Stem definition | Drug id | CAS RN |
---|---|---|
4566 | 502-85-2 |
Molecule | Description |
---|---|
Synonyms:
|
The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA.
|
Dose | Unit | Route |
---|---|---|
7.50 | g | O |
Property | Value | Reference |
---|---|---|
BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Date | Agency | Company | Orphan |
---|---|---|---|
July 17, 2002 | FDA | JAZZ PHARMS |
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 |
---|---|---|---|---|---|---|
Pre-existing condition improved | 1277.13 | 18.57 | 402 | 48050 | 7842 | 63432728 |
Sleep apnoea syndrome | 1226.84 | 18.57 | 546 | 47906 | 28587 | 63411983 |
Anxiety | 822.05 | 18.57 | 917 | 47535 | 216624 | 63223946 |
Suicidal ideation | 718.19 | 18.57 | 497 | 47955 | 61924 | 63378646 |
Somnolence | 655.14 | 18.57 | 742 | 47710 | 177943 | 63262627 |
Depression | 637.13 | 18.57 | 766 | 47686 | 195726 | 63244844 |
Somnambulism | 634.29 | 18.57 | 215 | 48237 | 5328 | 63435242 |
Feeling abnormal | 534.68 | 18.57 | 611 | 47841 | 147781 | 63292789 |
Surgery | 509.54 | 18.57 | 326 | 48126 | 35586 | 63404984 |
Product administration interrupted | 500.46 | 18.57 | 174 | 48278 | 4662 | 63435908 |
Unevaluable event | 454.12 | 18.57 | 349 | 48103 | 51037 | 63389533 |
Enuresis | 442.50 | 18.57 | 136 | 48316 | 2437 | 63438133 |
Therapeutic response unexpected | 437.40 | 18.57 | 235 | 48217 | 18524 | 63422046 |
Snoring | 350.97 | 18.57 | 129 | 48323 | 4073 | 63436497 |
Migraine | 300.48 | 18.57 | 382 | 48070 | 102964 | 63337606 |
Initial insomnia | 273.66 | 18.57 | 120 | 48332 | 6037 | 63434533 |
Weight decreased | 265.99 | 18.57 | 625 | 47827 | 276173 | 63164397 |
Blood pressure increased | 244.39 | 18.57 | 441 | 48011 | 161621 | 63278949 |
Feeling drunk | 228.13 | 18.57 | 94 | 48358 | 4048 | 63436522 |
Bipolar disorder | 223.52 | 18.57 | 113 | 48339 | 7847 | 63432723 |
Panic attack | 222.33 | 18.57 | 163 | 48289 | 22168 | 63418402 |
Hangover | 221.24 | 18.57 | 72 | 48380 | 1564 | 63439006 |
Insomnia | 220.87 | 18.57 | 499 | 47953 | 214753 | 63225817 |
Poor quality sleep | 197.30 | 18.57 | 145 | 48307 | 19790 | 63420780 |
Parasomnia | 190.00 | 18.57 | 50 | 48402 | 494 | 63440076 |
Sleep paralysis | 189.66 | 18.57 | 52 | 48400 | 608 | 63439962 |
Abnormal dreams | 180.88 | 18.57 | 108 | 48344 | 10408 | 63430162 |
Tremor | 175.71 | 18.57 | 341 | 48111 | 131898 | 63308672 |
Restless legs syndrome | 174.90 | 18.57 | 131 | 48321 | 18400 | 63422170 |
Rash | 172.37 | 18.57 | 108 | 48344 | 560763 | 62879807 |
Hunger | 170.72 | 18.57 | 83 | 48369 | 5296 | 63435274 |
Drug ineffective | 164.60 | 18.57 | 346 | 48106 | 1044419 | 62396151 |
Acute kidney injury | 164.45 | 18.57 | 9 | 48443 | 263406 | 63177164 |
Post-traumatic stress disorder | 160.59 | 18.57 | 79 | 48373 | 5172 | 63435398 |
Sleep-related eating disorder | 159.21 | 18.57 | 48 | 48404 | 803 | 63439767 |
Hysterectomy | 151.63 | 18.57 | 93 | 48359 | 9406 | 63431164 |
Condition aggravated | 148.14 | 18.57 | 653 | 47799 | 401564 | 63039006 |
Cataplexy | 144.76 | 18.57 | 49 | 48403 | 1207 | 63439363 |
Pyrexia | 143.89 | 18.57 | 91 | 48361 | 470387 | 62970183 |
Abnormal sleep-related event | 140.95 | 18.57 | 43 | 48409 | 750 | 63439820 |
Stress | 133.45 | 18.57 | 207 | 48245 | 66960 | 63373610 |
Major depression | 131.83 | 18.57 | 80 | 48372 | 7938 | 63432632 |
Diarrhoea | 130.79 | 18.57 | 216 | 48236 | 715150 | 62725420 |
Suicide attempt | 129.87 | 18.57 | 194 | 48258 | 60724 | 63379846 |
Joint swelling | 124.92 | 18.57 | 47 | 48405 | 327619 | 63112951 |
Irritability | 124.90 | 18.57 | 137 | 48315 | 31557 | 63409013 |
General physical health deterioration | 119.38 | 18.57 | 9 | 48443 | 201393 | 63239177 |
Neutropenia | 119.35 | 18.57 | 3 | 48449 | 175002 | 63265568 |
Wrong technique in product usage process | 118.12 | 18.57 | 188 | 48264 | 62152 | 63378418 |
Hypertension | 115.48 | 18.57 | 470 | 47982 | 278833 | 63161737 |
Narcolepsy | 110.26 | 18.57 | 41 | 48411 | 1337 | 63439233 |
Bruxism | 107.69 | 18.57 | 53 | 48399 | 3472 | 63437098 |
Intervertebral disc protrusion | 106.72 | 18.57 | 110 | 48342 | 23599 | 63416971 |
Product use issue | 106.58 | 18.57 | 390 | 48062 | 220130 | 63220440 |
Glossodynia | 105.99 | 18.57 | 8 | 48444 | 178868 | 63261702 |
Contraindicated product administered | 103.98 | 18.57 | 20 | 48432 | 217628 | 63222942 |
Dizziness | 103.56 | 18.57 | 620 | 47832 | 429305 | 63011265 |
Retching | 102.77 | 18.57 | 87 | 48365 | 14558 | 63426012 |
Drug intolerance | 100.89 | 18.57 | 55 | 48397 | 308606 | 63131964 |
Death | 100.54 | 18.57 | 83 | 48369 | 374298 | 63066272 |
Psychotic disorder | 99.33 | 18.57 | 110 | 48342 | 25602 | 63414968 |
Nephrolithiasis | 98.61 | 18.57 | 140 | 48312 | 41844 | 63398726 |
Perinatal depression | 98.15 | 18.57 | 32 | 48420 | 699 | 63439871 |
Product use in unapproved indication | 95.64 | 18.57 | 12 | 48440 | 179068 | 63261502 |
Lethargy | 94.08 | 18.57 | 160 | 48292 | 55847 | 63384723 |
Haemoglobin decreased | 93.85 | 18.57 | 4 | 48448 | 145481 | 63295089 |
Crying | 92.13 | 18.57 | 101 | 48351 | 23242 | 63417328 |
Thrombocytopenia | 91.74 | 18.57 | 6 | 48446 | 151151 | 63289419 |
Disability | 91.52 | 18.57 | 90 | 48362 | 18257 | 63422313 |
Substance use | 91.22 | 18.57 | 28 | 48424 | 499 | 63440071 |
Pruritus | 91.16 | 18.57 | 85 | 48367 | 361368 | 63079202 |
Postural orthostatic tachycardia syndrome | 91.01 | 18.57 | 35 | 48417 | 1254 | 63439316 |
Feeling jittery | 90.74 | 18.57 | 78 | 48374 | 13325 | 63427245 |
Wound | 89.51 | 18.57 | 10 | 48442 | 163253 | 63277317 |
White blood cell count decreased | 89.15 | 18.57 | 4 | 48448 | 139100 | 63301470 |
Memory impairment | 88.68 | 18.57 | 225 | 48227 | 104033 | 63336537 |
Maternal exposure during pregnancy | 88.21 | 18.57 | 29 | 48423 | 220033 | 63220537 |
Hypnagogic hallucination | 87.62 | 18.57 | 22 | 48430 | 177 | 63440393 |
Seizure | 86.76 | 18.57 | 260 | 48192 | 132374 | 63308196 |
Drug diversion | 86.22 | 18.57 | 31 | 48421 | 917 | 63439653 |
Fall | 85.75 | 18.57 | 552 | 47900 | 391782 | 63048788 |
Arthralgia | 84.02 | 18.57 | 195 | 48257 | 569515 | 62871055 |
Hospitalisation | 82.35 | 18.57 | 193 | 48259 | 84888 | 63355682 |
Gastrooesophageal reflux disease | 81.96 | 18.57 | 207 | 48245 | 95432 | 63345138 |
Therapeutic product effect decreased | 81.86 | 18.57 | 23 | 48429 | 193164 | 63247406 |
Road traffic accident | 81.41 | 18.57 | 119 | 48333 | 36513 | 63404057 |
Sleep talking | 81.03 | 18.57 | 30 | 48422 | 966 | 63439604 |
Illness | 80.88 | 18.57 | 139 | 48313 | 48920 | 63391650 |
Paranoia | 79.13 | 18.57 | 68 | 48384 | 11611 | 63428959 |
Sudden onset of sleep | 77.47 | 18.57 | 25 | 48427 | 528 | 63440042 |
Disease progression | 77.15 | 18.57 | 4 | 48448 | 122754 | 63317816 |
Toxicity to various agents | 76.57 | 18.57 | 47 | 48405 | 247203 | 63193367 |
Alopecia | 76.46 | 18.57 | 87 | 48365 | 337449 | 63103121 |
Anaemia | 76.34 | 18.57 | 67 | 48385 | 293363 | 63147207 |
Blister | 76.33 | 18.57 | 6 | 48446 | 129808 | 63310762 |
Hyperhidrosis | 74.91 | 18.57 | 216 | 48236 | 107620 | 63332950 |
Intentional product use issue | 74.66 | 18.57 | 241 | 48211 | 127651 | 63312919 |
Apnoea | 71.90 | 18.57 | 55 | 48397 | 7967 | 63432603 |
Back injury | 71.11 | 18.57 | 59 | 48393 | 9601 | 63430969 |
Nausea | 69.97 | 18.57 | 974 | 47478 | 853497 | 62587073 |
Abdominal pain | 69.36 | 18.57 | 73 | 48379 | 293383 | 63147187 |
Platelet count decreased | 69.32 | 18.57 | 5 | 48447 | 116117 | 63324453 |
Knee operation | 69.29 | 18.57 | 48 | 48404 | 5965 | 63434605 |
Victim of sexual abuse | 68.40 | 18.57 | 24 | 48428 | 660 | 63439910 |
Pneumonia | 68.35 | 18.57 | 155 | 48297 | 456612 | 62983958 |
Periodic limb movement disorder | 68.32 | 18.57 | 19 | 48433 | 235 | 63440335 |
Musculoskeletal stiffness | 67.78 | 18.57 | 28 | 48424 | 184590 | 63255980 |
Extra dose administered | 66.93 | 18.57 | 48 | 48404 | 6302 | 63434268 |
Gastric bypass | 66.72 | 18.57 | 31 | 48421 | 1786 | 63438784 |
Infection | 66.30 | 18.57 | 47 | 48405 | 229126 | 63211444 |
Lower respiratory tract infection | 65.67 | 18.57 | 11 | 48441 | 132296 | 63308274 |
Impaired gastric emptying | 65.65 | 18.57 | 58 | 48394 | 10274 | 63430296 |
Nightmare | 65.47 | 18.57 | 77 | 48375 | 19117 | 63421453 |
Mobility decreased | 64.96 | 18.57 | 8 | 48444 | 121151 | 63319419 |
Ankle fracture | 64.88 | 18.57 | 74 | 48378 | 17781 | 63422789 |
Attention deficit hyperactivity disorder | 64.65 | 18.57 | 36 | 48416 | 3040 | 63437530 |
Arthropathy | 64.27 | 18.57 | 51 | 48401 | 234741 | 63205829 |
Asthma exercise induced | 64.10 | 18.57 | 19 | 48433 | 299 | 63440271 |
Head injury | 63.80 | 18.57 | 91 | 48361 | 27305 | 63413265 |
Therapeutic product effect incomplete | 62.95 | 18.57 | 10 | 48442 | 125046 | 63315524 |
Hallucination | 62.75 | 18.57 | 133 | 48319 | 54684 | 63385886 |
Fibromyalgia | 62.67 | 18.57 | 168 | 48284 | 80252 | 63360318 |
Endometriosis | 62.56 | 18.57 | 43 | 48409 | 5277 | 63435293 |
Vitamin D deficiency | 61.69 | 18.57 | 64 | 48388 | 13828 | 63426742 |
Stomatitis | 61.64 | 18.57 | 15 | 48437 | 138710 | 63301860 |
Erythema | 60.83 | 18.57 | 29 | 48423 | 175722 | 63264848 |
Discomfort | 60.45 | 18.57 | 26 | 48426 | 167348 | 63273222 |
Middle insomnia | 59.33 | 18.57 | 60 | 48392 | 12583 | 63427987 |
Alcohol abuse | 58.88 | 18.57 | 30 | 48422 | 2116 | 63438454 |
Generalised anxiety disorder | 56.93 | 18.57 | 29 | 48423 | 2045 | 63438525 |
Foot fracture | 56.52 | 18.57 | 80 | 48372 | 23834 | 63416736 |
Cholecystectomy | 56.29 | 18.57 | 54 | 48398 | 10623 | 63429947 |
Spinal operation | 55.71 | 18.57 | 48 | 48404 | 8223 | 63432347 |
Pleural effusion | 55.67 | 18.57 | 4 | 48448 | 93206 | 63347364 |
Lyme disease | 55.63 | 18.57 | 34 | 48418 | 3415 | 63437155 |
Obsessive-compulsive disorder | 55.40 | 18.57 | 36 | 48416 | 4024 | 63436546 |
Systemic lupus erythematosus | 55.16 | 18.57 | 47 | 48405 | 208871 | 63231699 |
Sepsis | 54.96 | 18.57 | 24 | 48428 | 153099 | 63287471 |
Drug tolerance | 54.42 | 18.57 | 44 | 48408 | 6905 | 63433665 |
Emotional disorder | 52.98 | 18.57 | 58 | 48394 | 13321 | 63427249 |
Product preparation error | 52.92 | 18.57 | 41 | 48411 | 6051 | 63434519 |
Hepatic enzyme increased | 52.83 | 18.57 | 46 | 48406 | 202282 | 63238288 |
Rheumatoid factor positive | 52.25 | 18.57 | 3 | 48449 | 84403 | 63356167 |
Completed suicide | 52.01 | 18.57 | 23 | 48429 | 145650 | 63294920 |
Alanine aminotransferase increased | 50.67 | 18.57 | 9 | 48443 | 103761 | 63336809 |
Shoulder operation | 50.45 | 18.57 | 28 | 48424 | 2349 | 63438221 |
Ill-defined disorder | 50.32 | 18.57 | 3 | 48449 | 81752 | 63358818 |
Helicobacter infection | 50.04 | 18.57 | 6 | 48446 | 92779 | 63347791 |
Exposure during pregnancy | 49.95 | 18.57 | 243 | 48209 | 155304 | 63285266 |
Pollakiuria | 49.82 | 18.57 | 82 | 48370 | 27855 | 63412715 |
Acne | 49.35 | 18.57 | 74 | 48378 | 23219 | 63417351 |
Intentional dose omission | 48.67 | 18.57 | 44 | 48408 | 8031 | 63432539 |
Hypotension | 48.02 | 18.57 | 84 | 48368 | 272520 | 63168050 |
Essential tremor | 47.67 | 18.57 | 21 | 48431 | 1067 | 63439503 |
Choking | 46.57 | 18.57 | 47 | 48405 | 9832 | 63430738 |
Asthenia | 46.10 | 18.57 | 145 | 48307 | 383459 | 63057111 |
Therapy non-responder | 46.07 | 18.57 | 3 | 48449 | 75898 | 63364672 |
Pain | 46.04 | 18.57 | 354 | 48098 | 740274 | 62700296 |
Tachyphrenia | 46.01 | 18.57 | 22 | 48430 | 1352 | 63439218 |
Muscle spasms | 45.95 | 18.57 | 238 | 48214 | 155912 | 63284658 |
Cardiac failure | 45.15 | 18.57 | 7 | 48445 | 89135 | 63351435 |
Dyspnoea | 44.99 | 18.57 | 308 | 48144 | 661005 | 62779565 |
Gastrointestinal haemorrhage | 44.40 | 18.57 | 5 | 48447 | 81171 | 63359399 |
Nervousness | 43.66 | 18.57 | 82 | 48370 | 30897 | 63409673 |
Concussion | 43.61 | 18.57 | 44 | 48408 | 9200 | 63431370 |
Mental disorder | 43.45 | 18.57 | 74 | 48378 | 25845 | 63414725 |
Respiratory failure | 43.36 | 18.57 | 12 | 48440 | 101846 | 63338724 |
Hallucination, auditory | 43.00 | 18.57 | 51 | 48401 | 12773 | 63427797 |
Cystitis interstitial | 42.73 | 18.57 | 22 | 48430 | 1586 | 63438984 |
Hyponatraemia | 42.65 | 18.57 | 16 | 48436 | 111884 | 63328686 |
Back disorder | 42.31 | 18.57 | 47 | 48405 | 10970 | 63429600 |
Impaired healing | 41.96 | 18.57 | 13 | 48439 | 102529 | 63338041 |
Respiratory depression | 41.84 | 18.57 | 52 | 48400 | 13663 | 63426907 |
Leukopenia | 41.68 | 18.57 | 5 | 48447 | 77285 | 63363285 |
Aspartate aminotransferase increased | 41.61 | 18.57 | 9 | 48443 | 90268 | 63350302 |
Swelling | 41.48 | 18.57 | 93 | 48359 | 275285 | 63165285 |
Ehlers-Danlos syndrome | 41.01 | 18.57 | 12 | 48440 | 180 | 63440390 |
Nocturia | 40.72 | 18.57 | 40 | 48412 | 8101 | 63432469 |
Rheumatoid arthritis | 40.49 | 18.57 | 83 | 48369 | 253736 | 63186834 |
Asthma | 39.32 | 18.57 | 197 | 48255 | 127364 | 63313206 |
Thirst | 39.30 | 18.57 | 51 | 48401 | 13990 | 63426580 |
Delusion | 38.99 | 18.57 | 47 | 48405 | 11970 | 63428600 |
Incorrect dose administered | 38.64 | 18.57 | 117 | 48335 | 59851 | 63380719 |
Dry mouth | 37.76 | 18.57 | 138 | 48314 | 77725 | 63362845 |
Treatment noncompliance | 37.55 | 18.57 | 86 | 48366 | 37239 | 63403331 |
Palpitations | 37.51 | 18.57 | 178 | 48274 | 112592 | 63327978 |
Seborrhoea | 37.29 | 18.57 | 14 | 48438 | 469 | 63440101 |
Autoimmune thyroiditis | 37.20 | 18.57 | 28 | 48424 | 3958 | 63436612 |
Nerve compression | 37.04 | 18.57 | 40 | 48412 | 9047 | 63431523 |
Abnormal behaviour | 37.01 | 18.57 | 62 | 48390 | 21364 | 63419206 |
Renal failure | 36.89 | 18.57 | 22 | 48430 | 117630 | 63322940 |
Vertigo | 36.87 | 18.57 | 115 | 48337 | 59772 | 63380798 |
Victim of chemical submission | 35.97 | 18.57 | 14 | 48438 | 518 | 63440052 |
Wrong dose | 35.93 | 18.57 | 18 | 48434 | 1225 | 63439345 |
Gastrectomy | 35.60 | 18.57 | 15 | 48437 | 683 | 63439887 |
Essential hypertension | 35.51 | 18.57 | 30 | 48422 | 5003 | 63435567 |
Hyperpathia | 34.94 | 18.57 | 7 | 48445 | 16 | 63440554 |
Colonoscopy | 34.53 | 18.57 | 19 | 48433 | 1567 | 63439003 |
Muscle tightness | 34.52 | 18.57 | 44 | 48408 | 11856 | 63428714 |
Anger | 34.48 | 18.57 | 45 | 48407 | 12411 | 63428159 |
Euphoric mood | 34.22 | 18.57 | 29 | 48423 | 4858 | 63435712 |
Autonomic nervous system imbalance | 33.66 | 18.57 | 23 | 48429 | 2795 | 63437775 |
No adverse event | 32.74 | 18.57 | 87 | 48365 | 41318 | 63399252 |
Wheezing | 32.71 | 18.57 | 16 | 48436 | 95579 | 63344991 |
Folliculitis | 32.43 | 18.57 | 7 | 48445 | 70310 | 63370260 |
Liver injury | 32.42 | 18.57 | 4 | 48448 | 60516 | 63380054 |
Disorientation | 32.32 | 18.57 | 84 | 48368 | 39368 | 63401202 |
Temporomandibular joint syndrome | 32.25 | 18.57 | 26 | 48426 | 4063 | 63436507 |
Urticaria | 32.07 | 18.57 | 48 | 48404 | 165754 | 63274816 |
Disturbance in attention | 32.00 | 18.57 | 82 | 48370 | 38107 | 63402463 |
Intervertebral disc degeneration | 31.94 | 18.57 | 49 | 48403 | 15683 | 63424887 |
Nasopharyngitis | 31.81 | 18.57 | 315 | 48137 | 253942 | 63186628 |
Foot operation | 31.54 | 18.57 | 33 | 48419 | 7198 | 63433372 |
Victim of spousal abuse | 31.20 | 18.57 | 6 | 48446 | 10 | 63440560 |
Oedema peripheral | 31.04 | 18.57 | 61 | 48391 | 189450 | 63251120 |
Agitation | 30.76 | 18.57 | 108 | 48344 | 59649 | 63380921 |
Carpal tunnel syndrome | 30.46 | 18.57 | 56 | 48396 | 20761 | 63419809 |
Conduction disorder | 30.37 | 18.57 | 17 | 48435 | 1450 | 63439120 |
Polycystic ovaries | 30.22 | 18.57 | 26 | 48426 | 4445 | 63436125 |
Muscle twitching | 30.16 | 18.57 | 54 | 48398 | 19614 | 63420956 |
Sleep attacks | 30.04 | 18.57 | 8 | 48444 | 83 | 63440487 |
Metabolic surgery | 29.86 | 18.57 | 16 | 48436 | 1252 | 63439318 |
Tooth extraction | 29.85 | 18.57 | 38 | 48414 | 10226 | 63430344 |
Rapid eye movements sleep abnormal | 29.82 | 18.57 | 9 | 48443 | 151 | 63440419 |
Nasal septum deviation | 29.64 | 18.57 | 17 | 48435 | 1519 | 63439051 |
Blood creatinine increased | 29.61 | 18.57 | 15 | 48437 | 87829 | 63352741 |
Hypothyroidism | 29.19 | 18.57 | 85 | 48367 | 42547 | 63398023 |
Victim of abuse | 28.83 | 18.57 | 8 | 48444 | 98 | 63440472 |
Spinal fusion surgery | 28.79 | 18.57 | 28 | 48424 | 5600 | 63434970 |
Rotator cuff syndrome | 28.75 | 18.57 | 43 | 48409 | 13459 | 63427111 |
Neuralgia | 28.62 | 18.57 | 62 | 48390 | 25864 | 63414706 |
Headache | 28.36 | 18.57 | 657 | 47795 | 632584 | 62807986 |
Wisdom teeth removal | 28.14 | 18.57 | 12 | 48440 | 563 | 63440007 |
Cardiac arrest | 28.05 | 18.57 | 18 | 48434 | 92527 | 63348043 |
Premenstrual dysphoric disorder | 27.59 | 18.57 | 7 | 48445 | 59 | 63440511 |
Product taste abnormal | 27.40 | 18.57 | 18 | 48434 | 2049 | 63438521 |
Lung disorder | 27.13 | 18.57 | 7 | 48445 | 62254 | 63378316 |
Urinary tract infection | 27.10 | 18.57 | 107 | 48345 | 264577 | 63175993 |
Neck injury | 26.98 | 18.57 | 18 | 48434 | 2103 | 63438467 |
Moaning | 26.68 | 18.57 | 13 | 48439 | 833 | 63439737 |
Neck surgery | 26.63 | 18.57 | 17 | 48435 | 1843 | 63438727 |
Endodontic procedure | 26.59 | 18.57 | 21 | 48431 | 3186 | 63437384 |
Seizure like phenomena | 26.49 | 18.57 | 14 | 48438 | 1065 | 63439505 |
Tonsillectomy | 26.26 | 18.57 | 13 | 48439 | 862 | 63439708 |
Seasonal affective disorder | 26.25 | 18.57 | 10 | 48442 | 349 | 63440221 |
Scoliosis | 25.83 | 18.57 | 31 | 48421 | 7857 | 63432713 |
Hyperkalaemia | 25.81 | 18.57 | 5 | 48447 | 54198 | 63386372 |
Blood pressure systolic increased | 25.71 | 18.57 | 3 | 48449 | 47394 | 63393176 |
Hypersomnia | 25.70 | 18.57 | 48 | 48404 | 18007 | 63422563 |
Restlessness | 25.46 | 18.57 | 64 | 48388 | 29389 | 63411181 |
Hypopnoea | 25.45 | 18.57 | 22 | 48430 | 3784 | 63436786 |
Oral surgery | 24.73 | 18.57 | 14 | 48438 | 1220 | 63439350 |
Social anxiety disorder | 24.48 | 18.57 | 10 | 48442 | 421 | 63440149 |
Hypokalaemia | 24.28 | 18.57 | 26 | 48426 | 103778 | 63336792 |
Prescribed overdose | 24.26 | 18.57 | 69 | 48383 | 34084 | 63406486 |
Borderline personality disorder | 24.20 | 18.57 | 12 | 48440 | 799 | 63439771 |
Ankle operation | 24.18 | 18.57 | 14 | 48438 | 1273 | 63439297 |
Incoherent | 24.05 | 18.57 | 23 | 48429 | 4507 | 63436063 |
Mast cell activation syndrome | 24.00 | 18.57 | 12 | 48440 | 813 | 63439757 |
Obesity | 23.75 | 18.57 | 63 | 48389 | 29889 | 63410681 |
Dental operation | 23.67 | 18.57 | 14 | 48438 | 1325 | 63439245 |
Psoriatic arthropathy | 23.63 | 18.57 | 21 | 48431 | 91499 | 63349071 |
Accident | 23.62 | 18.57 | 26 | 48426 | 6006 | 63434564 |
Libido increased | 23.61 | 18.57 | 14 | 48438 | 1331 | 63439239 |
Abdominal discomfort | 23.48 | 18.57 | 146 | 48306 | 320739 | 63119831 |
Meniscus injury | 23.37 | 18.57 | 28 | 48424 | 7086 | 63433484 |
Sleep terror | 23.20 | 18.57 | 18 | 48434 | 2662 | 63437908 |
Blood glucose increased | 23.13 | 18.57 | 18 | 48434 | 83738 | 63356832 |
Dyskinesia | 23.07 | 18.57 | 65 | 48387 | 31937 | 63408633 |
Urinary incontinence | 23.05 | 18.57 | 65 | 48387 | 31949 | 63408621 |
Seasonal allergy | 23.01 | 18.57 | 50 | 48402 | 20900 | 63419670 |
Musculoskeletal pain | 22.85 | 18.57 | 22 | 48430 | 92255 | 63348315 |
Migraine with aura | 22.84 | 18.57 | 18 | 48434 | 2722 | 63437848 |
Mitral valve prolapse | 22.76 | 18.57 | 17 | 48435 | 2376 | 63438194 |
Victim of crime | 22.74 | 18.57 | 7 | 48445 | 126 | 63440444 |
Drug interaction | 22.58 | 18.57 | 94 | 48358 | 229037 | 63211533 |
Loss of consciousness | 22.58 | 18.57 | 161 | 48291 | 117960 | 63322610 |
Pituitary tumour | 22.43 | 18.57 | 12 | 48440 | 936 | 63439634 |
Intentional product misuse | 22.35 | 18.57 | 99 | 48353 | 60818 | 63379752 |
Rash erythematous | 22.31 | 18.57 | 3 | 48449 | 42507 | 63398063 |
Oxygen saturation decreased | 22.07 | 18.57 | 21 | 48431 | 88564 | 63352006 |
Rash pruritic | 22.04 | 18.57 | 9 | 48443 | 59790 | 63380780 |
Face injury | 22.01 | 18.57 | 19 | 48433 | 3263 | 63437307 |
Liver function test abnormal | 21.80 | 18.57 | 5 | 48447 | 48176 | 63392394 |
Metabolic acidosis | 21.80 | 18.57 | 4 | 48448 | 45065 | 63395505 |
Pain in extremity | 21.66 | 18.57 | 156 | 48296 | 331330 | 63109240 |
Liver disorder | 21.62 | 18.57 | 7 | 48445 | 53680 | 63386890 |
Haematochezia | 21.52 | 18.57 | 7 | 48445 | 53537 | 63387033 |
Paraesthesia | 21.35 | 18.57 | 198 | 48254 | 156768 | 63283802 |
Food craving | 21.33 | 18.57 | 14 | 48438 | 1592 | 63438978 |
Joint injury | 21.25 | 18.57 | 60 | 48392 | 29512 | 63411058 |
Blood testosterone increased | 21.05 | 18.57 | 7 | 48445 | 163 | 63440407 |
Red blood cell count decreased | 21.02 | 18.57 | 3 | 48449 | 40642 | 63399928 |
Cartilage injury | 20.96 | 18.57 | 15 | 48437 | 1962 | 63438608 |
Gallbladder operation | 20.85 | 18.57 | 16 | 48436 | 2327 | 63438243 |
Blood sodium increased | 20.76 | 18.57 | 17 | 48435 | 2715 | 63437855 |
Mood altered | 20.74 | 18.57 | 39 | 48413 | 14704 | 63425866 |
Therapeutic procedure | 20.57 | 18.57 | 11 | 48441 | 857 | 63439713 |
Skin exfoliation | 20.47 | 18.57 | 4 | 48448 | 43098 | 63397472 |
Pulmonary embolism | 20.47 | 18.57 | 36 | 48416 | 116648 | 63323922 |
Blood alkaline phosphatase increased | 20.38 | 18.57 | 4 | 48448 | 42963 | 63397607 |
Drug withdrawal syndrome | 20.35 | 18.57 | 56 | 48396 | 27138 | 63413432 |
Electrocardiogram QT prolonged | 20.31 | 18.57 | 10 | 48442 | 59520 | 63381050 |
Post procedural complication | 20.20 | 18.57 | 42 | 48410 | 17032 | 63423538 |
Withdrawal syndrome | 20.03 | 18.57 | 46 | 48406 | 19951 | 63420619 |
Rapid eye movement sleep behaviour disorder | 20.01 | 18.57 | 8 | 48444 | 318 | 63440252 |
Panic reaction | 19.93 | 18.57 | 20 | 48432 | 4154 | 63436416 |
Affective disorder | 19.88 | 18.57 | 24 | 48428 | 6122 | 63434448 |
White coat hypertension | 19.80 | 18.57 | 10 | 48442 | 692 | 63439878 |
Upper airway resistance syndrome | 19.71 | 18.57 | 4 | 48448 | 10 | 63440560 |
Motion sickness | 19.42 | 18.57 | 11 | 48441 | 960 | 63439610 |
Dyspnoea exertional | 19.29 | 18.57 | 11 | 48441 | 60291 | 63380279 |
Therapeutic product effect prolonged | 19.27 | 18.57 | 8 | 48444 | 351 | 63440219 |
Progesterone decreased | 19.19 | 18.57 | 6 | 48446 | 114 | 63440456 |
Delayed sleep phase | 19.18 | 18.57 | 4 | 48448 | 12 | 63440558 |
Hypersensitivity | 18.99 | 18.57 | 138 | 48314 | 292547 | 63148023 |
Influenza like illness | 18.91 | 18.57 | 14 | 48438 | 66810 | 63373760 |
International normalised ratio increased | 18.78 | 18.57 | 6 | 48446 | 46419 | 63394151 |
Body temperature increased | 18.65 | 18.57 | 3 | 48449 | 37189 | 63403381 |
Hypertonic bladder | 18.64 | 18.57 | 18 | 48434 | 3570 | 63437000 |
Complex regional pain syndrome | 18.62 | 18.57 | 15 | 48437 | 2342 | 63438228 |
Hepatic function abnormal | 18.61 | 18.57 | 3 | 48449 | 37139 | 63403431 |
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 |
---|---|---|---|---|---|---|
Sleep apnoea syndrome | 746.64 | 24.84 | 303 | 16694 | 20018 | 34919916 |
Pre-existing condition improved | 488.42 | 24.84 | 133 | 16864 | 2459 | 34937475 |
Suicidal ideation | 347.03 | 24.84 | 226 | 16771 | 40162 | 34899772 |
Depression | 330.28 | 24.84 | 314 | 16683 | 96784 | 34843150 |
Product use issue | 256.75 | 24.84 | 226 | 16771 | 62990 | 34876944 |
Product administration interrupted | 250.36 | 24.84 | 73 | 16924 | 1742 | 34938192 |
Somnambulism | 240.14 | 24.84 | 80 | 16917 | 2992 | 34936942 |
Somnolence | 232.91 | 24.84 | 278 | 16719 | 110838 | 34829096 |
Anxiety | 205.38 | 24.84 | 247 | 16750 | 99181 | 34840753 |
Feeling abnormal | 204.22 | 24.84 | 199 | 16798 | 63036 | 34876898 |
Therapeutic response unexpected | 162.34 | 24.84 | 84 | 16913 | 9673 | 34930261 |
Unevaluable event | 137.09 | 24.84 | 119 | 16878 | 32471 | 34907463 |
Hunger | 136.97 | 24.84 | 45 | 16952 | 1609 | 34938325 |
Insomnia | 133.35 | 24.84 | 205 | 16792 | 103702 | 34836232 |
Blood pressure increased | 132.03 | 24.84 | 187 | 16810 | 87915 | 34852019 |
Surgery | 130.70 | 24.84 | 83 | 16914 | 14074 | 34925860 |
Enuresis | 125.13 | 24.84 | 46 | 16951 | 2307 | 34937627 |
Sleep-related eating disorder | 120.03 | 24.84 | 28 | 16969 | 265 | 34939669 |
Snoring | 116.15 | 24.84 | 48 | 16949 | 3298 | 34936636 |
Acute kidney injury | 114.65 | 24.84 | 9 | 16988 | 304979 | 34634955 |
Bipolar disorder | 105.33 | 24.84 | 46 | 16951 | 3623 | 34936311 |
Hypertension | 103.61 | 24.84 | 214 | 16783 | 136229 | 34803705 |
Initial insomnia | 98.99 | 24.84 | 42 | 16955 | 3082 | 34936852 |
Intervertebral disc protrusion | 93.45 | 24.84 | 59 | 16938 | 9897 | 34930037 |
Hangover | 92.71 | 24.84 | 30 | 16967 | 1021 | 34938913 |
Nephrolithiasis | 91.34 | 24.84 | 92 | 16905 | 30241 | 34909693 |
Pyrexia | 90.77 | 24.84 | 25 | 16972 | 332988 | 34606946 |
Post-traumatic stress disorder | 89.88 | 24.84 | 34 | 16963 | 1847 | 34938087 |
Sleep paralysis | 88.29 | 24.84 | 20 | 16977 | 164 | 34939770 |
Condition aggravated | 85.27 | 24.84 | 245 | 16752 | 191951 | 34747983 |
Wrong technique in product usage process | 83.40 | 24.84 | 95 | 16902 | 35891 | 34904043 |
Disability | 82.06 | 24.84 | 42 | 16955 | 4723 | 34935211 |
Feeling drunk | 82.02 | 24.84 | 32 | 16965 | 1891 | 34938043 |
Cataplexy | 81.79 | 24.84 | 21 | 16976 | 305 | 34939629 |
Restless legs syndrome | 74.66 | 24.84 | 48 | 16949 | 8306 | 34931628 |
Poor quality sleep | 72.70 | 24.84 | 47 | 16950 | 8209 | 34931725 |
Anaemia | 70.45 | 24.84 | 14 | 16983 | 233321 | 34706613 |
Substance use | 70.25 | 24.84 | 22 | 16975 | 672 | 34939262 |
Abnormal sleep-related event | 68.97 | 24.84 | 20 | 16977 | 467 | 34939467 |
Narcolepsy | 67.34 | 24.84 | 20 | 16977 | 509 | 34939425 |
Shoulder operation | 67.30 | 24.84 | 24 | 16973 | 1102 | 34938832 |
Drug abuse | 66.56 | 24.84 | 148 | 16849 | 98948 | 34840986 |
Alcohol abuse | 65.64 | 24.84 | 36 | 16961 | 4654 | 34935280 |
Weight decreased | 65.25 | 24.84 | 211 | 16786 | 176090 | 34763844 |
Migraine | 61.96 | 24.84 | 58 | 16939 | 17420 | 34922514 |
Abnormal dreams | 61.51 | 24.84 | 41 | 16956 | 7537 | 34932397 |
Thrombocytopenia | 60.35 | 24.84 | 4 | 16993 | 156243 | 34783691 |
Suicide attempt | 58.43 | 24.84 | 83 | 16914 | 39033 | 34900901 |
Pneumonia | 55.37 | 24.84 | 57 | 16940 | 362570 | 34577364 |
Parasomnia | 54.60 | 24.84 | 16 | 16981 | 388 | 34939546 |
Spinal operation | 53.75 | 24.84 | 27 | 16970 | 2917 | 34937017 |
Drug diversion | 53.53 | 24.84 | 19 | 16978 | 860 | 34939074 |
Middle insomnia | 53.29 | 24.84 | 36 | 16961 | 6766 | 34933168 |
Intentional product use issue | 52.73 | 24.84 | 100 | 16897 | 59716 | 34880218 |
Nasopharyngitis | 52.11 | 24.84 | 109 | 16888 | 69859 | 34870075 |
Overdose | 51.31 | 24.84 | 127 | 16870 | 90932 | 34849002 |
Spinal fusion surgery | 50.76 | 24.84 | 19 | 16978 | 1002 | 34938932 |
Death | 49.80 | 24.84 | 73 | 16924 | 397976 | 34541958 |
No adverse event | 48.87 | 24.84 | 58 | 16939 | 22869 | 34917065 |
Irritability | 48.61 | 24.84 | 60 | 16937 | 24630 | 34915304 |
Wrong dose | 48.40 | 24.84 | 16 | 16981 | 583 | 34939351 |
Rash | 48.35 | 24.84 | 24 | 16973 | 222728 | 34717206 |
Diarrhoea | 48.29 | 24.84 | 72 | 16925 | 389840 | 34550094 |
Blood cholesterol increased | 47.17 | 24.84 | 54 | 16943 | 20489 | 34919445 |
Intentional product misuse | 46.21 | 24.84 | 81 | 16916 | 45530 | 34894404 |
Sepsis | 44.34 | 24.84 | 13 | 16984 | 166548 | 34773386 |
Hospitalisation | 43.94 | 24.84 | 90 | 16907 | 56812 | 34883122 |
Head injury | 43.85 | 24.84 | 49 | 16948 | 18111 | 34921823 |
Road traffic accident | 43.71 | 24.84 | 48 | 16949 | 17402 | 34922532 |
Hypotension | 43.59 | 24.84 | 27 | 16970 | 221622 | 34718312 |
Back injury | 43.13 | 24.84 | 26 | 16971 | 4015 | 34935919 |
Hypnagogic hallucination | 42.92 | 24.84 | 9 | 16988 | 49 | 34939885 |
Stress | 41.82 | 24.84 | 62 | 16935 | 30285 | 34909649 |
Haemoglobin decreased | 41.49 | 24.84 | 5 | 16992 | 120767 | 34819167 |
Knee operation | 40.56 | 24.84 | 20 | 16977 | 2077 | 34937857 |
Memory impairment | 40.13 | 24.84 | 74 | 16923 | 43244 | 34896690 |
Product use in unapproved indication | 40.03 | 24.84 | 5 | 16992 | 117494 | 34822440 |
Food craving | 39.71 | 24.84 | 13 | 16984 | 459 | 34939475 |
Attention deficit hyperactivity disorder | 36.80 | 24.84 | 20 | 16977 | 2539 | 34937395 |
Tachyphrenia | 36.71 | 24.84 | 16 | 16981 | 1253 | 34938681 |
Agitation | 36.56 | 24.84 | 84 | 16913 | 57315 | 34882619 |
Feeling jittery | 35.76 | 24.84 | 23 | 16974 | 3980 | 34935954 |
Lethargy | 35.30 | 24.84 | 68 | 16929 | 41054 | 34898880 |
White blood cell count decreased | 35.25 | 24.84 | 3 | 16994 | 95442 | 34844492 |
Concussion | 34.94 | 24.84 | 19 | 16978 | 2414 | 34937520 |
Fall | 34.77 | 24.84 | 192 | 16805 | 202693 | 34737241 |
Drug tolerance | 34.58 | 24.84 | 20 | 16977 | 2862 | 34937072 |
Sleep talking | 34.09 | 24.84 | 12 | 16985 | 530 | 34939404 |
Foot operation | 34.01 | 24.84 | 13 | 16984 | 726 | 34939208 |
Headache | 33.80 | 24.84 | 189 | 16808 | 200446 | 34739488 |
Disease progression | 33.59 | 24.84 | 6 | 16991 | 108071 | 34831863 |
Panic attack | 32.85 | 24.84 | 31 | 16966 | 9401 | 34930533 |
Lower limb fracture | 32.68 | 24.84 | 22 | 16975 | 4109 | 34935825 |
Loss of consciousness | 32.36 | 24.84 | 101 | 16896 | 82566 | 34857368 |
Renal failure | 31.57 | 24.84 | 12 | 16985 | 130545 | 34809389 |
Prescribed overdose | 31.49 | 24.84 | 32 | 16965 | 10615 | 34929319 |
Confusional arousal | 31.22 | 24.84 | 6 | 16991 | 19 | 34939915 |
Fibromyalgia | 30.67 | 24.84 | 19 | 16978 | 3081 | 34936853 |
Major depression | 30.66 | 24.84 | 22 | 16975 | 4550 | 34935384 |
Periodic limb movement disorder | 30.38 | 24.84 | 8 | 16989 | 129 | 34939805 |
Product preparation error | 30.27 | 24.84 | 17 | 16980 | 2300 | 34937634 |
Nightmare | 29.99 | 24.84 | 36 | 16961 | 14355 | 34925579 |
Obesity | 29.81 | 24.84 | 34 | 16963 | 12844 | 34927090 |
Gastrointestinal haemorrhage | 29.56 | 24.84 | 4 | 16993 | 88473 | 34851461 |
Hyponatraemia | 29.46 | 24.84 | 3 | 16994 | 82688 | 34857246 |
Abdominal pain | 29.37 | 24.84 | 22 | 16975 | 163596 | 34776338 |
Gastrooesophageal reflux disease | 29.28 | 24.84 | 60 | 16937 | 37864 | 34902070 |
Hyperhidrosis | 29.18 | 24.84 | 92 | 16905 | 75600 | 34864334 |
Nasal septum deviation | 29.03 | 24.84 | 13 | 16984 | 1086 | 34938848 |
Treatment noncompliance | 28.57 | 24.84 | 50 | 16947 | 28050 | 34911884 |
Extra dose administered | 28.52 | 24.84 | 20 | 16977 | 3989 | 34935945 |
Respiratory failure | 27.93 | 24.84 | 9 | 16988 | 108563 | 34831371 |
Craniocerebral injury | 27.31 | 24.84 | 18 | 16979 | 3245 | 34936689 |
Incorrect dose administered | 26.57 | 24.84 | 60 | 16937 | 40455 | 34899479 |
Moaning | 26.34 | 24.84 | 11 | 16986 | 775 | 34939159 |
Psychotic disorder | 25.50 | 24.84 | 44 | 16953 | 24408 | 34915526 |
Erythema | 25.37 | 24.84 | 6 | 16991 | 88774 | 34851160 |
Tremor | 25.34 | 24.84 | 93 | 16904 | 82494 | 34857440 |
Illness | 25.22 | 24.84 | 32 | 16965 | 13497 | 34926437 |
Diabetes mellitus | 24.92 | 24.84 | 64 | 16933 | 46809 | 34893125 |
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 |
---|---|---|---|---|---|---|
Sleep apnoea syndrome | 775.66 | 19.59 | 366 | 36839 | 36112 | 79671071 |
Somnolence | 676.35 | 19.59 | 686 | 36519 | 238295 | 79468888 |
Pre-existing condition improved | 556.51 | 19.59 | 173 | 37032 | 5390 | 79701793 |
Feeling abnormal | 503.49 | 19.59 | 486 | 36719 | 158713 | 79548470 |
Anxiety | 472.61 | 19.59 | 580 | 36625 | 247932 | 79459251 |
Somnambulism | 469.42 | 19.59 | 153 | 37052 | 5568 | 79701615 |
Depression | 456.50 | 19.59 | 533 | 36672 | 216257 | 79490926 |
Suicidal ideation | 377.99 | 19.59 | 301 | 36904 | 76039 | 79631144 |
Enuresis | 352.55 | 19.59 | 107 | 37098 | 3069 | 79704114 |
Product administration interrupted | 306.65 | 19.59 | 101 | 37104 | 3798 | 79703385 |
Surgery | 289.45 | 19.59 | 184 | 37021 | 32582 | 79674601 |
Initial insomnia | 267.19 | 19.59 | 106 | 37099 | 6832 | 79700351 |
Feeling drunk | 264.96 | 19.59 | 95 | 37110 | 4624 | 79702559 |
Unevaluable event | 259.82 | 19.59 | 212 | 36993 | 55373 | 79651810 |
Insomnia | 239.32 | 19.59 | 418 | 36787 | 244752 | 79462431 |
Hangover | 238.04 | 19.59 | 72 | 37133 | 2040 | 79705143 |
Acute kidney injury | 211.27 | 19.59 | 7 | 37198 | 519397 | 79187786 |
Poor quality sleep | 209.16 | 19.59 | 131 | 37074 | 22591 | 79684592 |
Abnormal dreams | 204.62 | 19.59 | 102 | 37103 | 11310 | 79695873 |
Snoring | 203.78 | 19.59 | 82 | 37123 | 5484 | 79701699 |
Migraine | 203.77 | 19.59 | 227 | 36978 | 87266 | 79619917 |
Suicide attempt | 194.56 | 19.59 | 216 | 36989 | 82716 | 79624467 |
Sleep paralysis | 191.24 | 19.59 | 47 | 37158 | 591 | 79706592 |
Lethargy | 186.02 | 19.59 | 209 | 36996 | 81083 | 79626100 |
Therapeutic response unexpected | 178.58 | 19.59 | 113 | 37092 | 19833 | 79687350 |
Bipolar disorder | 162.60 | 19.59 | 77 | 37128 | 7630 | 79699553 |
Irritability | 161.56 | 19.59 | 142 | 37063 | 41002 | 79666181 |
Weight decreased | 158.36 | 19.59 | 442 | 36763 | 354756 | 79352427 |
Tremor | 152.94 | 19.59 | 280 | 36925 | 169803 | 79537380 |
Condition aggravated | 147.95 | 19.59 | 541 | 36664 | 500583 | 79206600 |
Panic attack | 147.23 | 19.59 | 108 | 37097 | 24108 | 79683075 |
Cataplexy | 141.24 | 19.59 | 40 | 37165 | 894 | 79706289 |
Blood pressure increased | 140.85 | 19.59 | 307 | 36898 | 211053 | 79496130 |
Hunger | 132.49 | 19.59 | 60 | 37145 | 5368 | 79701815 |
Dizziness | 127.47 | 19.59 | 534 | 36671 | 525907 | 79181276 |
Restless legs syndrome | 125.30 | 19.59 | 91 | 37114 | 20001 | 79687182 |
Pyrexia | 115.40 | 19.59 | 89 | 37116 | 678620 | 79028563 |
Fall | 114.38 | 19.59 | 490 | 36715 | 487139 | 79220044 |
Sleep-related eating disorder | 109.88 | 19.59 | 31 | 37174 | 683 | 79706500 |
Thrombocytopenia | 109.80 | 19.59 | 3 | 37202 | 265256 | 79441927 |
Middle insomnia | 107.59 | 19.59 | 76 | 37129 | 15993 | 79691190 |
Abnormal sleep-related event | 107.49 | 19.59 | 32 | 37173 | 857 | 79706326 |
Anaemia | 107.20 | 19.59 | 37 | 37168 | 444978 | 79262205 |
Narcolepsy | 103.88 | 19.59 | 34 | 37171 | 1252 | 79705931 |
General physical health deterioration | 101.25 | 19.59 | 7 | 37198 | 275231 | 79431952 |
Wrong technique in product usage process | 100.85 | 19.59 | 147 | 37058 | 73728 | 79633455 |
Rash | 100.62 | 19.59 | 74 | 37131 | 578284 | 79128899 |
Memory impairment | 99.16 | 19.59 | 183 | 37022 | 111551 | 79595632 |
Seizure | 98.15 | 19.59 | 249 | 36956 | 188585 | 79518598 |
Road traffic accident | 95.98 | 19.59 | 110 | 37095 | 43554 | 79663629 |
Product use issue | 93.20 | 19.59 | 261 | 36944 | 209561 | 79497622 |
Agitation | 93.15 | 19.59 | 167 | 37038 | 99548 | 79607635 |
Sleep talking | 92.68 | 19.59 | 30 | 37175 | 1066 | 79706117 |
Intervertebral disc protrusion | 91.66 | 19.59 | 81 | 37124 | 23540 | 79683643 |
Head injury | 90.45 | 19.59 | 99 | 37106 | 37270 | 79669913 |
Parasomnia | 89.25 | 19.59 | 25 | 37180 | 536 | 79706647 |
Hypnagogic hallucination | 88.06 | 19.59 | 20 | 37185 | 174 | 79707009 |
Crying | 87.39 | 19.59 | 78 | 37127 | 22965 | 79684218 |
Hysterectomy | 86.45 | 19.59 | 47 | 37158 | 6225 | 79700958 |
Drug ineffective | 85.55 | 19.59 | 242 | 36963 | 1080671 | 78626512 |
Psychotic disorder | 85.48 | 19.59 | 101 | 37104 | 41301 | 79665882 |
Shoulder operation | 85.31 | 19.59 | 36 | 37169 | 2716 | 79704467 |
Product use in unapproved indication | 84.89 | 19.59 | 9 | 37196 | 250350 | 79456833 |
Stress | 84.38 | 19.59 | 141 | 37064 | 79471 | 79627712 |
Back injury | 82.83 | 19.59 | 55 | 37150 | 10468 | 79696715 |
Post-traumatic stress disorder | 82.72 | 19.59 | 42 | 37163 | 4839 | 79702344 |
Nightmare | 81.57 | 19.59 | 79 | 37126 | 25782 | 79681401 |
Haemoglobin decreased | 80.66 | 19.59 | 6 | 37199 | 222113 | 79485070 |
Nervousness | 76.52 | 19.59 | 86 | 37119 | 33329 | 79673854 |
Extra dose administered | 76.12 | 19.59 | 48 | 37157 | 8367 | 79698816 |
Feeling jittery | 75.19 | 19.59 | 56 | 37149 | 12785 | 79694398 |
Joint swelling | 74.82 | 19.59 | 21 | 37184 | 288625 | 79418558 |
Pneumonia | 74.45 | 19.59 | 121 | 37084 | 660125 | 79047058 |
Platelet count decreased | 74.43 | 19.59 | 4 | 37201 | 194660 | 79512523 |
Nausea | 74.43 | 19.59 | 726 | 36479 | 956470 | 78750713 |
Hallucination | 74.26 | 19.59 | 139 | 37066 | 85606 | 79621577 |
Retching | 72.00 | 19.59 | 62 | 37143 | 17405 | 79689778 |
Hypotension | 71.87 | 19.59 | 60 | 37145 | 440257 | 79266926 |
White blood cell count decreased | 71.58 | 19.59 | 4 | 37201 | 188284 | 79518899 |
Alcohol abuse | 70.63 | 19.59 | 39 | 37166 | 5324 | 79701859 |
Diarrhoea | 69.64 | 19.59 | 197 | 37008 | 880292 | 78826891 |
Hypertension | 69.42 | 19.59 | 322 | 36883 | 330670 | 79376513 |
Substance use | 68.66 | 19.59 | 23 | 37182 | 911 | 79706272 |
Incorrect dose administered | 67.32 | 19.59 | 125 | 37080 | 76505 | 79630678 |
Sudden onset of sleep | 64.27 | 19.59 | 20 | 37185 | 624 | 79706559 |
Headache | 64.13 | 19.59 | 522 | 36683 | 653250 | 79053933 |
Disease progression | 64.12 | 19.59 | 6 | 37199 | 184356 | 79522827 |
Sepsis | 60.46 | 19.59 | 25 | 37180 | 269403 | 79437780 |
Hyperhidrosis | 60.05 | 19.59 | 181 | 37024 | 151311 | 79555872 |
Concussion | 59.15 | 19.59 | 43 | 37162 | 9460 | 79697723 |
Spinal operation | 59.00 | 19.59 | 40 | 37165 | 7877 | 79699306 |
Death | 58.20 | 19.59 | 110 | 37095 | 566404 | 79140779 |
Pruritus | 58.19 | 19.59 | 59 | 37146 | 394589 | 79312594 |
Spinal fusion surgery | 57.97 | 19.59 | 34 | 37171 | 5204 | 79701979 |
Alanine aminotransferase increased | 57.32 | 19.59 | 5 | 37200 | 162565 | 79544618 |
Tachyphrenia | 57.20 | 19.59 | 25 | 37180 | 2055 | 79705128 |
Foot fracture | 56.28 | 19.59 | 60 | 37145 | 21921 | 79685262 |
Knee operation | 54.42 | 19.59 | 34 | 37171 | 5832 | 79701351 |
Abnormal behaviour | 53.39 | 19.59 | 75 | 37130 | 36346 | 79670837 |
Paranoia | 53.25 | 19.59 | 55 | 37150 | 19377 | 79687806 |
Loss of consciousness | 52.44 | 19.59 | 185 | 37020 | 167758 | 79539425 |
Hallucination, auditory | 52.13 | 19.59 | 56 | 37149 | 20637 | 79686546 |
Gastric bypass | 50.51 | 19.59 | 20 | 37185 | 1281 | 79705902 |
Respiratory depression | 49.88 | 19.59 | 63 | 37142 | 27567 | 79679616 |
Disorientation | 49.71 | 19.59 | 98 | 37107 | 62678 | 79644505 |
Overdose | 49.24 | 19.59 | 193 | 37012 | 184013 | 79523170 |
Pollakiuria | 49.09 | 19.59 | 73 | 37132 | 37244 | 79669939 |
Wrong dose | 48.67 | 19.59 | 21 | 37184 | 1673 | 79705510 |
Drug intolerance | 48.19 | 19.59 | 32 | 37173 | 264087 | 79443096 |
Erythema | 48.06 | 19.59 | 22 | 37183 | 223268 | 79483915 |
Hyponatraemia | 47.84 | 19.59 | 12 | 37193 | 177836 | 79529347 |
Vertigo | 47.81 | 19.59 | 102 | 37103 | 68980 | 79638203 |
Pleural effusion | 47.28 | 19.59 | 6 | 37199 | 145256 | 79561927 |
Ankle fracture | 46.44 | 19.59 | 48 | 37157 | 16921 | 79690262 |
Attention deficit hyperactivity disorder | 46.17 | 19.59 | 25 | 37180 | 3284 | 79703899 |
Renal failure | 44.51 | 19.59 | 19 | 37186 | 200949 | 79506234 |
Aspartate aminotransferase increased | 44.46 | 19.59 | 6 | 37199 | 138635 | 79568548 |
Drug diversion | 44.32 | 19.59 | 18 | 37187 | 1232 | 79705951 |
Anger | 44.21 | 19.59 | 47 | 37158 | 17115 | 79690068 |
Delusion | 44.11 | 19.59 | 51 | 37154 | 20372 | 79686811 |
Intentional product misuse | 43.79 | 19.59 | 120 | 37085 | 95045 | 79612138 |
Emotional disorder | 43.59 | 19.59 | 43 | 37162 | 14344 | 79692839 |
Muscle spasms | 43.44 | 19.59 | 179 | 37026 | 174551 | 79532632 |
Confusional state | 43.29 | 19.59 | 275 | 36930 | 317722 | 79389461 |
Infection | 43.14 | 19.59 | 30 | 37175 | 241682 | 79465501 |
Conduction disorder | 42.93 | 19.59 | 24 | 37181 | 3355 | 79703828 |
Victim of sexual abuse | 42.71 | 19.59 | 14 | 37191 | 518 | 79706665 |
Leukopenia | 42.70 | 19.59 | 3 | 37202 | 116510 | 79590673 |
Abdominal pain | 42.32 | 19.59 | 73 | 37132 | 389496 | 79317687 |
Contraindicated product administered | 41.66 | 19.59 | 11 | 37194 | 157527 | 79549656 |
Therapeutic product effect incomplete | 41.24 | 19.59 | 8 | 37197 | 141637 | 79565546 |
Foot operation | 40.44 | 19.59 | 28 | 37177 | 5705 | 79701478 |
Cholecystectomy | 39.93 | 19.59 | 34 | 37171 | 9398 | 79697785 |
Major depression | 39.31 | 19.59 | 33 | 37172 | 8947 | 79698236 |
Cardiac failure | 38.75 | 19.59 | 12 | 37193 | 154830 | 79552353 |
Cardiac arrest | 38.54 | 19.59 | 16 | 37189 | 172080 | 79535103 |
Endometriosis | 38.48 | 19.59 | 23 | 37182 | 3645 | 79703538 |
Nephrolithiasis | 38.40 | 19.59 | 80 | 37125 | 53211 | 79653972 |
Completed suicide | 38.22 | 19.59 | 35 | 37170 | 245732 | 79461451 |
Periodic limb movement disorder | 37.88 | 19.59 | 10 | 37195 | 170 | 79707013 |
Apnoea | 37.37 | 19.59 | 36 | 37169 | 11668 | 79695515 |
Pericarditis | 37.30 | 19.59 | 3 | 37202 | 104233 | 79602950 |
Respiratory failure | 37.13 | 19.59 | 19 | 37186 | 180892 | 79526291 |
Bruxism | 36.50 | 19.59 | 23 | 37182 | 4003 | 79703180 |
Blister | 36.40 | 19.59 | 6 | 37199 | 119470 | 79587713 |
Ankle operation | 36.26 | 19.59 | 15 | 37190 | 1076 | 79706107 |
Gastrooesophageal reflux disease | 36.18 | 19.59 | 119 | 37086 | 104127 | 79603056 |
Lower respiratory tract infection | 36.17 | 19.59 | 8 | 37197 | 129212 | 79577971 |
Moaning | 35.66 | 19.59 | 15 | 37190 | 1122 | 79706061 |
Product preparation error | 35.57 | 19.59 | 26 | 37179 | 5767 | 79701416 |
Mobility decreased | 35.36 | 19.59 | 7 | 37198 | 122168 | 79585015 |
Mental disorder | 35.25 | 19.59 | 57 | 37148 | 31245 | 79675938 |
Palpitations | 34.91 | 19.59 | 134 | 37071 | 126476 | 79580707 |
Muscle tightness | 34.39 | 19.59 | 36 | 37169 | 12878 | 79694305 |
No adverse event | 34.33 | 19.59 | 62 | 37143 | 37130 | 79670053 |
Hyperkalaemia | 34.29 | 19.59 | 6 | 37199 | 114392 | 79592791 |
Victim of spousal abuse | 34.14 | 19.59 | 6 | 37199 | 10 | 79707173 |
Coma | 34.13 | 19.59 | 114 | 37091 | 100535 | 79606648 |
Product taste abnormal | 34.05 | 19.59 | 18 | 37187 | 2253 | 79704930 |
Fibromyalgia | 33.53 | 19.59 | 85 | 37120 | 64255 | 79642928 |
Muscle twitching | 33.37 | 19.59 | 49 | 37156 | 24715 | 79682468 |
Renal impairment | 33.24 | 19.59 | 16 | 37189 | 157767 | 79549416 |
Drug abuse | 33.10 | 19.59 | 157 | 37048 | 162534 | 79544649 |
Procedural pain | 33.04 | 19.59 | 47 | 37158 | 23037 | 79684146 |
Arthralgia | 32.96 | 19.59 | 146 | 37059 | 571657 | 79135526 |
Stomatitis | 32.29 | 19.59 | 14 | 37191 | 146743 | 79560440 |
Postural orthostatic tachycardia syndrome | 31.50 | 19.59 | 13 | 37192 | 927 | 79706256 |
Incoherent | 31.08 | 19.59 | 27 | 37178 | 7665 | 79699518 |
Dry mouth | 31.01 | 19.59 | 101 | 37104 | 87918 | 79619265 |
Victim of chemical submission | 30.52 | 19.59 | 11 | 37194 | 543 | 79706640 |
Gallbladder operation | 30.37 | 19.59 | 16 | 37189 | 1989 | 79705194 |
Thinking abnormal | 30.34 | 19.59 | 34 | 37171 | 13127 | 79694056 |
Restlessness | 30.28 | 19.59 | 67 | 37138 | 46425 | 79660758 |
Accidental poisoning | 30.26 | 19.59 | 15 | 37190 | 1642 | 79705541 |
Rotator cuff syndrome | 30.10 | 19.59 | 35 | 37170 | 14060 | 79693123 |
Tooth extraction | 29.91 | 19.59 | 31 | 37174 | 10964 | 79696219 |
Perinatal depression | 29.76 | 19.59 | 10 | 37195 | 400 | 79706783 |
Glossodynia | 29.73 | 19.59 | 6 | 37199 | 103331 | 79603852 |
Intentional product use issue | 29.65 | 19.59 | 145 | 37060 | 151967 | 79555216 |
Therapy non-responder | 29.58 | 19.59 | 4 | 37201 | 92301 | 79614882 |
Disturbance in attention | 29.54 | 19.59 | 70 | 37135 | 50731 | 79656452 |
Blood creatinine increased | 29.34 | 19.59 | 18 | 37187 | 155039 | 79552144 |
Choking | 29.17 | 19.59 | 32 | 37173 | 12069 | 79695114 |
Euphoric mood | 28.98 | 19.59 | 26 | 37179 | 7700 | 79699483 |
Paraesthesia | 28.78 | 19.59 | 160 | 37045 | 176163 | 79531020 |
Nerve compression | 28.71 | 19.59 | 28 | 37177 | 9211 | 79697972 |
Hypersomnia | 28.71 | 19.59 | 44 | 37161 | 23042 | 79684141 |
Rheumatoid arthritis | 28.65 | 19.59 | 33 | 37172 | 208437 | 79498746 |
Dyskinesia | 28.57 | 19.59 | 64 | 37141 | 44709 | 79662474 |
Intentional dose omission | 27.92 | 19.59 | 27 | 37178 | 8790 | 79698393 |
Cardio-respiratory arrest | 27.89 | 19.59 | 8 | 37197 | 108502 | 79598681 |
Metabolic acidosis | 27.87 | 19.59 | 3 | 37202 | 82526 | 79624657 |
Wheezing | 27.51 | 19.59 | 10 | 37195 | 116654 | 79590529 |
Amnesia | 27.51 | 19.59 | 78 | 37127 | 62979 | 79644204 |
Wound | 27.33 | 19.59 | 10 | 37195 | 116169 | 79591014 |
Food craving | 27.33 | 19.59 | 14 | 37191 | 1643 | 79705540 |
Hepatic enzyme increased | 27.22 | 19.59 | 27 | 37178 | 182583 | 79524600 |
Medication error | 27.16 | 19.59 | 82 | 37123 | 68560 | 79638623 |
Lung disorder | 27.02 | 19.59 | 3 | 37202 | 80554 | 79626629 |
Illness | 26.95 | 19.59 | 64 | 37141 | 46447 | 79660736 |
Oedema peripheral | 26.72 | 19.59 | 48 | 37157 | 252240 | 79454943 |
Urinary tract infection | 26.66 | 19.59 | 55 | 37150 | 274457 | 79432726 |
Panic reaction | 26.54 | 19.59 | 20 | 37185 | 4645 | 79702538 |
Drug tolerance | 26.42 | 19.59 | 26 | 37179 | 8649 | 79698534 |
Obsessive-compulsive disorder | 26.40 | 19.59 | 22 | 37183 | 5905 | 79701278 |
Unresponsive to stimuli | 26.30 | 19.59 | 71 | 37134 | 55717 | 79651466 |
Drug withdrawal syndrome | 26.04 | 19.59 | 53 | 37152 | 34665 | 79672518 |
Essential hypertension | 25.99 | 19.59 | 22 | 37183 | 6031 | 79701152 |
Therapeutic product effect decreased | 25.86 | 19.59 | 23 | 37182 | 163840 | 79543343 |
Lower limb fracture | 25.77 | 19.59 | 42 | 37163 | 23173 | 79684010 |
Inappropriate schedule of product administration | 25.76 | 19.59 | 127 | 37078 | 133501 | 79573682 |
Seizure like phenomena | 25.75 | 19.59 | 14 | 37191 | 1853 | 79705330 |
Metabolic surgery | 25.59 | 19.59 | 12 | 37193 | 1162 | 79706021 |
Essential tremor | 25.24 | 19.59 | 13 | 37192 | 1542 | 79705641 |
Rapid eye movements sleep abnormal | 25.08 | 19.59 | 8 | 37197 | 271 | 79706912 |
Hormone level abnormal | 24.84 | 19.59 | 14 | 37191 | 1988 | 79705195 |
Urticaria | 24.71 | 19.59 | 30 | 37175 | 185171 | 79522012 |
Confusional arousal | 24.52 | 19.59 | 6 | 37199 | 74 | 79707109 |
Aggression | 24.17 | 19.59 | 65 | 37140 | 50893 | 79656290 |
Treatment noncompliance | 24.12 | 19.59 | 66 | 37139 | 52202 | 79654981 |
Neuralgia | 23.91 | 19.59 | 50 | 37155 | 33334 | 79673849 |
Thirst | 23.88 | 19.59 | 36 | 37169 | 18583 | 79688600 |
Sleep attacks | 23.86 | 19.59 | 7 | 37198 | 178 | 79707005 |
Musculoskeletal stiffness | 23.72 | 19.59 | 28 | 37177 | 174980 | 79532203 |
Dyspnoea | 23.66 | 19.59 | 271 | 36934 | 856754 | 78850429 |
Generalised anxiety disorder | 23.63 | 19.59 | 14 | 37191 | 2183 | 79705000 |
Haematochezia | 23.39 | 19.59 | 6 | 37199 | 87639 | 79619544 |
Nasopharyngitis | 23.31 | 19.59 | 200 | 37005 | 253681 | 79453502 |
Disability | 23.25 | 19.59 | 34 | 37171 | 17086 | 79690097 |
Dyspnoea exertional | 23.17 | 19.59 | 6 | 37199 | 87067 | 79620116 |
Hypokalaemia | 22.99 | 19.59 | 20 | 37185 | 144020 | 79563163 |
Sleep terror | 22.93 | 19.59 | 18 | 37187 | 4440 | 79702743 |
Gastrectomy | 22.90 | 19.59 | 9 | 37196 | 565 | 79706618 |
Investigation | 22.75 | 19.59 | 14 | 37191 | 2337 | 79704846 |
Inappropriate affect | 22.54 | 19.59 | 12 | 37193 | 1524 | 79705659 |
Intervertebral disc degeneration | 22.38 | 19.59 | 32 | 37173 | 15753 | 79691430 |
Hospitalisation | 21.43 | 19.59 | 94 | 37111 | 94142 | 79613041 |
Alopecia | 21.09 | 19.59 | 48 | 37157 | 231307 | 79475876 |
Asthenia | 21.05 | 19.59 | 146 | 37059 | 511543 | 79195640 |
Seborrhoea | 20.91 | 19.59 | 8 | 37197 | 467 | 79706716 |
Limb injury | 20.88 | 19.59 | 44 | 37161 | 29484 | 79677699 |
Ehlers-Danlos syndrome | 20.78 | 19.59 | 6 | 37199 | 144 | 79707039 |
Wisdom teeth removal | 20.75 | 19.59 | 8 | 37197 | 477 | 79706706 |
Neck injury | 20.60 | 19.59 | 14 | 37191 | 2767 | 79704416 |
Sedation | 20.53 | 19.59 | 62 | 37143 | 51833 | 79655350 |
Oxygen saturation decreased | 20.50 | 19.59 | 18 | 37187 | 129029 | 79578154 |
Lyme disease | 20.49 | 19.59 | 15 | 37190 | 3335 | 79703848 |
International normalised ratio increased | 20.42 | 19.59 | 7 | 37198 | 84714 | 79622469 |
Seasonal affective disorder | 20.28 | 19.59 | 7 | 37198 | 304 | 79706879 |
Scoliosis | 20.22 | 19.59 | 21 | 37184 | 7443 | 79699740 |
Hypopnoea | 20.12 | 19.59 | 18 | 37187 | 5311 | 79701872 |
Victim of abuse | 20.12 | 19.59 | 5 | 37200 | 66 | 79707117 |
Cheyne-Stokes respiration | 20.08 | 19.59 | 8 | 37197 | 521 | 79706662 |
Colonoscopy | 19.88 | 19.59 | 12 | 37193 | 1935 | 79705248 |
Blood alkaline phosphatase increased | 19.83 | 19.59 | 3 | 37202 | 63661 | 79643522 |
Nocturia | 19.79 | 19.59 | 28 | 37177 | 13653 | 79693530 |
None
Source | Code | Description |
---|---|---|
ATC | N01AX11 | NERVOUS SYSTEM ANESTHETICS ANESTHETICS, GENERAL Other general anesthetics |
ATC | N07XX04 | NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs |
MeSH PA | D000759 | Adjuvants, Anesthesia |
MeSH PA | D000777 | Anesthetics |
MeSH PA | D018686 | Anesthetics, Intravenous |
MeSH PA | D002491 | Central Nervous System Agents |
MeSH PA | D002492 | Central Nervous System Depressants |
CHEBI has role | CHEBI:35717 | hypnotics |
CHEBI has role | CHEBI:38869 | general anaesthetic |
CHEBI has role | CHEBI:50910 | agente neurotoxico |
CHEBI has role | CHEBI:53353 | GHB receptor agonists |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Narcolepsy | indication | 60380001 | DOID:8986 |
Cataplexy and narcolepsy | indication | 193042000 | |
Suicidal thoughts | contraindication | 6471006 | |
Alcoholism | contraindication | 7200002 | |
Alcohol intoxication | contraindication | 25702006 | |
Depressive disorder | contraindication | 35489007 | |
Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
Chronic heart failure | contraindication | 48447003 | |
Succinate-semialdehyde dehydrogenase deficiency | contraindication | 49748000 | |
Acute nephropathy | contraindication | 58574008 | |
Substance abuse | contraindication | 66214007 | |
Incontinence of feces | contraindication | 72042002 | |
Sleep apnea | contraindication | 73430006 | DOID:0050847 |
Sleep walking disorder | contraindication | 80495009 | |
Decreased respiratory function | contraindication | 80954004 | |
Seizure disorder | contraindication | 128613002 | |
Urinary incontinence | contraindication | 165232002 | |
Disease of liver | contraindication | 235856003 | DOID:409 |
Impaired cognition | contraindication | 386806002 | |
Chronic lung disease | contraindication | 413839001 | |
Psychiatric Disturbance | contraindication |
None
None
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
0.5GM/ML | XYREM | JAZZ PHARMS | N021196 | July 17, 2002 | RX | SOLUTION | ORAL | 7668730 | June 16, 2024 | METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION |
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | 10675258 | Jan. 11, 2033 | TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY WITH A MIXTURE OF SODIUM, POTASSIUM, MAGNESIUM, AND CALCIUM SALTS OF GHB |
0.5GM/ML | XYREM | JAZZ PHARMS | N021196 | July 17, 2002 | RX | SOLUTION | ORAL | 10213400 | March 15, 2033 | METHOD OF REDUCING ADVERSE EFFECTS IN PATIENTS SUFFERING FROM EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY WHO ARE CONCOMITANTLY ADMINISTERED SODIUM OXYBATE AND DIVALPROEX SODIUM |
0.5GM/ML | XYREM | JAZZ PHARMS | N021196 | July 17, 2002 | RX | SOLUTION | ORAL | 10864181 | March 15, 2033 | METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED. |
0.5GM/ML | XYREM | JAZZ PHARMS | N021196 | July 17, 2002 | RX | SOLUTION | ORAL | 11253494 | March 15, 2033 | METHOD OF REDUCING ADVERSE EFFECTS IN PATIENTS WHO ARE CONCOMITANTLY ADMINISTERED A SALT OF GAMMA-HYDROXYBUTYRATE AND DIVALPROEX SODIUM |
0.5GM/ML | XYREM | JAZZ PHARMS | N021196 | July 17, 2002 | RX | SOLUTION | ORAL | 11253494 | March 15, 2033 | METHOD OF TREATING PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED |
0.5GM/ML | XYREM | JAZZ PHARMS | N021196 | July 17, 2002 | RX | SOLUTION | ORAL | 8772306 | March 15, 2033 | METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED. |
0.5GM/ML | XYREM | JAZZ PHARMS | N021196 | July 17, 2002 | RX | SOLUTION | ORAL | 9050302 | March 15, 2033 | METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED. |
0.5GM/ML | XYREM | JAZZ PHARMS | N021196 | July 17, 2002 | RX | SOLUTION | ORAL | 9486426 | March 15, 2033 | METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED. |
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | 10213400 | March 15, 2033 | METHOD OF REDUCING ADVERSE EFFECTS IN PATIENTS SUFFERING FROM EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY WHO ARE CONCOMITANTLY ADMINISTERED SODIUM OXYBATE AND DIVALPROEX SODIUM |
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | 10864181 | March 15, 2033 | METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED |
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | 11253494 | March 15, 2033 | METHOD OF REDUCING ADVERSE EFFECTS IN PATIENTS WHO ARE CONCOMITANTLY ADMINISTERED A SALT OF GAMMA-HYDROXYBUTYRATE AND DIVALPROEX SODIUM |
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | 11253494 | March 15, 2033 | METHOD OF TREATING PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED |
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | 8772306 | March 15, 2033 | METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED. |
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | 8772306 | March 15, 2033 | METHOD OF TREATING PATIENTS WITH IDIOPATHIC HYPERSOMNIA WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED |
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | 9050302 | March 15, 2033 | METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED. |
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | 9486426 | March 15, 2033 | METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED. |
4.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 10952986 | July 21, 2037 | TREATMENT OF A DISORDER TREATABLE WITH GAMMA-HYDROXYBUTYRATE USING A SINGLE, DAILY DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION |
4.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11000498 | July 21, 2037 | TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY |
4.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11400065 | July 21, 2037 | TREATMENT OF NARCOLEPSY AND ASSOCIATED DISORDERS AND SYMPTOMS USING A COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY |
4.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11602512 | July 21, 2037 | TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A SINGLE DAILY, BEDTIME DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION |
4.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11602513 | July 21, 2037 | TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-DAILY PHARMACEUTICAL FORMULATION COMPRISING AN OXYBATE |
6GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 10952986 | July 21, 2037 | TREATMENT OF A DISORDER TREATABLE WITH GAMMA-HYDROXYBUTYRATE USING A SINGLE, DAILY DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION |
6GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11000498 | July 21, 2037 | TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY |
6GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11400065 | July 21, 2037 | TREATMENT OF NARCOLEPSY AND ASSOCIATED DISORDERS AND SYMPTOMS USING A COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY |
6GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11602512 | July 21, 2037 | TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A SINGLE DAILY, BEDTIME DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION |
6GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11602513 | July 21, 2037 | TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-DAILY PHARMACEUTICAL FORMULATION COMPRISING AN OXYBATE |
7.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 10952986 | July 21, 2037 | TREATMENT OF A DISORDER TREATABLE WITH GAMMA-HYDROXYBUTYRATE USING A SINGLE, DAILY DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION |
7.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11000498 | July 21, 2037 | TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY |
7.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11400065 | July 21, 2037 | TREATMENT OF NARCOLEPSY AND ASSOCIATED DISORDERS AND SYMPTOMS USING A COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY |
7.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11602512 | July 21, 2037 | TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A SINGLE DAILY, BEDTIME DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION |
7.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11602513 | July 21, 2037 | TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-DAILY PHARMACEUTICAL FORMULATION COMPRISING AN OXYBATE |
9GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 10952986 | July 21, 2037 | TREATMENT OF A DISORDER TREATABLE WITH GAMMA-HYDROXYBUTYRATE USING A SINGLE, DAILY DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION |
9GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11000498 | July 21, 2037 | TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY |
9GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11400065 | July 21, 2037 | TREATMENT OF NARCOLEPSY AND ASSOCIATED DISORDERS AND SYMPTOMS USING A COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY |
9GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11602512 | July 21, 2037 | TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A SINGLE DAILY, BEDTIME DOSE OF A GAMMA-HYDROXYBUTYRATE FORMULATION |
9GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11602513 | July 21, 2037 | TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-DAILY PHARMACEUTICAL FORMULATION COMPRISING AN OXYBATE |
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | 11426373 | Sept. 19, 2037 | TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY WITH A MIXTURE OF SODIUM, POTASSIUM, MAGNESIUM, AND CALCIUM SALTS OF GHB ADMINISTERED BETWEEN 2 AND 4 HOURS AFTER EATING |
4.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11583510 | Feb. 7, 2042 | TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION |
6GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11583510 | Feb. 7, 2042 | TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION |
7.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11583510 | Feb. 7, 2042 | TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION |
9GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | 11583510 | Feb. 7, 2042 | TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | July 21, 2023 | NEW PRODUCT |
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | Aug. 12, 2024 | INDICATED FOR THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS |
0.5GM/ML | XYREM | JAZZ PHARMS | N021196 | July 17, 2002 | RX | SOLUTION | ORAL | Oct. 26, 2025 | INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY |
0.5GM/ML | XYREM | JAZZ PHARMS | N021196 | July 17, 2002 | RX | SOLUTION | ORAL | April 26, 2026 | PEDIATRIC EXCLUSIVITY |
4.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | May 1, 2026 | NEW PRODUCT |
6GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | May 1, 2026 | NEW PRODUCT |
7.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | May 1, 2026 | NEW PRODUCT |
9GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | May 1, 2026 | NEW PRODUCT |
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | July 21, 2027 | INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY |
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | XYWAV | JAZZ | N212690 | July 21, 2020 | RX | SOLUTION | ORAL | Aug. 12, 2028 | THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS |
4.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | May 1, 2030 | TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULTS WITH NARCOLEPSY |
6GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | May 1, 2030 | TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULTS WITH NARCOLEPSY |
7.5GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | May 1, 2030 | TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULTS WITH NARCOLEPSY |
9GM/PACKET | LUMRYZ | AVADEL CNS | N214755 | May 1, 2023 | RX | FOR SUSPENSION, EXTENDED RELEASE | ORAL | May 1, 2030 | TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULTS WITH NARCOLEPSY |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
GABA-B receptor | GPCR | AGONIST | CHEMBL | CHEMBL | |||||
Calcium/calmodulin-dependent protein kinase type II subunit alpha | Kinase | Ki | 5.37 | CHEMBL | |||||
Gamma-hydroxybutyrate receptor | Unclassified | IC50 | 5.18 | CHEMBL |
ID | Source |
---|---|
D05866 | KEGG_DRUG |
4021348 | VUID |
N0000148768 | NUI |
4021348 | VANDF |
CHEBI:30830 | CHEBI |
CHEMBL1200682 | ChEMBL_ID |
591-81-1 | SECONDARY_CAS_RN |
DB09072 | DRUGBANK_ID |
7G33012534 | UNII |
DB01440 | DRUGBANK_ID |
1546380 | RXNORM |
16840 | MMSL |
326245 | MMSL |
44375 | MMSL |
d04806 | MMSL |
006073 | NDDF |
006074 | NDDF |
259470008 | SNOMEDCT_US |
410917003 | SNOMEDCT_US |
782570005 | SNOMEDCT_US |
785621006 | SNOMEDCT_US |
C0037537 | UMLSCUI |
D012978 | MESH_DESCRIPTOR_UI |
CHEMBL1342 | ChEMBL_ID |
23663870 | PUBCHEM_CID |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
sodium oxybate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-9628 | SOLUTION | 0.50 g | ORAL | NDA authorized generic | 31 sections |
Lumryz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13551-001 | FOR SUSPENSION, EXTENDED RELEASE | 4.50 g | ORAL | NDA | 21 sections |
Lumryz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13551-002 | FOR SUSPENSION, EXTENDED RELEASE | 6 g | ORAL | NDA | 21 sections |
Lumryz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13551-003 | FOR SUSPENSION, EXTENDED RELEASE | 7.50 g | ORAL | NDA | 21 sections |
Lumryz | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13551-004 | FOR SUSPENSION, EXTENDED RELEASE | 9 g | ORAL | NDA | 21 sections |
Xyrem | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68727-100 | SOLUTION | 0.50 g | ORAL | NDA | 31 sections |
Xyrem | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68727-100 | SOLUTION | 0.50 g | ORAL | NDA | 31 sections |
Xyrem | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68727-100 | SOLUTION | 0.50 g | ORAL | NDA | 31 sections |
Xyrem | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68727-100 | SOLUTION | 0.50 g | ORAL | NDA | 31 sections |
XYWAV | HUMAN PRESCRIPTION DRUG LABEL | 4 | 68727-150 | SOLUTION | 0.50 g | ORAL | NDA | 31 sections |
XYWAV | HUMAN PRESCRIPTION DRUG LABEL | 4 | 68727-150 | SOLUTION | 0.50 g | ORAL | NDA | 31 sections |
XYWAV | HUMAN PRESCRIPTION DRUG LABEL | 4 | 68727-150 | SOLUTION | 0.50 g | ORAL | NDA | 31 sections |
XYWAV | HUMAN PRESCRIPTION DRUG LABEL | 4 | 68727-150 | SOLUTION | 0.50 g | ORAL | NDA | 31 sections |
sodium oxybate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69238-2391 | SOLUTION | 0.50 g | ORAL | NDA authorized generic | 31 sections |