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)
Respiratory depression22.02.01.010; 17.02.05.0470.002498%Not Available
Respiratory distress22.02.01.012--Not Available
Respiratory failure22.02.06.002; 14.01.04.003--
Restlessness19.11.02.002; 17.02.05.0210.007568%
Rhinitis22.07.03.006; 11.01.13.004--
Rhinorrhoea22.12.03.0210.004924%
Rubber sensitivity10.01.01.025; 23.03.04.0360.001847%Not Available
Salivary hypersecretion07.06.01.0090.001847%Not Available
Sedation17.02.04.0050.013651%Not Available
Sensory loss17.02.07.007--Not Available
Serotonin syndrome17.05.02.004; 15.05.04.016; 12.03.01.0410.000724%Not Available
Sexual dysfunction19.08.05.002; 21.03.02.003--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin hypertrophy23.01.04.0020.001231%Not Available
Skin irritation23.03.04.0090.008183%Not Available
Skin lesion23.03.03.010--Not Available
Skin necrosis23.03.03.0110.000362%Not Available
Skin reaction10.01.03.019; 23.03.03.0130.006517%Not Available
Sleep terror19.02.03.008; 17.15.02.0060.000797%Not Available
Sluggishness08.01.01.0040.003693%Not Available
Somnambulism19.02.03.006; 17.15.02.0040.001231%Not Available
Somnolence17.02.04.006; 19.02.05.0030.048338%
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Tachycardia02.03.02.007--Not Available
Therapeutic response decreased08.06.01.0160.009595%Not Available
Therapeutic response unexpected08.06.01.0010.005540%Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tongue discolouration07.14.02.0060.001231%Not Available
Tooth disorder07.09.05.0010.002643%Not Available
Toothache07.09.06.0010.002643%
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