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Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
alpha-2 adrenoreceptor agonists	2683	51322-75-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: DS 103-282 tizanidine tizanidine hydrochloride tizanidine HCl AN021 DS103-282	Tizanidine is an agonist at alpha2-adrenergic receptor sites and presumably reduces spasticity by increasing presynaptic inhibition of motor neurons. In animal models, tizanidine has no direct effect on skeletal muscle fibers or the neuromuscular junction, and no major effect on monosynaptic spinal reflexes. The effects of tizanidine are greatest on polysynaptic pathways. The overall effect of these actions is thought to reduce facilitation of spinal motor neurons. Molecular weight: 253.71 Formula: C9H8ClN5S CLOGP: 2.32 LIPINSKI: 0 HAC: 5 HDO: 2 TPSA: 62.20 ALOGS: -3.28 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

DS 103-282
tizanidine
tizanidine hydrochloride
tizanidine HCl
AN021
DS103-282

Tizanidine is an agonist at alpha2-adrenergic receptor sites and presumably reduces spasticity by increasing presynaptic inhibition of motor neurons. In animal models, tizanidine has no direct effect on skeletal muscle fibers or the neuromuscular junction, and no major effect on monosynaptic spinal reflexes. The effects of tizanidine are greatest on polysynaptic pathways. The overall effect of these actions is thought to reduce facilitation of spinal motor neurons.

Molecular weight: 253.71
Formula: C9H8ClN5S
CLOGP: 2.32
LIPINSKI: 0
HAC: 5
HDO: 2
TPSA: 62.20
ALOGS: -3.28
ROTB: 1

Status: OFP

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

Drug dosage:

Dose	Unit	Route
12	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	2.36 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	21 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	2.40 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	11 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.70 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2.40 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	18.25 mg/mL	Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	0.739		High	1
caco2-efflux	Caco-2 efflux ratio (BA/AB)	1.167		High	1
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	15.631	10^-6 cm/s	High	1
dh-clint	Dog hepatocyte intrinsic clearance	4.519	uL/min/10^6 cells	High	1
dppb	Dog plasma protein binding (% unbound)	68.580	%	High	1
fcs-ppb	Fetal calf serum protein binding (% unbound)	77.250	%	High	1
herg	hERG pIC50	4.667	pIC50	High	1
hh-clint	Human hepatocyte intrinsic clearance	1.054	uL/min/10^6 cells	High	1
hlm-clint	Human liver microsomal intrinsic clearance	7.096	uL/min/mg protein	High	1
hppb	Human plasma protein binding (% unbound)	60.770	%	High	1
kinase-safety-class	ACVR2B,AURKA,AXL,BRAF,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,MAP3K1,MAP3K21,MAP3K7,MAPK10,MAPK7,MARK4,NTRK2,PDK2,PDK4,PDPK1,PIK3CB,PRKDC,SIK2,SIK3,STK33,TEK,TTK	34
kinase-selectivity-class	CDK9,GRK2,MAPK7,PDK1	4
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	2.466		High	1
mh-clint	Mouse hepatocyte intrinsic clearance	13.183		High	1
mppb	Mouse plasma protein binding (% unbound)	70.910		High	1
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	3.199		High	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pld-class	Phospholipidosis risk class (1 = positive, 0 = negative)	0		High	1
pppb	Pig plasma protein binding (% unbound)	70.050	%	High	1
rh-clint	Rat hepatocyte intrinsic clearance	8.375	uL/min/10^6 cells	High	1
rh-fuinc	Rat hepatocyte fraction unbound in incubation	93.360	%	High	1
rppb	Rat plasma protein binding (% unbound)	66.310	%	High	1
solubility-dd	Solubility at pH 7.4 in DMSO	872.971	uM	High	1

Approvals:

Date	Agency	Company	Orphan
Nov. 27, 1996	FDA	ACORDA

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
Multiple sclerosis relapse	458.16	10.74	342	63379	51963	90512763
Completed suicide	450.19	10.74	532	63189	144526	90420200
Pneumonia aspiration	260.59	10.74	222	63499	40718	90524008
Multiple sclerosis	232.51	10.74	177	63544	27663	90537063
Somnolence	222.92	10.74	469	63252	208615	90356111
Synovitis	200.75	10.74	7	63714	329745	90234981
Hand deformity	192.98	10.74	3	63718	296359	90268367
Glossodynia	191.88	10.74	8	63713	321771	90242955
Coma	172.00	10.74	233	63488	72399	90492327
Pericarditis	170.77	10.74	4	63717	270147	90294579
Systemic lupus erythematosus	162.87	10.74	29	63692	361867	90202859
Suspected suicide	160.68	10.74	94	63627	9474	90555252
Contraindicated product administered	152.26	10.74	22	63699	320117	90244609
Lower respiratory tract infection	150.19	10.74	6	63715	250653	90314073
Infusion related reaction	148.16	10.74	54	63667	416726	90148000
Product dose omission issue	144.26	10.74	492	63229	291195	90273531
Helicobacter infection	140.95	10.74	4	63717	226846	90337880
Fall	139.17	10.74	688	63033	481122	90083604
Maternal exposure during pregnancy	136.07	10.74	42	63679	360021	90204705
Drug withdrawal syndrome	134.23	10.74	131	63590	28592	90536134
Folliculitis	122.04	10.74	5	63716	204348	90360378
Urinary tract infection	120.39	10.74	479	63242	305153	90259573
Drug intolerance	120.17	10.74	84	63637	447507	90117219
Gastrooesophageal reflux disease	113.37	10.74	314	63407	166023	90398703
Wound	113.27	10.74	36	63685	302944	90261782
Depression	112.73	10.74	464	63257	300137	90264589
General physical health deterioration	111.77	10.74	55	63666	355060	90209666
Muscle injury	100.13	10.74	6	63715	176648	90388078
Treatment failure	92.74	10.74	49	63672	303879	90260847
Exposure during pregnancy	89.67	10.74	28	63693	238382	90326344
Withdrawal syndrome	89.30	10.74	94	63627	22430	90542296
Back pain	85.14	10.74	444	63277	316731	90247995
Hepatic enzyme increased	85.09	10.74	77	63644	360659	90204067
Joint swelling	84.41	10.74	140	63581	503160	90061566
Tremor	84.23	10.74	268	63453	152905	90411821
Impaired healing	78.76	10.74	33	63688	234166	90330560
Liver injury	78.13	10.74	13	63708	170554	90394172
Arthropathy	77.42	10.74	86	63635	366156	90198570
Sleep disorder due to general medical condition, insomnia type	77.33	10.74	3	63718	128691	90436035
Surgery	66.61	10.74	116	63605	44771	90519955
Migraine	65.17	10.74	286	63435	190106	90374620
COVID-19	64.28	10.74	262	63459	168581	90396145
C-reactive protein increased	61.88	10.74	25	63696	181364	90383362
Feeling abnormal	61.69	10.74	257	63464	166978	90397748
Therapeutic product effect decreased	61.07	10.74	63	63658	277508	90287218
Gait disturbance	60.69	10.74	351	63370	260145	90304581
Toxicity to various agents	60.15	10.74	377	63344	287469	90277257
Irritable bowel syndrome	59.58	10.74	36	63685	207412	90357314
Neutropenia	59.24	10.74	43	63678	224861	90339865
Hypersensitivity	57.94	10.74	148	63573	454529	90110197
Type 2 diabetes mellitus	57.36	10.74	36	63685	203208	90361518
Off label use	57.36	10.74	498	63223	1101754	89462972
Ill-defined disorder	56.09	10.74	30	63691	184861	90379865
Dysphoria	55.54	10.74	41	63680	6113	90558613
Febrile neutropenia	52.13	10.74	23	63698	158326	90406400
Headache	51.63	10.74	872	62849	861874	89702852
Stomatitis	51.21	10.74	71	63650	274627	90290099
Thrombocytopenia	51.05	10.74	43	63678	208682	90356044
Seizure	50.49	10.74	227	63494	152402	90412324
Muscle spasms	50.20	10.74	326	63395	251557	90313169
Therapy interrupted	49.38	10.74	109	63612	49999	90514727
Illness	49.28	10.74	148	63573	81821	90482905
Swelling	49.17	10.74	142	63579	418916	90145810
Facet joint syndrome	48.54	10.74	6	63715	98383	90466343
Vision blurred	48.36	10.74	179	63542	110114	90454612
Anxiety	47.85	10.74	377	63344	309395	90255331
Pulmonary fibrosis	47.47	10.74	9	63712	107494	90457232
Cardio-respiratory arrest	46.79	10.74	123	63598	63017	90501709
Product use issue	46.29	10.74	102	63619	329817	90234909
Stiff person syndrome	45.63	10.74	16	63705	478	90564248
Autonomic dysreflexia	45.46	10.74	15	63706	371	90564355
Alopecia	45.10	10.74	187	63534	494884	90069842
Injury	44.29	10.74	44	63677	197305	90367421
Live birth	43.88	10.74	3	63718	79104	90485622
Sleep apnoea syndrome	43.20	10.74	79	63642	31668	90533058
Vitamin D deficiency	42.56	10.74	57	63664	17499	90547227
Influenza like illness	42.43	10.74	139	63582	80472	90484254
Blister	41.69	10.74	72	63649	254926	90309800
Hypercholesterolaemia	41.37	10.74	10	63711	100882	90463844
Intervertebral disc protrusion	41.29	10.74	71	63650	27125	90537601
Product administration interrupted	40.63	10.74	47	63674	12445	90552281
Gastrointestinal disorder	40.59	10.74	74	63647	256613	90308113
Balance disorder	40.44	10.74	155	63566	96925	90467801
Injection site pain	40.39	10.74	234	63487	173465	90391261
Neuralgia	39.88	10.74	76	63645	31424	90533302
Abdominal discomfort	39.42	10.74	187	63534	477141	90087585
Neck pain	38.06	10.74	170	63551	113793	90450933
Loss of consciousness	38.03	10.74	197	63524	140041	90424685
Pre-existing condition improved	37.66	10.74	39	63682	9130	90555596
Suicidal ideation	35.90	10.74	124	63597	73731	90490995
Respiratory arrest	35.73	10.74	75	63646	33236	90531490
Stress	35.59	10.74	132	63589	81263	90483463
Discomfort	35.13	10.74	89	63632	274246	90290480
Peripheral venous disease	35.04	10.74	8	63713	83913	90480813
Bursitis	34.88	10.74	25	63696	131629	90433097
Malignant neoplasm progression	34.42	10.74	16	63705	106854	90457872
Joint range of motion decreased	34.34	10.74	27	63694	135616	90429110
Lung disorder	34.11	10.74	33	63688	149850	90414876
Hallucination	34.05	10.74	113	63608	65846	90498880
Blood cholesterol increased	33.75	10.74	59	63662	207953	90356773
Therapeutic response unexpected	33.05	10.74	57	63664	21823	90542903
Grip strength decreased	32.82	10.74	12	63709	92564	90472162
Wound infection	32.65	10.74	17	63704	106385	90458341
Hypotension	32.57	10.74	361	63360	325036	90239690
Spinal operation	32.55	10.74	38	63683	10158	90554568
Inflammation	32.43	10.74	47	63674	178545	90386181
Liver disorder	32.16	10.74	23	63698	121246	90443480
JC polyomavirus test positive	31.04	10.74	18	63703	1784	90562942
Pain	29.74	10.74	913	62808	995428	89569298
Myalgia	29.73	10.74	218	63503	174907	90389819
Nausea	29.67	10.74	1004	62717	1109312	89455414
Adjustment disorder with depressed mood	29.15	10.74	3	63718	56750	90507976
Panic attack	29.02	10.74	60	63661	26305	90538421
Pyrexia	28.48	10.74	312	63409	660173	89904553
Muscle spasticity	28.43	10.74	71	63650	35251	90529475
Chills	28.23	10.74	174	63547	131807	90432919
Mental status changes	28.11	10.74	82	63639	44597	90520129
Nervousness	27.99	10.74	69	63652	33987	90530739
Pancytopenia	27.92	10.74	26	63695	120237	90444489
Spinal osteoarthritis	27.78	10.74	49	63672	19099	90545627
Nasopharyngitis	27.77	10.74	170	63551	406934	90157792
Blood pressure systolic increased	27.72	10.74	4	63717	58341	90506385
Neurogenic bladder	27.69	10.74	22	63699	3656	90561070
Urinary incontinence	27.64	10.74	73	63648	37493	90527233
Appetite disorder	27.44	10.74	33	63688	9100	90555626
Haemorrhagic diathesis	27.32	10.74	26	63695	5498	90559228
Impaired gastric emptying	27.17	10.74	39	63682	12770	90551956
Autoimmune disorder	27.12	10.74	10	63711	76734	90487992
Epilepsy	26.95	10.74	12	63709	82194	90482532
Skin warm	26.83	10.74	30	63691	7657	90557069
Visual impairment	26.76	10.74	172	63549	132193	90432533
Disturbance in attention	26.39	10.74	83	63638	47026	90517700
Hypoaesthesia	26.33	10.74	337	63384	313873	90250853
Decreased interest	26.21	10.74	23	63698	4384	90560342
Therapy cessation	26.09	10.74	70	63651	36291	90528435
Bronchitis	25.75	10.74	190	63531	152737	90411989
Ankle fracture	25.60	10.74	49	63672	20321	90544405
Thinking abnormal	25.30	10.74	36	63685	11696	90553030
Lumbar radiculopathy	25.05	10.74	18	63703	2573	90562153
Rheumatoid arthritis	24.95	10.74	151	63570	362463	90202263
Intervertebral disc degeneration	24.79	10.74	44	63677	17230	90547496
Peroneal nerve palsy	24.60	10.74	25	63696	5723	90559003
Dysarthria	24.36	10.74	89	63632	54393	90510333
Serotonin syndrome	24.28	10.74	70	63651	37817	90526909
Central nervous system lesion	24.04	10.74	35	63686	11611	90553115
Drug dependence	23.66	10.74	59	63662	29268	90535458
Drug interaction	23.37	10.74	297	63424	276156	90288570
Temperature intolerance	23.17	10.74	35	63686	11995	90552731
Red blood cell sedimentation rate increased	22.78	10.74	15	63706	82580	90482146
Formication	22.66	10.74	22	63699	4769	90559957
Head injury	22.33	10.74	60	63661	31128	90533598
Crying	22.19	10.74	53	63668	25592	90539134
Suspected product quality issue	21.80	10.74	9	63712	423	90564303
Prescribed overdose	21.63	10.74	22	63699	97603	90467123
Blepharospasm	19.97	10.74	7	63714	55438	90509288
Lupus-like syndrome	19.72	10.74	5	63716	48841	90515885
Blood potassium decreased	19.70	10.74	76	63645	47651	90517075
Cardiac failure	19.69	10.74	29	63692	109467	90455259
Hepatic cirrhosis	19.56	10.74	10	63711	63243	90501483
Diplopia	19.33	10.74	54	63667	28660	90536066
Coeliac disease	19.13	10.74	4	63717	44606	90520120
Muscle tightness	18.99	10.74	34	63687	13405	90551321
Bladder disorder	18.87	10.74	30	63691	10742	90553984
Dry skin	18.76	10.74	116	63605	87957	90476769
Insomnia	18.72	10.74	334	63387	333140	90231586
Burning sensation	18.50	10.74	91	63630	63361	90501365
Photophobia	18.45	10.74	44	63677	21225	90543501
Disease progression	18.39	10.74	53	63668	156562	90408164
Cervical spinal stenosis	18.23	10.74	15	63706	2620	90562106
Injection site bruising	18.19	10.74	79	63642	52228	90512498
Nerve injury	18.19	10.74	30	63691	11076	90553650
Rash	18.12	10.74	424	63297	795676	89769050
Injection site erythema	18.09	10.74	125	63596	98377	90466349
Sinus bradycardia	17.98	10.74	38	63683	16914	90547812
Nerve compression	17.93	10.74	29	63692	10537	90554189
Psoriatic arthropathy	17.92	10.74	91	63630	228244	90336482
Liver function test increased	17.82	10.74	20	63701	84835	90479891
Initial insomnia	17.81	10.74	27	63694	9283	90555443
Areflexia	17.70	10.74	17	63704	3636	90561090
Secondary progressive multiple sclerosis	17.68	10.74	12	63709	1567	90563159
Dermatitis atopic	17.66	10.74	46	63675	23426	90541300
Pollakiuria	17.44	10.74	57	63664	32948	90531778
Irritability	17.43	10.74	60	63661	35602	90529124
Progressive multiple sclerosis	17.33	10.74	11	63710	1283	90563443
Dizziness	17.24	10.74	539	63182	588745	89975981
Bradycardia	16.97	10.74	109	63612	83738	90480988
Pneumonitis	16.93	10.74	5	63716	44165	90520561
Sinus disorder	16.88	10.74	58	63663	34389	90530337
Decorticate posture	16.78	10.74	7	63714	338	90564388
Paraesthesia	16.73	10.74	258	63463	250068	90314658
Intentional product misuse	16.63	10.74	114	63607	89490	90475236
Delirium	16.56	10.74	30	63691	104329	90460397
Mucosal inflammation	16.53	10.74	10	63711	57615	90507111
Arthritis infective	16.47	10.74	24	63697	7968	90556758
Product dose omission in error	16.28	10.74	41	63680	20462	90544264
Foot deformity	16.23	10.74	11	63710	59640	90505086
Muscular weakness	16.19	10.74	219	63502	206447	90358279
Loss of control of legs	16.19	10.74	11	63710	1439	90563287
Hypertonia	16.10	10.74	19	63702	5136	90559590
Cholestasis	16.10	10.74	3	63718	36296	90528430
Fatigue	16.07	10.74	977	62744	1153046	89411680
Neutrophil count decreased	15.98	10.74	16	63705	71516	90493210
Nail disorder	15.92	10.74	11	63710	59056	90505670
Dysstasia	15.78	10.74	46	63675	25006	90539720
Syncope	15.53	10.74	152	63569	132511	90432215
Blood pressure increased	15.45	10.74	209	63512	197008	90367718
Memory impairment	15.44	10.74	209	63512	197035	90367691
Hyperhidrosis	15.39	10.74	155	63566	136150	90428576
Intervertebral disc disorder	15.23	10.74	19	63702	5441	90559285
Respiratory alkalosis	14.76	10.74	15	63706	3433	90561293
Somnambulism	14.76	10.74	20	63701	6208	90558518
Jejunectomy	14.74	10.74	4	63717	49	90564677
Nephrolithiasis	14.74	10.74	71	63650	49014	90515712
Thrombosis	14.68	10.74	95	63626	73156	90491570
Influenza	14.60	10.74	156	63565	139108	90425618
Conduction disorder	14.41	10.74	11	63710	1724	90563002
Urosepsis	14.36	10.74	40	63681	21192	90543534
Concussion	14.33	10.74	27	63694	11064	90553662
Cervical radiculopathy	14.16	10.74	10	63711	1392	90563334
Breakthrough pain	14.12	10.74	10	63711	1397	90563329
Intentional product use issue	14.03	10.74	92	63629	216800	90347926
Mobility decreased	13.98	10.74	111	63610	250623	90314103
Aberrant aortic arch	13.96	10.74	3	63718	12	90564714
Fibula fracture	13.88	10.74	16	63705	4221	90560505
Withdrawal hypertension	13.82	10.74	5	63716	164	90564562
Bedridden	13.79	10.74	28	63693	12120	90552606
Premature delivery	13.78	10.74	5	63716	38757	90525969
Asthenia	13.75	10.74	481	63240	533270	90031456
Shrinking lung syndrome	13.65	10.74	5	63716	170	90564556
Frequent bowel movements	13.58	10.74	12	63709	56923	90507803
Breast cancer stage II	13.54	10.74	4	63717	35330	90529396
Drug tolerance decreased	13.54	10.74	3	63718	32127	90532599
Constipation	13.39	10.74	274	63447	280121	90284605
Vaginitis gardnerella	13.37	10.74	4	63717	71	90564655
Dyspepsia	13.36	10.74	83	63638	198077	90366649
Device expulsion	13.35	10.74	6	63715	40880	90523846
Post-traumatic stress disorder	13.34	10.74	20	63701	6808	90557918
Dysphagia	13.31	10.74	129	63592	112149	90452577
Emotional distress	13.23	10.74	56	63665	36606	90528120
Therapeutic product effect incomplete	13.18	10.74	81	63640	193815	90370911
Blood pressure orthostatic	13.06	10.74	4	63717	77	90564649
Fungal infection	13.02	10.74	62	63659	42599	90522127
Lymphocyte count decreased	13.01	10.74	54	63667	34996	90529730
Spinal pain	13.01	10.74	32	63689	15735	90548991
Tenderness	12.96	10.74	45	63676	26823	90537903
Vitamin D decreased	12.88	10.74	27	63694	11952	90552774
Abnormal dreams	12.84	10.74	26	63695	11231	90553495
Dehydration	12.83	10.74	200	63521	194247	90370479
Unresponsive to stimuli	12.82	10.74	57	63664	38064	90526662
Therapy non-responder	12.81	10.74	51	63670	136653	90428073
Pregnancy	12.62	10.74	15	63706	62032	90502694
Ligament sprain	12.44	10.74	30	63691	14569	90550157
Taste disorder	12.39	10.74	15	63706	61531	90503195
Skin burning sensation	12.34	10.74	36	63685	19575	90545151
Speech disorder	12.32	10.74	64	63657	45521	90519205
Impaired quality of life	12.25	10.74	40	63681	23104	90541622
Urinary tract disorder	12.13	10.74	14	63707	3697	90561029
Finger deformity	12.11	10.74	4	63717	32893	90531833
Drug ineffective	12.10	10.74	825	62896	1383473	89181253
Night sweats	12.09	10.74	48	63673	128718	90436008
Limb injury	12.06	10.74	49	63672	31459	90533267
Vitamin B12 deficiency	11.96	10.74	20	63701	7466	90557260
Spinal stenosis	11.95	10.74	33	63688	17391	90547335
Musculoskeletal pain	11.92	10.74	71	63650	171180	90393546
Hand fracture	11.86	10.74	19	63702	6846	90557880
Sleep disorder	11.82	10.74	86	63635	197944	90366782
Optic neuritis	11.82	10.74	23	63698	9655	90555071
Colitis ulcerative	11.80	10.74	15	63706	60251	90504475
Urticaria	11.80	10.74	152	63569	312582	90252144
Bone marrow failure	11.72	10.74	4	63717	32217	90532509
Knee operation	11.72	10.74	19	63702	6917	90557809
Micturition urgency	11.71	10.74	25	63696	11208	90553518
Injection site swelling	11.62	10.74	77	63644	59762	90504964
Adverse event	11.52	10.74	43	63678	117375	90447351
Paranoia	11.52	10.74	27	63694	12881	90551845
Nerve conduction studies abnormal	11.43	10.74	3	63718	32	90564694
Neuromyelitis optica spectrum disorder	11.40	10.74	9	63712	1481	90563245
CSF immunoglobulin increased	11.39	10.74	4	63717	120	90564606
Paraplegia	11.37	10.74	13	63708	3399	90561327
Enuresis	11.36	10.74	13	63708	3401	90561325
Application site erythema	11.26	10.74	16	63705	5192	90559534
International normalised ratio increased	11.25	10.74	10	63711	47306	90517420
Autonomic nervous system imbalance	11.25	10.74	13	63708	3437	90561289
Brain death	11.23	10.74	14	63707	4007	90560719
Autoimmune thyroiditis	11.14	10.74	17	63704	5876	90558850
Magnetic resonance imaging abnormal	11.14	10.74	13	63708	3473	90561253
CD4 lymphocytes decreased	11.11	10.74	9	63712	1538	90563188
Progressive multifocal leukoencephalopathy	11.09	10.74	30	63691	15625	90549101
Spinal disorder	11.05	10.74	25	63696	11654	90553072
Acute febrile neutrophilic dermatosis	10.97	10.74	13	63708	3532	90561194
Hyperkalaemia	10.92	10.74	18	63703	64946	90499780
Neurodermatitis	10.85	10.74	12	63709	3026	90561700
Neck surgery	10.81	10.74	10	63711	2040	90562686
Increased tendency to bruise	10.75	10.74	25	63696	11865	90552861

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
Completed suicide	164.89	13.87	206	18286	96259	42506584
Multiple sclerosis relapse	110.99	13.87	72	18420	14192	42588651
Multiple sclerosis	108.84	13.87	57	18435	7541	42595302
Drug withdrawal syndrome	101.22	13.87	80	18412	21469	42581374
Potassium wasting nephropathy	67.49	13.87	14	18478	82	42602761
Failure to suspend medication	61.03	13.87	17	18475	385	42602458
Febrile neutropenia	59.14	13.87	6	18486	185697	42417146
Intervertebral disc protrusion	53.91	13.87	42	18450	11030	42591813
Muscle spasticity	51.99	13.87	34	18458	6788	42596055
Serotonin syndrome	50.24	13.87	59	18433	25786	42577057
Suspected suicide	49.96	13.87	32	18460	6167	42596676
Muscle spasms	49.64	13.87	113	18379	85931	42516912
Anxiety	46.89	13.87	135	18357	118425	42484418
Back pain	44.54	13.87	149	18343	141627	42461216
Depression	41.34	13.87	124	18368	111239	42491604
Pain	41.02	13.87	212	18280	244636	42358207
Urinary tract infection	38.22	13.87	112	18380	99172	42503671
Fall	35.15	13.87	197	18295	234323	42368520
Road traffic accident	34.50	13.87	42	18450	19051	42583792
Protein S decreased	34.02	13.87	8	18484	89	42602754
Optic nerve operation	32.58	13.87	11	18481	481	42602362
Anaemia	32.03	13.87	45	18447	280233	42322610
Accidental death	30.14	13.87	18	18474	3065	42599778
Perineal infection	29.55	13.87	11	18481	641	42602202
Neutropenia	29.37	13.87	26	18466	199405	42403438
General physical health deterioration	28.55	13.87	15	18477	151231	42451612
Hypoaesthesia	26.90	13.87	80	18412	71383	42531460
Scrotal infection	26.81	13.87	11	18481	832	42602011
Progressive multiple sclerosis	26.24	13.87	8	18484	251	42602592
Kidney enlargement	26.08	13.87	11	18481	892	42601951
Spinal fusion surgery	25.90	13.87	12	18480	1217	42601626
Infected dermal cyst	25.73	13.87	11	18481	922	42601921
Thrombocytopenia	25.46	13.87	27	18465	190252	42412591
Wrong patient received product	25.23	13.87	17	18475	3566	42599277
Hyponatraemia	24.19	13.87	7	18485	101455	42501388
Drug abuser	23.07	13.87	16	18476	3515	42599328
Tooth injury	22.64	13.87	11	18481	1240	42601603
Secondary progressive multiple sclerosis	22.48	13.87	8	18484	410	42602433
Neuralgia	22.33	13.87	40	18452	25607	42577236
Inadequate analgesia	22.11	13.87	15	18477	3182	42599661
Intracranial aneurysm	21.77	13.87	12	18480	1756	42601087
Motor dysfunction	21.77	13.87	22	18470	8124	42594719
Muscular weakness	21.27	13.87	82	18410	83416	42519427
Withdrawal syndrome	21.20	13.87	29	18463	14746	42588097
Persistent depressive disorder	21.10	13.87	8	18484	491	42602352
Off label use	20.98	13.87	177	18315	638158	41964685
Spinal cord injury cauda equina	20.98	13.87	6	18486	150	42602693
Sedation	20.96	13.87	43	18449	30432	42572411
Somatosensory evoked potentials abnormal	20.54	13.87	6	18486	162	42602681
Arteriovenous fistula	20.46	13.87	10	18482	1142	42601701
Drug dependence	19.95	13.87	41	18451	29053	42573790
Urobilinogen urine increased	19.80	13.87	7	18485	352	42602491
Albuminuria	19.59	13.87	8	18484	598	42602245
Back disorder	19.55	13.87	20	18472	7494	42595349
Pancytopenia	19	13.87	14	18478	117729	42485114
Feeling abnormal	18.99	13.87	70	18422	69716	42533127
Insomnia	18.78	13.87	101	18391	118152	42484691
Memory impairment	18.68	13.87	56	18436	50166	42552677
Toxicity to various agents	18.64	13.87	166	18326	228970	42373873
Hypotension	18.64	13.87	182	18310	257449	42345394
Gait disturbance	18.59	13.87	88	18404	97912	42504931
Movement disorder	18.35	13.87	27	18465	14671	42588172
Respiratory arrest	18.25	13.87	39	18453	28385	42574458
Unemployment	17.78	13.87	4	18488	36	42602807
Dysdiadochokinesis	17.67	13.87	6	18486	267	42602576
Urine uric acid decreased	17.48	13.87	5	18487	125	42602718
Therapy interrupted	17.23	13.87	33	18459	22217	42580626
Urinary sediment abnormal	17.22	13.87	5	18487	132	42602711
Umbilical hernia	16.97	13.87	16	18476	5431	42597412
Blood folate increased	16.74	13.87	6	18486	314	42602529
Lipomatosis	16.72	13.87	6	18486	315	42602528
Gait inability	16.63	13.87	33	18459	22800	42580043
Vitamin B6 deficiency	16.43	13.87	6	18486	331	42602512
Back injury	15.95	13.87	14	18478	4334	42598509
Balance disorder	15.75	13.87	51	18441	47594	42555249
Fear of falling	15.73	13.87	6	18486	374	42602469
False positive investigation result	15.63	13.87	7	18485	656	42602187
Disease progression	15.46	13.87	24	18468	143632	42459211
Dermal cyst	15.30	13.87	10	18482	1993	42600850
Drug tolerance	14.98	13.87	12	18480	3278	42599565
Autonomic dysreflexia	14.93	13.87	4	18488	78	42602765
Decreased vibratory sense	14.88	13.87	6	18486	434	42602409
Mental status changes	14.76	13.87	46	18446	42069	42560774
Implant site infection	14.63	13.87	8	18484	1153	42601690
Cardio-respiratory arrest	14.45	13.87	57	18435	58579	42544264
Dizziness	14.25	13.87	168	18324	249086	42353757
Anal haemorrhage	14.20	13.87	11	18481	2862	42599981
Spinal osteoarthritis	13.92	13.87	18	18474	8668	42594175
Emotional distress	13.88	13.87	25	18467	16068	42586775

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
Completed suicide	627.30	10.99	740	63951	241641	110282967
Multiple sclerosis relapse	436.24	10.99	304	64387	49936	110474672
Multiple sclerosis	274.71	10.99	177	64514	25521	110499087
Drug withdrawal syndrome	212.43	10.99	177	64514	37877	110486731
Suspected suicide	198.68	10.99	119	64572	15080	110509528
Pneumonia aspiration	175.76	10.99	227	64464	81006	110443602
Urinary tract infection	158.84	10.99	485	64206	325797	110198811
Somnolence	156.98	10.99	455	64236	296994	110227614
Synovitis	138.18	10.99	5	64686	274087	110250521
Fall	133.15	10.99	700	63991	602782	109921826
General physical health deterioration	115.69	10.99	52	64639	425243	110099365
Coma	115.03	10.99	229	64462	117640	110406968
Hand deformity	113.68	10.99	3	64688	218503	110306105
Pericarditis	107.07	10.99	5	64686	219109	110305499
Febrile neutropenia	106.49	10.99	27	64664	316740	110207868
Lower respiratory tract infection	105.80	10.99	10	64681	243096	110281512
Glossodynia	102.54	10.99	7	64684	221997	110302611
Depression	100.11	10.99	409	64282	316926	110207682
Back pain	94.88	10.99	449	64242	370547	110154061
Product dose omission issue	93.15	10.99	404	64287	321378	110203230
Helicobacter infection	92.77	10.99	3	64688	181874	110342734
Gastrooesophageal reflux disease	91.67	10.99	272	64419	179704	110344904
Off label use	89.10	10.99	515	64176	1499670	109024938
Toxicity to various agents	85.15	10.99	526	64165	480029	110044579
Systemic lupus erythematosus	84.85	10.99	22	64669	254316	110270292
Withdrawal syndrome	82.88	10.99	97	64594	31283	110493325
Neutropenia	80.33	10.99	61	64630	374559	110150049
Infusion related reaction	76.81	10.99	66	64625	381096	110143512
Maternal exposure during pregnancy	76.08	10.99	27	64664	254856	110269752
Drug intolerance	73.05	10.99	78	64613	406434	110118174
Folliculitis	72.66	10.99	7	64684	167646	110356962
Intervertebral disc protrusion	72.13	10.99	85	64606	27613	110496995
Gait disturbance	66.96	10.99	331	64360	277877	110246731
Contraindicated product administered	66.46	10.99	31	64660	248236	110276372
Pain	66.09	10.99	850	63841	954105	109570503
Migraine	65.38	10.99	235	64456	171417	110353191
Thrombocytopenia	64.87	10.99	65	64626	348820	110175788
Muscle spasms	63.46	10.99	326	64365	277831	110246777
Muscle injury	63.41	10.99	5	64686	140802	110383806
Autonomic dysreflexia	60.64	10.99	19	64672	480	110524128
Serotonin syndrome	60.19	10.99	117	64574	59036	110465572
Feeling abnormal	60.19	10.99	237	64454	180474	110344134
Cardio-respiratory arrest	57.94	10.99	174	64517	115662	110408946
Potassium wasting nephropathy	54.19	10.99	14	64677	171	110524437
Surgery	53.91	10.99	91	64600	41192	110483416
Muscle spasticity	52.07	10.99	83	64608	35832	110488776
Anxiety	50.91	10.99	361	64330	344717	110179891
Sleep disorder due to general medical condition, insomnia type	49.75	10.99	3	64688	105640	110418968
Tremor	49.62	10.99	242	64449	201990	110322618
Failure to suspend medication	48.77	10.99	16	64675	470	110524138
Headache	48.73	10.99	755	63936	881622	109642986
C-reactive protein increased	48.61	10.99	34	64657	217885	110306723
Neck pain	46.38	10.99	168	64523	122962	110401646
Hepatic enzyme increased	45.87	10.99	73	64618	320819	110203789
Treatment failure	45.66	10.99	57	64634	277177	110247431
COVID-19	45.06	10.99	271	64420	244789	110279819
Respiratory arrest	44.99	10.99	103	64588	58196	110466412
Exposure during pregnancy	44.65	10.99	21	64670	167403	110357205
Dysphoria	44.63	10.99	34	64657	6394	110518214
Joint swelling	44.58	10.99	123	64568	442722	110081886
Stiff person syndrome	43.98	10.99	16	64675	644	110523964
Pancytopenia	43.80	10.99	35	64656	209578	110315030
Impaired healing	43.47	10.99	31	64660	196686	110327922
Liver injury	43.08	10.99	17	64674	150396	110374212
Mental status changes	42.55	10.99	119	64572	76003	110448605
Hypoaesthesia	41.93	10.99	321	64370	313902	110210706
Wound	40.95	10.99	46	64645	234391	110290217
Hypersensitivity	40.81	10.99	112	64579	403886	110120722
Facet joint syndrome	39.53	10.99	5	64686	96823	110427785
Hypotension	38.98	10.99	473	64218	523376	110001232
Product administration interrupted	38.65	10.99	40	64651	11252	110513356
Influenza like illness	37.96	10.99	126	64565	88286	110436322
Neuralgia	37.80	10.99	86	64605	48392	110476216
Malignant neoplasm progression	36.65	10.99	29	64662	174538	110350070
Visual impairment	35.98	10.99	165	64526	134263	110390345
Inflammation	35.89	10.99	36	64655	193202	110331406
Lung disorder	35.24	10.99	32	64659	180015	110344593
Therapy interrupted	35.15	10.99	85	64606	49737	110474871
JC polyomavirus test positive	34.95	10.99	20	64671	2327	110522281
Balance disorder	34.93	10.99	148	64543	116412	110408196
Stomatitis	34.50	10.99	66	64625	270176	110254432
Ill-defined disorder	34.28	10.99	25	64666	156828	110367780
Spinal osteoarthritis	33.99	10.99	50	64641	20133	110504475
Irritable bowel syndrome	33.58	10.99	28	64663	164187	110360421
Injection site pain	33.49	10.99	198	64493	177724	110346884
Lumbar radiculopathy	33.21	10.99	20	64671	2558	110522050
Drug dependence	32.82	10.99	83	64608	49937	110474671
Mucosal inflammation	32.66	10.99	8	64683	96133	110428475
Urinary incontinence	32.27	10.99	81	64610	48506	110476102
Pulmonary fibrosis	31.84	10.99	10	64681	102032	110422576
Hallucination	31.34	10.99	130	64561	101302	110423306
Neurogenic bladder	31.22	10.99	25	64666	5054	110519554
Pyrexia	31.08	10.99	356	64335	897909	109626699
Cardiac failure	30.44	10.99	39	64652	187587	110337021
Progressive multiple sclerosis	30.23	10.99	15	64676	1309	110523299
Disease progression	29.94	10.99	61	64630	243973	110280635
Loss of consciousness	29.87	10.99	207	64484	196099	110328509
Drug abuser	29.84	10.99	25	64666	5384	110519224
Type 2 diabetes mellitus	29.63	10.99	36	64655	177196	110347412
Sinus bradycardia	29.60	10.99	58	64633	29425	110495183
Accidental death	29.41	10.99	24	64667	4985	110519623
Liver disorder	29.40	10.99	24	64667	142219	110382389
Dysarthria	29.35	10.99	112	64579	84009	110440599
Optic nerve operation	29.32	10.99	11	64680	483	110524125
Panic attack	29.14	10.99	57	64634	28883	110495725
Peripheral venous disease	28.57	10.99	7	64684	84110	110440498
Vision blurred	28.55	10.99	150	64541	128872	110395736
Intervertebral disc degeneration	27.89	10.99	43	64648	18042	110506566
Protein S decreased	27.73	10.99	8	64683	151	110524457
Anaemia	27.56	10.99	197	64494	546889	109977719
Illness	27.52	10.99	108	64583	82063	110442545
Spinal operation	27.46	10.99	33	64658	10939	110513669
Arthropathy	27.34	10.99	82	64609	287440	110237168
Cholestasis	27.15	10.99	3	64688	64515	110460093
Appetite disorder	27.14	10.99	31	64660	9738	110514870
Insomnia	26.96	10.99	326	64365	360264	110164344
Seizure	26.77	10.99	221	64470	220964	110303644
Bursitis	26.75	10.99	22	64669	129896	110394712
Peroneal nerve palsy	26.72	10.99	27	64664	7387	110517221
Dizziness	26.32	10.99	563	64128	697630	109826978
Acute kidney injury	25.55	10.99	243	64448	635187	109889421
Nausea	25.53	10.99	922	63769	1234768	109289840
Therapeutic product effect decreased	25.20	10.99	67	64624	244249	110280359
Thinking abnormal	24.76	10.99	37	64654	15103	110509505
Haemorrhagic diathesis	24.63	10.99	26	64665	7482	110517126
Scrotal infection	24.47	10.99	11	64680	769	110523839
Wound infection	24.36	10.99	13	64678	96452	110428156
Product use issue	24.17	10.99	97	64594	311598	110213010
Gastrointestinal disorder	23.73	10.99	68	64623	241884	110282724
False positive investigation result	23.64	10.99	13	64678	1401	110523207
Perineal infection	23.35	10.99	11	64680	856	110523752
Back disorder	23.28	10.99	43	64648	20879	110503729
Multiple organ dysfunction syndrome	23.12	10.99	33	64658	151677	110372931
Vitamin D deficiency	23.04	10.99	40	64651	18512	110506096
Muscle tightness	22.62	10.99	35	64656	14727	110509881
Secondary progressive multiple sclerosis	22.38	10.99	13	64678	1556	110523052
Hyponatraemia	22.21	10.99	60	64631	217593	110307015
Head injury	21.86	10.99	65	64626	42952	110481656
Burning sensation	21.61	10.99	89	64602	69123	110455485
Grip strength decreased	21.46	10.99	10	64681	80164	110444444
Bronchitis	21.24	10.99	161	64530	156871	110367737
Joint range of motion decreased	21.16	10.99	24	64667	121808	110402800
Ankle fracture	21.14	10.99	40	64651	19779	110504829
Therapy cessation	21.13	10.99	66	64625	44791	110479817
Inadequate analgesia	21.12	10.99	20	64671	5057	110519551
Muscular weakness	20.96	10.99	230	64461	248238	110276370
Neutrophil count decreased	20.82	10.99	24	64667	120917	110403691
Toxic epidermal necrolysis	20.73	10.99	4	64687	56723	110467885
Dermatitis atopic	20.68	10.99	46	64645	25495	110499113
Crying	20.57	10.99	46	64645	25582	110499026
Frequent bowel movements	20.55	10.99	8	64683	71382	110453226
Blood creatinine increased	20.54	10.99	48	64643	182841	110341767
Skin warm	20.41	10.99	26	64665	9144	110515464
Disturbance in attention	20.37	10.99	81	64610	61914	110462694
Platelet count decreased	20.30	10.99	68	64623	230375	110294233
Emotional distress	20.22	10.99	65	64626	44782	110479826
Nerve injury	20.19	10.99	28	64663	10685	110513923
Drug interaction	20.02	10.99	407	64284	499776	110024832
Urobilinogen urine increased	19.85	10.99	9	64682	642	110523966
Intracranial aneurysm	19.35	10.99	19	64672	5021	110519587
Urinary sediment abnormal	19.32	10.99	6	64685	147	110524461
Formication	19.32	10.99	20	64671	5628	110518980
Bone marrow failure	19.29	10.99	5	64686	57843	110466765
Spinal cord injury cauda equina	19.21	10.99	6	64685	150	110524458
Hypercholesterolaemia	19.18	10.99	15	64676	90822	110433786
Psoriatic arthropathy	18.78	10.99	56	64635	196705	110327903
Infected dermal cyst	18.78	10.99	11	64680	1337	110523271
Concussion	18.59	10.99	28	64663	11510	110513098
Nervousness	18.08	10.99	55	64636	36796	110487812
Intervertebral disc disorder	17.93	10.99	19	64672	5493	110519115
Decreased interest	17.92	10.99	18	64673	4890	110519718
Bladder disorder	17.91	10.99	27	64664	11110	110513498
Nerve compression	17.91	10.99	27	64664	11110	110513498
Memory impairment	17.87	10.99	185	64506	196759	110327849
Influenza	17.87	10.99	164	64527	168937	110355671
Injection site erythema	17.83	10.99	105	64586	94071	110430537
Blepharospasm	17.80	10.99	5	64686	54846	110469762
Paraplegia	17.78	10.99	20	64671	6180	110518428
Sleep apnoea syndrome	17.68	10.99	58	64633	40389	110484219
Respiratory rate decreased	17.62	10.99	20	64671	6238	110518370
Neuromyelitis optica spectrum disorder	17.59	10.99	11	64680	1504	110523104
Somatosensory evoked potentials abnormal	17.37	10.99	6	64685	207	110524401
Kidney enlargement	17.36	10.99	11	64680	1540	110523068
Temperature intolerance	17.22	10.99	30	64661	13920	110510688
Blood potassium decreased	17.22	10.99	70	64621	54044	110470564
Fibula fracture	17.04	10.99	17	64674	4581	110520027
Bradycardia	17.03	10.99	152	64539	155365	110369243
Impaired gastric emptying	16.98	10.99	29	64662	13246	110511362
Pneumonitis	16.98	10.99	12	64679	76519	110448089
Injection site bruising	16.86	10.99	67	64624	51196	110473412
Stress	16.56	10.99	112	64579	105236	110419372
Red blood cell sedimentation rate increased	16.44	10.99	13	64678	78289	110446319
Ascites	16.43	10.99	18	64673	92790	110431818
Photophobia	16.12	10.99	42	64649	25729	110498879
Dysdiadochokinesis	16.11	10.99	7	64684	451	110524157
Agranulocytosis	16.07	10.99	8	64683	61752	110462856
Suicidal ideation	16.06	10.99	102	64589	93835	110430773
Urine uric acid decreased	16.01	10.99	5	64686	125	110524483
Jejunectomy	15.95	10.99	4	64687	43	110524565
Blood pressure systolic increased	15.94	10.99	15	64676	82976	110441632
Coeliac disease	15.88	10.99	3	64688	43184	110481424
Tooth injury	15.86	10.99	12	64679	2234	110522374
Nail disorder	15.86	10.99	7	64684	57928	110466680
Circulatory collapse	15.78	10.99	3	64688	42990	110481618
Sedation	15.40	10.99	81	64610	69602	110455006
Neurotoxicity	15.37	10.99	3	64688	42204	110482404
Pre-existing condition improved	15.31	10.99	19	64672	6507	110518101
Arteriovenous fistula	15.30	10.99	10	64681	1475	110523133
Myalgia	15.30	10.99	198	64493	222183	110302425
Pain in extremity	15.29	10.99	383	64308	486735	110037873
Blood cholesterol increased	15.29	10.99	56	64635	184729	110339879
Leukopenia	15.19	10.99	41	64650	148750	110375858
Therapeutic response unexpected	15.06	10.99	39	64652	23804	110500804
Haematochezia	14.92	10.99	28	64663	115496	110409112
Autoimmune disorder	14.88	10.99	10	64681	65473	110459135
Movement disorder	14.84	10.99	51	64640	36353	110488255
Colitis ulcerative	14.84	10.99	14	64677	77349	110447259
Unemployment	14.72	10.99	4	64687	60	110524548
White blood cells urine positive	14.68	10.99	20	64671	7504	110517104
Irritability	14.55	10.99	61	64630	47748	110476860
Chills	14.53	10.99	173	64518	190407	110334201
Blister	14.50	10.99	76	64615	227300	110297308
Shrinking lung syndrome	14.46	10.99	5	64686	173	110524435
Vaginitis gardnerella	14.26	10.99	4	64687	68	110524540
Cytomegalovirus infection	14.25	10.99	7	64684	54437	110470171
Bedridden	14.20	10.99	27	64664	13398	110511210
Loss of control of legs	14.20	10.99	11	64680	2121	110522487
Swelling	14.19	10.99	134	64557	350907	110173701
Hyperkalaemia	14.18	10.99	37	64654	135759	110388849
Tubulointerstitial nephritis	14.17	10.99	7	64684	54277	110470331
International normalised ratio increased	14.11	10.99	18	64673	86754	110437854
Hepatocellular injury	14.05	10.99	6	64685	50636	110473972
Diplopia	13.98	10.99	55	64636	41839	110482769
Lumbar spinal stenosis	13.94	10.99	18	64673	6415	110518193
Progressive multifocal leukoencephalopathy	13.93	10.99	39	64652	24917	110499691
Liver function test increased	13.75	10.99	19	64672	88529	110436079
Melaena	13.71	10.99	12	64679	68745	110455863
Tibia fracture	13.61	10.99	18	64673	6567	110518041
Intentional product misuse	13.59	10.99	128	64563	132776	110391832
Paraparesis	13.56	10.99	15	64676	4551	110520057
Magnetic resonance imaging abnormal	13.55	10.99	14	64677	3931	110520677
Albuminuria	13.43	10.99	8	64683	1003	110523605
Hyperhidrosis	13.40	10.99	168	64523	187130	110337478
Withdrawal hypertension	13.38	10.99	6	64685	417	110524191
Lymphocyte percentage decreased	13.34	10.99	16	64675	5294	110519314
Acute myeloid leukaemia	13.28	10.99	3	64688	38107	110486501
Dysstasia	13.26	10.99	46	64645	32940	110491668
Dry skin	13.25	10.99	108	64583	107545	110417063
Ligament sprain	13.08	10.99	29	64662	16039	110508569
Foot deformity	13.04	10.99	6	64685	48474	110476134
Limb injury	13.04	10.99	50	64641	37586	110487022
Persistent depressive disorder	12.96	10.99	9	64682	1468	110523140
Dysphagia	12.86	10.99	142	64549	153458	110371150
Lipomatosis	12.86	10.99	6	64685	457	110524151
Cystitis	12.74	10.99	74	64617	65962	110458646
Lupus-like syndrome	12.72	10.99	4	64687	40788	110483820
Umbilical hernia	12.71	10.99	18	64673	7004	110517604
Asthenia	12.70	10.99	508	64183	688491	109836117
Angioedema	12.61	10.99	24	64667	98476	110426132
Renal impairment	12.57	10.99	62	64629	188383	110336225
Syncope	12.56	10.99	177	64514	202359	110322249
Urosepsis	12.53	10.99	43	64648	30632	110493976
Gastrointestinal haemorrhage	12.51	10.99	52	64639	165466	110359142
Rash maculo-papular	12.48	10.99	15	64676	74207	110450401
Drug eruption	12.46	10.99	8	64683	53651	110470957
Overdose	12.43	10.99	199	64492	233595	110291013
Injection site swelling	12.42	10.99	70	64621	61720	110462888
Myofascial pain syndrome	12.39	10.99	11	64680	2562	110522046
Initial insomnia	12.38	10.99	22	64669	10367	110514241
Device failure	12.35	10.99	18	64673	7189	110517419
Arthritis infective	12.32	10.99	22	64669	10407	110514201
Torsade de pointes	12.30	10.99	35	64656	22565	110502043
Implant site swelling	12.26	10.99	6	64685	508	110524100
Dermal cyst	12.21	10.99	12	64679	3174	110521434
Implant site infection	12.19	10.99	10	64681	2093	110522515
Urinary tract disorder	12.11	10.99	16	64675	5828	110518780
Abdominal discomfort	12.09	10.99	160	64531	393698	110130910
Device allergy	11.98	10.99	3	64688	32	110524576
Obstructive airways disorder	11.98	10.99	6	64685	46143	110478465
Spinal nerve stimulator implantation	11.96	10.99	4	64687	125	110524483
Pneumocystis jirovecii pneumonia	11.96	10.99	5	64686	42730	110481878
Palpitations	11.91	10.99	144	64547	159068	110365540
Spinal stenosis	11.86	10.99	31	64660	19025	110505583
Tenderness	11.79	10.99	41	64650	29396	110495212
Vitamin B12 deficiency	11.61	10.99	21	64670	10034	110514574
Rectal haemorrhage	11.51	10.99	34	64657	119799	110404809
Central nervous system lesion	11.47	10.99	27	64664	15526	110509082
Vitamin B6 deficiency	11.42	10.99	6	64685	590	110524018
Respiratory paralysis	11.42	10.99	4	64687	144	110524464
Blood folate increased	11.40	10.99	6	64685	592	110524016
CSF immunoglobulin increased	11.23	10.99	3	64688	42	110524566
Hyporeflexia	11.22	10.99	13	64678	4147	110520461
Stress cardiomyopathy	11.18	10.99	27	64664	15779	110508829
T-lymphocyte count decreased	11.15	10.99	6	64685	620	110523988
Zinc deficiency	11.06	10.99	5	64686	354	110524254
Arterial perforation	11.04	10.99	3	64688	45	110524563
CD4 lymphocytes decreased	11.03	10.99	11	64680	2963	110521645

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	M03BX02	MUSCULO-SKELETAL SYSTEM MUSCLE RELAXANTS MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS Other centrally acting agents
FDA MoA	N0000009918	Adrenergic alpha2-Agonists
FDA EPC	N0000175554	Central alpha-2 Adrenergic Agonist
MeSH PA	D000316	Adrenergic alpha-Agonists
MeSH PA	D000322	Adrenergic Agonists
MeSH PA	D000700	Analgesics
MeSH PA	D000927	Anticonvulsants
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D009125	Muscle Relaxants, Central
MeSH PA	D009465	Neuromuscular Agents
MeSH PA	D010276	Parasympatholytics
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D018689	Sensory System Agents
MeSH PA	D058647	Adrenergic alpha-2 Receptor Agonists
CHEBI has role	CHEBI:63726	neuroprotective agent
CHEBI has role	CHEBI:35480	analgesic
CHEBI has role	CHEBI:35569	α-adrenergic agonist
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:51371	muscle relaxant

Related Drugs by ATC class:

M03BX Other centrally acting agents 9 drugs

baclofen cyclobenzaprine eperisone fenyramidol mephenesin pridinol tetrazepam thiocolchicoside tolperisone

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

Disease	Relation	SNOMED_ID	DOID
Spasticity	indication	221360009
Muscle spasticity of spinal origin	indication	416830008
Muscle Spasticity of Cerebral Origin	indication
Low blood pressure	contraindication	45007003
Bradycardia	contraindication	48867003
Hepatic failure	contraindication	59927004
Psychotic disorder	contraindication	69322001
Kidney disease	contraindication	90708001	DOID:557

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.01	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
EQ 2MG BASE/5ML	ONTRALFY	FIDELITY BIOPHARMA	N216190	Dec. 12, 2024	RX	SOLUTION	ORAL	12042484	May 7, 2042	TREATMENT OF SPASTICITY
EQ 2MG BASE/5ML	ONTRALFY	FIDELITY BIOPHARMA	N216190	Dec. 12, 2024	RX	SOLUTION	ORAL	12263158	May 7, 2042	TREATMENT OF SPASTICITY

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN	AGONIST	EC50	7.07	CHEMBL	CHEMBL
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN	AGONIST	IC50	7.80	IUPHAR	CHEMBL
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN	AGONIST	EC50	5.91	CHEMBL	CHEMBL
Nischarin	Membrane receptor	Q9Y2I1	NISCH_HUMAN		Ki	7.55	CHEMBL
Alpha-1A adrenergic receptor	GPCR		ADA1A_BOVIN		EC50	6.58	CHEMBL
Alpha-1B adrenergic receptor	GPCR		G3HDX1_CRIGR		EC50	6.49	CHEMBL

External reference:

ID	Source
4021025	VUID
N0000148492	NUI
D00776	KEGG_DRUG
64461-82-1	SECONDARY_CAS_RN
4021025	VANDF
4021027	VANDF
C0146011	UMLSCUI
CHEBI:63629	CHEBI
CHEMBL1079	ChEMBL_ID
CHEMBL1200329	ChEMBL_ID
DB00697	DRUGBANK_ID
C023754	MESH_SUPPLEMENTAL_RECORD_UI
5487	PUBCHEM_CID
7308	IUPHAR_LIGAND_ID
4697	INN_ID
6AI06C00GW	UNII
236460	RXNORM
22951	MMSL
37185	MMSL
44068	MMSL
5589	MMSL
d04102	MMSL
006021	NDDF
006022	NDDF
108461005	SNOMEDCT_US
108462003	SNOMEDCT_US
373440006	SNOMEDCT_US
6AI06C00GW	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
tizanidine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2788	CAPSULE, GELATIN COATED	2 mg	ORAL	NDA authorized generic	26 sections
tizanidine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2789	CAPSULE, GELATIN COATED	4 mg	ORAL	NDA authorized generic	26 sections
tizanidine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2790	CAPSULE, GELATIN COATED	6 mg	ORAL	NDA authorized generic	26 sections
tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8468	TABLET	2 mg	ORAL	ANDA	26 sections
tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8469	TABLET	4 mg	ORAL	ANDA	26 sections
tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6418	TABLET	4 mg	ORAL	ANDA	19 sections
tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	10544-576	TABLET	4 mg	ORAL	ANDA	20 sections
tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	10544-587	TABLET	2 mg	ORAL	ANDA	18 sections
tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	10544-863	TABLET	2 mg	ORAL	ANDA	18 sections
Tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	10544-890	TABLET	4 mg	ORAL	ANDA	22 sections
TIZANIDINE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-220	TABLET	2 mg	ORAL	ANDA	16 sections
TIZANIDINE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-221	TABLET	4 mg	ORAL	ANDA	16 sections
ZANAFLEX	HUMAN PRESCRIPTION DRUG LABEL	1	16590-756	CAPSULE	6 mg	ORAL	NDA	24 sections
ZANAFLEX	HUMAN PRESCRIPTION DRUG LABEL	1	16590-871	CAPSULE	4 mg	ORAL	NDA	24 sections
Tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	16714-171	TABLET	2 mg	ORAL	ANDA	27 sections
Tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	16714-172	TABLET	4 mg	ORAL	ANDA	27 sections
TIZANIDINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	21695-126	TABLET	2 mg	ORAL	ANDA	24 sections
TIZANIDINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	21695-127	TABLET	4 mg	ORAL	ANDA	24 sections
Zanaflex	HUMAN PRESCRIPTION DRUG LABEL	1	21695-373	CAPSULE, GELATIN COATED	4 mg	ORAL	NDA	26 sections
Tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	29300-168	TABLET	2 mg	ORAL	ANDA	27 sections
Tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	29300-169	TABLET	4 mg	ORAL	ANDA	27 sections
Tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	33261-103	TABLET	2 mg	ORAL	ANDA	22 sections
Tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	33261-104	TABLET	4 mg	ORAL	ANDA	22 sections
Tizanidine	HUMAN PRESCRIPTION DRUG LABEL	1	35356-662	TABLET	2 mg	ORAL	ANDA	27 sections
Tizanidine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	42291-810	CAPSULE, GELATIN COATED	2 mg	ORAL	ANDA	19 sections
Tizanidine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	42291-810	CAPSULE, GELATIN COATED	2 mg	ORAL	ANDA	19 sections
Tizanidine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	42291-811	CAPSULE, GELATIN COATED	4 mg	ORAL	ANDA	19 sections
Tizanidine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	42291-811	CAPSULE, GELATIN COATED	4 mg	ORAL	ANDA	19 sections
Tizanidine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	42291-812	CAPSULE, GELATIN COATED	6 mg	ORAL	ANDA	19 sections
Tizanidine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	42291-812	CAPSULE, GELATIN COATED	6 mg	ORAL	ANDA	19 sections

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General architecture

Using the assistant

tizanidine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: