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Sufenta (Sufentanil Citrate) - Side Effects and Adverse Reactions



The most common adverse reactions of opioids are respiratory depression and skeletal muscle rigidity, particularly of the truncal muscles. SUFENTA 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 anesthesia 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 [Incidence 3% to 9%] , hypertension, hypotension.

Musculoskeletal: chest wall rigidity.

Central Nervous System: somnolence.

Dermatological: pruritus (25%).

Gastrointestinal: nausea, vomiting.

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 [Incidence 0.3% to 1%] , 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.

Drug label data at the top of this Page last updated: 2008-07-02

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