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)
Nasal discomfort22.12.03.012--Not Available
Large intestinal haemorrhage24.07.02.026; 07.12.03.003--
Deafness bilateral04.02.01.0070.000211%Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Protein urine present13.13.02.006--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Clonic convulsion17.12.03.008--Not Available
Wound complication23.03.11.044; 12.01.08.010--
Affect lability19.04.01.001--Not Available
Skin burning sensation23.03.03.021; 17.02.06.009--Not Available
Inflammation of wound12.01.08.034; 08.01.05.012--Not Available
Haemorrhage24.07.01.002--Not Available
Faecaloma07.01.03.004--Not Available
Oral pustule11.01.04.015; 07.05.07.015--Not Available
Faecalith07.01.03.007--Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.003--Not Available
Paraesthesia oral07.05.05.035; 17.02.06.008--Not Available
Cognitive disorder19.21.02.001; 17.03.03.003--
Cancer pain16.32.03.0040.000211%Not Available
Hypogonadism05.05.04.002; 21.03.02.010--Not Available
Nuchal rigidity15.05.04.005; 17.05.02.006--Not Available
Vasodilation procedure25.03.01.001--Not Available
Muscle relaxant therapy25.16.01.001--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Angiopathy24.03.02.007--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Urine output increased13.13.03.002--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Hot flush21.02.02.001; 08.01.03.027; 24.03.01.005--
Adverse event08.06.01.0100.004821%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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