Subsys 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 Subsys.
Some side effects of Subsys 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: film, lozenge/troche, spray, tablet
Other dosage forms:
Along with its needed effects, fentanyl (the active ingredient contained in Subsys) 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 while taking fentanyl:More common
- Black, tarry stools
- blurred vision
- chest pain
- decreased urine
- difficult or labored breathing
- dry mouth
- fever or chills
- increased thirst
- irregular heartbeat
- loss of appetite
- lower back or side pain
- mood changes
- muscle pain or cramps
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- painful or difficult urination
- pale skin
- pounding in the ears
- rapid breathing
- 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
- Abdominal or stomach pain
- change in walking and balance
- clumsiness or unsteadiness
- decreased awareness or responsiveness
- decreased frequency of urination
- muscle twitching or jerking
- pounding in the ears
- rhythmic movement of the muscles
- seeing, hearing, or feeling things that are not there
- 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 while taking fentanyl:Symptoms of overdose
- Extremely shallow or slow breathing
Some side effects of fentanyl 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:More common
- Back pain
- difficulty having a bowel movement (stool)
- difficulty with moving
- feeling sad or empty
- lack or loss of strength
- loss of interest or pleasure
- muscle stiffness
- pain in the joints
- sleepiness or unusual drowsiness
- trouble concentrating
- trouble sleeping
- 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
- sensation of spinning
- 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:
- speech disorder
- stomach cramps
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 (the active ingredient contained in Subsys) 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 (the active ingredient contained in Subsys) 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 (the active ingredient contained in Subsys) 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 (the active ingredient contained in Subsys) anesthesia.
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 Subsys) 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 (the active ingredient contained in Subsys) 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 (the active ingredient contained in Subsys) 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 Subsys resources
- Subsys spray MedFacts Consumer Leaflet (Wolters Kluwer)
- Subsys Advanced Consumer (Micromedex) - Includes Dosage Information
- Subsys Prescribing Information (FDA)
- Subsys Consumer Overview
- Abstral MedFacts Consumer Leaflet (Wolters Kluwer)
- Abstral Consumer Overview
- Actiq Consumer Overview
- Actiq lozenge MedFacts Consumer Leaflet (Wolters Kluwer)
- Actiq Prescribing Information (FDA)
- Duragesic Advanced Consumer (Micromedex) - Includes Dosage Information
- Duragesic Consumer Overview
- Duragesic Prescribing Information (FDA)
- Duragesic patch MedFacts Consumer Leaflet (Wolters Kluwer)
- Fentanyl Professional Patient Advice (Wolters Kluwer)
- Fentanyl Citrate Monograph (AHFS DI)
- Fentora Prescribing Information (FDA)
- Fentora Consumer Overview
- Fentora MedFacts Consumer Leaflet (Wolters Kluwer)
- Ionsys Consumer Overview
- Ionsys Prescribing Information (FDA)
- Lazanda Advanced Consumer (Micromedex) - Includes Dosage Information
- Lazanda Consumer Overview
- Lazanda spray MedFacts Consumer Leaflet (Wolters Kluwer)
- Onsolis Prescribing Information (FDA)
- Onsolis soluble film MedFacts Consumer Leaflet (Wolters Kluwer)
- Onsolis Consumer Overview
- Sublimaze Prescribing Information (FDA)
- Sublimaze Advanced Consumer (Micromedex) - Includes Dosage Information
- fentanyl MedFacts Consumer Leaflet (Wolters Kluwer)
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