Flexeril Side Effects
Generic Name: Cyclobenzaprine,cyclobenzaprine
Please note - some side effects for Flexeril may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Flexeril - for the consumer
Flexeril
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Flexeril:
Seek medical attention right away if any of these SEVERE side effects occur when using Flexeril:Constipation; diarrhea; dizziness; drowsiness; dry mouth; fatigue; nausea; nervousness; stomach pain or upset.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fast or irregular heartbeat; mental or mood changes; numbness of an arm or a leg; one-sided weakness; seizures; sudden severe stomach pain; severe dizziness or vomiting; speech or vision problems; trouble urinating; yellowing of the skin or eyes.
For the professional
Flexeril
Incidence of most common adverse reactions in the 2 double-blind3, placebo-controlled 5 mg studies (incidence of > 3% on Flexeril 5 mg):
| Flexeril 5 mg N=464 |
Flexeril 10 mg N=249 |
Placebo N=469 |
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| Drowsiness | 29% | 38% | 10% |
| Dry Mouth | 21% | 32% | 7% |
| Fatigue | 6% | 6% | 3% |
| Headache | 5% | 5% | 8% |
Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.
The following list of adverse reactions is based on the experience in 473 patients treated with Flexeril 10 mg in additional controlled clinical studies, 7607 patients in the postmarketing surveillance program, and reports received since the drug was marketed. The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies.
The adverse reactions reported most frequently with Flexeril were drowsiness, dry mouth and dizziness. The incidence of these common adverse reactions was lower in the surveillance program than in the controlled clinical studies:
| Clinical Studies With Flexeril 10 mg |
Surveillance Program With Flexeril 10 mg |
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| Drowsiness | 39% | 16% |
| Dry Mouth | 27% | 7% |
| Dizziness | 11% | 3% |
Among the less frequent adverse reactions, there was no appreciable difference in incidence in controlled clinical studies or in the surveillance program. Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.
The following adverse reactions have been reported in post-marketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg tablet:
Body as a Whole: Syncope; malaise.
Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension.
Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.
Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash.
Musculoskeletal: Local weakness.
Nervous System and Psychiatric: Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia.
Skin: Sweating.
Special Senses: Ageusia; tinnitus.
Urogenital: Urinary frequency and/or retention.
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- Note: Flexeril 10 mg data are from one clinical trial. Flexeril 5 mg and placebo data are from two studies.
Causal Relationship Unknown
Other reactions, reported rarely for Flexeril under circumstances where a causal relationship could not be established or reported for other tricyclic drugs, are listed to serve as alerting information to physicians:
Body as a whole: Chest pain; edema.
Cardiovascular: Hypertension; myocardial infarction; heart block; stroke.
Digestive: Paralytic ileus, tongue discoloration; stomatitis; parotid swelling.
Endocrine: Inappropriate ADH syndrome.
Hematic and Lymphatic: Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia.
Metabolic, Nutritional and Immune: Elevation and lowering of blood sugar levels; weight gain or loss.
Musculoskeletal: Myalgia.
Nervous System and Psychiatric: Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy; Bell's palsy; alteration in EEG patterns; extrapyramidal symptoms.
Respiratory: Dyspnea.
Skin: Photosensitization; alopecia.
Urogenital: Impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.
TopMore resources:
Amrix Extended-Release Capsules
Flexeril - Includes detailed dosage instructions.
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