Comfort Pac with Cyclobenzaprine

Comfort Pac with Cyclobenzaprine is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain.

Comfort Pac with Cyclobenzaprine is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury.

Comfort Pac with Cyclobenzaprine may also be used for purposes not listed in this medication guide.

Do not use Comfort Pac with Cyclobenzaprine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

You should not use Comfort Pac with Cyclobenzaprine if you are allergic to it, or if you have:

• a heart rhythm disorder, or you have recently had a heart attack;

• congestive heart failure;

• heart block; or

• a thyroid disorder.

To make sure Comfort Pac with Cyclobenzaprine is safe for you, tell your doctor if you have:

• liver disease;

• glaucoma;

• enlarged prostate; or

• problems with urination.

Older adults may be more sensitive to the side effects of this medicine.

Comfort Pac with Cyclobenzaprine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether Comfort Pac with Cyclobenzaprine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Comfort Pac with Cyclobenzaprine can be fatal.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Comfort Pac with Cyclobenzaprine and call your doctor at once if you have:

• severe drowsiness, fast heart rate;

• tremors or shaking;

• pounding heartbeats or fluttering in your chest; or

• agitation, hallucinations, fever, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common side effects may include:

• headache, dizziness;

• drowsiness, tired feeling;

• trouble concentrating;

• blurred vision, dry mouth or throat, altered sense of taste; or

• nausea, upset stomach, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to cyclobenzaprine: compounding powder, oral capsule extended release, oral tablet, oral and topical kit

General

The most frequently occurring adverse reactions have included dry mouth, dizziness, fatigue, constipation, nausea, dyspepsia, and somnolence.[Ref]

Nervous system

Very common (10% or more): Drowsiness (up to 38%)
Common (1% to 10%): Dizziness, somnolence
Postmarketing reports: Headache, serotonin syndrome, seizures, ataxia, tremors, hypertonia, convulsions, abnormal sensations, paresthesia, ageusia[Ref]

Elderly patients may be particularly susceptible to the sedation and confusion which may accompany cyclobenzaprine therapy.[Ref]

Psychiatric

Common (1% to 10%): Irritability, mental acuity decreased, nervousness
Postmarketing reports: Nervousness, confusion, disorientation, insomnia, depressed mood, anxiety, agitation, psychosis, abnormal thinking and dreaming, hallucinations, excitement[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis, angioedema, pruritus, facial edema, urticaria, rash[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 32%)
Common (1% to 10%): Constipation, nausea, dyspepsia, abdominal pain, acid regurgitation, diarrhea
Postmarketing reports: Unpleasant taste, vomiting, anorexia, gastritis, thirst, flatulence, tongue edema[Ref]

Hepatic

Postmarketing reports: Abnormal liver function, hepatitis, jaundice, cholestasis[Ref]

Cardiovascular

Postmarketing reports: Syncope, tachycardia, arrhythmia, vasodilation, palpitation, hypotension[Ref]

Other

Common (1% to 10%): Fatigue
Postmarketing reports: Asthenia, malaise, vertigo[Ref]

Dermatologic

Postmarketing reports: Sweating[Ref]

Genitourinary

Postmarketing reports: Urinary frequency and/or retention[Ref]

Musculoskeletal

Postmarketing reports: Local weakness, dysarthria, muscle twitching[Ref]

Ocular

Postmarketing reports: Blurred vision, diplopia, tinnitus[Ref]

Respiratory

Common (1% to 10%): Upper respiratory infection, pharyngitis[Ref]

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer