Sufenta Side Effects

Generic name: sufentanil

Medically reviewed by Drugs.com. Last updated on Jan 19, 2025.

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

Applies to sufentanil: injection solution.

Other dosage forms:

• sublingual tablet

Important warnings This medicine can cause some serious health issues

Injection route (solution)

Sufentanil citrate injection 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.

Serious side effects of Sufenta

Along with its needed effects, sufentanil (the active ingredient contained in Sufenta) 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:

Incidence not known

• agitation
• blurred vision
• confusion
• cough
• darkening of the skin
• diarrhea
• difficult or troubled breathing
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast heartbeat
• fever
• hives, itching, or skin rash
• irregular, fast or slow, or shallow breathing
• loss of appetite
• mental depression
• muscle stiffness
• nausea
• overactive reflexes
• pale or blue lips, fingernails, or skin
• poor coordination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• restlessness
• shivering
• sweating
• talking or acting with excitement you cannot control
• tightness in the chest
• trembling or shaking
• twitching
• unusual tiredness or weakness
• vomiting

For healthcare professionals

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

General adverse events

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

• Uncommon (0.1% to 1%): Hypersensitivity
• Postmarketing reports: Anaphylaxis^[Ref]

Anaphylaxis has been reported with ingredients contained in the sufentanil (the active ingredient contained in Sufenta) sublingual tablet.^[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

• 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]

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

Opioids:

• Postmarketing reports: Adrenal insufficiency, androgen deficiency^[Ref]

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]

Renal

• Rare (less than 0.1%): Renal failure

Frequently asked questions

• What is the Dsuvia REMS program?
• How do you take the Dsuvia (sufentanil) tablet?
• Is Dsuvia (sufentanil) a controlled substance?

Further information

Sufenta 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer