Fentora Side Effects

Generic name: fentanyl

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

Some side effects of Fentora may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fentanyl: sublingual spray, sublingual tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking fentanyl (the active ingredient contained in Fentora) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fentanyl and call your doctor at once if you have a serious side effect such as:

• slow heart rate, weak or shallow breathing, sighing, severe drowsiness;

• confusion, extreme fear, unusual thoughts or behavior; or

• feeling like you might pass out.

Less serious side effects of fentanyl may include:

• dry mouth, nausea, vomiting, constipation;

• headache, drowsiness, tired feeling; or

• white patches or sores inside your mouth or on your lips.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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

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 (the active ingredient contained in Fentora) 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 (the active ingredient contained in Fentora) 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 (the active ingredient contained in Fentora) 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 (the active ingredient contained in Fentora) anesthesia.

Dermatologic

Dermatologic side effects have included pruritus which has been reported frequently. Localized rashes (associated with the use of transdermal fentanyl (the active ingredient contained in Fentora) 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 (the active ingredient contained in Fentora) 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 (the active ingredient contained in Fentora) 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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