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)
Nightmare19.02.03.0030.000024%Not Available
Oedema14.05.06.010; 08.01.07.0060.000063%Not Available
Osteoarthritis15.01.04.001--Not Available
Palpitations02.11.04.0120.000098%
Pancytopenia01.03.03.003--Not Available
Paraesthesia17.02.06.005; 23.03.03.094--
Paranoia19.05.01.005--Not Available
Parotid gland enlargement07.06.03.001--Not Available
Pharyngeal oedema23.04.01.016; 22.04.05.003; 10.01.05.0160.000035%Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pollakiuria20.02.02.0070.000016%
Productive cough22.02.03.005--
Pruritus23.03.12.001--
Pulmonary embolism24.01.06.001; 22.06.02.0010.000032%Not Available
Purpura01.01.04.003; 24.07.06.005; 23.06.01.004--
Rash23.03.13.001--Not Available
Rash pruritic23.03.13.0300.000024%Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.0010.000016%
Renal failure20.01.03.0050.000032%Not Available
Respiratory acidosis22.02.02.004; 14.01.04.0020.000024%Not Available
Respiratory arrest22.02.01.0090.000177%Not Available
Respiratory depression22.02.01.010; 17.02.05.0470.000064%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000056%
Restlessness19.11.02.002; 17.02.05.021--
Rhabdomyolysis15.05.05.0020.000096%
Rotator cuff syndrome12.01.07.018; 15.01.08.0020.000016%
Sedation17.02.04.0050.000098%Not Available
Seizure17.12.03.0010.000140%
Sensory loss17.02.07.007--Not Available
Serotonin syndrome17.05.02.004; 15.05.04.016; 12.03.01.0410.000016%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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