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)
Thinking abnormal19.10.03.001; 17.02.05.023--Not Available
Thirst14.03.02.007; 08.01.09.021--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tongue discolouration07.14.02.006--Not Available
Tongue oedema10.01.05.008; 07.14.02.007; 23.04.01.009--Not Available
Tremor17.01.06.002--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary retention20.02.02.011--
Urinary tract malformation20.08.03.002; 03.06.02.003--Not Available
Urticaria10.01.06.001; 23.04.02.001--
Vasodilatation24.03.02.003; 23.06.05.006--Not Available
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction19.08.04.001; 21.03.01.007--
Psychotic disorder19.03.01.002--
Bone marrow failure01.03.03.005--
Regurgitation07.01.07.004--Not Available
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