Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tizanidine hydrochloride
Drug ID BADD_D02231
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 D00776
MeSH ID C023754
PubChem ID 114869
TTD Drug ID D01MDT
NDC Product Code 75834-209; 51927-0020; 42291-811; 46708-492; 50742-225; 42291-810; 59651-314; 59651-315; 62332-493; 63629-2466; 72241-043; 46708-493; 59651-316; 60505-2650; 61919-196; 63629-2494; 71209-064; 71209-066; 63629-2467; 63629-5139; 70771-1069; 71209-065; 0591-2789; 72888-002; 55700-865; 60505-2648; 62332-492; 0591-2788; 71335-9743; 71610-114; 75834-208; 55700-999; 60505-2649; 70515-606; 70710-1112; 70771-1067; 72241-041; 49999-347; 70710-1113; 70771-1068; 71335-1698; 38779-2351; 65015-777; 42291-812; 46708-491; 50742-226; 62332-491; 70515-604; 71335-0317; 0591-2790; 75834-207; 66022-0202; 45865-954; 68788-8478; 70515-602; 70710-1111; 72888-003; 53747-003; 50742-224; 70515-594; 72241-042; 72888-001; 55111-020; 63278-0489
UNII B53E3NMY5C
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 C9H9Cl2N5S
CAS Registry Number 64461-82-1
SMILES C1CN=C(N1)NC2=C(C=CC3=NSN=C32)Cl.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)
Nervousness19.06.02.003--Not Available
Neuralgia17.02.07.005--
Neuropathy peripheral17.09.03.003--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Optic neuritis06.04.08.002; 10.02.01.097; 17.04.05.001--Not Available
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Otitis media11.01.05.004; 04.05.01.001--
Overdose12.11.01.002--Not Available
Paraesthesia23.03.03.094; 17.02.06.005--
Paralysis17.01.04.004--Not Available
Pathological fracture16.32.03.007; 15.08.02.008; 12.04.02.006--Not Available
Petechiae01.01.03.002; 24.07.06.004; 23.06.01.003--Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Phlebitis24.12.03.004; 12.02.01.002--
Pneumonia11.01.09.003; 22.07.01.003--Not Available
Pollakiuria20.02.02.007--
Pruritus23.03.12.001--
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Pyelonephritis20.01.09.001; 11.01.14.002--Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Respiratory acidosis22.02.02.004; 14.01.04.002--Not Available
Retinal haemorrhage24.07.05.003; 06.10.01.001--Not Available
Rhinitis11.01.13.004; 22.07.03.006--
Seizure17.12.03.001--
Sepsis11.01.11.003--
Sinusitis22.07.03.007; 11.01.13.005--
Skin cancer23.08.02.002; 16.03.02.002--Not Available
Skin ulcer23.07.03.003; 24.04.03.007--
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