Abstral Side Effects

Generic name: fentanyl

Medically reviewed by Drugs.com. Last updated on Oct 25, 2024.

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

Applies to fentanyl: transdermal patch extended release.

Other dosage forms:

• lozenge/troche, spray, tablet
• injection solution
• nasal spray

Important warnings This medicine can cause some serious health issues

Transdermal route (patch, extended release)

Addiction, Abuse, and Misuse; Risk Evaluation and Mitigation Strategy (REMS); Life-threatening Respiratory Depression; Accidental Exposure; Neonatal Opioid Withdrawal Syndrome; Cytochrome P450 3A4 Interaction; Risk of Increased Fentanyl Absorption with Application of External Heat; and Risks From Concomitant Use of Benzodiazepines or Other CNS Depressants. Fentanyl exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.

Assess patient’s risk before prescribing, and monitor regularly for these behaviors or conditions.To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.Serious, life-threatening, or fatal respiratory depression may occur.

Monitor closely, especially upon initiation or following a dose increase.Accidental exposure to fentanyl, especially in children, can result in fatal overdose of fentanyl.Prolonged use of fentanyl during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.

If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl.Exposure of the fentanyl application site and surrounding area to direct external heat sources has resulted in fatal overdose of fentanyl.

Warn patients to avoid exposing the fentanyl application site and surrounding area to direct external heat sources.Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Transdermal route (patch, device assisted)

Warning: Life-Threatening Respiratory Depression; Ionsys REMS; Addiction, Abuse, and Misuse; Cytochrome P450 3A4 Interaction; and Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants. Serious, life-threatening, or fatal respiratory depression may occur.

Monitor closely, especially upon initiation.

Only the patient should activate dosing.Fentanyl iontophoretic transdermal system is for use only in patients in the hospital.

Discontinue fentanyl iontophoretic transdermal system before patients leave the hospital.Because of the risk of respiratory depression from accidental exposure, fentanyl iontophoretic transdermal system is available through a restricted program called the fentanyl iontophoretic transdermal system REMS Program.

Healthcare facilities that dispense fentanyl iontophoretic transdermal system must be certified in this program and comply with the REMS requirements.Fentanyl iontophoretic transdermal system exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.

Assess patient’s risk before prescribing, and monitor regularly for these behaviors and conditions.Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl.Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Common side effects of Abstral

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 side effects

• constipation
• feeling cold
• sleepiness or unusual drowsiness
• trouble sleeping

Less common side effects

• dry mouth
• feeling of constant movement of self or surroundings
• feeling of crawling, tingling, or burning of the skin
• lack or loss of strength
• memory loss
• sensation of spinning
• unusual dreams

Rare side effects

• abnormal ejaculation
• decreased interest in sexual intercourse
• decreased sexual performance or desire
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• muscle twitching

Incidence not known

• belching
• heartburn
• indigestion
• stomach discomfort or upset

Serious side effects of Abstral

Along with its needed effects, fentanyl (the active ingredient contained in Abstral) 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:

Less common side effects

• anxiety
• bloating or swelling of the face, arms, hands, lower legs, or feet
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• confusion
• decrease in urine volume
• difficulty in breathing or swallowing
• difficulty in passing urine (dribbling)
• fast, irregular, pounding, or racing heartbeat or pulse
• painful urination
• rapid weight gain
• seeing, hearing, or feeling things that are not there
• skin itching, rash, or redness
• swelling of the face, throat, or tongue
• tremor
• unusual weight gain or loss
• upper stomach pain

Rare side effects

• bluish color of the fingernails, lips, skin, palms, or nail beds
• burning, itching, redness, skin rash, swelling, or soreness at the application site
• confusion about identity, place, and time
• false or unusual sense of well-being
• irregular, fast or slow, or shallow breathing

Incidence not known

• agitation
• blurred vision
• chest pain or discomfort
• cough
• darkening of the skin
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• headache
• hives
• lightheadedness, dizziness, or fainting
• loss of appetite
• mental depression
• nausea
• nervousness
• overactive reflexes
• poor coordination
• pounding in the ears
• restlessness
• severe constipation
• severe vomiting
• shivering
• sweating
• talking or acting with excitement you cannot control
• tightness in the chest
• unusual tiredness or weakness
• vomiting

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

Symptoms of overdose

• cold, clammy skin
• drowsiness that is so severe you are not able to answer when spoken to or, if asleep, cannot be awakened
• pinpoint (small) pupils in the eyes
• seizures
• slow heartbeat
• very slow or troubled breathing

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 adverse events

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

Further information

Abstral 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