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Comfort Pac with Cyclobenzaprine Side Effects

Generic Name: cyclobenzaprine

Note: This page contains information about the side effects of cyclobenzaprine. Some of the dosage forms included on this document may not apply to the brand name Comfort Pac with Cyclobenzaprine.

For the Consumer

Applies to cyclobenzaprine: oral capsule extended release, oral suspension, oral tablet

In addition to its needed effects, some unwanted effects may be caused by cyclobenzaprine (the active ingredient contained in Comfort Pac with Cyclobenzaprine). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking cyclobenzaprine:

Rare
  • Clumsiness or unsteadiness
  • confusion
  • fainting
  • mental depression
  • problems in urinating
  • ringing or buzzing in the ears
  • skin rash, hives, or itching occurring without other symptoms of an allergic reaction listed above
  • unusual thoughts or dreams
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking cyclobenzaprine, get emergency help immediately:

Symptoms of overdose:
  • Convulsions (seizures)
  • drowsiness (severe)
  • dry, hot, flushed skin
  • fast or irregular heartbeat
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • increase or decrease in body temperature
  • troubled breathing
  • unexplained muscle stiffness
  • unusual nervousness or restlessness (severe)
  • vomiting (occurring together with other symptoms of overdose)

Minor Side Effects

Some of the side effects that can occur with cyclobenzaprine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Blurred vision
  • dizziness, drowsiness, or lightheadedness
  • dryness of the mouth
Less common or rare:
  • Bloated feeling or gas, indigestion, nausea or vomiting, or stomach cramps or pain
  • constipation
  • diarrhea
  • excitement or nervousness
  • frequent urination
  • general feeling of discomfort or illness
  • headache
  • muscle twitching
  • numbness, tingling, pain, or weakness in hands or feet
  • pounding heartbeat
  • problems in speaking
  • trembling
  • trouble sleeping
  • unpleasant taste or other taste changes
  • unusual muscle weakness
  • unusual tiredness

For Healthcare Professionals

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]

References

1. "Product Information. Amrix (cyclobenzaprine)." A-S Medication Solutions, Chicago, IL.

2. "Product Information. Flexeril (cyclobenzaprine)." Merck & Co, Inc, West Point, PA.

Not all side effects for Comfort Pac with Cyclobenzaprine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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