pramipexole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	2233	104632-26-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: pramipexole hydrochloride pramipexole hydrochloride hydrate sifrol oprymea pramipexole (S)-Pramipexole mirapexin pramipexole dihydrochloride pramipexole dihydrochloride monohydrate pramipexole HCl pramipexol dihydrobromide	A dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity. Pramipexole alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the striatum. Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover. Molecular weight: 211.33 Formula: C10H17N3S CLOGP: 1.47 LIPINSKI: 0 HAC: 3 HDO: 2 TPSA: 50.94 ALOGS: -3.18 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

pramipexole hydrochloride
pramipexole hydrochloride hydrate
sifrol
oprymea
pramipexole
(S)-Pramipexole
mirapexin
pramipexole dihydrochloride
pramipexole dihydrochloride monohydrate
pramipexole HCl
pramipexol dihydrobromide

A dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity. Pramipexole alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the striatum. Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.

Molecular weight: 211.33
Formula: C10H17N3S
CLOGP: 1.47
LIPINSKI: 0
HAC: 3
HDO: 2
TPSA: 50.94
ALOGS: -3.18
ROTB: 3

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
2.50	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.20 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	90 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.30 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	93 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	7 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	7.20 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.85 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	12.40 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
July 1, 1997	FDA	BOEHRINGER INGELHEIM

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
Gambling disorder	476.44	11.68	115	31346	1096	56259510
Dyskinesia	393.58	11.68	229	31232	28879	56231727
Restless legs syndrome	319.24	11.68	166	31295	16781	56243825
Impulse-control disorder	312.05	11.68	74	31387	649	56259957
Compulsive shopping	296.08	11.68	71	31390	656	56259950
On and off phenomenon	270.39	11.68	78	31383	1546	56259060
Hallucination	233.00	11.68	204	31257	48945	56211661
Hallucination, visual	173.65	11.68	113	31348	17355	56243251
Gambling	153.93	11.68	34	31427	209	56260397
Parkinsonism hyperpyrexia syndrome	131.45	11.68	27	31434	110	56260496
Dystonia	127.50	11.68	82	31379	12339	56248267
Tremor	123.17	11.68	233	31228	120856	56139750
Hypersexuality	116.72	11.68	31	31430	446	56260160
Freezing phenomenon	114.68	11.68	37	31424	1080	56259526
Stoma site discharge	106.43	11.68	37	31424	1365	56259241
Muscle rigidity	93.90	11.68	64	31397	10607	56249999
Pleurothotonus	93.15	11.68	33	31428	1288	56259318
Stoma site erythema	93.11	11.68	31	31430	1001	56259605
Bradykinesia	92.66	11.68	48	31413	4806	56255800
Obsessive-compulsive disorder	92.57	11.68	44	31417	3662	56256944
Sudden onset of sleep	89.56	11.68	26	31435	527	56260079
Systemic lupus erythematosus	87.26	11.68	3	31458	180075	56080531
Stoma site pain	85.80	11.68	28	31433	848	56259758
Stereotypy	82.59	11.68	23	31438	399	56260207
Binge eating	73.56	11.68	21	31440	400	56260206
Camptocormia	70.99	11.68	19	31442	282	56260324
Fall	70.54	11.68	389	31072	357121	55903485
Orthostatic hypotension	66.06	11.68	87	31374	33112	56227494
Jealous delusion	63.45	11.68	12	31449	28	56260578
Glossodynia	63.39	11.68	6	31455	152452	56108154
Maternal exposure during pregnancy	57.96	11.68	17	31444	189536	56071070
Hyperkinesia	55.30	11.68	24	31437	1615	56258991
Therapeutic response shortened	54.85	11.68	44	31417	9342	56251264
Delusion	53.99	11.68	47	31414	11168	56249438
Parkinson's disease	53.06	11.68	22	31439	1322	56259284
Compulsive hoarding	52.58	11.68	11	31450	50	56260556
Rheumatoid arthritis	51.62	11.68	84	31377	382520	55878086
Psychotic disorder	50.41	11.68	64	31397	23494	56237112
Acute psychosis	50.37	11.68	25	31436	2287	56258319
Pericarditis	48.90	11.68	3	31458	108920	56151686
Drug dispensed to wrong patient	48.19	11.68	13	31448	199	56260407
Hand deformity	47.13	11.68	9	31452	134483	56126123
Torticollis	47.08	11.68	22	31439	1761	56258845
Diabetes mellitus inadequate control	46.98	11.68	48	31413	13932	56246674
Alopecia	45.90	11.68	58	31403	293400	55967206
Abnormal dreams	45.57	11.68	40	31421	9609	56250997
Neuroleptic malignant syndrome	45.25	11.68	43	31418	11435	56249171
Somnolence	45.18	11.68	196	31265	163217	56097389
Contraindicated product administered	43.55	11.68	25	31436	186261	56074345
Gait disturbance	41.46	11.68	191	31270	163130	56097476
Abnormal behaviour	40.13	11.68	53	31408	20219	56240387
Parkinsonism	40.01	11.68	37	31424	9509	56251097
Medication error	38.75	11.68	78	31383	42257	56218349
Vestibular migraine	38.07	11.68	11	31450	219	56260387
Sleep attacks	38.04	11.68	9	31452	78	56260528
Akinesia	37.64	11.68	18	31443	1518	56259088
Febrile neutropenia	37.11	11.68	7	31454	105538	56155068
Stoma site infection	36.15	11.68	14	31447	703	56259903
Discomfort	36.13	11.68	17	31444	141744	56118862
Psychomotor hyperactivity	35.35	11.68	35	31426	9785	56250821
Total lung capacity decreased	35.12	11.68	17	31444	1472	56259134
Dependence	33.17	11.68	18	31443	1979	56258627
Bronchopulmonary aspergillosis allergic	32.58	11.68	16	31445	1430	56259176
Multiple drug therapy	32.58	11.68	20	31441	2772	56257834
Blood pressure inadequately controlled	32.55	11.68	24	31437	4500	56256106
Pituitary haemorrhage	32.18	11.68	8	31453	87	56260519
Insomnia	32.04	11.68	200	31261	191660	56068946
Swelling	31.95	11.68	53	31408	239718	56020888
Dopamine dysregulation syndrome	31.75	11.68	9	31452	167	56260439
Dropped head syndrome	31.08	11.68	8	31453	101	56260505
Malignant polyp	31.07	11.68	9	31452	181	56260425
Anxiety	30.79	11.68	199	31262	192973	56067633
Lung opacity	30.50	11.68	18	31443	2323	56258283
Drug intolerance	29.63	11.68	65	31396	264753	55995853
Synovitis	29.47	11.68	28	31433	161277	56099329
Delirium	29.42	11.68	70	31391	42447	56218159
Rash	28.79	11.68	160	31301	492887	55767719
Fibroma	28.55	11.68	12	31449	746	56259860
Economic problem	28.38	11.68	16	31445	1895	56258711
Abdominal discomfort	27.89	11.68	72	31389	277202	55983404
Exercise tolerance decreased	27.73	11.68	23	31438	5115	56255491
Memory impairment	27.17	11.68	108	31353	86449	56174157
Neutropenia	27.13	11.68	29	31432	158138	56102468
Joint swelling	27.09	11.68	78	31383	289722	55970884
Product prescribing error	26.53	11.68	47	31414	23139	56237467
Depressed mood	26.40	11.68	61	31400	36298	56224308
Hypersensitivity	26.23	11.68	66	31395	256342	56004264
Hyperventilation	25.84	11.68	23	31438	5625	56254981
Crime	25.53	11.68	5	31456	15	56260591
Hyperphagia	25.44	11.68	14	31447	1582	56259024
Exposure during pregnancy	24.52	11.68	24	31437	136318	56124288
Orthostatic intolerance	24.39	11.68	12	31449	1077	56259529
Oedema peripheral	24.04	11.68	171	31290	171083	56089523
Posture abnormal	23.77	11.68	15	31446	2183	56258423
Malignant neoplasm progression	23.60	11.68	6	31455	73581	56187025
Amnesia	23.58	11.68	68	31393	46254	56214352
Deep brain stimulation	23.19	11.68	5	31456	27	56260579
Cognitive disorder	22.99	11.68	70	31391	49063	56211543
Drug interaction	22.07	11.68	196	31265	209559	56051047
Vaccination site oedema	21.92	11.68	4	31457	7	56260599
Withdrawal syndrome	21.87	11.68	38	31423	18424	56242182
Nightmare	21.74	11.68	36	31425	16790	56243816
Compulsions	21.61	11.68	7	31454	207	56260399
Vaccination site bruising	21.57	11.68	4	31457	8	56260598
Vaccination site pruritus	21.57	11.68	4	31457	8	56260598
Chorea	21.45	11.68	12	31449	1400	56259206
Snoring	21.37	11.68	17	31444	3564	56257042
Stomatitis	20.88	11.68	22	31439	120788	56139818
Restlessness	20.86	11.68	46	31415	26540	56234066
Movement disorder	20.80	11.68	38	31423	19160	56241446
Diarrhoea	20.69	11.68	243	31218	638264	55622342
Pulmonary fibrosis	20.59	11.68	49	31412	29709	56230897
Therapeutic response changed	20.58	11.68	10	31451	873	56259733
Stoma site inflammation	20.48	11.68	8	31453	411	56260195
Sleep apnoea syndrome	20.34	11.68	45	31416	26016	56234590
Female orgasmic disorder	20.14	11.68	5	31456	54	56260552
Blister	19.77	11.68	19	31442	108868	56151738
Muscle injury	19.51	11.68	3	31458	52497	56208109
Drug withdrawal syndrome	19.46	11.68	44	31417	25813	56234793
Stoma site hypergranulation	19.29	11.68	7	31454	293	56260313
Off label use	19.05	11.68	209	31252	555971	55704635
Heat stroke	18.98	11.68	9	31452	745	56259861
Serum serotonin increased	18.90	11.68	6	31455	166	56260440
Prescribed underdose	18.88	11.68	38	31423	20579	56240027
Aspiration	18.80	11.68	25	31436	9596	56251010
Blood calcium increased	18.80	11.68	23	31438	8131	56252475
Coronary artery dissection	18.72	11.68	9	31452	768	56259838
Product substitution issue	18.55	11.68	31	31430	14568	56246038
Toxicity to various agents	18.46	11.68	64	31397	224500	56036106
Product residue present	18.46	11.68	16	31445	3779	56256827
Depression	18.27	11.68	167	31294	179950	56080656
Suspiciousness	18.18	11.68	7	31454	346	56260260
Inhibitory drug interaction	18.15	11.68	13	31448	2331	56258275
Therapeutic product effect variable	18.14	11.68	10	31451	1134	56259472
Orgasm abnormal	18.10	11.68	5	31456	84	56260522
Treatment failure	18.08	11.68	43	31418	170349	56090257
Ill-defined disorder	17.79	11.68	8	31453	68535	56192071
Stoma site irritation	17.29	11.68	6	31455	220	56260386
Wound	17.27	11.68	32	31429	138772	56121834
Pre-existing condition improved	17.27	11.68	21	31440	7377	56253229
Conjunctival discolouration	17.05	11.68	5	31456	105	56260501
Stoma site reaction	17.04	11.68	6	31455	230	56260376
Narcolepsy	16.88	11.68	10	31451	1299	56259307
Meningorrhagia	16.88	11.68	5	31456	109	56260497
Bipolar disorder	16.86	11.68	21	31440	7559	56253047
Pancytopenia	16.67	11.68	15	31446	88700	56171906
Suicidal ideation	16.50	11.68	70	31391	57672	56202934
Granuloma skin	16.43	11.68	20	31441	7031	56253575
Hypercapnia	16.22	11.68	17	31444	5079	56255527
Dizziness	15.98	11.68	297	31164	375843	55884763
Confusional state	15.86	11.68	182	31279	207973	56052633
Thrombocytopenia	15.58	11.68	33	31428	136191	56124415
Vaccination site erythema	15.51	11.68	4	31457	51	56260555
Breath sounds abnormal	15.49	11.68	22	31439	8985	56251621
Disease progression	15.18	11.68	22	31439	105151	56155455
Compulsive sexual behaviour	14.90	11.68	4	31457	60	56260546
Pyrexia	14.86	11.68	156	31305	418617	55841989
Autonomic nervous system imbalance	14.82	11.68	12	31449	2581	56258025
Feeling abnormal	14.64	11.68	126	31335	133476	56127130
Product use issue	14.64	11.68	54	31407	185987	56074619
Drug abuse	14.51	11.68	10	31451	67600	56193006
Speech disorder	14.45	11.68	50	31411	37443	56223163
Nasopharyngitis	14.38	11.68	69	31392	220890	56039716
Infusion related reaction	14.33	11.68	64	31397	208867	56051739
Stoma site candida	14.28	11.68	3	31458	14	56260592
Stoma site haemorrhage	14.02	11.68	8	31453	970	56259636
Sputum discoloured	13.88	11.68	27	31434	14265	56246341
Blood parathyroid hormone decreased	13.75	11.68	20	31441	8344	56252262
Vitamin B6 deficiency	13.69	11.68	4	31457	83	56260523
Bulimia nervosa	13.63	11.68	6	31455	418	56260188
Middle insomnia	13.58	11.68	23	31438	10927	56249679
Irritable bowel syndrome	13.56	11.68	11	31450	68447	56192159
Balance disorder	13.52	11.68	81	31380	76439	56184167
Arthropathy	13.35	11.68	62	31399	200213	56060393
Initial insomnia	13.29	11.68	16	31445	5563	56255043
Endometrial cancer	13.19	11.68	12	31449	3018	56257588
Patient elopement	13.01	11.68	3	31458	23	56260583
Condition aggravated	12.84	11.68	267	31194	344631	55915975
Muscle atrophy	12.83	11.68	17	31444	6504	56254102
Mucosal inflammation	12.78	11.68	4	31457	42806	56217800
Infection	12.74	11.68	63	31398	200143	56060463
Kleptomania	12.68	11.68	3	31458	26	56260580
Choking	12.65	11.68	20	31441	8977	56251629
Panniculitis	12.64	11.68	21	31440	9821	56250785
Anisomastia	12.48	11.68	3	31458	28	56260578
Vaccination site pain	12.29	11.68	4	31457	120	56260486
Stoma site extravasation	12.13	11.68	5	31456	296	56260310
Muscle rupture	12.01	11.68	10	31451	2236	56258370
Reduced facial expression	11.75	11.68	9	31452	1787	56258819
Skull fracture	11.68	11.68	7	31454	929	56259677

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
Impulse-control disorder	762.87	14	174	19835	1102	31676233
Gambling disorder	611.51	14	152	19857	1450	31675885
Hypersexuality	589.02	14	144	19865	1274	31676061
Hallucination	450.23	14	309	19700	46101	31631234
Dyskinesia	341.43	14	194	19815	20716	31656619
On and off phenomenon	299.17	14	92	19917	2018	31675317
Restless legs syndrome	288.49	14	126	19883	7630	31669705
Dopamine dysregulation syndrome	232.86	14	52	19957	294	31677041
Hallucination, visual	196.34	14	123	19886	15671	31661664
Gambling	196.07	14	41	19968	160	31677175
Compulsive shopping	178.11	14	43	19966	358	31676977
Freezing phenomenon	123.21	14	42	19967	1288	31676047
Stereotypy	118.59	14	35	19974	663	31676672
Jealous delusion	110.15	14	27	19982	241	31677094
Obsessive-compulsive disorder	108.95	14	56	19953	4881	31672454
Needle fatigue	107.47	14	33	19976	719	31676616
Delusion	104.65	14	75	19934	11922	31665413
Gait spastic	101.57	14	33	19976	869	31676466
Relapsing-remitting multiple sclerosis	100.30	14	33	19976	905	31676430
Paraphilia	99.20	14	20	19989	62	31677273
Gait disturbance	91.05	14	170	19839	77325	31600010
Muscle rigidity	88.92	14	63	19946	9834	31667501
Nocturia	88.13	14	61	19948	9174	31668161
Libido increased	87.25	14	28	19981	708	31676627
Sudden onset of sleep	86.54	14	24	19985	360	31676975
Stoma site erythema	85.50	14	27	19982	647	31676688
Fall	84.88	14	284	19725	185805	31491530
Hypertonic bladder	80.60	14	33	19976	1697	31675638
Monoparesis	80.43	14	35	19974	2096	31675239
Parkinsonism hyperpyrexia syndrome	80.37	14	17	19992	71	31677264
Bradykinesia	77.11	14	40	19969	3552	31673783
Binge eating	74.56	14	17	19992	107	31677228
Micturition urgency	74.42	14	46	19963	5714	31671621
Memory impairment	73.90	14	105	19904	38025	31639310
Insomnia	72.92	14	175	19834	94661	31582674
Abnormal behaviour	72.22	14	82	19927	23746	31653589
Psychomotor hyperactivity	67.75	14	51	19958	8736	31668599
Movement disorder	65.74	14	55	19954	10964	31666371
Stoma site discharge	61.33	14	23	19986	934	31676401
Central nervous system lesion	60.80	14	41	19968	5907	31671428
Muscle spasticity	60.39	14	40	19969	5595	31671740
Balance disorder	59.57	14	94	19915	37328	31640007
Hyperkinesia	58.36	14	26	19983	1647	31675688
Dysarthria	54.56	14	83	19926	31934	31645401
Agitation	54.04	14	111	19898	54058	31623277
Impulsive behaviour	53.77	14	26	19983	1987	31675348
Toxicity to various agents	53.26	14	24	19985	181463	31495872
Confusional state	51.63	14	193	19816	133141	31544194
Encephalitis toxic	51.38	14	15	19994	273	31677062
Aggression	49.06	14	86	19923	37205	31640130
Compulsive hoarding	48.50	14	9	20000	15	31677320
Tremor	48.28	14	131	19878	76289	31601046
Parkinson's disease	47.84	14	22	19987	1501	31675834
Neuroleptic malignant syndrome	47.66	14	56	19953	16813	31660522
Ataxia	47.24	14	49	19960	12814	31664521
Psychotic disorder	47.07	14	64	19945	22229	31655106
Anxiety	46.86	14	145	19864	90888	31586447
Delirium	46.26	14	89	19920	41332	31636003
Stoma site pain	44.84	14	16	19993	563	31676772
Febrile neutropenia	44.63	14	11	19998	121838	31555497
Voyeurism	44.58	14	7	20002	0	31677335
Multiple sclerosis relapse	44.44	14	46	19963	12001	31665334
Neutropenia	43.67	14	17	19992	140347	31536988
Mania	43.11	14	40	19969	9137	31668198
Somnolence	42.76	14	149	19860	99296	31578039
Device dislocation	42.04	14	31	19978	5145	31672190
Sleep attacks	41.70	14	11	19998	135	31677200
Dependence	41.39	14	18	19991	1076	31676259
Diarrhoea	41.29	14	102	19907	352307	31325028
Dystonia	41.29	14	41	19968	10184	31667151
Compulsive sexual behaviour	40.33	14	12	19997	234	31677101
Pyrexia	39.58	14	83	19926	303757	31373578
Economic problem	38.80	14	18	19991	1253	31676082
Hyperphagia	38.18	14	18	19991	1300	31676035
Acute kidney injury	37.61	14	75	19934	279639	31397696
Hypomania	37.13	14	21	19988	2214	31675121
Excessive masturbation	36.35	14	9	20000	84	31677251
Posture abnormal	35.93	14	20	19989	2044	31675291
Pollakiuria	35.70	14	50	19959	17852	31659483
Dizziness	34.93	14	230	19779	198917	31478418
Restlessness	33.51	14	56	19953	23305	31654030
Suspiciousness	33.28	14	11	19998	306	31677029
Dementia	33.21	14	40	19969	12320	31665015
Delusional disorder, jealous type	31.84	14	5	20004	0	31677335
Therapeutic product effect variable	31.63	14	18	19991	1920	31675415
Paranoia	31.42	14	36	19973	10519	31666816
Akinesia	31.03	14	18	19991	1990	31675345
Personality change	30.82	14	25	19984	4770	31672565
Somnambulism	29.96	14	20	19989	2832	31674503
Depression	29.89	14	125	19884	90690	31586645
Pancytopenia	29.86	14	9	20000	87307	31590028
Disturbance in attention	29.81	14	52	19957	22398	31654937
Bipolar I disorder	29.52	14	13	19996	801	31676534
Sexually inappropriate behaviour	29.30	14	11	19998	448	31676887
Reduced facial expression	29.07	14	13	19996	831	31676504
Platelet count decreased	28.79	14	17	19992	110418	31566917
Road traffic accident	28.65	14	43	19966	16338	31660997
Cognitive disorder	28.36	14	54	19955	24869	31652466
Hypervigilance	27.91	14	8	20001	136	31677199
Contraindicated product prescribed	27.88	14	10	19999	357	31676978
Dropped head syndrome	27.70	14	8	20001	140	31677195
Acute psychosis	27.62	14	16	19993	1765	31675570
Sleep disorder	27.45	14	55	19954	26293	31651042
Erectile dysfunction	27.44	14	46	19963	19189	31658146
Obsessive-compulsive personality disorder	27.43	14	8	20001	145	31677190
Embedded device	27.10	14	9	20000	254	31677081
Motor dysfunction	26.67	14	26	19983	6313	31671022
Hallucination, tactile	26.43	14	9	20000	275	31677060
Anticholinergic syndrome	25.92	14	13	19996	1075	31676260
Compulsions	25.40	14	8	20001	190	31677145
Condition aggravated	24.93	14	183	19826	163826	31513509
Spontaneous penile erection	24.82	14	8	20001	205	31677130
Troponin increased	24.66	14	31	19978	9971	31667364
Parkinsonism	24.35	14	27	19982	7609	31669726
Human ehrlichiosis	24.29	14	8	20001	220	31677115
Malignant neoplasm progression	23.84	14	10	19999	78988	31598347
Stoma site haemorrhage	23.77	14	11	19998	761	31676574
Dysstasia	23.59	14	32	19977	11086	31666249
Drug withdrawal syndrome	23.05	14	42	19967	18708	31658627
Medical device site dryness	22.74	14	5	20004	26	31677309
Device effect decreased	22.70	14	4	20005	4	31677331
Intentional medical device removal by patient	22.68	14	8	20001	272	31677063
Depressive symptom	22.63	14	15	19994	2099	31675236
Device occlusion	22.53	14	23	19986	5902	31671433
Stoma site hypergranulation	22.48	14	7	20002	160	31677175
Bradycardia	22.46	14	95	19914	69232	31608103
Food interaction	22.09	14	11	19998	896	31676439
Sleep-related eating disorder	22.06	14	8	20001	295	31677040
Sleep apnoea syndrome	21.99	14	41	19968	18584	31658751
Stoma site inflammation	21.99	14	9	20000	462	31676873
Sepsis	21.89	14	39	19970	151890	31525445
Verbal abuse	21.88	14	7	20002	175	31677160
Rapid eye movements sleep abnormal	21.77	14	7	20002	178	31677157
Inappropriate antidiuretic hormone secretion	21.51	14	31	19978	11356	31665979
Cardiac dysfunction	21.03	14	14	19995	1973	31675362
Withdrawal syndrome	20.83	14	31	19978	11686	31665649
VACTERL syndrome	20.46	14	5	20004	44	31677291
Abnormal dreams	19.09	14	23	19986	7085	31670250
Cardiac arrest	18.93	14	17	19992	89045	31588290
Device issue	18.88	14	25	19984	8459	31668876
Marital problem	18.76	14	5	20004	64	31677271
Tension	18.57	14	13	19996	1988	31675347
Off label use	18.46	14	136	19873	347138	31330197
White blood cell count decreased	18.19	14	17	19992	87381	31589954
Stoma site infection	18.12	14	9	20000	729	31676606
Hyperkalaemia	18.08	14	9	20000	64342	31612993
Sexual activity increased	18.00	14	4	20005	22	31677313
Rash	17.99	14	66	19943	201420	31475915
Gait inability	17.64	14	38	19971	19106	31658229
Nightmare	17.27	14	29	19980	12108	31665227
Torticollis	17.27	14	10	19999	1102	31676233
Disease progression	17.23	14	19	19990	90445	31586890
Mobility decreased	17.23	14	47	19962	27422	31649913
Visual impairment	17.17	14	51	19958	31228	31646107
Anaemia	17.12	14	73	19936	213449	31463886
Eosinophilic fasciitis	17.08	14	5	20004	92	31677243
Sopor	16.97	14	28	19981	11524	31665811
Device alarm issue	16.94	14	8	20001	580	31676755
Suicidal ideation	16.89	14	56	19953	36350	31640985
Lung hyperinflation	16.88	14	9	20000	845	31676490
Interstitial lung disease	16.64	14	9	20000	61394	31615941
Device kink	16.53	14	7	20002	392	31676943
Hyperthyroidism	16.44	14	25	19984	9606	31667729
Device loosening	16.24	14	5	20004	110	31677225
Therapeutic response unexpected	16.22	14	24	19985	9000	31668335
Neutrophil count decreased	15.46	14	5	20004	46389	31630946
Mental impairment	15.23	14	24	19985	9508	31667827
Excessive exercise	15.21	14	3	20006	8	31677327
Paedophilia	15.21	14	3	20006	8	31677327
Rapid eye movement sleep behaviour disorder	15.06	14	5	20004	141	31677194
Hemivertebra	14.99	14	5	20004	143	31677192
Pleurothotonus	14.88	14	9	20000	1074	31676261
IVth nerve paresis	14.29	14	3	20006	12	31677323
Drug hypersensitivity	14.10	14	15	19994	72584	31604751

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
Impulse-control disorder	754.95	11.38	178	39927	1501	70886838
Gambling disorder	658.80	11.38	164	39941	1774	70886565
Dyskinesia	559.56	11.38	326	39779	40748	70847591
Hallucination	448.34	11.38	360	39745	75900	70812439
Restless legs syndrome	413.67	11.38	204	39901	18224	70870115
On and off phenomenon	410.41	11.38	122	39983	2664	70885675
Hypersexuality	407.24	11.38	107	39998	1456	70886883
Hallucination, visual	297.60	11.38	193	39912	29144	70859195
Compulsive shopping	279.44	11.38	69	40036	719	70887620
Dopamine dysregulation syndrome	241.61	11.38	56	40049	434	70887905
Parkinsonism hyperpyrexia syndrome	212.22	11.38	44	40061	187	70888152
Gambling	184.46	11.38	41	40064	257	70888082
Freezing phenomenon	154.51	11.38	51	40054	1583	70886756
Dystonia	148.57	11.38	108	39997	19598	70868741
Stereotypy	143.98	11.38	42	40063	856	70887483
Jealous delusion	142.57	11.38	33	40072	254	70888085
Bradykinesia	127.74	11.38	69	40036	7433	70880906
Fall	121.03	11.38	534	39571	443562	70444777
Muscle rigidity	117.91	11.38	92	40013	18558	70869781
Stoma site discharge	115.76	11.38	42	40063	1737	70886602
Binge eating	115.72	11.38	31	40074	456	70887883
Delusion	115.70	11.38	92	40013	19073	70869266
Stoma site erythema	110.24	11.38	38	40067	1350	70886989
Obsessive-compulsive disorder	107.39	11.38	55	40050	5315	70883024
Tremor	106.81	11.38	257	39848	155367	70732972
Needle fatigue	101.96	11.38	31	40074	732	70887607
Hyperkinesia	99.93	11.38	42	40063	2581	70885758
Neuroleptic malignant syndrome	97.03	11.38	95	40010	25912	70862427
Psychotic disorder	95.23	11.38	112	39993	37589	70850750
Gait spastic	92.31	11.38	31	40074	1016	70887323
Compulsive hoarding	91.45	11.38	18	40087	55	70888284
Stoma site pain	91.23	11.38	32	40073	1198	70887141
Sudden onset of sleep	90.35	11.38	27	40078	600	70887739
Gait disturbance	85.23	11.38	264	39841	184842	70703497
Relapsing-remitting multiple sclerosis	84.09	11.38	31	40074	1342	70886997
Pleurothotonus	83.88	11.38	36	40069	2330	70886009
Abnormal behaviour	79.30	11.38	98	40007	34611	70853728
Insomnia	75.93	11.38	283	39822	217523	70670816
Acute psychosis	72.25	11.38	38	40067	3878	70884461
Febrile neutropenia	70.03	11.38	15	40090	204303	70684036
Akinesia	68.26	11.38	34	40071	3097	70885242
Nocturia	68.18	11.38	56	40049	12148	70876191
Therapeutic response shortened	67.76	11.38	57	40048	12781	70875558
Torticollis	66.62	11.38	30	40075	2179	70886160
Delirium	65.49	11.38	136	39969	74478	70813861
Monoparesis	64.41	11.38	33	40072	3191	70885148
Movement disorder	63.12	11.38	73	40032	24056	70864283
Paraphilia	62.94	11.38	13	40092	54	70888285
Camptocormia	61.96	11.38	19	40086	462	70887877
Orthostatic hypotension	61.08	11.38	107	39998	51636	70836703
Sleep attacks	59.67	11.38	15	40090	169	70888170
Hypertonic bladder	59.44	11.38	33	40072	3750	70884589
Neutropenia	59.30	11.38	36	40069	257120	70631219
Anxiety	56.10	11.38	260	39845	220070	70668269
Toxicity to various agents	55.84	11.38	81	40024	382091	70506248
Psychomotor hyperactivity	55.01	11.38	55	40050	15378	70872961
Impulsive behaviour	54.47	11.38	28	40077	2726	70885613
Parkinson's disease	52.94	11.38	24	40081	1771	70886568
Parkinsonism	51.67	11.38	53	40052	15272	70873067
Micturition urgency	51.16	11.38	46	40059	11268	70877071
Therapeutic product effect variable	50.86	11.38	23	40082	1687	70886652
Dropped head syndrome	50.37	11.38	14	40091	238	70888101
Drug withdrawal syndrome	49.93	11.38	76	40029	32639	70855700
Encephalitis toxic	48.28	11.38	14	40091	279	70888060
Posture abnormal	47.47	11.38	28	40077	3568	70884771
Memory impairment	47.19	11.38	137	39968	92504	70795835
Somnolence	46.71	11.38	243	39862	215363	70672976
Suspiciousness	45.54	11.38	16	40089	602	70887737
Cognitive disorder	45.39	11.38	104	40001	60852	70827487
Central nervous system lesion	43.68	11.38	44	40061	12409	70875930
Libido increased	42.84	11.38	21	40084	1848	70886491
Balance disorder	42.78	11.38	130	39975	89998	70798341
Restlessness	42.00	11.38	81	40024	42047	70846292
Pancytopenia	41.05	11.38	17	40088	151090	70737249
Agitation	40.92	11.38	131	39974	93244	70795095
Multiple sclerosis relapse	40.81	11.38	81	40024	42936	70845403
Aggression	39.83	11.38	86	40019	48360	70839979
Pyrexia	39.38	11.38	193	39912	606759	70281580
Voyeurism	38.87	11.38	6	40099	0	70888339
Rash	38.78	11.38	153	39952	510409	70377930
Diarrhoea	38.67	11.38	272	39833	783069	70105270
Malignant neoplasm progression	37.71	11.38	11	40094	121728	70766611
Economic problem	36.76	11.38	20	40085	2184	70886155
Stoma site infection	36.74	11.38	17	40088	1315	70887024
Abnormal dreams	36.35	11.38	37	40068	10566	70877773
Confusional state	36.27	11.38	280	39825	284118	70604221
Rheumatoid arthritis	35.96	11.38	69	40036	291736	70596603
Hyperphagia	35.49	11.38	20	40085	2339	70886000
Drug dispensed to wrong patient	35.21	11.38	13	40092	565	70887774
Dizziness	34.74	11.38	408	39697	463733	70424606
Withdrawal syndrome	34.04	11.38	55	40050	24849	70863490
Pericarditis	33.99	11.38	4	40101	84701	70803638
Mania	33.73	11.38	45	40060	17129	70871210
Depressive symptom	33.70	11.38	26	40079	5155	70883184
Excessive masturbation	33.45	11.38	8	40097	72	70888267
Compulsions	33.09	11.38	11	40094	349	70887990
Depressed mood	32.88	11.38	75	40030	43745	70844594
Reduced facial expression	32.86	11.38	19	40086	2333	70886006
Dementia	32.78	11.38	51	40054	22314	70866025
Hand deformity	32.52	11.38	5	40100	86477	70801862
Acute kidney injury	32.47	11.38	148	39957	474476	70413863
Delusional disorder, jealous type	32.39	11.38	5	40100	0	70888339
Erectile dysfunction	32.11	11.38	39	40066	13523	70874816
Nightmare	31.75	11.38	50	40055	22106	70866233
Medication error	31.75	11.38	87	40018	56825	70831514
Total lung capacity decreased	30.46	11.38	17	40088	1952	70886387
Troponin increased	30.31	11.38	42	40063	16572	70871767
Multiple drug therapy	29.91	11.38	20	40085	3172	70885167
Blood pressure inadequately controlled	29.86	11.38	25	40080	5567	70882772
Dysarthria	29.67	11.38	90	40015	62223	70826116
Stomatitis	29.58	11.38	18	40087	128493	70759846
Condition aggravated	29.40	11.38	370	39735	427265	70461074
Oedema peripheral	29.30	11.38	225	39880	227866	70660473
Ataxia	28.68	11.38	49	40056	23168	70865171
Glossodynia	28.32	11.38	7	40098	86480	70801859
Maternal exposure during pregnancy	28.21	11.38	15	40090	115330	70773009
Bronchopulmonary aspergillosis allergic	27.76	11.38	16	40089	1953	70886386
Inappropriate antidiuretic hormone secretion	27.29	11.38	48	40057	23228	70865111
Malignant polyp	27.29	11.38	8	40097	166	70888173
Pollakiuria	27.04	11.38	59	40046	33402	70854937
Snoring	26.34	11.38	22	40083	4882	70883457
Prescribed underdose	26.24	11.38	45	40060	21340	70866999
Sexually inappropriate behaviour	25.66	11.38	10	40095	505	70887834
Contraindicated product administered	25.62	11.38	23	40082	134589	70753750
Dependence	25.46	11.38	16	40089	2284	70886055
Discomfort	25.36	11.38	14	40091	105422	70782917
Marital problem	25.29	11.38	8	40097	216	70888123
Personality change	25.17	11.38	28	40077	8842	70879497
Obsessive-compulsive personality disorder	24.97	11.38	7	40098	123	70888216
Platelet count decreased	24.80	11.38	39	40066	178183	70710156
Sleep apnoea syndrome	24.55	11.38	56	40049	32657	70855682
Product residue present	24.33	11.38	18	40087	3352	70884987
Compulsive sexual behaviour	24.18	11.38	8	40097	250	70888089
Kleptomania	23.62	11.38	5	40100	24	70888315
Muscle spasticity	23.60	11.38	41	40064	19648	70868691
Dysstasia	23.38	11.38	47	40058	25132	70863207
Device dislocation	23.32	11.38	44	40061	22463	70865876
Depression	23.21	11.38	192	39913	198782	70689557
Diabetes mellitus inadequate control	23.13	11.38	44	40061	22601	70865738
Bipolar I disorder	22.91	11.38	14	40091	1903	70886436
Pituitary haemorrhage	22.87	11.38	8	40097	297	70888042
Disturbance in attention	22.37	11.38	64	40041	42830	70845509
Cardiac arrest	22.21	11.38	35	40070	159799	70728540
Hallucination, tactile	21.94	11.38	9	40096	520	70887819
Therapeutic response unexpected	21.89	11.38	38	40067	18193	70870146
Vaccination site bruising	21.87	11.38	4	40101	7	70888332
Chorea	21.87	11.38	14	40091	2064	70886275
Pulmonary fibrosis	21.73	11.38	55	40050	34255	70854084
Vaccination site pruritus	21.52	11.38	4	40101	8	70888331
Vaccination site oedema	21.52	11.38	4	40101	8	70888331
Off label use	21.38	11.38	294	39811	742766	70145573
Orthostatic intolerance	21.36	11.38	13	40092	1754	70886585
Mucosal inflammation	21.25	11.38	6	40099	67844	70820495
Product prescribing error	21.18	11.38	59	40046	38893	70849446
Device occlusion	21.17	11.38	28	40077	10567	70877772
Hyperventilation	20.94	11.38	23	40082	7163	70881176
Spontaneous penile erection	20.67	11.38	6	40099	120	70888219
Lung opacity	20.66	11.38	17	40088	3696	70884643
Stoma site inflammation	20.63	11.38	9	40096	606	70887733
Suicidal ideation	20.61	11.38	86	40019	69510	70818829
Stoma site hypergranulation	20.58	11.38	8	40097	401	70887938
Blister	20.58	11.38	16	40089	100510	70787829
Human ehrlichiosis	20.47	11.38	8	40097	407	70887932
Autonomic nervous system imbalance	20.33	11.38	18	40087	4321	70884018
Alopecia	20.27	11.38	52	40053	198438	70689901
Synovitis	20.23	11.38	26	40079	129202	70759137
Rapid eye movements sleep abnormal	20.22	11.38	7	40098	252	70888087
Drug intolerance	20.19	11.38	63	40042	225624	70662715
Verbal abuse	20.09	11.38	7	40098	257	70888082
Food interaction	19.98	11.38	12	40093	1581	70886758
Hypervigilance	19.52	11.38	8	40097	461	70887878
Paedophilia	19.44	11.38	3	40102	0	70888339
Paranoia	19.43	11.38	35	40070	17253	70871086
Disease progression	19.32	11.38	37	40068	156635	70731704
Vestibular migraine	19.30	11.38	6	40099	153	70888186
Thrombocytopenia	19.18	11.38	70	40035	239040	70649299
Duodenal ulcer perforation	19.11	11.38	3	40102	51109	70837230
Irritable bowel syndrome	18.98	11.38	3	40102	50847	70837492
Device kink	18.91	11.38	12	40093	1743	70886596
Urticaria	18.83	11.38	40	40065	163009	70725330
Hypomania	18.68	11.38	20	40085	6052	70882287
Hypersensitivity	18.61	11.38	67	40038	229745	70658594
Intentional medical device removal by patient	18.06	11.38	7	40098	348	70887991
Bone marrow failure	18.05	11.38	3	40102	49007	70839332
Product substitution issue	17.72	11.38	35	40070	18478	70869861
Female orgasmic disorder	17.49	11.38	4	40101	29	70888310
White blood cell count decreased	17.05	11.38	45	40060	170096	70718243
Blood calcium increased	16.80	11.38	23	40082	8970	70879369
Device issue	16.79	11.38	40	40065	23985	70864354
Stoma site haemorrhage	16.72	11.38	11	40094	1698	70886641
Drug reaction with eosinophilia and systemic symptoms	16.62	11.38	6	40099	58007	70830332
Hepatocellular injury	16.58	11.38	3	40102	46088	70842251
Nasopharyngitis	16.56	11.38	67	40038	222139	70666200
Fibroma	16.37	11.38	8	40097	699	70887640
Obsessive thoughts	16.12	11.38	9	40096	1034	70887305
Joint swelling	16.08	11.38	81	40024	253130	70635209
Conjunctival discolouration	16.06	11.38	5	40100	128	70888211
Serum serotonin increased	15.97	11.38	6	40099	274	70888065
Contraindicated product prescribed	15.88	11.38	10	40095	1433	70886906
Abdominal discomfort	15.82	11.38	65	40040	214593	70673746
Delusion of replacement	15.31	11.38	5	40100	150	70888189
Exercise tolerance decreased	15.27	11.38	21	40084	8227	70880112
Anticholinergic syndrome	15.25	11.38	13	40092	2967	70885372
Stoma site extravasation	15.12	11.38	6	40099	318	70888021
Vaccination site erythema	15.11	11.38	4	40101	56	70888283
Stoma site candida	15.04	11.38	3	40102	10	70888329
Parkinsonian gait	14.86	11.38	8	40097	856	70887483
Ascites	14.80	11.38	10	40095	67537	70820802
Orgasm abnormal	14.63	11.38	5	40100	173	70888166
Speech disorder	14.59	11.38	62	40043	50518	70837821
Swelling	14.59	11.38	56	40049	188483	70699856
Sleep disorder	14.58	11.38	78	40027	69794	70818545
Choking	14.54	11.38	24	40081	11036	70877303
Interstitial lung disease	14.47	11.38	23	40082	104662	70783677
Device connection issue	14.46	11.38	8	40097	903	70887436
Neutrophil count decreased	13.93	11.38	16	40089	83540	70804799
Somnambulism	13.90	11.38	16	40089	5244	70883095
Feeling abnormal	13.83	11.38	132	39973	142187	70746152
Drug tolerance decreased	13.82	11.38	22	40083	9811	70878528
Hiccups	13.77	11.38	21	40084	9031	70879308
Coronary artery dissection	13.73	11.38	8	40097	996	70887343
Amnesia	13.57	11.38	62	40043	52093	70836246
Ill-defined disorder	13.55	11.38	7	40098	54734	70833605
Euphoric mood	13.45	11.38	18	40087	6871	70881468
Sleep-related eating disorder	13.42	11.38	7	40098	702	70887637
Plasma cell myeloma	13.35	11.38	13	40092	73188	70815151
Cardiac dysfunction	13.34	11.38	13	40092	3524	70884815
Treatment failure	13.05	11.38	40	40065	144102	70744237
Micturition disorder	12.92	11.38	13	40092	3662	70884677
Motor dysfunction	12.86	11.38	25	40080	13045	70875294
Anisomastia	12.86	11.38	3	40102	24	70888315
Hypersomnia	12.85	11.38	33	40072	20731	70867608
Muscle injury	12.83	11.38	3	40102	38491	70849848
Bradycardia	12.82	11.38	117	39988	124498	70763841
Stoma site irritation	12.80	11.38	5	40100	254	70888085
Heat stroke	12.77	11.38	9	40096	1554	70886785
Middle insomnia	12.77	11.38	26	40079	14027	70874312
Sputum discoloured	12.76	11.38	31	40074	18820	70869519
Sexual activity increased	12.75	11.38	3	40102	25	70888314
Drug resistance	12.68	11.38	3	40102	38187	70850152
Eosinophilic fasciitis	12.54	11.38	5	40100	268	70888071
Excessive exercise	12.54	11.38	3	40102	27	70888312
Inhibitory drug interaction	12.53	11.38	13	40092	3794	70884545
Vaccination site pain	12.34	11.38	4	40101	117	70888222
Meningorrhagia	12.22	11.38	5	40100	287	70888052
Deep vein thrombosis	12.19	11.38	28	40077	111014	70777325
Liver injury	12.18	11.38	4	40101	41031	70847308
Bladder sphincter atony	12.03	11.38	4	40101	127	70888212
Lung hyperinflation	11.99	11.38	9	40096	1712	70886627
Apathy	11.99	11.38	23	40082	11885	70876454
Sepsis	11.95	11.38	85	40020	244460	70643879
Granuloma skin	11.94	11.38	18	40087	7664	70880675
Irritability	11.92	11.38	48	40057	38177	70850162
Aspiration	11.89	11.38	29	40076	17646	70870693
Keloid scar	11.86	11.38	4	40101	133	70888206
Blood creatine phosphokinase increased	11.85	11.38	67	40038	61196	70827143
Agranulocytosis	11.83	11.38	4	40101	40294	70848045
Underdose	11.77	11.38	40	40065	29343	70858996
Metabolic acidosis	11.59	11.38	15	40090	74331	70814008
Exposure during pregnancy	11.44	11.38	20	40085	87697	70800642
Infection	11.44	11.38	71	40034	210714	70677625

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N04BC05	NERVOUS SYSTEM ANTI-PARKINSON DRUGS DOPAMINERGIC AGENTS Dopamine agonists
FDA MoA	N0000000117	Dopamine Agonists
MeSH PA	D018726	Anti-Dyskinesia Agents
MeSH PA	D000975	Antioxidants
MeSH PA	D000978	Antiparkinson Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D015259	Dopamine Agents
MeSH PA	D018491	Dopamine Agonists
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D020011	Protective Agents
CHEBI has role	CHEBI:48407	antiparkinson agent
CHEBI has role	CHEBI:48578	free radical scavengers
CHEBI has role	CHEBI:51065	Dopamine receptor agonist
CHEBI has role	CHEBI:66956	antidyskinetic agent
FDA EPC	N0000175768	Nonergot Dopamine Agonist

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Restless legs	indication	32914008	DOID:0050425
Parkinson's disease	indication	49049000	DOID:14330
Fibromyalgia	off-label use	203082005	DOID:631
Hallucinations	contraindication	7011001
Dyskinesia	contraindication	9748009
Orthostatic hypotension	contraindication	28651003
Narcolepsy	contraindication	60380001	DOID:8986
Psychotic disorder	contraindication	69322001
Sleep apnea	contraindication	73430006	DOID:0050847
Kidney disease	contraindication	90708001	DOID:557
Drowsy	contraindication	271782001
Malignant melanoma	contraindication	372244006
Breastfeeding (mother)	contraindication	413712001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.57	Basic
pKa2	5.18	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
0.375MG	MIRAPEX ER	BOEHRINGER INGELHEIM	N022421	Feb. 19, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8679533	Sept. 8, 2029	TREATMENT OF PARKINSONS DISEASE
0.75MG	MIRAPEX ER	BOEHRINGER INGELHEIM	N022421	Feb. 19, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8679533	Sept. 8, 2029	TREATMENT OF PARKINSONS DISEASE
1.5MG	MIRAPEX ER	BOEHRINGER INGELHEIM	N022421	Feb. 19, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8679533	Sept. 8, 2029	TREATMENT OF PARKINSONS DISEASE
2.25MG	MIRAPEX ER	BOEHRINGER INGELHEIM	N022421	June 17, 2011	RX	TABLET, EXTENDED RELEASE	ORAL	8679533	Sept. 8, 2029	TREATMENT OF PARKINSONS DISEASE
3.75MG	MIRAPEX ER	BOEHRINGER INGELHEIM	N022421	June 17, 2011	RX	TABLET, EXTENDED RELEASE	ORAL	8679533	Sept. 8, 2029	TREATMENT OF PARKINSONS DISEASE
3MG	MIRAPEX ER	BOEHRINGER INGELHEIM	N022421	Feb. 19, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8679533	Sept. 8, 2029	TREATMENT OF PARKINSONS DISEASE
4.5MG	MIRAPEX ER	BOEHRINGER INGELHEIM	N022421	Feb. 19, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8679533	Sept. 8, 2029	TREATMENT OF PARKINSONS DISEASE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN	AGONIST	EC50	6.60	WOMBAT-PK	CHEMBL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		Ki	7.12	PDSP
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Ki	6.16	WOMBAT-PK
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN		EC50	5.93	CHEMBL
5-hydroxytryptamine receptor 7	GPCR	P34969	5HT7R_HUMAN		Ki	5.93	PDSP
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN		Ki	6.20	WOMBAT-PK
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN	AGONIST	EC50	8.67	WOMBAT-PK
Histamine H2 receptor	GPCR	P25021	HRH2_HUMAN		Ki	5.57	PDSP
5-hydroxytryptamine receptor 1B	GPCR	P28222	5HT1B_HUMAN		Ki	5.46	PDSP
5-hydroxytryptamine receptor 1D	GPCR	P28221	5HT1D_HUMAN		Ki	5.78	PDSP
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN		Ki	7.28	PDSP
D(4) dopamine receptor	GPCR	P21917	DRD4_HUMAN	AGONIST	Ki	9.31	CHEMBL
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN		Ki	4	CHEMBL
D(2) dopamine receptor	GPCR		DRD2_RAT		Ki	8.51	CHEMBL
D(2) dopamine receptor	GPCR		DRD2_BOVIN		Kd	8.80	CHEMBL
D(3) dopamine receptor	GPCR		DRD3_RAT		Ki	9.35	CHEMBL

External reference:

ID	Source
4024071	VUID
N0000022076	NUI
D00559	KEGG_DRUG
191217-81-9	SECONDARY_CAS_RN
4021042	VANDF
4024071	VANDF
C0074710	UMLSCUI
CHEBI:8356	CHEBI
G6L	PDB_CHEM_ID
CHEMBL301265	ChEMBL_ID
DB00413	DRUGBANK_ID
CHEMBL3182733	ChEMBL_ID
CHEMBL542257	ChEMBL_ID
D000077487	MESH_DESCRIPTOR_UI
119570	PUBCHEM_CID
6227	INN_ID
953	IUPHAR_LIGAND_ID
83619PEU5T	UNII
236747	RXNORM
169631	MMSL
23370	MMSL
5340	MMSL
d04145	MMSL
006721	NDDF
006722	NDDF
108471007	SNOMEDCT_US
386852009	SNOMEDCT_US
412282004	SNOMEDCT_US
725650009	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0109	TABLET, EXTENDED RELEASE	0.38 mg	ORAL	NDA	32 sections
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0109	TABLET, EXTENDED RELEASE	0.38 mg	ORAL	NDA	32 sections
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0113	TABLET, EXTENDED RELEASE	1.50 mg	ORAL	NDA	32 sections
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0113	TABLET, EXTENDED RELEASE	1.50 mg	ORAL	NDA	32 sections
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0115	TABLET, EXTENDED RELEASE	3 mg	ORAL	NDA	32 sections
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0115	TABLET, EXTENDED RELEASE	3 mg	ORAL	NDA	32 sections
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0116	TABLET, EXTENDED RELEASE	4.50 mg	ORAL	NDA	32 sections
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0116	TABLET, EXTENDED RELEASE	4.50 mg	ORAL	NDA	32 sections
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0285	TABLET, EXTENDED RELEASE	0.75 mg	ORAL	NDA	32 sections
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0285	TABLET, EXTENDED RELEASE	0.75 mg	ORAL	NDA	32 sections
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0286	TABLET, EXTENDED RELEASE	2.25 mg	ORAL	NDA	32 sections
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0286	TABLET, EXTENDED RELEASE	2.25 mg	ORAL	NDA	32 sections
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0287	TABLET, EXTENDED RELEASE	3.75 mg	ORAL	NDA	32 sections
Mirapex ER	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0287	TABLET, EXTENDED RELEASE	3.75 mg	ORAL	NDA	32 sections
Pramipexole Dihydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7597	TABLET	1 mg	ORAL	ANDA	28 sections
Pramipexole Dihydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6704	TABLET	0.25 mg	ORAL	ANDA	20 sections
Pramipexole Dihydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6704	TABLET	0.25 mg	ORAL	ANDA	20 sections
Pramipexole DihydrochlorideExtended-Release	HUMAN PRESCRIPTION DRUG LABEL	1	10370-251	TABLET, EXTENDED RELEASE	0.38 mg	ORAL	ANDA	28 sections
Pramipexole DihydrochlorideExtended-Release	HUMAN PRESCRIPTION DRUG LABEL	1	10370-251	TABLET, EXTENDED RELEASE	0.38 mg	ORAL	ANDA	28 sections
Pramipexole DihydrochlorideExtended-Release	HUMAN PRESCRIPTION DRUG LABEL	1	10370-252	TABLET, EXTENDED RELEASE	0.75 mg	ORAL	ANDA	28 sections
Pramipexole DihydrochlorideExtended-Release	HUMAN PRESCRIPTION DRUG LABEL	1	10370-252	TABLET, EXTENDED RELEASE	0.75 mg	ORAL	ANDA	28 sections
Pramipexole DihydrochlorideExtended-Release	HUMAN PRESCRIPTION DRUG LABEL	1	10370-253	TABLET, EXTENDED RELEASE	1.50 mg	ORAL	ANDA	28 sections
Pramipexole DihydrochlorideExtended-Release	HUMAN PRESCRIPTION DRUG LABEL	1	10370-253	TABLET, EXTENDED RELEASE	1.50 mg	ORAL	ANDA	28 sections
Pramipexole DihydrochlorideExtended-Release	HUMAN PRESCRIPTION DRUG LABEL	1	10370-254	TABLET, EXTENDED RELEASE	3 mg	ORAL	ANDA	28 sections
Pramipexole DihydrochlorideExtended-Release	HUMAN PRESCRIPTION DRUG LABEL	1	10370-254	TABLET, EXTENDED RELEASE	3 mg	ORAL	ANDA	28 sections
Pramipexole DihydrochlorideExtended-Release	HUMAN PRESCRIPTION DRUG LABEL	1	10370-255	TABLET, EXTENDED RELEASE	4.50 mg	ORAL	ANDA	28 sections
Pramipexole DihydrochlorideExtended-Release	HUMAN PRESCRIPTION DRUG LABEL	1	10370-255	TABLET, EXTENDED RELEASE	4.50 mg	ORAL	ANDA	28 sections
Pramipexole DihydrochlorideExtended-Release	HUMAN PRESCRIPTION DRUG LABEL	1	10370-305	TABLET, EXTENDED RELEASE	2.25 mg	ORAL	ANDA	28 sections
Pramipexole DihydrochlorideExtended-Release	HUMAN PRESCRIPTION DRUG LABEL	1	10370-305	TABLET, EXTENDED RELEASE	2.25 mg	ORAL	ANDA	28 sections
Pramipexole DihydrochlorideExtended-Release	HUMAN PRESCRIPTION DRUG LABEL	1	10370-306	TABLET, EXTENDED RELEASE	3.75 mg	ORAL	ANDA	28 sections