Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tizanidine
Drug ID BADD_D02230
Description Tizanidine is a fast-acting drug used for the management of muscle spasm, which may result from the effects of multiple sclerosis, stroke, an acquired brain injury, or a spinal cord injury [T574]. It may also be caused by musculoskeletal injury [A177583]. Regardless of the cause, muscle spasticity can be an extremely painful and debilitating condition. Initially approved by the FDA in 1996, tizanidine is an Alpha-2 adrenergic receptor agonist reducing spasticity by the presynaptic inhibition of excitatory neurotransmitters that cause firing of neurons promoting muscle spasm [FDA label].
Indications and Usage Tizanidine is indicated for the relief of muscle spasticity, which can interfere with daily activities. The general recommendation is to reserve tizanidine use for periods of time when there is a particular need for relief, as it has a short duration of action [FDA label, F4471].
Marketing Status approved; investigational
ATC Code M03BX02
DrugBank ID DB00697
KEGG ID D08611
MeSH ID C023754
PubChem ID 5487
TTD Drug ID D01MDT
NDC Product Code 72789-325; 35356-662; 50090-0840; 51655-740; 53002-1418; 57664-502; 60760-694; 70771-1335; 72578-096; 61919-221; 63187-009; 63187-910; 63629-8533; 68084-645; 29300-168; 29300-169; 42291-809; 55111-180; 60760-263; 63629-2371; 71610-228; 60760-505; 63187-493; 63187-673; 68084-775; 70518-3658; 71610-451; 0615-8468; 72578-097; 0904-6418; 43063-868; 60505-0251; 60760-782; 67877-614; 68071-5268; 70518-2210; 70771-1336; 71205-311; 71335-1016; 71335-1799; 0615-8360; 76420-228; 55111-179; 60505-0252; 60760-719; 63629-3209; 67877-613; 68788-7782; 70518-3181; 71610-162; 71610-455; 42291-808; 50090-0841; 63187-145; 63629-1673; 67296-1599; 70518-0133; 70518-1439; 70518-3112; 71610-167; 0615-8274; 0615-8469; 72789-326; 16714-172; 50090-0811; 50090-5767; 51655-603; 53002-1437; 68071-3440; 70518-0573; 72789-327; 76420-229; 43063-455; 55154-7287; 57664-503; 63629-2370; 68788-7781; 68788-7991; 16714-171; 71335-0914; 43353-167; 50268-759; 50268-760
UNII 6AI06C00GW
Synonyms tizanidine | 5-chloro-4-(2-imidazolin-2-yl-amino)-2,1,3-benzothiadiazole | Zanaflex | tizanidine hydrochloride | tizanidine monohydrochloride | DS 103-282 | Sirdalud
Chemical Information
Molecular Formula C9H8ClN5S
CAS Registry Number 51322-75-9
SMILES C1CN=C(N1)NC2=C(C=CC3=NSN=C32)Cl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Thrombocytopenia01.08.01.002--Not Available
Thrombocytosis01.08.02.001--Not Available
Tinnitus17.04.07.004; 04.04.01.0020.000204%
Torsade de pointes02.03.04.005--Not Available
Tremor17.01.06.0020.000293%
Urethral disorder20.07.01.002--Not Available
Urinary retention20.02.02.011--
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.0010.000178%
Uterine leiomyoma21.07.02.004; 16.04.02.001--Not Available
Vaginal infection21.14.02.002; 11.01.10.002--
Vascular purpura01.01.04.007; 23.06.01.008; 24.07.06.011--Not Available
Vasodilatation24.03.02.003; 23.06.05.006--Not Available
Ventricular extrasystoles02.03.04.007--Not Available
Ventricular fibrillation02.03.04.008--
Ventricular tachycardia02.03.04.0100.000105%
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Visual field defect17.17.01.001; 06.02.07.003--Not Available
Vomiting07.01.07.003--
Vulvovaginal candidiasis21.14.02.003; 11.03.03.005--Not Available
Weight decreased13.15.01.005--
Withdrawal hypertension24.08.02.009; 08.06.02.0070.000052%Not Available
Withdrawal syndrome19.07.06.023; 08.06.02.0120.000167%Not Available
Mental status changes19.07.01.0010.000078%Not Available
Cardiotoxicity02.11.01.009; 12.03.01.0070.000105%Not Available
Balance disorder17.02.02.007; 08.01.03.0810.000178%Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.0120.000167%Not Available
Acute coronary syndrome02.02.02.015; 24.04.04.011--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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