Fentanyl Side Effects

Brand Names: Fentora, Ionsys, Duragesic, Actiq, Sublimaze

Please note - some side effects for Fentanyl 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).

Side Effects of Fentanyl - for the Consumer

Fentanyl

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 Fentanyl:

Anxiety; confusion; constipation; difficulty walking; dizziness; drowsiness; dry mouth; headache; indigestion; itching; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); hallucinations; muscle rigidity; seizures; slow or irregular heartbeat; slowed breathing; trouble breathing; weakness.

Fentanyl Lozenge

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 Fentanyl Lozenge:

Accidental injury; anxiety; confusion; constipation; difficulty walking; dizziness; drowsiness; dry mouth; headache; indigestion; itching; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive dizziness; excessive drowsiness; fainting; fatigue; hallucinations; muscle rigidity; seizures; shock (changes in skin color); slow heartbeat; slowed breathing; trouble breathing; weakness.

Fentanyl Patch

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 Fentanyl Patch:

Constipation; diarrhea; dizziness; dry mouth; exaggerated sense of well-being; headache; indigestion; loss of appetite; nausea; nervousness or anxiety; redness or discomfort on skin where patch is applied; sleepiness; sleeplessness; stomach pain or discomfort; sweating; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; depression; difficulty urinating; excessive dizziness; excessive drowsiness; fainting; fatigue; fever; hallucinations; interrupted or difficult breathing; memory loss; muscle rigidity; seizures; shock (changes in skin color); slow heartbeat; slowed or irregular breathing; tremor; weakness.

Fentanyl Tablet

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 Fentanyl Tablet:

Constipation; diarrhea; dizziness; drowsiness; headache; mouth pain or irritation; nausea; numbness or tingling at the site where the tablet is used; stomach pain; vomiting; weakness or tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mood or mental changes (eg, depression); mouth sores, ulcers, bleeding, or inflammation; numbness or tingling in the hands, legs, or feet; severe drowsiness; severe dry eyes, mouth, or skin; severe or persistent dizziness; shortness of breath; slowed breathing; swelling of the hands, feet, or ankles; unusual bruising or bleeding; unusual or severe weakness or tiredness; yellowing of the eyes or skin.

Fentanyl Side Effects - for the Professional

Fentanyl

In postmarketing experience, deaths from hypoventilation due to inappropriate use of Fentanyl transdermal system have been reported.

Premarketing Clinical Trial Experience

Although Fentanyl transdermal system use in post-operative or acute pain and in patients who are not opioid-tolerant is CONTRAINDICATED, the safety of Fentanyl transdermal system was originally evaluated in 357 post-operative adult patients for 1 to 3 days and 153 cancer patients for a total of 510 patients. The duration of Fentanyl transdermal system use varied in cancer patients; 56% of patients used Fentanyl transdermal system for over 30 days, 28% continued treatment for more than 4 months, and 10% used Fentanyl transdermal system for more than 1 year.

Hypoventilation was the most serious adverse reaction observed in 13 (4%) post-operative patients and in 3 (2%) of the cancer patients. Hypotension and hypertension were observed in 11 (3%) and 4 (1%) of the opioid-naive patients.

Various adverse events were reported; a causal relationship to Fentanyl transdermal system was not always determined. The frequencies presented here reflect the actual frequency of each adverse effect in patients who received Fentanyl transdermal system. There has been no attempt to correct for a placebo effect, concomitant use of other opioids, or to subtract the frequencies reported by placebo-treated patients in controlled trials.

Adverse reactions reported in 153 cancer patients at a frequency of 1% or greater are presented in TABLE 1; similar reactions were seen in the 357 post-operative patients.

In the pediatric population, the safety of Fentanyl transdermal system has been evaluated in 291 patients with chronic pain 2 to 18 years of age. The duration of Fentanyl transdermal system use varied; 20% of pediatric patients were treated for ≤ 15 days; 46% for 16 to 30 days; 16% for 31 to 60 days; and 17% for at least 61 days. Twenty-five patients were treated with Fentanyl transdermal system for at least 4 months and 9 patients for more than 9 months.

There was no apparent pediatric-specific risk associated with Fentanyl transdermal system use in children as young as 2 years old when used as directed. The most common adverse events were fever (35%), vomiting (33%), and nausea (24%).

Adverse events reported in pediatric patients at a rate of ≥ 1% are presented in TABLE 1.

The following adverse effects have been reported in less than 1% of the 510 adult post-operative and cancer patients studied:

Cardiovascular:bradycardia

Digestive:abdominal distention

Nervous:aphasia, hypertonia, vertigo, stupor, hypotonia, depersonalization, hostility

Respiratory:stertorous breathing, asthma, respiratory disorder

Skin and Appendages, General:exfoliative dermatitis, pustules

Special Senses:amblyopia

Urogenital:bladder pain, oliguria, urinary frequency

Postmarketing Experience – Adults

The following adverse reactions have been reported in association with the use of Fentanyl transdermal system and not reported in the premarketing adverse reactions section above:

Body as a Whole:edema

Cardiovascular:tachycardia

Metabolic and Nutritional:weight loss

Special Senses:blurred vision

Urogenital:decreased libido, anorgasmia, ejaculatory difficulty

Side Effects by Body System

Nervous system

Nervous system side effects have included mental and respiratory depression (particularly in the elderly), stupor, delirium, somnolence, and dysphoria. Muscle rigidity (involving the respiratory musculature including the glottis) may also occur and further aggravate the respiratory depression associated with fentanyl therapy. Myoclonus has been reported with the use of transdermal therapy. A case of severe hemiplegic migraine attack precipitated by fentayl sedation has also been reported.

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.

Other

Fentanyl shares the potential for abuse associated with other narcotic analgesics. Cases of inhalation of the contents of fentanyl patches and oral ingestion of intravenous preparations have been reported.

Other side effects have included withdrawal symptoms (agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting, and sweating) after either abrupt cessation or fast tapering of narcotic analgesics.

Cardiovascular

Cardiovascular side effects have included hypotension, bradycardia, and arrhythmias rarely.

One report has suggested that epidural fentanyl 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.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and constipation have been reported to have occurred commonly. Dental decay of varying severity including dental caries, tooth loss, and gum line erosion have been reported. Choledochoduodenal sphincter spasm has been reported rarely.

Respiratory

Respiratory side effects have included respiratory depression which has been frequently observed with fentanyl therapy and one case of acute noncardiogenic pulmonary edema. Coughing has been reported following fentanyl administration for anesthesia induction.

Genitourinary

Genitourinary side effects including urinary retention have been reported for other narcotic analgesics. A case of priapism has been associated with fentanyl anesthesia.

Dermatologic

Dermatologic side effects have included pruritus which has been reported frequently. Localized rashes (associated with the use of transdermal fentanyl patches) and, less commonly, systemic rashes have also been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported rarely.

Hematologic

The hemolysis observed may have been related to rapid injection of large volumes of hypotonic fentanyl solution. The authors therefore recommend slower injection rates and/or mixture in isotonic fluid.

Hematologic side effects have included one study which suggested that a small amount of hemolysis (of uncertain clinical significance) may occur in patients treated with fentanyl.

Immunologic

Immunologic side effects including a case of recurrent herpes simplex infection have been reported following epidural administration of fentanyl. Intravenous fentanyl has been reported to increase natural killer cell cytotoxicity and circulating CD16+ lymphocyte levels.

Metabolic

Metabolic side effects including a case of syndrome of inappropriate antidiuretic hormone have been reported.

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