Sufenta Side Effects

Generic name: sufentanil

Medically reviewed by Drugs.com. Last updated on Oct 11, 2024.

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: sublingual tablet.

Other dosage forms:

• injection solution

Precautions

It is very important that your doctor check your progress closely while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

This medicine may be habit-forming. If you feel that the medicine is not working as well, check with your doctor.

This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if think you are pregnant or if you plan to become pregnant while using this medicine.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of Sufenta

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:

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:

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

Symptoms of overdose

• blue lips and fingernails
• blurred vision
• chest pain
• choking
• cold and clammy skin
• constricted pupils
• coughing that sometimes produces a pink frothy sputum
• decreased awareness or responsiveness
• difficult or troubled breathing
• irregular, fast or slow, or shallow breathing
• loss of consciousness
• pale or blue lips, fingernails, or skin
• severe sleepiness
• slow heartbeat
• swelling in the legs and ankles

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

See also:

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