Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fentanyl hydrochloride
Drug ID BADD_D00881
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 For the treatment of cancer patients with severe pain that breaks through their regular narcotic therapy.
Marketing Status Prescription; Discontinued
ATC Code N01AH01; N02AB03
DrugBank ID DB00813
KEGG ID D10811
MeSH ID D005283
PubChem ID 83932
TTD Drug ID D0E1WI
NDC Product Code 0406-1165
Synonyms Fentanyl | Phentanyl | Fentanest | Fentanyl Citrate | R-4263 | R 4263 | R4263 | Sublimaze | Transmucosal Oral Fentanyl Citrate | Duragesic | Durogesic | Fentora
Chemical Information
Molecular Formula C22H29ClN2O
CAS Registry Number 1443-54-5
SMILES CCC(=O)N(C1CCN(CC1)CCC2=CC=CC=C2)C3=CC=CC=C3.Cl
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Abscess11.01.08.001--Not Available
Agitation17.02.05.012; 19.06.02.001--
Anaemia01.03.02.001--
Anxiety19.06.02.002--
Apnoea22.02.01.001--
Application site erythema08.02.01.001; 12.07.01.001; 23.03.06.005--Not Available
Application site oedema08.02.01.020; 12.07.01.020--Not Available
Application site pain08.02.01.004; 12.07.01.004--Not Available
Application site pruritus08.02.01.005; 12.07.01.005; 23.03.12.004--Not Available
Application site reaction08.02.01.006; 12.07.01.006--Not Available
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
Asthma10.01.03.010; 22.03.01.002--Not Available
Atelectasis22.01.02.001--
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Bradycardia02.03.02.002--Not Available
Chest pain02.02.02.011; 08.01.08.002; 22.02.08.003--Not Available
Chills08.01.09.001; 15.05.03.016--
Confusional state17.02.03.005; 19.13.01.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Dehydration14.05.05.001--
Dermatitis bullous23.03.01.002--
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.007--
Dyspnoea02.01.03.002; 22.02.01.004--
Dysuria20.02.02.002--
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