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Fentanyl is undoubtedly one of the most dangerous drugs out there. One thing is for sure: Fentanyl is now everywhere in the U. Even more disturbing is that the levels of exposure are almost completely unpredictable and often deadly.
Medically reviewed by Drugs. Last updated on Nov 16, Commonly reported side effects of fentanyl include: fever, respiratory depression, nausea, vomiting, and diaphoresis. Other side effects include: hypoventilation. See below for a comprehensive list of adverse effects.
Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of fentanyl sublingual spray, especially by children, can result in a fatal overdose of fentanyl.
The history of fentanyl
Keep out of reach of children. Ensure proper storage and disposal. 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 s and symptoms of respiratory depression and sedation.
When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to fentanyl sublingual spray. When dispensing, do not substitute with any other fentanyl products. Fentanyl sublingual spray exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.
Prolonged use of fentanyl sublingual spray during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.
If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Monitor for respiratory depression during treatment. Accidental ingestion of fentanyl can result in a fatal overdose, especially in children; keep out of reach of children. Use with CYP3A4 inhibitors or inducers may change fentanyl plasma levels resulting in a fatal overdose of fentanyl and monitoring is recommended. Reserve concomitant prescribing for patients with inadequate alternative treatment options, limit dosage and duration to the minimum required, and monitor for respiratory depression and sedation.
When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products. Fentanyl is a Schedule II controlled substance with abuse liability similar to other opioid analgesics. Assess risk prior to initiation and monitor for s of misuse, abuse, and addiction during treatment.
Prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome. If prolonged use is required in a pregnant woman, advise patient of potential fetal risk and ensure appropriate treatment will be available. Use with CYP3A4 inhibitors or inducers may change fentanyl plasma levels resulting in fatal overdose and monitoring is recommended.
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Along with its needed effects, fentanyl 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:. 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:. Managing side effects general information 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.
The most commonly reported adverse reactions included headache, nausea, vomiting, ,dizziness, and constipation. Very rare less than 0. Postmarketing reports : Loss of consciousness, vertigocoma, 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.
Uncommon 0. Rare less than 0. Frequency not reported : Syncopevasodilation, bradycardiabigeminy, myocardial infarct.
What is fentanyl?
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.
Postmarketing reports : Ileusdental caries, tooth loss, gingival recession, gingivitisgingival bleeding, lip edema, pharyngeal edema, gum bleeding, ulcer [ Ref ].
Frequency not reported : Urinary tract infection, urination impaired, hematuriaurinary urgency, dysuria [ Ref ]. Postmarketing reports : Application site discharge, application site bleeding, application site infection, rash and scab, erosion, hyperesthesia, application site necrosis [ Ref ]. 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.
The hemolysis observed may have been related to rapid injection of large volumes of hypotonic fentanyl solution. Frequency not reported : abnormal healing, dehydration [ Ref ]. Frequency not reported : Nervousness [ Ref ]. Frequency not reported : Asthmahiccup, atelectasis, hyperventilation. Postmarketing reports : Respiratory arrest [ Ref ]. Ionsys fentanyl. Palmer CM "Early respiratory depression following intrathecal fentanyl-morphine combination. Mirenda J, Tabatabai M, Wong K "Delayed and prolonged rigidity greater than 24 h following high-dose fentanyl anesthesia.
Bernstein KJ, Klausner MA "Potential dangers related Smoking fentanyl side effects transdermal fentanyl duragesic r when used for postoperative pain. Hoien AO "Another case of grand mal seizure after fentanyl administration. Incidence, duration, and plasma concentrations.
Eisenach JC "Respiratory depression following intrathecal opioids. Freeman AB, Steinbrook RA "Recurrence of pulsus alternans after fentanyl injection in a patient with aortic stenosis and congestive heart failure.
Furuya H, Okumura F "Hemolysis after administration of high-dose fentanyl. Always consult your healthcare provider to ensure the information displayed on this applies to your personal circumstances.
What is fentanyl?
Some side effects may not be reported. You may report them to the FDA. Fentanyl Side Effects Medically reviewed by Drugs. Consumer Professional In Summary Commonly reported side effects of fentanyl include: fever, respiratory depression, nausea, vomiting, and diaphoresis. Managing side effects general information. References 1. Cerner Multum, Inc. Jackson FW "Fentanyl and the wooden chest. Sosis M "Fentanyl and emesis.
Expert Review Panel" Ananthanarayan C "Tussive effect of fentanyl. Need to Know:. Drug Status Availability Prescription only Rx. Related Drugs.