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)	20 mg/mL	Bocci G, Oprea TI, Benet LZ
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
Sept. 12, 2008	EMA	KRKA, D.D., NOVO MESTO
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	483.45	11.42	117	35180	1135	63452590
Dyskinesia	445.21	11.42	256	35041	31746	63421979
Impulse-control disorder	305.90	11.42	74	35223	716	63453009
Compulsive shopping	293.40	11.42	71	35226	688	63453037
On and off phenomenon	287.63	11.42	84	35213	1751	63451974
Hallucination	245.86	11.42	220	35077	54597	63399128
Hallucination, visual	183.07	11.42	121	35176	19177	63434548
Gambling	153.69	11.42	34	35263	212	63453513
Parkinsonism hyperpyrexia syndrome	146.07	11.42	30	35267	123	63453602
Dystonia	136.80	11.42	89	35208	13730	63439995
Restless legs syndrome	135.43	11.42	99	35198	18432	63435293
Tremor	133.65	11.42	253	35044	131986	63321739
Freezing phenomenon	126.19	11.42	41	35256	1231	63452494
Stoma site discharge	124.73	11.42	43	35254	1555	63452170
Hypersexuality	114.11	11.42	31	35266	491	63453234
Muscle rigidity	99.22	11.42	68	35229	11432	63442293
Systemic lupus erythematosus	98.85	11.42	4	35293	208914	63244811
Pleurothotonus	92.64	11.42	33	35264	1316	63452409
Fall	91.87	11.42	446	34851	391888	63061837
Stoma site erythema	91.33	11.42	32	35265	1215	63452510
Stoma site pain	89.92	11.42	30	35267	980	63452745
Bradykinesia	89.89	11.42	48	35249	5140	63448585
Sudden onset of sleep	89.69	11.42	26	35271	527	63453198
Obsessive-compulsive disorder	88.97	11.42	44	35253	4016	63449709
Stereotypy	81.65	11.42	23	35274	419	63453306
Glossodynia	76.72	11.42	6	35291	178870	63274855
Binge eating	70.86	11.42	21	35276	461	63453264
Camptocormia	70.59	11.42	19	35278	290	63453435
Maternal exposure during pregnancy	70.00	11.42	18	35279	220044	63233681
Total lung capacity decreased	67.45	11.42	30	35267	2153	63451572
Jealous delusion	63.51	11.42	12	35285	28	63453697
Bronchopulmonary aspergillosis allergic	63.32	11.42	29	35268	2229	63451496
Pericarditis	60.64	11.42	3	35294	131576	63322149
Orthostatic hypotension	60.62	11.42	87	35210	36073	63417652
Lung opacity	59.68	11.42	31	35266	3137	63450588
Hand deformity	59.15	11.42	9	35288	159448	63294277
Alopecia	58.34	11.42	61	35236	337475	63116250
Hyperkinesia	54.53	11.42	24	35273	1680	63452045
Pulmonary fibrosis	52.92	11.42	86	35211	39723	63414002
Compulsive hoarding	52.64	11.42	11	35286	50	63453675
Delusion	51.40	11.42	47	35250	11970	63441755
Acute psychosis	51.30	11.42	26	35271	2499	63451226
Therapeutic response shortened	47.95	11.42	45	35252	11843	63441882
Psychotic disorder	47.77	11.42	65	35232	25647	63428078
Neuroleptic malignant syndrome	47.41	11.42	45	35252	12011	63441714
Discomfort	45.56	11.42	18	35279	167356	63286369
Torticollis	45.33	11.42	22	35275	1927	63451798
Somnolence	45.22	11.42	208	35089	178477	63275248
Breath sounds abnormal	45.15	11.42	42	35255	10931	63442794
Granuloma skin	44.12	11.42	37	35260	8400	63445325
Diabetes mellitus inadequate control	44.04	11.42	48	35249	15078	63438647
Drug dispensed to wrong patient	42.89	11.42	13	35284	309	63453416
Abnormal dreams	42.79	11.42	40	35257	10476	63443249
Stoma site infection	41.54	11.42	16	35281	796	63452929
Febrile neutropenia	41.04	11.42	8	35289	118441	63335284
Swelling	40.91	11.42	56	35241	275322	63178403
Insomnia	40.77	11.42	231	35066	215021	63238704
Akinesia	40.14	11.42	19	35278	1574	63452151
Aspiration	39.84	11.42	39	35258	10812	63442913
Blood parathyroid hormone decreased	39.37	11.42	37	35260	9754	63443971
Blood calcium increased	38.88	11.42	36	35261	9314	63444411
Gait disturbance	38.33	11.42	202	35095	182976	63270749
Abnormal behaviour	38.05	11.42	53	35244	21373	63432352
Vestibular migraine	37.90	11.42	11	35286	224	63453501
Sleep attacks	37.68	11.42	9	35288	82	63453643
Panniculitis	36.45	11.42	38	35259	11347	63442378
Contraindicated product administered	35.72	11.42	41	35256	217607	63236118
Medication error	34.25	11.42	84	35213	52200	63401525
Psychomotor hyperactivity	33.09	11.42	35	35262	10628	63443097
Abdominal discomfort	32.79	11.42	82	35215	320803	63132922
Dependence	32.60	11.42	18	35279	2059	63451666
Pituitary haemorrhage	32.30	11.42	8	35289	86	63453639
Exposure during pregnancy	31.77	11.42	24	35273	155523	63298202
Dopamine dysregulation syndrome	31.59	11.42	9	35288	171	63453554
Sputum discoloured	31.39	11.42	42	35255	16305	63437420
Malignant polyp	31.07	11.42	9	35288	182	63453543
Fibroma	30.76	11.42	13	35284	824	63452901
Blood pressure inadequately controlled	30.62	11.42	24	35273	4954	63448771
Skin necrosis	30.16	11.42	38	35259	13912	63439813
Multiple drug therapy	30.13	11.42	21	35276	3625	63450100
Drug interaction	29.95	11.42	224	35073	228907	63224818
Rash	29.43	11.42	187	35110	560684	62893041
Withdrawal syndrome	29.05	11.42	45	35252	19952	63433773
Anxiety	28.62	11.42	213	35084	217328	63236397
Drug intolerance	28.43	11.42	83	35214	308578	63145147
Economic problem	27.88	11.42	16	35281	1970	63451755
Depressed mood	27.86	11.42	66	35231	40125	63413600
Prescribed underdose	27.73	11.42	55	35242	29634	63424091
Malignant neoplasm progression	27.50	11.42	6	35291	82115	63371610
Diarrhoea	27.04	11.42	261	35036	715105	62738620
Dropped head syndrome	26.77	11.42	8	35289	181	63453544
Parkinsonism	26.75	11.42	31	35266	10408	63443317
Exercise tolerance decreased	26.48	11.42	23	35274	5474	63448251
Oedema peripheral	26.32	11.42	188	35109	189323	63264402
Orthostatic intolerance	26.31	11.42	13	35284	1184	63452541
Drug withdrawal syndrome	26.15	11.42	51	35246	27143	63426582
Parkinsonian gait	25.75	11.42	10	35287	509	63453216
Neutropenia	25.56	11.42	36	35261	174969	63278756
Crime	25.55	11.42	5	35292	15	63453710
Snoring	25.29	11.42	20	35277	4182	63449543
Stomatitis	25.15	11.42	24	35273	138701	63315024
Drug tolerance decreased	24.94	11.42	39	35258	17434	63436291
Product prescribing error	24.91	11.42	49	35248	26240	63427485
Delirium	24.82	11.42	73	35224	50468	63403257
Toxicity to various agents	24.61	11.42	64	35233	247186	63206539
Hyperventilation	24.37	11.42	23	35274	6093	63447632
Hyperphagia	24.09	11.42	14	35283	1765	63451960
Blood test abnormal	23.87	11.42	36	35261	15593	63438132
Ill-defined disorder	23.57	11.42	8	35289	81747	63371978
Muscle injury	23.52	11.42	4	35293	65341	63388384
Wound	23.43	11.42	34	35263	163229	63290496
Posture abnormal	23.03	11.42	15	35282	2317	63451408
Rheumatoid nodule	22.71	11.42	37	35260	17118	63436607
Chorea	22.58	11.42	13	35284	1611	63452114
Deep brain stimulation	21.98	11.42	5	35292	36	63453689
Vaccination site oedema	21.94	11.42	4	35293	7	63453718
Serum serotonin increased	21.94	11.42	7	35290	198	63453527
Rales	21.94	11.42	31	35266	12666	63441059
Blister	21.78	11.42	24	35273	129790	63323935
Basal cell carcinoma	21.64	11.42	48	35249	27943	63425782
Compulsions	21.61	11.42	7	35290	208	63453517
Vaccination site bruising	21.59	11.42	4	35293	8	63453717
Off label use	21.47	11.42	256	35041	674206	62779519
Hypersensitivity	21.33	11.42	87	35210	292598	63161127
Vaccination site pruritus	20.70	11.42	4	35293	11	63453714
Stoma site reaction	20.44	11.42	7	35290	248	63453477
Bronchiectasis	20.27	11.42	34	35263	16108	63437617
Movement disorder	20.07	11.42	40	35257	21621	63432104
Female orgasmic disorder	20.00	11.42	5	35292	56	63453669
Product residue present	19.88	11.42	17	35280	3962	63449763
Pancytopenia	19.73	11.42	15	35282	96918	63356807
Chronic obstructive pulmonary disease	19.72	11.42	78	35219	62608	63391117
Cognitive disorder	19.66	11.42	72	35225	55743	63397982
Stoma site inflammation	19.27	11.42	8	35289	485	63453240
Disease progression	19.19	11.42	24	35273	122734	63330991
Liver injury	19.13	11.42	5	35292	60515	63393210
Memory impairment	19.12	11.42	111	35186	104147	63349578
Therapeutic response changed	19.04	11.42	10	35287	1035	63452690
Restlessness	18.95	11.42	47	35250	29406	63424319
Obstructive airways disorder	18.91	11.42	38	35259	20661	63433064
Stoma site hypergranulation	18.84	11.42	7	35290	315	63453410
Stoma site haemorrhage	18.81	11.42	10	35287	1061	63452664
Delusion of parasitosis	18.51	11.42	4	35293	22	63453703
Nightmare	18.46	11.42	36	35261	19158	63434567
Joint swelling	18.31	11.42	107	35190	327559	63126166
Sleep apnoea syndrome	18.23	11.42	46	35251	29087	63424638
Orgasm abnormal	18.13	11.42	5	35292	84	63453641
Heat stroke	18.02	11.42	9	35288	839	63452886
Product substitution issue	17.88	11.42	32	35265	15964	63437761
Coronary artery dissection	17.88	11.42	9	35288	853	63452872
Irritable bowel syndrome	17.76	11.42	12	35285	82400	63371325
Suspiciousness	17.73	11.42	7	35290	372	63453353
Bipolar disorder	17.71	11.42	22	35275	7938	63445787
Parkinson's disease	17.60	11.42	10	35287	1209	63452516
Therapeutic product effect variable	17.57	11.42	10	35287	1213	63452512
Gastrointestinal disorder	17.23	11.42	29	35268	131210	63322515
Stoma site irritation	17.22	11.42	6	35291	224	63453501
Hypercapnia	17.16	11.42	18	35279	5413	63448312
Ulcer	17.15	11.42	42	35255	26065	63427660
Pre-existing condition improved	17.10	11.42	22	35275	8222	63445503
Conjunctival discolouration	17.08	11.42	5	35292	105	63453620
Wrong device used	16.89	11.42	4	35293	35	63453690
Device connection issue	16.85	11.42	8	35289	667	63453058
Infection	16.76	11.42	68	35229	229105	63224620
Synovitis	16.66	11.42	51	35246	186867	63266858
Feeling abnormal	16.59	11.42	140	35157	148252	63305473
Amnesia	16.55	11.42	68	35229	55517	63398208
Speech disorder	16.55	11.42	55	35242	40574	63413151
Narcolepsy	16.46	11.42	10	35287	1368	63452357
Blood cholesterol increased	16.20	11.42	17	35280	94015	63359710
Autonomic nervous system imbalance	16.08	11.42	13	35284	2805	63450920
Suicidal ideation	16.01	11.42	73	35224	62348	63391377
Hypercalcaemia	15.96	11.42	43	35254	28279	63425446
Inhibitory drug interaction	15.95	11.42	13	35284	2836	63450889
Depression	15.83	11.42	173	35124	196319	63257406
Blood creatinine increased	15.77	11.42	93	35204	87751	63365974
Nasopharyngitis	15.30	11.42	81	35216	254176	63199549
Stoma site extravasation	15.20	11.42	6	35291	319	63453406
Loss of personal independence in daily activities	14.96	11.42	99	35198	97191	63356534
Compulsive sexual behaviour	14.93	11.42	4	35293	60	63453665
Red blood cell sedimentation rate increased	14.87	11.42	56	35241	43926	63409799
Mucosal inflammation	14.60	11.42	4	35293	46924	63406801
Pyrexia	14.39	11.42	180	35117	470298	62983427
Stoma site candida	14.29	11.42	3	35294	14	63453711
Balance disorder	14.27	11.42	88	35209	84334	63369391
Meningorrhagia	14.24	11.42	5	35292	191	63453534
Vaccination site erythema	13.94	11.42	4	35293	78	63453647
Confusional state	13.83	11.42	196	35101	236184	63217541
Drug eruption	13.66	11.42	41	35256	28653	63425072
Haemoptysis	13.64	11.42	41	35256	28685	63425040
Urticaria	13.55	11.42	47	35250	165755	63287970
Arthritis	13.29	11.42	110	35187	115811	63337914
Hyperpyrexia	13.23	11.42	13	35284	3619	63450106
Peripheral swelling	13.04	11.42	214	35083	265728	63187997
Bulimia nervosa	13.02	11.42	6	35291	468	63453257
Hydronephrosis	12.78	11.42	22	35275	10640	63443085
Condition aggravated	12.76	11.42	303	34994	401914	63051811
Kleptomania	12.70	11.42	3	35294	26	63453699
Vitamin B6 deficiency	12.68	11.42	4	35293	109	63453616
Endometrial cancer	12.61	11.42	12	35285	3213	63450512
Middle insomnia	12.51	11.42	24	35273	12619	63441106
Anisomastia	12.50	11.42	3	35294	28	63453697
Skin ulcer	12.30	11.42	52	35245	42993	63410732
Therapeutic response decreased	12.27	11.42	67	35230	61458	63392267
Initial insomnia	12.10	11.42	16	35281	6141	63447584
Muscle atrophy	11.90	11.42	17	35280	7016	63446709
Patient elopement	11.89	11.42	3	35294	35	63453690
Agitation	11.86	11.42	65	35232	59692	63394033
Hepatotoxicity	11.82	11.42	3	35294	37038	63416687
Microcephaly	11.69	11.42	7	35290	933	63452792
Type 2 diabetes mellitus	11.63	11.42	11	35286	63857	63389868
Product administration error	11.62	11.42	33	35264	22364	63431361

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	787.58	13.47	178	21081	1123	34934549
Gambling disorder	616.76	13.47	153	21106	1507	34934165
Hypersexuality	592.02	13.47	145	21114	1348	34934324
Hallucination	487.66	13.47	333	20926	51165	34884507
Dyskinesia	387.10	13.47	213	21046	22200	34913472
On and off phenomenon	320.49	13.47	100	21159	2397	34933275
Dopamine dysregulation syndrome	231.01	13.47	54	21205	402	34935270
Hallucination, visual	211.87	13.47	133	21126	17658	34918014
Gambling	202.39	13.47	42	21217	164	34935508
Compulsive shopping	184.56	13.47	44	21215	360	34935312
Freezing phenomenon	138.14	13.47	47	21212	1489	34934183
Needle fatigue	120.26	13.47	37	21222	844	34934828
Relapsing-remitting multiple sclerosis	117.94	13.47	38	21221	1012	34934660
Stereotypy	117.03	13.47	35	21224	723	34934949
Gait spastic	112.31	13.47	37	21222	1059	34934613
Jealous delusion	111.96	13.47	28	21231	285	34935387
Bradykinesia	111.07	13.47	52	21207	3841	34931831
Delusion	110.57	13.47	78	21181	12557	34923115
Gait disturbance	109.24	13.47	190	21069	84950	34850722
Obsessive-compulsive disorder	107.42	13.47	57	21202	5507	34930165
Muscle rigidity	106.39	13.47	71	21188	10447	34925225
Restless legs syndrome	103.31	13.47	64	21195	8290	34927382
Paraphilia	99.94	13.47	20	21239	62	34935610
Nocturia	98.67	13.47	67	21192	10143	34925529
Hypertonic bladder	93.13	13.47	37	21222	1827	34933845
Monoparesis	91.48	13.47	39	21220	2307	34933365
Sudden onset of sleep	91.07	13.47	25	21234	375	34935297
Fall	88.88	13.47	298	20961	202587	34733085
Stoma site erythema	88.22	13.47	29	21230	824	34934848
Libido increased	84.28	13.47	28	21231	823	34934849
Parkinsonism hyperpyrexia syndrome	80.81	13.47	17	21242	72	34935600
Micturition urgency	80.70	13.47	50	21209	6475	34929197
Movement disorder	79.03	13.47	63	21196	12185	34923487
Insomnia	78.35	13.47	186	21073	103721	34831951
Memory impairment	76.61	13.47	112	21147	43206	34892466
Binge eating	74.78	13.47	17	21242	110	34935562
Abnormal behaviour	73.27	13.47	83	21176	24886	34910786
Muscle spasticity	72.52	13.47	45	21214	5843	34929829
Central nervous system lesion	68.68	13.47	45	21214	6418	34929254
Psychomotor hyperactivity	67.50	13.47	52	21207	9570	34926102
Balance disorder	67.42	13.47	102	21157	40552	34895120
Dysarthria	61.59	13.47	90	21169	34692	34900980
Stoma site discharge	60.33	13.47	24	21235	1189	34934483
Toxicity to various agents	59.08	13.47	24	21235	200338	34735334
Hyperkinesia	57.92	13.47	26	21233	1742	34933930
Confusional state	55.43	13.47	203	21056	143957	34791715
Agitation	53.62	13.47	112	21147	57287	34878385
Psychotic disorder	53.38	13.47	70	21189	24382	34911290
Ataxia	52.95	13.47	53	21206	13800	34921872
Impulsive behaviour	52.92	13.47	26	21233	2136	34933536
Somnolence	52.82	13.47	168	21091	110948	34824724
Delirium	52.25	13.47	95	21164	43896	34891776
Encephalitis toxic	51.93	13.47	15	21244	273	34935399
Tremor	51.89	13.47	138	21121	82449	34853223
Anxiety	50.64	13.47	154	21105	99274	34836398
Febrile neutropenia	50.09	13.47	11	21248	136838	34798834
Aggression	49.94	13.47	87	21172	38877	34896795
Neuroleptic malignant syndrome	49.88	13.47	58	21201	17876	34917796
Multiple sclerosis relapse	49.74	13.47	50	21209	13083	34922589
Compulsive hoarding	48.84	13.47	9	21250	15	34935657
Neutropenia	47.48	13.47	18	21241	156760	34778912
Stoma site pain	46.50	13.47	17	21242	667	34935005
Voyeurism	44.84	13.47	7	21252	0	34935672
Device dislocation	44.33	13.47	34	21225	6215	34929457
Dystonia	44.24	13.47	43	21216	10802	34924870
Mania	43.16	13.47	40	21219	9471	34926201
Diarrhoea	43.02	13.47	110	21149	389802	34545870
Pyrexia	42.33	13.47	87	21172	332926	34602746
Sleep attacks	41.67	13.47	11	21248	141	34935531
Embedded device	41.39	13.47	13	21246	318	34935354
Dependence	41.17	13.47	18	21241	1132	34934540
Compulsive sexual behaviour	40.53	13.47	12	21247	239	34935433
Pleurothotonus	40.36	13.47	18	21241	1187	34934485
Dizziness	39.93	13.47	248	21011	218273	34717399
Pollakiuria	39.39	13.47	54	21205	19620	34916052
Acute kidney injury	39.32	13.47	79	21180	304909	34630763
Economic problem	38.96	13.47	18	21241	1289	34934383
Delusional disorder, jealous type	38.44	13.47	6	21253	0	34935672
Posture abnormal	37.82	13.47	21	21238	2218	34933454
Hyperphagia	37.50	13.47	18	21241	1405	34934267
Hypomania	36.80	13.47	21	21238	2338	34933334
Akinesia	35.58	13.47	20	21239	2164	34933508
Restlessness	35.42	13.47	59	21200	25423	34910249
Excessive masturbation	34.79	13.47	9	21250	106	34935566
Somnambulism	34.13	13.47	22	21237	3050	34932622
Paranoia	33.51	13.47	39	21220	12029	34923643
Therapeutic product effect variable	33.39	13.47	20	21239	2436	34933236
Erectile dysfunction	33.09	13.47	51	21208	20586	34915086
Suspiciousness	32.96	13.47	11	21248	328	34935344
Personality change	32.22	13.47	26	21233	5113	34930559
Troponin increased	31.95	13.47	37	21222	11352	34924320
Parkinsonian gait	31.82	13.47	12	21247	514	34935158
Drug withdrawal syndrome	31.78	13.47	49	21210	19785	34915887
Platelet count decreased	31.15	13.47	17	21242	119700	34815972
Dementia	31.00	13.47	40	21219	13708	34921964
Bipolar I disorder	30.41	13.47	13	21246	774	34934898
Reduced facial expression	29.36	13.47	14	21245	1077	34934595
Road traffic accident	29.22	13.47	44	21215	17406	34918266
Depression	28.65	13.47	126	21133	96972	34838700
Sexually inappropriate behaviour	28.53	13.47	11	21248	501	34935171
Cognitive disorder	27.96	13.47	57	21202	28636	34907036
Hypervigilance	27.94	13.47	8	21251	141	34935531
Dropped head syndrome	27.73	13.47	8	21251	145	34935527
Acute psychosis	27.66	13.47	16	21243	1827	34933845
Obsessive-compulsive personality disorder	27.47	13.47	8	21251	150	34935522
Pancytopenia	27.04	13.47	12	21247	95145	34840527
Disturbance in attention	27.03	13.47	53	21206	25892	34909780
Contraindicated product prescribed	27.00	13.47	10	21249	407	34935265
Malignant neoplasm progression	26.81	13.47	10	21249	88036	34847636
Intentional medical device removal by patient	25.90	13.47	9	21250	304	34935368
Stoma site hypergranulation	25.89	13.47	8	21251	185	34935487
Parkinson's disease	25.83	13.47	14	21245	1410	34934262
Hallucination, tactile	25.54	13.47	9	21250	317	34935355
Bradycardia	25.47	13.47	102	21157	75316	34860356
Sleep disorder	25.21	13.47	58	21201	31630	34904042
VACTERL syndrome	25.06	13.47	6	21253	50	34935622
Spontaneous penile erection	24.69	13.47	8	21251	217	34935455
Withdrawal syndrome	24.64	13.47	34	21225	12421	34923251
Anticholinergic syndrome	24.49	13.47	13	21246	1256	34934416
Hyperthyroidism	24.22	13.47	31	21228	10535	34925137
Compulsions	24.11	13.47	8	21251	234	34935438
Condition aggravated	23.94	13.47	199	21060	191997	34743675
Parkinsonism	23.77	13.47	27	21232	8111	34927561
Dysstasia	23.70	13.47	33	21226	12162	34923510
Medical device site dryness	22.92	13.47	5	21254	26	34935646
Device issue	22.91	13.47	29	21230	9748	34925924
Device effect decreased	22.85	13.47	4	21255	4	34935668
Stoma site haemorrhage	22.67	13.47	11	21248	879	34934793
Sleep-related eating disorder	22.62	13.47	8	21251	285	34935387
Inappropriate antidiuretic hormone secretion	22.56	13.47	33	21226	12720	34922952
Gait inability	22.35	13.47	43	21216	20715	34914957
Food interaction	21.96	13.47	11	21248	942	34934730
Rapid eye movements sleep abnormal	21.92	13.47	7	21252	181	34935491
Abnormal dreams	21.89	13.47	25	21234	7553	34928119
Motor dysfunction	21.85	13.47	24	21235	6950	34928722
Oedema peripheral	21.83	13.47	136	21123	119676	34815996
Stoma site inflammation	21.78	13.47	9	21250	492	34935180
Sleep apnoea syndrome	21.76	13.47	42	21217	20279	34915393
Sepsis	21.53	13.47	43	21216	166518	34769154
Device occlusion	21.33	13.47	23	21236	6522	34929150
Verbal abuse	21.22	13.47	7	21252	201	34935471
Human ehrlichiosis	20.75	13.47	8	21251	364	34935308
Disease progression	19.69	13.47	22	21237	108055	34827617
Device alarm issue	19.61	13.47	9	21250	635	34935037
Cardiac dysfunction	19.45	13.47	14	21245	2324	34933348
Hyperkalaemia	19.32	13.47	9	21250	69380	34866292
Cardiac arrest	19.31	13.47	18	21241	96141	34839531
Depressive symptom	19.07	13.47	15	21244	2844	34932828
White blood cell count decreased	19.01	13.47	18	21241	95427	34840245
Marital problem	18.95	13.47	5	21254	64	34935608
Hemivertebra	18.87	13.47	6	21253	153	34935519
Mobility decreased	18.54	13.47	50	21209	30078	34905594
Sexual activity increased	18.15	13.47	4	21255	22	34935650
Cerebral hypoperfusion	18.10	13.47	8	21251	516	34935156
Rash	18.05	13.47	72	21187	222680	34712992
Tension	18.03	13.47	13	21246	2162	34933510
Off label use	17.98	13.47	166	21093	419358	34516314
Anaemia	17.93	13.47	77	21182	233258	34702414
Stoma site infection	17.64	13.47	9	21250	801	34934871
Stoma site discomfort	17.58	13.47	4	21255	26	34935646
Adrenal insufficiency	17.51	13.47	31	21228	14016	34921656
Interstitial lung disease	17.37	13.47	9	21250	65273	34870399
Suicidal ideation	17.29	13.47	59	21200	40329	34895343
Torticollis	17.27	13.47	10	21249	1144	34934528
Eosinophilic fasciitis	17.11	13.47	5	21254	95	34935577
Neutrophil count decreased	16.96	13.47	5	21254	51099	34884573
Visual impairment	16.85	13.47	54	21205	35748	34899924
Lung hyperinflation	16.75	13.47	9	21250	891	34934781
Sopor	16.73	13.47	28	21231	12108	34923564
Device kink	16.27	13.47	7	21252	423	34935249
Nightmare	15.72	13.47	30	21229	14361	34921311
Therapeutic response unexpected	15.48	13.47	24	21235	9733	34925939
Excessive exercise	15.32	13.47	3	21256	8	34935664
Paedophilia	15.32	13.47	3	21256	8	34935664
Device loosening	15.21	13.47	5	21254	142	34935530
Rapid eye movement sleep behaviour disorder	14.80	13.47	5	21254	155	34935517
Chorea	14.79	13.47	9	21250	1128	34934544
Mental impairment	14.47	13.47	24	21235	10298	34925374
Vomiting	14.35	13.47	90	21169	247531	34688141
Therapeutic response shortened	14.33	13.47	20	21239	7384	34928288
Mucosal inflammation	14.32	13.47	3	21256	38619	34897053
Hypokinesia	14.31	13.47	22	21237	8858	34926814
Faecaloma	14.30	13.47	17	21242	5360	34930312
Alanine aminotransferase increased	14.12	13.47	17	21242	80798	34854874
Drug hypersensitivity	14.01	13.47	17	21242	80512	34855160
IVth nerve paresis	13.85	13.47	3	21256	15	34935657
Thrombocytopenia	13.62	13.47	49	21210	156198	34779474

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	768.24	11.57	182	44340	1592	79698274
Gambling disorder	663.57	11.57	166	44356	1860	79698006
Dyskinesia	631.86	11.57	362	44160	44411	79655455
Hallucination	487.82	11.57	395	44127	85350	79614516
On and off phenomenon	432	11.57	131	44391	3109	79696757
Hypersexuality	405.65	11.57	108	44414	1572	79698294
Hallucination, visual	316.56	11.57	208	44314	32521	79667345
Compulsive shopping	282.94	11.57	70	44452	746	79699120
Dopamine dysregulation syndrome	249.90	11.57	58	44464	459	79699407
Parkinsonism hyperpyrexia syndrome	227.05	11.57	47	44475	201	79699665
Gambling	190.22	11.57	42	44480	258	79699608
Freezing phenomenon	178.77	11.57	59	44463	1855	79698011
Dystonia	159.75	11.57	116	44406	21283	79678583
Bradykinesia	146.37	11.57	77	44445	7966	79691900
Jealous delusion	143.61	11.57	34	44488	296	79699570
Restless legs syndrome	143.39	11.57	106	44416	19986	79679880
Fall	142.84	11.57	594	43928	487035	79212831
Stereotypy	142.38	11.57	42	44480	903	79698963
Muscle rigidity	131.01	11.57	100	44422	19782	79680084
Stoma site discharge	129.01	11.57	48	44474	2161	79697705
Tremor	121.39	11.57	283	44239	169800	79530066
Binge eating	114.75	11.57	31	44491	478	79699388
Needle fatigue	113.96	11.57	35	44487	867	79698999
Delusion	113.66	11.57	93	44429	20330	79679536
Pleurothotonus	112.43	11.57	45	44477	2471	79697395
Stoma site erythema	109.41	11.57	40	44482	1713	79698153
Gait spastic	104.23	11.57	35	44487	1162	79698704
Obsessive-compulsive disorder	102.93	11.57	55	44467	5872	79693994
Neuroleptic malignant syndrome	100.77	11.57	99	44423	27460	79672406
Relapsing-remitting multiple sclerosis	99.80	11.57	36	44486	1483	79698383
Hyperkinesia	98.84	11.57	42	44480	2687	79697179
Psychotic disorder	97.58	11.57	118	44404	41284	79658582
Stoma site pain	97.47	11.57	35	44487	1423	79698443
Sudden onset of sleep	94.31	11.57	28	44494	616	79699250
Compulsive hoarding	91.67	11.57	18	44504	55	79699811
Gait disturbance	89.54	11.57	287	44235	207219	79492647
Insomnia	88.16	11.57	319	44203	244851	79455015
Febrile neutropenia	79.72	11.57	16	44506	230983	79468883
Abnormal behaviour	76.52	11.57	98	44424	36323	79663543
Monoparesis	73.68	11.57	37	44485	3474	79696392
Nocturia	73.41	11.57	61	44461	13620	79686246
Acute psychosis	73.18	11.57	39	44483	4141	79695725
Akinesia	72.74	11.57	36	44486	3276	79696590
Movement disorder	69.69	11.57	81	44441	27178	79672688
Toxicity to various agents	68.22	11.57	81	44441	421459	79278407
Hypertonic bladder	67.42	11.57	37	44485	4164	79695702
Torticollis	64.76	11.57	30	44492	2357	79697509
Drug withdrawal syndrome	64.57	11.57	88	44434	34630	79665236
Therapeutic response shortened	63.68	11.57	60	44462	15803	79684063
Paraphilia	63.10	11.57	13	44509	54	79699812
Delirium	62.71	11.57	143	44379	84484	79615382
Camptocormia	61.93	11.57	19	44503	469	79699397
Neutropenia	59.81	11.57	44	44478	287666	79412200
Sleep attacks	59.78	11.57	15	44507	170	79699696
Total lung capacity decreased	59.16	11.57	30	44492	2875	79696991
Orthostatic hypotension	58.23	11.57	109	44413	56055	79643811
Somnolence	56.09	11.57	273	44249	238708	79461158
Micturition urgency	54.97	11.57	50	44472	12591	79687275
Anxiety	54.87	11.57	279	44243	248233	79451633
Bronchopulmonary aspergillosis allergic	54.83	11.57	29	44493	3032	79696834
Pulmonary fibrosis	53.93	11.57	92	44430	44020	79655846
Impulsive behaviour	53.44	11.57	28	44494	2872	79696994
Psychomotor hyperactivity	53.33	11.57	56	44466	16793	79683073
Therapeutic product effect variable	50.65	11.57	24	44498	1985	79697881
Parkinsonian gait	49.57	11.57	19	44503	929	79698937
Balance disorder	49.38	11.57	144	44378	98713	79601153
Central nervous system lesion	48.82	11.57	48	44474	13320	79686546
Posture abnormal	48.51	11.57	29	44493	3837	79696029
Encephalitis toxic	48.46	11.57	14	44508	279	79699587
Diarrhoea	46.90	11.57	294	44228	880195	78819671
Dropped head syndrome	46.32	11.57	14	44508	328	79699538
Suspiciousness	45.02	11.57	16	44506	631	79699235
Malignant neoplasm progression	43.72	11.57	11	44511	135979	79563887
Pericarditis	43.52	11.57	4	44518	104232	79595634
Lung opacity	43.11	11.57	30	44492	5144	79694722
Withdrawal syndrome	42.46	11.57	63	44459	26791	79673075
Pancytopenia	41.96	11.57	20	44502	165725	79534141
Parkinsonism	41.92	11.57	49	44473	16535	79683331
Multiple sclerosis relapse	41.77	11.57	85	44437	46448	79653418
Libido increased	41.73	11.57	21	44501	1980	79697886
Memory impairment	41.46	11.57	147	44375	111587	79588279
Stoma site infection	40.92	11.57	19	44503	1501	79698365
Hand deformity	40.79	11.57	5	44517	103914	79595952
Oedema peripheral	40.38	11.57	260	44262	252028	79447838
Pyrexia	39.60	11.57	220	44302	678489	79021377
Agitation	39.44	11.57	134	44388	99581	79600285
Delusional disorder, jealous type	38.95	11.57	6	44516	0	79699866
Voyeurism	38.95	11.57	6	44516	0	79699866
Restlessness	38.32	11.57	82	44440	46410	79653456
Erectile dysfunction	38.19	11.57	44	44478	14620	79685246
Prescribed underdose	37.99	11.57	63	44459	29451	79670415
Cognitive disorder	37.97	11.57	105	44417	69821	79630045
Aggression	37.62	11.57	86	44436	50872	79648994
Granuloma skin	37.40	11.57	35	44487	9139	79690727
Rash	36.78	11.57	182	44340	578176	79121690
Economic problem	36.45	11.57	20	44502	2250	79697616
Abnormal dreams	36.24	11.57	38	44484	11374	79688492
Glossodynia	35.96	11.57	7	44515	103330	79596536
Acute kidney injury	35.63	11.57	159	44363	519245	79180621
Blood calcium increased	35.50	11.57	36	44486	10364	79689502
Maternal exposure during pregnancy	35.29	11.57	16	44506	136522	79563344
Blood parathyroid hormone decreased	35.11	11.57	36	44486	10500	79689366
Confusional state	35.09	11.57	300	44222	317697	79382169
Troponin increased	34.59	11.57	48	44474	19207	79680659
Hyperphagia	34.26	11.57	20	44502	2532	79697334
Drug tolerance decreased	33.90	11.57	39	44483	12939	79686927
Depressed mood	33.80	11.57	80	44442	48400	79651466
Stomatitis	33.78	11.57	20	44502	146737	79553129
Panniculitis	33.71	11.57	38	44484	12333	79687533
Dysarthria	33.28	11.57	98	44424	67524	79632342
Ataxia	32.97	11.57	54	44468	24985	79674881
Drug dispensed to wrong patient	32.84	11.57	13	44509	693	79699173
Dementia	32.23	11.57	53	44469	24606	79675260
Mania	32.02	11.57	45	44477	18215	79681651
Compulsions	31.88	11.57	11	44511	397	79699469
Excessive masturbation	31.39	11.57	8	44514	97	79699769
Product residue present	30.63	11.57	21	44501	3515	79696351
Discomfort	30.52	11.57	16	44506	125601	79574265
Reduced facial expression	30.24	11.57	19	44503	2746	79697120
Chorea	29.99	11.57	18	44504	2399	79697467
Blood pressure inadequately controlled	29.98	11.57	26	44496	6151	79693715
Dizziness	29.68	11.57	435	44087	526006	79173860
Depressive symptom	29.10	11.57	26	44496	6397	79693469
Condition aggravated	29.01	11.57	416	44106	500708	79199158
Breath sounds abnormal	28.94	11.57	40	44482	15944	79683922
Platelet count decreased	28.75	11.57	40	44482	194624	79505242
Medication error	28.70	11.57	94	44428	68548	79631318
Muscle spasticity	27.85	11.57	46	44476	21429	79678437
Nightmare	27.81	11.57	51	44471	25810	79674056
Device dislocation	27.66	11.57	51	44471	25919	79673947
Pollakiuria	27.57	11.57	63	44459	37254	79662612
Sputum discoloured	27.43	11.57	46	44476	21697	79678169
Alopecia	27.27	11.57	55	44467	231300	79468566
Malignant polyp	27.21	11.57	8	44514	170	79699696
Duodenal ulcer perforation	26.45	11.57	3	44519	66208	79633658
Inappropriate antidiuretic hormone secretion	25.95	11.57	50	44472	26263	79673603
Aspiration	25.91	11.57	43	44479	20115	79679751
Multiple drug therapy	25.74	11.57	20	44502	4058	79695808
Marital problem	25.39	11.57	8	44514	216	79699650
Stoma site extravasation	25.30	11.57	9	44513	356	79699510
Dysstasia	25.28	11.57	51	44471	27695	79672171
Sexually inappropriate behaviour	25.23	11.57	10	44512	535	79699331
Dependence	24.89	11.57	16	44506	2406	79697460
Obsessive-compulsive personality disorder	24.80	11.57	7	44515	128	79699738
Mucosal inflammation	24.51	11.57	6	44516	75574	79624292
Disease progression	24.23	11.57	41	44481	184321	79515545
Snoring	24.17	11.57	22	44500	5544	79694322
Compulsive sexual behaviour	24.16	11.57	8	44514	254	79699612
Personality change	23.97	11.57	29	44493	10141	79689725
Kleptomania	23.68	11.57	5	44517	24	79699842
Stoma site hypergranulation	23.56	11.57	9	44513	436	79699430
Cardiac arrest	22.87	11.57	38	44484	172058	79527808
Stoma site inflammation	22.87	11.57	10	44512	686	79699180
Pituitary haemorrhage	22.82	11.57	8	44514	303	79699563
Urticaria	22.71	11.57	43	44479	185158	79514708
Off label use	22.48	11.57	364	44158	906851	78793015
Irritable bowel syndrome	22.11	11.57	4	44518	62237	79637629
Sleep apnoea syndrome	22.05	11.57	57	44465	36421	79663445
Vaccination site bruising	21.92	11.57	4	44518	7	79699859
Device connection issue	21.86	11.57	11	44511	1037	79698829
Bipolar I disorder	21.72	11.57	14	44508	2115	79697751
Vaccination site oedema	21.58	11.57	4	44518	8	79699858
Autonomic nervous system imbalance	21.49	11.57	19	44503	4611	79695255
Diabetes mellitus inadequate control	21.39	11.57	44	44478	24220	79675646
Skin necrosis	21.15	11.57	37	44485	18050	79681816
White blood cell count decreased	21.14	11.57	46	44476	188242	79511624
Intentional medical device removal by patient	21.11	11.57	8	44514	379	79699487
Hallucination, tactile	20.83	11.57	9	44513	600	79699266
Vaccination site pruritus	20.68	11.57	4	44518	11	79699855
Stoma site haemorrhage	20.54	11.57	13	44509	1903	79697963
Paranoia	20.49	11.57	38	44484	19394	79680472
Orthostatic intolerance	20.49	11.57	13	44509	1911	79697955
Spontaneous penile erection	20.43	11.57	6	44516	127	79699739
Blister	20.32	11.57	22	44500	119454	79580412
Musculoskeletal stiffness	20.28	11.57	167	44355	174841	79525025
Rapid eye movements sleep abnormal	19.79	11.57	7	44515	272	79699594
Therapeutic response unexpected	19.79	11.57	38	44484	19908	79679958
Verbal abuse	19.62	11.57	7	44515	279	79699587
Depression	19.58	11.57	196	44326	216594	79483272
Rheumatoid nodule	19.53	11.57	35	44487	17403	79682463
Paedophilia	19.47	11.57	3	44519	0	79699866
Hyperventilation	19.40	11.57	23	44499	7876	79691990
Food interaction	19.38	11.57	12	44510	1690	79698176
Vestibular migraine	19.33	11.57	6	44516	154	79699712
Product prescribing error	19.30	11.57	62	44460	44751	79655115
Device issue	19.18	11.57	45	44477	27063	79672803
Suicidal ideation	19.18	11.57	89	44433	76251	79623615
Hypervigilance	19.14	11.57	8	44514	491	79699375
Blood test abnormal	19.14	11.57	35	44487	17675	79682191
Device occlusion	18.99	11.57	28	44494	11838	79688028
Delusion of parasitosis	18.98	11.57	4	44518	19	79699847
Swelling	18.95	11.57	60	44462	216651	79483215
Bone marrow failure	18.78	11.57	3	44519	51104	79648762
Serum serotonin increased	18.65	11.57	7	44515	323	79699543
Drug intolerance	18.59	11.57	80	44442	264039	79435827
Human ehrlichiosis	18.29	11.57	8	44514	549	79699317
Obsessive thoughts	18.25	11.57	10	44512	1122	79698744
Device kink	18.20	11.57	12	44510	1883	79697983
Ill-defined disorder	18.18	11.57	7	44515	65868	79633998
Disturbance in attention	18.12	11.57	66	44456	50735	79649131
Drug interaction	18.12	11.57	329	44193	414854	79285012
Loss of personal independence in daily activities	17.81	11.57	108	44414	102472	79597394
Nasopharyngitis	17.80	11.57	77	44445	253804	79446062
Fibroma	17.52	11.57	9	44513	886	79698980
Drug reaction with eosinophilia and systemic symptoms	17.44	11.57	7	44515	64237	79635629
Female orgasmic disorder	17.42	11.57	4	44518	30	79699836
Liver injury	17.40	11.57	5	44517	56609	79643257
Contraindicated product administered	17.27	11.57	39	44483	157499	79542367
Speech disorder	17.16	11.57	68	44454	54377	79645489
Hepatocellular injury	17.03	11.57	3	44519	47590	79652276
Abdominal discomfort	17.00	11.57	77	44445	250650	79449216
Product substitution issue	17.00	11.57	36	44486	20220	79679646
Hypomania	16.95	11.57	21	44501	7523	79692343
Neutrophil count decreased	16.32	11.57	17	44505	93942	79605924
Conjunctival discolouration	16.12	11.57	5	44517	128	79699738
Stoma site irritation	16.02	11.57	6	44516	275	79699591
Interstitial lung disease	15.77	11.57	24	44498	112576	79587290
Wrong device used	15.73	11.57	4	44518	48	79699818
Exposure during pregnancy	15.72	11.57	20	44502	101112	79598754
Constipation	15.56	11.57	233	44289	282817	79417049
Muscle injury	15.46	11.57	4	44518	48557	79651309
Thrombocytopenia	15.40	11.57	86	44436	265173	79434693
Feeling abnormal	15.38	11.57	146	44376	159053	79540813
Delusion of replacement	14.95	11.57	5	44517	164	79699702
Obstructive airways disorder	14.91	11.57	45	44477	31414	79668452
Infection	14.78	11.57	77	44445	241635	79458231
Hypersensitivity	14.69	11.57	86	44436	262153	79437713
Parkinson's disease	14.65	11.57	10	44512	1661	79698205
Somnambulism	14.62	11.57	17	44505	5704	79694162
Orgasm abnormal	14.50	11.57	5	44517	180	79699686
Choking	14.47	11.57	25	44497	12076	79687790
Stoma site candida	14.46	11.57	3	44519	13	79699853
Drug resistance	14.39	11.57	3	44519	42210	79657656
Contraindicated product prescribed	14.39	11.57	10	44512	1711	79698155
Vaccination site pain	14.02	11.57	5	44517	199	79699667
Deep vein thrombosis	14.02	11.57	29	44493	120890	79578976
Exercise tolerance decreased	13.94	11.57	21	44501	9050	79690816
Rales	13.93	11.57	33	44489	19968	79679898
Ascites	13.89	11.57	13	44509	75549	79624317
Stoma site reaction	13.86	11.57	6	44516	402	79699464
Agranulocytosis	13.79	11.57	4	44518	45026	79654840
Hyperthyroidism	13.72	11.57	35	44487	22174	79677692
Lung hyperinflation	13.69	11.57	10	44512	1849	79698017
Blood cholesterol increased	13.60	11.57	16	44506	83704	79616162
Bronchiectasis	13.55	11.57	35	44487	22351	79677515
Euphoric mood	13.49	11.57	19	44503	7707	79692159
Sleep-related eating disorder	13.46	11.57	7	44515	707	79699159
Bradycardia	13.43	11.57	125	44397	135432	79564434
Vaccination site erythema	13.39	11.57	4	44518	90	79699776
Anticholinergic syndrome	13.25	11.57	13	44509	3598	79696268
Apathy	13.21	11.57	25	44497	12952	79686914
Impaired healing	12.95	11.57	18	44504	87637	79612229
Angioedema	12.93	11.57	14	44508	76021	79623845
Anisomastia	12.90	11.57	3	44519	24	79699842
Coronary artery dissection	12.86	11.57	8	44514	1136	79698730
Hypersomnia	12.86	11.57	35	44487	23051	79676815
Middle insomnia	12.84	11.57	28	44494	16041	79683825
Sexual activity increased	12.79	11.57	3	44519	25	79699841
Sopor	12.73	11.57	44	44478	32966	79666900
Coma	12.66	11.57	23	44499	100626	79599240
Multiple sclerosis	12.63	11.57	34	44488	22248	79677618
Peripheral swelling	12.58	11.57	216	44306	269401	79430465
Eosinophilic fasciitis	12.40	11.57	5	44517	280	79699586
Blood creatine phosphokinase increased	12.38	11.57	71	44451	66019	79633847
Hiccups	12.36	11.57	21	44501	10010	79689856
Excessive exercise	12.30	11.57	3	44519	30	79699836
Poor quality sleep	12.21	11.57	34	44488	22688	79677178
Multiple organ dysfunction syndrome	12.20	11.57	31	44491	120215	79579651
Heat stroke	12.18	11.57	9	44513	1694	79698172
Hallucination, auditory	12.16	11.57	32	44490	20661	79679205
Cholestasis	12.13	11.57	7	44515	52102	79647764
Micturition disorder	12.06	11.57	13	44509	4015	79695851
Bladder sphincter atony	12.02	11.57	4	44518	129	79699737
Neoplasm progression	11.95	11.57	7	44515	51675	79648191
Hepatotoxicity	11.81	11.57	7	44515	51345	79648521
Cardiac dysfunction	11.81	11.57	13	44509	4111	79695755
Hypokinesia	11.74	11.57	30	44492	19030	79680836
Meningorrhagia	11.73	11.57	5	44517	322	79699544
Myelosuppression	11.59	11.57	4	44518	40292	79659574

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 H1 receptor	GPCR	P35367	HRH1_HUMAN		Kd	8.35	CHEMBL
Histamine H2 receptor	GPCR	P25021	HRH2_HUMAN		Ki	5.57	PDSP
Histamine H4 receptor	GPCR	Q9H3N8	HRH4_HUMAN		Kd	7.80	CHEMBL
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
953	IUPHAR_LIGAND_ID
6227	INN_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