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Sufentanil Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 29, 2023.

Applies to sufentanil: sublingual tablet. Other dosage forms:

Warning

Sublingual route (Tablet)

Accidental exposure to or ingestion of sufentanil sublingual tablets, especially in children, can result in respiratory depression and death. Because of the potential for life-threatening respiratory depression due to accidental exposure, sufentanil sublingual tablets are only available through a restricted program called the Dsuvia REMS Program. Sufentanil sublingual tablets must only be dispensed to patients in a certified medically supervised healthcare setting. Discontinue use of sufentanil sublingual tablets prior to discharge or transfer from the certified medically supervised healthcare setting.Serious, life-threatening, or fatal respiratory depression may occur with the use of sufentanil sublingual tablets. Monitor for respiratory depression, especially during initiation of sufentanil sublingual tablets.Sufentanil sublingual tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing sufentanil sublingual tablets, and monitor all patients regularly for the development of these behaviors or conditions.Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of sufentanil.Concomitant use of opioids with benzodiazepines or other central nervous system (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. Follow patients for signs and symptoms of respiratory depression and sedation.

Serious side effects of Sufentanil

Along with its needed effects, sufentanil 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 or nurse immediately if any of the following side effects occur while taking sufentanil:

Less common

Rare

Incidence not known

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

Symptoms of overdose

Other side effects of Sufentanil

Some side effects of sufentanil 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

Rare

For Healthcare Professionals

Applies to sufentanil: compounding powder, injectable solution, sublingual tablet.

General

The most commonly reported adverse events with the sublingual tablet have been nausea, headache, vomiting, dizziness, and hypotension; with the injectable formulation, apnea, rigidity, and bradycardia have been commonly reported.[Ref]

Respiratory

Common (1% to 10%): Respiratory depression

Uncommon (0.1% to 1%): Apnea

Rare (less than 0.1%): Hypoxia, bradypnea, hiccups, atelectasis, hypoventilation, respiratory distress, respiratory failure

Frequency not reported: Respiratory arrest[Ref]

Hypersensitivity

Anaphylaxis has been reported with ingredients contained in the sufentanil sublingual tablet.[Ref]

Uncommon (0.1% to 1%): Hypersensitivity

Postmarketing reports: Anaphylaxis[Ref]

Cardiovascular

Common (1% to 10%): Increased heart rate, increased blood pressure, decreased blood pressure

Uncommon (0.1% to 1%): Decreased heart rate, hypotension

Rare (less than 0.1%):: Bradycardia, sinus tachycardia, flushing

Frequency not reported: Severe bradycardia, severe hypotension including orthostatic hypotension, syncope[Ref]

Musculoskeletal

Common (1% to 10%): Involuntary muscle spasms, muscle twitching

Frequency not reported: Muscle rigidity, muscle movement[Ref]

Gastrointestinal

Very common (10% or more): Nausea (29%; sublingual tablet), vomiting

Common (1% to 10%): Constipation, dyspepsia

Uncommon (0.1% to 1%): Dry mouth

Rare (less than 0.1%): Flatulence, diarrhea, dry mouth, eructation, retching, abdominal discomfort, abdominal distension, abdominal pain upper, gastritis, postoperative ileus, hypoesthesia oral

Opioids:

Frequency not reported: increase in serum amylase[Ref]

Psychiatric

Common (1% to 10%): Confusional state

Uncommon (0.1% to 1%): Apathy, nervousness

Rare (less than 0.1%): Memory impairment, insomnia, confusional state, anxiety, agitation, disorientation, euphoric mood, hallucination, mental status changes

Frequency not reported: Addiction, abuse, misuse[Ref]

Nervous system

Cases of serotonin syndrome have been reported during concomitant use of opioids with serotonergic drugs.[Ref]

Very common (10% or more): Headache (12.1%; sublingual tablet)

Common (1% to 10%): Dizziness, sedation

Uncommon (0.1% to 1%): Somnolence, paresthesia, ataxia, dystonia, hyperreflexia

Rare (less than 0.1%): Pre-syncope, lethargy

Frequency not reported: Seizures, coma

Opioids:

Postmarketing reports: Serotonin syndrome[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 25%)

Uncommon (0.1% to 1%): Hyperhidrosis, rash, dry skin

Frequency not reported: Erythema[Ref]

Genitourinary

Common (1% to 10%): Urinary retention

Rare (less than 0.1%): urinary hesitation, oliguria[Ref]

Ocular

Uncommon (0.1% to 1%): Vision disturbances

Frequency not reported: Miosis[Ref]

Other

Very common (10% or more): Pyrexia

Uncommon (0.1% to 1%): Chills, asthenia

Frequency not reported: Drug withdrawal syndrome[Ref]

Endocrine

Cases of adrenal insufficiency have been reported with opioid use of greater than 1-month duration. Cases of androgen deficiency have occurred with chronic opioid use.[Ref]

Opioids:

Postmarketing reports: Adrenal insufficiency, androgen deficiency[Ref]

Renal

Rare (less than 0.1%): Renal failure

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Product Information. SUFentanil Citrate (sufentanil). Akorn Inc. 2017.

Further information

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