Cyclobenzaprine: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Cyclobenzaprine. Educational only — not medical advice.

Reported adverse reactions

Reaction	Highest frequency reported*
Drowsiness	38%
Dry mouth	32%
Dizziness	11%
Headache	8%
Fatigue	6%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

Cyclobenzaprine hydrochloride tablets, USP are 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 hydrochloride tablets should be used only for short periods (up to 2 or 3 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 hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.

Source: FDA labeling via NIH DailyMed (set 12454c61…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.

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