Dsuvia Side Effects
Generic name: sufentanil
Medically reviewed by Drugs.com. Last updated on Feb 25, 2024.
Note: This document contains side effect information about sufentanil. Some dosage forms listed on this page may not apply to the brand name Dsuvia.
Applies to sufentanil: injection solution. Other dosage forms:
Warning
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 Dsuvia
Along with its needed effects, sufentanil (the active ingredient contained in Dsuvia) 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
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 (the active ingredient contained in Dsuvia) 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
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?
More about Dsuvia (sufentanil)
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- Dosage information
- During pregnancy
- FDA approval history
- Drug class: Opioids (narcotic analgesics)
- Breastfeeding
Patient resources
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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.