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)
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Dysuria20.02.02.002--
Encephalopathy17.13.02.0010.000032%
Eosinophilia01.02.04.001--
Euphoric mood19.04.02.006--
Extrapyramidal disorder17.01.02.007--
Eye swelling06.08.03.0030.000055%Not Available
Face oedema08.01.07.003; 23.04.01.004; 10.01.05.002--
Facial paralysis17.04.03.008--Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.000144%Not Available
Feeling jittery08.01.09.016--Not Available
Flatulence07.01.04.002--
Gait disturbance17.02.05.016; 08.01.02.002; 15.03.05.0130.000024%
Galactorrhoea21.05.02.002; 05.03.04.002--Not Available
Gastritis07.08.02.001--
Gastrointestinal pain07.01.05.005--
Generalised tonic-clonic seizure17.12.01.0020.000016%Not Available
Gynaecomastia21.05.04.003; 05.05.02.003--
Hallucination19.10.04.0030.000143%
Hallucination, auditory19.10.04.0040.000035%Not Available
Headache17.14.01.001--
Hepatic function abnormal09.01.02.001--Not Available
Hepatitis09.01.07.004--Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.000016%Not Available
Hyperaesthesia23.03.03.080; 17.02.06.0040.000016%Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.0030.000117%
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ADReCS-Target
Drug Name ADR Term Target
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