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)
Myalgia15.05.02.001--
Narcolepsy19.02.02.002; 17.15.01.0020.001412%Not Available
Nasal septum deviation22.04.03.0190.000362%Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.0010.131182%
Neck pain15.03.04.009--
Necrosis24.04.02.006; 08.03.03.0010.000724%Not Available
Nervousness19.06.02.0030.007930%Not Available
Neuralgia17.02.07.0050.002028%
Night sweats23.02.03.006; 08.01.03.0310.006155%Not Available
Nightmare19.02.03.003--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oedema peripheral14.05.06.011; 02.05.04.007; 08.01.07.0070.019915%
Oral mucosal blistering07.05.05.0170.002462%Not Available
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Pain08.01.08.0040.117315%
Pain in extremity15.03.04.010--
Palpitations02.11.04.012--
Paraesthesia23.03.03.094; 17.02.06.005--
Pemphigoid23.03.01.004; 10.04.02.002--Not Available
Personality change19.05.01.006; 17.02.05.0190.000797%
Pharyngeal oedema22.04.05.003; 10.01.05.016; 23.04.01.0160.002824%Not Available
Placental disorder18.05.02.0010.000543%Not Available
Pre-eclampsia24.08.07.002; 20.01.08.002; 18.02.03.0020.000543%Not Available
Pre-existing condition improved08.01.03.0430.002462%Not Available
Pruritus23.03.12.0010.056775%
Psychotic behaviour19.03.01.0030.000362%Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Respiration abnormal22.02.01.041--Not Available
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