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)
Tremor17.01.06.0020.017959%
Trigeminal neuralgia17.04.08.0010.000362%Not Available
Ulcer08.03.06.0010.000543%Not Available
Unresponsive to stimuli17.02.05.0310.001448%Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary hesitation20.02.02.0090.002462%Not Available
Urinary incontinence17.05.01.008; 20.02.02.010--
Urinary retention20.02.02.011--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Uterine disorder21.07.01.0060.000362%Not Available
Vasodilatation23.06.05.006; 24.03.02.003--Not Available
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Wheezing22.03.01.009--
Withdrawal syndrome19.07.06.023; 08.06.02.0120.007314%Not Available
Yawning22.12.03.0370.003693%Not Available
Mental status changes19.07.01.001--Not Available
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.003259%Not Available
Fibromyalgia15.05.02.0020.000797%Not Available
Energy increased08.01.03.0170.001847%Not Available
Application site vesicles23.03.01.009; 12.07.01.009; 08.02.01.0090.098450%Not Available
Application site dryness23.03.03.024; 12.07.01.011; 08.02.01.0110.023391%Not Available
Application site inflammation12.07.01.024; 08.02.01.0240.004309%Not Available
Application site papules23.03.03.022; 12.07.01.025; 08.02.01.0250.004924%Not Available
Emotional distress19.04.02.0080.034072%Not Available
Application site paraesthesia17.02.06.012; 12.07.01.026; 08.02.01.0260.002462%Not Available
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