Fentanyl Side Effects
Some side effects of fentanyl 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
Other dosage forms:
Get emergency medical help if you have any of these signs of an allergic reaction while taking fentanyl: 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 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.
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 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 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 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 side effects including urinary retention have been reported for other narcotic analgesics. A case of priapism has been associated with fentanyl anesthesia.
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 side effects including anaphylaxis have been reported rarely.
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 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 side effects including a case of syndrome of inappropriate antidiuretic hormone have been reported.
More fentanyl resources
- fentanyl MedFacts Consumer Leaflet (Wolters Kluwer)
- fentanyl Buccal mucosa, Oromucosal Advanced Consumer (Micromedex) - Includes Dosage Information
- Abstral Consumer Overview
- Abstral MedFacts Consumer Leaflet (Wolters Kluwer)
- Actiq Consumer Overview
- Actiq lozenge MedFacts Consumer Leaflet (Wolters Kluwer)
- Actiq Prescribing Information (FDA)
- Duragesic Advanced Consumer (Micromedex) - Includes Dosage Information
- Duragesic Prescribing Information (FDA)
- Duragesic patch MedFacts Consumer Leaflet (Wolters Kluwer)
- Duragesic Consumer Overview
- Fentanyl Professional Patient Advice (Wolters Kluwer)
- Fentanyl Citrate Monograph (AHFS DI)
- Fentora Consumer Overview
- Fentora Prescribing Information (FDA)
- Fentora MedFacts Consumer Leaflet (Wolters Kluwer)
- Ionsys Prescribing Information (FDA)
- Ionsys Consumer Overview
- Lazanda spray MedFacts Consumer Leaflet (Wolters Kluwer)
- Lazanda Advanced Consumer (Micromedex) - Includes Dosage Information
- Lazanda Consumer Overview
- Onsolis Prescribing Information (FDA)
- Onsolis soluble film MedFacts Consumer Leaflet (Wolters Kluwer)
- Onsolis Consumer Overview
- Sublimaze Advanced Consumer (Micromedex) - Includes Dosage Information
- Sublimaze Prescribing Information (FDA)
- Subsys Prescribing Information (FDA)
- Subsys Consumer Overview
- Subsys spray MedFacts Consumer Leaflet (Wolters Kluwer)
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