Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fentanyl
Drug ID BADD_D00879
Description Fentanyl, a potent opioid agonist, was developed in the 1950s to fill a need for strong and rapid analgesia.[A179542] Because of these characteristics, fentanyl is commonly used to treat chronic cancer pain or in anesthesia.[Label,L6598,L6601,L6604,L6607,L922,L6610,L6613] Fentanyl is related to other opioids like [morphine] and [oxycodone]. Fentanyl's high potency has also made it a common adulterant in illicit drugs, especially heroin.[A179542] In 2017, 47600 overdose deaths in the United States involved some opioid (over 2/3 of all overdose deaths).[L6748] Opioid overdoses kill an average of 11 Canadians daily.[L6751] Fentanyl was FDA approved in 1968.[Label,L6598,L6601,L6604,L6607,L922,L6610,L6613]
Indications and Usage Fentanyl intravenous or intramuscular injections are indicated for short term analgesia during induction, maintenance, and recovery from general or regional anesthesia.[Label] These injections are also used with a neuroleptic for premedication, induction, and as an adjunct to maintenance of anesthesia.[Label] Finally, fentanyl intravenous or intramuscular injections are used with oxygen for anesthesia in high risk patients.[Label] Fentanyl sublingual tablets, transmucosal lozenges, buccal tablets, sublingual sprays, transdermal systems, and nasal sprays are indicated for the management of breakthrough pain in opioid tolerant cancer patients who require around the clock pain management.[L6598,L6601,L6604,L6607,L922,L6610]
Marketing Status approved; illicit; investigational; vet_approved
ATC Code N01AH01; N02AB03
DrugBank ID DB00813
KEGG ID D00320
MeSH ID D005283
PubChem ID 3345
TTD Drug ID D0E1WI
NDC Product Code 59116-2642; 55700-753; 60505-7008; 60505-7016; 60505-7017; 59116-2645; 60505-7015; 60505-7083; 63629-4813; 47781-427; 63459-541; 63629-4976; 0378-9126; 60505-7010; 60505-7080; 59116-2643; 47781-424; 60505-7006; 60505-7087; 63459-544; 63459-548; 0378-9125; 59116-2641; 64181-0008; 47781-423; 60505-7012; 60505-7013; 60505-7082; 63459-546; 0378-9121; 0378-9127; 60505-7011; 0378-9119; 0378-9122; 55700-973; 60505-7086; 63629-4974; 59116-2646; 55700-597; 60505-7014; 60505-7085; 0378-9123; 59116-2640; 47781-426; 47781-428; 55700-772; 60505-7007; 60505-7009; 60505-7081; 60505-7084; 63459-542; 0378-9124; 59116-2644; 55700-748; 55700-749; 55700-972
UNII UF599785JZ
Synonyms Fentanyl | Phentanyl | Fentanest | Fentanyl Citrate | R-4263 | R 4263 | R4263 | Sublimaze | Transmucosal Oral Fentanyl Citrate | Duragesic | Durogesic | Fentora
Chemical Information
Molecular Formula C22H28N2O
CAS Registry Number 437-38-7
SMILES CCC(=O)N(C1CCN(CC1)CCC2=CC=CC=C2)C3=CC=CC=C3
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)
Withdrawal syndrome19.07.06.023; 08.06.02.0120.004271%Not Available
Mental status changes19.07.01.0010.001205%Not Available
Wound secretion12.01.08.007; 08.01.03.035--Not Available
Onychoclasis23.02.05.005--Not Available
Application site vesicles23.03.01.009; 12.07.01.009; 08.02.01.009--Not Available
Brain oedema17.07.02.003; 12.01.10.0100.001797%
Application site infection12.07.01.012; 11.01.08.012; 08.02.01.015--Not Available
Chapped lips07.05.01.004--Not Available
Brain death17.02.03.003; 08.04.01.0040.001374%Not Available
Emotional distress19.04.02.008--Not Available
Gingival ulceration07.09.13.014--Not Available
General physical health deterioration08.01.03.018--Not Available
Balance disorder08.01.03.081; 17.02.02.007--Not Available
Bradyphrenia19.10.03.002; 17.03.03.0040.000317%Not Available
Lung cancer metastatic22.08.01.004; 16.19.02.0030.000634%Not Available
Application site eczema23.03.04.015; 12.07.01.019; 08.02.01.019--Not Available
Pneumomediastinum22.09.03.0040.000423%Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.012--Not Available
Subileus07.13.01.004--Not Available
Contusion15.03.05.007; 24.07.06.001; 23.03.11.002; 12.01.06.001--
Musculoskeletal chest pain22.09.01.001; 15.03.04.012--
Deep vein thrombosis24.01.02.003--Not Available
Therapy naive08.06.01.029--Not Available
Wound haemorrhage24.07.01.029; 12.01.08.017--Not Available
Rhinalgia22.12.03.020--Not Available
Ear discomfort04.03.01.005--Not Available
Application site discharge23.03.03.049; 12.07.01.039; 08.02.01.039--Not Available
Upper respiratory tract congestion22.12.03.033--Not Available
Lymphatic disorder01.09.01.003--Not Available
Wound23.03.11.043; 12.01.08.009--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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