Sufenta Side Effects

Generic Name: sufentanil

Please note - some side effects for Sufenta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Sufenta - for the Consumer

Sufenta

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sufenta:

Anxiety; confusion; constipation; difficulty walking; dizziness; drowsiness; dry mouth; headache; indigestion; itching; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); hallucinations; muscle rigidity; seizures; slow or irregular heartbeat; slowed breathing; trouble breathing; weakness.

Sufentanil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sufentanil:

Anxiety; confusion; constipation; difficulty walking; dizziness; drowsiness; dry mouth; headache; indigestion; itching; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); hallucinations; muscle rigidity; seizures; slow or irregular heartbeat; slowed breathing; trouble breathing; weakness.

Sufenta Side Effects - for the Professional

Sufenta

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

Cardiovascular: bradycardia1, hypertension1, hypotension1.

Musculoskeletal: chest wall rigidity1.

Central Nervous System: somnolence1.

Dermatological: pruritus (25%).

Gastrointestinal: nausea1, vomiting1.

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: arrhythmia2, tachycardia2, cardiac arrest.

Central Nervous System: chills2.

Dermatological: erythema2.

Musculoskeletal: skeletal muscle rigidity of neck and extremities.

Respiratory: apnea2, bronchospasm2, postoperative respiratory depression2.

Miscellaneous: intraoperative muscle movement2.

1

Incidence 3% to 9%

2

Incidence 0.3% to 1%

Side Effects by Body System

Respiratory

Respiratory side effects including respiratory depression, apnea, and bronchospasm have been reported frequently.

Cardiovascular

Cardiovascular side effects including hypotension, hypertension, bradycardia, cardiac arrest, and arrhythmias have been reported infrequently.

Musculoskeletal

Musculoskeletal side effects including skeletal muscle rigidity, particularly of the truncal muscles, intraoperative muscle movement, and chest wall rigidity have been reported frequently.

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting have been reported.

Genitourinary

Genitourinary side effects including urinary retention have been reported commonly.

Dermatologic

Dermatologic side effects including pruritus and erythema have been reported.

General

General side effects including chills and somnolence have been reported.

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