Duragesic Side Effects

Generic name: fentanyl

Note: This page contains information about the side effects of fentanyl. Some of the dosage forms included on this document may not apply to the brand name Duragesic.

For the Consumer

Applies to fentanyl: film, lozenge/troche, spray, tablet

In addition to its needed effects, some unwanted effects may be caused by fentanyl (the active ingredient contained in Duragesic). 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 fentanyl:

More common:

• 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
• 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
• wrinkled skin

Less common:

• 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

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

Symptoms of overdose:

• Extremely shallow or slow breathing

Minor Side Effects

Some of the side effects that can occur with fentanyl 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:

• 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
• tiredness
• trouble concentrating
• trouble sleeping
• weight loss

Less common:

• 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

Incidence not known:

• Tooth pain
• trouble with gums
• trouble with teeth

Applies to fentanyl: injection injectable, injection solution

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

If any of the following side effects occur while taking fentanyl, check with your doctor or nurse immediately:

More common:

• Chest pain or discomfort
• difficult or troubled breathing
• irregular, fast or slow, or shallow breathing
• lightheadedness, dizziness, or fainting
• pale or blue lips, fingernails, or skin
• severe muscle stiffness
• slow or irregular heartbeat
• unusual tiredness

Incidence not known:

• Blurred vision
• change in consciousness
• chills
• confusion
• cough
• difficulty with swallowing
• fast heartbeat
• feeling cold
• headache
• hives, itching, or skin rash
• inability to move the eyes
• inability to sit still
• increased blinking or spasms of the eyelid
• nervousness
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• restlessness
• seeing, hearing, or feeling things that are not there
• sticking out the tongue when not meaning to
• sweating
• tightness in the chest
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual facial expressions

Minor Side Effects

Some of the side effects that can occur with fentanyl 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:

Incidence not known:

• Increased sweating
• redness of the skin
• vomiting
• welts

Applies to fentanyl: nasal spray

In addition to its needed effects, some unwanted effects may be caused by fentanyl (the active ingredient contained in Duragesic). 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 fentanyl:

More common:

• Fever

Less common:

• Abdominal or stomach pain
• anxiety
• black, tarry stools
• bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody nose
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chest pain
• chills
• clay-colored stools
• confusion
• cough
• cough producing mucus
• dark urine
• decreased urination
• decreased weight
• difficult or labored breathing
• difficult, burning, or painful urination
• difficulty with breathing
• dizziness or lightheadedness
• dry mouth
• ear congestion
• fainting
• frequent urge to urinate
• headache
• hives
• hoarseness
• increase in heart rate
• increased sweating
• irritation
• itching
• joint pain, stiffness, or swelling
• loss of appetite
• loss of voice
• lower back or side pain
• nausea
• nervousness
• pain, redness, or swelling in the arm or leg
• pale skin
• pounding in the ears
• rapid breathing
• rapid weight gain
• rash
• redness of the skin
• runny or stuffy nose
• shortness of breath
• slow or fast heartbeat
• sneezing
• sore throat
• sudden shortness of breath or troubled breathing
• sunken eyes
• swelling of the eyelids, face, lips, hands, or feet
• thirst
• tightness in the chest
• tingling of the hands or feet
• troubled breathing or swallowing
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting of blood
• wrinkled skin
• yellow eyes or skin

Incidence not known:

• Irregular, fast or slow, or shallow breathing
• pale or blue lips, fingernails, or skin

Minor Side Effects

Some of the side effects that can occur with fentanyl 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:

• Difficulty having a bowel movement (stool)
• sleepiness or unusual drowsiness
• vomiting

Less common:

• Acid or sour stomach
• back pain
• belching
• burning feeling in the chest or stomach
• change in taste
• confusion about identity, place, and time
• decreased appetite
• depression
• diarrhea
• difficulty with moving
• drooping upper eyelids
• dry eyes
• flushed, dry skin
• fruit-like breath odor
• heartburn
• hyperventilation
• increased hunger
• increased thirst
• increased urination
• indigestion
• irregular heartbeats
• irritability
• irritation or soreness of the mouth
• lack or loss of strength
• loss of taste
• muscle aches
• muscle pain or stiffness
• pain in the arms or legs
• pain in the rectum
• restlessness
• shaking
• sleeplessness
• stomach discomfort or upset
• stomach bloating
• sweating
• tenderness in the stomach area
• trouble with sleeping
• troubled breathing
• unable to sleep
• unexplained weight loss

Applies to fentanyl: transdermal patch device assisted, transdermal patch extended release

In addition to its needed effects, some unwanted effects may be caused by fentanyl (the active ingredient contained in Duragesic). 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 fentanyl:

More common:

• Decrease in the amount of urine or in the frequency of urination
• seeing, hearing, or feeling things that are not there

Less common:

• Chest pain
• difficulty with speaking
• fainting
• mood or mental changes
• problems with walking
• redness, swelling, itching, or bumps on the skin at the place of application
• spitting blood

Incidence not known:

• Bloating or swelling of the face, hands, lower legs, or feet
• fast or pounding heartbeat or pulse
• rapid weight gain

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

Symptoms of overdose:

• Cold, clammy skin
• convulsions (seizures)
• drowsiness that is so severe you are not able to answer when spoken to or, if asleep, cannot be awakened
• pinpoint (small) pupils in the eyes
• slow heartbeat
• very slow or troubled breathing

Minor Side Effects

Some of the side effects that can occur with fentanyl 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:

• Abdominal or stomach pain that was not present before treatment
• confusion
• constipation
• diarrhea
• dizziness, drowsiness, or lightheadedness
• false sense of well-being
• feeling anxious
• headache
• indigestion
• loss of appetite
• nausea or vomiting
• sweating
• weakness

Less common:

• Feeling anxious and restless at the same time
• feeling of crawling, tingling, or burning of the skin
• memory loss
• unusual dreams

Incidence not known:

• Change or problem with discharge of semen
• decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• not able to have an orgasm
• weight loss

Side Effects: Post Treatment

After you stop taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:

• Body aches
• fast heartbeat
• fever, runny nose, or sneezing
• gooseflesh feeling
• increased sweating
• increased yawning
• nervousness, restlessness, or irritability
• shivering or trembling
• stomach cramps
• trouble sleeping
• unusually large pupils in the eyes

For Healthcare Professionals

Applies to fentanyl: buccal film, buccal tablet, compounding powder, injectable solution, intravenous solution, nasal spray, oral lozenge, oral transmucosal lozenge, sublingual spray, sublingual tablet, transdermal device, transdermal film extended release

General

The most commonly reported adverse reactions included headache, nausea, vomiting, ,dizziness, and constipation.^[Ref]

Nervous system

Very common (10% or more): Somnolence, dizziness
Common (1% to 10%): Sedation, pyrexia, fatigue, lethargy, tremor, headache, chills, irritability, malaise, confusion, abnormal thinking, anxiety, dysphoria
Uncommon (0.1% to 1%): Hyperesthesia
Very rare (less than 0.01%): Severe hemiplegic migraine
Frequency not reported: Slurred speech, paresthesia, hypesthesia, tremor
Postmarketing reports: Loss of consciousness, vertigo, coma, shock, convulsion^[Ref]

Cases of seizures have occasionally been reported, but some investigators have suggested that the seizure-like events reported may have been episodes of fentanyl induced-rigidity.^[Ref]

Cardiovascular

One report has suggested that epidural fentanyl (the active ingredient contained in Duragesic) may mask the pain of myocardial ischemia in patients treated with fentanyl for other reasons. Another report has suggested that QTc interval prolongation may occur in some patients receiving the related narcotic sufentanil. Another report has implicated fentanyl as a potential cause of pulsus alternans in a patient with aortic stenosis and congestive heart failure.

Nevertheless, fentanyl has been advocated by some as a satisfactory agent for coronary artery surgery.^[Ref]

Common (1% to 10%): Tachycardia
Uncommon (0.1% to 1%): Sinus tachycardia, chest pain, hypertension, hypotension, palpitations
Rare (less than 0.1%): Arrhythmias, cardiac arrest
Frequency not reported: Syncope, vasodilation, bradycardia, bigeminy, myocardial infarct
Postmarketing reports: Circulatory depression^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (18%), vomiting (10%), constipation
Common (1% to 10%): Dry mouth, abdominal distension, gastritis, dysphagia, dyspepsia, gastroesophageal reflux disease, ascites, hematemesis, taste perversion, abdominal pain, dehydration, anorexia, cachexia, vomiting, dry mouth, mouth ulcers/stomatitis, tongue edema
Uncommon (0.1% to 1%): Abdomen enlarged, flatulence
Rare (less than 0.1%): Choledochoduodenal sphincter spasm
Frequency not reported: Diarrhea
Postmarketing reports: Ileus, dental caries, tooth loss, gingival recession, gingivitis, gingival bleeding, lip edema, pharyngeal edema, gum bleeding, ulcer^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary retention
Very rare (less than 0.01%): Priapism
Frequency not reported: Urinary tract infection, urination impaired, hematuria, urinary urgency, dysuria^[Ref]

Dermatologic

Approximately 60% of patients had some redness at the skin site 24-hours after removal of the iontophoretic transdermal system. The majority of skin events were categorized as mild, erythema and papules were observed; 2 patients had hyperpigmentation at the application site lasting 2 to 3 weeks; 3 patients had a rectangular mark at the application site which persisted for up to 3 months.^[Ref]

Very common(10% or more): Iontophoretic transdermal system: Application site reaction-Erythema (14%)
Common (1% to 10%): Application site irritation, pruritus
Uncommon (0.1% to 1%): Hyperhidrosis, rash
Rare (less than 0.1%): Systemic rashes
Frequency not reported: vesicles, papules/pustules, dry and flaky skin, vesiculobullous rash wound site oozing/bleeding, wound site inflammation/erythema
Postmarketing reports: Application site discharge, application site bleeding, application site infection, rash and scab, erosion, hyperesthesia, application site necrosis^[Ref]

Hypersensitivity

Rare (less than 0.1%): Anaphylaxis^[Ref]

Hematologic

The hemolysis observed may have been related to rapid injection of large volumes of hypotonic fentanyl (the active ingredient contained in Duragesic) solution. The authors therefore recommend slower injection rates and/or mixture in isotonic fluid.^[Ref]

Common (1% to 10%): Anemia, neutropenia, lymphadenopathy, thrombocytopenia, leukopenia, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood glucose increased, blood lactate increased, hypoalbuminemia, vasodilation^[Ref]

Immunologic

Uncommon (0.1% to 1%): Oral candidiasis, cellulitis, pneumonia, urinary tract infection, oral herpes, gastroenteritis, laryngitis
Very rare (less than 0.01%): Recurrent herpes simplex infection following epidural administration^[Ref]

Metabolic

Common (1% to 10%): Asthenia, peripheral edema, weight decreased, hypokalemia, hyponatremia, hypocalcemia
Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone
Frequency not reported: abnormal healing, dehydration^[Ref]

Endocrine

Uncommon (0.1% to 1%): Hot flush^[Ref]

Musculoskeletal

Common (1% to 10%): Fall/accidental injury, back pain, arthralgia, joint swelling, muscular weakness, myoclonus, involuntary muscle contractions, muscle rigidity (involving the respiratory musculature including the glottis)
Frequency not reported: Leg cramps, myalgia
Postmarketing reports: Abnormal gait/incoordination^[Ref]

Ocular

Uncommon (0.1% to 1%): Vision blurred, dry eye
Rare (less than 0.1%): Abnormal vision^[Ref]

Psychiatric

Common (1% to 10%): Depression, confusional state, hallucination, insomnia
Uncommon (0.1% to 1%): Anxiety, agitation, restlessness, agitation, disorientation, abnormal dreams, depersonalization, depression, emotional lability, euphoria, delirium
Frequency not reported: Nervousness^[Ref]

Respiratory

Common (1% to 10%): Dyspnea, rhinitis, yawning, respiratory distress, apnea, bradypnea, hypoventilation, respiratory depression
Uncommon (0.1% to 1%): Cough, increased bronchial secretion, dysphonia, pharyngolaryngeal pain, wheezing, hypoxia, exertional dyspnea
Very rare (less than 0.01%): Acute noncardiogenic pulmonary edema
Frequency not reported: Asthma, hiccup, atelectasis, hyperventilation
Postmarketing reports: Respiratory arrest^[Ref]

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