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 Buprenorphine is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Buprenorphine is also used in combination with [naloxone] in a fixed-dose combination product for the treatment of moderate to severe opioid use disorder.[F4715,F4718]
Marketing Status approved; illicit; investigational; vet_approved
ATC Code N02AE01; N07BC01
DrugBank ID DB00921
KEGG ID D07132
MeSH ID D002047
PubChem ID 644073
TTD Drug ID D06AWE
NDC Product Code 10920-593; 71795-2200; 0093-3656; 59011-758; 63629-9475; 12578-607; 12496-0100; 58284-232; 58284-264; 59011-751; 69238-1204; 51927-0062; 58284-208; 58284-228; 59011-750; 59011-752; 68071-2592; 12707-036; 42858-353; 47781-408; 58118-0501; 47848-030; 0093-3239; 47781-406; 59011-757; 62756-460; 73548-1039; 0093-3658; 42858-502; 58284-216; 60687-492; 69238-1505; 71335-1154; 0792-0631; 42858-493; 42858-586; 0228-3153; 69238-1202; 65267-203; 12496-0300; 47781-419; 60687-481; 62756-459; 69238-1203; 69238-1205; 38779-3255; 49812-0239; 65724-0050; 0093-3657; 42858-501; 42858-750; 42858-839; 58284-224; 58284-296; 71335-0950; 0093-3659; 47781-407; 0228-3156; 58064-408; 58118-0502
UNII 40D3SCR4GZ
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
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)
Application site urticaria10.01.06.002; 08.02.01.028; 23.04.02.002; 12.07.01.0280.020421%Not Available
Intervertebral disc protrusion15.10.01.0040.000978%Not Available
Injection site discolouration23.03.03.046; 12.07.03.038; 08.02.03.0380.006517%Not Available
Application site discharge23.03.03.049; 12.07.01.039; 08.02.01.0390.023753%Not Available
Musculoskeletal discomfort15.03.04.0010.001231%Not Available
Application site swelling12.07.01.027; 08.02.01.0270.019082%Not Available
Injection site swelling12.07.03.018; 08.02.03.0170.037222%Not Available
Type IV hypersensitivity reaction10.01.03.0220.000797%Not Available
Affect lability19.04.01.001--Not Available
Injection site discomfort08.02.03.018; 12.07.03.0190.008618%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.003693%Not Available
Foetal death08.04.01.011; 18.01.02.0030.001086%
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.001412%Not Available
Bipolar disorder19.16.01.0030.001231%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.001593%Not Available
Application site discolouration23.03.03.023; 12.07.01.030; 08.02.01.0300.020168%Not Available
Application site scar12.07.01.033; 08.02.01.033; 23.03.11.0100.019552%Not Available
Injection site scar23.03.11.016; 12.07.03.050; 08.02.03.0500.002462%Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Adverse event08.06.01.010--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Feeling of body temperature change08.01.09.0120.005721%Not Available
Drug intolerance08.06.01.013--Not Available
Psychotic disorder19.03.01.002--
Unevaluable event08.01.03.0510.016004%Not Available
Application site discomfort08.02.01.034; 12.07.01.0340.004924%Not Available
Application site hypersensitivity12.07.01.014; 10.01.03.009; 08.02.01.0130.003259%Not Available
Application site induration12.07.01.015; 08.02.01.0140.002643%Not Available
Breakthrough pain16.32.03.016; 08.01.08.0260.009414%Not Available
Application site exfoliation23.03.07.007; 12.07.01.022; 08.02.01.0220.021653%Not Available
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