Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Buprenorphine
Drug ID BADD_D00310
Description Buprenorphine is a weak partial mu-opioid receptor agonist and a weak kappa-opioid receptor antagonist used for the treatment of severe pain.[A186283,A186292] It is also commonly used as an alternative to [methadone] for the treatment of severe opioid addiction.[F4715,F4718] Buprenorphine is commercially available as the brand name product Suboxone which is formulated in a 4:1 fixed-dose combination product along with [naloxone], a non-selective competitive opioid receptor antagonist. Combination with naloxone is intended to reduce the abuse potential of Suboxone, as naloxone is poorly absorbed by the oral route (and has no effect when taken orally), but would reverse the opioid agonist effects of buprenorphine if injected intravenously.[A186289,F4715,F4718] Buprenorphine has poor gastrointestinal absorption and is therefore formulated as a sublingual tablet.
Indications and Usage For the treatment of moderate to severe pain, peri-operative analgesia, and opioid dependence.
Marketing Status Prescription; Discontinued
ATC Code N02AE01; N07BC01
DrugBank ID DB00921
KEGG ID D07132
MeSH ID D002047
PubChem ID 644073
TTD Drug ID D06AWE
NDC Product Code 51927-0062; 12578-607; 65724-0050; 0093-3659; 71335-0353; 42858-586; 60687-492; 62756-460; 59011-750; 65267-203; 67509-003; 12496-0100; 60687-481; 42858-353; 69238-1203; 42858-501; 59011-758; 62756-459; 71335-1154; 12496-0300; 69238-1505; 38779-3255; 59011-751; 68071-2592; 59011-757; 50090-5805; 73548-1039; 0093-3657; 0792-0631; 59011-752; 71335-0950; 69238-1202; 69238-1204; 0228-3153; 42858-502; 49812-0239; 0093-3239; 70518-1625; 42858-750; 0093-3658; 42858-493; 42858-839; 71795-2200; 0093-3656; 10920-593; 0228-3156; 12707-036; 47848-030; 69238-1205
Synonyms Buprenorphine | Buprenex | Prefin | Subutex | Buprex | Temgesic | Temgésic | 6029-M | 6029 M | 6029M | RX-6029-M | RX 6029 M | RX6029M | Buprenorphine Hydrochloride | Hydrochloride, Buprenorphine
Chemical Information
Molecular Formula C29H41NO4
CAS Registry Number 52485-79-7
SMILES CC(C)(C)C(C)(C1CC23CCC1(C4C25CCN(C3CC6=C5C(=C(C=C6)O)O4)CC7CC7)OC)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Congenital genitourinary abnormality21.15.02.002; 20.08.03.001; 03.06.02.0020.001859%Not Available
Unevaluable event08.01.03.0510.027878%Not Available
Poor quality sleep19.02.05.005; 17.15.04.0020.001859%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.010--Not Available
Breakthrough pain16.32.03.016; 08.01.08.0260.013010%Not Available
Procedural pain12.02.05.007; 08.01.08.0090.003717%Not Available
Head titubation17.01.06.0060.001859%Not Available
Skin abrasion12.01.06.010; 23.03.11.0180.001859%Not Available
Dysmorphism15.11.06.001; 03.11.06.0010.002788%Not Available
Substance abuse19.07.02.0060.002788%Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.004--
Acute kidney injury20.01.03.016--
Hypoxic-ischaemic encephalopathy24.04.06.021; 22.02.02.011; 17.13.02.0060.000485%Not Available
Medication residue present13.15.01.0320.007434%Not Available
Liver function test increased13.03.01.044--Not Available
Depersonalisation/derealisation disorder19.14.01.004--Not Available
Gastroschisis07.16.06.006; 03.04.07.0090.003717%Not Available
Maternal drugs affecting foetus12.03.03.006; 18.03.03.0090.007434%Not Available
Foetal malformation18.03.02.016; 03.02.01.0120.001212%Not Available
Appendix disorder07.11.01.0200.002788%Not Available
Communication disorder19.19.01.0080.001859%Not Available
Congenital nose malformation22.10.02.003; 03.16.04.0010.001859%Not Available
Foetal non-stress test abnormal13.21.01.0080.009293%Not Available
Dermal absorption impaired23.03.03.064; 08.06.01.0300.003717%Not Available
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