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Sufentanil Side Effects

For the Consumer

Applies to sufentanil: injection solution

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.

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:

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

Uncommon (0.1% to 1%): Hypersensitivity

Postmarketing reports: Anaphylaxis[Ref]

Anaphylaxis has been reported with ingredients contained in the sufentanil 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

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

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. SUFentanil Citrate (SUFentanil)." Akorn Inc, Buffalo Grove, IL.

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.

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