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)
Head titubation17.01.06.0060.001231%Not Available
Application site burn23.03.11.013; 12.07.01.038; 08.02.01.0380.066551%Not Available
Application site erosion23.07.03.011; 12.07.01.021; 08.02.01.0210.020494%Not Available
Bone loss15.02.04.0200.000797%Not Available
Injection site injury12.07.03.046; 08.02.03.0460.002462%Not Available
Substance abuse19.07.06.0180.002462%Not Available
Application site scab23.03.03.050; 12.07.01.042; 08.02.01.0420.009161%Not Available
Application site haematoma12.07.01.031; 08.02.01.031; 24.07.01.0240.001231%Not Available
Hypoxic-ischaemic encephalopathy24.04.06.021; 22.02.02.011; 17.13.02.0060.000362%Not Available
Application site haemorrhage24.07.01.048; 12.07.01.040; 08.02.01.0400.010826%Not Available
Depersonalisation/derealisation disorder19.14.01.004--Not Available
Concomitant disease aggravated08.01.03.063--Not Available
Small for dates baby18.04.02.0020.000362%Not Available
Self esteem decreased19.05.02.0040.000543%Not Available
Appendix disorder07.11.01.0200.000543%Not Available
Communication disorder19.19.01.0080.000362%Not Available
Stress cardiomyopathy24.04.04.026; 02.04.01.0120.000362%Not Available
Dermal absorption impaired08.06.01.030; 23.03.03.0640.003078%Not Available
Poor feeding infant18.04.06.006; 14.03.02.0220.000362%Not Available
Allergic reaction to excipient10.01.01.0350.004309%Not Available
Application site bruise23.03.11.026; 12.07.01.048; 08.02.01.048; 24.07.06.0260.005105%Not Available
Application site laceration23.03.11.027; 12.07.01.052; 08.02.01.0520.000797%Not Available
Application site odour12.07.01.054; 08.02.01.0540.004671%Not Available
Application site perspiration12.07.01.055; 08.02.01.0550.001231%Not Available
Drug effect less than expected08.06.01.0360.005105%Not Available
Inadequate analgesia12.02.20.006; 08.06.01.0400.110363%Not Available
Injection site discharge08.02.03.057; 12.07.03.0570.010211%Not Available
Injection site erosion23.07.03.028; 12.07.03.058; 08.02.03.0580.013288%Not Available
Injection site scab23.03.03.088; 12.07.03.069; 08.02.03.0690.001231%Not Available
Oral administration complication12.07.04.035; 08.02.04.0350.002462%Not Available
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