Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Buprenorphine hydrochloride
Drug ID BADD_D00311
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 N07BC01; N02AE01
DrugBank ID DB00921
KEGG ID D00836
MeSH ID D002047
PubChem ID 3033050
TTD Drug ID D06AWE
NDC Product Code 0792-0634; 38779-0888; 53747-012; 42023-179; 59385-025; 61960-9064; 59385-021; 0406-3210; 0792-0630; 12578-608; 57587-924; 57587-930; 65267-104; 67509-008; 12496-0757; 59385-022; 59385-027; 73548-0608; 0406-2910; 49452-8253; 50383-924; 50383-930; 71795-1100; 59385-024; 59385-026; 0409-2012; 70518-2216; 10920-590; 62756-316; 65724-4521; 0406-2933; 47848-007; 51927-0140; 50090-1571; 12707-035; 51634-0608; 51927-1012; 62991-1583; 0143-9246; 59385-023
UNII 56W8MW3EN1
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 C29H42ClNO4
CAS Registry Number 53152-21-9
SMILES CC(C)(C)C(C)(C1CC23CCC1(C4C25CCN(C3CC6=C5C(=C(C=C6)O)O4)CC7CC7)OC)O.Cl
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)
Abdominal pain07.01.05.002--
Abscess11.01.08.001---
Adrenal insufficiency14.11.01.004; 05.01.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Androgen deficiency21.16.02.001; 05.05.02.008--
Anxiety19.06.02.002--
Asthenia08.01.01.001---
Back pain15.03.04.005--
Chills15.05.03.016; 08.01.09.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness17.02.05.003; 02.11.04.006; 24.06.02.007--
Dyspepsia07.01.02.001--
Headache17.14.01.001--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Infection11.01.08.002---
Influenza11.05.03.001; 22.07.02.001---
Injury12.01.08.004---
Insomnia19.02.01.002; 17.15.03.002--
Lacrimation increased06.08.02.004--
Nausea07.01.07.001--
Nervousness19.06.02.003---
Pain08.01.08.004--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pyrexia08.05.02.003--
Rhinitis22.07.03.006; 11.01.13.004--
Serotonin syndrome17.05.02.004; 15.05.04.016; 12.03.01.041---
Somnolence19.02.05.003; 17.02.04.006--
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