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Side Effects & Adverse Reactions

Serotonin Syndrome

The development of a potentially life-threatening serotonin syndrome has been reported with Cyclobenzaprine Hydrochloride when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or (MAO) inhibitors. The concomitant use of Cyclobenzaprine Hydrochloride with MAO inhibitors is contraindicated (see CONTRAINDICATIONS). Serotonin syndrome symptoms may include mental status changes (e.g., confusion, agitation, hallucinations), autonomic instability (e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Treatment with Cyclobenzaprine Hydrochloride and any concomitant serotonergic agents should be discontinued immediately if the above reactions occur and supportive symptomatic treatment should be initiated. If concomitant treatment with Cyclobenzaprine Hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see PRECAUTIONS, Drug Interactions).

Cyclobenzaprine is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. In short term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred (see WARNINGS, below, and ADVERSE REACTIONS).

Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.

Cyclobenzaprine HCl may enhance the effects of alcohol, barbiturates, and other CNS depressants.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.

Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.

Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.


There is currently no drug history available for this drug.

Other Information

Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:

Chemical Structure - Cyclobenzaprine HCL

C20H21N•HCl               M.W. 311.9

Cyclobenzaprine hydrochloride tablets, USP are available for oral administration as 5 mg, 7.5 mg and 10 mg tablets. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide.

Laxative Manufacturers

  • Allegiant Health
    Laxative (Bisacodyl) Tablet [Allegiant Health]
  • Walgreen Co.
    Laxative (Sennoside) Tablet [Walgreen Co.]
  • Meijer Distribution Inc
    Laxative (Bisacodyl) Suppository [Meijer Distribution Inc]
  • Liddell Laboratories, Inc.
    Laxative (Aloe Socotrina, Alumina, Boldo, Bryonia, Graphittes, Iris Versicolor, Lactobacillus Acidophilus, Lycopodium Clavatum, Nux Vomica, Pyrogenium, Rhamnus Purshiana,) Spray [Liddell Laboratories, Inc.]
  • Cvs Pharmacy
    Laxative (Bisacodyl) Suppository [Cvs Pharmacy]
  • Wal-mart Stores Inc
    Laxative (Sennosides) Tablet [Wal-mart Stores Inc]
  • Rite Aid
    Laxative (Bisacodyl) Tablet [Rite Aid]
  • Western Family Foods Inc
    Laxative (Bisacodyl) Suppository [Western Family Foods Inc]
  • Safeway
    Laxative (Bisacodyl) Tablet [Safeway]
  • Meijer Distribution Inc
    Laxative (Bisacodyl) Suppository [Meijer Distribution Inc]
  • Rite Aid
    Laxative (Sennosides) Tablet [Rite Aid]
  • Family Dollar (Family Wellness)
    Laxative (Bisacodyl) Tablet, Coated [Family Dollar (Family Wellness)]
  • Mckesson (Health Mart)
    Laxative (Bisacodyl) Tablet, Coated [Mckesson (Health Mart)]
  • Healthy Accents (Dza Brands, Llc)
    Laxative (Bisacodyl) Tablet, Coated [Healthy Accents (Dza Brands, Llc)]
  • Rite Aid Corporation
    Laxative (Polyethylene Glycol 3350) Powder [Rite Aid Corporation]
  • Stephen L. Lafrance Pharmacy, Inc.
    Laxative (Bisacodyl) Tablet [Stephen L. Lafrance Pharmacy, Inc.]
  • Chain Drug Marketing Association, Inc.
    Laxative (Bisacodyl) Suppository [Chain Drug Marketing Association, Inc.]
  • Freds Inc
    Laxative (Bisacodyl) Tablet, Coated [Freds Inc]
  • Army And Air Force Exchange Service
    Laxative (Bisacodyl) Tablet, Coated [Army And Air Force Exchange Service]

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