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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Abnormal sensation in eye06.01.01.001--Not Available
Abscess11.01.08.001--Not Available
Accidental overdose12.09.03.001--Not Available
Acidosis14.01.03.002--
Acute respiratory distress syndrome10.02.01.067; 22.01.03.001; 24.03.02.0340.000529%
Administration site reaction12.07.04.011; 08.02.04.011--Not Available
Adrenal insufficiency14.11.01.004; 05.01.02.0010.000211%
Ageusia17.02.07.001; 07.14.03.003--Not Available
Agitation17.02.05.012; 19.06.02.001--
Akathisia19.06.02.006; 17.01.02.002--
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.001--Not Available
Alveolar proteinosis22.01.02.009; 10.04.04.0180.000211%Not Available
Amblyopia06.02.01.001--Not Available
Amnesia19.20.01.001; 17.03.02.001--
Anaemia01.03.02.001--
Anaphylactic reaction10.01.07.001; 24.06.03.0060.001692%
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Androgen deficiency21.16.02.001; 05.05.02.008--
Angina pectoris02.02.02.002; 24.04.04.002--
Anorectal disorder07.03.01.001--Not Available
Anorgasmia19.08.01.001--
Anosmia22.04.03.006; 17.04.04.001--
Anterograde amnesia19.20.01.005; 17.03.02.0050.000740%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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