Alfentanil (Alfentanil Hydrochloride) - 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. 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 incidencein 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%

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ALFENTANIL

Possible Alfentanil side effects / adverse reactions in 54 year old male

Reported by a consumer/non-health professional from United Kingdom on 2007-01-08

Patient: 54 year old male

Reactions: Toxic Epidermal Necrolysis

Suspect drug(s):
Amoxicillin
    Dosage: 1g three times per day
    Indication: Drug USE FOR Unknown Indication

Actrapid
    Indication: Drug USE FOR Unknown Indication

Alfentanil
    Indication: Drug USE FOR Unknown Indication

Aquasept
    Indication: Drug USE FOR Unknown Indication

Bactroban
    Indication: Drug USE FOR Unknown Indication

Calcium Chloride
    Indication: Drug USE FOR Unknown Indication

Calcium Gluconate
    Indication: Drug USE FOR Unknown Indication

Ceftriaxone
    Indication: Drug USE FOR Unknown Indication

Clexane
    Dosage: 20mg per day
    Indication: Drug USE FOR Unknown Indication

Dobutamine HCL
    Indication: Drug USE FOR Unknown Indication

Fluconazole
    Dosage: 200mg per day
    Indication: Drug USE FOR Unknown Indication

Fragmin
    Dosage: 2500iu per day
    Indication: Drug USE FOR Unknown Indication

Furosemide
    Dosage: 20mg twice per day
    Indication: Drug USE FOR Unknown Indication

Furosemide
    Dosage: 20mg per day
    Administration route: Oral

Hydrocortisone
    Dosage: 100mg single dose
    Indication: Drug USE FOR Unknown Indication

Lactulose
    Indication: Drug USE FOR Unknown Indication

Lansoprazole
    Indication: Drug USE FOR Unknown Indication

Lorazepam
    Indication: Drug USE FOR Unknown Indication

Magnesium Sulfate
    Indication: Drug USE FOR Unknown Indication

Noradrenaline
    Indication: Drug USE FOR Unknown Indication

Omeprazole
    Indication: Drug USE FOR Unknown Indication

Acetaminophen
    Indication: Drug USE FOR Unknown Indication

Piriton
    Dosage: 10mg four times per day
    Indication: Drug USE FOR Unknown Indication

Potassium Chloride
    Indication: Drug USE FOR Unknown Indication

Potassium Phosphates
    Indication: Drug USE FOR Unknown Indication

Propofol
    Indication: Drug USE FOR Unknown Indication

Ventolin
    Indication: Drug USE FOR Unknown Indication

Sando-K
    Indication: Drug USE FOR Unknown Indication

Silver Sulphadiazine
    Administration route: Topical
    Indication: Drug USE FOR Unknown Indication

Simvastatin
    Dosage: 40mg per day
    Indication: Drug USE FOR Unknown Indication

Sodium Bicarbonate
    Indication: Drug USE FOR Unknown Indication

Sodium Chloride 0.9%
    Indication: Drug USE FOR Unknown Indication

Thiamin
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication

Tinzaparin
    Dosage: 3500mcl per day
    Indication: Drug USE FOR Unknown Indication

Vitamin K
    Indication: Drug USE FOR Unknown Indication

Other drugs received by patient: Amoxicillin; Aspirin; Atrovent; Ciprofloxacin; Amoxicillin + Clavulanate Potassium; Erythromycin; Metoclopramide; Midodrine; Pantoprazole Sodium; Piperacillin and Tazobactam; Vancomycin; Zopiclone

Possible Alfentanil side effects / adverse reactions in 54 year old male

Reported by a consumer/non-health professional from United Kingdom on 2007-01-09

Patient: 54 year old male

Reactions: Toxic Epidermal Necrolysis

Suspect drug(s):
Rocephin
    Indication: Drug USE FOR Unknown Indication

Actrapid
    Indication: Drug USE FOR Unknown Indication

Vitamin K
    Indication: Drug USE FOR Unknown Indication

Tinzaparin
    Indication: Drug USE FOR Unknown Indication

Thiamin
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication

Sodium Chloride
    Indication: Drug USE FOR Unknown Indication

Sodium Bicarbonate
    Indication: Drug USE FOR Unknown Indication

Simvastatin
    Indication: Drug USE FOR Unknown Indication

Silver Sulphadiazine
    Administration route: Topical
    Indication: Drug USE FOR Unknown Indication

Sando-K
    Indication: Drug USE FOR Unknown Indication

Ventolin
    Indication: Drug USE FOR Unknown Indication

Propofol
    Indication: Drug USE FOR Unknown Indication

Potassium Phosphates
    Indication: Drug USE FOR Unknown Indication

Potassium Chloride
    Indication: Drug USE FOR Unknown Indication

Piriton
    Indication: Drug USE FOR Unknown Indication

Acetaminophen
    Indication: Drug USE FOR Unknown Indication

Omeprazole
    Indication: Drug USE FOR Unknown Indication

Noradrenaline
    Indication: Drug USE FOR Unknown Indication

Magnesium Sulfate
    Indication: Drug USE FOR Unknown Indication

Lorazepam
    Indication: Drug USE FOR Unknown Indication

Lansoprazole
    Indication: Drug USE FOR Unknown Indication

Lactulose
    Indication: Drug USE FOR Unknown Indication

Hydrocortisone
    Indication: Drug USE FOR Unknown Indication

Furosemide
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication

Furosemide

Fragmin
    Indication: Drug USE FOR Unknown Indication

Fluconazole
    Indication: Drug USE FOR Unknown Indication

Dobutamine HCL
    Indication: Drug USE FOR Unknown Indication

Clexane
    Indication: Drug USE FOR Unknown Indication

Calcium Gluconate
    Indication: Drug USE FOR Unknown Indication

Calcium Chloride
    Indication: Drug USE FOR Unknown Indication

Bactroban
    Indication: Drug USE FOR Unknown Indication

Aquasept
    Indication: Drug USE FOR Unknown Indication

Amoxicillin
    Indication: Drug USE FOR Unknown Indication

Alfentanil
    Indication: Drug USE FOR Unknown Indication

Other drugs received by patient: Amoxicillin; Aspirin; Atrovent; Ciprofloxacin; Amoxicillin + Clavulanate Potassium; Erythromycin; Metoclopramide; Midodrine; Pantoprazole Sodium; Tazocin; Vancomycin; Zopiclone

Possible Alfentanil side effects / adverse reactions in 54 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2007-01-10

Patient: 54 year old male

Reactions: Toxic Epidermal Necrolysis

Suspect drug(s):
Acetaminophen

Amoxicillin

Furosemide

Furosemide
    Administration route: Oral

Hydrocortisone

Potassium Chloride

Ventolin

Silver Sulfadiazine
    Administration route: Topical

Actrapid

Alfentanil

Aquasept

Bactroban

Calcium Chloride

Calcium Gluconate

Ceftriaxone

Clexane

Dobutamine HCL

Fluconazole

Fragmin

Lactulose

Lansoprazole

Lorazepam

Magnesium Sulfate

Noradrenaline

Omeprazole

Piriton

Potassium Phosphates

Propofol

Sando-K

Simvastatin

Sodium Bicarbonate

Sodium Chloride

Thiamin
    Administration route: Oral

Tinzaparin

Vitamin K

Other drugs received by patient: Aspirin; Atrovent; Ciprofloxacin; Amoxicillin + Clavulanate Potassium; Erythromycin; Metoclopramide; Midodrine HCL; Pantoprazole Sodium; Tazocin; Vancomycin; Zopiclone; Amoxicillin