Sufenta Side Effects

Generic name: sufentanil

Medically reviewed by Drugs.com. Last updated on Apr 12, 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

Precautions

Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

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 or your child 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 or your child have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with sufentanil (the active ingredient contained in Sufenta) may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.

Tell your doctor if you or your child have stiffness in the muscles of your neck, chest, hands, or legs after receiving this medicine.

Check with your doctor right away if you or your child 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.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

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 eat grapefruit or drink grapefruit juice while you are using this medicine.

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.

See also:

Serious side effects of Sufenta

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:

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

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