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	437.33	11.34	350	42076	62071	63384525
Anxiety	279.59	11.34	512	41914	217029	63229567
Product quality issue	250.79	11.34	201	42225	35664	63410932
Product substitution issue	241.38	11.34	144	42282	15852	63430744
Depression	225.73	11.34	441	41985	196051	63250545
Agitation	213.07	11.34	230	42196	59527	63387069
Disturbance in attention	191.59	11.34	177	42249	38012	63408584
Aggression	179.99	11.34	139	42287	23359	63423237
Drug abuse	169.29	11.34	225	42201	72293	63374303
Tachycardia	168.08	11.34	291	42135	117865	63328731
No adverse event	161.11	11.34	167	42259	41238	63405358
Intentional overdose	154.85	11.34	218	42208	73934	63372662
Attention deficit hyperactivity disorder	154.72	11.34	63	42363	3013	63443583
Irritability	147.65	11.34	141	42285	31553	63415043
Abnormal behaviour	143.22	11.34	117	42309	21309	63425287
Pre-existing condition improved	142.31	11.34	81	42345	8163	63438433
Precocious puberty	133.94	11.34	31	42395	197	63446399
Intentional self-injury	132.60	11.34	121	42305	25566	63421030
Tic	130.44	11.34	46	42380	1474	63445122
Contraindicated product administered	111.62	11.34	9	42417	217639	63228957
Suicide attempt	109.63	11.34	167	42259	60751	63385845
Pulmonary malformation	105.68	11.34	27	42399	272	63446324
Glossodynia	105.64	11.34	3	42423	178873	63267723
Joint swelling	104.72	11.34	44	42382	327622	63118974
Cataplexy	103.94	11.34	37	42389	1219	63445377
Somnolence	102.73	11.34	307	42119	178378	63268218
Tremor	101.82	11.34	253	42173	131986	63314610
Toxicity to various agents	98.93	11.34	376	42050	246874	63199722
Mydriasis	94.33	11.34	72	42354	11884	63434712
Feeling abnormal	92.03	11.34	262	42164	148130	63298466
Psychotic disorder	91.64	11.34	99	42327	25613	63420983
Therapeutic response unexpected	90.30	11.34	85	42341	18674	63427922
Application site erythema	90.22	11.34	50	42376	4785	63441811
Somnambulism	89.11	11.34	52	42374	5491	63441105
Hallucination, auditory	87.74	11.34	71	42355	12753	63433843
Systemic lupus erythematosus	84.91	11.34	18	42408	208900	63237696
Wrong technique in product usage process	83.97	11.34	150	42276	62190	63384406
Withdrawal syndrome	80.19	11.34	82	42344	19915	63426681
Sleep apnoea syndrome	76.71	11.34	96	42330	29037	63417559
Intentional product misuse	75.00	11.34	141	42285	60776	63385820
Lung cyst	74.05	11.34	21	42405	323	63446273
Dystonia	73.08	11.34	66	42360	13753	63432843
Arthropathy	72.63	11.34	33	42393	234759	63211837
Overdose	72.12	11.34	204	42222	114874	63331722
Swelling	71.73	11.34	48	42378	275330	63171266
Product administered at inappropriate site	71.20	11.34	37	42389	3112	63443484
Respiratory tract malformation	71.03	11.34	18	42408	175	63446421
Paranoia	70.22	11.34	60	42366	11619	63434977
Apathy	69.47	11.34	53	42373	8741	63437855
Panic attack	69.31	11.34	80	42346	22251	63424345
Infusion related reaction	69.22	11.34	39	42387	245482	63201114
Enuresis	69.20	11.34	34	42392	2539	63444057
Pericarditis	68.67	11.34	5	42421	131574	63315022
Psychomotor hyperactivity	66.61	11.34	56	42370	10607	63435989
Diarrhoea	65.95	11.34	251	42175	715115	62731481
Application site irritation	65.29	11.34	29	42397	1721	63444875
Wound	64.44	11.34	15	42411	163248	63283348
Arthralgia	64.11	11.34	183	42243	569527	62877069
Rheumatoid arthritis	63.77	11.34	46	42380	253773	63192823
Lower respiratory tract infection	63.74	11.34	7	42419	132300	63314296
Drug dependence	63.38	11.34	80	42346	24403	63422193
Acute kidney injury	63.28	11.34	50	42376	263365	63183231
Insomnia	63.18	11.34	298	42128	214954	63231642
Bruxism	61.82	11.34	35	42391	3490	63443106
Chorea	60.87	11.34	27	42399	1597	63444999
Dyskinesia	60.78	11.34	90	42336	31912	63414684
Obsessive-compulsive disorder	59.80	11.34	36	42390	4024	63442572
Product administration error	57.69	11.34	73	42353	22324	63424272
Drug intolerance	57.65	11.34	73	42353	308588	63138008
Pre-eclampsia	57.12	11.34	48	42378	9085	63437511
Crying	56.85	11.34	74	42352	23269	63423327
Product colour issue	56.82	11.34	20	42406	637	63445959
Adhesive tape use	56.81	11.34	9	42417	0	63446596
Hallucination	56.74	11.34	118	42308	54699	63391897
Social anxiety disorder	56.72	11.34	18	42408	413	63446183
Headache	54.52	11.34	654	41772	632587	62814009
Infection	54.41	11.34	44	42382	229129	63217467
Memory impairment	54.14	11.34	173	42253	104085	63342511
Product administration interrupted	54.02	11.34	36	42390	4800	63441796
Completed suicide	53.67	11.34	216	42210	145457	63301139
Rapid eye movement sleep behaviour disorder	52.97	11.34	16	42410	310	63446286
Blister	51.08	11.34	12	42414	129802	63316794
Maternal exposure during breast feeding	50.85	11.34	33	42393	4208	63442388
Treatment failure	50.07	11.34	36	42390	199007	63247589
Hallucination, visual	49.86	11.34	63	42363	19235	63427361
Educational problem	49.51	11.34	16	42410	390	63446206
Product tampering	49.05	11.34	16	42410	402	63446194
Impulsive behaviour	48.89	11.34	23	42403	1560	63445036
Abdominal discomfort	48.24	11.34	88	42338	320797	63125799
Adulterated product	47.73	11.34	14	42412	244	63446352
Heart rate increased	46.78	11.34	154	42272	94084	63352512
Euphoric mood	46.61	11.34	33	42393	4854	63441742
Drug diversion	46.26	11.34	19	42407	929	63445667
Mood swings	46.24	11.34	59	42367	18189	63428407
General physical health deterioration	46.16	11.34	40	42386	201362	63245234
Bipolar disorder	46.04	11.34	40	42386	7920	63438676
Rash	45.84	11.34	206	42220	560665	62885931
Anaemia	45.43	11.34	79	42347	293351	63153245
Hepatic enzyme increased	45.39	11.34	41	42385	202287	63244309
Seizure	45.18	11.34	192	42234	132442	63314154
Claustrophobia	44.95	11.34	19	42407	999	63445597
Parasomnia	44.92	11.34	16	42410	528	63446068
Peripheral swelling	44.53	11.34	68	42358	265874	63180722
Snoring	43.88	11.34	30	42396	4172	63442424
Growth retardation	43.01	11.34	20	42406	1321	63445275
Neutropenia	42.28	11.34	33	42393	174972	63271624
Muscle contracture	42.04	11.34	20	42406	1391	63445205
Sleep-related eating disorder	41.33	11.34	17	42409	834	63445762
Anger	40.98	11.34	46	42380	12410	63434186
Febrile neutropenia	40.95	11.34	14	42412	118435	63328161
Application site pruritus	40.56	11.34	28	42398	3956	63442640
Palpitations	40.55	11.34	166	42260	112604	63333992
Perinatal depression	40.32	11.34	16	42410	715	63445881
Affective disorder	39.88	11.34	33	42393	6113	63440483
Depressed mood	39.83	11.34	85	42341	40106	63406490
Mobility decreased	39.07	11.34	16	42410	121143	63325453
Hypersomnia	39.01	11.34	54	42372	18001	63428595
Application site urticaria	38.86	11.34	12	42414	251	63446345
Restlessness	38.53	11.34	70	42356	29383	63417213
Emotional disorder	38.31	11.34	46	42380	13333	63433263
Lactation disorder	38.09	11.34	13	42413	377	63446219
Misophonia	37.87	11.34	6	42420	0	63446596
Splenic infarction	37.86	11.34	20	42406	1739	63444857
Exposure via breast milk	37.63	11.34	21	42405	2036	63444560
Blood pressure increased	37.49	11.34	210	42216	161852	63284744
Alopecia	37.45	11.34	109	42317	337427	63109169
Muscle twitching	36.89	11.34	55	42371	19613	63426983
Poor sucking reflex	36.84	11.34	12	42414	300	63446296
Hyperreflexia	36.72	11.34	31	42395	5903	63440693
Major depression	36.06	11.34	35	42391	7983	63438613
Hyperventilation	35.91	11.34	31	42395	6085	63440511
Haemoglobin decreased	35.69	11.34	27	42399	145458	63301138
Multiple sclerosis relapse	35.43	11.34	91	42335	48387	63398209
Mania	34.56	11.34	42	42384	12325	63434271
Livedo reticularis	34.37	11.34	21	42405	2411	63444185
Dyspnoea	34.00	11.34	281	42145	661032	62785564
Negative thoughts	33.43	11.34	15	42411	912	63445684
Migraine	33.18	11.34	147	42279	103199	63343397
Folliculitis	33.16	11.34	4	42422	70313	63376283
Somatic symptom disorder	32.64	11.34	21	42405	2639	63443957
Thrombocytopenia	32.28	11.34	32	42394	151125	63295471
Death	32.05	11.34	135	42291	374246	63072350
Feeling jittery	31.87	11.34	42	42384	13361	63433235
Weight decreased	31.68	11.34	303	42123	276495	63170101
Post-traumatic stress disorder	31.61	11.34	27	42399	5224	63441372
Application site rash	31.34	11.34	20	42406	2478	63444118
Exposure during pregnancy	31.10	11.34	194	42232	155353	63291243
Tardive dyskinesia	30.75	11.34	33	42393	8469	63438127
Muscle injury	30.12	11.34	4	42422	65341	63381255
Pulse abnormal	29.84	11.34	19	42407	2345	63444251
Discomfort	29.76	11.34	41	42385	167333	63279263
Pancytopenia	29.36	11.34	14	42412	96919	63349677
Impaired healing	29.28	11.34	16	42410	102526	63344070
Hyperhidrosis	29.22	11.34	146	42280	107690	63338906
Delusion of parasitosis	29.09	11.34	6	42420	20	63446576
Mood altered	28.76	11.34	42	42384	14701	63431895
Burnout syndrome	28.42	11.34	9	42417	205	63446391
Sleep paralysis	28.09	11.34	12	42414	648	63445948
Interstitial lung disease	28.04	11.34	4	42422	61904	63384692
Loss of consciousness	27.93	11.34	154	42272	117967	63328629
Drug hypersensitivity	27.86	11.34	110	42316	310577	63136019
Tachyphrenia	27.82	11.34	15	42411	1359	63445237
Trichotillomania	27.80	11.34	8	42418	130	63446466
Sepsis	27.74	11.34	37	42389	153086	63293510
Solar urticaria	27.27	11.34	7	42419	72	63446524
Nightmare	26.88	11.34	47	42379	19147	63427449
Meningitis streptococcal	26.78	11.34	8	42418	149	63446447
Serotonin syndrome	26.52	11.34	59	42367	28623	63417973
Drug withdrawal syndrome	26.35	11.34	57	42369	27137	63419459
Abnormal sleep-related event	25.97	11.34	12	42414	781	63445815
Pneumonia	25.80	11.34	189	42237	456578	62990018
Drug screen negative	25.56	11.34	9	42417	287	63446309
Hangover	25.38	11.34	15	42411	1621	63444975
Cardiac failure	25.32	11.34	14	42412	89128	63357468
Maternal exposure during pregnancy	25.16	11.34	70	42356	219992	63226604
Illness	25.08	11.34	81	42345	48978	63397618
Amenorrhoea	25.03	11.34	32	42394	9882	63436714
Narcolepsy	25.02	11.34	14	42412	1364	63445232
Multiple organ dysfunction syndrome	24.94	11.34	4	42422	56748	63389848
Chronic fatigue syndrome	24.88	11.34	13	42413	1105	63445491
Product taste abnormal	24.58	11.34	16	42410	2051	63444545
C-reactive protein increased	23.97	11.34	17	42409	94690	63351906
Psychiatric symptom	23.86	11.34	23	42403	5200	63441396
Surgery	23.79	11.34	65	42361	35847	63410749
Stress	23.44	11.34	98	42328	67069	63379527
Knee arthroplasty	23.42	11.34	4	42422	54202	63392394
Pyrexia	23.18	11.34	202	42224	470276	62976320
Cyanosis	23.11	11.34	41	42385	16894	63429702
Axonal neuropathy	23.08	11.34	12	42414	1010	63445586
Wound infection fungal	22.87	11.34	7	42419	142	63446454
Cardiac failure congestive	22.86	11.34	17	42409	92416	63354180
Therapeutic response changed	22.83	11.34	12	42414	1033	63445563
CSWS syndrome	22.62	11.34	5	42421	25	63446571
Tachypnoea	22.47	11.34	41	42385	17261	63429335
Open angle glaucoma	22.40	11.34	8	42418	266	63446330
Nystagmus	22.24	11.34	24	42402	6196	63440400
Neurological symptom	21.89	11.34	23	42403	5760	63440836
Logorrhoea	21.77	11.34	16	42410	2494	63444102
Formication	21.72	11.34	20	42406	4271	63442325
Ill-defined disorder	21.59	11.34	14	42412	81741	63364855
Hallucination, tactile	21.46	11.34	8	42418	301	63446295
Hyperkalaemia	21.33	11.34	5	42421	54198	63392398
Gastrointestinal haemorrhage	21.30	11.34	14	42412	81162	63365434
Incorrect product administration duration	21.24	11.34	32	42394	11514	63435082
Vision blurred	21.16	11.34	119	42307	91805	63354791
Septic shock	21.15	11.34	9	42417	66620	63379976
Cholestasis of pregnancy	21.04	11.34	12	42414	1213	63445383
Muscle spasms	20.94	11.34	177	42249	155973	63290623
Musculoskeletal stiffness	20.90	11.34	59	42367	184559	63262037
Libido decreased	20.87	11.34	16	42410	2656	63443940
Stomatitis	20.85	11.34	38	42388	138687	63307909
Amphetamines positive	20.78	11.34	7	42419	195	63446401
Initial insomnia	20.70	11.34	23	42403	6134	63440462
Acne	20.52	11.34	47	42379	23246	63423350
Nervousness	20.44	11.34	56	42370	30923	63415673
Optic disc haemorrhage	20.43	11.34	6	42420	105	63446491
Protrusion tongue	20.06	11.34	8	42418	362	63446234
Product prescribing error	19.88	11.34	50	42376	26239	63420357
Substance abuse	19.79	11.34	20	42406	4787	63441809
Renal impairment	19.68	11.34	18	42408	88337	63358259
Application site discolouration	19.58	11.34	10	42416	811	63445785
Dizziness	19.50	11.34	399	42027	429526	63017070
Social avoidant behaviour	19.30	11.34	16	42410	2972	63443624
Antiphospholipid syndrome	19.21	11.34	13	42413	1777	63444819
Eosinophilic myocarditis	19.12	11.34	9	42417	611	63445985
Compulsive lip biting	18.94	11.34	3	42423	0	63446596
Delusion	18.91	11.34	31	42395	11986	63434610
Foot fracture	18.63	11.34	46	42380	23868	63422728
Bezoar	18.61	11.34	12	42414	1514	63445082
Sensory level abnormal	18.50	11.34	6	42420	148	63446448
Application site pain	18.33	11.34	18	42408	4164	63442432
Learning disorder	18.27	11.34	9	42417	676	63445920
Brain injury	18.20	11.34	23	42403	7020	63439576
Food craving	18.05	11.34	12	42414	1594	63445002
Gastrointestinal disorder	17.95	11.34	38	42388	131201	63315395
Hunger	17.92	11.34	20	42406	5359	63441237
Renal failure	17.88	11.34	32	42394	117620	63328976
Psoriatic arthropathy	17.73	11.34	21	42405	91499	63355097
Decreased appetite	17.57	11.34	250	42176	250802	63195794
Hypersensitivity	17.53	11.34	119	42307	292566	63154030
Thinking abnormal	17.49	11.34	28	42398	10615	63435981
Atrial fibrillation	17.48	11.34	32	42394	116604	63329992
Product complaint	17.46	11.34	31	42395	12778	63433818
Platelet count decreased	17.28	11.34	32	42394	116090	63330506
Mental disorder	17.25	11.34	47	42379	25872	63420724
Mucosal inflammation	17.19	11.34	5	42421	46923	63399673
Bisexuality	16.86	11.34	3	42423	3	63446593
Hypotension	16.74	11.34	110	42316	272494	63174102
Gastric bypass	16.71	11.34	12	42414	1805	63444791
Product availability issue	16.70	11.34	17	42409	4104	63442492
Pseudoporphyria	16.65	11.34	6	42420	205	63446391
Rectal haemorrhage	16.59	11.34	6	42420	49024	63397572
Disease progression	16.41	11.34	36	42390	122722	63323874
Long QT syndrome congenital	16.40	11.34	5	42421	100	63446496
Pleural effusion	16.39	11.34	23	42403	93187	63353409
Akathisia	16.33	11.34	25	42401	9121	63437475
Pain	16.32	11.34	374	42052	740254	62706342
Respiratory failure	16.12	11.34	27	42399	101831	63344765
Raynaud's phenomenon	15.86	11.34	10	42416	1214	63445382
Leukopenia	15.77	11.34	17	42409	77273	63369323
Myoclonic epilepsy	15.63	11.34	10	42416	1244	63445352
Red blood cell sedimentation rate increased	15.54	11.34	5	42421	43977	63402619
Type 2 diabetes mellitus	15.47	11.34	12	42414	63856	63382740
Hepatotoxicity	15.43	11.34	3	42423	37038	63409558
Grimacing	15.42	11.34	7	42419	437	63446159
Congenital cystic lung	15.25	11.34	4	42422	45	63446551
Foetal exposure timing unspecified	15.21	11.34	6	42420	264	63446332
C-reactive protein abnormal	15.00	11.34	6	42420	46090	63400506
Schizoaffective disorder bipolar type	14.92	11.34	5	42421	137	63446459
Panic reaction	14.74	11.34	16	42410	4158	63442438
Heavy menstrual bleeding	14.71	11.34	35	42391	17738	63428858
Malignant neoplasm progression	14.70	11.34	20	42406	82101	63364495
Vasospasm	14.55	11.34	8	42418	754	63445842
Pruritus	14.51	11.34	163	42263	361290	63085306
Hallucinations, mixed	14.48	11.34	17	42409	4812	63441784
Body temperature increased	14.36	11.34	56	42370	37136	63409460
Hip arthroplasty	14.24	11.34	7	42419	47639	63398957
Lactic acidosis	14.17	11.34	4	42422	38283	63408313
Hyponatraemia	14.00	11.34	34	42392	111866	63334730
Affect lability	13.95	11.34	26	42400	11125	63435471
White blood cell count decreased	13.93	11.34	47	42379	139057	63307539
Irritable bowel syndrome	13.84	11.34	21	42405	82391	63364205
Brain death	13.70	11.34	14	42412	3396	63443200
Phobia	13.64	11.34	6	42420	348	63446248
Consciousness fluctuating	13.58	11.34	8	42418	859	63445737
Product dose omission issue	13.57	11.34	226	42200	234087	63212509
Oedema	13.57	11.34	28	42398	97594	63349002
Bursitis	13.47	11.34	4	42422	37037	63409559
Therapeutic product effect incomplete	13.39	11.34	41	42385	125015	63321581
Cerebral artery occlusion	13.35	11.34	8	42418	887	63445709
Muscle discomfort	13.29	11.34	5	42421	193	63446403
Pseudolymphoma	13.11	11.34	7	42419	622	63445974
Pelvic inflammatory disease	13.09	11.34	10	42416	1652	63444944
Hyperacusis	13.00	11.34	11	42415	2102	63444494
Serum serotonin decreased	12.84	11.34	3	42423	20	63446576
Nephrogenic diabetes insipidus	12.84	11.34	8	42418	951	63445645
Sleep attacks	12.81	11.34	4	42422	87	63446509
Oculogyric crisis	12.78	11.34	10	42416	1711	63444885
Muscle tightness	12.76	11.34	26	42400	11874	63434722
Status epilepticus	12.61	11.34	30	42396	15203	63431393
Intrusive thoughts	12.61	11.34	5	42421	223	63446373
Rash pruritic	12.37	11.34	13	42413	59786	63386810
Distractibility	12.34	11.34	6	42420	438	63446158
Foetal exposure during pregnancy	12.24	11.34	48	42378	31914	63414682
International normalised ratio increased	12.19	11.34	8	42418	46417	63400179
Amnesia	12.16	11.34	71	42355	55514	63391082
Horner's syndrome	12.15	11.34	3	42423	26	63446570
Therapy non-responder	12.12	11.34	20	42406	75881	63370715
Herpes zoster	12.02	11.34	23	42403	82439	63364157
Seizure like phenomena	11.97	11.34	8	42418	1071	63445525
Extrapyramidal disorder	11.92	11.34	27	42399	13257	63433339
Treatment noncompliance	11.90	11.34	53	42373	37272	63409324
Infected cyst	11.76	11.34	8	42418	1104	63445492
Drug abuser	11.74	11.34	12	42414	2911	63443685
Neutrophil percentage increased	11.67	11.34	12	42414	2931	63443665
Tongue biting	11.65	11.34	9	42417	1511	63445085
Menstrual disorder	11.64	11.34	16	42410	5297	63441299
Impulse-control disorder	11.62	11.34	7	42419	783	63445813
Prehypertension	11.59	11.34	3	42423	32	63446564
Bartonellosis	11.59	11.34	3	42423	32	63446564
External ear cellulitis	11.45	11.34	5	42421	285	63446311
Choreoathetosis	11.34	11.34	6	42420	523	63446073

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	905.34	13.08	433	42142	16602	34897754
Aggression	708.42	13.08	492	42083	38472	34875884
No adverse event	636.22	13.08	378	42197	22549	34891807
Tic	541.28	13.08	168	42407	1890	34912466
Agitation	465.17	13.08	453	42122	56946	34857410
Abnormal behaviour	436.44	13.08	308	42267	24661	34889695
Suicidal ideation	420.93	13.08	367	42208	40021	34874335
Product substitution issue	387.39	13.08	206	42369	9889	34904467
Irritability	357.77	13.08	272	42303	24418	34889938
Psychomotor hyperactivity	332	13.08	183	42392	9439	34904917
Application site erythema	317.12	13.08	116	42459	2220	34912136
Wrong technique in product usage process	308.23	13.08	293	42282	35693	34878663
Dyskinesia	266.84	13.08	220	42355	22193	34892163
Attention deficit hyperactivity disorder	264.03	13.08	104	42471	2455	34911901
Anxiety	243.52	13.08	435	42140	98993	34815363
Dystonia	242.61	13.08	156	42419	10689	34903667
Disturbance in attention	223.52	13.08	212	42363	25733	34888623
Growth retardation	222.37	13.08	84	42491	1764	34912592
Product administration error	214.79	13.08	170	42405	16174	34898182
Psychotic disorder	209.11	13.08	199	42376	24253	34890103
Acute kidney injury	206.91	13.08	58	42517	304930	34609426
Crying	200.84	13.08	111	42464	5751	34908605
Suicide attempt	192.91	13.08	238	42337	38878	34875478
Product administered at inappropriate site	189.83	13.08	79	42496	2157	34912199
Insomnia	180.86	13.08	394	42181	103513	34810843
Drug dependence	171.72	13.08	178	42397	24039	34890317
Application site irritation	171.29	13.08	54	42521	641	34913715
Intentional overdose	167.72	13.08	235	42340	43439	34870917
Choreoathetosis	167.62	13.08	59	42516	1005	34913351
Depression	166.48	13.08	366	42209	96732	34817624
Application site pruritus	164.55	13.08	63	42512	1374	34912982
Pneumonia	162.62	13.08	123	42452	362504	34551852
Death	152.05	13.08	157	42418	397892	34516464
Incorrect product administration duration	150.96	13.08	86	42489	4725	34909631
Anger	150.54	13.08	121	42454	11763	34902593
Tachycardia	148.07	13.08	322	42253	84450	34829906
Withdrawal syndrome	145.56	13.08	121	42454	12334	34902022
Drug abuse	137.59	13.08	344	42231	98752	34815604
Impulsive behaviour	136.53	13.08	62	42513	2100	34912256
Intentional product misuse	135.91	13.08	218	42357	45393	34868963
Hallucination, visual	130.14	13.08	133	42442	17658	34896698
Overdose	129.45	13.08	319	42256	90740	34823616
Intentional self-injury	123.29	13.08	115	42460	13656	34900700
Anaemia	122.39	13.08	66	42509	233269	34681087
Disturbance in social behaviour	116.63	13.08	53	42522	1798	34912558
Educational problem	115.34	13.08	38	42537	524	34913832
Product adhesion issue	114.22	13.08	50	42525	1550	34912806
Depressed mood	112.47	13.08	128	42447	19189	34895167
Paranoia	112.33	13.08	103	42472	11965	34902391
Drug ineffective	110.10	13.08	938	41637	455813	34458543
Drug diversion	109.55	13.08	41	42534	838	34913518
Hallucination	109.18	13.08	212	42363	51286	34863070
Toxicity to various agents	105.65	13.08	503	42072	199859	34714497
Trismus	104.46	13.08	54	42521	2441	34911915
Serotonin syndrome	104.25	13.08	125	42450	19808	34894548
Trichotillomania	102.78	13.08	23	42552	57	34914299
Coronary artery dissection	101.74	13.08	30	42545	279	34914077
Diarrhoea	100.24	13.08	203	42372	389709	34524647
Mydriasis	98.76	13.08	77	42498	7160	34907196
Priapism	95.11	13.08	65	42510	4929	34909427
Hypotension	94.31	13.08	79	42496	221570	34692786
Hallucination, auditory	92.48	13.08	92	42483	11825	34902531
Oppositional defiant disorder	92.46	13.08	32	42543	517	34913839
Affect lability	92.42	13.08	57	42518	3626	34910730
Dyspnoea	90.28	13.08	204	42371	376578	34537778
Palpitations	90.14	13.08	169	42406	39817	34874539
Sepsis	87.41	13.08	47	42528	166514	34747842
Emotional disorder	87.21	13.08	65	42510	5651	34908705
Homicidal ideation	86.99	13.08	49	42526	2633	34911723
Product complaint	83.27	13.08	64	42511	5826	34908530
Somnolence	80.97	13.08	308	42267	110808	34803548
Sleep disorder	80.41	13.08	141	42434	31547	34882809
Bruxism	79.76	13.08	40	42535	1695	34912661
Hallucination, tactile	78.97	13.08	25	42550	301	34914055
General physical health deterioration	76.91	13.08	30	42545	128239	34786117
Application site rash	75.18	13.08	31	42544	826	34913530
Mood altered	74.86	13.08	72	42503	8880	34905476
Therapeutic product effect decreased	74.79	13.08	144	42431	34599	34879757
Precocious puberty	74.10	13.08	20	42555	130	34914226
Hyperkinesia	73.25	13.08	38	42537	1730	34912626
Product prescribing error	72.97	13.08	113	42462	22814	34891542
Feeling abnormal	72.90	13.08	205	42370	63030	34851326
Febrile neutropenia	72.69	13.08	38	42537	136811	34777545
Logorrhoea	72.45	13.08	42	42533	2384	34911972
Gastrointestinal haemorrhage	71.77	13.08	11	42564	88466	34825890
Delusion	68.97	13.08	81	42494	12554	34901802
Decreased eye contact	68.73	13.08	25	42550	470	34913886
Pyrexia	68.31	13.08	195	42380	332818	34581538
Mania	67.55	13.08	70	42505	9441	34904915
Restlessness	66.75	13.08	115	42460	25367	34888989
Renal impairment	65.71	13.08	17	42558	94496	34819860
Renal failure	63.97	13.08	40	42535	130517	34783839
Thrombocytopenia	63.59	13.08	58	42517	156189	34758167
Headache	63	13.08	439	42136	200196	34714160
Decreased appetite	61.92	13.08	380	42195	166012	34748344
Oromandibular dystonia	61.09	13.08	23	42552	478	34913878
Interstitial lung disease	60.74	13.08	5	42570	65277	34849079
Multiple organ dysfunction syndrome	58.82	13.08	11	42564	76555	34837801
Euphoric mood	58.13	13.08	51	42524	5590	34908766
Cardiac failure congestive	57.84	13.08	15	42560	83255	34831101
Neutropenia	57.18	13.08	64	42511	156714	34757642
Platelet count decreased	56.85	13.08	38	42537	119679	34794677
Gynaecomastia	56.79	13.08	66	42509	10114	34904242
Apathy	56.54	13.08	55	42520	6877	34907479
Application site urticaria	56.00	13.08	14	42561	64	34914292
Speech disorder	55.93	13.08	107	42468	25579	34888777
Kounis syndrome	55.74	13.08	36	42539	2482	34911874
Dermo-hypodermitis	55.14	13.08	21	42554	451	34913905
Obsessive-compulsive disorder	54.74	13.08	49	42526	5515	34908841
Application site pain	54.26	13.08	32	42543	1876	34912480
Alice in wonderland syndrome	53.07	13.08	10	42565	5	34914351
Enuresis	52.98	13.08	34	42541	2319	34912037
Drug use disorder	51.64	13.08	42	42533	4149	34910207
Adhesive tape use	51.41	13.08	9	42566	0	34914356
Haemoglobin decreased	51.34	13.08	43	42532	120729	34793627
Product taste abnormal	50.85	13.08	26	42549	1148	34913208
Therapeutic response unexpected	50.69	13.08	61	42514	9696	34904660
Blood creatinine increased	49.48	13.08	27	42548	94949	34819407
Formication	49.33	13.08	29	42546	1690	34912666
Dermatillomania	48.90	13.08	12	42563	50	34914306
Drug screen negative	48.61	13.08	15	42560	165	34914191
Oedema peripheral	48.10	13.08	45	42530	119767	34794589
Suicidal behaviour	47.60	13.08	27	42548	1470	34912886
Mood swings	47.07	13.08	53	42522	7848	34906508
Product administered to patient of inappropriate age	47.05	13.08	36	42539	3255	34911101
Substance abuse	46.80	13.08	52	42523	7589	34906767
Respiratory failure	45.72	13.08	39	42536	108533	34805823
Torticollis	45.52	13.08	24	42551	1130	34913226
Pancytopenia	45.44	13.08	30	42545	95127	34819229
Atrial fibrillation	44.56	13.08	50	42525	122343	34792013
Social avoidant behaviour	44.38	13.08	34	42541	3080	34911276
Panic attack	44.22	13.08	56	42519	9376	34904980
Hyperkalaemia	43.64	13.08	15	42560	69374	34844982
Autism spectrum disorder	41.64	13.08	29	42546	2267	34912089
Bipolar disorder	41.52	13.08	35	42540	3634	34910722
Distractibility	41.40	13.08	16	42559	358	34913998
Raynaud's phenomenon	41.34	13.08	15	42560	280	34914076
Sleep apnoea syndrome	41.02	13.08	82	42493	20239	34894117
Completed suicide	40.84	13.08	231	42344	97937	34816419
Device difficult to use	39.91	13.08	31	42544	2866	34911490
White blood cell count decreased	39.31	13.08	35	42540	95410	34818946
Substance use disorder	38.90	13.08	19	42556	760	34913596
Generalised tonic-clonic seizure	38.68	13.08	82	42493	21092	34893264
Poisoning	38.53	13.08	60	42515	12166	34902190
Cardiac failure	38.14	13.08	33	42542	91215	34823141
Septic shock	38.03	13.08	20	42555	71814	34842542
Increased appetite	37.87	13.08	46	42529	7383	34906973
Asthenia	37.80	13.08	162	42413	245089	34669267
Extrapyramidal disorder	37.55	13.08	61	42514	12819	34901537
Hallucinations, mixed	37.53	13.08	29	42546	2660	34911696
Disease progression	37.35	13.08	46	42529	108031	34806325
Product use issue	37.09	13.08	164	42411	63052	34851304
Hypertension	36.73	13.08	288	42287	136155	34778201
Peripheral swelling	36.71	13.08	24	42551	76517	34837839
Tardive dyskinesia	36.49	13.08	40	42535	5750	34908606
Cataplexy	36.28	13.08	14	42561	312	34914044
Keratoconus	36.06	13.08	11	42564	116	34914240
Cough	36.03	13.08	81	42494	150059	34764297
Arthralgia	35.91	13.08	98	42477	169943	34744413
Joint swelling	35.87	13.08	14	42561	59876	34854480
Heart rate increased	35.81	13.08	131	42444	46212	34868144
Treatment noncompliance	35.24	13.08	94	42481	28006	34886350
Product colour issue	34.95	13.08	16	42559	552	34913804
Seizure	34.94	13.08	233	42342	104624	34809732
Hyponatraemia	34.44	13.08	30	42545	82661	34831695
Ventricular parasystole	34.27	13.08	6	42569	0	34914356
Drug withdrawal syndrome	34.16	13.08	75	42500	19759	34894597
Arteriospasm coronary	33.69	13.08	30	42545	3352	34911004
Coordination abnormal	33.66	13.08	44	42531	7600	34906756
Muscle contracture	33.12	13.08	20	42555	1224	34913132
Pain	32.89	13.08	133	42442	204542	34709814
Mental disorder	32.67	13.08	63	42512	15146	34899210
Screaming	32.32	13.08	21	42554	1463	34912893
Malignant neoplasm progression	32	13.08	36	42539	88010	34826346
Pre-existing condition improved	31.98	13.08	26	42549	2566	34911790
Drug tolerance	31.60	13.08	27	42548	2855	34911501
Infection	31.09	13.08	39	42536	90876	34823480
Infusion related reaction	30.81	13.08	13	42562	53044	34861312
Rebound effect	30.57	13.08	28	42547	3246	34911110
Nervousness	30.55	13.08	55	42520	12551	34901805
Tremor	30.26	13.08	188	42387	82399	34831957
Melaena	29.60	13.08	4	42571	35376	34878980
Chronic kidney disease	29.42	13.08	7	42568	41203	34873153
Phobia	29.33	13.08	10	42565	154	34914202
Incorrect dose administered	29.19	13.08	112	42463	40403	34873953
Affective disorder	29.01	13.08	31	42544	4329	34910027
Product dispensing error	29.01	13.08	37	42538	6237	34908119
Excessive eye blinking	29.01	13.08	14	42561	545	34913811
Pleural effusion	28.92	13.08	34	42541	81512	34832844
Sympathomimetic effect	28.56	13.08	5	42570	0	34914356
Onychophagia	28.53	13.08	8	42567	61	34914295
Gilbert's syndrome	28.37	13.08	7	42568	30	34914326
Rheumatoid arthritis	28.30	13.08	6	42569	38232	34876124
Self-injurious ideation	27.60	13.08	20	42555	1664	34912692
Tourette's disorder	27.56	13.08	8	42567	70	34914286
Fear	27.06	13.08	47	42528	10429	34903927
Substance-induced psychotic disorder	27.04	13.08	20	42555	1718	34912638
COVID-19	26.79	13.08	33	42542	77517	34836839
Thinking abnormal	26.52	13.08	35	42540	6102	34908254
Personality change	26.48	13.08	32	42543	5107	34909249
Peripheral coldness	26.29	13.08	38	42537	7213	34907143
Dysphemia	26.27	13.08	19	42556	1576	34912780
Ascites	26.11	13.08	12	42563	46559	34867797
Acute psychosis	25.99	13.08	20	42555	1823	34912533
Colitis	25.82	13.08	7	42568	37743	34876613
Hyperhidrosis	25.68	13.08	169	42406	75523	34838833
Oxygen saturation decreased	25.63	13.08	17	42558	53801	34860555
International normalised ratio increased	25.30	13.08	13	42562	47314	34867042
Constipation	25.28	13.08	84	42491	136898	34777458
Neuropathy peripheral	25.19	13.08	39	42536	83224	34831132
Mucosal inflammation	24.88	13.08	8	42567	38614	34875742
Application site erosion	24.85	13.08	8	42567	102	34914254
Somnambulism	24.35	13.08	24	42551	3048	34911308
Cerebral congestion	24.26	13.08	6	42569	26	34914330
Oculogyric crisis	24.11	13.08	18	42557	1568	34912788
Polydipsia psychogenic	24.10	13.08	8	42567	113	34914243
Multiple cardiac defects	24.04	13.08	7	42568	62	34914294
Change in sustained attention	23.79	13.08	5	42570	8	34914348
Erection increased	23.78	13.08	12	42563	515	34913841
Dehydration	23.77	13.08	80	42495	129889	34784467
Erythema	23.73	13.08	45	42530	88735	34825621
Abdominal distension	23.42	13.08	22	42553	58470	34855886
Fall	23.35	13.08	148	42427	202737	34711619
Metabolic acidosis	23.35	13.08	12	42563	43668	34870688
C-reactive protein increased	23.29	13.08	19	42556	54079	34860277
Daydreaming	23.09	13.08	12	42563	548	34913808
Device adhesion issue	23.08	13.08	22	42553	2682	34911674
Weight gain poor	22.93	13.08	15	42560	1057	34913299
Animal phobia	22.85	13.08	4	42571	0	34914356
Liver disorder	22.79	13.08	6	42569	32991	34881365
Regressive behaviour	22.64	13.08	6	42569	36	34914320
Delayed puberty	22.62	13.08	9	42566	218	34914138
Productive cough	22.38	13.08	9	42566	37804	34876552
Pain in extremity	22.37	13.08	79	42496	126434	34787922
Sudden death	22.33	13.08	54	42521	15147	34899209
Stereotypy	22.31	13.08	13	42562	745	34913611
Hypokalaemia	22.03	13.08	23	42552	58191	34856165
Blood urea increased	21.99	13.08	5	42570	30359	34883997
Tongue spasm	21.72	13.08	6	42569	43	34914313
Illusion	21.26	13.08	13	42562	814	34913542
Prostate cancer	21.03	13.08	11	42564	39638	34874718
Renal disorder	21.03	13.08	3	42572	25477	34888879
Blood creatine phosphokinase increased	20.96	13.08	109	42466	44748	34869608
Product residue present	20.93	13.08	21	42554	2725	34911631
Narcolepsy	20.86	13.08	11	42564	518	34913838
Neutrophil count decreased	20.72	13.08	19	42556	51085	34863271
Petit mal epilepsy	20.68	13.08	22	42553	3056	34911300
Cholestasis	20.41	13.08	4	42571	26944	34887412
Plasma cell myeloma	20.40	13.08	13	42562	42024	34872332
Negativism	20.27	13.08	10	42565	409	34913947
Pica	20.15	13.08	5	42570	22	34914334
Pericardial effusion	20.13	13.08	3	42572	24659	34889697
Weight increased	20.06	13.08	187	42388	92846	34821510
Hypocalcaemia	19.73	13.08	3	42572	24286	34890070
Drug reaction with eosinophilia and systemic symptoms	19.30	13.08	8	42567	33004	34881352
Wolff-Parkinson-White syndrome	19.23	13.08	8	42567	218	34914138
Application site scab	19.20	13.08	6	42569	69	34914287
Dissociative disorder	19.20	13.08	10	42565	459	34913897
School refusal	19.16	13.08	5	42570	28	34914328
Suspiciousness	19.15	13.08	9	42566	330	34914026
Drooling	18.98	13.08	22	42553	3360	34910996
Dyspnoea exertional	18.88	13.08	15	42560	43264	34871092
Urinary incontinence	18.68	13.08	58	42517	18816	34895540
Panic reaction	18.63	13.08	15	42560	1460	34912896
Accidental exposure to product by child	18.62	13.08	15	42560	1461	34912895
Migraine	18.51	13.08	55	42520	17423	34896933
Performance status decreased	18.51	13.08	24	42551	4113	34910243
Libido increased	18.43	13.08	12	42563	839	34913517
Coronary artery disease	18.38	13.08	19	42556	48286	34866070
Application site dryness	18.13	13.08	6	42569	84	34914272
Major depression	18.12	13.08	25	42550	4547	34909809
Urinary tract infection	18.07	13.08	48	42527	84033	34830323
Idiopathic intracranial hypertension	17.97	13.08	11	42564	690	34913666
Exposure via direct contact	17.85	13.08	5	42570	38	34914318
Chronic obstructive pulmonary disease	17.77	13.08	20	42555	48898	34865458
Chorea	17.50	13.08	13	42562	1124	34913232
Hypoxia	17.44	13.08	25	42550	55070	34859286
Physical assault	17.42	13.08	13	42562	1132	34913224
Acute respiratory distress syndrome	17.41	13.08	5	42570	25964	34888392
Drug resistance	17.37	13.08	5	42570	25922	34888434
Pulmonary embolism	17.26	13.08	54	42521	89692	34824664
Sexual dysfunction	17.23	13.08	29	42546	6274	34908082
Rash	17.14	13.08	181	42394	222571	34691785
Cardiac contusion	17.14	13.08	3	42572	0	34914356
Limb girth decreased	17.14	13.08	3	42572	0	34914356
Cerebral arteritis	17.14	13.08	3	42572	0	34914356
Pneumonitis	17.10	13.08	10	42565	33868	34880488
Hypoglycaemia	17.09	13.08	25	42550	54615	34859741
Scoliosis	17.09	13.08	19	42556	2774	34911582
Haematoma	17.04	13.08	5	42570	25600	34888756
Eye movement disorder	17.01	13.08	23	42552	4104	34910252
Depersonalisation/derealisation disorder	16.99	13.08	10	42565	584	34913772
Incorrect route of product administration	16.96	13.08	48	42527	14797	34899559
Application site discolouration	16.96	13.08	8	42567	296	34914060
Thrombosis	16.87	13.08	22	42553	50436	34863920
Sydenham's chorea	16.63	13.08	4	42571	15	34914341
Lung disorder	16.46	13.08	11	42564	34685	34879671
Lower respiratory tract infection	16.45	13.08	9	42566	31628	34882728
Therapeutic response changed	16.44	13.08	9	42566	457	34913899
Opisthotonus	16.42	13.08	9	42566	458	34913898
Back pain	16.05	13.08	85	42490	121704	34792652
Insulin resistance	16.04	13.08	10	42565	648	34913708
Application site ulcer	15.87	13.08	4	42571	19	34914337
Meningitis staphylococcal	15.81	13.08	5	42570	60	34914296
Bone marrow failure	15.69	13.08	8	42567	29245	34885111
Testicular failure	15.66	13.08	5	42570	62	34914294
Shock	15.59	13.08	5	42570	24174	34890182
Muscle twitching	15.58	13.08	37	42538	10261	34904095
Vasospasm	15.55	13.08	8	42567	358	34913998
Stubbornness	15.54	13.08	4	42571	21	34914335
Tri-iodothyronine increased	15.44	13.08	5	42570	65	34914291
Haemoptysis	15.43	13.08	12	42563	34994	34879362
Therapeutic product effect increased	15.31	13.08	10	42565	703	34913653
Poor quality product administered	15.31	13.08	15	42560	1892	34912464
Hepatic function abnormal	15.19	13.08	19	42556	44344	34870012
Dependence	15.18	13.08	12	42563	1138	34913218
Product dose omission issue	15.15	13.08	217	42358	119494	34794862
Dissociation	15.13	13.08	14	42561	1644	34912712
Rectal haemorrhage	15.12	13.08	16	42559	40233	34874123
Psychopathic personality	15.06	13.08	3	42572	3	34914353
Anorexia nervosa	15.06	13.08	3	42572	3	34914353
Hypomagnesaemia	15.04	13.08	4	42571	21847	34892509
Amnesia	14.88	13.08	68	42507	26495	34887861
Erectile dysfunction	14.82	13.08	57	42518	20580	34893776
Parasomnia	14.80	13.08	8	42567	396	34913960
Congestive cardiomyopathy	14.79	13.08	30	42545	7480	34906876
Stomatitis	14.77	13.08	18	42557	42496	34871860
Frustration tolerance decreased	14.76	13.08	17	42558	2579	34911777
Accommodation disorder	14.71	13.08	7	42568	264	34914092
Device breakage	14.68	13.08	16	42559	2284	34912072
Dysphoria	14.67	13.08	16	42559	2286	34912070
Strabismus	14.62	13.08	14	42561	1717	34912639
Vision blurred	14.61	13.08	101	42474	45862	34868494
Feeling jittery	14.55	13.08	21	42554	3982	34910374
Hypersexuality	14.39	13.08	13	42562	1480	34912876
Stress cardiomyopathy	14.34	13.08	15	42560	2044	34912312
Epiphyses delayed fusion	14.20	13.08	3	42572	5	34914351
Chills	14.06	13.08	51	42524	80992	34833364
Poor quality sleep	13.96	13.08	31	42544	8225	34906131
Therapeutic product effect delayed	13.91	13.08	12	42563	1286	34913070
Wrong product administered	13.86	13.08	24	42551	5310	34909046
Schizotypal personality disorder	13.85	13.08	3	42572	6	34914350
Application site laceration	13.85	13.08	3	42572	6	34914350
Initial insomnia	13.78	13.08	18	42557	3106	34911250
Prescribed overdose	13.73	13.08	36	42539	10611	34903745
Injection site abscess	13.73	13.08	10	42565	839	34913517
Blood growth hormone decreased	13.68	13.08	4	42571	36	34914320
Agranulocytosis	13.56	13.08	6	42569	23815	34890541
Myocarditis	13.50	13.08	42	42533	13640	34900716
Arthropathy	13.50	13.08	8	42567	26899	34887457
Electrocardiogram T wave inversion	13.35	13.08	15	42560	2216	34912140
Pressure of speech	13.29	13.08	8	42567	487	34913869
Accidental exposure to product	13.28	13.08	40	42535	12762	34901594
Akathisia	13.21	13.08	30	42545	8079	34906277
Ataxia	13.18	13.08	42	42533	13811	34900545

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	740.69	11.43	475	62291	50483	79631139
Agitation	632.63	11.43	566	62200	99149	79582473
Suicidal ideation	601.99	11.43	491	62275	75849	79605773
Product substitution issue	550.42	11.43	284	62482	19972	79661650
Tic	509.42	11.43	158	62608	2828	79678794
Abnormal behaviour	478.96	11.43	319	62447	36102	79645520
Irritability	430.07	11.43	313	62453	40831	79640791
Product quality issue	424.06	11.43	288	62478	33652	79647970
Anxiety	323.02	11.43	646	62120	247866	79433756
Attention deficit hyperactivity disorder	315.73	11.43	113	62653	3196	79678426
No adverse event	311.57	11.43	248	62518	36944	79644678
Dystonia	299.66	11.43	195	62571	21204	79660418
Tachycardia	293.22	11.43	512	62254	177256	79504366
Psychomotor hyperactivity	292.54	11.43	176	62590	16673	79664949
Dyskinesia	289.26	11.43	257	62509	44516	79637106
Disturbance in attention	276.56	11.43	265	62501	50536	79631086
Intentional overdose	269.80	11.43	373	62393	105587	79576035
Toxicity to various agents	263.91	11.43	829	61937	420711	79260911
Suicide attempt	243.42	11.43	313	62453	82619	79599003
Depression	228.82	11.43	518	62248	216272	79465350
Psychotic disorder	215.98	11.43	211	62555	41191	79640431
Intentional self-injury	215.19	11.43	189	62577	32230	79649392
Drug abuse	207.62	11.43	420	62346	162271	79519351
Overdose	198.62	11.43	444	62322	183762	79497860
Insomnia	189.30	11.43	520	62246	244650	79436972
Withdrawal syndrome	183.14	11.43	159	62607	26695	79654927
Acute kidney injury	180.41	11.43	92	62674	519312	79162310
Mydriasis	174.75	11.43	130	62636	17513	79664109
Hallucination, visual	172.94	11.43	168	62598	32561	79649061
Intentional product misuse	168.43	11.43	283	62483	94882	79586740
Choreoathetosis	166.49	11.43	58	62708	1512	79680110
Drug dependence	166.13	11.43	182	62584	40587	79641035
Crying	164.37	11.43	140	62626	22903	79658719
Educational problem	162.42	11.43	42	62724	372	79681250
Precocious puberty	161.15	11.43	40	62726	295	79681327
Paranoia	155.10	11.43	126	62640	19306	79662316
Growth retardation	154.42	11.43	58	62708	1885	79679737
Application site erythema	154.37	11.43	77	62689	5033	79676589
Hallucination	153.08	11.43	256	62510	85489	79596133
Anger	144.88	11.43	115	62651	17047	79664575
Hallucination, auditory	142.06	11.43	123	62643	20570	79661052
Impulsive behaviour	135.19	11.43	59	62707	2841	79678781
Product administration error	129.45	11.43	142	62624	31704	79649918
Somnolence	125.95	11.43	444	62322	238537	79443085
Diarrhoea	125.31	11.43	322	62444	880167	78801455
Serotonin syndrome	122.82	11.43	164	62602	44863	79636759
Anaemia	121.69	11.43	103	62663	444912	79236710
Wrong technique in product usage process	120.58	11.43	212	62554	73663	79607959
Tremor	119.65	11.43	349	62417	169734	79511888
Joint swelling	117.99	11.43	40	62726	288606	79393016
Completed suicide	108.99	11.43	432	62334	245335	79436287
Product administered at inappropriate site	108.83	11.43	56	62710	3909	79677713
Trismus	107.73	11.43	62	62704	5405	79676217
Priapism	107.66	11.43	58	62708	4447	79677175
Synovitis	104.72	11.43	3	62763	150731	79530891
Apathy	103.25	11.43	84	62682	12893	79668729
Muscle contracture	101.10	11.43	45	62721	2272	79679350
Enuresis	99.32	11.43	49	62717	3127	79678495
Hallucination, tactile	98.74	11.43	31	62735	578	79681044
Mania	96.95	11.43	94	62672	18166	79663456
Mood altered	96.88	11.43	93	62673	17754	79663868
Bruxism	96.68	11.43	52	62714	3974	79677648
Pneumonia	96.45	11.43	238	62528	660008	79021614
Oppositional defiant disorder	96.27	11.43	29	62737	468	79681154
Affect lability	96.22	11.43	76	62690	11183	79670439
Death	91.79	11.43	193	62573	566321	79115301
Depressed mood	90.86	11.43	148	62618	48332	79633290
General physical health deterioration	90.65	11.43	52	62714	275186	79406436
Coronary artery dissection	90.37	11.43	34	62732	1110	79680512
Homicidal ideation	89.65	11.43	47	62719	3410	79678212
Application site irritation	89.57	11.43	38	62728	1706	79679916
Trichotillomania	87.96	11.43	22	62744	168	79681454
Emotional disorder	87.77	11.43	80	62686	14307	79667315
Incorrect product administration duration	87.69	11.43	74	62692	11948	79669674
Euphoric mood	85.75	11.43	61	62705	7665	79673957
Cataplexy	85.73	11.43	31	62735	903	79680719
Hyperkinesia	85.03	11.43	42	62724	2687	79678935
Delusion	84.62	11.43	92	62674	20331	79661291
Restlessness	84.53	11.43	140	62626	46352	79635270
Contraindicated product administered	84.07	11.43	12	62754	157526	79524096
Dyspnoea	79.51	11.43	376	62390	856649	78824973
Peripheral swelling	79.17	11.43	58	62708	269559	79412063
Arthralgia	78.92	11.43	212	62554	571591	79110031
Pulmonary malformation	78.74	11.43	21	62745	212	79681410
Obsessive-compulsive disorder	78.06	11.43	52	62714	5875	79675747
Feeling abnormal	77.19	11.43	288	62478	158911	79522711
Drug diversion	76.95	11.43	31	62735	1219	79680403
Palpitations	75.21	11.43	245	62521	126365	79555257
Infusion related reaction	75.09	11.43	44	62722	230193	79451429
Arthropathy	75.07	11.43	23	62743	177088	79504534
Chorea	74.72	11.43	37	62729	2380	79679242
Logorrhoea	71.65	11.43	44	62722	4321	79677301
Tardive dyskinesia	70.87	11.43	62	62704	10509	79671113
Febrile neutropenia	70.03	11.43	48	62718	230951	79450671
Drug intolerance	69.84	11.43	63	62703	264056	79417566
Decreased eye contact	69.39	11.43	26	62740	839	79680783
Thrombocytopenia	69.28	11.43	64	62702	265195	79416427
Rheumatoid arthritis	69.17	11.43	39	62727	208431	79473191
Panic attack	68.80	11.43	90	62676	24126	79657496
Neutropenia	67.66	11.43	76	62690	287634	79393988
Seizure	67.46	11.43	311	62455	188523	79493099
Heart rate increased	66.72	11.43	228	62538	120496	79561126
Application site pruritus	66.64	11.43	40	62726	3770	79677852
Interstitial lung disease	66.53	11.43	6	62760	112594	79569028
Sepsis	65.76	11.43	69	62697	269359	79412263
Systemic lupus erythematosus	65.17	11.43	9	62757	121140	79560482
Headache	64.72	11.43	792	61974	652980	79028642
Infection	64.69	11.43	57	62709	241655	79439967
Mood swings	64.59	11.43	79	62687	19801	79661821
Lower respiratory tract infection	64.13	11.43	12	62754	129208	79552414
Gynaecomastia	63.82	11.43	51	62715	7630	79673992
Swelling	63.11	11.43	47	62719	216664	79464958
Product adhesion issue	62.35	11.43	34	62732	2670	79678952
Hypotension	61.64	11.43	162	62604	440155	79241467
Gastrointestinal haemorrhage	61.14	11.43	20	62746	147699	79533923
Sleep apnoea syndrome	59.91	11.43	105	62661	36373	79645249
Somnambulism	58.54	11.43	43	62723	5678	79675944
Lung cyst	58.50	11.43	18	62748	313	79681309
Cardiac failure congestive	57.68	11.43	20	62746	142382	79539240
Glossodynia	57.21	11.43	7	62759	103330	79578292
Drug withdrawal syndrome	57.10	11.43	100	62666	34618	79647004
Treatment failure	56.40	11.43	32	62734	170454	79511168
Renal impairment	56.06	11.43	27	62739	157756	79523866
Extrapyramidal disorder	54.90	11.43	78	62688	22601	79659021
Multiple organ dysfunction syndrome	53.94	11.43	14	62752	120232	79561390
Substance abuse	53.66	11.43	53	62713	10473	79671149
Product taste abnormal	53.60	11.43	29	62737	2242	79679380
Dermo-hypodermitis	53.59	11.43	21	62745	767	79680855
Pericarditis	53.20	11.43	9	62757	104227	79577395
Adhesive tape use	52.75	11.43	9	62757	3	79681619
Kounis syndrome	52.65	11.43	36	62730	4246	79677376
Pyrexia	51.63	11.43	318	62448	678391	79003231
Alice in wonderland syndrome	51.00	11.43	11	62755	39	79681583
Oromandibular dystonia	50.87	11.43	22	62744	1036	79680586
Hyperhidrosis	50.80	11.43	245	62521	151247	79530375
Haemoglobin decreased	49.70	11.43	61	62705	222058	79459564
Muscle twitching	49.68	11.43	78	62688	24686	79656936
Platelet count decreased	49.60	11.43	48	62718	194616	79487006
Therapeutic response unexpected	48.88	11.43	69	62697	19877	79661745
Social anxiety disorder	48.88	11.43	18	62748	553	79681069
Affective disorder	48.30	11.43	45	62721	8274	79673348
Pancytopenia	48.18	11.43	36	62730	165709	79515913
Hallucinations, mixed	47.33	11.43	41	62725	6858	79674764
Decreased appetite	46.90	11.43	443	62323	341975	79339647
Substance use disorder	46.72	11.43	20	62746	918	79680704
Social avoidant behaviour	46.61	11.43	35	62731	4779	79676843
Generalised tonic-clonic seizure	46.28	11.43	105	62661	43805	79637817
Product tampering	46.11	11.43	16	62750	412	79681210
Respiratory tract malformation	45.94	11.43	12	62754	111	79681511
Mobility decreased	44.80	11.43	20	62746	122155	79559467
Rapid eye movement sleep behaviour disorder	44.78	11.43	16	62750	450	79681172
Hyperkalaemia	44.74	11.43	17	62749	114381	79567241
Wound	44.23	11.43	18	62748	116161	79565461
Application site rash	44.21	11.43	25	62741	2107	79679515
Adulterated product	43.67	11.43	14	62752	280	79681342
Cardiac failure	43.27	11.43	35	62731	154807	79526815
Poisoning	43.13	11.43	74	62692	25198	79656424
Blister	43.12	11.43	20	62746	119456	79562166
Ventricular parasystole	43.04	11.43	7	62759	0	79681622
Maternal exposure during breast feeding	42.99	11.43	27	62739	2758	79678864
Respiratory failure	42.27	11.43	48	62718	180863	79500759
Product administered to patient of inappropriate age	42.19	11.43	35	62731	5518	79676104
Renal failure	42.07	11.43	58	62708	200910	79480712
Drug use disorder	41.23	11.43	42	62724	8609	79673013
Increased appetite	41.20	11.43	49	62717	11929	79669693
Drug hypersensitivity	41.01	11.43	111	62655	298805	79382817
Claustrophobia	40.93	11.43	20	62746	1250	79680372
Keratoconus	40.64	11.43	11	62755	118	79681504
Somatic symptom disorder	40.18	11.43	25	62741	2512	79679110
Poor sucking reflex	40.15	11.43	11	62755	124	79681498
Bipolar disorder	39.65	11.43	39	62727	7668	79673954
Atrial fibrillation	39.56	11.43	59	62707	197827	79483795
Speech disorder	39.46	11.43	113	62653	54332	79627290
Rash	39.39	11.43	280	62486	578078	79103544
Suicidal behaviour	39.21	11.43	27	62739	3220	79678402
Formication	38.88	11.43	32	62734	4991	79676631
Lactation disorder	37.72	11.43	12	62754	234	79681388
Application site urticaria	37.62	11.43	12	62754	236	79681386
Nervousness	37.57	11.43	82	62684	33333	79648289
Therapeutic response changed	37.52	11.43	19	62747	1282	79680340
Sleep disorder	37.41	11.43	150	62616	85527	79596095
Change in sustained attention	37.26	11.43	7	62759	9	79681613
Oculogyric crisis	36.72	11.43	25	62741	2927	79678695
Septic shock	36.56	11.43	26	62740	122775	79558847
Torticollis	36.49	11.43	23	62743	2364	79679258
Hepatic enzyme increased	35.96	11.43	55	62711	182555	79499067
Feeling jittery	35.35	11.43	47	62719	12794	79668828
Pain	35.31	11.43	369	62397	703433	78978189
Disturbance in social behaviour	35.03	11.43	30	62736	4940	79676682
Vision blurred	34.58	11.43	170	62596	105728	79575894
Mental disorder	34.27	11.43	76	62690	31226	79650396
Distractibility	34.22	11.43	15	62751	730	79680892
Pre-existing condition improved	34.06	11.43	31	62735	5532	79676090
Oedema peripheral	33.62	11.43	95	62671	252193	79429429
Memory impairment	33.42	11.43	175	62591	111559	79570063
Petit mal epilepsy	33.29	11.43	31	62735	5696	79675926
Exposure via breast milk	33.04	11.43	16	62750	980	79680642
Hyponatraemia	32.73	11.43	56	62710	177792	79503830
Arteriospasm coronary	32.73	11.43	33	62733	6683	79674939
Akathisia	32.68	11.43	46	62720	13213	79668409
Raynaud's phenomenon	32.41	11.43	16	62750	1022	79680600
Hypersomnia	32.28	11.43	62	62704	23024	79658598
Loss of consciousness	31.91	11.43	234	62532	167709	79513913
Treatment noncompliance	31.79	11.43	102	62664	52166	79629456
Incorrect dose administered	31.74	11.43	132	62634	76498	79605124
Pleural effusion	31.33	11.43	41	62725	145221	79536401
School refusal	31.04	11.43	7	62759	32	79681590
Sudden death	30.92	11.43	60	62706	22451	79659171
Stereotypy	30.81	11.43	15	62751	930	79680692
Malignant neoplasm progression	30.77	11.43	37	62729	135953	79545669
Misophonia	30.74	11.43	5	62761	0	79681622
Dermatillomania	30.74	11.43	10	62756	210	79681412
Negative thoughts	30.63	11.43	17	62749	1382	79680240
White blood cell count decreased	30.52	11.43	64	62702	188224	79493398
Disease progression	30.44	11.43	62	62704	184300	79497322
C-reactive protein increased	30.39	11.43	34	62732	128993	79552629
Screaming	30.32	11.43	25	62741	3908	79677714
Excessive eye blinking	30.12	11.43	18	62748	1683	79679939
Hypertension	30.07	11.43	395	62371	330597	79351025
Thinking abnormal	30.01	11.43	44	62722	13117	79668505
Hyperventilation	29.99	11.43	34	62732	7865	79673757
Product dispensing error	29.75	11.43	44	62722	13219	79668403
Drug reaction with eosinophilia and systemic symptoms	29.74	11.43	7	62759	64237	79617385
Pre-eclampsia	29.66	11.43	32	62734	7009	79674613
Hepatotoxicity	29.63	11.43	3	62763	51349	79630273
Blood creatinine increased	29.30	11.43	48	62718	155009	79526613
Drug tolerance	29.04	11.43	35	62731	8640	79672982
Application site discolouration	29.03	11.43	14	62752	850	79680772
Peripheral coldness	28.90	11.43	48	62718	15922	79665700
Abdominal discomfort	28.77	11.43	101	62665	250626	79430996
Sleep-related eating disorder	28.40	11.43	13	62753	701	79680921
Hyperreflexia	28.34	11.43	34	62732	8351	79673271
Mucosal inflammation	28.30	11.43	12	62754	75568	79606054
Solar urticaria	28.08	11.43	8	62758	105	79681517
Parasomnia	28.07	11.43	12	62754	549	79681073
Autism spectrum disorder	28.00	11.43	15	62751	1137	79680485
Delayed puberty	27.93	11.43	9	62757	183	79681439
Eye movement disorder	27.93	11.43	33	62733	7978	79673644
Inflammation	27.71	11.43	20	62746	93733	79587889
Tachypnoea	27.70	11.43	71	62695	31992	79649630
Status epilepticus	27.64	11.43	61	62705	24980	79656642
Melaena	27.47	11.43	7	62759	60883	79620739
Protrusion tongue	27.22	11.43	11	62755	436	79681186
CSWS syndrome	27.05	11.43	6	62760	25	79681597
Product complaint	26.71	11.43	42	62724	13307	79668315
Blood creatine phosphokinase increased	26.71	11.43	113	62653	65977	79615645
Cough	26.70	11.43	174	62592	366615	79315007
International normalised ratio increased	26.47	11.43	17	62749	84704	79596918
Coordination abnormal	26.08	11.43	48	62718	17264	79664358
Product prescribing error	25.94	11.43	86	62680	44727	79636895
Rectal haemorrhage	25.69	11.43	14	62752	76286	79605336
Vasospasm	25.43	11.43	14	62752	1120	79680502
Erection increased	25.40	11.43	10	62756	370	79681252
Stomatitis	25.40	11.43	48	62718	146709	79534913
Nightmare	25.23	11.43	60	62706	25801	79655821
Substance-induced psychotic disorder	25.00	11.43	21	62745	3368	79678254
Major depression	24.92	11.43	33	62733	8947	79672675
Multiple sclerosis relapse	24.92	11.43	87	62679	46446	79635176
Erythema	24.91	11.43	91	62675	223199	79458423
Panic reaction	24.73	11.43	24	62742	4641	79676981
Personality change	24.65	11.43	35	62731	10135	79671487
Body temperature increased	24.61	11.43	84	62682	44336	79637286
Testicular failure	24.59	11.43	4	62762	0	79681622
Cardiac contusion	24.59	11.43	4	62762	0	79681622
Urine amphetamine negative	24.59	11.43	4	62762	0	79681622
Meningitis streptococcal	24.50	11.43	8	62758	170	79681452
Tachyphrenia	24.42	11.43	17	62749	2063	79679559
Impaired healing	24.25	11.43	20	62746	87635	79593987
Maternal exposure during pregnancy	24.21	11.43	44	62722	136494	79545128
Migraine	24.10	11.43	134	62632	87359	79594263
Dehydration	24	11.43	107	62659	248080	79433542
Wolff-Parkinson-White syndrome	23.92	11.43	9	62757	294	79681328
Narcolepsy	23.79	11.43	14	62752	1272	79680350
Self-injurious ideation	23.71	11.43	21	62745	3617	79678005
Strabismus	23.68	11.43	18	62748	2503	79679119
Fear	23.64	11.43	53	62713	21933	79659689
Hunger	23.44	11.43	25	62741	5403	79676219
Initial insomnia	23.23	11.43	28	62738	6910	79674712
Polydipsia psychogenic	23.05	11.43	8	62758	206	79681416
Foetal exposure timing unspecified	23.02	11.43	6	62760	55	79681567
Burnout syndrome	23.01	11.43	9	62757	327	79681295
Bone marrow failure	22.82	11.43	6	62760	51101	79630521
Hypersexuality	22.75	11.43	15	62751	1665	79679957
Wound infection fungal	22.70	11.43	8	62758	216	79681406
Oedema	22.60	11.43	37	62729	119543	79562079
Product administration interrupted	22.46	11.43	21	62745	3878	79677744
Optic disc haemorrhage	22.17	11.43	7	62759	133	79681489
Coronary artery disease	22.06	11.43	12	62754	65462	79616160
Hypocalcaemia	22.03	11.43	6	62760	49918	79631704
Hangover	21.89	11.43	16	62750	2096	79679526
Tongue biting	21.83	11.43	16	62750	2105	79679517
Poor quality product administered	21.71	11.43	20	62746	3625	79677997
Osteoarthritis	21.68	11.43	22	62744	87287	79594335
Product dose omission issue	21.46	11.43	293	62473	247244	79434378
Compulsions	21.32	11.43	9	62757	399	79681223
Osteoporosis	21.22	11.43	8	62758	54104	79627518
Chronic kidney disease	21.04	11.43	13	62753	66141	79615481
Pulse abnormal	21.00	11.43	19	62747	3365	79678257
Neurological symptom	20.95	11.43	30	62736	8753	79672869
Pruritus	20.94	11.43	204	62562	394444	79287178
Amenorrhoea	20.94	11.43	28	62738	7664	79673958
Surgery	20.89	11.43	65	62701	32701	79648921
Ill-defined disorder	20.88	11.43	13	62753	65862	79615760
Dysphoria	20.79	11.43	22	62744	4712	79676910
Congestive cardiomyopathy	20.77	11.43	35	62731	11745	79669877
Agranulocytosis	20.66	11.43	5	62761	45025	79636597
Chronic fatigue syndrome	20.65	11.43	13	62753	1334	79680288
Upper gastrointestinal haemorrhage	20.19	11.43	4	62762	41376	79640246
Persecutory delusion	20.13	11.43	22	62744	4887	79676735
Drug screen negative	20.12	11.43	8	62758	304	79681318
Product colour issue	20.11	11.43	11	62755	869	79680753
Scoliosis	20.06	11.43	27	62739	7437	79674185
Cyanosis	19.95	11.43	54	62712	25128	79656494
Sympathomimetic effect	19.85	11.43	6	62760	98	79681524
Psychiatric symptom	19.75	11.43	26	62740	7009	79674613
Splenic infarction	19.71	11.43	19	62747	3645	79677977
Grimacing	19.66	11.43	10	62756	681	79680941
Onychophagia	19.52	11.43	6	62760	104	79681518
Liver disorder	19.45	11.43	17	62749	72400	79609222
Myelosuppression	19.44	11.43	4	62762	40292	79641330
Alopecia	19.33	11.43	105	62661	231250	79450372
Accidental exposure to product by child	19.29	11.43	17	62749	2909	79678713
Constipation	19.23	11.43	137	62629	282913	79398709
Cataract subcapsular	19.21	11.43	11	62755	950	79680672
Tongue spasm	19.20	11.43	6	62760	110	79681512
Asthenia	18.95	11.43	286	62480	511403	79170219
Wrong product administered	18.93	11.43	29	62737	8983	79672639
Electrocardiogram QRS complex prolonged	18.85	11.43	32	62734	10801	79670821
Hypersensitivity	18.77	11.43	125	62641	262114	79419508
Irritable bowel syndrome	18.75	11.43	13	62753	62228	79619394
Hypoglycaemia	18.68	11.43	32	62734	101562	79580060
Hepatic function abnormal	18.64	11.43	18	62748	73089	79608533
Gastrointestinal disorder	18.59	11.43	43	62723	122162	79559460
Weight gain poor	18.53	11.43	11	62755	1016	79680606
Toxic epidermal necrolysis	18.50	11.43	6	62760	44575	79637047
Animal phobia	18.44	11.43	3	62763	0	79681622
Limb girth decreased	18.44	11.43	3	62763	0	79681622
Cerebral arteritis	18.44	11.43	3	62763	0	79681622
Herpes zoster	18.35	11.43	28	62738	93055	79588567
Dissociation	18.22	11.43	19	62747	4002	79677620
Talipes	18.18	11.43	6	62760	132	79681490
Cerebral congestion	18.04	11.43	5	62761	59	79681563
Hypokalaemia	17.90	11.43	56	62710	143984	79537638
Pericardial effusion	17.86	11.43	7	62759	46230	79635392
Ascites	17.69	11.43	20	62746	75542	79606080
Illusion	17.62	11.43	13	62753	1728	79679894
Oxygen saturation decreased	17.62	11.43	48	62718	128999	79552623
Acute psychosis	17.61	11.43	19	62747	4161	79677461
Phobia	17.54	11.43	8	62758	428	79681194
Substance abuser	17.50	11.43	6	62760	149	79681473
Sleep paralysis	17.48	11.43	9	62757	629	79680993
Atrioventricular block second degree	17.48	11.43	25	62741	7287	79674335
Open angle glaucoma	17.35	11.43	8	62758	439	79681183
Eosinophilia	17.29	11.43	7	62759	45338	79636284
Sinus tachycardia	17.22	11.43	66	62700	36842	79644780
Foetal exposure during pregnancy	17.20	11.43	22	62744	5768	79675854
Electrocardiogram QT prolonged	17.19	11.43	126	62640	90260	79591362
Hyperphagia	17.17	11.43	15	62751	2537	79679085
Lactic acidosis	17.16	11.43	18	62748	70341	79611281
Drug ineffective	16.98	11.43	1025	61741	1079888	78601734
Disinhibition	16.94	11.43	15	62751	2583	79679039
Neutrophil count decreased	16.90	11.43	30	62736	93929	79587693
Sensory level abnormal	16.85	11.43	6	62760	167	79681455
Daydreaming	16.85	11.43	10	62756	923	79680699
Psoriatic arthropathy	16.83	11.43	22	62744	77977	79603645
Hypoxia	16.80	11.43	35	62731	103208	79578414
Dysphemia	16.76	11.43	17	62749	3467	79678155
Opisthotonus	16.74	11.43	9	62757	687	79680935
Hypomagnesaemia	16.70	11.43	8	62758	46903	79634719
Tourette's disorder	16.58	11.43	5	62761	81	79681541
Product residue present	16.55	11.43	17	62749	3519	79678103
Drug eruption	16.41	11.43	7	62759	43928	79637694
Bisexuality	16.37	11.43	3	62763	3	79681619
Cholestasis of pregnancy	16.27	11.43	10	62756	983	79680639
Hypokinesia	16.25	11.43	42	62724	19018	79662604
Hypnagogic hallucination	16.18	11.43	6	62760	188	79681434
Livedo reticularis	16.16	11.43	18	62748	4085	79677537
Gastric bypass	16.14	11.43	11	62755	1290	79680332
Lung disorder	16.10	11.43	24	62742	80533	79601089
Knee arthroplasty	15.97	11.43	7	62759	43241	79638381
Application site pain	15.64	11.43	19	62747	4728	79676894
Nystagmus	15.60	11.43	28	62738	9876	79671746
Arthritis	15.48	11.43	43	62723	114837	79566785
Bundle branch block right	15.46	11.43	30	62736	11221	79670401
Meningitis staphylococcal	15.37	11.43	5	62761	105	79681517
Dissociative disorder	15.35	11.43	9	62757	812	79680810
Poor quality sleep	15.35	11.43	46	62720	22676	79658946
Concussion	15.14	11.43	27	62739	9476	79672146
Electroencephalogram abnormal	15.13	11.43	20	62746	5414	79676208
Injection site pain	15.08	11.43	52	62714	129786	79551836
Hepatitis	15.06	11.43	13	62753	55714	79625908
Amnesia	15.05	11.43	93	62673	62964	79618658
Urinary incontinence	15.04	11.43	68	62698	40841	79640781
Hyperglycaemia	15.01	11.43	20	62746	70315	79611307
Negativism	14.94	11.43	9	62757	854	79680768
Plasma cell myeloma	14.92	11.43	12	62754	53247	79628375
Tooth discolouration	14.87	11.43	10	62756	1147	79680475
Hyperacusis	14.82	11.43	13	62753	2210	79679412
Staring	14.76	11.43	14	62752	2631	79678991
Chronic obstructive pulmonary disease	14.72	11.43	28	62738	85391	79596231
Myocarditis	14.68	11.43	44	62722	21689	79659933
Anaphylactic shock	14.66	11.43	5	62761	35991	79645631
Rash pruritic	14.65	11.43	21	62745	71608	79610014
Myelodysplastic syndrome	14.63	11.43	3	62763	30298	79651324
Dyspnoea exertional	14.61	11.43	29	62737	87044	79594578
Sudden onset of sleep	14.58	11.43	8	62758	636	79680986
Epiphyses delayed fusion	14.55	11.43	3	62763	8	79681614
Antiphospholipid syndrome	14.54	11.43	12	62754	1879	79679743
Psychotic symptom	14.53	11.43	14	62752	2683	79678939
Musculoskeletal stiffness	14.30	11.43	80	62686	174928	79506694
Schizotypal personality disorder	14.29	11.43	3	62763	9	79681613
Brain oedema	14.19	11.43	48	62718	25215	79656407
Thrombosis	14.12	11.43	28	62738	84072	79597550
Rash maculo-papular	14.07	11.43	14	62752	56064	79625558
Psoriasis	14.05	11.43	31	62735	89556	79592066
Neoplasm progression	14.04	11.43	12	62754	51670	79629952
Physical assault	14.03	11.43	11	62755	1600	79680022
Leukopenia	13.99	11.43	46	62720	116467	79565155
Application site erosion	13.92	11.43	6	62760	280	79681342
Contusion	13.86	11.43	65	62701	148711	79532911
Injection site abscess	13.86	11.43	11	62755	1629	79679993
Brain injury	13.79	11.43	29	62737	11488	79670134
Chills	13.78	11.43	72	62694	160162	79521460
Renal disorder	13.78	11.43	8	62758	42097	79639525
Food craving	13.76	11.43	11	62755	1646	79679976
COVID-19 pneumonia	13.64	11.43	3	62763	28846	79652776
Long QT syndrome congenital	13.63	11.43	5	62761	152	79681470
Hyperthermia	13.62	11.43	38	62728	17999	79663623
Drug abuser	13.56	11.43	20	62746	5993	79675629
Colitis	13.56	11.43	23	62743	73284	79608338
Hepatic failure	13.48	11.43	17	62749	61195	79620427
Foot fracture	13.46	11.43	43	62723	21938	79659684
Hypertonia	13.44	11.43	22	62744	7210	79674412
Red blood cell sedimentation rate increased	13.31	11.43	10	62756	45932	79635690
Diverticulitis	13.31	11.43	10	62756	45926	79635696
Insulin resistance	13.29	11.43	10	62756	1369	79680253
Musculoskeletal pain	13.28	11.43	39	62727	102315	79579307
Shock	13.25	11.43	9	62757	43539	79638083
Muscle spasms	13.22	11.43	202	62564	174528	79507094
Erectile dysfunction	13.21	11.43	33	62733	14631	79666991
Water intoxication	13.21	11.43	8	62758	766	79680856
Injection site erythema	13.15	11.43	26	62740	78171	79603451
Regressive behaviour	13.04	11.43	5	62761	172	79681450
Cytokine release syndrome	13.02	11.43	6	62760	35992	79645630
Device difficult to use	13.00	11.43	31	62735	13354	79668268
Hepatocellular injury	12.99	11.43	11	62755	47582	79634040
Tubulointerstitial nephritis	12.89	11.43	7	62759	38228	79643394
Hip arthroplasty	12.87	11.43	6	62760	35750	79645872
Discomfort	12.84	11.43	53	62713	125564	79556058
Full blood count abnormal	12.81	11.43	8	62758	40466	79641156
Incorrect route of product administration	12.80	11.43	58	62708	34871	79646751
Hyperprolactinaemia	12.70	11.43	17	62749	4659	79676963
Acute respiratory failure	12.63	11.43	17	62749	59524	79622098
Learning disorder	12.58	11.43	7	62759	572	79681050
Sydenham's chorea	12.48	11.43	3	62763	19	79681603
Intracranial pressure increased	12.44	11.43	23	62743	8299	79673323
Libido decreased	12.44	11.43	18	62748	5303	79676319
Neurotoxicity	12.43	11.43	5	62761	32513	79649109
Delusion of parasitosis	12.35	11.43	3	62763	20	79681602
Autophobia	12.35	11.43	3	62763	20	79681602
Dermal absorption impaired	12.35	11.43	3	62763	20	79681602
Erythromelalgia	12.21	11.43	5	62761	205	79681417
Malaise	12.20	11.43	293	62473	489576	79192046
Eosinophilic myocarditis	12.09	11.43	9	62757	1213	79680409
Pressure of speech	12.05	11.43	9	62757	1219	79680403
Haematoma	12.02	11.43	14	62752	52181	79629441
Drug interaction	12.00	11.43	419	62347	414764	79266858
Application site scab	11.97	11.43	5	62761	216	79681406
Libido increased	11.96	11.43	11	62755	1990	79679632
Unresponsive to stimuli	11.91	11.43	80	62686	55708	79625914
Pulmonary mass	11.88	11.43	4	62762	29030	79652592
Psychological abuse	11.87	11.43	3	62763	24	79681598
Perinatal depression	11.86	11.43	6	62760	404	79681218
Osteonecrosis of jaw	11.78	11.43	10	62756	43216	79638406
Device breakage	11.77	11.43	26	62740	10649	79670973
Hepatitis C virus test positive	11.76	11.43	6	62760	411	79681211
Verbigeration	11.76	11.43	3	62763	25	79681597
Haematochezia	11.66	11.43	33	62733	87612	79594010
Excessive masturbation	11.60	11.43	4	62762	101	79681521
Blood pressure increased	11.55	11.43	232	62534	211128	79470494
Cardiac fibrillation	11.55	11.43	8	62758	963	79680659
Schizoaffective disorder bipolar type	11.53	11.43	5	62761	237	79681385
Blood pressure systolic increased	11.50	11.43	22	62744	66964	79614658
Bursitis	11.46	11.43	7	62759	35837	79645785
Sedation	11.43	11.43	75	62691	51820	79629802

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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	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	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
35MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
45MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
55MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
70MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
85MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	DISCN	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
7236	IUPHAR_LIGAND_ID
485	INN_ID
207ZZ9QZ49	UNII
203188	RXNORM
1038	MMSL
253246	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	0078-0370	CAPSULE, EXTENDED RELEASE	20 mg	ORAL	NDA	33 sections
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	0078-0371	CAPSULE, EXTENDED RELEASE	30 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	0078-0372	CAPSULE, EXTENDED RELEASE	40 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 LA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0424	CAPSULE, EXTENDED RELEASE	10 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	0078-0439	TABLET	5 mg	ORAL	NDA	30 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	0078-0440	TABLET	10 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
Ritalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0441	TABLET	20 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	0093-5292	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	0093-5293	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	0093-5295	CAPSULE, EXTENDED RELEASE	10 mg	ORAL	ANDA	34 sections