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

Stem definition	Drug id	CAS RN
tricyclic compounds	2017	28721-07-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: oxcarbazepine oxacarbazepine oxecarb oxetol	an antiepileptic drug, precise mechanism by which oxcarbazepine exerts its antiseizure effect is unknown, however, in vitro electrophysiological studies indicate that it produces blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses Molecular weight: 252.27 Formula: C15H12N2O2 CLOGP: 1.21 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 63.40 ALOGS: -3.20 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

oxcarbazepine
oxacarbazepine
oxecarb
oxetol

an antiepileptic drug, precise mechanism by which oxcarbazepine exerts its antiseizure effect is unknown, however, in vitro electrophysiological studies indicate that it produces blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses

Molecular weight: 252.27
Formula: C15H12N2O2
CLOGP: 1.21
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 63.40
ALOGS: -3.20
ROTB: 0

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.31 mg/mL	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	135.90 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	95 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Jan. 14, 2000	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
Seizure	1207.19	13.38	757	28930	131877	63327458
Hyponatraemia	579.82	13.38	453	29234	111447	63347888
Abortion spontaneous	261.23	13.38	199	29488	46996	63412339
Status epilepticus	231.91	13.38	122	29565	15111	63444224
Generalised tonic-clonic seizure	212.37	13.38	145	29542	28871	63430464
Multiple-drug resistance	202.46	13.38	80	29607	5090	63454245
Epilepsy	181.07	13.38	128	29559	26937	63432398
Focal dyscognitive seizures	175.98	13.38	62	29625	2859	63456476
Diplopia	167.54	13.38	116	29571	23612	63435723
Product substitution issue	164.33	13.38	99	29588	15897	63443438
Petit mal epilepsy	149.58	13.38	59	29628	3735	63455600
Completed suicide	149.00	13.38	254	29433	145419	63313916
Aggression	136.41	13.38	102	29585	23396	63435939
Drug interaction	124.00	13.38	307	29380	228824	63230511
Psychogenic seizure	121.68	13.38	41	29646	1651	63457684
Somnolence	120.38	13.38	261	29426	178424	63280911
Balance disorder	110.74	13.38	165	29522	84257	63375078
Partial seizures	109.92	13.38	54	29633	5788	63453547
Sedation	106.51	13.38	110	29577	38699	63420636
Blood sodium decreased	105.81	13.38	89	29598	24163	63435172
Inappropriate antidiuretic hormone secretion	105.42	13.38	74	29613	15388	63443947
Mitochondrial DNA mutation	91.43	13.38	24	29663	398	63458937
Myoclonic epilepsy	88.65	13.38	30	29657	1224	63458111
Abnormal behaviour	88.09	13.38	76	29611	21350	63437985
Psychotic disorder	87.54	13.38	82	29605	25630	63433705
Joint swelling	83.17	13.38	25	29662	327641	63131694
Exposure during pregnancy	82.55	13.38	207	29480	155340	63303995
Drug reaction with eosinophilia and systemic symptoms	82.37	13.38	90	29597	33746	63425589
Irritability	81.89	13.38	87	29600	31607	63427728
Propofol infusion syndrome	75.37	13.38	25	29662	958	63458377
Toxicity to various agents	75.03	13.38	270	29417	246980	63212355
Infusion related reaction	73.66	13.38	13	29674	245508	63213827
Ataxia	73.04	13.38	59	29628	15136	63444199
Cognitive disorder	71.60	13.38	108	29579	55707	63403628
Glossodynia	70.77	13.38	3	29684	178873	63280462
Suicidal ideation	70.63	13.38	114	29573	62307	63397028
Arthralgia	69.87	13.38	99	29588	569611	62889724
Mania	68.03	13.38	52	29635	12315	63447020
Contraindicated product administered	66.44	13.38	11	29676	217637	63241698
Arthropathy	65.08	13.38	15	29672	234777	63224558
Hyperammonaemic encephalopathy	62.83	13.38	28	29659	2406	63456929
Suicide attempt	61.88	13.38	106	29581	60812	63398523
Infantile spasms	60.18	13.38	15	29672	200	63459135
Sedation complication	58.79	13.38	50	29637	13772	63445563
Systemic lupus erythematosus	58.59	13.38	13	29674	208905	63250430
Creatinine renal clearance decreased	57.42	13.38	53	29634	16255	63443080
Speech disorder	56.98	13.38	82	29605	40547	63418788
Peripheral swelling	56.28	13.38	27	29660	265915	63193420
Blood gases abnormal	56.08	13.38	19	29668	778	63458557
Gene mutation	55.66	13.38	23	29664	1642	63457693
Drug ineffective for unapproved indication	55.65	13.38	74	29613	33989	63425346
Tremor	55.07	13.38	161	29526	132078	63327257
Nystagmus	55.00	13.38	35	29652	6185	63453150
Alopecia	54.10	13.38	47	29640	337489	63121846
Nasopharyngitis	53.51	13.38	26	29661	254231	63205104
Diarrhoea	52.68	13.38	166	29521	715200	62744135
Swelling	52.37	13.38	32	29655	275346	63183989
Infection	52.06	13.38	21	29666	229152	63230183
Bipolar disorder	51.72	13.38	37	29650	7923	63451412
Hypochloraemia	51.50	13.38	23	29664	1986	63457349
Dizziness	51.21	13.38	360	29327	429565	63029770
CSF oligoclonal band present	50.96	13.38	15	29672	385	63458950
Agitation	50.51	13.38	96	29591	59661	63399674
Sudden unexplained death in epilepsy	49.57	13.38	14	29673	309	63459026
Anticonvulsant drug level decreased	47.71	13.38	19	29668	1233	63458102
Intentional overdose	46.10	13.38	105	29582	74047	63385288
Rheumatoid arthritis	44.87	13.38	32	29655	253787	63205548
Pleocytosis	43.62	13.38	16	29671	829	63458506
Blood calcium decreased	42.49	13.38	57	29630	26394	63432941
Sopor	42.27	13.38	52	29635	22112	63437223
Orthostatic hypotension	42.20	13.38	67	29620	36093	63423242
Depressed level of consciousness	42.07	13.38	91	29596	61987	63397348
Simple partial seizures	41.66	13.38	14	29673	559	63458776
Drug level decreased	40.73	13.38	32	29655	7887	63451448
Overdose	39.47	13.38	131	29556	114947	63344388
Maternal exposure during pregnancy	39.37	13.38	205	29482	219857	63239478
Respiratory arrest	38.81	13.38	61	29626	32584	63426751
Gastric lavage	38.71	13.38	8	29679	42	63459293
Depression	37.92	13.38	187	29500	196305	63263030
Pneumonia	37.16	13.38	101	29586	456666	63002669
Tonic convulsion	36.97	13.38	16	29671	1281	63458054
Aura	36.47	13.38	15	29672	1058	63458277
Febrile neutropenia	36.09	13.38	6	29681	118443	63340892
Memory impairment	36.03	13.38	119	29568	104139	63355196
Paradoxical drug reaction	35.81	13.38	23	29664	4129	63455206
Sinusitis	35.75	13.38	32	29655	226621	63232714
Encephalitis	35.49	13.38	31	29656	8849	63450486
Cross sensitivity reaction	34.85	13.38	18	29669	2144	63457191
Pain	34.70	13.38	204	29483	740424	62718911
Cough	34.68	13.38	52	29635	292691	63166644
Mental disorder	34.43	13.38	51	29636	25868	63433467
Abdominal discomfort	34.27	13.38	61	29626	320824	63138511
Trigeminal neuralgia	34.13	13.38	21	29666	3498	63455837
Discomfort	33.87	13.38	18	29669	167356	63291979
Abortion induced	33.58	13.38	32	29655	10210	63449125
Dyskinesia	32.90	13.38	56	29631	31946	63427389
Hypothermia	32.83	13.38	36	29651	13545	63445790
Atonic seizures	32.62	13.38	12	29675	627	63458708
General physical health deterioration	32.29	13.38	28	29659	201374	63257961
Fall	31.73	13.38	301	29386	392033	63067302
Impaired healing	31.68	13.38	5	29682	102537	63356798
Aphasia	31.64	13.38	56	29631	32944	63426391
Stomatitis	31.02	13.38	13	29674	138712	63320623
Unmasking of previously unidentified disease	31.00	13.38	13	29674	963	63458372
Electroencephalogram abnormal	30.83	13.38	20	29667	3652	63455683
Helicobacter infection	29.88	13.38	4	29683	92781	63366554
Pregnancy	29.67	13.38	58	29629	36778	63422557
Partial seizures with secondary generalisation	29.67	13.38	10	29677	403	63458932
Neurotoxicity	29.43	13.38	38	29649	16952	63442383
Drug intolerance	29.22	13.38	63	29624	308598	63150737
Dyspnoea	28.94	13.38	186	29501	661127	62798208
Drug resistance	28.86	13.38	44	29643	22889	63436446
Stevens-Johnson syndrome	28.80	13.38	46	29641	24904	63434431
Reversible cerebral vasoconstriction syndrome	28.72	13.38	17	29670	2641	63456694
Therapeutic product effect decreased	28.45	13.38	29	29658	193158	63266177
Electrocardiogram QRS complex prolonged	28.41	13.38	23	29664	5915	63453420
Blood osmolarity decreased	28.27	13.38	12	29675	916	63458419
Multiple sclerosis	28.22	13.38	45	29642	24327	63435008
Neuroleptic malignant syndrome	27.49	13.38	31	29656	12025	63447310
Anaemia	26.86	13.38	61	29626	293369	63165966
Blood lactic acid increased	26.84	13.38	24	29663	7062	63452273
Brown tumour	26.63	13.38	6	29681	50	63459285
Intentional self-injury	26.47	13.38	45	29642	25642	63433693
Drug withdrawal convulsions	26.29	13.38	13	29674	1412	63457923
Wound	25.80	13.38	23	29664	163240	63296095
Dysmorphism	25.63	13.38	15	29672	2281	63457054
Change in seizure presentation	25.56	13.38	9	29678	414	63458921
Low set ears	25.32	13.38	8	29679	262	63459073
Lennox-Gastaut syndrome	25.12	13.38	8	29679	269	63459066
Hypersensitivity	25.07	13.38	63	29624	292622	63166713
Catatonia	25.01	13.38	19	29668	4458	63454877
Tardive dyskinesia	24.95	13.38	25	29662	8477	63450858
Coma blister	24.85	13.38	7	29680	153	63459182
Loss of consciousness	24.63	13.38	115	29572	118006	63341329
Poisoning	24.30	13.38	31	29656	13669	63445666
Electrocardiogram repolarisation abnormality	24.25	13.38	12	29675	1305	63458030
Cardio-respiratory arrest	23.98	13.38	72	29615	59887	63399448
Multiple drug therapy	23.80	13.38	17	29670	3629	63455706
Renal impairment	23.76	13.38	6	29681	88349	63370986
Psychomotor hyperactivity	23.60	13.38	27	29660	10636	63448699
Gaze palsy	23.40	13.38	12	29675	1408	63457927
Dysphoria	23.26	13.38	19	29668	4947	63454388
Phobia	23.19	13.38	8	29679	346	63458989
Therapeutic product effective for unapproved indication	23.06	13.38	6	29681	96	63459239
Herpes oesophagitis	23.03	13.38	7	29680	201	63459134
Bipolar I disorder	22.78	13.38	13	29674	1886	63457449
Arthritis	22.67	13.38	13	29674	115908	63343427
Therapeutic product ineffective for unapproved indication	22.46	13.38	7	29680	219	63459116
Parkinsonism	22.38	13.38	26	29661	10413	63448922
Brain operation	22.37	13.38	9	29678	600	63458735
Drug level increased	22.34	13.38	39	29648	22697	63436638
Ventricular hypokinesia	22.25	13.38	18	29669	4626	63454709
Immune thrombocytopenia	22.14	13.38	26	29661	10530	63448805
Drug withdrawal syndrome	22.12	13.38	43	29644	27151	63432184
Hallucination	22.08	13.38	66	29621	54751	63404584
Systolic dysfunction	22.06	13.38	12	29675	1587	63457748
Musculoskeletal stiffness	21.64	13.38	33	29654	184585	63274750
Paranoia	21.62	13.38	27	29660	11652	63447683
Intentional product use issue	21.45	13.38	17	29670	127875	63331460
Psoriatic arthropathy	21.40	13.38	8	29679	91512	63367823
Irritable bowel syndrome	21.39	13.38	6	29681	82406	63376929
Hypoxic-ischaemic encephalopathy	21.35	13.38	17	29670	4270	63455065
Screaming	20.82	13.38	15	29672	3247	63456088
Atrioventricular block first degree	20.64	13.38	21	29666	7252	63452083
Caesarean section	20.48	13.38	32	29655	17000	63442335
Electrocardiogram ST segment elevation	20.48	13.38	16	29671	3911	63455424
Chronic papillomatous dermatitis	20.47	13.38	5	29682	61	63459274
Crying	20.33	13.38	38	29649	23305	63436030
Anger	20.24	13.38	27	29660	12429	63446906
Congenital epiglottal anomaly	20.01	13.38	3	29684	0	63459335
Follicular mucinosis	20.01	13.38	3	29684	0	63459335
Mood altered	19.57	13.38	29	29658	14714	63444621
Head injury	19.52	13.38	41	29646	27355	63431980
Strabismus	19.48	13.38	12	29675	2002	63457333
Hepatic enzyme increased	19.37	13.38	41	29646	202287	63257048
Coma	19.21	13.38	70	29617	64294	63395041
Visual impairment	18.93	13.38	84	29603	84362	63374973
Epilepsy surgery	18.90	13.38	4	29683	24	63459311
Cardiac arrest	18.49	13.38	89	29598	92456	63366879
Muscle twitching	18.37	13.38	33	29654	19635	63439700
Fatigue	18.27	13.38	299	29388	887729	62571606
Normal newborn	18.26	13.38	21	29666	8320	63451015
Ammonia increased	18.09	13.38	16	29671	4640	63454695
Hypotonia	18.05	13.38	22	29665	9263	63450072
Acute kidney injury	17.99	13.38	63	29624	263352	63195983
Malignant neoplasm progression	17.87	13.38	8	29679	82113	63377222
Pain in extremity	17.83	13.38	87	29600	331399	63127936
Seizure cluster	17.79	13.38	6	29681	242	63459093
Shock	17.76	13.38	36	29651	23427	63435908
Atrial fibrillation	17.75	13.38	17	29670	116619	63342716
Developmental delay	17.38	13.38	10	29677	1473	63457862
Hypogammaglobulinaemia	17.35	13.38	19	29668	7136	63452199
Musculoskeletal pain	17.13	13.38	11	29676	92266	63367069
Logorrhoea	17.07	13.38	12	29675	2498	63456837
Therapeutic response unexpected	16.92	13.38	31	29656	18728	63440607
Neonatal seizure	16.74	13.38	7	29680	515	63458820
Coordination abnormal	16.73	13.38	26	29661	13747	63445588
Anticonvulsant drug level above therapeutic	16.61	13.38	7	29680	525	63458810
Stillbirth	16.50	13.38	18	29669	6732	63452603
Rash maculo-papular	16.41	13.38	42	29645	31854	63427481
Gun shot wound	16.18	13.38	5	29682	152	63459183
Gastrointestinal disorder	15.82	13.38	23	29664	131216	63328119
Asthma	15.73	13.38	22	29665	127539	63331796
Productive cough	15.68	13.38	5	29682	63203	63396132
Antinuclear antibody positive	15.63	13.38	19	29668	7980	63451355
Automatism	15.49	13.38	4	29683	62	63459273
Granulocytopenia	15.41	13.38	16	29671	5656	63453679
Treatment failure	15.41	13.38	45	29642	198998	63260337
Restlessness	15.38	13.38	39	29648	29414	63429921
Hallucination, auditory	15.29	13.38	24	29663	12800	63446535
Cardiopulmonary failure	15.22	13.38	13	29674	3599	63455736
Sleep paralysis	15.16	13.38	7	29680	653	63458682
Drug ineffective	15.16	13.38	614	29073	1044151	62415184
Delusion	15.04	13.38	23	29664	11994	63447341
Mood swings	15.02	13.38	29	29658	18219	63441116
Learning disorder	14.91	13.38	7	29680	678	63458657
Educational problem	14.91	13.38	6	29681	400	63458935
Pleural effusion	14.87	13.38	13	29674	93197	63366138
Postictal state	14.87	13.38	8	29679	1035	63458300
Thyroxine free decreased	14.79	13.38	7	29680	691	63458644
Sepsis	14.68	13.38	31	29656	153092	63306243
Behaviour disorder	14.48	13.38	12	29675	3187	63456148
Disturbance in attention	14.46	13.38	45	29642	38144	63421191
Retrognathia	14.26	13.38	6	29681	448	63458887
Impulsive behaviour	14.22	13.38	9	29678	1574	63457761
Social fear	14.18	13.38	3	29684	18	63459317
Viral titre decreased	14.18	13.38	3	29684	18	63459317
Immunodeficiency common variable	14.06	13.38	5	29682	237	63459098
Hyperkalaemia	13.97	13.38	4	29683	54199	63405136
Product complaint	13.94	13.38	23	29664	12786	63446549
Fever neonatal	13.90	13.38	3	29684	20	63459315
Blood prolactin increased	13.54	13.38	12	29675	3491	63455844
Lethargy	13.54	13.38	57	29630	55950	63403385
Gait disturbance	13.52	13.38	138	29549	183040	63276295
Poisoning deliberate	13.38	13.38	21	29666	11197	63448138

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
Seizure	1068.95	13.61	689	19123	104168	34832951
Hyponatraemia	357.12	13.61	327	19485	82364	34854755
Product substitution issue	197.79	13.61	102	19710	9993	34927126
Aggression	195.52	13.61	168	19644	38796	34898323
Generalised tonic-clonic seizure	180.25	13.61	125	19687	21049	34916070
Epilepsy	171.58	13.61	122	19690	21373	34915746
Multiple-drug resistance	151.14	13.61	69	19743	5170	34931949
Drug ineffective	124.76	13.61	549	19263	456202	34480917
Status epilepticus	122.91	13.61	81	19731	12533	34924586
Partial seizures	119.66	13.61	57	19755	4703	34932416
Stevens-Johnson syndrome	117.85	13.61	92	19720	18547	34918572
Petit mal epilepsy	106.32	13.61	46	19766	3032	34934087
Somnolence	102.83	13.61	207	19605	110909	34826210
Sudden unexplained death in epilepsy	102.16	13.61	28	19784	450	34936669
Ataxia	74.05	13.61	62	19750	13791	34923328
Abnormal behaviour	72.84	13.61	80	19732	24889	34912230
Nystagmus	70.95	13.61	40	19772	4675	34932444
Inappropriate antidiuretic hormone secretion	70.08	13.61	58	19754	12695	34924424
Death	68.58	13.61	75	19737	397974	34539145
Drug interaction	66.91	13.61	279	19533	225667	34711452
Focal dyscognitive seizures	62.40	13.61	25	19787	1356	34935763
Electroencephalogram abnormal	57.22	13.61	28	19784	2450	34934669
Febrile neutropenia	56.33	13.61	6	19806	136843	34800276
Intellectual disability	56.25	13.61	23	19789	1315	34935804
Pneumonia	54.34	13.61	76	19736	362551	34574568
Acute kidney injury	52.96	13.61	57	19755	304931	34632188
Irritability	51.99	13.61	67	19745	24623	34912496
Neuroleptic malignant syndrome	51.50	13.61	57	19755	17877	34919242
Hypochloraemia	48.65	13.61	17	19795	628	34936491
Coma	48.13	13.61	90	19722	45588	34891531
Hyperammonaemic encephalopathy	46.99	13.61	24	19788	2300	34934819
Behaviour disorder	46.53	13.61	31	19781	4879	34932240
Anaemia	45.84	13.61	39	19773	233296	34703823
Memory impairment	45.21	13.61	85	19727	43233	34893886
Dyspnoea	43.61	13.61	93	19719	376689	34560430
Myoclonic epilepsy	42.29	13.61	18	19794	1139	34935980
Agitation	40.52	13.61	96	19716	57303	34879816
Diarrhoea	39.71	13.61	103	19709	389809	34547310
Educational problem	39.29	13.61	14	19798	548	34936571
Blood sodium decreased	38.85	13.61	47	19765	16204	34920915
Colitis ischaemic	38.84	13.61	31	19781	6444	34930675
Cognitive disorder	38.64	13.61	63	19749	28630	34908489
Intentional self-injury	38.21	13.61	43	19769	13728	34923391
Psychomotor hyperactivity	35.55	13.61	35	19777	9587	34927532
Completed suicide	34.42	13.61	128	19684	98040	34839079
Aura	33.62	13.61	11	19801	331	34936788
Drug level decreased	31.73	13.61	30	19782	7816	34929303
Autonomic nervous system imbalance	31.39	13.61	19	19793	2532	34934587
Simple partial seizures	31.18	13.61	10	19802	282	34936837
Depressed mood	31.01	13.61	46	19766	19271	34917848
Psychotic disorder	30.66	13.61	52	19760	24400	34912719
Autism spectrum disorder	30.60	13.61	18	19794	2278	34934841
Anticonvulsant drug level decreased	30.29	13.61	14	19798	1078	34936041
Sepsis	28.98	13.61	31	19781	166530	34770589
Impulsive behaviour	28.94	13.61	17	19795	2145	34934974
Cardiac failure congestive	28.86	13.61	6	19806	83264	34853855
Depression	28.69	13.61	120	19692	96978	34840141
Speech disorder developmental	28.67	13.61	17	19795	2183	34934936
Dissociation	27.50	13.61	15	19797	1643	34935476
Tic	27.07	13.61	16	19796	2042	34935077
Hyperammonaemia	27.01	13.61	25	19787	6342	34930777
Suicidal ideation	26.83	13.61	66	19746	40322	34896797
Thyroxine free decreased	26.63	13.61	9	19803	300	34936819
Drug withdrawal convulsions	26.28	13.61	13	19799	1164	34935955
Developmental coordination disorder	26.13	13.61	8	19804	193	34936926
Platelet count decreased	26.03	13.61	18	19794	119699	34817420
Anxiety	25.66	13.61	118	19694	99310	34837809
Arthralgia	25.02	13.61	36	19776	170005	34767114
Disturbance in attention	24.71	13.61	49	19763	25896	34911223
Otitis media	24.52	13.61	17	19795	2855	34934264
Irregular sleep phase	24.42	13.61	6	19806	61	34937058
Seizure cluster	24.10	13.61	7	19805	140	34936979
Diplopia	24.06	13.61	38	19774	16805	34920314
Hypothermia	23.94	13.61	30	19782	10718	34926401
Gait disturbance	23.43	13.61	103	19709	85037	34852082
Drug withdrawal syndrome	23.32	13.61	41	19771	19793	34917326
Coordination abnormal	23.16	13.61	25	19787	7619	34929500
Brain malformation	23.10	13.61	7	19805	163	34936956
Dysmorphism	23.07	13.61	17	19795	3139	34933980
Hallucination, auditory	23.01	13.61	31	19781	11886	34925233
Enuresis	22.64	13.61	15	19797	2338	34934781
Sopor	22.57	13.61	31	19781	12105	34925014
Pancytopenia	22.48	13.61	13	19799	95144	34841975
Affective disorder	22.23	13.61	19	19793	4341	34932778
Condition aggravated	22.06	13.61	185	19627	192011	34745108
Speech disorder	21.51	13.61	46	19766	25640	34911479
Balance disorder	21.47	13.61	61	19751	40593	34896526
Psychogenic seizure	21.39	13.61	8	19804	360	34936759
Gastrointestinal haemorrhage	21.02	13.61	12	19800	88465	34848654
Wrong patient received product	21.01	13.61	15	19797	2639	34934480
Renal failure	20.86	13.61	26	19786	130531	34806588
Malignant neoplasm progression	20.84	13.61	12	19800	88034	34849085
Dizziness	20.82	13.61	202	19610	218319	34718800
Idiopathic generalised epilepsy	20.80	13.61	5	19807	46	34937073
Nervousness	20.20	13.61	30	19782	12576	34924543
Oedema peripheral	20.06	13.61	23	19789	119789	34817330
Trigeminal neuralgia	20.05	13.61	11	19801	1218	34935901
Bradykinesia	19.92	13.61	17	19795	3876	34933243
Motor developmental delay	19.90	13.61	9	19803	659	34936460
Back pain	19.72	13.61	24	19788	121765	34815354
Hypotension	19.24	13.61	63	19749	221586	34715533
Granulocytopenia	19.07	13.61	21	19791	6546	34930573
Anger	18.64	13.61	28	19784	11856	34925263
Cardiac failure	18.18	13.61	15	19797	91233	34845886
Overweight	18.07	13.61	12	19800	1878	34935241
Dyskinesia	17.47	13.61	39	19773	22374	34914745
Congenital scoliosis	17.26	13.61	5	19807	99	34937020
Anticonvulsant drug level increased	17.26	13.61	11	19801	1605	34935514
Large granular lymphocytosis	17.26	13.61	6	19806	218	34936901
Parasomnia	17.17	13.61	7	19805	397	34936722
Suicide attempt	17.17	13.61	55	19757	39061	34898058
Interstitial lung disease	16.77	13.61	8	19804	65274	34871845
Bipolar disorder	16.72	13.61	15	19797	3654	34933465
Drug abuse	16.61	13.61	19	19793	99077	34838042
Craniocerebral injury	16.19	13.61	14	19798	3249	34933870
Confusional state	16.12	13.61	138	19674	144022	34793097
Congenital knee deformity	16.09	13.61	5	19807	127	34936992
Mental disorder	16.05	13.61	30	19782	15179	34921940
Psychomotor skills impaired	15.92	13.61	15	19797	3891	34933228
Colitis microscopic	15.77	13.61	12	19800	2325	34934794
Tremor	15.70	13.61	90	19722	82497	34854622
Staring	15.69	13.61	10	19802	1460	34935659
Haemoglobin decreased	15.46	13.61	28	19784	120744	34816375
Neutropenia	15.44	13.61	42	19770	156736	34780383
Therapeutic response unexpected	15.32	13.61	23	19789	9734	34927385
General physical health deterioration	15.32	13.61	31	19781	128238	34808881
Hyperthermia	15.30	13.61	24	19788	10553	34926566
Lid lag	15.28	13.61	3	19809	9	34937110
Change in seizure presentation	15.02	13.61	5	19807	159	34936960
Loss of consciousness	15.00	13.61	89	19723	82578	34854541
Thrombosis	14.89	13.61	5	19807	50453	34886666
Dystonia	14.85	13.61	24	19788	10821	34926298
Lethargy	14.70	13.61	54	19758	41068	34896051
Sleep deficit	14.68	13.61	7	19805	578	34936541
Terminal insomnia	14.65	13.61	7	19805	581	34936538
Head banging	14.51	13.61	5	19807	177	34936942
Catatonia	14.47	13.61	16	19796	5009	34932110
Infusion related reaction	14.41	13.61	6	19806	53051	34884068
Mania	14.34	13.61	22	19790	9489	34927630
Tardive dyskinesia	14.25	13.61	17	19795	5773	34931346
Hand fracture	14.24	13.61	11	19801	2181	34934938
Croup infectious	14.04	13.61	6	19806	383	34936736
Product complaint	14.02	13.61	17	19795	5873	34931246
Anticonvulsant drug level below therapeutic	14.01	13.61	7	19805	640	34936479
Mood altered	13.91	13.61	21	19791	8931	34928188
Disease progression	13.88	13.61	25	19787	108052	34829067
Epileptic encephalopathy	13.86	13.61	5	19807	203	34936916
Thrombotic thrombocytopenic purpura	13.85	13.61	13	19799	3357	34933762
Infantile spasms	13.81	13.61	5	19807	205	34936914
Drug eruption	13.72	13.61	33	19779	19865	34917254
Wrong product administered	13.69	13.61	16	19796	5318	34931801
Withdrawal syndrome	13.68	13.61	25	19787	12430	34924689
Product quality issue	13.68	13.61	30	19782	17005	34920114
Cross sensitivity reaction	13.67	13.61	9	19803	1388	34935731
Anticonvulsant drug level above therapeutic	13.66	13.61	7	19805	675	34936444

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
Seizure	1399.92	12.63	960	37593	187874	79517961
Hyponatraemia	769.28	12.63	657	37896	177191	79528644
Generalised tonic-clonic seizure	295.26	12.63	211	38342	43699	79662136
Multiple-drug resistance	288.41	12.63	121	38432	8687	79697148
Aggression	273.72	12.63	214	38339	50744	79655091
Status epilepticus	273.21	12.63	163	38390	24878	79680957
Epilepsy	235.60	12.63	179	38374	40681	79665154
Completed suicide	212.77	12.63	406	38147	245361	79460474
Focal dyscognitive seizures	203.32	12.63	73	38480	3439	79702396
Partial seizures	199.52	12.63	94	38459	8884	79696951
Product substitution issue	195.69	12.63	122	38431	20134	79685701
Petit mal epilepsy	191.94	12.63	80	38473	5647	79700188
Somnolence	190.07	12.63	381	38172	238600	79467235
Drug interaction	186.74	12.63	530	38023	414653	79291182
Inappropriate antidiuretic hormone secretion	155.47	12.63	117	38436	26196	79679639
Psychogenic seizure	138.15	12.63	47	38506	1884	79703951
Diplopia	134.77	12.63	119	38434	33347	79672488
Stevens-Johnson syndrome	129.99	12.63	125	38428	39041	79666794
Nystagmus	125.30	12.63	71	38482	9833	79696002
Sudden unexplained death in epilepsy	124.66	12.63	34	38519	634	79705201
Balance disorder	118.90	12.63	189	38364	98668	79607167
Ataxia	114.98	12.63	96	38457	24943	79680892
Psychotic disorder	104.45	12.63	114	38439	41288	79664547
Hyperammonaemic encephalopathy	102.97	12.63	49	38504	4733	79701102
Abnormal behaviour	101.99	12.63	106	38447	36315	79669520
Myoclonic epilepsy	99.38	12.63	37	38516	1933	79703902
Sedation	96.17	12.63	122	38431	51773	79654062
Hypochloraemia	90.60	12.63	37	38516	2478	79703357
Mitochondrial DNA mutation	90.02	12.63	24	38529	409	79705426
Neuroleptic malignant syndrome	89.64	12.63	87	38466	27472	79678363
Cognitive disorder	88.65	12.63	137	38416	69789	79636046
Irritability	86.36	12.63	103	38450	41041	79664794
Drug reaction with eosinophilia and systemic symptoms	85.87	12.63	129	38424	64115	79641720
Suicidal ideation	83.70	12.63	140	38413	76200	79629635
Drug ineffective	83.08	12.63	841	37712	1080072	78625763
Agitation	80.31	12.63	160	38393	99555	79606280
Blood sodium decreased	77.74	12.63	88	38465	33167	79672668
Febrile neutropenia	77.68	12.63	10	38543	230989	79474846
Electroencephalogram abnormal	71.57	12.63	40	38513	5394	79700441
Arthralgia	71.16	12.63	104	38449	571699	79134136
Infantile spasms	69.66	12.63	18	38535	270	79705565
Suicide attempt	67.90	12.63	134	38419	82798	79623037
Pneumonia	66.75	12.63	137	38416	660109	79045726
Drug level decreased	63.61	12.63	54	38499	14348	79691487
Sopor	63.37	12.63	79	38474	32931	79672904
Infusion related reaction	62.48	12.63	17	38536	230220	79475615
Joint swelling	62.06	12.63	31	38522	288615	79417220
Anticonvulsant drug level decreased	61.40	12.63	26	38527	1908	79703927
Propofol infusion syndrome	60.77	12.63	26	38527	1957	79703878
Diarrhoea	59.70	12.63	222	38331	880267	78825568
Anaemia	57.24	12.63	79	38474	444936	79260899
Memory impairment	56.31	12.63	149	38404	111585	79594250
Mania	56.31	12.63	56	38497	18204	79687631
Hypothermia	56.26	12.63	62	38491	22684	79683151
Coma	55.66	12.63	139	38414	100510	79605325
Dyspnoea	55.56	12.63	220	38333	856805	78849030
Toxicity to various agents	54.22	12.63	369	38184	421171	79284664
Bipolar disorder	53.99	12.63	38	38515	7669	79698166
Sedation complication	53.85	12.63	51	38502	15618	79690217
Intentional self-injury	53.49	12.63	72	38481	32347	79673488
Speech disorder	52.03	12.63	94	38459	54351	79651484
Blood gases abnormal	51.72	12.63	20	38533	1160	79704675
Creatinine renal clearance decreased	50.86	12.63	54	38499	18948	79686887
Dizziness	50.42	12.63	430	38123	526011	79179824
Intentional overdose	50.08	12.63	138	38415	105822	79600013
CSF oligoclonal band present	49.71	12.63	15	38538	406	79705429
Behaviour disorder	48.63	12.63	33	38520	6280	79699555
Acute kidney injury	48.13	12.63	113	38440	519291	79186544
Contraindicated product administered	48.00	12.63	9	38544	157529	79548306
Dyskinesia	47.58	12.63	81	38472	44692	79661143
Drug ineffective for unapproved indication	47.11	12.63	87	38466	51151	79654684
Arthropathy	46.34	12.63	14	38539	177097	79528738
Lower respiratory tract infection	44.89	12.63	5	38548	129215	79576620
Gene mutation	44.41	12.63	23	38530	2663	79703172
Swelling	44.03	12.63	25	38528	216686	79489149
Peripheral swelling	43.20	12.63	40	38513	269577	79436258
Drug withdrawal syndrome	42.56	12.63	67	38486	34651	79671184
Drug withdrawal convulsions	42.53	12.63	21	38532	2199	79703636
Simple partial seizures	42.13	12.63	15	38538	689	79705146
Death	41.53	12.63	138	38415	566376	79139459
Rheumatoid arthritis	41.01	12.63	25	38528	208445	79497390
Mental disorder	40.60	12.63	62	38491	31240	79674595
General physical health deterioration	40.48	12.63	44	38509	275194	79430641
Cross sensitivity reaction	40.04	12.63	24	38529	3688	79702147
Intellectual disability	39.44	12.63	17	38536	1303	79704532
Pericarditis	38.96	12.63	3	38550	104233	79601602
Granulocytopenia	38.89	12.63	37	38516	11394	79694441
Glossodynia	38.55	12.63	3	38550	103334	79602501
Dissociation	38.27	12.63	24	38529	3997	79701838
Trigeminal neuralgia	38.06	12.63	23	38530	3586	79702249
Depression	37.47	12.63	205	38348	216585	79489250
Depressed level of consciousness	37.18	12.63	117	38436	96535	79609300
Catatonia	36.97	12.63	32	38521	8724	79697111
Tremor	36.53	12.63	171	38382	169912	79535923
Gastric lavage	36.11	12.63	8	38545	59	79705776
Thyroxine free decreased	36.07	12.63	15	38538	1052	79704783
Drug resistance	35.49	12.63	69	38484	42144	79663691
Multiple drug therapy	35.48	12.63	23	38530	4055	79701780
Psychomotor hyperactivity	35.05	12.63	42	38511	16807	79689028
Pleocytosis	34.87	12.63	16	38537	1423	79704412
Anger	34.43	12.63	42	38511	17120	79688715
Seizure cluster	33.59	12.63	11	38542	391	79705444
Reversible cerebral vasoconstriction syndrome	33.58	12.63	20	38533	3037	79702798
Sepsis	33.44	12.63	49	38504	269379	79436456
Blood calcium decreased	33.06	12.63	57	38496	31762	79674073
Cardiac failure	32.70	12.63	17	38536	154825	79551010
Infection	31.95	12.63	42	38511	241670	79464165
Brain malformation	31.55	12.63	7	38546	52	79705783
Anticonvulsant drug level above therapeutic	31.48	12.63	14	38539	1157	79704678
Respiratory arrest	31.30	12.63	79	38474	57471	79648364
Electrocardiogram QRS complex prolonged	31.16	12.63	32	38521	10801	79695034
Tonic convulsion	31.04	12.63	17	38536	2203	79703632
Lennox-Gastaut syndrome	30.97	12.63	9	38544	213	79705622
Cough	30.68	12.63	84	38469	366705	79339130
Hyperammonaemia	30.53	12.63	32	38521	11061	79694774
Overdose	30.36	12.63	172	38381	184034	79521801
Oedema peripheral	30.22	12.63	47	38506	252241	79453594
Malignant neoplasm progression	30.13	12.63	14	38539	135976	79569859
Paradoxical drug reaction	29.82	12.63	26	38527	7159	79698676
Alopecia	29.77	12.63	41	38512	231314	79474521
Hallucination, auditory	29.72	12.63	43	38510	20650	79685185
Stomatitis	29.70	12.63	17	38536	146740	79559095
Fall	29.65	12.63	363	38190	487266	79218569
Aphasia	29.55	12.63	68	38485	46664	79659171
Impulsive behaviour	29.35	12.63	18	38535	2882	79702953
Educational problem	29.31	12.63	10	38543	404	79705431
Gait disturbance	29.25	12.63	186	38367	207320	79498515
Nasopharyngitis	28.82	12.63	49	38504	253832	79452003
Temporal lobe epilepsy	28.59	12.63	10	38543	436	79705399
Partial seizures with secondary generalisation	28.58	12.63	11	38542	630	79705205
Tardive dyskinesia	28.22	12.63	30	38523	10541	79695294
Malaise	27.81	12.63	132	38421	489737	79216098
Aura	27.72	12.63	12	38541	930	79704905
Back pain	27.47	12.63	67	38486	304113	79401722
Paranoia	27.36	12.63	40	38513	19392	79686443
Bradykinesia	27.30	12.63	26	38527	8017	79697818
Blood creatine phosphokinase increased	27.27	12.63	82	38471	66008	79639827
Blood osmolarity decreased	26.72	12.63	13	38540	1318	79704517
Anticonvulsant drug level below therapeutic	26.13	12.63	12	38541	1069	79704766
Brown tumour	26.12	12.63	6	38547	53	79705782
Wrong patient received product	26.09	12.63	20	38533	4598	79701237
Dysmorphism	26.01	12.63	10	38543	571	79705264
Multiple sclerosis	25.93	12.63	42	38511	22240	79683595
Poisoning	25.90	12.63	45	38508	25227	79680608
Disturbance in attention	25.84	12.63	68	38485	50733	79655102
Drug level increased	25.40	12.63	58	38495	39593	79666242
Encephalitis autoimmune	25.18	12.63	15	38538	2279	79703556
Psoriatic arthropathy	24.75	12.63	4	38549	77995	79627840
Cardio-respiratory arrest	24.70	12.63	111	38442	108399	79597436
Encephalitis	24.68	12.63	33	38520	14727	79691108
Parkinsonism	24.61	12.63	35	38518	16549	79689286
Systemic lupus erythematosus	24.56	12.63	14	38539	121135	79584700
Atrial fibrillation	24.53	12.63	36	38517	197850	79507985
Autonomic nervous system imbalance	23.88	12.63	19	38534	4611	79701224
Strabismus	23.87	12.63	15	38538	2506	79703329
Gaze palsy	23.84	12.63	16	38537	2989	79702846
Pain	23.64	12.63	222	38331	703580	79002255
Bipolar I disorder	23.57	12.63	14	38539	2115	79703720
Change in seizure presentation	23.42	12.63	9	38544	513	79705322
Loss of consciousness	23.33	12.63	150	38403	167793	79538042
Abortion spontaneous	23.32	12.63	47	38506	29460	79676375
Staring	23.21	12.63	15	38538	2630	79703205
Therapeutic product ineffective for unapproved indication	23.04	12.63	7	38546	194	79705641
Irregular sleep phase	22.92	12.63	6	38547	95	79705740
Parasomnia	22.79	12.63	9	38544	552	79705283
Impaired healing	22.79	12.63	7	38546	87648	79618187
Pain in extremity	22.62	12.63	95	38458	364443	79341392
Learning disorder	22.52	12.63	9	38544	570	79705265
Arthritis	22.27	12.63	14	38539	114866	79590969
Colitis ischaemic	22.18	12.63	32	38521	15327	79690508
Screaming	22.15	12.63	17	38536	3916	79701919
Therapeutic product effective for unapproved indication	22.09	12.63	6	38547	110	79705725
Hypotonia	21.87	12.63	29	38524	12841	79692994
Psychomotor skills impaired	21.83	12.63	19	38534	5218	79700617
Terminal insomnia	21.80	12.63	11	38542	1206	79704629
Coma blister	21.79	12.63	7	38546	234	79705601
Asthma	21.67	12.63	20	38533	135075	79570760
Tic	21.56	12.63	15	38538	2971	79702864
Unmasking of previously unidentified disease	21.41	12.63	13	38540	2044	79703791
Helicobacter infection	21.19	12.63	4	38549	69700	79636135
Affective disorder	21.13	12.63	23	38530	8296	79697539
Speech disorder developmental	21.07	12.63	9	38544	675	79705160
Fear	21.05	12.63	38	38515	21948	79683887
Discomfort	20.87	12.63	18	38535	125599	79580236
Dysarthria	20.83	12.63	76	38477	67546	79638289
Orthostatic hypotension	20.69	12.63	67	38486	56097	79649738
Lethargy	20.68	12.63	86	38467	81206	79624629
Coordination abnormal	20.65	12.63	33	38520	17279	79688556
Idiopathic generalised epilepsy	20.54	12.63	5	38548	58	79705777
Musculoskeletal pain	20.50	12.63	12	38541	102342	79603493
Hallucination	20.48	12.63	89	38464	85656	79620179
Delusion	20.45	12.63	36	38517	20387	79685448
Neurotoxicity	20.21	12.63	47	38506	32471	79673364
Gastrointestinal haemorrhage	20.20	12.63	25	38528	147694	79558141
Atonic seizures	19.96	12.63	9	38544	768	79705067
Craniocerebral injury	19.96	12.63	18	38535	5178	79700657
Blood antidiuretic hormone decreased	19.91	12.63	3	38550	0	79705835
Mood altered	19.90	12.63	33	38520	17814	79688021
Depressed mood	19.85	12.63	60	38493	48420	79657415
Hypersensitivity	19.78	12.63	63	38490	262176	79443659
Postictal psychosis	19.72	12.63	6	38547	167	79705668
Cardiac failure congestive	19.58	12.63	24	38529	142378	79563457
Drug eruption	19.55	12.63	56	38497	43879	79661956
Drug intolerance	19.54	12.63	64	38489	264055	79441780
Dysphoria	19.38	12.63	17	38536	4717	79701118
Leukopenia	19.32	12.63	109	38444	116404	79589431
Head injury	18.98	12.63	50	38503	37319	79668516
Rash maculo-papular	18.97	12.63	65	38488	56013	79649822
Nausea	18.78	12.63	338	38215	956858	78748977
Herpes zoster	18.52	12.63	11	38542	93072	79612763
Haemoglobin decreased	18.45	12.63	51	38502	222068	79483767
Anticonvulsant drug level increased	18.39	12.63	13	38540	2640	79703195
Sleep paralysis	18.35	12.63	8	38545	630	79705205
Herpes oesophagitis	18.33	12.63	7	38546	392	79705443
Productive cough	18.20	12.63	10	38543	88321	79617514
Blood chloride decreased	18.03	12.63	21	38532	8156	79697679
Dystonia	18.01	12.63	35	38518	21364	79684471
Muscle twitching	17.87	12.63	38	38515	24726	79681109
Electrocardiogram repolarisation abnormality	17.82	12.63	12	38541	2255	79703580
Agranulocytosis	17.76	12.63	55	38498	44975	79660860
Product administration error	17.61	12.63	44	38509	31802	79674033
Drug screen positive	17.60	12.63	18	38535	6045	79699790
Poisoning deliberate	17.34	12.63	32	38521	18796	79687039
Disorientation	17.23	12.63	68	38485	62708	79643127
Myocardial infarction	17.05	12.63	40	38513	184089	79521746
Eye movement disorder	16.71	12.63	20	38533	7991	79697844
Rasmussen encephalitis	16.61	12.63	3	38550	6	79705829
Developmental coordination disorder	16.61	12.63	3	38550	6	79705829
Atrioventricular block first degree	16.56	12.63	25	38528	12466	79693369
Logorrhoea	16.53	12.63	15	38538	4350	79701485
Dyspnoea exertional	16.35	12.63	11	38542	87062	79618773
Blood pressure fluctuation	16.34	12.63	6	38547	67139	79638696
Enuresis	16.31	12.63	13	38540	3163	79702672
Neuropathy peripheral	16.27	12.63	27	38526	141278	79564557
Nervousness	16.25	12.63	44	38509	33371	79672464
Acidosis hyperchloraemic	16.23	12.63	8	38545	834	79705001
Pancytopenia	16.17	12.63	35	38518	165710	79540125
Developmental delay	16.04	12.63	9	38544	1222	79704613
Product colour issue	15.90	12.63	8	38545	872	79704963
Hippocampal sclerosis	15.89	12.63	5	38548	156	79705679
Mental status changes	15.61	12.63	69	38484	66890	79638945
Musculoskeletal stiffness	15.43	12.63	39	38514	174969	79530866
Renal failure	15.34	12.63	48	38505	200920	79504915
Antinuclear antibody positive	15.33	12.63	19	38534	7871	79697964
Normal newborn	15.32	12.63	18	38535	7054	79698781
Extensor plantar response	15.18	12.63	10	38543	1811	79704024
Crying	15.08	12.63	34	38519	23009	79682826
Exposure during pregnancy	15.08	12.63	92	38461	101040	79604795
Anxiety	15.06	12.63	185	38368	248327	79457508
Large granular lymphocytosis	15.06	12.63	6	38547	377	79705458
Macule	14.96	12.63	12	38541	2945	79702890
Restlessness	14.95	12.63	53	38500	46439	79659396
Mucosal inflammation	14.94	12.63	9	38544	75571	79630264
Weight increased	14.91	12.63	202	38351	277184	79428651
Brain operation	14.89	12.63	7	38546	658	79705177
Postictal state	14.85	12.63	10	38543	1879	79703956
Dermatitis exfoliative	14.82	12.63	22	38531	10807	79695028
Gamma-glutamyltransferase increased	14.82	12.63	59	38494	54621	79651214
Abdominal pain	14.77	12.63	119	38434	389450	79316385
Sinusitis	14.71	12.63	47	38506	195454	79510381
Abnormal sensation in eye	14.63	12.63	10	38543	1925	79703910
Fever neonatal	14.54	12.63	3	38550	15	79705820
Drop attacks	14.53	12.63	8	38545	1047	79704788
Ammonia increased	14.21	12.63	18	38535	7617	79698218
Fatigue	14.17	12.63	342	38211	929385	78776450
Epistaxis	14.10	12.63	20	38533	111495	79594340
Viral titre decreased	14.08	12.63	3	38550	18	79705817
Therapeutic product effect decreased	14.08	12.63	37	38516	163826	79542009
Renal impairment	14.04	12.63	35	38518	157748	79548087
Libido decreased	14.02	12.63	15	38538	5306	79700529
Confusional state	13.74	12.63	223	38330	317774	79388061
Therapeutic response unexpected	13.70	12.63	30	38523	19916	79685919
Immune thrombocytopenia	13.64	12.63	28	38525	17777	79688058
Ascites	13.58	12.63	10	38543	75552	79630283
Social fear	13.56	12.63	3	38550	22	79705813
Blood lactic acid increased	13.46	12.63	23	38530	12721	79693114
Antipsychotic drug level decreased	13.43	12.63	8	38545	1216	79704619
Disease progression	13.40	12.63	45	38508	184317	79521518
Folliculitis	13.39	12.63	5	38548	55375	79650460
Follicular mucinosis	13.33	12.63	3	38550	24	79705811
Neutropenia	13.28	12.63	83	38470	287627	79418208
Pulmonary embolism	13.10	12.63	41	38512	171613	79534222
Head banging	13.06	12.63	6	38547	535	79705300
Heart rate decreased	13.04	12.63	9	38544	70307	79635528
Abdominal distension	12.75	12.63	24	38529	119626	79586209
Withdrawal syndrome	12.70	12.63	35	38518	26819	79679016
Product complaint	12.69	12.63	23	38530	13326	79692509
Nasal congestion	12.67	12.63	11	38542	76541	79629294
Muscle rigidity	12.64	12.63	29	38524	19853	79685982

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N03AF02	NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Carboxamide derivatives
FDA PE	N0000008486	Decreased Central Nervous System Disorganized Electrical Activity
MeSH PA	D000927	Anticonvulsants
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D065701	Cytochrome P-450 CYP3A Inducers
MeSH PA	D049990	Membrane Transport Modulators
MeSH PA	D065606	Metabolic Side Effects of Drugs and Substances
MeSH PA	D026941	Sodium Channel Blockers
MeSH PA	D061567	Voltage-Gated Sodium Channel Blockers
CHEBI has role	CHEBI:35623	anticonvulsants
CHEBI has role	CHEBI:88188	allergenic drug
FDA EPC	N0000175753	Anti-epileptic Agent

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

Disease	Relation	SNOMED_ID	DOID
Localization-related epilepsy	indication	230381009	DOID:2234
Epilepsy characterized by intractable complex partial seizures	indication	442481002
Simple partial seizure	indication	117891000119100
Suicidal thoughts	contraindication	6471006
Mood swings	contraindication	18963009
Depressive disorder	contraindication	35489007
Syndrome of inappropriate vasopressin secretion	contraindication	55004003	DOID:3401
Acute nephropathy	contraindication	58574008
Hyponatremia	contraindication	89627008
Impaired renal function disorder	contraindication	197663003

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.9	acidic

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
150MG	OXTELLAR XR	SUPERNUS PHARMS	N202810	Oct. 19, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	10220042	April 13, 2027	TREATMENT OF PARTIAL-ONSET SEIZURES
150MG	OXTELLAR XR	SUPERNUS PHARMS	N202810	Oct. 19, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	7910131	April 13, 2027	TREATMENT OF PARTIAL-ONSET SEIZURES
150MG	OXTELLAR XR	SUPERNUS PHARMS	N202810	Oct. 19, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	9119791	April 13, 2027	TREATMENT OF PARTIAL-ONSET SEIZURES
300MG	OXTELLAR XR	SUPERNUS PHARMS	N202810	Oct. 19, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	10220042	April 13, 2027	TREATMENT OF PARTIAL-ONSET SEIZURES
300MG	OXTELLAR XR	SUPERNUS PHARMS	N202810	Oct. 19, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	7910131	April 13, 2027	TREATMENT OF PARTIAL-ONSET SEIZURES
300MG	OXTELLAR XR	SUPERNUS PHARMS	N202810	Oct. 19, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	9119791	April 13, 2027	TREATMENT OF PARTIAL-ONSET SEIZURES
600MG	OXTELLAR XR	SUPERNUS PHARMS	N202810	Oct. 19, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	10220042	April 13, 2027	TREATMENT OF PARTIAL-ONSET SEIZURES
600MG	OXTELLAR XR	SUPERNUS PHARMS	N202810	Oct. 19, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	7910131	April 13, 2027	TREATMENT OF PARTIAL-ONSET SEIZURES
600MG	OXTELLAR XR	SUPERNUS PHARMS	N202810	Oct. 19, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	9119791	April 13, 2027	TREATMENT OF PARTIAL-ONSET SEIZURES

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Sodium channel protein type 5 subunit alpha	Ion channel	Q14524	SCN5A_HUMAN	BLOCKER				WOMBAT-PK	CHEMBL

External reference:

ID	Source
4021196	VUID
N0000148642	NUI
D00533	KEGG_DRUG
4021196	VANDF
C0069751	UMLSCUI
CHEBI:7824	CHEBI
CHEMBL1068	ChEMBL_ID
DB00776	DRUGBANK_ID
D000078330	MESH_DESCRIPTOR_UI
34312	PUBCHEM_CID
7254	IUPHAR_LIGAND_ID
4585	INN_ID
VZI5B1W380	UNII
32624	RXNORM
121517	MMSL
8631	MMSL
d04513	MMSL
006035	NDDF
116511002	SNOMEDCT_US
387025007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Oxcarbazepine	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0199	SUSPENSION	300 mg	ORAL	ANDA	30 sections
Oxcarbazepine	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0199	SUSPENSION	300 mg	ORAL	ANDA	30 sections
Trileptal	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0337	TABLET, FILM COATED	300 mg	ORAL	NDA	33 sections
Trileptal	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0337	TABLET, FILM COATED	300 mg	ORAL	NDA	33 sections
Trileptal	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0337	TABLET, FILM COATED	300 mg	ORAL	NDA	33 sections
Trileptal	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0357	SUSPENSION	60 mg	ORAL	NDA	33 sections
Trileptal	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0357	SUSPENSION	60 mg	ORAL	NDA	33 sections
Trileptal	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0357	SUSPENSION	60 mg	ORAL	NDA	33 sections
Trileptal	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0456	TABLET, FILM COATED	150 mg	ORAL	NDA	33 sections
Trileptal	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0456	TABLET, FILM COATED	150 mg	ORAL	NDA	33 sections
Trileptal	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0456	TABLET, FILM COATED	150 mg	ORAL	NDA	33 sections
Trileptal	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0457	TABLET, FILM COATED	600 mg	ORAL	NDA	33 sections
Trileptal	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0457	TABLET, FILM COATED	600 mg	ORAL	NDA	33 sections
Trileptal	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0457	TABLET, FILM COATED	600 mg	ORAL	NDA	33 sections
Oxcarbazepine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8153	TABLET, FILM COATED	150 mg	ORAL	ANDA	30 sections
Oxcarbazepine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8153	TABLET, FILM COATED	150 mg	ORAL	ANDA	30 sections
Oxcarbazepine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8292	TABLET, FILM COATED	300 mg	ORAL	ANDA	30 sections
Oxcarbazepine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8292	TABLET, FILM COATED	300 mg	ORAL	ANDA	30 sections
Oxcarbazepine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8447	TABLET, FILM COATED	150 mg	ORAL	ANDA	28 sections
Oxcarbazepine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8448	TABLET, FILM COATED	300 mg	ORAL	ANDA	28 sections
Oxcarbazepine	HUMAN PRESCRIPTION DRUG LABEL	1	0781-6270	SUSPENSION	60 mg	ORAL	NDA authorized generic	31 sections
Oxcarbazepine	HUMAN PRESCRIPTION DRUG LABEL	1	0781-6270	SUSPENSION	60 mg	ORAL	NDA authorized generic	31 sections
OXCARBAZEPINE	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7262	TABLET, FILM COATED	150 mg	ORAL	ANDA	32 sections
OXCARBAZEPINE	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7263	TABLET, FILM COATED	300 mg	ORAL	ANDA	32 sections
OXCARBAZEPINE	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7264	TABLET, FILM COATED	600 mg	ORAL	ANDA	32 sections
OXTELLAR XR	HUMAN PRESCRIPTION DRUG LABEL	1	17772-121	TABLET	150 mg	ORAL	NDA	34 sections
OXTELLAR XR	HUMAN PRESCRIPTION DRUG LABEL	1	17772-121	TABLET	150 mg	ORAL	NDA	34 sections
OXTELLAR XR	HUMAN PRESCRIPTION DRUG LABEL	1	17772-121	TABLET	150 mg	ORAL	NDA	34 sections
OXTELLAR XR	HUMAN PRESCRIPTION DRUG LABEL	1	17772-121	TABLET	150 mg	ORAL	NDA	34 sections
OXTELLAR XR	HUMAN PRESCRIPTION DRUG LABEL	1	17772-122	TABLET	300 mg	ORAL	NDA	34 sections