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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ALFENTANIL: 378 Adverse Event Reports & Safety Profile

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378
Total FAERS Reports
32 (8.5%)
Deaths Reported
123
Hospitalizations
378
As Primary/Secondary Suspect
103
Life-Threatening
7
Disabilities
Dec 29, 1986
FDA Approved
Prescription
Status
Yes
Generic Available

FDA Application: 019353 ·

First Report: 1992 · Latest Report: 20250318

What Are the Most Common ALFENTANIL Side Effects?

#1 Most Reported
Toxic epidermal necrolysis
46 reports (12.2%)
#2 Most Reported
Anaphylactic shock
45 reports (11.9%)
#3 Most Reported
Off label use
44 reports (11.6%)

All ALFENTANIL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxic epidermal necrolysis 46 12.2% 0 0
Anaphylactic shock 45 11.9% 0 8
Off label use 44 11.6% 2 4
Drug hypersensitivity 27 7.1% 0 0
Product use in unapproved indication 25 6.6% 0 1
Methaemoglobinaemia 21 5.6% 0 21
Hypotension 17 4.5% 4 3
Disseminated intravascular coagulation 16 4.2% 2 12
Respiratory depression 15 4.0% 4 2
Toxicity to various agents 15 4.0% 10 2
Anaphylactic reaction 14 3.7% 0 6
Exposure during pregnancy 14 3.7% 0 1
Dyspnoea 13 3.4% 0 8
Product quality issue 13 3.4% 0 12
Foetal exposure during pregnancy 12 3.2% 4 0
Premature baby 12 3.2% 0 0
Change in seizure presentation 11 2.9% 0 11
Epilepsy with myoclonic-atonic seizures 11 2.9% 0 11
Vomiting 11 2.9% 0 6
Bronchospasm 10 2.7% 0 2

Who Reports ALFENTANIL Side Effects? Age & Gender Data

Gender: 43.4% female, 56.6% male. Average age: 46.3 years. Most reports from: GB. View detailed demographics →

Is ALFENTANIL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 41 0 0
2012 2 1 1
2013 8 0 4
2014 5 1 1
2015 7 0 4
2016 17 0 11
2017 16 0 2
2018 6 0 4
2019 18 0 7
2020 8 2 3
2021 9 0 1
2022 27 0 13
2023 36 0 21
2024 31 0 14
2025 6 0 6

View full timeline →

What Is ALFENTANIL Used For?

IndicationReports
Product used for unknown indication 87
General anaesthesia 59
Anaesthesia 43
Ill-defined disorder 40
Pneumonia 34
Induction of anaesthesia 29
Sedative therapy 13
Analgesic therapy 12
Anaesthesia procedure 8
Sedation 8

ALFENTANIL vs Alternatives: Which Is Safer?

ALFENTANIL vs ALFUZOSIN ALFENTANIL vs ALGLUCOSIDASE ALFA ALFENTANIL vs ALIMTA ALFENTANIL vs ALIROCUMAB ALFENTANIL vs ALISKIREN ALFENTANIL vs ALISKIREN HEMIFUMARATE ALFENTANIL vs ALISKIREN\HYDROCHLOROTHIAZIDE ALFENTANIL vs ALIZAPRIDE ALFENTANIL vs ALLANTOIN ALFENTANIL vs ALLEGRA

Official FDA Label for ALFENTANIL

Official prescribing information from the FDA-approved drug label.