Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cyclobenzaprine hydrochloride
Drug ID BADD_D00546
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 D00772
MeSH ID C004704
PubChem ID 22576
TTD Drug ID D01KHH
NDC Product Code 72888-013; 76420-030; 46438-0631; 51927-0175; 53296-0003; 65372-1156; 65862-190; 67763-107; 0093-3420; 43547-399; 50090-1848; 50090-5772; 50268-190; 53746-540; 55700-981; 60760-767; 63459-700; 63629-9297; 67296-1441; 68071-3404; 68084-753; 70518-3474; 72888-014; 59349-0014; 50090-5712; 55700-696; 60505-3972; 63187-380; 63187-923; 67296-1534; 68788-7445; 69306-075; 70518-0191; 70518-2788; 71335-2110; 72789-115; 72789-156; 76420-033; 76420-265; 38779-0395; 49452-2407; 68981-008; 71574-112; 0093-3421; 50090-5713; 51655-539; 55700-925; 57237-266; 61919-537; 65862-191; 67296-1343; 67296-1621; 68071-3462; 70518-3415; 71335-0096; 72189-283; 59746-211; 62332-649; 63629-1209; 63629-1210; 63629-2424; 68788-8167; 68788-8221; 68788-9967; 70518-3764; 71205-897; 71335-1266; 71335-2156; 72789-036; 72789-073; 76420-019; 76420-256; 76420-269; 76420-271; 10702-007; 66577-013; 24979-035; 42708-172; 50090-4727; 52817-331; 55700-762; 55700-926; 60760-366; 61919-261; 63459-701; 65162-540; 71205-678; 71335-1099; 65977-0030; 76420-168; 76420-298; 16571-782; 29300-413; 50090-4722; 50090-4729; 50090-4730; 50090-5326; 59746-735; 63187-342; 63187-590; 63629-1211; 63629-8206; 63629-8983; 68071-2790; 68071-2880; 68071-4655; 70199-014; 70518-2611; 71205-132; 71335-1293; 71610-428; 72888-012; 76420-010; 80425-0019; 59917-091; 76420-992; 0093-1920; 0093-1921; 0093-3422; 24979-036; 29300-414; 42708-081; 43547-400; 59746-177; 67296-1396; 67296-1763; 68071-2659; 68788-7536; 70518-3356; 71205-858; 0591-3330; 71610-016; 46438-0050; 59917-090; 65015-722; 71554-116; 76420-991; 79572-011; 42291-154; 43063-494; 43063-516; 50090-5896; 51655-818; 52817-330; 52817-332; 60760-536; 60760-766; 63187-011; 63187-157; 63629-1213; 63629-7803; 67296-1524; 71205-059; 71205-065; 71205-454; 71335-0921; 72189-101; 72789-046; 82982-027; 0115-1436; 45865-962; 50090-5756; 50090-5900; 50436-9804; 53002-0524; 53746-541; 60429-876; 60505-3973; 62332-646; 62332-647; 63629-1212; 65162-541; 68071-2673; 68071-4951; 68788-8474; 70518-3702; 71205-857; 71335-1961; 71335-1962; 0615-8182; 76420-268; 0395-8051; 62991-1040; 29300-415; 43063-917; 45865-433; 51655-427; 55700-239; 55700-599; 55700-858; 60760-363; 60760-365; 60760-889; 63187-094; 68788-8471; 69420-1001; 70518-3251; 70934-442; 71205-201; 71205-356; 71335-1253; 72189-080; 72189-280; 76420-011; 10702-006; 66064-1022; 82060-001; 16571-783; 0115-1437; 45865-801; 50090-5256; 50090-5711; 50436-9805; 51655-592; 53002-0520; 53002-0523
UNII 0VE05JYS2P
Synonyms cyclobenzaprine | Flexeril | Lisseril | cyclobenzaprine hydrochloride
Chemical Information
Molecular Formula C20H22ClN
CAS Registry Number 6202-23-9
SMILES CN(C)CCC=C1C2=CC=CC=C2C=CC3=CC=CC=C31.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)
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Libido increased21.03.02.007; 19.08.03.002--
Liver function test abnormal13.03.04.030--Not Available
Malaise08.01.01.003--
Muscle twitching15.05.03.005--Not Available
Muscular weakness17.05.03.005; 15.05.06.001--
Myalgia15.05.02.001--
Myocardial infarction02.02.02.007; 24.04.04.009--
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Palpitations02.11.04.012--
Paraesthesia17.02.06.005; 23.03.03.094--
Paranoia19.05.01.005--Not Available
Parotid gland enlargement07.06.03.001--Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Photosensitivity reaction23.03.09.003--
Pollakiuria20.02.02.007--
Pruritus23.03.12.001--
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Rash23.03.13.001--Not Available
Seizure17.12.03.001--
Sensory disturbance17.02.07.006--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stomatitis07.05.06.005--
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Tachycardia02.03.02.007--Not Available
Testicular swelling21.13.01.003--Not Available
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