Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cyclobenzaprine
Drug ID BADD_D00545
Description Cyclobenzaprine, a centrally-acting muscle relaxant, was first synthesized in 1961[A185039] and has been available for human use since 1977.[A184982] It was initially studied for use as antidepressant given its structural similarity to tricyclic antidepressants - it differs from [Amitriptyline] by only a single double bond.[A185039,A184982] Since its approval, it has remained relatively popular as an adjunctive, short-term treatment for acute skeletal muscle spasms secondary to musculoskeletal injury.
Indications and Usage Cyclobenzaprine is indicated as a short-term (2-3 weeks) adjunct therapy, along with rest and physical therapy, for relief of muscle spasm associated with acute, painful musculoskeletal conditions. It has not been found effective in the treatment of spasticity originating from cerebral or spinal cord disease, or spasticity in children with cerebral palsy.[L8408,L8411] Cyclobenzaprine is also occasionally used off-label for reducing pain and sleep disturbances in patients with fibromyalgia.[A184946]
Marketing Status approved
ATC Code M03BX08
DrugBank ID DB00924
KEGG ID D07758
MeSH ID C004704
PubChem ID 2895
TTD Drug ID D01KHH
NDC Product Code 53002-3080; 70518-0082; 70518-3159; 51655-973; 60687-558; 63187-812; 0615-8084; 51927-0118; 50268-191; 69097-846; 50436-0401; 61919-305; 53002-0521; 58118-0846; 69097-845
UNII 69O5WQQ5TI
Synonyms cyclobenzaprine | Flexeril | Lisseril | cyclobenzaprine hydrochloride
Chemical Information
Molecular Formula C20H21N
CAS Registry Number 303-53-7
SMILES CN(C)CCC=C1C2=CC=CC=C2C=CC3=CC=CC=C31
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)
Vascular purpura23.06.01.008; 01.01.04.007; 24.07.06.011--Not Available
Ventricular tachycardia02.03.04.0100.000040%
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.0070.000051%
Vomiting07.01.07.003--
Weight increased13.15.01.006--
Wheezing22.03.01.0090.000055%
Mental status changes19.07.01.0010.000135%Not Available
Fibromyalgia15.05.02.002--Not Available
Cardiotoxicity02.11.01.009; 12.03.01.0070.000016%Not Available
Deep vein thrombosis24.01.02.0030.000064%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Inappropriate antidiuretic hormone secretion05.03.03.001; 14.05.07.001--Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.000063%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.012--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Ill-defined disorder08.01.03.049--Not Available
Psychotic disorder19.03.01.002--
Metabolic encephalopathy17.13.01.001; 14.11.01.0130.000056%Not Available
Bone marrow failure01.03.03.005--
Liver injury09.01.07.022; 12.01.17.0120.000048%Not Available
Regurgitation07.01.07.004--Not Available
Acute kidney injury20.01.03.0160.000056%
Painful ejaculation21.03.01.014; 19.08.05.0070.000032%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000064%
Distributive shock24.06.02.0220.000024%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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