July 25, 2016
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Sufenta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Sufenta (sufentanil citrate) Injection is an opioid analgesic used in anesthesia to prevent pain in patients undergoing surgery or medical procedures. Common side effects of Sufenta include respiratory depression and muscle stiffness.

Talk to your doctor about your individual dosage recommendation. Sufenta must be administered under a doctor's supervision. Some drugs may interact with Sufenta. Tell your doctor all medications you take. Before taking Sufenta tell your doctor if you have liver or kidney dysfunction. Exercise caution if you are pregnant or breastfeeding and taking Sufenta.

Our Sufenta (sufentanil citrate) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Sufenta FDA Prescribing Information: Side Effects
(Adverse Reactions)


The most common adverse reactions of opioids are respiratory depression and skeletal muscle rigidity, particularly of the truncal muscles. SUFENTA (sufentanil citrate injection) may produce muscular rigidity that involves the skeletal muscles of the neck and extremities. See CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS on the management of respiratory depression and skeletal muscle rigidity. Urinary retention has been associated with the use of epidural opioids but was not reported in the clinical trials of epidurally administered sufentanil due to the use of indwelling catheters. The incidence of urinary retention in patients without urinary catheters receiving epidural sufentanil is unknown; return of normal bladder activity may be delayed. The following adverse reaction information is derived from controlled clinical trials in 320 patients who received intravenous sufentanil during surgical anesthe-sia and in 340 patients who received epidural sufentanil plus bupivacaine 0.125% for analgesia during labor and is presented below. Based on the observed frequency, none of the reactions occurring with an incidence less than 1% were observed during clinical trials of epidural sufentanil used during labor and delivery (N=340).

In general cardiovascular and musculoskeletal adverse experiences were not observed in clinical trials of epidural sufentanil. Hypotension was observed 7 times more frequently in intravenous trials than in epidural trials. The incidence of central nervous system, dermatological and gastrointestinal adverse experiences was approximately 4 to 25 times higher in studies of epidural use in labor and delivery.

Probably Causally Related: Incidence Greater than 1% - Derived from clinical trials (See preceding paragraph)

Cardiovascular: bradycardia*, hypertension*, hypotension*.
Musculoskeletal: chest wall rigidity*.
Central Nervous System: somnolence*.
Dermatological: pruritus (25%).
Gastrointestinal: nausea*, vomiting*.
*Incidence 3% to 9%

Probably Causally Related: Incidence Less than 1% - Derived from clinical trials (Adverse events reported in post-marketing surveillance, not seen in clinical trials, are italicized.)

Body as a whole: anaphylaxis.
Cardiovascular: arrhythmia*, tachycardia*, cardiac arrest.
Central Nervous System: chills*.
Dermatological: erythema*.
Musculoskeletal: skeletal muscle rigidity of neck and extremities.
Respiratory: apnea*, bronchospasm*, postoperative respiratory depression*.
Miscellaneous: intraoperative muscle movement*.
*Incidence 0.3% to 1%


SUFENTA (sufentanil citrate) is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and therefore has the potential for being abused.

Read the entire FDA prescribing information for Sufenta (Sufentanil Citrate Injection)

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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