Fentanyl (Buccal Mucosa Route, Oromucosal Route, Sublingual Route)

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Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Black, tarry stools
• Blurred vision
• Chest pain
• Confusion
• Convulsions
• Cough
• Decreased urine
• Difficult or labored breathing
• Dizziness
• Dry mouth
• Fainting
• Fever or chills
• Increased thirst
• Irregular heartbeat
• Lightheadedness
• Loss of appetite
• Lower back or side pain
• Mood changes
• Muscle pain or cramps
• Nausea or vomiting
• Nervousness
• Numbness or tingling in the hands, feet, or lips
• Painful or difficult urination
• Pale skin
• Pounding in the ears
• Rapid breathing
• Shortness of breath
• Sneezing
• Sore throat
• Sunken eyes
• Swelling of the hands, ankles, feet, or lower legs
• Tightness in the chest
• Troubled breathing with exertion
• Ulcers, sores, or white spots in the mouth
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Wheezing
• Wrinkled skin

• Abdominal or stomach pain
• Change in walking and balance
• Clumsiness or unsteadiness
• Decreased awareness or responsiveness
• Decreased frequency of urination
• Headache
• Muscle twitching or jerking
• Pounding in the ears
• Rhythmic movement of the muscles
• Seeing, hearing, or feeling things that are not there
• Seizures
• Severe constipation
• Severe sleepiness
• Shakiness in the legs, arms, hands, or feet
• Slow or fast heartbeat
• Thinking abnormalities
• Trembling or shaking of the hands or feet

Get emergency help immediately if any of the following symptoms of overdose occur:

• Extremely shallow or slow breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• Diarrhea
• Difficulty having a bowel movement (stool)
• Difficulty with moving
• Discouragement
• Feeling sad or empty
• Irritability
• Lack or loss of strength
• Loss of interest or pleasure
• Muscle stiffness
• Pain in the joints
• Sleepiness or unusual drowsiness
• Sleeplessness
• Tiredness
• Trouble concentrating
• Trouble sleeping
• Unable to sleep
• Weight loss

• Changes in vision
• Excessive muscle tone
• Feeling of constant movement of self or surroundings
• Feeling of warmth or heat
• Flushing or redness of the skin, especially on the face and neck
• Irritation, pain, or sores at the site of application
• Itching skin
• Muscle tension or tightness
• Rash
• Sensation of spinning
• Sweating

• Tooth pain
• Trouble with gums
• Trouble with teeth

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Restlessness
• Speech disorder
• Stomach cramps
• Weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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