Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sufentanil
Drug ID BADD_D02082
Description Sufentanil is an opioid analgesic that is used as an adjunct in anesthesia, in balanced anesthesia, and as a primary anesthetic agent. It is administered by the intravenous, epidural and sublingual routes. Also known as _Dsuvia_, the sublingual form is used for the management of acute pain in adults that is severe to warrant the use of an opioid analgesic in certified medically supervised healthcare settings, including hospitals, surgical centers, and emergency departments [L4717]. Consideration may be made in the future for the use of the sublingual form in the US military in cases where analgesia is required immediately [L4718]. The sublingual form, manufactured by AcelRx Pharmaceuticals, Inc. (AcelRx), was approved on November 2, 2018 [L4717]. This route of administration is intended to be a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage acute pain without difficult intravenous or epidural administration [L4717], [A39633].
Indications and Usage The indications for this drug are as follows: 1. As an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated. 2. As a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated. 3. For epidural administration as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery 4. The sublingual form is indicated for the management of acute pain in adults that is severe to warrant the use of an opioid analgesic in certified medically supervised healthcare settings, including hospitals, surgical centers, and emergency departments. [FDA label]
Marketing Status approved; investigational
ATC Code N01AH03
DrugBank ID DB00708
KEGG ID D05938
MeSH ID D017409
PubChem ID 41693
TTD Drug ID D0D8DD
NDC Product Code 0406-0310; 67651-0327; 0406-0330; 61621-430
UNII AFE2YW0IIZ
Synonyms Sufentanil | Sulfentanyl | Sulfentanil | Sufenta | Sufentanil-Ratiopharm | Sufentanil Ratiopharm | SufentanilRatiopharm | Sufentanil Curasan | Curasan, Sufentanil | Sufentanil-Hameln | Sufentanil Hameln | SufentanilHameln | R-30730 | R 30730 | R30730 | Sufentanil Citrate | Citrate, Sufentanil
Chemical Information
Molecular Formula C22H30N2O2S
CAS Registry Number 56030-54-7
SMILES CCC(=O)N(C1=CC=CC=C1)C2(CCN(CC2)CCC3=CC=CS3)COC
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Acute respiratory distress syndrome10.02.01.067; 22.01.03.001; 24.03.02.0340.000179%
Anaemia01.03.02.0010.000179%
Anaphylactic reaction10.01.07.001; 24.06.03.0060.001250%
Anaphylactic shock10.01.07.002; 24.06.02.0040.003572%-
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.0010.000447%-
Anorectal disorder07.03.01.0010.000179%-
Apnoea22.02.01.001--
Arachnoiditis12.02.04.002; 17.06.01.0010.000179%
Arrhythmia02.03.02.001---
Body temperature increased13.15.01.001---
Bradycardia02.03.02.0020.000357%-
Bradycardia foetal02.03.02.018; 18.03.02.0060.000536%-
Bronchospasm10.01.03.012; 22.03.01.0040.000893%
Cardiac arrest02.03.04.0010.000447%
Cardiac failure02.05.01.0010.000179%
Cardio-respiratory arrest02.03.04.002; 22.02.06.0070.000268%-
Cardiogenic shock02.05.01.003; 24.06.02.0060.000179%-
Cauda equina syndrome17.10.03.0060.000268%-
Chills08.01.09.001; 15.05.03.016--
Circulatory collapse24.06.02.0010.000536%-
Coma17.02.09.0010.000357%-
Confusional state17.02.03.005; 19.13.01.001--
Cyanosis02.11.04.004; 22.02.02.007; 23.06.04.005; 24.03.01.0070.000179%
Dermatitis23.03.04.002---
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Drug abuse19.07.06.0100.000179%-
Drug ineffective08.06.01.0060.001340%-
Drug interaction08.06.03.0010.000268%-
Drug withdrawal syndrome08.06.02.004; 19.07.06.0130.000179%-
Dysgeusia07.14.03.001; 17.02.07.0030.000179%
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