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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 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%



REPORTS OF SUSPECTED ALFENTANIL SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Alfentanil side effects / adverse reactions in female

Reported by a physician from Denmark on 2011-10-12

Patient: female

Reactions: Fatigue, Caesarean Section, Maternal Drugs Affecting Foetus, Respiratory Depression

Suspect drug(s):
Baclofen
    Dosage: 10 mg; trpl

Propavan (Propiomazine Maleate)
    Dosage: 25 mg, qd; trpl
    Indication: Prophylaxis

Nitrazepam
    Dosage: 5 mg; qd; trpl
    Indication: Prophylaxis

Lyrica
    Dosage: 350 mg;qd;trpl

Alfentanil
    Dosage: 0.5 mg iv
    Start date: 2011-07-13
    End date: 2011-07-13

Carbamazepine
    Dosage: 1800 mg; qd;trpl
    Indication: Epilepsy

Zolpidem Tartrate
    Dosage: 10 mg;qd;trpl
    Indication: Prophylaxis

Venlafaxine Hydrochloride
    Dosage: 75 mg;qd;trpl

Pentothal Matrium (Thiopental Sodium)
    Dosage: 500 mg; iv
    Start date: 2011-07-13
    End date: 2011-07-13

Celocurin (Suxamethonium Chloride)
    Dosage: 100 mg; iv
    Start date: 2011-07-13
    End date: 2011-07-13



Possible Alfentanil side effects / adverse reactions in male

Reported by a physician from France on 2011-11-02

Patient: male

Reactions: Anaphylactic Shock

Adverse event resulted in: hospitalization

Suspect drug(s):
Etomidate
    Dosage: once/single administration
    Indication: Anaesthesia
    Start date: 2011-07-01
    End date: 2011-07-01

Diprivan
    Dosage: once/single administration
    Indication: Anaesthesia
    Start date: 2011-07-01
    End date: 2011-07-01

Alfentanil
    Dosage: once/single administration
    Indication: Anaesthesia
    Start date: 2011-07-01
    End date: 2011-07-01

Augmentin
    Dosage: once/single administration
    Start date: 2011-07-01
    End date: 2011-07-01



Possible Alfentanil side effects / adverse reactions in 61 year old male

Reported by a consumer/non-health professional from Germany on 2011-11-28

Patient: 61 year old male weighing 84.0 kg (184.8 pounds)

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: death, life threatening event, hospitalization

Suspect drug(s):
Succinylcholine Chloride
    Dosage: unk
    Start date: 1996-04-25

Calciparine
    Dosage: unk
    Indication: Prophylaxis
    Start date: 1996-04-25
    End date: 1996-04-30

Ubretid
    Dosage: unk
    Indication: Prophylaxis
    Start date: 1996-04-27

Propulsin
    Dosage: unk
    Administration route: Oral
    Start date: 1996-04-29
    End date: 1996-04-30

Digitoxin TAB
    Dosage: unk
    Indication: Cardiac Failure
    Start date: 1996-05-02
    End date: 1996-05-07

Temazepam
    Dosage: unk
    Administration route: Oral
    Indication: Sedation
    Start date: 1996-04-24
    End date: 1996-04-24

Takus
    Dosage: unk
    Indication: Prophylaxis
    Start date: 1996-05-07
    End date: 1996-05-07

Adalat
    Dosage: unk
    Administration route: Oral
    Indication: Essential Hypertension
    Start date: 1996-04-26
    End date: 1996-04-28

Tracrium
    Dosage: unk
    Start date: 1996-04-25

Aldactone
    Dosage: unk
    Indication: Ascites
    Start date: 1996-05-03
    End date: 1996-05-07

Acetylcysteine
    Dosage: unk
    Start date: 1996-05-01
    End date: 1996-05-07

Lasix
    Dosage: unk
    Start date: 1996-05-01
    End date: 1996-05-07

Captopril
    Dosage: unk
    Administration route: Oral
    Indication: Essential Hypertension
    Start date: 1996-04-27
    End date: 1996-04-30

Panthenol
    Dosage: unk
    Indication: Prophylaxis
    Start date: 1996-04-30
    End date: 1996-05-01

Lefax
    Dosage: unk
    Administration route: Oral
    Indication: Flatulence
    Start date: 1996-04-27
    End date: 1996-04-27

Paractol
    Dosage: unk
    Administration route: Oral
    Indication: Flatulence
    Start date: 1996-04-29
    End date: 1996-04-30

Meropenem
    Dosage: unk
    Start date: 1996-05-01
    End date: 1996-05-07

Sufenta Preservative Free
    Dosage: unk
    Start date: 1996-05-01
    End date: 1996-05-05

Atropine Sulfate
    Dosage: unk
    Indication: Surgery
    Start date: 1996-04-25

Alfentanil
    Dosage: unk
    Start date: 1996-04-25

Dipidolor
    Dosage: unk
    Start date: 1996-04-26
    End date: 1996-04-28

Hetastarch IN Sodium Chloride
    Dosage: unk
    Start date: 1996-05-06
    End date: 1996-05-06

Nitrazepam
    Dosage: unk
    Start date: 1996-05-01
    End date: 1996-05-05

Carbocisteine
    Dosage: unk
    Start date: 1996-04-25
    End date: 1996-04-26

Dopamine Hydrochloride
    Dosage: unk
    Indication: Renal Failure
    Start date: 1996-05-01
    End date: 1996-05-07

Clonidine
    Dosage: unk
    Indication: Essential Hypertension
    Start date: 1996-05-01
    End date: 1996-05-01

Propofol
    Dosage: unk
    Start date: 1996-05-05
    End date: 1996-05-06

Prostigmin Bromide
    Dosage: unk
    Start date: 1996-05-05
    End date: 1996-05-05

Bepanthen
    Dosage: unk
    Indication: Prophylaxis
    Start date: 1996-05-05
    End date: 1996-05-05

Famotidine
    Dosage: unk
    Indication: Prophylaxis
    Start date: 1996-05-07
    End date: 1996-05-07

Dobutrex
    Dosage: unk
    Start date: 1996-05-02
    End date: 1996-05-07

Other drugs received by patient: Nutriflex ^braun^; Losferron; Sodium Chloride; Multibionta; TPN Electrolytes IN Plastic Container; Ringers Solution; Potassium Chloride; Lipovenoes; Magnesium Sulfate; Sterofundin; Multivitamin Additive



See index of all Alfentanil side effect reports >>

Drug label data at the top of this Page last updated: 2014-08-03

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