levodopa Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
dopamine receptor agonists, dopamine derivatives, used as antiparkinsonism/prolactin inhibitors	1567	59-92-7

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: levodopa ledopa 3-Hydroxy-L-tyrosine DOPA dihydroxyphenylalanine

The naturally occurring form of DIHYDROXYPHENYLALANINE and the immediate precursor of DOPAMINE. Unlike dopamine itself, it can be taken orally and crosses the blood-brain barrier. It is rapidly taken up by dopaminergic neurons and converted to DOPAMINE. It is used for the treatment of PARKINSONIAN DISORDERS and is usually given with agents that inhibit its conversion to dopamine outside of the central nervous system. Molecular weight: 197.19 Formula: C9H11NO4 CLOGP: -2.82 LIPINSKI: 0 HAC: 5 HDO: 4 TPSA: 103.78 ALOGS: -1.78 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
3.50	g	O
0.60	g	O
0.45	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	1.65 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	674.47 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	41 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.70 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	23 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.76 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.30 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Sept. 19, 2019	EMA	Acorda Therapeutics Ireland Limited
June 4, 1970	FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Dyskinesia	1869.51	12.13	826	52652	28099	46604485
On and off phenomenon	1506.31	12.13	368	53110	1623	46630961
Hallucination	1498.61	12.13	847	52631	49104	46583480
Stoma site discharge	1328.43	12.13	331	53147	1609	46630975
Freezing phenomenon	966.27	12.13	243	53235	1234	46631350
Stoma site erythema	779.15	12.13	195	53283	967	46631617
Fall	722.18	12.13	1322	52156	327775	46304809
Hyperkinesia	702.36	12.13	197	53281	1615	46630969
Stoma site pain	643.86	12.13	165	53313	915	46631669
Device dislocation	634.64	12.13	363	53115	21439	46611145
Stoma site infection	525.25	12.13	133	53345	697	46631887
Hallucination, visual	513.20	12.13	295	53183	17578	46615006
Bradykinesia	465.12	12.13	174	53304	3792	46628792
Muscle rigidity	454.71	12.13	224	53254	9737	46622847
General physical health deterioration	426.77	12.13	591	52887	115178	46517406
Tremor	397.55	12.13	571	52907	115068	46517516
Akinesia	390.22	12.13	125	53353	1676	46630908
Stoma site hypergranulation	387.05	12.13	94	53384	401	46632183
Device occlusion	348.96	12.13	159	53319	5786	46626798
Stoma site inflammation	348.31	12.13	90	53388	518	46632066
Delusion	321.99	12.13	185	53293	11003	46621581
Confusional state	314.86	12.13	615	52863	159277	46473307
Gait disturbance	276.53	12.13	551	52927	144712	46487872
Stoma site extravasation	268.51	12.13	67	53411	327	46632257
Dystonia	263.63	12.13	163	53315	11094	46621490
Device issue	254.56	12.13	199	53279	19781	46612803
Dopamine dysregulation syndrome	239.44	12.13	57	53421	219	46632365
Stoma site irritation	233.05	12.13	56	53422	226	46632358
Parkinson's disease	227.03	12.13	80	53398	1459	46631125
Parkinsonism	211.68	12.13	125	53353	7823	46624761
Dysphagia	210.61	12.13	343	53135	76969	46555615
Rheumatoid arthritis	208.70	12.13	18	53460	240197	46392387
Dementia	199.54	12.13	153	53325	14777	46617807
Stoma site reaction	198.23	12.13	50	53428	257	46632327
Mobility decreased	185.98	12.13	284	53194	60310	46572274
Therapeutic response shortened	185.31	12.13	99	53379	5100	46627484
Impulse-control disorder	178.07	12.13	55	53423	649	46631935
Fibroma	174.99	12.13	58	53420	871	46631713
Device connection issue	171.70	12.13	53	53425	624	46631960
Delirium	170.90	12.13	212	53266	37016	46595568
Orthostatic hypotension	168.98	12.13	173	53305	24485	46608099
Cognitive disorder	162.87	12.13	206	53272	36677	46595907
Rash	161.63	12.13	105	53373	356407	46276177
Device kink	160.80	12.13	66	53412	1852	46630732
Pneumoperitoneum	152.86	12.13	59	53419	1403	46631181
Therapeutic product effect variable	151.03	12.13	54	53424	1029	46631555
Headache	141.52	12.13	206	53272	478146	46154438
Hypophagia	139.52	12.13	170	53308	29136	46603448
Psychotic disorder	139.45	12.13	150	53328	22471	46610113
Stoma site haemorrhage	137.08	12.13	49	53429	933	46631651
Hypokinesia	136.09	12.13	109	53369	11213	46621371
Somnolence	132.25	12.13	437	53041	156084	46476500
Parkinsonism hyperpyrexia syndrome	130.91	12.13	32	53446	141	46632443
Stoma site odour	127.64	12.13	27	53451	50	46632534
Hip fracture	126.33	12.13	154	53324	26402	46606182
Speech disorder	120.18	12.13	176	53302	35991	46596593
Compulsive shopping	119.84	12.13	42	53436	753	46631831
Reduced facial expression	119.64	12.13	47	53431	1173	46631411
Drug hypersensitivity	118.51	12.13	66	53412	243759	46388825
Pneumonia aspiration	115.60	12.13	161	53317	31444	46601140
Neuroleptic malignant syndrome	114.75	12.13	98	53380	11024	46621560
Arthralgia	114.72	12.13	150	53328	364453	46268131
Diarrhoea	113.57	12.13	301	53177	559301	46073283
Abnormal dreams	113.11	12.13	94	53384	10185	46622399
Restlessness	111.77	12.13	142	53336	25382	46607202
Abnormal behaviour	109.85	12.13	128	53350	20930	46611654
Underdose	102.21	12.13	119	53359	19439	46613145
Disorientation	98.00	12.13	162	53316	36756	46595828
Infusion related reaction	95.33	12.13	5	53473	101203	46531381
Sinusitis	94.95	12.13	17	53461	129751	46502833
Alopecia	94.47	12.13	34	53444	162380	46470204
Device alarm issue	93.79	12.13	41	53437	1349	46631235
Sudden onset of sleep	93.02	12.13	33	53445	614	46631970
Joint swelling	92.87	12.13	37	53441	166036	46466548
Embedded device	91.38	12.13	51	53427	2865	46629719
Prescribed underdose	90.71	12.13	89	53389	11964	46620620
Balance disorder	89.75	12.13	216	53262	64305	46568279
Jealous delusion	89.63	12.13	20	53458	53	46632531
Femoral neck fracture	86.88	12.13	73	53405	8030	46624554
Pruritus	86.56	12.13	90	53388	242262	46390322
Pleurothotonus	83.97	12.13	36	53442	1129	46631455
Incorrect route of product administration	82.81	12.13	98	53380	16285	46616299
Nocturia	82.19	12.13	67	53411	7065	46625519
Stereotypy	81.67	12.13	27	53451	402	46632182
Death	80.82	12.13	658	52820	334890	46297694
Febrile neutropenia	79.64	12.13	8	53470	94619	46537965
Vitamin B6 deficiency	79.00	12.13	19	53459	77	46632507
Aggression	78.92	12.13	113	53365	22631	46609953
Fluid intake reduced	76.91	12.13	48	53430	3318	46629266
Agitation	76.51	12.13	185	53293	55230	46577354
Completed suicide	76.04	12.13	36	53442	145884	46486700
Dropped head syndrome	74.48	12.13	19	53459	103	46632481
Neutropenia	73.59	12.13	36	53442	143168	46489416
Toxicity to various agents	72.97	12.13	81	53397	211685	46420899
Choking	72.84	12.13	67	53411	8309	46624275
Injection site pain	72.24	12.13	17	53461	107135	46525449
Weight decreased	71.96	12.13	450	53028	210399	46422185
Maternal exposure during pregnancy	71.70	12.13	15	53463	102534	46530050
Nasopharyngitis	71.47	12.13	44	53434	153954	46478630
Urticaria	71.45	12.13	23	53455	117869	46514715
Posture abnormal	70.53	12.13	39	53439	2151	46630433
Gambling disorder	67.75	12.13	32	53446	1264	46631320
Swelling	67.55	12.13	29	53449	124482	46508102
Stoma site discomfort	66.98	12.13	17	53461	90	46632494
Psychomotor hyperactivity	66.84	12.13	68	53410	9545	46623039
Stoma complication	66.77	12.13	20	53458	211	46632373
Nonspecific reaction	65.28	12.13	35	53443	1815	46630769
Orthostatic intolerance	64.99	12.13	30	53448	1124	46631460
Exposure during pregnancy	64.02	12.13	22	53456	108190	46524394
Torticollis	63.96	12.13	34	53444	1733	46630851
Decubitus ulcer	63.40	12.13	67	53411	9831	46622753
Treatment failure	62.29	12.13	15	53463	93072	46539512
Bezoar	62.03	12.13	31	53447	1388	46631196
Thrombocytopenia	61.80	12.13	34	53444	126547	46506037
Contraindicated product administered	61.76	12.13	9	53469	79938	46552646
Cough	61.36	12.13	106	53372	230143	46402441
Wrong technique in device usage process	60.77	12.13	34	53444	1919	46630665
Acute kidney injury	58.90	12.13	113	53365	235742	46396842
Dyspnoea	58.00	12.13	350	53128	515198	46117386
Anxiety	55.72	12.13	378	53100	181579	46451005
Gait inability	55.68	12.13	124	53354	35079	46597505
Tension	55.61	12.13	37	53441	2855	46629729
Parkinsonian gait	55.18	12.13	21	53457	480	46632104
Hypersensitivity	54.55	12.13	55	53423	150266	46482318
Pancytopenia	54.43	12.13	15	53463	85043	46547541
Stoma site cellulitis	54.28	12.13	12	53466	30	46632554
Urinary tract infection	54.02	12.13	434	53044	219832	46412752
Nightmare	54.00	12.13	80	53398	16518	46616066
Asthma	53.47	12.13	19	53459	91523	46541061
Dysstasia	53.00	12.13	82	53396	17586	46614998
Intentional medical device removal by patient	52.71	12.13	17	53461	233	46632351
Platelet count decreased	51.59	12.13	25	53453	99999	46532585
Stoma site abscess	51.34	12.13	14	53464	102	46632482
Device colour issue	51.12	12.13	11	53467	23	46632561
Pain	50.92	12.13	329	53149	476619	46155965
Parkinsonian crisis	50.80	12.13	11	53467	24	46632560
Drug dispensed to wrong patient	50.04	12.13	16	53462	213	46632371
Excessive granulation tissue	50.02	12.13	23	53455	854	46631730
Memory impairment	49.14	12.13	197	53281	77140	46555444
Hallucination, auditory	48.92	12.13	61	53417	10695	46621889
Device leakage	48.77	12.13	44	53434	5321	46627263
Paranoia	48.04	12.13	60	53418	10537	46622047
Chest pain	48.03	12.13	80	53398	176244	46456340
Motor dysfunction	47.90	12.13	50	53428	7232	46625352
Hypersexuality	47.89	12.13	19	53459	487	46632097
Drug intolerance	47.66	12.13	59	53419	146990	46485594
Off label use	47.45	12.13	249	53229	379592	46252992
Bedridden	46.63	12.13	55	53423	9104	46623480
Camptocormia	46.62	12.13	15	53463	204	46632380
Movement disorder	46.13	12.13	75	53403	16774	46615810
Stoma site oedema	45.73	12.13	9	53469	9	46632575
Stoma site induration	45.73	12.13	9	53469	9	46632575
Deep brain stimulation	45.73	12.13	9	53469	9	46632575
Depressed mood	45.72	12.13	111	53367	33208	46599376
Psoriasis	44.75	12.13	17	53461	78587	46553997
Initial insomnia	43.43	12.13	38	53440	4414	46628170
Hepatic enzyme increased	42.85	12.13	20	53458	81767	46550817
Injection site erythema	42.53	12.13	16	53462	74411	46558173
White blood cell count decreased	41.93	12.13	40	53438	112191	46520393
Terminal state	41.33	12.13	28	53450	2226	46630358
Apathy	40.97	12.13	46	53432	7222	46625362
Back pain	40.85	12.13	115	53363	209924	46422660
Malignant neoplasm progression	40.52	12.13	12	53466	64914	46567670
Pemphigus	40.33	12.13	3	53475	45271	46587313
Stoma site candida	39.77	12.13	9	53469	26	46632558
Oromandibular dystonia	39.62	12.13	16	53462	430	46632154
Musculoskeletal stiffness	39.06	12.13	218	53260	97775	46534809
Product availability issue	38.90	12.13	21	53457	1104	46631480
Stomatitis	38.50	12.13	15	53463	68282	46564302
Ileus	37.69	12.13	62	53416	14002	46618582
Loss of consciousness	37.46	12.13	232	53246	108006	46524578
Compulsive hoarding	36.53	12.13	10	53468	74	46632510
Dementia with Lewy bodies	36.24	12.13	13	53465	250	46632334
Device loosening	36.22	12.13	14	53464	334	46632250
Abortion spontaneous	35.91	12.13	4	53474	43642	46588942
Therapeutic product effect delayed	35.62	12.13	24	53454	1891	46630693
Altered state of consciousness	35.53	12.13	81	53397	23267	46609317
Unintentional medical device removal	34.97	12.13	34	53444	4519	46628065
Prescribed overdose	34.91	12.13	51	53427	10398	46622186
Multiple system atrophy	34.88	12.13	12	53466	203	46632381
Drooling	34.58	12.13	29	53449	3180	46629404
Myalgia	34.29	12.13	55	53423	123033	46509551
Erythema	34.26	12.13	70	53408	142750	46489834
Glossodynia	34.25	12.13	5	53473	44368	46588216
Medical device site pain	34.14	12.13	12	53466	217	46632367
Apraxia	33.59	12.13	22	53456	1653	46630931
Restless legs syndrome	33.58	12.13	63	53415	15780	46616804
Herpes zoster	33.44	12.13	18	53460	67854	46564730
Sleep talking	33.30	12.13	18	53460	949	46631635
Oropharyngeal pain	33.27	12.13	22	53456	74146	46558438
Fracture	33.06	12.13	64	53414	16407	46616177
Aspiration	32.54	12.13	47	53431	9484	46623100
Acute psychosis	32.43	12.13	23	53455	1969	46630615
Injection site swelling	32.42	12.13	4	53474	40323	46592261
Vitamin B12 decreased	31.83	12.13	26	53452	2749	46629835
Injection site pruritus	31.81	12.13	4	53474	39739	46592845
Psychotic symptom	31.50	12.13	17	53461	893	46631691
Epilepsy	31.41	12.13	78	53400	23660	46608924
Anaphylactic reaction	31.05	12.13	11	53467	53101	46579483
Syncope	31.01	12.13	216	53262	104587	46527997
Psoriatic arthropathy	30.79	12.13	3	53475	36376	46596208
Polyneuropathy	30.75	12.13	51	53427	11593	46620991
Device breakage	30.50	12.13	46	53432	9646	46622938
Stoma site hypersensitivity	30.49	12.13	6	53472	6	46632578
Cerebral atrophy	30.34	12.13	32	53446	4684	46627900
Abdominal discomfort	29.94	12.13	82	53396	151083	46481501
Product prescribing error	29.90	12.13	69	53409	19978	46612606
Euthanasia	29.80	12.13	7	53471	25	46632559
Pelvic fracture	29.75	12.13	50	53428	11489	46621095
Upper respiratory tract infection	29.68	12.13	18	53460	63538	46569046
Product administration error	29.64	12.13	68	53410	19613	46612971
Injection site reaction	29.57	12.13	9	53469	47840	46584744
Illusion	29.14	12.13	17	53461	1039	46631545
Medical device change	29.03	12.13	12	53466	343	46632241
Device physical property issue	28.98	12.13	19	53459	1430	46631154
Migraine	28.51	12.13	23	53455	70003	46562581
Pyrexia	28.46	12.13	259	53219	348543	46284041
Suspiciousness	28.45	12.13	12	53466	361	46632223
Injection site bruising	27.54	12.13	4	53474	35632	46596952
Enteral nutrition	27.43	12.13	7	53471	38	46632546
Arthropathy	27.41	12.13	34	53444	84666	46547918
Resting tremor	27.23	12.13	14	53464	666	46631918
Fatigue	27.15	12.13	513	52965	608184	46024400
Neutrophil count decreased	27.14	12.13	8	53470	43418	46589166
Helplessness	27.02	12.13	10	53468	211	46632373
Depressed level of consciousness	26.93	12.13	117	53361	47452	46585132
Extra dose administered	26.89	12.13	30	53448	4677	46627907
Femur fracture	26.56	12.13	98	53380	36899	46595685
Gastrostomy	26.43	12.13	13	53465	562	46632022
Nasal congestion	26.40	12.13	11	53467	48102	46584482
Hallucinations, mixed	26.34	12.13	27	53451	3822	46628762
Catecholamines urine increased	26.34	12.13	6	53472	18	46632566
Aphasia	26.07	12.13	82	53396	28485	46604099
Device placement issue	25.77	12.13	11	53467	341	46632243
Drug interaction	25.72	12.13	350	53128	202744	46429840
Hyperventilation	25.64	12.13	32	53446	5615	46626969
Anaemia	25.42	12.13	180	53298	255599	46376985
Medical device site ulcer	25.41	12.13	5	53473	5	46632579
Stoma site rash	25.41	12.13	5	53473	5	46632579
Medical device site injury	25.41	12.13	5	53473	5	46632579
Gastrointestinal complication associated with device	25.41	12.13	5	53473	5	46632579
Lymphadenopathy	25.33	12.13	4	53474	33484	46599100
Peritonitis	25.26	12.13	66	53412	20648	46611936
Abnormal faeces	25.20	12.13	27	53451	4022	46628562
Alanine aminotransferase increased	25.12	12.13	39	53439	88412	46544172
Intussusception	25.10	12.13	12	53466	487	46632097
Epistaxis	25.10	12.13	22	53456	64283	46568301
Wrong technique in product usage process	25.04	12.13	126	53352	54296	46578288
Liver function test abnormal	24.92	12.13	11	53467	46476	46586108
Middle insomnia	24.23	12.13	41	53437	9474	46623110
Interstitial lung disease	24.20	12.13	16	53462	53933	46578651
Medical device site hyperaesthesia	24.10	12.13	5	53473	8	46632576
Salivary hypersecretion	23.80	12.13	33	53445	6412	46626172
Radioisotope scan abnormal	23.76	12.13	9	53469	203	46632381
Head injury	23.68	12.13	72	53406	24564	46608020
Chest discomfort	23.60	12.13	42	53436	90227	46542357
COVID-19	23.49	12.13	60	53418	18515	46614069
Feeding disorder	23.45	12.13	42	53436	10152	46622432
Decreased appetite	23.31	12.13	331	53147	193505	46439079
Poor quality sleep	23.30	12.13	53	53425	15200	46617384
Faecaloma	23.28	12.13	36	53442	7716	46624868
Heart rate increased	23.19	12.13	31	53447	74760	46557824
Bradyphrenia	23.16	12.13	32	53446	6198	46626386
Disturbance in attention	22.99	12.13	84	53394	31476	46601108
Mental disorder	22.94	12.13	67	53411	22358	46610226
General physical condition abnormal	22.80	12.13	24	53454	3504	46629080
Oedema	22.68	12.13	26	53452	67045	46565539
Wheezing	22.41	12.13	17	53461	53369	46579215
Hand deformity	22.29	12.13	6	53472	34568	46598016
Bone pain	22.28	12.13	13	53465	46877	46585707
Rapid eye movement sleep behaviour disorder	22.15	12.13	8	53470	157	46632427
Bronchitis	22.11	12.13	56	53422	105923	46526661
Behaviour disorder	21.71	12.13	18	53460	1943	46630641
Plasma cell myeloma	21.61	12.13	12	53466	44466	46588118
Rhinorrhoea	21.56	12.13	14	53464	47651	46584933
Medical device site erosion	21.48	12.13	5	53473	17	46632567
Lower respiratory tract infection	21.32	12.13	19	53459	55070	46577514
Emotional disorder	21.29	12.13	45	53433	12279	46620305
Sopor	21.01	12.13	60	53418	19768	46612816
Eczema eyelids	21.00	12.13	7	53471	107	46632477
Clavicle fracture	20.87	12.13	21	53457	2908	46629676
Therapeutic product effect incomplete	20.76	12.13	157	53321	77996	46554588
Vascular encephalopathy	20.69	12.13	10	53468	416	46632168
Chorea	20.52	12.13	14	53464	1126	46631458
Nausea	20.47	12.13	616	52862	686838	45945746
Extrapyramidal disorder	20.47	12.13	42	53436	11226	46621358
Medical device site dryness	20.32	12.13	4	53474	4	46632580
Osteonecrosis of jaw	20.32	12.13	7	53471	34395	46598189
Hypertension	20.07	12.13	137	53341	196219	46436365
Cachexia	19.90	12.13	26	53452	4773	46627811
Product use issue	19.75	12.13	50	53428	94594	46537990
Breast cancer	19.75	12.13	14	53464	45504	46587080
Swelling face	19.70	12.13	19	53459	53040	46579544
Mucosal inflammation	19.70	12.13	10	53468	38966	46593618
Hallucination, tactile	19.54	12.13	8	53470	223	46632361
Leukopenia	19.53	12.13	30	53448	68313	46564271
Vaginal haemorrhage	19.50	12.13	3	53475	25601	46606983
Arthritis	19.30	12.13	37	53441	77279	46555305
Obsessive-compulsive disorder	19.24	12.13	21	53457	3194	46629390
Limbic encephalitis	19.24	12.13	8	53470	232	46632352
Eating disorder	19.23	12.13	48	53430	14606	46617978
Upper limb fracture	19.09	12.13	50	53428	15663	46616921
Impulsive behaviour	19.09	12.13	15	53463	1500	46631084
Diet refusal	19.07	12.13	11	53467	658	46631926
Intentional overdose	19.05	12.13	28	53450	64916	46567668
Fibromyalgia	18.96	12.13	9	53469	36454	46596130
Faeces hard	18.76	12.13	14	53464	1297	46631287
Influenza like illness	18.74	12.13	23	53455	57547	46575037
Wheelchair user	18.66	12.13	23	53455	3985	46628599
Dyschezia	18.63	12.13	15	53463	1553	46631031
Disease progression	18.46	12.13	49	53429	91251	46541333
Neoplasm progression	18.44	12.13	4	53474	26679	46605905
Weight increased	18.21	12.13	112	53366	164361	46468223
Incontinence	18.20	12.13	37	53441	9825	46622759
Viral infection	18.12	12.13	6	53472	30229	46602355
Gastrostomy tube site complication	18.09	12.13	4	53474	10	46632574
Granuloma	18.01	12.13	22	53456	3776	46628808
Sputum retention	17.76	12.13	9	53469	415	46632169
Immobile	17.64	12.13	24	53454	4582	46628002
Hyponatraemic syndrome	17.59	12.13	10	53468	582	46632002
Rash pruritic	17.41	12.13	15	53463	44200	46588384
Renal impairment	17.36	12.13	37	53441	74335	46558249
Postural reflex impairment	17.32	12.13	3	53475	0	46632584
Cellulitis	17.22	12.13	34	53444	70254	46562330
Transient aphasia	17.02	12.13	5	53473	49	46632535
Dairy intolerance	17.02	12.13	5	53473	49	46632535
Aspartate aminotransferase increased	16.87	12.13	41	53437	78659	46553925
Red blood cell sedimentation rate increased	16.72	12.13	3	53475	22886	46609698
Pyramidal tract syndrome	16.71	12.13	8	53470	326	46632258
Tarsal tunnel syndrome	16.65	12.13	10	53468	645	46631939
Gastric perforation	16.64	12.13	13	53465	1289	46631295
Incoherent	16.51	12.13	23	53455	4489	46628095
Influenza	16.51	12.13	50	53428	89220	46543364
Wrist fracture	16.50	12.13	39	53439	11464	46621120
Serotonin syndrome	16.42	12.13	63	53415	24157	46608427
Pain in jaw	16.39	12.13	12	53466	38360	46594224
Constipation	16.25	12.13	285	53193	173812	46458772
Infrequent bowel movements	16.23	12.13	12	53466	1096	46631488
Chills	16.22	12.13	56	53422	95976	46536608
Locked-in syndrome	16.20	12.13	8	53470	349	46632235
Neuropathy peripheral	16.04	12.13	52	53426	90841	46541743
Bone marrow failure	15.93	12.13	7	53471	29662	46602922
Cerebellar haematoma	15.85	12.13	8	53470	366	46632218
Gastrooesophageal reflux disease	15.72	12.13	39	53439	74305	46558279
Pericarditis	15.72	12.13	4	53474	23923	46608661
Medical device site scab	15.63	12.13	4	53474	22	46632562
Progressive supranuclear palsy	15.54	12.13	5	53473	68	46632516
Inhibitory drug interaction	15.51	12.13	15	53463	1980	46630604
Rehabilitation therapy	15.45	12.13	12	53466	1180	46631404
Urge incontinence	15.32	12.13	10	53468	747	46631837
Deep vein thrombosis	15.24	12.13	44	53434	79729	46552855
Medical device site abscess	15.24	12.13	3	53475	3	46632581
Medical device site discolouration	15.24	12.13	3	53475	3	46632581
Medical device site vesicles	15.24	12.13	3	53475	3	46632581
Sedative therapy	15.24	12.13	3	53475	3	46632581
Propulsive gait	15.24	12.13	3	53475	3	46632581
Medication error	15.24	12.13	73	53405	30838	46601746
Pregnancy	15.22	12.13	6	53472	27131	46605453
Flushing	15.20	12.13	32	53446	64582	46568002
Nuchal rigidity	15.18	12.13	9	53469	567	46632017
Unresponsive to stimuli	15.16	12.13	75	53403	32099	46600485
Product use in unapproved indication	15.01	12.13	53	53425	90220	46542364
Dry eye	14.99	12.13	8	53470	30314	46602270
Supine hypertension	14.97	12.13	5	53473	77	46632507
Mouth ulceration	14.94	12.13	6	53472	26826	46605758
Hepatotoxicity	14.92	12.13	5	53473	25004	46607580
Device difficult to use	14.74	12.13	30	53448	7974	46624610
Multiple sclerosis	14.72	12.13	5	53473	24786	46607798
Gastrointestinal stoma complication	14.58	12.13	13	53465	1548	46631036
Heat stroke	14.54	12.13	9	53469	613	46631971
Purpura senile	14.37	12.13	9	53469	626	46631958
Screaming	14.35	12.13	18	53460	3173	46629411
Respiratory dyskinesia	14.34	12.13	4	53474	32	46632552
Saliva altered	14.27	12.13	7	53471	301	46632283
Unevaluable event	14.13	12.13	96	53382	46079	46586505
Pulmonary arterial hypertension	14.11	12.13	6	53472	25922	46606662
Persecutory delusion	14.11	12.13	16	53462	2539	46630045
Vitamin B6 decreased	14.03	12.13	3	53475	6	46632578
Vaccination site oedema	14.02	12.13	4	53474	35	46632549
Vestibular disorder	14.01	12.13	12	53466	1354	46631230
Fear of falling	14.00	12.13	6	53472	188	46632396
Vaccination site bruising	13.92	12.13	4	53474	36	46632548
Vaccination site pruritus	13.92	12.13	4	53474	36	46632548
Pulmonary fibrosis	13.91	12.13	3	53475	20089	46612495
Hepatic failure	13.57	12.13	11	53467	33405	46599179
Sleep disorder	13.56	12.13	96	53382	46699	46585885
Multiple sclerosis relapse	13.53	12.13	17	53461	42108	46590476
Catatonia	13.50	12.13	19	53459	3743	46628841
Dyspnoea exertional	13.50	12.13	23	53455	50266	46582318
Listless	13.43	12.13	14	53464	2021	46630563
Device use issue	13.43	12.13	12	53466	1433	46631151
Diabetes mellitus	13.35	12.13	23	53455	50042	46582542
Immune-mediated adverse reaction	13.22	12.13	6	53472	216	46632368
Impaired self-care	13.20	12.13	13	53465	1755	46630829
Delusion of parasitosis	13.17	12.13	3	53475	9	46632575
Cogwheel rigidity	13.11	12.13	12	53466	1478	46631106
Autonomic nervous system imbalance	13.07	12.13	15	53463	2411	46630173
Communication disorder	13.04	12.13	15	53463	2418	46630166
Hypernatraemia	13	12.13	25	53453	6376	46626208
Blood bilirubin increased	12.97	12.13	12	53466	34172	46598412
Mixed dementia	12.93	12.13	3	53475	10	46632574
Hypersomnia	12.90	12.13	43	53435	15396	46617188
Rash maculo-papular	12.86	12.13	8	53470	27866	46604718
Blood glucose increased	12.84	12.13	41	53437	71972	46560612
Acute abdomen	12.83	12.13	12	53466	1520	46631064
Haemoptysis	12.82	12.13	7	53471	26182	46606402
Mini mental status examination abnormal	12.71	12.13	3	53475	11	46632573
Tongue necrosis	12.71	12.13	3	53475	11	46632573
Wrong product administered	12.70	12.13	23	53455	5607	46626977
Cardiac failure congestive	12.64	12.13	58	53420	91692	46540892
Foetal exposure during pregnancy	12.64	12.13	10	53468	30737	46601847
Injection site haemorrhage	12.61	12.13	4	53474	20705	46611879
Device deposit issue	12.51	12.13	3	53475	12	46632572
Feeling abnormal	12.49	12.13	207	53271	124853	46507731
Osteoporosis	12.41	12.13	17	53461	40591	46591993
Hyperthermia	12.41	12.13	28	53450	7986	46624598
Pain in extremity	12.41	12.13	215	53263	258465	46374119
Product dose omission issue	12.37	12.13	266	53212	168254	46464330
Normochromic normocytic anaemia	12.37	12.13	20	53458	4452	46628132
Night sweats	12.33	12.13	8	53470	27242	46605342
Psychiatric symptom	12.28	12.13	20	53458	4477	46628107
Abdominal rigidity	12.24	12.13	12	53466	1610	46630974
Labelled drug-drug interaction medication error	12.23	12.13	30	53448	9031	46623553
Ear pain	12.20	12.13	5	53473	22087	46610497
Anaphylactic shock	12.19	12.13	4	53474	20270	46612314
Urine calcium/creatinine ratio increased	12.19	12.13	5	53473	140	46632444

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hallucination	2402.24	13.28	1430	63688	47629	29839731
On and off phenomenon	1873.30	13.28	540	64578	2351	29885009
Dyskinesia	1713.03	13.28	870	64248	20964	29866396
Device dislocation	1268.69	13.28	459	64659	4572	29882788
Freezing phenomenon	1251.24	13.28	361	64757	1575	29885785
Fall	1126.50	13.28	1658	63460	180214	29707146
Stoma site discharge	1096.57	13.28	308	64810	1193	29886167
Stoma site erythema	830.29	13.28	229	64889	815	29886545
Embedded device	645.95	13.28	164	64954	381	29886979
Hyperkinesia	583.80	13.28	206	64912	1892	29885468
Stoma site infection	573.08	13.28	168	64950	783	29886577
Hallucination, visual	552.31	13.28	376	64742	15737	29871623
Muscle rigidity	544.63	13.28	316	64802	9945	29877415
Confusional state	519.18	13.28	996	64122	133838	29753522
Bradykinesia	477.16	13.28	200	64918	3030	29884330
Delusion	474.35	13.28	306	64812	11683	29875677
Device occlusion	456.35	13.28	236	64882	5884	29881476
Stoma site pain	455.44	13.28	132	64986	586	29886774
Akinesia	441.72	13.28	176	64942	2324	29885036
Dopamine dysregulation syndrome	429.92	13.28	118	65000	410	29886950
Device issue	426.17	13.28	245	64873	7571	29879789
General physical health deterioration	416.22	13.28	764	64354	99180	29788180
Mobility decreased	412.94	13.28	386	64732	25613	29861747
Stoma site inflammation	398.89	13.28	115	65003	499	29886861
Hypersexuality	390.94	13.28	140	64978	1347	29886013
Dysphagia	388.26	13.28	544	64574	56154	29831206
Gait disturbance	376.82	13.28	622	64496	74155	29813205
Dementia	369.15	13.28	266	64852	12195	29875165
Impulse-control disorder	361.70	13.28	130	64988	1265	29886095
Stoma site hypergranulation	337.67	13.28	89	65029	253	29887107
Gambling disorder	323.20	13.28	129	64989	1711	29885649
Pneumonia aspiration	312.98	13.28	398	64720	37382	29849978
Tremor	304.50	13.28	569	64549	74794	29812566
Intentional medical device removal by patient	278.00	13.28	76	65042	259	29887101
Aggression	271.85	13.28	367	64751	36540	29850820
Cognitive disorder	271.83	13.28	295	64823	23395	29863965
Device kink	254.00	13.28	80	65038	495	29886865
Abnormal behaviour	251.21	13.28	294	64824	25329	29862031
Stoma site haemorrhage	246.69	13.28	88	65030	836	29886524
Device connection issue	239.45	13.28	74	65044	426	29886934
Stoma site reaction	210.96	13.28	58	65060	203	29887157
Restlessness	202.93	13.28	248	64870	22351	29865009
Fibroma	202.02	13.28	58	65060	247	29887113
Device alarm issue	199.81	13.28	72	65046	706	29886654
Dystonia	197.35	13.28	166	64952	9561	29877799
Somnolence	192.75	13.28	553	64565	96210	29791150
Toxicity to various agents	191.53	13.28	73	65045	177110	29710250
Febrile neutropenia	190.90	13.28	10	65108	106683	29780677
Parkinson's disease	187.06	13.28	86	65032	1642	29885718
Balance disorder	184.10	13.28	304	64814	36189	29851171
Stoma site extravasation	180.04	13.28	47	65071	127	29887233
Therapeutic product effect variable	178.68	13.28	78	65040	1311	29886049
Abnormal dreams	176.10	13.28	144	64974	7971	29879389
Diarrhoea	165.17	13.28	297	64821	333806	29553554
Agitation	163.17	13.28	362	64756	53711	29833649
Prescribed underdose	162.75	13.28	135	64983	7624	29879736
Orthostatic hypotension	154.92	13.28	224	64894	23755	29863605
Hypokinesia	149.54	13.28	125	64993	7135	29880225
Psychotic disorder	149.35	13.28	208	64910	21307	29866053
Urinary tract infection	148.55	13.28	423	64695	73236	29814124
Speech disorder	148.29	13.28	222	64896	24290	29863070
Hip fracture	140.79	13.28	146	64972	10978	29876382
Underdose	140.62	13.28	152	64966	11989	29875371
Neutropenia	138.73	13.28	53	65065	128487	29758873
Rash	131.62	13.28	134	64984	191755	29695605
Stoma site irritation	131.16	13.28	36	65082	125	29887235
Unintentional medical device removal	130.20	13.28	72	65046	2059	29885301
Incorrect route of product administration	129.90	13.28	141	64977	11174	29876186
Acute kidney injury	129.35	13.28	250	64868	273592	29613768
Platelet count decreased	128.14	13.28	36	65082	106093	29781267
Posture abnormal	127.86	13.28	68	65050	1796	29885564
Wrong technique in device usage process	127.54	13.28	55	65063	896	29886464
Nonspecific reaction	125.91	13.28	60	65058	1246	29886114
Stoma site odour	120.20	13.28	30	65088	63	29887297
Parkinsonism	119.30	13.28	110	65008	7159	29880201
Device breakage	116.51	13.28	61	65057	1559	29885801
Jealous delusion	116.51	13.28	37	65081	236	29887124
Parkinsonism hyperpyrexia syndrome	116.12	13.28	31	65087	94	29887266
Musculoskeletal stiffness	115.92	13.28	247	64871	35634	29851726
Memory impairment	115.63	13.28	252	64866	36922	29850438
Decubitus ulcer	114.72	13.28	111	65007	7677	29879683
Pancytopenia	114.17	13.28	23	65095	85029	29802331
Gait inability	113.03	13.28	170	64948	18671	29868689
Thrombocytopenia	111.80	13.28	81	65037	136963	29750397
Dysstasia	108.71	13.28	124	64994	10381	29876979
Reduced facial expression	107.53	13.28	46	65072	734	29886626
Malignant neoplasm progression	107.07	13.28	15	65103	72272	29815088
Deep brain stimulation	106.95	13.28	25	65093	34	29887326
Alanine aminotransferase increased	104.15	13.28	18	65100	74258	29813102
Death	102.31	13.28	1205	63913	356078	29531282
Compulsive shopping	102.22	13.28	38	65080	410	29886950
Delirium	101.77	13.28	253	64865	40378	29846982
Disorientation	101.16	13.28	216	64902	31202	29856158
Pruritus	100.19	13.28	67	65051	118137	29769223
Therapeutic response shortened	100.10	13.28	74	65044	3526	29883834
Dyspnoea	97.03	13.28	385	64733	332910	29554450
Nightmare	96.39	13.28	125	64993	11951	29875409
Poor quality sleep	95.17	13.28	97	65021	7144	29880216
Device deployment issue	93.49	13.28	26	65092	96	29887264
Paranoia	93.36	13.28	113	65005	10075	29877285
Device difficult to use	91.26	13.28	38	65080	565	29886795
Prescribed overdose	88.49	13.28	101	65017	8460	29878900
Headache	86.28	13.28	166	64952	182140	29705220
Bedridden	85.52	13.28	68	65050	3614	29883746
Arthralgia	85.10	13.28	102	65016	135689	29751671
Tension	81.39	13.28	48	65070	1555	29885805
Choking	79.52	13.28	74	65044	4872	29882488
Completed suicide	78.27	13.28	61	65057	99431	29787929
Aspartate aminotransferase increased	77.47	13.28	21	65097	63401	29823959
Device leakage	76.89	13.28	64	65054	3630	29883730
Stoma site discomfort	76.89	13.28	20	65098	53	29887307
Device expulsion	76.05	13.28	21	65097	75	29887285
Infusion related reaction	75.10	13.28	3	65115	40561	29846799
Sleep talking	74.75	13.28	31	65087	456	29886904
Drug hypersensitivity	74.27	13.28	28	65090	68491	29818869
Stoma site induration	73.70	13.28	19	65099	48	29887312
Neuroleptic malignant syndrome	73.21	13.28	129	64989	16166	29871194
Aspiration	71.70	13.28	101	65017	10450	29876910
Excessive granulation tissue	71.27	13.28	30	65088	459	29886901
Rheumatoid arthritis	70.19	13.28	5	65113	41192	29846168
Bezoar	70.10	13.28	36	65082	883	29886477
Hyperkalaemia	69.85	13.28	28	65090	65982	29821378
Anaemia	69.14	13.28	227	64891	207765	29679595
Parkinsonian gait	69.00	13.28	29	65089	442	29886918
Drooling	68.73	13.28	55	65063	2950	29884410
Renal failure	68.62	13.28	109	65009	128857	29758503
Cogwheel rigidity	68.35	13.28	38	65080	1098	29886262
Device physical property issue	68.15	13.28	32	65086	642	29886718
Movement disorder	67.74	13.28	95	65023	9788	29877572
Hypophagia	67.14	13.28	149	64969	22087	29865273
Plasma cell myeloma	66.63	13.28	17	65101	53445	29833915
White blood cell count decreased	66.62	13.28	51	65067	83896	29803464
Nocturia	66.27	13.28	86	65032	8226	29879134
Pyrexia	65.73	13.28	374	64744	294115	29593245
Urticaria	64.98	13.28	19	65099	54587	29832773
Stereotypy	64.77	13.28	29	65089	519	29886841
Foetal exposure during pregnancy	64.21	13.28	4	65114	36867	29850493
Nausea	64.21	13.28	381	64737	296576	29590784
Myalgia	64.19	13.28	44	65074	76623	29810737
Device use issue	63.50	13.28	21	65097	155	29887205
Psoriasis	62.50	13.28	9	65109	42497	29844863
Psychomotor hyperactivity	60.80	13.28	82	65036	8142	29879218
Sudden onset of sleep	59.99	13.28	26	65092	429	29886931
Renal impairment	59.65	13.28	57	65061	84127	29803233
Intentional device misuse	59.62	13.28	22	65096	232	29887128
Stomatitis	59.47	13.28	6	65112	37273	29850087
Femoral neck fracture	59.23	13.28	50	65068	2892	29884468
Motor dysfunction	58.25	13.28	68	65050	5834	29881526
Hypersomnia	57.99	13.28	95	65023	11221	29876139
Gambling	57.90	13.28	21	65097	210	29887150
Middle insomnia	57.79	13.28	67	65051	5706	29881654
Leukopenia	57.52	13.28	25	65093	56134	29831226
Resting tremor	56.91	13.28	27	65091	555	29886805
Feeling abnormal	56.57	13.28	259	64859	56497	29830863
Stoma site ulcer	56.06	13.28	15	65103	46	29887314
Blood creatinine increased	55.77	13.28	70	65048	91305	29796055
Fluid intake reduced	54.76	13.28	48	65070	2922	29884438
Stoma complication	54.16	13.28	19	65099	171	29887189
Obsessive-compulsive disorder	53.56	13.28	55	65063	4086	29883274
Sexually inappropriate behaviour	53.39	13.28	22	65096	318	29887042
Libido increased	52.89	13.28	29	65089	815	29886545
Septic shock	52.58	13.28	37	65081	63570	29823790
Cough	52.19	13.28	123	64995	125519	29761841
Chest pain	51.42	13.28	112	65006	117515	29769845
Vomiting	51.24	13.28	275	64843	219543	29667817
Angioedema	51.21	13.28	7	65111	34377	29852983
Interstitial lung disease	51.12	13.28	34	65084	60163	29827197
Rapid eye movement sleep behaviour disorder	50.93	13.28	16	65102	98	29887262
Off label use	50.62	13.28	326	64792	248964	29638396
Suspiciousness	50.54	13.28	22	65096	367	29886993
Stoma site oedema	49.88	13.28	12	65106	20	29887340
Device loosening	49.86	13.28	14	65104	54	29887306
Illusion	49.82	13.28	27	65091	741	29886619
Compulsive sexual behaviour	49.08	13.28	19	65099	231	29887129
Epistaxis	49.07	13.28	27	65091	52954	29834406
Loss of personal independence in daily activities	48.62	13.28	129	64989	21406	29865954
Product dose omission issue	48.35	13.28	353	64765	91278	29796082
Sleep disorder	47.73	13.28	139	64979	24340	29863020
Treatment failure	47.30	13.28	9	65109	34670	29852690
Rehabilitation therapy	47.09	13.28	24	65094	579	29886781
Anaphylactic reaction	45.97	13.28	4	65114	27978	29859382
Supine hypertension	45.07	13.28	18	65100	239	29887121
Paraphilia	44.95	13.28	14	65104	83	29887277
Fracture	44.57	13.28	60	65058	5946	29881414
Bone marrow failure	44.51	13.28	6	65112	29779	29857581
Oropharyngeal pain	44.39	13.28	5	65113	28491	29858869
Asthma	44.12	13.28	12	65106	36162	29851198
Enteral nutrition	43.43	13.28	12	65106	43	29887317
Cardiac failure congestive	43.31	13.28	73	65045	84334	29803026
Terminal state	43.27	13.28	46	65072	3558	29883802
Blood glucose increased	43.18	13.28	42	65076	61488	29825872
Hepatic enzyme increased	42.99	13.28	10	65108	33484	29853876
Neuropathy peripheral	42.98	13.28	54	65064	70421	29816939
Pancreatitis	42.85	13.28	13	65105	36477	29850883
Erythema	42.56	13.28	64	65054	77387	29809973
Constipation	42.46	13.28	403	64715	112503	29774857
Weight decreased	42.42	13.28	508	64610	150413	29736947
Hyperglycaemia	42.33	13.28	12	65106	35188	29852172
Initial insomnia	42.13	13.28	39	65079	2550	29884810
Volvulus	41.95	13.28	29	65089	1242	29886118
Therapeutic product effect incomplete	41.92	13.28	165	64953	33669	29853691
Fine motor skill dysfunction	41.91	13.28	28	65090	1133	29886227
Medical device removal	41.81	13.28	15	65103	145	29887215
Depressed mood	41.52	13.28	105	65013	16924	29870436
Injection site pain	41.05	13.28	8	65110	30302	29857058
Haemoglobin decreased	41.04	13.28	120	64998	113978	29773382
Hypersensitivity	40.14	13.28	35	65083	53993	29833367
Device placement issue	39.98	13.28	9	65109	9	29887351
Blood bilirubin increased	39.64	13.28	15	65103	36621	29850739
Product use in unapproved indication	39.43	13.28	62	65056	73631	29813729
Nasopharyngitis	39.21	13.28	42	65076	58807	29828553
Wheelchair user	38.96	13.28	25	65093	944	29886416
Impulsive behaviour	38.74	13.28	33	65085	1932	29885428
Influenza like illness	38.64	13.28	5	65113	25600	29861760
Chest discomfort	38.19	13.28	26	65092	45454	29841906
Salivary hypersecretion	38.07	13.28	63	65055	7503	29879857
Hepatic function abnormal	37.95	13.28	22	65096	41923	29845437
Chills	37.63	13.28	62	65056	72276	29815084
Disease progression	37.47	13.28	73	65045	79801	29807559
Product use complaint	37.35	13.28	26	65092	1126	29886234
Medical device site dryness	37.29	13.28	10	65108	31	29887329
Gastrostomy	37.27	13.28	22	65096	714	29886646
Apathy	37.03	13.28	56	65062	6176	29881184
Therapeutic product effect decreased	37.00	13.28	143	64975	28933	29858427
Camptocormia	36.94	13.28	14	65104	160	29887200
Medical device pain	36.88	13.28	11	65107	55	29887305
Ascites	36.76	13.28	16	65102	35905	29851455
Hepatic failure	36.73	13.28	14	65104	34029	29853331
Hypokalaemia	36.70	13.28	33	65085	50159	29837201
Head injury	36.45	13.28	100	65018	16920	29870440
Diabetes mellitus	36.41	13.28	23	65095	41842	29845518
Deep vein thrombosis	36.22	13.28	47	65071	60454	29826906
Coronary artery disease	35.97	13.28	33	65085	49679	29837681
Drug abuse	35.96	13.28	78	65040	81994	29805366
Dysarthria	35.62	13.28	146	64972	30344	29857016
Sinusitis	35.50	13.28	14	65104	33331	29854029
Chronic kidney disease	35.45	13.28	19	65099	37819	29849541
Inguinal hernia	35.23	13.28	59	65059	7096	29880264
Immobile	34.55	13.28	32	65086	2094	29885266
Dyspnoea exertional	34.37	13.28	17	65101	35413	29851947
Multiple organ dysfunction syndrome	34.35	13.28	53	65065	63434	29823926
Hepatocellular injury	33.92	13.28	7	65111	25464	29861896
Food interaction	33.76	13.28	22	65096	853	29886507
Drug reaction with eosinophilia and systemic symptoms	33.72	13.28	10	65108	28478	29858882
Tachycardia	33.21	13.28	69	65049	73670	29813690
Sepsis	33.04	13.28	185	64933	146210	29741150
Femur fracture	33.00	13.28	58	65060	7251	29880109
Gastrointestinal motility disorder	32.99	13.28	32	65086	2219	29885141
Behaviour disorder	32.95	13.28	33	65085	2379	29884981
Liver function test abnormal	32.94	13.28	13	65105	30937	29856423
Wheezing	32.92	13.28	13	65105	30925	29856435
Autonomic nervous system imbalance	32.85	13.28	33	65085	2388	29884972
Medical device discomfort	32.44	13.28	10	65108	57	29887303
Screaming	31.81	13.28	25	65093	1306	29886054
Heart rate increased	31.37	13.28	23	65095	38698	29848662
Therapeutic product effect delayed	31.29	13.28	23	65095	1086	29886274
Respiratory failure	31.22	13.28	113	65005	100529	29786831
Delusion of replacement	31.14	13.28	12	65106	144	29887216
Therapeutic response unexpected	30.72	13.28	63	65055	8840	29878520
Myocardial infarction	30.42	13.28	155	64963	125470	29761890
Anxiety	29.99	13.28	313	64805	89558	29797802
Atrial fibrillation	29.97	13.28	127	64991	107997	29779363
Communication disorder	29.87	13.28	30	65088	2170	29885190
Device power source issue	29.76	13.28	14	65104	282	29887078
Neutrophil count decreased	29.75	13.28	29	65089	42425	29844935
Osteonecrosis of jaw	29.68	13.28	3	65115	18615	29868745
Cellulitis	29.41	13.28	35	65083	46749	29840611
Daydreaming	29.04	13.28	16	65102	454	29886906
Therapy non-responder	28.77	13.28	14	65104	29439	29857921
Persecutory delusion	28.72	13.28	29	65089	2111	29885249
Joint swelling	28.58	13.28	36	65082	46910	29840450
Dementia with Lewy bodies	28.49	13.28	17	65101	563	29886797
Chronic obstructive pulmonary disease	28.47	13.28	35	65083	46091	29841269
Acute myeloid leukaemia	28.45	13.28	3	65115	18003	29869357
Progressive supranuclear palsy	28.26	13.28	9	65109	58	29887302
Hypocalcaemia	28.20	13.28	6	65112	21370	29865990
Fluid overload	28.16	13.28	4	65114	19088	29868272
Multiple system atrophy	27.80	13.28	12	65106	196	29887164
Blood alkaline phosphatase increased	27.79	13.28	17	65101	31470	29855890
Hallucination, auditory	27.76	13.28	64	65054	9725	29877635
Liver disorder	27.73	13.28	15	65103	29707	29857653
Gastrointestinal haemorrhage	27.70	13.28	91	65027	83355	29804005
Myelodysplastic syndrome	27.54	13.28	4	65114	18774	29868586
Rapid eye movements sleep abnormal	27.41	13.28	12	65106	203	29887157
Intentional overdose	27.19	13.28	30	65088	41451	29845909
Chorea	27.17	13.28	21	65097	1070	29886290
Nasal congestion	27.13	13.28	4	65114	18562	29868798
Swelling	27.09	13.28	23	65095	35952	29851408
Back pain	26.92	13.28	123	64995	102473	29784887
Hallucinations, mixed	26.86	13.28	30	65088	2453	29884907
Pain	26.82	13.28	243	64875	172398	29714962
Mental disorder	26.82	13.28	77	65041	13372	29873988
Hypoxia	26.80	13.28	39	65079	47815	29839545
Postoperative delirium	26.50	13.28	8	65110	42	29887318
Acute psychosis	26.24	13.28	26	65092	1850	29885510
Acute myocardial infarction	26.04	13.28	47	65071	52892	29834468
Lactic acidosis	25.99	13.28	18	65100	31195	29856165
Abnormal faeces	25.89	13.28	30	65088	2553	29884807
Disturbance in attention	25.87	13.28	106	65012	22023	29865337
Product availability issue	25.48	13.28	17	65101	686	29886674
Inflammatory marker increased	25.43	13.28	33	65085	3155	29884205
Postural reflex impairment	25.32	13.28	6	65112	9	29887351
Medical device site injury	25.32	13.28	6	65112	9	29887351
Device colour issue	25.32	13.28	6	65112	9	29887351
Euthanasia	25.19	13.28	8	65110	51	29887309
Stoma site abscess	25.06	13.28	8	65110	52	29887308
Fatigue	24.95	13.28	520	64598	320153	29567207
Device programming error	24.94	13.28	6	65112	10	29887350
Medical device change	24.89	13.28	10	65108	135	29887225
Acute respiratory distress syndrome	24.74	13.28	10	65108	23462	29863898
Hypertension	24.40	13.28	159	64959	121195	29766165
Intentional product use issue	24.28	13.28	26	65092	36414	29850946
Parkinsonian crisis	24.24	13.28	6	65112	12	29887348
Disseminated intravascular coagulation	24.11	13.28	9	65109	22162	29865198
Dyschezia	23.94	13.28	20	65098	1140	29886220
Cardiogenic shock	23.80	13.28	4	65114	16857	29870503
Food refusal	23.52	13.28	10	65108	157	29887203
Rhabdomyolysis	23.48	13.28	66	65052	63514	29823846
Pneumoperitoneum	23.45	13.28	23	65095	1617	29885743
Product use issue	23.40	13.28	40	65078	45976	29841384
Marital problem	23.10	13.28	8	65110	69	29887291
Jaundice	22.98	13.28	22	65096	32464	29854896
Suspected COVID-19	22.98	13.28	12	65106	305	29887055
Obsessive-compulsive personality disorder	22.91	13.28	10	65108	168	29887192
Hepatitis	22.80	13.28	10	65108	22346	29865014
Sleep attacks	22.80	13.28	10	65108	170	29887190
Pelvic fracture	22.73	13.28	26	65092	2182	29885178
Insomnia	22.70	13.28	306	64812	93030	29794330
Metabolic acidosis	22.52	13.28	29	65089	37432	29849928
Incontinence	22.43	13.28	41	65077	5285	29882075
Vitamin B6 decreased	22.21	13.28	5	65113	5	29887355
Compulsions	22.18	13.28	10	65108	182	29887178
Hepatotoxicity	22.16	13.28	6	65112	18139	29869221
Anosmia	22.08	13.28	25	65093	2075	29885285
Rash maculo-papular	22.05	13.28	14	65104	25404	29861956
Feeding disorder	22.00	13.28	43	65075	5828	29881532
Polyneuropathy	21.96	13.28	66	65052	11757	29875603
Arthritis	21.78	13.28	13	65105	24388	29862972
Palliative care	21.76	13.28	12	65106	341	29887019
Fear of falling	21.76	13.28	12	65106	341	29887019
Syncope	21.75	13.28	281	64837	84622	29802738
Upper limb fracture	21.66	13.28	35	65083	4085	29883275
Panic attack	21.65	13.28	54	65064	8627	29878733
Medical device site erosion	21.61	13.28	7	65111	48	29887312
Coronavirus infection	21.59	13.28	32	65086	3466	29883894
Pneumonitis	21.35	13.28	17	65101	27437	29859923
Saliva discolouration	21.31	13.28	5	65113	7	29887353
Micturition urgency	21.24	13.28	36	65082	4371	29882989
Skin exfoliation	21.17	13.28	12	65106	23160	29864200
Torticollis	21.09	13.28	18	65100	1057	29886303
Medical device site warmth	20.91	13.28	5	65113	8	29887352
Hepatic encephalopathy	20.87	13.28	3	65115	14189	29873171
Phlebitis infective	20.74	13.28	9	65109	149	29887211
Gout	20.63	13.28	6	65112	17309	29870051
Compulsive hoarding	20.63	13.28	6	65112	27	29887333
Complication of device insertion	20.61	13.28	8	65110	98	29887262
Wrong technique in product usage process	20.60	13.28	127	64991	31028	29856332
Blood pressure fluctuation	20.58	13.28	84	65034	17419	29869941
Anger	20.58	13.28	62	65056	11058	29876302
Drug resistance	20.54	13.28	9	65109	20124	29867236
Alien limb syndrome	20.54	13.28	5	65113	9	29887351
Proteinuria	20.36	13.28	5	65113	16140	29871220
Thrombosis	20.31	13.28	38	65080	42193	29845167
Hypoglycaemia	20.28	13.28	51	65067	50930	29836430
Neoplasm progression	20.13	13.28	7	65111	18016	29869344
Gastrointestinal stoma complication	20.13	13.28	19	65099	1273	29886087
Saliva altered	20.00	13.28	9	65109	163	29887197
Dry skin	19.99	13.28	12	65106	22442	29864918
Tubulointerstitial nephritis	19.90	13.28	7	65111	17884	29869476
COVID-19	19.62	13.28	84	65034	17794	29869566
Serotonin syndrome	19.59	13.28	84	65034	17807	29869553
Oedema	19.54	13.28	40	65078	42953	29844407
Vitamin B6 deficiency	19.42	13.28	9	65109	175	29887185
Hypomagnesaemia	19.33	13.28	6	65112	16592	29870768
Impaired self-care	19.30	13.28	16	65102	902	29886458
Pleural effusion	19.29	13.28	89	65029	73977	29813383
Voyeurism	19.29	13.28	5	65113	13	29887347
Herpes zoster	19.25	13.28	22	65096	29921	29857439
Nasal discomfort	19.24	13.28	18	65100	1193	29886167
Influenza	19.20	13.28	41	65077	43357	29844003
Infrequent bowel movements	19.20	13.28	14	65104	653	29886707
Sinus tachycardia	19.17	13.28	5	65113	15499	29871861
Palpitations	19.16	13.28	27	65091	33546	29853814
Catheter site discharge	19.13	13.28	13	65105	541	29886819
Unresponsive to stimuli	18.94	13.28	110	65008	26309	29861051
Gastric perforation	18.93	13.28	23	65095	2058	29885302
Somatic delusion	18.91	13.28	8	65110	124	29887236
Mitral valve sclerosis	18.68	13.28	8	65110	128	29887232
Bone pain	18.65	13.28	9	65109	19017	29868343
Cerebral atrophy	18.51	13.28	34	65084	4399	29882961
Binge eating	18.47	13.28	7	65111	80	29887280
Secretion discharge	18.41	13.28	31	65087	3744	29883616
Skin ulcer	18.34	13.28	9	65109	18840	29868520
Anaphylactic shock	18.31	13.28	4	65114	13989	29873371
Economic problem	18.21	13.28	19	65099	1438	29885922
Mastication disorder	18.19	13.28	17	65101	1125	29886235
Hallucination, tactile	18.17	13.28	10	65108	283	29887077
Medical device site pain	18.16	13.28	7	65111	84	29887276
Urinary incontinence	18.13	13.28	79	65039	16861	29870499
Mixed dementia	18.09	13.28	9	65109	206	29887154
International normalised ratio increased	18.03	13.28	49	65069	47690	29839670
Oesophageal achalasia	17.95	13.28	10	65108	290	29887070
Feeding tube user	17.83	13.28	6	65112	47	29887313
Sexual inhibition	17.77	13.28	4	65114	4	29887356
Stoma site pruritus	17.77	13.28	4	65114	4	29887356
Medical device site abscess	17.77	13.28	4	65114	4	29887356
Alopecia	17.58	13.28	10	65108	19265	29868095
Hypercalcaemia	17.56	13.28	3	65115	12492	29874868
Bradyphrenia	17.35	13.28	31	65087	3926	29883434
Splenomegaly	17.35	13.28	4	65114	13476	29873884
Pneumothorax	16.90	13.28	7	65111	16186	29871174
Panic reaction	16.79	13.28	18	65100	1405	29885955
Upper respiratory tract infection	16.79	13.28	21	65097	27455	29859905
Soft tissue haemorrhage	16.70	13.28	8	65110	168	29887192
Renal disorder	16.65	13.28	16	65102	23568	29863792
Angina pectoris	16.58	13.28	24	65094	29494	29857866
Excessive masturbation	16.58	13.28	7	65111	108	29887252
Medical device site scab	16.50	13.28	4	65114	7	29887353
Medical device site discolouration	16.50	13.28	4	65114	7	29887353
Transaminases increased	16.46	13.28	16	65102	23441	29863919
Colitis	16.40	13.28	26	65092	30794	29856566
Decreased interest	16.40	13.28	22	65096	2173	29885187
Pain in extremity	16.29	13.28	157	64961	110064	29777296
Respiratory dyskinesia	16.29	13.28	5	65113	28	29887332
Hypertonia	16.29	13.28	32	65086	4353	29883007
Drug interaction	16.25	13.28	321	64797	199247	29688113
Hepatic steatosis	16.09	13.28	6	65112	14787	29872573
Thunderclap headache	16.03	13.28	6	65112	66	29887294
Verbal abuse	16.00	13.28	8	65110	185	29887175
Ventricular tachycardia	15.92	13.28	17	65101	23845	29863515
Osteomyelitis	15.89	13.28	6	65112	14675	29872685
Nervousness	15.83	13.28	59	65059	11729	29875631
Impaired quality of life	15.83	13.28	18	65100	1501	29885859
Haemoptysis	15.81	13.28	27	65091	31051	29856309
Flushing	15.58	13.28	25	65093	29467	29857893
Lymphadenopathy	15.57	13.28	18	65100	24358	29863002
Colitis ulcerative	15.46	13.28	6	65112	14428	29872932
Psychotic behaviour	15.43	13.28	11	65107	495	29886865
Poisoning	15.42	13.28	3	65115	11379	29875981
Soft tissue mass	15.42	13.28	9	65109	286	29887074
Fluid replacement	15.40	13.28	3	65115	0	29887360
Gamma-glutamyltransferase increased	15.40	13.28	25	65093	29325	29858035
Grimacing	15.39	13.28	9	65109	287	29887073
Medical device site discharge	15.35	13.28	5	65113	35	29887325
Dependence	15.34	13.28	16	65102	1210	29886150
Drug intolerance	15.29	13.28	49	65069	45242	29842118
Medical device site ulcer	15.27	13.28	4	65114	11	29887349
Emotional disorder	15.22	13.28	34	65084	5060	29882300
Blood cholesterol increased	15.20	13.28	9	65109	16961	29870399
Hyperbilirubinaemia	15.16	13.28	9	65109	16933	29870427
Hepatic cirrhosis	15.03	13.28	8	65110	15991	29871369
Faecaloma	15.00	13.28	31	65087	4374	29882986
Delusional disorder, unspecified type	14.98	13.28	13	65105	781	29886579
Rash erythematous	14.97	13.28	16	65102	22436	29864924
Coagulopathy	14.95	13.28	11	65107	18476	29868884
Electrocardiogram QT prolonged	14.92	13.28	35	65083	35800	29851560
Medical device site infection	14.91	13.28	8	65110	215	29887145
Hyperthermia	14.80	13.28	52	65066	10047	29877313
Patient uncooperative	14.79	13.28	7	65111	143	29887217
Defiant behaviour	14.77	13.28	4	65114	13	29887347
Tricuspid valve sclerosis	14.77	13.28	5	65113	40	29887320
Obsessive thoughts	14.75	13.28	12	65106	659	29886701
Marasmus	14.57	13.28	11	65107	541	29886819
Anticholinergic syndrome	14.56	13.28	13	65105	811	29886549
Protrusion tongue	14.46	13.28	8	65110	229	29887131
Migraine	14.38	13.28	5	65113	12869	29874491
Eye haematoma	14.35	13.28	5	65113	44	29887316
Gastric fistula	14.25	13.28	5	65113	45	29887315
Hypermobility syndrome	14.18	13.28	8	65110	238	29887122
Pericardial effusion	14.18	13.28	15	65103	21129	29866231
Decreased activity	14.15	13.28	27	65091	3594	29883766
Skin maceration	14.13	13.28	4	65114	16	29887344
Toxic epidermal necrolysis	14.09	13.28	11	65107	17929	29869431
Electrocardiogram QT interval	14.06	13.28	5	65113	47	29887313
Contraindicated product prescribed	14.02	13.28	9	65109	340	29887020
Nephropathy toxic	14.01	13.28	3	65115	10636	29876724
Wrong device used	13.94	13.28	4	65114	17	29887343
Cystitis	13.93	13.28	45	65073	8329	29879031
Adrenal insufficiency	13.67	13.28	3	65115	10460	29876900
Eosinophilic fasciitis	13.63	13.28	6	65112	103	29887257
Ventricular fibrillation	13.60	13.28	8	65110	15130	29872230
Cervical vertebral fracture	13.59	13.28	18	65100	1756	29885604
Device material issue	13.58	13.28	4	65114	19	29887341
Stevens-Johnson syndrome	13.49	13.28	11	65107	17545	29869815
Drug eruption	13.44	13.28	11	65107	17515	29869845
Mood altered	13.43	13.28	44	65074	8206	29879154
Blood lactate dehydrogenase increased	13.39	13.28	15	65103	20586	29866774
Medical device site necrosis	13.33	13.28	3	65115	3	29887357
Device-device incompatibility	13.33	13.28	3	65115	3	29887357
Propulsive gait	13.33	13.28	3	65115	3	29887357
Stoma site hypersensitivity	13.33	13.28	3	65115	3	29887357
Medical device battery replacement	13.33	13.28	3	65115	3	29887357
Social stay hospitalisation	13.33	13.28	3	65115	3	29887357
Medical device site granuloma	13.33	13.28	3	65115	3	29887357
Stoma site cellulitis	13.33	13.28	3	65115	3	29887357
Foreign body in throat	13.28	13.28	5	65113	56	29887304

Pharmacologic Action:

Source	Code	Description
ATC	N04BA01	NERVOUS SYSTEM ANTI-PARKINSON DRUGS DOPAMINERGIC AGENTS Dopa and dopa derivatives
ATC	N04BA02	NERVOUS SYSTEM ANTI-PARKINSON DRUGS DOPAMINERGIC AGENTS Dopa and dopa derivatives
ATC	N04BA03	NERVOUS SYSTEM ANTI-PARKINSON DRUGS DOPAMINERGIC AGENTS Dopa and dopa derivatives
FDA CS	M0370111	Amino Acids, Aromatic
MeSH PA	D018726	Anti-Dyskinesia Agents
MeSH PA	D000978	Antiparkinson Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D015259	Dopamine Agents
MeSH PA	D018377	Neurotransmitter Agents
CHEBI has role	CHEBI:35219	plant growth inhibitors
CHEBI has role	CHEBI:48407	antiparkinson agent
CHEBI has role	CHEBI:48560	dopamine agents
CHEBI has role	CHEBI:50266	prodrugs
CHEBI has role	CHEBI:50910	agente neurotoxico
CHEBI has role	CHEBI:59174	haptens
CHEBI has role	CHEBI:62215	allelochemicals
CHEBI has role	CHEBI:66956	antidyskinetic drugs
CHEBI has role	CHEBI:75771	mus musculus metabolite
CHEBI has role	CHEBI:76924	plant metabolites
CHEBI has role	CHEBI:77746	h. sapiens metabolites
FDA EPC	N0000193220	Aromatic Amino Acid

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Postencephalitic parkinsonism	indication	19972008	DOID:14332
Parkinsonism	indication	32798002
Parkinson's disease	indication	49049000	DOID:14330
Restless legs	off-label use	32914008	DOID:0050425
Age-related macular degeneration	off-label use	267718000	DOID:10871
Suicidal thoughts	contraindication	6471006
Hallucinations	contraindication	7011001
Dyskinesia	contraindication	9748009
Peptic ulcer	contraindication	13200003	DOID:750
Disorder of lung	contraindication	19829001	DOID:850
Myocardial infarction	contraindication	22298006	DOID:5844
Orthostatic hypotension	contraindication	28651003
Obstruction of bile duct	contraindication	30144000
Depressive disorder	contraindication	35489007
Conduction disorder of the heart	contraindication	44808001
Duodenal ulcer disease	contraindication	51868009	DOID:1724
Diarrhea	contraindication	62315008
Psychotic disorder	contraindication	69322001
Diabetes mellitus	contraindication	73211009	DOID:9351
Gastrointestinal hemorrhage	contraindication	74474003
Open-angle glaucoma	contraindication	84494001	DOID:1067
Kidney disease	contraindication	90708001	DOID:557
Acute disease of cardiovascular system	contraindication	128487001
Seizure disorder	contraindication	128613002
Drug-induced psychosis	contraindication	191483003	DOID:1742
Disease of liver	contraindication	235856003	DOID:409
Retention of urine	contraindication	267064002
Psychoneurotic personality disorder	contraindication	268634009
Malignant melanoma	contraindication	372244006
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Cardiovascular event risk	contraindication	395112001
Gastric ulcer	contraindication	397825006	DOID:10808

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.31	acidic
pKa2	9.07	acidic
pKa3	13.05	acidic
pKa4	10.01	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
42MG	INBRIJA	ACORDA	N209184	Dec. 21, 2018	RX	POWDER	INHALATION	Dec. 21, 2021	NEW PRODUCT
4.63MG/ML;20MG/ML	DUOPA	ABBVIE INC	N203952	Jan. 9, 2015	RX	SUSPENSION	ENTERAL	Jan. 9, 2022	TREATMENT OF MOTOR FLUCTUATIONS IN PATIENTS WITH ADVANCED PARKINSONS DISEASE

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN	AGONIST				WOMBAT-PK	SCIENTIFIC LITERATURE
D(1A) dopamine receptor	GPCR	P21728	DRD1_HUMAN	AGONIST				WOMBAT-PK	SCIENTIFIC LITERATURE
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN		IC50	5.54		DRUG MATRIX
Tyrosine-protein kinase Lck	Kinase	P06239	LCK_HUMAN		IC50	5.43		DRUG MATRIX
Tyrosine-protein kinase Fyn	Kinase	P06241	FYN_HUMAN		IC50	5.67		DRUG MATRIX
Arachidonate 15-lipoxygenase	Enzyme		LOX15_RABIT		IC50	5.65		DRUG MATRIX

External reference:

ID	Source
4017790	VUID
N0000146151	NUI
D00059	KEGG_DRUG
4017790	VANDF
C0023570	UMLSCUI
CHEBI:15765	CHEBI
DAH	PDB_CHEM_ID
TY3	PDB_CHEM_ID
6047	PUBCHEM_CID
CHEMBL1009	ChEMBL_ID
DB01235	DRUGBANK_ID
D004295	MESH_DESCRIPTOR_UI
D007980	MESH_DESCRIPTOR_UI
3639	IUPHAR_LIGAND_ID
2651	INN_ID
46627O600J	UNII
6375	RXNORM
1804	MMSL
4971	MMSL
d00277	MMSL
001639	NDDF
15383004	SNOMEDCT_US
387086006	SNOMEDCT_US
65955006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
SINEMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-3915	TABLET	100 mg	ORAL	NDA	25 sections
SINEMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-3916	TABLET	100 mg	ORAL	NDA	25 sections
SINEMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-3917	TABLET	250 mg	ORAL	NDA	25 sections
SINEMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-6722	TABLET	100 mg	ORAL	NDA	25 sections
SINEMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-6723	TABLET	250 mg	ORAL	NDA	25 sections
SINEMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-6724	TABLET	100 mg	ORAL	NDA	25 sections
Duopa	HUMAN PRESCRIPTION DRUG LABEL	2	0074-3012	SUSPENSION	20 mg	ENTERAL	NDA	27 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0407	TABLET, FILM COATED	50 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0408	TABLET, FILM COATED	100 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0409	TABLET, FILM COATED	150 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0527	TABLET, FILM COATED	200 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0544	TABLET, FILM COATED	75 mg	ORAL	NDA	25 sections
Stalevo	HUMAN PRESCRIPTION DRUG LABEL	3	0078-0545	TABLET, FILM COATED	125 mg	ORAL	NDA	25 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0228-2538	TABLET	100 mg	ORAL	ANDA	11 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0228-2539	TABLET	100 mg	ORAL	ANDA	11 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0228-2540	TABLET	250 mg	ORAL	ANDA	11 sections
Carbidopa and Levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0378-0078	TABLET	100 mg	ORAL	ANDA	24 sections
Carbidopa and Levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0378-0085	TABLET	100 mg	ORAL	ANDA	24 sections
Carbidopa and Levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0378-0088	TABLET, EXTENDED RELEASE	100 mg	ORAL	ANDA	24 sections
Carbidopa and Levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0378-0094	TABLET, EXTENDED RELEASE	200 mg	ORAL	ANDA	24 sections
Carbidopa and Levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0378-1133	TABLET	250 mg	ORAL	ANDA	24 sections
Carbidopa, Levodopa and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0378-8300	TABLET, FILM COATED	50 mg	ORAL	NDA authorized generic	24 sections
Carbidopa, Levodopa and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0378-8301	TABLET, FILM COATED	75 mg	ORAL	NDA authorized generic	24 sections
Carbidopa, Levodopa and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0378-8302	TABLET, FILM COATED	100 mg	ORAL	NDA authorized generic	24 sections
Carbidopa, Levodopa and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0378-8303	TABLET, FILM COATED	125 mg	ORAL	NDA authorized generic	24 sections
Carbidopa, Levodopa and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0378-8304	TABLET, FILM COATED	150 mg	ORAL	NDA authorized generic	24 sections
Carbidopa, Levodopa and Entacapone	HUMAN PRESCRIPTION DRUG LABEL	3	0378-8305	TABLET, FILM COATED	200 mg	ORAL	NDA authorized generic	24 sections
Carbidopa and Levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0615-4568	TABLET, EXTENDED RELEASE	200 mg	ORAL	ANDA	11 sections
Carbidopa and Levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0615-4569	TABLET, EXTENDED RELEASE	100 mg	ORAL	ANDA	11 sections
Carbidopa and levodopa	HUMAN PRESCRIPTION DRUG LABEL	2	0615-8067	TABLET	100 mg	ORAL	ANDA	12 sections