Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fentanyl citrate
Drug ID BADD_D00880
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 D01399
MeSH ID D005283
PubChem ID 13810
TTD Drug ID D0E1WI
NDC Product Code 81565-205; 49812-0001; 63323-806; 72572-170; 72572-171; 0406-1333; 0406-1344; 38779-1756; 62991-1405; 51862-638; 63459-502; 63459-504; 0406-9206; 0406-9216; 0641-6026; 59116-3281; 0093-7869; 51862-634; 51862-636; 63459-506; 63459-508; 0406-9204; 0409-9093; 63323-808; 63459-512; 0409-1276; 0641-6248; 0093-7867; 0641-6247; 17478-030; 51754-2160; 0406-9212; 0409-9094; 0641-6027; 0641-6249; 0406-1130; 0093-7865; 0093-7870; 63323-810; 0641-6030; 51927-0042; 51862-635; 0641-6028; 61960-9500; 63275-5100; 64181-0007; 81371-2010; 72572-172; 0641-6024; 0641-6025; 0641-6029; 49452-0032; 59116-3280; 59116-3282; 0093-7866; 0093-7868; 51754-2150; 0406-9202; 0406-9208; 0406-1205; 51552-0687; 82393-118; 51862-637
UNII MUN5LYG46H
Synonyms Fentanyl | Phentanyl | Fentanest | Fentanyl Citrate | R-4263 | R 4263 | R4263 | Sublimaze | Transmucosal Oral Fentanyl Citrate | Duragesic | Durogesic | Fentora
Chemical Information
Molecular Formula C28H36N2O8
CAS Registry Number 990-73-8
SMILES CCC(=O)N(C1CCN(CC1)CCC2=CC=CC=C2)C3=CC=CC=C3.C(C(=O)O)C(CC(=O)O)(C(=O)O)O
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)
Tooth loss12.01.17.026; 07.09.09.001--Not Available
Tremor17.01.06.002--
Ulcer08.03.06.001--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary retention20.02.02.011--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria10.01.06.001; 23.04.02.001--
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Vaginal infection21.14.02.002; 11.01.10.002--
Vasodilatation24.03.02.003; 23.06.05.006--Not Available
Vertigo04.04.01.003; 17.02.12.002--
Viral infection11.05.04.001--Not Available
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Wheezing22.03.01.009--
Mental status changes19.07.01.001--Not Available
Gingival ulceration07.09.13.014--Not Available
Balance disorder08.01.03.081; 17.02.02.007--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
Large intestinal haemorrhage24.07.02.026; 07.12.03.003--
Affect lability19.04.01.001--Not Available
Haemorrhage24.07.01.002--Not Available
Faecaloma07.01.03.004--Not Available
Cancer pain16.32.03.004--Not Available
Nuchal rigidity15.05.04.005; 17.05.02.006--Not Available
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