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Alfentanil Side Effects

Brand Names: Alfenta

Please note - some side effects for Alfentanil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Alfentanil Side Effects - for the Professional

Alfentanil

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

The adverse experience profile from 696 patients receiving Alfentanil for Monitored Anesthesia Care (MAC) is similar to the profile established with Alfentanil during general anesthesia. Respiratory events reported during MAC included hypoxia, apnea, and bradypnea. Other adverse events reported by patients receiving Alfentanil for MAC, in order of decreasing frequency, were nausea, hypotension, vomiting, pruritus, confusion, somnolence and agitation.

The following adverse reaction information is derived from controlled and open clinical trials in 785 patients who received intravenous Alfentanil during induction and maintenance of general anesthesia. The controlled trials included treatment comparisons with fentanyl, thiopental sodium, enflurane, saline placebo and halothane. The incidence of certain side effects is influenced by the type of use, e.g., chest wall rigidity has a higher reported incidence in clinical trials of Alfentanil induction, and by the type of surgery, e.g., nausea and vomiting have a higher reported incidence in patients undergoing gynecologic surgery. The overall reports of nausea and vomiting with Alfentanil were comparable to fentanyl.

Incidence Greater than 1% − Probably Causally Related (Derived from clinical trials)

Gastrointestinal:

nausea (28%), vomiting (18%)

Cardiovascular:

arrhythmia, bradycardia (14%), hypertension (18%), hypotension (10%), tachycardia (12%)

Musculoskeletal:

chest wall rigidity (17%), skeletal muscle movements*

Respiratory:

apnea*, postoperative respiratory depression

Central Nervous System:

blurred vision, dizziness*, sleepiness/postoperative sedation

*Incidence 3% to 9%  All others 1% to 3%

Incidence Less than 1% − Probably Causally Related (Derived from clinical trials)

Adverse events reported in post-marketing surveillance, not seen in clinical trials, are italicized.

Body as a whole:

anaphylaxis

Central Nervous System:

headache*, myoclonic movements, postoperative confusion*, postoperative euphoria*, shivering*

Dermatological:

itching*, urticaria*

Injection Site:

pain*

Musculoskeletal:

skeletal muscle rigidity of neck and extremities

Respiratory:

bronchospasm, hypercarbia*, laryngospasm*

*Incidence 0.3% to 1%

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have included nausea (28%) and vomiting (18%).

Cardiovascular

Cardiovascular side effects have included hypertension (18%), chest wall rigidity (17%), arrhythmias (14%), bradycardia (14%), tachycardia (12%), and hypotension (10%). Rare cardiovascular reactions have included asystole and sinus arrest.

Musculoskeletal

Musculoskeletal side effects have included skeletal muscle movements (3% to 9%), and truncal rigidity, particularly of the neck and extremities (<1%).

Respiratory

Respiratory side effects have included apnea (3% to 9%), postoperative respiratory depression (<1%), bronchospasm, hypercarbia, and laryngospasm (all <1%).

Respiratory depression has been reversed with the opiate antagonist, naloxone.

Nervous system

Nervous system side effects have included dizziness (3% to 9%), headache, myoclonic and dystonic movements, confusion, euphoria, and shivering (all <1%).

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported rarely .

Dermatologic

Dermatologic side effects have included pruritus and urticaria (<1%). Pruritus may occur with greater frequency in patients receiving epidural alfentanil (up to 60% in one study).

Pruritus during epidural infusions has been described as segmental (occurring on the chest) versus the face and arms, which is often seen with morphine.

Diphenhydramine is effective in relieving pruritus associated with opioids.

Local

Local side effects, such as injection site pain (<1%) have been reported.

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