DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Sufentanil (Sufentanil Citrate Epidural) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The most common adverse reactions of opioids are respiratory depression and skeletal muscle rigidity, particularly of the truncal muscles. Sufentanil 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*, 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*.

*0.3% to 1%.



REPORTS OF SUSPECTED SUFENTANIL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Sufentanil. The information is not vetted and should not be considered as verified clinical evidence.

Possible Sufentanil side effects / adverse reactions in 66 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-30

Patient: 66 year old female

Reactions: Haemorrhage, Rash, Bradycardia, Shock

Adverse event resulted in: life threatening event

Suspect drug(s):
Dopram
    Dosage: 1 df, single
    Start date: 2012-02-19
    End date: 2012-02-19

Sufentanil
    Dosage: 1 df, 1x/day
    Indication: General Anaesthesia
    Start date: 2012-02-19
    End date: 2012-02-19

Solu-Medrol
    Dosage: 1 df, 1x/day
    Start date: 2012-02-19
    End date: 2012-02-19

Etomidate
    Dosage: 1 df, single
    Indication: General Anaesthesia
    Start date: 2012-02-19
    End date: 2012-02-19

Amoxicillin Trihydrate
    Dosage: 1 df, single
    Indication: Antibiotic Prophylaxis
    Start date: 2012-02-19
    End date: 2012-02-19



Possible Sufentanil side effects / adverse reactions in 44 year old female

Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-05-11

Patient: 44 year old female

Reactions: Hypersensitivity, Hypotension, Bronchospasm, Cardiac Arrest

Suspect drug(s):
Midazolam HCL
    Indication: Induction of Anaesthesia
    Start date: 2012-01-01
    End date: 2012-01-01

Rocuronium Bromide
    Indication: Induction of Anaesthesia
    Start date: 2012-01-01
    End date: 2012-01-01

Sufentanil
    Indication: Induction of Anaesthesia
    Start date: 2012-01-01
    End date: 2012-01-01

Diprivan
    Indication: Induction of Anaesthesia
    Start date: 2012-01-01
    End date: 2012-01-01



See index of all Sufentanil side effect reports >>

Drug label data at the top of this Page last updated: 2011-10-11

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017