | Nov. 23, 2025 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8895617 | Nov. 23, 2025 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8895615 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8895615 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8895616 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8895616 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8895617 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8895617 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 9072697 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 9072697 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8895615 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8895615 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8895616 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8895616 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8895617 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8895617 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 9072697 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 9072697 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8895615 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8895615 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8895616 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8895616 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8895617 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8895617 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 9072697 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 9072697 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8796337 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8895615 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8895615 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8895616 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8895616 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8895617 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8895617 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 9072697 | Nov. 23, 2025 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 9072697 | Nov. 23, 2025 | TREATMENT OF PARKINSONS DISEASE |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8574626 | Nov. 28, 2025 | A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8574626 | Nov. 28, 2025 | A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8574626 | Nov. 28, 2025 | A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8574626 | Nov. 28, 2025 | A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8389578 | Jan. 22, 2028 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING IMMEDIATE RELEASE LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8389578 | Jan. 22, 2028 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING IMMEDIATE RELEASE LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8389578 | Jan. 22, 2028 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8389578 | Jan. 22, 2028 | TREATMENT OF PARKINSONS DISEASE |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8389578 | Jan. 22, 2028 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8389578 | Jan. 22, 2028 | TREATMENT OF PARKINSONS DISEASE |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8389578 | Jan. 22, 2028 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 8389578 | Jan. 22, 2028 | TREATMENT OF PARKINSONS DISEASE |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8389578 | Jan. 22, 2028 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8389578 | Jan. 22, 2028 | TREATMENT OF PARKINSONS DISEASE |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11197835 | Dec. 2, 2030 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8741343 | Dec. 2, 2030 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9867791 | Dec. 2, 2030 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9867792 | Dec. 2, 2030 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9867793 | Dec. 2, 2030 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9877933 | Dec. 2, 2030 | TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11197835 | Dec. 2, 2030 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8741343 | Dec. 2, 2030 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9867791 | Dec. 2, 2030 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9867792 | Dec. 2, 2030 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9867793 | Dec. 2, 2030 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9877933 | Dec. 2, 2030 | TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 10646456 | June 17, 2034 | TREATMENT OF DYSKINESIA, DECREASING OFF TIME, AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 10646456 | June 17, 2034 | TREATMENT OF DYSKINESIA, DECREASING OFF TIME, AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 10154971 | Dec. 4, 2034 | TREATMENT OF DYSKINESIA AND DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 10154971 | Dec. 4, 2034 | TREATMENT OF DYSKINESIA AND DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 10213393 | Feb. 15, 2038 | A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 10213394 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 10500170 | Feb. 15, 2038 | A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 10500171 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 10500172 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 129MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 10512617 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10213393 | Feb. 15, 2038 | A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10213394 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10500170 | Feb. 15, 2038 | A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10500171 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10500172 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 161MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | April 22, 2020 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10512617 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 10213393 | Feb. 15, 2038 | A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 10213394 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 10500170 | Feb. 15, 2038 | A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 10500171 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 10500172 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 193MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | RX | TABLET, EXTENDED RELEASE | ORAL | 10512617 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10213393 | Feb. 15, 2038 | A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10213394 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10500170 | Feb. 15, 2038 | A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10500171 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10500172 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 258MG BASE | OSMOLEX ER | ADAMAS OPERATIONS | N209410 | Feb. 16, 2018 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10512617 | Feb. 15, 2038 | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11077073 | Aug. 23, 2038 | DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11077073 | Aug. 23, 2038 | TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11077073 | Aug. 23, 2038 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11077073 | Aug. 23, 2038 | DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11077073 | Aug. 23, 2038 | TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11077073 | Aug. 23, 2038 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 137MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | Aug. 24, 2024 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
| EQ 68.5MG BASE | GOCOVRI | ADAMAS OPERATIONS | N208944 | Aug. 24, 2017 | RX | CAPSULE, EXTENDED RELEASE | ORAL | Aug. 24, 2024 | TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Glutamate [NMDA] receptor | Ion channel | BLOCKER | Ki | 4.98 | CHEMBL | CHEMBL | |||
| Sigma non-opioid intracellular receptor 1 | Membrane receptor | Ki | 7.69 | CHEMBL | |||||
| Multidrug and toxin extrusion protein 1 | Transporter | IC50 | 4.42 | CHEMBL | |||||
| Matrix protein 2 | Ion channel | INHIBITOR | IC50 | 4.80 | CHEMBL | CHEMBL | |||
| Matrix protein 2 | Unclassified | IC50 | 4.80 | CHEMBL | |||||
| Matrix protein 2 | Unclassified | Kd | 6.50 | CHEMBL | |||||
| Matrix protein 2 | Unclassified | EC50 | 6.18 | CHEMBL | |||||
| Matrix protein 2 | Unclassified | Kd | 6.50 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4019601 | VUID |
| N0000147697 | NUI |
| D00777 | KEGG_DRUG |
| 665-66-7 | SECONDARY_CAS_RN |
| 282415 | RXNORM |
| C0002403 | UMLSCUI |
| CHEBI:2618 | CHEBI |
| 308 | PDB_CHEM_ID |
| CHEMBL660 | ChEMBL_ID |
| DB00915 | DRUGBANK_ID |
| CHEMBL1569 | ChEMBL_ID |
| D000547 | MESH_DESCRIPTOR_UI |
| 2130 | PUBCHEM_CID |
| 1816 | INN_ID |
| 4128 | IUPHAR_LIGAND_ID |
| 31377-23-8 | SECONDARY_CAS_RN |
| BF4C9Z1J53 | UNII |
| 2543 | MMSL |
| 33122 | MMSL |
| 34880 | MMSL |
| 4161 | MMSL |
| d00086 | MMSL |
| 372763006 | SNOMEDCT_US |
| 51361008 | SNOMEDCT_US |
| 64507008 | SNOMEDCT_US |
| 703084004 | SNOMEDCT_US |
| CHEMBL465617 | ChEMBL_ID |
| 4018546 | VANDF |
| 4019601 | VANDF |
| 001640 | NDDF |
| 004663 | NDDF |
| 006089 | NDDF |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0121-0646 | SOLUTION | 50 mg | ORAL | ANDA | 24 sections |
| AMANTADINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0121-0646 | SOLUTION | 50 mg | ORAL | ANDA | 24 sections |
| AMANTADINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0121-0646 | SOLUTION | 50 mg | ORAL | ANDA | 24 sections |
| AMANTADINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0121-0646 | SOLUTION | 50 mg | ORAL | ANDA | 24 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-1704 | CAPSULE | 100 mg | ORAL | ANDA | 22 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-1868 | CAPSULE | 100 mg | ORAL | ANDA | 21 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-4920 | TABLET | 100 mg | ORAL | ANDA | 19 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8263 | CAPSULE | 100 mg | ORAL | ANDA | 13 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0832-0111 | TABLET | 100 mg | ORAL | ANDA | 24 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0832-0111 | TABLET | 100 mg | ORAL | ANDA | 24 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0832-1015 | CAPSULE, GELATIN COATED | 100 mg | ORAL | ANDA | 23 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0832-1015 | CAPSULE, GELATIN COATED | 100 mg | ORAL | ANDA | 23 sections |
| amantadine hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-6630 | CAPSULE | 100 mg | ORAL | ANDA | 20 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7042 | CAPSULE | 100 mg | ORAL | ANDA | 13 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10135-692 | TABLET | 100 mg | ORAL | ANDA | 22 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10135-692 | TABLET | 100 mg | ORAL | ANDA | 22 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10135-693 | CAPSULE, GELATIN COATED | 100 mg | ORAL | ANDA | 22 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10135-693 | CAPSULE, GELATIN COATED | 100 mg | ORAL | ANDA | 22 sections |
| Amantadine HCl | Human Prescription Drug Label | 1 | 10888-5006 | CAPSULE, LIQUID FILLED | 100 mg | ORAL | ANDA | 19 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16571-834 | CAPSULE | 100 mg | ORAL | ANDA | 11 sections |
| AMANTADINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-008 | CAPSULE | 100 mg | ORAL | ANDA | 24 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17856-0093 | SOLUTION | 50 mg | ORAL | ANDA | 25 sections |
| AMANTADINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17856-0646 | SOLUTION | 50 mg | ORAL | ANDA | 24 sections |
| AMANTADINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17856-0646 | SOLUTION | 50 mg | ORAL | ANDA | 24 sections |
| Amantadine HCl | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-564 | CAPSULE | 100 mg | ORAL | ANDA | 20 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-362 | CAPSULE | 100 mg | ORAL | ANDA | 13 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-362 | CAPSULE | 100 mg | ORAL | ANDA | 13 sections |
| Amantadine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-362 | CAPSULE | 100 mg | ORAL | ANDA | 13 sections |
| AMANTADINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24689-105 | CAPSULE | 100 mg | ORAL | ANDA | 12 sections |
| AMANTADINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24689-112 | TABLET | 100 mg | ORAL | ANDA | 12 sections |