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

Stem definition	Drug id	CAS RN
	1767	113-45-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: methylphenidate calocain methylphenidan phenidylate methylphenidate hydrochloride concerta methylphenidate HCl	A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE. Molecular weight: 233.31 Formula: C14H19NO2 CLOGP: 2.56 LIPINSKI: 0 HAC: 3 HDO: 1 TPSA: 38.33 ALOGS: -3.11 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

methylphenidate
calocain
methylphenidan
phenidylate
methylphenidate hydrochloride
concerta
methylphenidate HCl

A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.

Molecular weight: 233.31
Formula: C14H19NO2
CLOGP: 2.56
LIPINSKI: 0
HAC: 3
HDO: 1
TPSA: 38.33
ALOGS: -3.11
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
30	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	4.29 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	22 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	2.20 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	9.42 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)	4.80 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Dec. 5, 1955	FDA	NOVARTIS

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
Suicidal ideation	342.73	11.18	300	36623	55085	50513116
Product quality issue	255.40	11.18	198	36725	30660	50537541
Anxiety	246.22	11.18	454	36469	177152	50391049
Product substitution issue	223.41	11.18	135	36788	13922	50554279
Agitation	212.55	11.18	227	36696	53157	50515044
Depression	204.66	11.18	403	36520	165020	50403181
Aggression	173.61	11.18	135	36788	20981	50547220
Tachycardia	165.21	11.18	276	36647	99487	50468714
Disturbance in attention	161.55	11.18	153	36770	31033	50537168
Drug abuse	160.72	11.18	208	36715	59638	50508563
No adverse event	155.67	11.18	155	36768	33423	50534778
Attention deficit hyperactivity disorder	149.63	11.18	59	36864	2370	50565831
Irritability	135.06	11.18	133	36790	28293	50539908
Abnormal behaviour	134.72	11.18	113	36810	19545	50548656
Pre-existing condition improved	130.72	11.18	75	36848	7022	50561179
Tic	128.65	11.18	44	36879	1173	50567028
Intentional overdose	119.93	11.18	185	36738	62319	50505882
Precocious puberty	112.04	11.18	27	36896	189	50568012
Cataplexy	102.85	11.18	36	36887	1030	50567171
Suicide attempt	99.06	11.18	153	36770	51579	50516622
Mydriasis	96.26	11.18	72	36851	10555	50557646
Tremor	90.33	11.18	234	36689	114669	50453532
Intentional self-injury	89.66	11.18	97	36826	23015	50545186
Application site erythema	89.08	11.18	50	36873	4488	50563713
Hallucination, auditory	89.05	11.18	69	36854	10659	50557542
Psychotic disorder	88.95	11.18	94	36829	21718	50546483
Joint swelling	83.92	11.18	37	36886	245249	50322952
Therapeutic response unexpected	82.24	11.18	78	36845	15837	50552364
Contraindicated product administered	79.95	11.18	8	36915	148950	50419251
Pulmonary malformation	77.88	11.18	20	36903	187	50568014
Wrong technique in product usage process	75.52	11.18	141	36782	55369	50512832
Toxicity to various agents	72.47	11.18	327	36596	212172	50356029
Glossodynia	71.40	11.18	3	36920	115566	50452635
Product administered at inappropriate site	71.00	11.18	35	36888	2408	50565793
Overdose	70.19	11.18	195	36728	99532	50468669
Psychomotor hyperactivity	69.00	11.18	56	36867	9245	50558956
Sleep apnoea syndrome	68.82	11.18	86	36837	23782	50544419
Apathy	68.05	11.18	51	36872	7497	50560704
Somnambulism	67.35	11.18	43	36880	4881	50563320
Application site irritation	65.08	11.18	29	36894	1586	50566615
Insomnia	64.85	11.18	276	36647	174589	50393612
Chorea	63.58	11.18	27	36896	1313	50566888
Feeling abnormal	62.89	11.18	218	36705	125274	50442927
Rheumatoid arthritis	62.55	11.18	35	36888	202515	50365686
Diarrhoea	60.85	11.18	223	36700	588253	49979948
Rapid eye movement sleep behaviour disorder	60.12	11.18	16	36907	174	50568027
Somnolence	58.52	11.18	246	36677	154739	50413462
Bruxism	58.33	11.18	33	36890	3007	50565194
Product colour issue	57.92	11.18	20	36903	549	50567652
Hallucination	57.91	11.18	114	36809	46543	50521658
Intentional product misuse	57.78	11.18	114	36809	46620	50521581
Acute kidney injury	57.68	11.18	49	36874	228009	50340192
Product administration error	56.83	11.18	71	36852	19628	50548573
Panic attack	56.26	11.18	70	36853	19272	50548929
Swelling	56.09	11.18	39	36884	200833	50367368
Arthralgia	55.28	11.18	152	36771	438550	50129651
Dystonia	55.14	11.18	55	36868	11871	50556330
Systemic lupus erythematosus	55.14	11.18	17	36906	140605	50427596
Drug dependence	55.07	11.18	70	36853	19689	50548512
Enuresis	54.53	11.18	28	36895	2101	50566100
Obsessive-compulsive disorder	52.85	11.18	32	36891	3308	50564893
Dyskinesia	52.75	11.18	82	36841	27779	50540422
Social anxiety disorder	52.35	11.18	17	36906	384	50567817
Lung cyst	51.97	11.18	14	36909	160	50568041
Infusion related reaction	51.33	11.18	30	36893	169527	50398674
Arthropathy	50.62	11.18	26	36897	157880	50410321
Educational problem	49.21	11.18	16	36907	363	50567838
Lower respiratory tract infection	48.82	11.18	6	36917	95195	50473006
Impulsive behaviour	48.76	11.18	23	36900	1435	50566766
Parasomnia	48.28	11.18	16	36907	386	50567815
Anaemia	47.63	11.18	69	36854	252387	50315814
Headache	45.78	11.18	567	36356	505968	50062233
Peripheral swelling	45.38	11.18	50	36873	205886	50362315
Euphoric mood	44.80	11.18	31	36892	4024	50564177
Crying	44.23	11.18	64	36859	20352	50547849
Completed suicide	44.17	11.18	202	36721	131687	50436514
Neutropenia	43.63	11.18	27	36896	147938	50420263
Muscle twitching	43.52	11.18	55	36868	15376	50552825
Muscle contracture	43.34	11.18	20	36903	1187	50567014
Withdrawal syndrome	42.35	11.18	58	36865	17532	50550669
Growth retardation	42.30	11.18	19	36904	1059	50567142
Drug diversion	41.64	11.18	17	36906	748	50567453
Wound	41.09	11.18	13	36910	105781	50462420
Restlessness	40.73	11.18	69	36854	25104	50543097
Infection	40.34	11.18	40	36883	172914	50395287
Pericarditis	40.25	11.18	5	36918	78684	50489517
Memory impairment	39.84	11.18	138	36785	79222	50488979
Application site pruritus	39.80	11.18	28	36895	3731	50564470
Febrile neutropenia	39.76	11.18	11	36912	97656	50470545
Respiratory tract malformation	39.58	11.18	10	36913	87	50568114
Hallucination, visual	38.90	11.18	54	36869	16528	50551673
Pre-eclampsia	38.86	11.18	38	36885	8006	50560195
Maternal exposure during breast feeding	38.61	11.18	26	36897	3228	50564973
Splenic infarction	38.47	11.18	20	36903	1540	50566661
Treatment failure	38.03	11.18	27	36896	137610	50430591
Migraine	37.87	11.18	131	36792	75149	50493052
Paranoia	37.64	11.18	42	36881	10306	50557895
Heart rate increased	37.63	11.18	133	36790	77117	50491084
Seizure	37.59	11.18	178	36745	117696	50450505
Abdominal discomfort	37.44	11.18	70	36853	231571	50336630
Depressed mood	37.32	11.18	79	36844	33944	50534257
Rash	36.93	11.18	179	36744	437292	50130909
Hyperventilation	36.85	11.18	31	36892	5378	50562823
Bipolar disorder	36.60	11.18	34	36889	6723	50561478
Drug intolerance	36.49	11.18	65	36858	219039	50349162
Anger	36.18	11.18	43	36880	11290	50556911
Blister	35.95	11.18	9	36914	85409	50482792
Haemoglobin decreased	35.09	11.18	25	36898	127191	50441010
Emotional disorder	34.68	11.18	43	36880	11793	50556408
Dyspnoea	34.56	11.18	246	36677	547362	50020839
Affective disorder	33.88	11.18	29	36894	5152	50563049
Application site urticaria	33.77	11.18	11	36912	251	50567950
Multiple sclerosis relapse	33.20	11.18	87	36836	42877	50525324
Delusion of parasitosis	33.19	11.18	6	36917	6	50568195
Negative thoughts	33.14	11.18	15	36908	851	50567350
Death	33.04	11.18	124	36799	325255	50242946
Exposure during pregnancy	32.43	11.18	174	36749	120841	50447360
Livedo reticularis	32.30	11.18	20	36903	2152	50566049
Feeling jittery	31.83	11.18	40	36883	11120	50557081
Mania	30.93	11.18	39	36884	10877	50557324
General physical health deterioration	30.90	11.18	35	36888	142399	50425802
Snoring	30.80	11.18	23	36900	3361	50564840
Hepatic enzyme increased	30.63	11.18	33	36890	137347	50430854
Weight decreased	29.95	11.18	269	36654	220976	50347225
Exposure via breast milk	29.63	11.18	17	36906	1591	50566610
Sepsis	29.56	11.18	32	36891	132893	50435308
Solar urticaria	29.05	11.18	7	36916	49	50568152
Serotonin syndrome	28.99	11.18	59	36864	24654	50543547
Perinatal depression	28.95	11.18	12	36911	549	50567652
Drug hypersensitivity	28.61	11.18	91	36832	250919	50317282
Sleep-related eating disorder	28.44	11.18	13	36910	755	50567446
Post-traumatic stress disorder	27.96	11.18	24	36899	4279	50563922
Mood altered	27.60	11.18	40	36883	12733	50555468
Hypersomnia	27.50	11.18	44	36879	15270	50552931
Lactation disorder	27.39	11.18	10	36913	324	50567877
Pneumonia	27.37	11.18	163	36760	378238	50189963
Thrombocytopenia	27.01	11.18	32	36891	127641	50440560
Pancytopenia	26.67	11.18	14	36909	84016	50484185
Meningitis streptococcal	26.24	11.18	8	36915	146	50568055
Application site rash	25.99	11.18	18	36905	2339	50565862
Mobility decreased	25.85	11.18	13	36910	79935	50488266
Product taste abnormal	25.77	11.18	16	36907	1729	50566472
Interstitial lung disease	25.73	11.18	4	36919	53172	50515029
Drug screen negative	25.59	11.18	9	36914	261	50567940
Optic disc haemorrhage	25.55	11.18	6	36917	37	50568164
Tachyphrenia	25.20	11.18	14	36909	1231	50566970
Adhesive tape use	24.90	11.18	4	36919	0	50568201
Psychiatric symptom	24.76	11.18	23	36900	4547	50563654
Chronic fatigue syndrome	24.75	11.18	13	36910	1022	50567179
Maternal exposure during pregnancy	24.31	11.18	50	36873	159728	50408473
Burnout syndrome	24.30	11.18	8	36915	189	50568012
Multiple organ dysfunction syndrome	23.87	11.18	4	36919	50333	50517868
Alopecia	23.82	11.18	95	36828	244952	50323249
Hangover	23.78	11.18	14	36909	1375	50566826
Cyanosis	23.74	11.18	41	36882	15143	50553058
Cardiac failure	23.64	11.18	13	36910	76027	50492174
Tachypnoea	23.63	11.18	40	36883	14537	50553664
Mood swings	23.55	11.18	42	36881	15912	50552289
Wound infection fungal	23.37	11.18	7	36916	120	50568081
Nightmare	23.30	11.18	42	36881	16044	50552157
Axonal neuropathy	23.23	11.18	12	36911	912	50567289
Abnormal sleep-related event	23.16	11.18	11	36912	697	50567504
Eosinophilic myocarditis	22.95	11.18	9	36914	356	50567845
Sleep paralysis	22.88	11.18	10	36913	522	50567679
Cardiac failure congestive	22.72	11.18	17	36906	84365	50483836
Open angle glaucoma	22.46	11.18	8	36915	241	50567960
Product prescribing error	22.21	11.18	48	36875	20913	50547288
Palpitations	22.08	11.18	131	36792	94375	50473826
Amphetamines positive	21.69	11.18	7	36916	155	50568046
Logorrhoea	21.61	11.18	16	36907	2308	50565893
Gastrointestinal haemorrhage	20.75	11.18	14	36909	73307	50494894
Narcolepsy	20.67	11.18	12	36911	1148	50567053
Septic shock	20.52	11.18	8	36915	57167	50511034
Protrusion tongue	20.51	11.18	8	36915	312	50567889
Hyperkalaemia	20.36	11.18	5	36918	48084	50520117
Blood pressure increased	20.16	11.18	166	36757	132966	50435235
Antiphospholipid syndrome	20.13	11.18	13	36910	1504	50566697
Long QT syndrome congenital	19.84	11.18	5	36918	43	50568158
Application site discolouration	19.60	11.18	10	36913	740	50567461
Sensory level abnormal	19.50	11.18	6	36917	113	50568088
Hallucination, tactile	19.47	11.18	7	36916	217	50567984
Renal failure	19.24	11.18	30	36893	106603	50461598
Trichotillomania	19.16	11.18	6	36917	120	50568081
Libido decreased	19.10	11.18	15	36908	2361	50565840
Discomfort	19.08	11.18	31	36892	108349	50459852
Substance abuse	19.03	11.18	19	36904	4105	50564096
Initial insomnia	19.02	11.18	21	36902	5094	50563107
Bezoar	19.00	11.18	12	36911	1336	50566865
Social avoidant behaviour	18.99	11.18	16	36907	2781	50565420
Atrial fibrillation	18.96	11.18	28	36895	101717	50466484
Pain	18.93	11.18	303	36620	578600	49989601
Compulsive lip biting	18.67	11.18	3	36920	0	50568201
Drug withdrawal syndrome	18.57	11.18	50	36873	25031	50543170
Incorrect product administration duration	18.54	11.18	28	36895	9247	50558954
Application site pain	18.45	11.18	18	36905	3780	50564421
Pyrexia	18.40	11.18	183	36740	380020	50188181
Learning disorder	18.40	11.18	9	36914	609	50567592
Renal impairment	18.20	11.18	17	36906	75644	50492557
Respiratory failure	18.08	11.18	24	36899	91157	50477044
Pleural effusion	17.67	11.18	20	36903	81434	50486767
Impaired healing	17.60	11.18	15	36908	69771	50498430
Nystagmus	17.59	11.18	21	36902	5540	50562661
Nervousness	17.42	11.18	52	36871	27599	50540602
Hypotension	17.22	11.18	101	36822	235368	50332833
Delusion	17.13	11.18	29	36894	10540	50557661
Major depression	17.02	11.18	23	36900	6861	50561340
Folliculitis	16.76	11.18	4	36919	39221	50528980
Hunger	16.72	11.18	18	36905	4245	50563956
Product complaint	16.68	11.18	30	36893	11436	50556765
Platelet count decreased	16.64	11.18	30	36893	100696	50467505
Bisexuality	16.59	11.18	3	36920	3	50568198
Thinking abnormal	16.51	11.18	27	36896	9540	50558661
Acne	16.50	11.18	41	36882	19554	50548647
Dizziness	16.50	11.18	349	36574	346020	50222181
Leukopenia	16.45	11.18	15	36908	67513	50500688
Stress	16.24	11.18	80	36843	53713	50514488
Tardive dyskinesia	16.03	11.18	23	36900	7256	50560945
C-reactive protein increased	15.91	11.18	15	36908	66459	50501742
Therapeutic response changed	15.87	11.18	9	36914	824	50567377
Foot fracture	15.84	11.18	41	36882	20050	50548151
Decreased appetite	15.57	11.18	219	36704	200704	50367497
Schizoaffective disorder bipolar type	15.48	11.18	5	36918	111	50568090
Mucosal inflammation	15.46	11.18	5	36918	40137	50528064
Hyperhidrosis	15.46	11.18	115	36808	89311	50478890
Raynaud's phenomenon	15.42	11.18	10	36913	1166	50567035
Vasospasm	15.25	11.18	8	36915	627	50567574
Grimacing	15.19	11.18	7	36916	414	50567787
Stomatitis	15.17	11.18	32	36891	101312	50466889
Congenital cystic lung	15.16	11.18	4	36919	42	50568159
Lactic acidosis	15.06	11.18	3	36920	33352	50534849
Brain death	15.06	11.18	14	36909	2769	50565432
Affect lability	15.00	11.18	25	36898	8973	50559228
Consciousness fluctuating	14.75	11.18	8	36915	671	50567530
Loss of consciousness	14.67	11.18	128	36795	104225	50463976
Knee arthroplasty	14.65	11.18	4	36919	35842	50532359
Body temperature increased	14.43	11.18	53	36870	31288	50536913
International normalised ratio increased	13.97	11.18	7	36916	43145	50525056
Hyperacusis	13.67	11.18	11	36912	1793	50566408
Formication	13.61	11.18	15	36908	3631	50564570
Heavy menstrual bleeding	13.60	11.18	33	36890	15504	50552697
Gastric bypass	13.53	11.18	10	36913	1438	50566763
Phobia	13.50	11.18	6	36917	326	50567875
Malignant neoplasm progression	13.44	11.18	18	36905	68106	50500095
Small fibre neuropathy	13.36	11.18	5	36918	174	50568027
Pelvic inflammatory disease	13.09	11.18	10	36913	1512	50566689
Treatment noncompliance	13.06	11.18	50	36873	30100	50538101
Serum serotonin decreased	12.99	11.18	3	36920	17	50568184
Cerebral artery occlusion	12.99	11.18	8	36915	852	50567349
Cleft lip and palate	12.99	11.18	6	36917	357	50567844
Regressive behaviour	12.97	11.18	4	36919	76	50568125
Diplopia	12.88	11.18	37	36886	19223	50548978
Rectal haemorrhage	12.87	11.18	6	36917	38552	50529649
Nephrogenic diabetes insipidus	12.81	11.18	8	36915	873	50567328
Herpes zoster	12.69	11.18	20	36903	70766	50497435
Muscle tightness	12.60	11.18	25	36898	10255	50557946
Mental disorder	12.59	11.18	40	36883	21951	50546250
Hepatic failure	12.47	11.18	4	36919	32279	50535922
Gastrointestinal disorder	12.39	11.18	32	36891	94424	50473777
Distractibility	12.33	11.18	6	36917	401	50567800
Poor sucking reflex	12.31	11.18	5	36918	217	50567984
Tongue biting	12.02	11.18	9	36914	1321	50566880
Horner's syndrome	11.99	11.18	3	36920	25	50568176
Seizure like phenomena	11.90	11.18	8	36915	990	50567211
Pruritus	11.89	11.18	141	36782	283427	50284774
Prehypertension	11.88	11.18	3	36920	26	50568175
Choreoathetosis	11.88	11.18	6	36917	435	50567766
Illness	11.72	11.18	42	36881	24498	50543703
Cough	11.70	11.18	116	36807	241148	50327053
Radius fracture	11.63	11.18	13	36910	3196	50565005
Neutrophil percentage increased	11.55	11.18	12	36911	2715	50565486
Hyponatraemia	11.54	11.18	34	36889	96105	50472096
Amnesia	11.46	11.18	61	36862	42199	50526002
Muscle spasms	11.45	11.18	141	36782	125412	50442789
Disease progression	11.44	11.18	34	36889	95832	50472369
Oculogyric crisis	11.40	11.18	9	36914	1428	50566773
Extrapyramidal disorder	11.39	11.18	26	36897	11744	50556457
Food craving	11.39	11.18	9	36914	1430	50566771
Petit mal epilepsy	11.37	11.18	13	36910	3276	50564925
Diaphragmalgia	11.31	11.18	4	36919	118	50568083
Status epilepticus	11.23	11.18	28	36895	13378	50554823
Ill-defined disorder	11.23	11.18	14	36909	54640	50513561
Hepatotoxicity	11.20	11.18	3	36920	27223	50540978
Drug abuser	11.19	11.18	12	36911	2816	50565385

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
Product quality issue	895.43	13.26	430	38265	15465	29520367
No adverse event	651.11	13.26	358	38337	17120	29518712
Aggression	649.84	13.26	463	38232	35078	29500754
Tic	523.04	13.26	162	38533	1673	29534159
Agitation	424.43	13.26	423	38272	50881	29484951
Abnormal behaviour	410.22	13.26	296	38399	22831	29513001
Suicidal ideation	366.92	13.26	328	38367	34388	29501444
Product substitution issue	363.90	13.26	196	38499	8976	29526856
Irritability	348.93	13.26	264	38431	21888	29513944
Psychomotor hyperactivity	321.60	13.26	174	38521	8039	29527793
Wrong technique in product usage process	314.49	13.26	288	38407	31140	29504692
Application site erythema	306.22	13.26	112	38583	1987	29533845
Attention deficit hyperactivity disorder	253.51	13.26	99	38596	2118	29533714
Dyskinesia	253.39	13.26	210	38485	19851	29515981
Dystonia	225.33	13.26	147	38548	9602	29526230
Growth retardation	215.53	13.26	81	38614	1555	29534277
Psychotic disorder	214.27	13.26	192	38503	20162	29515670
Anxiety	211.62	13.26	391	38304	84974	29450858
Disturbance in attention	205.82	13.26	192	38503	21232	29514600
Product administration error	204.40	13.26	161	38534	14149	29521683
Acute kidney injury	201.35	13.26	50	38645	265217	29270615
Crying	197.37	13.26	109	38586	5242	29530590
Product administered at inappropriate site	186.80	13.26	74	38621	1646	29534186
Application site irritation	168.20	13.26	53	38642	581	29535251
Suicide attempt	166.47	13.26	214	38481	33896	29501936
Choreoathetosis	165.93	13.26	59	38636	961	29534871
Application site pruritus	162.84	13.26	62	38633	1235	29534597
Insomnia	158.54	13.26	355	38340	88406	29447426
Pneumonia	153.87	13.26	117	38578	320055	29215777
Incorrect product administration duration	153.67	13.26	84	38611	3957	29531875
Tachycardia	150.45	13.26	308	38387	72102	29463730
Intentional product misuse	149.94	13.26	205	38490	34456	29501376
Depression	141.47	13.26	331	38364	84816	29451016
Anger	133.30	13.26	112	38583	10778	29525054
Death	132.56	13.26	152	38543	341932	29193900
Impulsive behaviour	129.11	13.26	59	38636	1884	29533948
Hallucination, visual	127.96	13.26	126	38569	14889	29520943
Disturbance in social behaviour	117.25	13.26	53	38642	1649	29534183
Intentional overdose	116.78	13.26	193	38502	38335	29497497
Anaemia	111.87	13.26	62	38633	200889	29334943
Educational problem	111.07	13.26	37	38658	490	29535342
Drug dependence	109.24	13.26	136	38559	20845	29514987
Withdrawal syndrome	106.46	13.26	99	38596	10893	29524939
Paranoia	103.55	13.26	93	38602	9784	29526048
Trismus	103.36	13.26	54	38641	2319	29533513
Palpitations	101.05	13.26	165	38530	32439	29503393
Drug ineffective	99.75	13.26	812	37883	362358	29173474
Hallucination	99.73	13.26	196	38499	44516	29491316
Overdose	96.07	13.26	275	38420	79544	29456288
Mydriasis	94.56	13.26	72	38623	6013	29529819
Priapism	92.41	13.26	63	38632	4425	29531407
Hallucination, auditory	92.13	13.26	86	38609	9507	29526325
Serotonin syndrome	91.94	13.26	114	38581	17398	29518434
Oppositional defiant disorder	91.27	13.26	32	38663	499	29535333
Drug diversion	88.27	13.26	35	38660	780	29535052
Coronary artery dissection	87.93	13.26	25	38670	186	29535646
Depressed mood	87.84	13.26	108	38587	16340	29519492
Diarrhoea	87.74	13.26	191	38504	332507	29203325
Hypotension	85.71	13.26	77	38618	194277	29341555
Sleep disorder	84.65	13.26	130	38565	24256	29511576
Product complaint	84.09	13.26	64	38631	5341	29530491
Homicidal ideation	83.80	13.26	48	38647	2476	29533356
Somnolence	83.05	13.26	291	38404	93664	29442168
Dyspnoea	82.53	13.26	192	38503	326540	29209292
Febrile neutropenia	81.41	13.26	23	38672	112217	29423615
Hallucination, tactile	80.95	13.26	25	38670	255	29535577
Sepsis	80.82	13.26	43	38652	142639	29393193
Bruxism	80.42	13.26	40	38655	1547	29534285
Emotional disorder	80.29	13.26	60	38635	4871	29530961
Product prescribing error	78.71	13.26	107	38588	17869	29517963
Therapeutic product effect decreased	77.99	13.26	139	38556	29312	29506520
Trichotillomania	76.40	13.26	18	38677	55	29535777
Precocious puberty	75.37	13.26	20	38675	111	29535721
Feeling abnormal	74.83	13.26	197	38498	54248	29481584
Toxicity to various agents	73.33	13.26	432	38263	173229	29362603
Application site rash	73.06	13.26	30	38665	734	29535098
Mood altered	72.71	13.26	70	38625	8041	29527791
Logorrhoea	71.94	13.26	42	38653	2246	29533586
Gastrointestinal haemorrhage	70.75	13.26	10	38685	79523	29456309
Affect lability	68.25	13.26	47	38648	3355	29532477
Drug abuse	67.64	13.26	244	38451	79639	29456193
Decreased eye contact	67.48	13.26	25	38670	460	29535372
Restlessness	67.15	13.26	111	38584	22034	29513798
Renal failure	65.31	13.26	37	38658	118562	29417270
Mania	65.21	13.26	68	38627	8595	29527237
Intentional self-injury	65.21	13.26	81	38614	12380	29523452
Headache	63.50	13.26	417	38278	173590	29362242
General physical health deterioration	62.77	13.26	28	38667	102829	29433003
Product adhesion issue	62.72	13.26	33	38662	1438	29534394
Euphoric mood	61.89	13.26	51	38644	4774	29531058
Cardiac failure congestive	60.75	13.26	13	38682	76568	29459264
Pyrexia	59.01	13.26	187	38508	287435	29248397
Renal impairment	58.34	13.26	17	38678	81316	29454516
Obsessive-compulsive disorder	57.93	13.26	48	38647	4528	29531304
Oromandibular dystonia	57.23	13.26	22	38673	450	29535382
Speech disorder	57.20	13.26	107	38588	23409	29512423
Decreased appetite	57.12	13.26	355	38340	144987	29390845
Interstitial lung disease	57.01	13.26	5	38690	57713	29478119
Multiple organ dysfunction syndrome	55.98	13.26	8	38687	63108	29472724
Haemoglobin decreased	55.23	13.26	37	38658	108338	29427494
Thrombocytopenia	55.19	13.26	57	38638	134766	29401066
Apathy	54.83	13.26	53	38642	6118	29529714
Application site pain	53.26	13.26	31	38664	1648	29534184
Product administered to patient of inappropriate age	51.67	13.26	36	38659	2619	29533213
Platelet count decreased	50.36	13.26	38	38657	104634	29431198
Formication	50.36	13.26	29	38666	1511	29534321
Neutropenia	50.26	13.26	59	38636	131652	29404180
Therapeutic response unexpected	49.83	13.26	59	38636	8579	29527253
Drug screen negative	49.38	13.26	15	38680	144	29535688
Blood creatinine increased	47.62	13.26	26	38669	85076	29450756
Pancytopenia	47.14	13.26	25	38670	83143	29452689
Alice in wonderland syndrome	46.79	13.26	9	38686	5	29535827
Delusion	46.44	13.26	65	38630	11151	29524681
Product taste abnormal	46.10	13.26	24	38671	1023	29534809
Application site urticaria	45.62	13.26	12	38683	64	29535768
Gynaecomastia	45.56	13.26	55	38640	8162	29527670
Suicidal behaviour	45.43	13.26	26	38669	1339	29534493
Torticollis	45.08	13.26	24	38671	1071	29534761
Enuresis	44.68	13.26	30	38665	2054	29533778
Respiratory failure	44.54	13.26	37	38658	97094	29438738
Mood swings	44.29	13.26	51	38644	7200	29528632
Social avoidant behaviour	43.93	13.26	34	38661	2908	29532924
Oedema peripheral	41.00	13.26	45	38650	103512	29432320
Raynaud's phenomenon	40.64	13.26	15	38680	273	29535559
Autism spectrum disorder	40.59	13.26	28	38667	2004	29533828
Product colour issue	40.33	13.26	16	38679	357	29535475
Keratoconus	40.31	13.26	11	38684	69	29535763
Hyperkalaemia	40.21	13.26	15	38680	61377	29474455
Hypertension	39.78	13.26	275	38420	116339	29419493
Atrial fibrillation	38.51	13.26	49	38646	105597	29430235
Hallucinations, mixed	38.26	13.26	29	38666	2404	29533428
Heart rate increased	38.21	13.26	125	38570	38813	29497019
Drug use disorder	37.41	13.26	33	38662	3389	29532443
Hyperkinesia	36.66	13.26	24	38671	1575	29534257
Extrapyramidal disorder	36.53	13.26	57	38638	10774	29525058
Product use issue	36.01	13.26	148	38547	51296	29484536
Increased appetite	35.94	13.26	42	38653	6022	29529810
Tardive dyskinesia	35.56	13.26	39	38656	5219	29530613
Asthenia	35.49	13.26	153	38542	215097	29320735
Septic shock	35.16	13.26	19	38676	62541	29473291
Dermatillomania	34.86	13.26	9	38686	44	29535788
Treatment noncompliance	34.62	13.26	89	38606	24138	29511694
Drug tolerance	34.61	13.26	26	38669	2127	29533705
Bipolar disorder	34.48	13.26	31	38664	3264	29532568
White blood cell count decreased	34.36	13.26	35	38660	83327	29452505
Cardiac failure	34.17	13.26	32	38663	79255	29456577
Screaming	33.94	13.26	21	38674	1249	29534583
Ventricular parasystole	33.84	13.26	6	38689	0	29535832
Rebound effect	33.70	13.26	25	38670	2006	29533826
Coordination abnormal	33.67	13.26	44	38651	7070	29528762
Completed suicide	33.26	13.26	217	38478	90029	29445803
Muscle contracture	33.20	13.26	20	38675	1133	29534699
Peripheral swelling	32.13	13.26	22	38673	63717	29472115
Sleep apnoea syndrome	32.01	13.26	71	38624	17528	29518304
Affective disorder	31.90	13.26	29	38666	3097	29532735
Tremor	31.61	13.26	184	38511	73354	29462478
Arthralgia	31.26	13.26	87	38608	139530	29396302
Generalised tonic-clonic seizure	31.25	13.26	74	38621	19065	29516767
Panic attack	31.17	13.26	46	38649	8280	29527552
Joint swelling	31.06	13.26	13	38682	49617	29486215
Excessive eye blinking	30.95	13.26	14	38681	436	29535396
Incorrect dose administered	30.68	13.26	104	38591	32880	29502952
Cough	30.63	13.26	76	38619	126651	29409181
Cataplexy	30.57	13.26	12	38683	260	29535572
Nervousness	29.45	13.26	53	38642	11253	29524579
Pain	29.38	13.26	120	38575	171312	29364520
Pre-existing condition improved	29.28	13.26	24	38671	2229	29533603
Phobia	29.06	13.26	10	38685	147	29535685
Hyperhidrosis	28.72	13.26	163	38532	64377	29471455
Peripheral coldness	28.63	13.26	38	38657	6198	29529634
Infusion related reaction	28.27	13.26	11	38684	43875	29491957
Sympathomimetic effect	28.20	13.26	5	38690	0	29535832
Onychophagia	27.97	13.26	8	38687	61	29535771
Gilbert's syndrome	27.87	13.26	7	38688	30	29535802
Melaena	27.52	13.26	4	38691	31172	29504660
Chronic kidney disease	27.24	13.26	7	38688	36409	29499423
Malignant neoplasm progression	27.17	13.26	34	38661	73825	29462007
Tourette's disorder	27.00	13.26	8	38687	70	29535762
Metabolic acidosis	26.76	13.26	8	38687	37654	29498178
Application site erosion	26.70	13.26	8	38687	73	29535759
Drug withdrawal syndrome	26.66	13.26	67	38628	17917	29517915
Pleural effusion	26.56	13.26	33	38662	71875	29463957
Infection	26.53	13.26	37	38658	76714	29459118
Hyponatraemia	26.08	13.26	30	38665	67603	29468229
International normalised ratio increased	25.63	13.26	13	38682	44359	29491473
Self-injurious ideation	25.53	13.26	19	38676	1532	29534300
Device difficult to use	25.15	13.26	19	38676	1567	29534265
Disease progression	24.96	13.26	43	38652	81873	29453959
Change in sustained attention	24.74	13.26	5	38690	5	29535827
Product dispensing error	24.56	13.26	33	38662	5447	29530385
Mental disorder	24.53	13.26	53	38642	12852	29522980
Dysphemia	24.40	13.26	18	38677	1432	29534400
Rheumatoid arthritis	24.40	13.26	6	38689	32146	29503686
Seizure	24.12	13.26	206	38489	92917	29442915
Dermo-hypodermitis	24.11	13.26	10	38685	251	29535581
Fall	23.95	13.26	135	38560	177043	29358789
Cerebral congestion	23.83	13.26	6	38689	26	29535806
Polydipsia psychogenic	23.67	13.26	8	38687	111	29535721
Multiple cardiac defects	23.55	13.26	7	38688	62	29535770
Substance use disorder	23.50	13.26	10	38685	268	29535564
Oxygen saturation decreased	23.33	13.26	15	38680	44922	29490910
Delayed puberty	23.19	13.26	9	38686	189	29535643
Stereotypy	23.14	13.26	13	38682	646	29535186
Pain in extremity	23.11	13.26	71	38624	110362	29425470
Somnambulism	22.94	13.26	23	38672	2775	29533057
Substance-induced psychotic disorder	22.84	13.26	17	38678	1371	29534461
Neuropathy peripheral	22.83	13.26	36	38659	70991	29464841
Erythema	22.75	13.26	40	38655	75566	29460266
Distractibility	22.71	13.26	10	38685	292	29535540
Adhesive tape use	22.56	13.26	4	38691	0	29535832
Blood creatine phosphokinase increased	22.45	13.26	109	38586	40535	29495297
Weight gain poor	22.44	13.26	14	38681	845	29534987
Sudden death	22.44	13.26	54	38641	14056	29521776
Illusion	22.37	13.26	13	38682	689	29535143
Regressive behaviour	22.21	13.26	6	38689	36	29535796
Acute psychosis	21.99	13.26	18	38677	1669	29534163
Tongue spasm	21.94	13.26	6	38689	38	29535794
Blood urea increased	21.82	13.26	5	38690	28107	29507725
Petit mal epilepsy	21.63	13.26	22	38673	2700	29533132
Colitis	21.55	13.26	7	38688	31241	29504591
Constipation	21.41	13.26	77	38618	114083	29421749
Dehydration	21.13	13.26	78	38617	114670	29421162
Product residue present	21.05	13.26	21	38674	2518	29533314
Oculogyric crisis	20.91	13.26	16	38679	1345	29534487
Application site dryness	20.72	13.26	6	38689	48	29535784
Erection increased	20.66	13.26	11	38684	491	29535341
Negativism	20.64	13.26	10	38685	365	29535467
Lactic acidosis	20.46	13.26	7	38688	30240	29505592
Migraine	20.23	13.26	48	38647	12382	29523450
Mucosal inflammation	20.21	13.26	8	38687	31587	29504245
Muscle twitching	20.11	13.26	37	38658	7989	29527843
Coronary artery disease	20.03	13.26	17	38678	44173	29491659
Productive cough	19.86	13.26	8	38687	31251	29504581
Plasma cell myeloma	19.80	13.26	12	38683	37103	29498729
Renal disorder	19.71	13.26	3	38692	22592	29513240
Liver disorder	19.52	13.26	6	38689	27743	29508089
Suspiciousness	19.39	13.26	9	38686	298	29535534
Ascites	19.32	13.26	12	38683	36607	29499225
School refusal	19.28	13.26	5	38690	25	29535807
Substance abuse	19.21	13.26	33	38662	6754	29529078
Panic reaction	19.20	13.26	15	38680	1300	29534532
Application site scab	19.19	13.26	6	38689	64	29535768
Performance status decreased	19.13	13.26	24	38671	3703	29532129
Scoliosis	19.03	13.26	19	38676	2281	29533551
Incorrect route of product administration	18.99	13.26	43	38652	10758	29525074
Poisoning	18.94	13.26	41	38654	9952	29525880
C-reactive protein increased	18.90	13.26	18	38677	44245	29491587
Accidental exposure to product by child	18.82	13.26	15	38680	1339	29534493
Hypokalaemia	18.57	13.26	23	38672	50180	29485652
Cholestasis	18.56	13.26	4	38691	23458	29512374
Drug resistance	18.47	13.26	3	38692	21537	29514295
Chorea	18.39	13.26	13	38682	968	29534864
Shock	18.31	13.26	3	38692	21401	29514431
Neutrophil count decreased	18.27	13.26	18	38677	43549	29492283
Pneumonitis	18.11	13.26	7	38688	28037	29507795
Abdominal distension	18.10	13.26	20	38675	45891	29489941
Pericardial effusion	18.08	13.26	3	38692	21205	29514627
Drooling	18.03	13.26	21	38674	3000	29532832
Fear	18.02	13.26	39	38656	9465	29526367
Hepatic function abnormal	17.92	13.26	15	38680	39244	29496588
Off label use	17.80	13.26	517	38178	300283	29235549
Hypocalcaemia	17.45	13.26	3	38692	20662	29515170
Tri-iodothyronine increased	17.38	13.26	5	38690	39	29535793
Insulin resistance	17.31	13.26	10	38685	524	29535308
Physical assault	17.22	13.26	13	38682	1071	29534761
Urinary incontinence	17.15	13.26	54	38641	16427	29519405
Libido increased	16.96	13.26	11	38684	710	29535122
Cardiac contusion	16.92	13.26	3	38692	0	29535832
Limb girth decreased	16.92	13.26	3	38692	0	29535832
Anorexia nervosa	16.92	13.26	3	38692	0	29535832
Rash	16.81	13.26	163	38532	189656	29346176
Testicular failure	16.75	13.26	5	38690	45	29535787
Dyspnoea exertional	16.58	13.26	14	38681	36476	29499356
Depersonalisation/derealisation disorder	16.53	13.26	10	38685	571	29535261
Amnesia	16.51	13.26	66	38629	22577	29513255
Weight increased	16.50	13.26	163	38532	76504	29459328
Lower respiratory tract infection	16.48	13.26	7	38688	26495	29509337
Poor quality product administered	16.48	13.26	15	38680	1604	29534228
Drug reaction with eosinophilia and systemic symptoms	16.47	13.26	8	38687	27984	29507848
Haematoma	16.36	13.26	5	38690	23207	29512625
Sydenham's chorea	16.35	13.26	4	38691	15	29535817
Idiopathic intracranial hypertension	16.31	13.26	10	38685	585	29535247
Vision blurred	16.27	13.26	99	38596	40077	29495755
Urinary tract infection	16.23	13.26	45	38650	72309	29463523
Hypoxia	16.21	13.26	23	38672	47356	29488476
Strabismus	16.17	13.26	14	38681	1402	29534430
Pulmonary embolism	16.15	13.26	49	38646	76485	29459347
Application site ulcer	16.14	13.26	4	38691	16	29535816
Wolff-Parkinson-White syndrome	16.10	13.26	7	38688	198	29535634
Opisthotonus	16.06	13.26	9	38686	445	29535387
Acute respiratory distress syndrome	16.06	13.26	5	38690	22930	29512902
Rectal haemorrhage	16.02	13.26	13	38682	34536	29501296
Vasospasm	15.93	13.26	8	38687	316	29535516
Bone marrow failure	15.91	13.26	8	38687	27441	29508391
Therapeutic response changed	15.90	13.26	8	38687	317	29535515
Stubbornness	15.77	13.26	4	38691	18	29535814
Product dose omission issue	15.73	13.26	194	38501	96189	29439643
Meningitis staphylococcal	15.69	13.26	5	38690	57	29535775
Accommodation disorder	15.57	13.26	7	38688	215	29535617
Daydreaming	15.56	13.26	9	38686	473	29535359
Major depression	15.54	13.26	22	38673	3813	29532019
Application site discolouration	15.51	13.26	7	38688	217	29535615
Poor quality sleep	15.25	13.26	31	38664	7202	29528630
Social anxiety disorder	15.07	13.26	7	38688	232	29535600
Hypoglycaemia	15.07	13.26	25	38670	48321	29487511
Parasomnia	14.94	13.26	8	38687	361	29535471
Psychopathic personality	14.85	13.26	3	38692	3	29535829
Stomatitis	14.81	13.26	16	38679	37097	29498735
Injection site abscess	14.71	13.26	10	38685	699	29535133
Eye movement disorder	14.68	13.26	21	38674	3675	29532157
Thrombosis	14.62	13.26	21	38674	43024	29492808
Lung disorder	14.61	13.26	11	38684	30351	29505481
Inappropriate affect	14.53	13.26	9	38686	536	29535296
Stress cardiomyopathy	14.52	13.26	14	38681	1610	29534222
Initial insomnia	14.45	13.26	18	38677	2757	29533075
Blood growth hormone decreased	14.41	13.26	4	38691	27	29535805
Blood thyroid stimulating hormone increased	14.38	13.26	19	38676	3086	29532746
Myocardial infarction	14.36	13.26	85	38610	110211	29425621
Frustration tolerance decreased	14.02	13.26	16	38679	2236	29533596
Epiphyses delayed fusion	13.99	13.26	3	38692	5	29535827
Chronic obstructive pulmonary disease	13.89	13.26	20	38675	40935	29494897
COVID-19	13.85	13.26	16	38679	35998	29499834
Electrocardiogram T wave inversion	13.83	13.26	15	38680	1982	29533850
Back pain	13.76	13.26	78	38617	102206	29433626
Sedation	13.72	13.26	52	38643	17353	29518479
Personality change	13.72	13.26	23	38672	4615	29531217
Schizotypal personality disorder	13.63	13.26	3	38692	6	29535826
Sexual dysfunction	13.57	13.26	26	38669	5788	29530044
Prescribed overdose	13.56	13.26	33	38662	8650	29527182
Haemoptysis	13.54	13.26	12	38683	30538	29505294
Therapeutic product effect increased	13.47	13.26	9	38686	611	29535221
Dependence	13.40	13.26	11	38684	1024	29534808
Nightmare	13.37	13.26	39	38656	11378	29524454
Compulsions	13.35	13.26	6	38689	184	29535648
Pressure of speech	13.33	13.26	8	38687	450	29535382
Dysphoria	13.26	13.26	15	38680	2077	29533755

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
Aggression	685.75	11.32	451	54997	45781	64397503
Agitation	598.97	11.32	541	54907	87826	64355458
Product substitution issue	511.43	11.32	267	55181	17594	64425690
Suicidal ideation	501.92	11.32	433	55015	66109	64377175
Tic	494.94	11.32	153	55295	2466	64440818
Abnormal behaviour	452.75	11.32	309	55139	33313	64409971
Product quality issue	427.85	11.32	285	55163	29514	64413770
Irritability	416.58	11.32	304	55144	36442	64406842
No adverse event	318.50	11.32	234	55214	28327	64414957
Attention deficit hyperactivity disorder	298.83	11.32	106	55342	2664	64440620
Tachycardia	289.92	11.32	486	54962	149093	64294191
Psychomotor hyperactivity	284.79	11.32	169	55279	14282	64429002
Anxiety	283.68	11.32	572	54876	202077	64241207
Dystonia	269.69	11.32	180	55268	18685	64424599
Dyskinesia	268.19	11.32	242	55206	39146	64404138
Disturbance in attention	234.78	11.32	229	55219	40845	64402439
Psychotic disorder	213.16	11.32	201	55247	34377	64408907
Suicide attempt	211.04	11.32	282	55166	70725	64372559
Depression	204.30	11.32	472	54976	182819	64260465
Toxicity to various agents	194.95	11.32	720	54728	362793	64080491
Intentional overdose	185.87	11.32	301	55147	89643	64353641
Insomnia	185.85	11.32	477	54971	197359	64245925
Acute kidney injury	173.36	11.32	85	55363	449155	63994129
Mydriasis	171.89	11.32	126	55322	15186	64428098
Choreoathetosis	166.12	11.32	58	55390	1389	64441895
Overdose	163.74	11.32	398	55050	159168	64284116
Precocious puberty	161.25	11.32	40	55408	266	64443018
Intentional product misuse	160.45	11.32	250	55198	72045	64371239
Educational problem	154.98	11.32	41	55407	363	64442921
Hallucination, visual	154.95	11.32	153	55295	27681	64415603
Application site erythema	151.27	11.32	76	55372	4613	64438671
Crying	149.79	11.32	130	55318	19960	64423324
Growth retardation	146.89	11.32	54	55394	1507	64441777
Hallucination	144.14	11.32	239	55209	72549	64370735
Hallucination, auditory	139.38	11.32	116	55332	16823	64426461
Product administration error	128.64	11.32	138	55310	27505	64415779
Impulsive behaviour	128.56	11.32	57	55391	2606	64440678
Anger	127.86	11.32	107	55341	15634	64427650
Intentional self-injury	123.01	11.32	138	55310	28906	64414378
Anaemia	119.05	11.32	91	55357	378589	64064695
Wrong technique in product usage process	118.91	11.32	206	55242	64768	64378516
Drug abuse	118.86	11.32	314	55134	132060	64311224
Tremor	117.59	11.32	336	55112	147894	64295390
Withdrawal syndrome	115.92	11.32	121	55327	23371	64419913
Serotonin syndrome	113.58	11.32	154	55294	39128	64404156
Diarrhoea	112.88	11.32	288	55160	722416	63720868
Paranoia	112.30	11.32	101	55347	16251	64427033
Trismus	108.96	11.32	62	55386	4839	64438445
Drug dependence	107.76	11.32	138	55310	33174	64410110
Priapism	104.11	11.32	56	55392	3914	64439370
Product administered at inappropriate site	102.06	11.32	51	55397	3059	64440225
Apathy	100.98	11.32	81	55367	11151	64432133
Muscle contracture	100.62	11.32	45	55403	2100	64441184
Hallucination, tactile	98.83	11.32	30	55418	453	64442831
Bruxism	97.51	11.32	52	55396	3572	64439712
Joint swelling	97.20	11.32	32	55416	215350	64227934
Somnolence	94.67	11.32	386	55062	203259	64240025
Oppositional defiant disorder	94.39	11.32	29	55419	457	64442827
Pneumonia	94.36	11.32	214	55234	559362	63883922
Mania	93.38	11.32	91	55357	16195	64427089
Mood altered	92.97	11.32	90	55358	15889	64427395
Application site irritation	90.06	11.32	38	55410	1538	64441746
Completed suicide	88.68	11.32	405	55043	224009	64219275
Incorrect product administration duration	86.94	11.32	70	55378	9688	64433596
Death	86.82	11.32	178	55270	482527	63960757
Cataplexy	86.60	11.32	31	55417	800	64442484
Enuresis	86.43	11.32	44	55404	2746	64440538
Euphoric mood	84.93	11.32	59	55389	6532	64436752
Restlessness	84.65	11.32	135	55313	39650	64403634
Homicidal ideation	82.78	11.32	45	55403	3212	64440072
Obsessive-compulsive disorder	81.21	11.32	51	55397	4767	64438517
Affect lability	81.17	11.32	65	55383	8925	64434359
Febrile neutropenia	79.35	11.32	31	55417	187626	64255658
Dyspnoea	78.51	11.32	335	55113	718339	63724945
Chorea	78.28	11.32	37	55411	1963	64441321
Peripheral swelling	76.90	11.32	42	55406	209111	64234173
Coronary artery dissection	76.56	11.32	29	55419	881	64442403
Emotional disorder	75.21	11.32	72	55376	12535	64430749
Trichotillomania	72.45	11.32	19	55429	162	64443122
Synovitis	72.21	11.32	3	55445	99087	64344197
Logorrhoea	71.02	11.32	44	55404	4015	64439269
Drug diversion	70.32	11.32	29	55419	1107	64442177
Decreased eye contact	70.27	11.32	26	55422	739	64442545
Depressed mood	69.81	11.32	126	55322	40886	64402398
General physical health deterioration	68.24	11.32	46	55402	204379	64238905
Arthralgia	66.72	11.32	179	55269	442081	64001203
Rheumatoid arthritis	66.44	11.32	29	55419	164265	64279019
Palpitations	65.26	11.32	218	55230	104270	64339014
Neutropenia	65.05	11.32	66	55382	239558	64203726
Sepsis	64.19	11.32	62	55386	230279	64213005
Application site pruritus	63.54	11.32	39	55409	3500	64439784
Feeling abnormal	63.42	11.32	255	55193	133347	64309937
Heart rate increased	62.63	11.32	207	55241	98468	64344816
Interstitial lung disease	62.24	11.32	6	55442	97726	64345558
Headache	60.98	11.32	709	54739	528758	63914526
Contraindicated product administered	60.49	11.32	10	55438	107819	64335465
Delusion	60.42	11.32	76	55372	17938	64425346
Muscle twitching	60.33	11.32	78	55370	18920	64424364
Hypotension	59.89	11.32	151	55297	380823	64062461
Thrombocytopenia	59.21	11.32	63	55385	223738	64219546
Gastrointestinal haemorrhage	59.06	11.32	20	55428	132292	64310992
Infusion related reaction	59.04	11.32	34	55414	164433	64278851
Cardiac failure congestive	57.83	11.32	20	55428	130560	64312724
Arthropathy	56.27	11.32	17	55431	120950	64322334
Tardive dyskinesia	55.86	11.32	53	55395	9125	64434159
Panic attack	54.36	11.32	78	55370	20875	64422409
Extrapyramidal disorder	54.01	11.32	75	55373	19477	64423807
Haemoglobin decreased	53.76	11.32	53	55395	195010	64248274
Multiple organ dysfunction syndrome	53.46	11.32	11	55437	101402	64341882
Gynaecomastia	53.26	11.32	43	55405	5973	64437311
Lower respiratory tract infection	52.57	11.32	9	55439	94605	64348679
Seizure	52.21	11.32	282	55166	166610	64276674
Pulmonary malformation	51.94	11.32	14	55434	134	64443150
Renal impairment	51.25	11.32	26	55422	134991	64308293
Swelling	50.89	11.32	38	55410	160180	64283104
Somnambulism	50.35	11.32	39	55409	5102	64438182
Product taste abnormal	49.04	11.32	27	55421	1976	64441308
Oromandibular dystonia	48.81	11.32	21	55427	892	64442392
Rapid eye movement sleep behaviour disorder	48.29	11.32	16	55432	325	64442959
Pancytopenia	48.14	11.32	32	55416	143277	64300007
Sleep disorder	47.91	11.32	136	55312	59573	64383711
Infection	47.83	11.32	53	55395	184827	64258457
Social anxiety disorder	47.70	11.32	17	55431	433	64442851
Drug intolerance	46.36	11.32	56	55392	187936	64255348
Sleep apnoea syndrome	46.18	11.32	88	55360	29744	64413540
Affective disorder	45.88	11.32	41	55407	6539	64436745
Platelet count decreased	45.71	11.32	46	55402	167665	64275619
Social avoidant behaviour	45.57	11.32	35	55413	4522	64438762
Drug hypersensitivity	44.97	11.32	85	55363	237730	64205554
Alice in wonderland syndrome	44.95	11.32	10	55438	38	64443246
Renal failure	44.93	11.32	54	55394	181634	64261650
Keratoconus	44.76	11.32	11	55437	70	64443214
Treatment failure	43.58	11.32	23	55425	116793	64326491
Decreased appetite	43.36	11.32	400	55048	280889	64162395
Product administered to patient of inappropriate age	43.11	11.32	34	55414	4567	64438717
Respiratory failure	43.03	11.32	45	55403	161138	64282146
Pyrexia	42.79	11.32	293	55155	558351	63884933
Hallucinations, mixed	42.77	11.32	38	55410	6014	64437270
Increased appetite	42.59	11.32	48	55400	10098	64433186
Ventricular parasystole	42.42	11.32	7	55441	0	64443284
Hyperkalaemia	42.24	11.32	17	55431	101112	64342172
Therapeutic response unexpected	42.23	11.32	62	55386	16939	64426345
Drug withdrawal syndrome	42.05	11.32	87	55361	31204	64412080
Systemic lupus erythematosus	41.78	11.32	8	55440	77604	64365680
Application site rash	41.51	11.32	24	55424	1930	64441354
Hyperhidrosis	41.05	11.32	214	55234	124706	64318578
Mood swings	40.95	11.32	62	55386	17406	64425878
Hyperkinesia	40.54	11.32	26	55422	2520	64440764
Cardiac failure	40.01	11.32	33	55415	132340	64310944
Disturbance in social behaviour	39.19	11.32	30	55418	3857	64439427
Hypertension	39.10	11.32	367	55081	258894	64184390
Atrial fibrillation	39.05	11.32	54	55394	171035	64272249
Generalised tonic-clonic seizure	38.24	11.32	97	55351	39760	64403524
Change in sustained attention	38.09	11.32	7	55441	6	64443278
Speech disorder	37.56	11.32	109	55339	48332	64394952
Suicidal behaviour	37.56	11.32	26	55422	2861	64440423
Feeling jittery	37.48	11.32	46	55402	10589	64432695
Lung cyst	36.87	11.32	11	55437	156	64443128
Glossodynia	36.28	11.32	6	55442	64690	64378594
Pain	35.90	11.32	304	55144	553207	63890077
Nervousness	34.92	11.32	78	55370	29478	64413806
Cough	34.60	11.32	138	55310	302010	64141274
Petit mal epilepsy	34.38	11.32	31	55417	5001	64438283
Torticollis	34.09	11.32	22	55426	2155	64441129
Product adhesion issue	34.02	11.32	23	55425	2436	64440848
Adhesive tape use	33.93	11.32	6	55442	3	64443281
Excessive eye blinking	33.67	11.32	18	55430	1242	64442042
Septic shock	33.48	11.32	25	55423	105412	64337872
Mobility decreased	33.37	11.32	16	55432	85824	64357460
Oculogyric crisis	33.36	11.32	23	55425	2515	64440769
Incorrect dose administered	32.92	11.32	121	55327	60644	64382640
Sudden death	31.99	11.32	60	55388	20036	64423248
Treatment noncompliance	31.96	11.32	96	55352	43386	64399898
Therapeutic response changed	31.89	11.32	16	55432	968	64442316
Peripheral coldness	31.54	11.32	48	55400	13536	64429748
Rash	31.47	11.32	248	55200	458301	63984983
Raynaud's phenomenon	31.40	11.32	16	55432	1000	64442284
Drug use disorder	31.33	11.32	32	55416	6022	64437262
Stereotypy	31.19	11.32	15	55433	827	64442457
School refusal	30.98	11.32	7	55441	29	64443255
Pleural effusion	30.87	11.32	38	55410	126521	64316763
Substance abuse	30.84	11.32	39	55409	9253	64434031
Screaming	30.77	11.32	25	55423	3504	64439780
Maternal exposure during breast feeding	30.65	11.32	20	55428	1996	64441288
Solar urticaria	30.53	11.32	8	55440	68	64443216
Oedema peripheral	30.24	11.32	87	55361	210230	64233054
Negative thoughts	30.18	11.32	17	55431	1301	64441983
Bipolar disorder	30.13	11.32	33	55415	6728	64436556
Blister	30.11	11.32	16	55432	80951	64362333
Formication	30.08	11.32	27	55421	4330	64438954
Melaena	29.95	11.32	5	55443	53543	64389741
Drug tolerance	29.40	11.32	31	55417	6054	64437230
Delayed puberty	29.11	11.32	9	55439	145	64443139
International normalised ratio increased	28.92	11.32	16	55432	79151	64364133
Pericarditis	28.68	11.32	9	55439	62507	64380777
Wound	28.60	11.32	15	55433	76462	64366822
Parasomnia	28.50	11.32	12	55436	483	64442801
Malignant neoplasm progression	28.48	11.32	33	55415	112838	64330446
Substance use disorder	28.38	11.32	11	55437	356	64442928
Hyperventilation	28.10	11.32	32	55416	6808	64436476
Pre-existing condition improved	28.03	11.32	27	55421	4735	64438549
Tachypnoea	27.96	11.32	67	55381	26504	64416780
Blood creatine phosphokinase increased	27.94	11.32	112	55336	58446	64384838
Blood creatinine increased	27.94	11.32	46	55402	135736	64307548
Nightmare	27.77	11.32	58	55390	20935	64422349
Protrusion tongue	27.54	11.32	11	55437	386	64442898
Application site discolouration	27.20	11.32	13	55435	707	64442577
Lactation disorder	27.20	11.32	9	55439	182	64443102
Product prescribing error	27.00	11.32	79	55369	35190	64408094
Body temperature increased	26.99	11.32	81	55367	36585	64406699
Migraine	26.87	11.32	116	55332	62561	64380723
Coordination abnormal	26.77	11.32	47	55401	14917	64428367
Vasospasm	26.77	11.32	14	55434	924	64442360
Drug reaction with eosinophilia and systemic symptoms	26.35	11.32	7	55441	54210	64389074
Lactic acidosis	26.17	11.32	10	55438	61400	64381884
Product complaint	26.02	11.32	41	55407	11913	64431371
Erythema	25.72	11.32	79	55369	186991	64256293
Hypersomnia	25.53	11.32	54	55394	19663	64423621
Coronary artery disease	25.49	11.32	10	55438	60423	64382861
Hyponatraemia	25.49	11.32	56	55392	148283	64295001
Vision blurred	25.16	11.32	148	55300	90168	64353116
Asthenia	25.13	11.32	241	55207	427803	64015481
Application site urticaria	25.11	11.32	9	55439	233	64443051
Erection increased	25.01	11.32	10	55438	352	64442932
Strabismus	24.92	11.32	18	55430	2119	64441165
Rectal haemorrhage	24.83	11.32	11	55437	61806	64381478
White blood cell count decreased	24.40	11.32	63	55385	157774	64285510
Optic disc haemorrhage	24.39	11.32	7	55441	86	64443198
Urine amphetamine negative	24.24	11.32	4	55444	0	64443284
Cardiac contusion	24.24	11.32	4	55444	0	64443284
Testicular failure	24.24	11.32	4	55444	0	64443284
Maternal exposure during pregnancy	24.22	11.32	28	55420	95856	64347428
Hepatotoxicity	24.05	11.32	3	55445	39959	64403325
Mental disorder	23.96	11.32	63	55385	26382	64416902
Eye movement disorder	23.95	11.32	30	55418	7049	64436235
Poisoning	23.92	11.32	56	55392	21823	64421461
Autism spectrum disorder	23.91	11.32	13	55435	928	64442356
Meningitis streptococcal	23.90	11.32	8	55440	168	64443116
Mucosal inflammation	23.81	11.32	12	55436	62572	64380712
Bone marrow failure	23.67	11.32	6	55442	47946	64395338
Multiple sclerosis relapse	23.20	11.32	83	55365	41052	64402232
Status epilepticus	23.20	11.32	55	55393	21608	64421676
Exposure via breast milk	23.09	11.32	12	55436	782	64442502
Abdominal discomfort	22.99	11.32	80	55368	182242	64261042
Wound infection fungal	22.97	11.32	8	55440	190	64443094
Memory impairment	22.97	11.32	139	55309	85543	64357741
Dehydration	22.94	11.32	102	55346	216661	64226623
Substance-induced psychotic disorder	22.93	11.32	19	55429	2736	64440548
Product colour issue	22.62	11.32	11	55437	622	64442662
Polydipsia psychogenic	22.59	11.32	8	55440	200	64443084
Scoliosis	22.56	11.32	27	55421	6055	64437229
Hepatic enzyme increased	22.37	11.32	49	55399	129894	64313390
Poor quality product administered	22.35	11.32	20	55428	3195	64440089
Tachyphrenia	22.33	11.32	16	55432	1860	64441424
Hangover	22.14	11.32	16	55432	1885	64441399
Pre-eclampsia	22.03	11.32	27	55421	6204	64437080
Compulsions	21.99	11.32	9	55439	337	64442947
Initial insomnia	21.91	11.32	26	55422	5778	64437506
Product dispensing error	21.84	11.32	37	55411	11413	64431871
Sympathomimetic effect	21.59	11.32	6	55442	65	64443219
Disease progression	21.56	11.32	57	55391	141623	64301661
Cyanosis	21.33	11.32	54	55394	22101	64421183
Dermo-hypodermitis	21.15	11.32	10	55438	531	64442753
Hunger	21.02	11.32	22	55426	4259	64439025
Wolff-Parkinson-White syndrome	20.73	11.32	8	55440	256	64443028
C-reactive protein increased	20.61	11.32	31	55417	94878	64348406
Tongue spasm	20.52	11.32	6	55442	79	64443205
Oxygen saturation decreased	20.51	11.32	38	55410	107138	64336146
Weight gain poor	20.50	11.32	11	55437	765	64442519
Self-injurious ideation	20.49	11.32	19	55429	3178	64440106
Upper gastrointestinal haemorrhage	20.35	11.32	3	55445	35217	64408067
Panic reaction	20.32	11.32	21	55427	4006	64439278
Psychiatric symptom	20.30	11.32	26	55422	6247	64437037
Abdominal distension	20.23	11.32	32	55416	95962	64347322
Drug screen negative	20.22	11.32	8	55440	274	64443010
Splenic infarction	20.18	11.32	19	55429	3238	64440046
Onychophagia	20.05	11.32	6	55442	86	64443198
Incorrect route of product administration	19.60	11.32	54	55394	23244	64420040
Burnout syndrome	19.53	11.32	8	55440	300	64442984
Narcolepsy	19.53	11.32	12	55436	1079	64442205
Distractibility	19.46	11.32	10	55438	636	64442648
Hepatic function abnormal	19.46	11.32	16	55432	64297	64378987
Respiratory tract malformation	19.46	11.32	5	55443	39	64443245
Osteoporosis	19.40	11.32	6	55442	42074	64401210
Chronic kidney disease	19.35	11.32	13	55435	57906	64385378
Grimacing	19.19	11.32	10	55438	655	64442629
Hypocalcaemia	19.17	11.32	6	55442	41747	64401537
Stomatitis	19.13	11.32	41	55407	109564	64333720
Akathisia	19.12	11.32	35	55413	11475	64431809
Cataract subcapsular	19.10	11.32	11	55437	878	64442406
Sinus tachycardia	19.06	11.32	66	55382	32122	64411162
Thinking abnormal	19.02	11.32	35	55413	11521	64431763
Dermatillomania	18.98	11.32	7	55441	197	64443087
Sleep-related eating disorder	18.95	11.32	10	55438	672	64442612
Hypoglycaemia	18.91	11.32	30	55418	89862	64353422
Cerebral congestion	18.83	11.32	5	55443	45	64443239
Agranulocytosis	18.46	11.32	5	55443	38224	64405060
Long QT syndrome congenital	18.44	11.32	5	55443	49	64443235
Atrioventricular block second degree	18.19	11.32	25	55423	6429	64436855
Limb girth decreased	18.18	11.32	3	55445	0	64443284
Herpes zoster	18.05	11.32	25	55423	79162	64364122
Poor quality sleep	18.05	11.32	46	55402	18905	64424379
Open angle glaucoma	17.93	11.32	8	55440	371	64442913
Phobia	17.83	11.32	8	55440	376	64442908
Illusion	17.80	11.32	13	55435	1557	64441727
Disinhibition	17.70	11.32	15	55433	2228	64441056
Inflammation	17.68	11.32	18	55430	65282	64378002
Sensory level abnormal	17.62	11.32	6	55442	133	64443151
Loss of consciousness	17.56	11.32	200	55248	148165	64295119
Fear	17.21	11.32	47	55401	20124	64423160
Dysphoria	17.14	11.32	20	55428	4368	64438916
Hypnagogic hallucination	17.13	11.32	6	55442	145	64443139
Amnesia	16.75	11.32	84	55364	48185	64395099
Anaphylactic shock	16.59	11.32	3	55445	30325	64412959
Product residue present	16.53	11.32	17	55431	3225	64440059
Hepatic failure	16.49	11.32	14	55434	55380	64387904
Oedema	16.37	11.32	34	55414	91901	64351383
Accidental exposure to product by child	16.37	11.32	15	55433	2470	64440814
Opisthotonus	16.30	11.32	9	55439	662	64442622
Hypoxia	16.21	11.32	32	55416	88117	64355167
Tourette's disorder	16.14	11.32	5	55443	81	64443203
Chronic fatigue syndrome	16.11	11.32	11	55437	1184	64442100
Bisexuality	16.10	11.32	3	55445	3	64443281
Neutrophil count decreased	16.02	11.32	26	55422	77170	64366114
Prescribed overdose	16.00	11.32	46	55402	20285	64422999
Psoriasis	15.98	11.32	23	55425	71680	64371604
Regressive behaviour	15.98	11.32	5	55443	84	64443200
Toxic epidermal necrolysis	15.92	11.32	6	55442	37160	64406124
Major depression	15.90	11.32	26	55422	7790	64435494
Pruritus	15.82	11.32	182	55266	312218	64131066
Hyperphagia	15.75	11.32	14	55434	2217	64441067
Pericardial effusion	15.74	11.32	7	55441	39247	64404037
Tooth discolouration	15.72	11.32	10	55438	955	64442329
Concussion	15.61	11.32	26	55422	7912	64435372
Nystagmus	15.60	11.32	28	55420	9040	64434244
Bundle branch block right	15.53	11.32	30	55418	10239	64433045
Brain oedema	15.53	11.32	48	55400	22027	64421257
Antiphospholipid syndrome	15.49	11.32	12	55436	1570	64441714
Osteoarthritis	15.46	11.32	19	55429	63317	64379967
Injection site pain	15.34	11.32	47	55401	111361	64331923
Hyperacusis	15.34	11.32	13	55435	1932	64441352
Negativism	15.26	11.32	9	55439	751	64442533
Meningitis staphylococcal	15.21	11.32	5	55443	99	64443185
Hypokalaemia	15.02	11.32	54	55394	121849	64321435
Sleep paralysis	14.99	11.32	8	55440	550	64442734
Eosinophilia	14.94	11.32	7	55441	38069	64405215
Substance abuser	14.89	11.32	5	55443	106	64443178
Staring	14.82	11.32	14	55434	2396	64440888
Application site erosion	14.80	11.32	6	55442	219	64443065
Wrong product administered	14.80	11.32	25	55423	7695	64435589
Ascites	14.71	11.32	19	55429	61982	64381302
Product use issue	14.71	11.32	197	55251	151518	64291766
Livedo reticularis	14.69	11.32	17	55431	3680	64439604
Injection site abscess	14.56	11.32	11	55437	1387	64441897
Insulin resistance	14.53	11.32	10	55438	1090	64442194
Plasma cell myeloma	14.52	11.32	11	55437	46064	64397220
Myelodysplastic syndrome	14.51	11.32	3	55445	27576	64415708
Acute psychosis	14.48	11.32	17	55431	3735	64439549
Leukopenia	14.45	11.32	42	55406	101200	64342084
Sudden onset of sleep	14.41	11.32	8	55440	595	64442689
Talipes	14.39	11.32	5	55443	118	64443166
Application site pain	14.37	11.32	18	55430	4230	64439054
Eosinophilic myocarditis	14.31	11.32	9	55439	843	64442441
Surgery	14.29	11.32	55	55393	28158	64415126
Epiphyses delayed fusion	14.29	11.32	3	55445	8	64443276
Hypertonia	14.19	11.32	22	55426	6303	64436981
Congestive cardiomyopathy	14.18	11.32	29	55419	10315	64432969
Hyperglycaemia	14.14	11.32	19	55429	60949	64382335
Schizotypal personality disorder	14.03	11.32	3	55445	9	64443275
Hepatocellular injury	14.00	11.32	11	55437	45224	64398060
Electrocardiogram QRS complex prolonged	13.97	11.32	27	55421	9217	64434067
Schizoaffective disorder bipolar type	13.93	11.32	5	55443	130	64443154
Constipation	13.91	11.32	128	55320	229209	64214075
Drug ineffective	13.80	11.32	867	54581	839380	63603904
Drug eruption	13.64	11.32	7	55441	36129	64407155
Injection site erythema	13.63	11.32	25	55423	70775	64372509
Physical assault	13.58	11.32	11	55437	1535	64441749
Shock	13.57	11.32	8	55440	38232	64405052
Dysphemia	13.51	11.32	15	55433	3104	64440180
Palmar-plantar erythrodysaesthesia syndrome	13.49	11.32	4	55444	28815	64414469
Dyspnoea exertional	13.36	11.32	27	55421	73703	64369581
Urinary incontinence	13.32	11.32	64	55384	36087	64407197
Arthritis	13.30	11.32	33	55415	83781	64359503
Haematochezia	13.17	11.32	23	55425	66350	64376934
Poor sucking reflex	13.14	11.32	4	55444	61	64443223
Chills	13.10	11.32	67	55381	137197	64306087
Liver disorder	13.02	11.32	16	55432	53335	64389949
Hypomagnesaemia	13.01	11.32	8	55440	37368	64405916
Hepatitis	12.99	11.32	12	55436	45570	64397714
Pressure of speech	12.99	11.32	9	55439	992	64442292
Electroencephalogram abnormal	12.96	11.32	19	55429	5184	64438100
Sedation	12.90	11.32	70	55378	41392	64401892
Impaired healing	12.89	11.32	20	55428	60453	64382831
Myocarditis	12.87	11.32	38	55410	17005	64426279
Personality change	12.87	11.32	25	55423	8568	64434716
Water intoxication	12.79	11.32	8	55440	742	64442542
Drug abuser	12.75	11.32	20	55428	5788	64437496
Libido decreased	12.69	11.32	18	55430	4766	64438518
Neoplasm progression	12.63	11.32	10	55438	40954	64402330
Gastric bypass	12.60	11.32	9	55439	1041	64442243
COVID-19	12.54	11.32	23	55425	65117	64378167
Hepatitis C virus test positive	12.51	11.32	6	55442	329	64442955
Product dose omission issue	12.49	11.32	236	55212	194511	64248773
Full blood count abnormal	12.42	11.32	5	55443	29752	64413532
Pneumonitis	12.40	11.32	15	55433	50350	64392934
Learning disorder	12.39	11.32	7	55441	539	64442745
Psychotic symptom	12.35	11.32	12	55436	2126	64441158
Gastrointestinal disorder	12.24	11.32	38	55410	89671	64353613
Haematoma	12.23	11.32	13	55435	46237	64397047
Gastrooesophageal reflux disease	12.23	11.32	34	55414	83109	64360175
Sydenham's chorea	12.22	11.32	3	55445	19	64443265
Asphyxia	12.16	11.32	26	55422	9540	64433744
Defect conduction intraventricular	12.10	11.32	6	55442	354	64442930
Autophobia	12.09	11.32	3	55445	20	64443264
Bezoar	12.05	11.32	12	55436	2191	64441093
Henoch-Schonlein purpura	12.04	11.32	12	55436	2194	64441090
Electrocardiogram ST segment elevation	11.96	11.32	22	55426	7237	64436047
Osteonecrosis of jaw	11.94	11.32	10	55438	39815	64403469
Thrombosis	11.85	11.32	27	55421	70615	64372669
Application site scab	11.81	11.32	5	55443	204	64443080
Arrhythmia	11.80	11.32	82	55366	52862	64390422
Hypomania	11.77	11.32	19	55429	5635	64437649
Hypersensitivity	11.76	11.32	110	55338	196342	64246942
Renal disorder	11.73	11.32	8	55440	35357	64407927
Muscle tightness	11.66	11.32	28	55420	11087	64432197
Myocardial infarction	11.65	11.32	89	55359	165732	64277552
Injection site swelling	11.65	11.32	11	55437	41342	64401942
Rash maculo-papular	11.59	11.32	14	55434	47012	64396272
Persecutory delusion	11.56	11.32	16	55432	4142	64439142
Verbigeration	11.50	11.32	3	55445	25	64443259
Streptococcal infection	11.50	11.32	22	55426	7457	64435827

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N06BA04	NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS Centrally acting sympathomimetics
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D000697	Central Nervous System Stimulants
MeSH PA	D015259	Dopamine Agents
MeSH PA	D018765	Dopamine Uptake Inhibitors
MeSH PA	D049990	Membrane Transport Modulators
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D014179	Neurotransmitter Uptake Inhibitors
CHEBI has role	CHEBI:35337	analeptic
CHEBI has role	CHEBI:35471	psychotropic drugs
CHEBI has role	CHEBI:35524	sympathomimetic
CHEBI has role	CHEBI:35640	adrenergic uptake inhibitors
CHEBI has role	CHEBI:37962	adrenergic agents
CHEBI has role	CHEBI:51039	dopamine reuptake inhibitor
FDA PE	N0000175729	Central Nervous System Stimulation
FDA EPC	N0000175739	Central Nervous System Stimulant

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

Disease	Relation	SNOMED_ID	DOID
Narcolepsy	indication	60380001	DOID:8986
Attention deficit hyperactivity disorder	indication	406506008
Depressive disorder	off-label use	35489007
Cognitive Impairment following Traumatic Brain Injury	off-label use
Gilles de la Tourette's syndrome	contraindication	5158005	DOID:11119
Dependent drug abuse	contraindication	6525002
Alcoholism	contraindication	7200002
Sinus tachycardia	contraindication	11092001
Bipolar disorder	contraindication	13746004	DOID:3312
Mood swings	contraindication	18963009
Lowered convulsive threshold	contraindication	19260006
Myocardial infarction	contraindication	22298006	DOID:5844
Glaucoma	contraindication	23986001	DOID:1686
Feeling agitated	contraindication	24199005
Short bowel syndrome	contraindication	26629001	DOID:10605
Hyperthyroidism	contraindication	34486009	DOID:7998
Hypertensive disorder	contraindication	38341003	DOID:10763
Conduction disorder of the heart	contraindication	44808001
Chronic heart failure	contraindication	48447003
Tension	contraindication	53489000
Anorexia nervosa	contraindication	56882008	DOID:8689
Aggressive behavior	contraindication	61372001
Substance abuse	contraindication	66214007
Psychotic disorder	contraindication	69322001
Severe anxiety (panic)	contraindication	80583007
Epilepsy	contraindication	84757009	DOID:1826
Leukopenia	contraindication	84828003	DOID:615
Cardiomyopathy	contraindication	85898001	DOID:0050700
Thyrotoxicosis	contraindication	90739004	DOID:7997
Blurring of visual image	contraindication	111516008
Gastrointestinal obstruction	contraindication	126765001
Structural disorder of heart	contraindication	128599005
Seizure disorder	contraindication	128613002
Liver function tests abnormal	contraindication	166603001
Angina pectoris	contraindication	194828000
Motor tic disorder	contraindication	230337001
Cerebrovascular accident	contraindication	230690007
Mania	contraindication	231494001
Esophageal dysmotility	contraindication	266434009	DOID:9192
Anemia	contraindication	271737000	DOID:2355
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Visual impairment	contraindication	397540003
Disorder of coronary artery	contraindication	414024009
Myocardial infarction in recovery phase	contraindication	418044006
Hypertensive urgency	contraindication	443482000
Life-Threatening Cardiac Arrhythmias	contraindication
Uncontrolled Epilepsy	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.68	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
10MG/9HR (1.1MG/HR)	DAYTRANA	NOVEN PHARMS INC	N021514	April 6, 2006	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9668981	Oct. 7, 2025	METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF
15MG/9HR (1.6MG/HR)	DAYTRANA	NOVEN PHARMS INC	N021514	April 6, 2006	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9668981	Oct. 7, 2025	METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF
20MG/9HR (2.2MG/HR)	DAYTRANA	NOVEN PHARMS INC	N021514	April 6, 2006	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9668981	Oct. 7, 2025	METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF
30MG/9HR (3.3MG/HR)	DAYTRANA	NOVEN PHARMS INC	N021514	April 6, 2006	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9668981	Oct. 7, 2025	METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF
5MG/ML	QUILLIVANT XR	NEXTWAVE	N202100	Sept. 27, 2012	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	8465765	Feb. 15, 2031	TREATING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH METHYLPHENIDATE, SUCH AS ADHD, BY ADMINISTERING THE FORMULATION RECITED IN CLAIMS 1 OR 2
5MG/ML	QUILLIVANT XR	NEXTWAVE	N202100	Sept. 27, 2012	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	8563033	Feb. 15, 2031	TREATING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH METHYLPHENIDATE, SUCH AS ADHD, BY ADMINISTERING THE FORMULATION RECITED IN CLAIMS 1 OR 2
5MG/ML	QUILLIVANT XR	NEXTWAVE	N202100	Sept. 27, 2012	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	8778390	Feb. 15, 2031	TREATMENT OF A PATIENT BY ADMINISTERING THE FORMULATION RECITED IN CLAIM 1 OR CLAIM 23
5MG/ML	QUILLIVANT XR	NEXTWAVE	N202100	Sept. 27, 2012	RX	FOR SUSPENSION, EXTENDED RELEASE	ORAL	8956649	Feb. 15, 2031	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING THE COMPOSITION OF CLAIM 1
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10292937	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10617651	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10881618	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	11241391	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	8916588	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9028868	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9034902	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9603809	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10292937	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10617651	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10881618	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	11241391	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	8916588	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9028868	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9034902	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9603809	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10292937	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10617651	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10881618	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	11241391	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	8916588	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9028868	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9034902	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
40MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9603809	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10292937	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10617651	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10881618	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	11241391	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	8916588	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9028868	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9034902	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
60MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9603809	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10292937	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10617651	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10881618	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	11241391	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	8916588	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9028868	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9034902	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
80MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9603809	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
20MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	10857143	Aug. 14, 2033	A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED
20MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	11103495	Aug. 14, 2033	A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED
20MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	9295642	Aug. 14, 2033	A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
20MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	9545399	Aug. 14, 2033	A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
20MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	9844544	Aug. 14, 2033	A METHOD OF PROVIDING A SUBJECT WITH A THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET AS CLAIMED
30MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	10857143	Aug. 14, 2033	A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED
30MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	11103495	Aug. 14, 2033	A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED
30MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	9295642	Aug. 14, 2033	A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
30MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	9545399	Aug. 14, 2033	A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
30MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	9844544	Aug. 14, 2033	A METHOD OF PROVIDING A SUBJECT WITH A THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET AS CLAIMED
40MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	10857143	Aug. 14, 2033	A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED
40MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	11103495	Aug. 14, 2033	A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED
40MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	9295642	Aug. 14, 2033	A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
40MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	9545399	Aug. 14, 2033	A METHOD OF PROVIDING A SUBJECT WITH THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET ACCORDING TO CLAIM 1
40MG	QUILLICHEW ER	NEXTWAVE PHARMS	N207960	Dec. 4, 2015	RX	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	9844544	Aug. 14, 2033	A METHOD OF PROVIDING A SUBJECT WITH A THERAPEUTICALLY EFFECTIVE AMOUNT OF RACEMIC METHYLPHENIDATE BY ORALLY ADMINISTERING TO SAID SUBJECT A SINGLE METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET AS CLAIMED
25MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10111839	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10292939	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10449159	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10500162	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10512613	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
25MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10568841	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10111839	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10292939	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10449159	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10500162	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10512613	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10568841	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10111839	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10292939	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10449159	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10500162	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10512613	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10568841	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10111839	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10292939	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10449159	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10500162	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10512613	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10568841	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10111839	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10292939	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10449159	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10500162	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10512613	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10568841	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10111839	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10292939	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10449159	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10500162	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10512613	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10568841	Oct. 30, 2035	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
17.3MG	COTEMPLA XR-ODT	NEOS THERAPS INC	N205489	June 19, 2017	RX	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE	ORAL	11166947	Jan. 25, 2038	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS
25.9MG	COTEMPLA XR-ODT	NEOS THERAPS INC	N205489	June 19, 2017	RX	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE	ORAL	11166947	Jan. 25, 2038	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS
8.6MG	COTEMPLA XR-ODT	NEOS THERAPS INC	N205489	June 19, 2017	RX	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE	ORAL	11166947	Jan. 25, 2038	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS
25MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10722473	Nov. 19, 2038	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
35MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10722473	Nov. 19, 2038	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
45MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10722473	Nov. 19, 2038	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
55MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10722473	Nov. 19, 2038	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
70MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10722473	Nov. 19, 2038	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
85MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	10722473	Nov. 19, 2038	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
25MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	Feb. 27, 2022	NEW PRODUCT
35MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	Feb. 27, 2022	NEW PRODUCT
45MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	Feb. 27, 2022	NEW PRODUCT
55MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	Feb. 27, 2022	NEW PRODUCT
70MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	Feb. 27, 2022	NEW PRODUCT
85MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	Feb. 27, 2022	NEW PRODUCT
25MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
35MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
45MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
55MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
70MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
85MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	RX	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN	INHIBITOR	Ki	6.96	CHEMBL	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN	INHIBITOR	Ki	6.18	CHEMBL	CHEMBL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		Ki	5.25	PDSP
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN		Ki	6.07	PDSP
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN		Ki	5.62	PDSP
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		Ki	4.19	CHEMBL
Sodium-dependent dopamine transporter	Transporter		SC6A3_RAT		IC50	7.08	CHEMBL

External reference:

ID	Source
4019832	VUID
N0000147920	NUI
D01296	KEGG_DRUG
23655-65-4	SECONDARY_CAS_RN
4018198	VANDF
4019832	VANDF
C0025810	UMLSCUI
CHEBI:6887	CHEBI
CHEMBL796	ChEMBL_ID
DB00422	DRUGBANK_ID
CHEMBL1722	ChEMBL_ID
D008774	MESH_DESCRIPTOR_UI
4158	PUBCHEM_CID
485	INN_ID
7236	IUPHAR_LIGAND_ID
207ZZ9QZ49	UNII
203188	RXNORM
1038	MMSL
32827	MMSL
37867	MMSL
5092	MMSL
d00900	MMSL
001540	NDDF
004619	NDDF
18548003	SNOMEDCT_US
373337007	SNOMEDCT_US
42163009	SNOMEDCT_US
20748-11-2	SECONDARY_CAS_RN

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ritalin LA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0370	CAPSULE, EXTENDED RELEASE	20 mg	ORAL	NDA	33 sections
Ritalin LA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0371	CAPSULE, EXTENDED RELEASE	30 mg	ORAL	NDA	33 sections
Ritalin LA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0372	CAPSULE, EXTENDED RELEASE	40 mg	ORAL	NDA	33 sections
Ritalin LA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0424	CAPSULE, EXTENDED RELEASE	10 mg	ORAL	NDA	33 sections
Ritalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0439	TABLET	5 mg	ORAL	NDA	30 sections
Ritalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0440	TABLET	10 mg	ORAL	NDA	30 sections
Ritalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0441	TABLET	20 mg	ORAL	NDA	30 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5292	CAPSULE, EXTENDED RELEASE	50 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5292	CAPSULE, EXTENDED RELEASE	50 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5293	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5293	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5295	CAPSULE, EXTENDED RELEASE	10 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5295	CAPSULE, EXTENDED RELEASE	10 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5296	CAPSULE, EXTENDED RELEASE	20 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5296	CAPSULE, EXTENDED RELEASE	20 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5297	CAPSULE, EXTENDED RELEASE	30 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5297	CAPSULE, EXTENDED RELEASE	30 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5298	CAPSULE, EXTENDED RELEASE	40 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5298	CAPSULE, EXTENDED RELEASE	40 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(LA)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5346	CAPSULE, EXTENDED RELEASE	20 mg	ORAL	ANDA	29 sections
Methylphenidate Hydrochloride(LA)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5347	CAPSULE, EXTENDED RELEASE	30 mg	ORAL	ANDA	29 sections
Methylphenidate Hydrochloride(LA)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5348	CAPSULE, EXTENDED RELEASE	40 mg	ORAL	ANDA	29 sections
Methylphenidate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1736	CAPSULE, EXTENDED RELEASE	10 mg	ORAL	ANDA	15 sections
Methylphenidate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1737	CAPSULE, EXTENDED RELEASE	20 mg	ORAL	ANDA	15 sections
Methylphenidate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1738	CAPSULE, EXTENDED RELEASE	30 mg	ORAL	ANDA	15 sections
Methylphenidate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1739	CAPSULE, EXTENDED RELEASE	40 mg	ORAL	ANDA	15 sections
Methylphenidate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1740	CAPSULE, EXTENDED RELEASE	50 mg	ORAL	ANDA	15 sections
Methylphenidate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1741	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	15 sections
METHYLPHENIDATE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1800	TABLET	5 mg	ORAL	ANDA	27 sections
METHYLPHENIDATE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1801	TABLET	10 mg	ORAL	ANDA	27 sections