Subsys Side Effects

Generic name: fentanyl

Medically reviewed by Drugs.com. Last updated on Jun 3, 2024.

Note: This document provides detailed information about Subsys Side Effects associated with fentanyl. Some dosage forms listed on this page may not apply specifically to the brand name Subsys.

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

Other dosage forms:

• injection solution
• nasal spray
• transdermal patch extended release

Serious side effects of Subsys

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:

Get emergency help immediately if any of the following symptoms of overdose occur while taking fentanyl:

Symptoms of overdose

• extremely shallow or slow breathing

Other side effects of Subsys

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:

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

• 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]

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.^[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

• 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]

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]

Hypersensitivity

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

Hematologic

• 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]

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.^[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]

Frequently asked questions

• Which drugs cause opioid-induced constipation?
• Which painkiller should you use?
• How long does Fentanyl stay in your system?
• Why is fentanyl so dangerous?
• Fentanyl test strips: where to get & how to use?
• What are the symptoms of a fentanyl overdose?
• Carfentanil vs Fentanyl: Which is more dangerous?
• How does fentanyl compare to heroin or other opiates?

Further information

Subsys side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer