Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Rilpivirine hydrochloride
Drug ID BADD_D01941
Description Rilpivirine is non-nucleoside reverse transcriptase inhibitor (NNRTI) which is used for the treatment of HIV-1 infections in treatment-naive patients.[A31328] It is a diarylpyrimidine derivative.[A31329] The internal conformational flexibility of rilpivirine and the plasticity of it interacting binding site gives it a very high potency and reduces the chance of resistance compared to other NNRTI's.[A31331] Rilpivirine was developed by Tilbotec, Inc. and FDA approved on May 20, 2011.[L1030] On November 21, 2017, Rilpivirine, in combination with [dolutegravir], was approved as part of the first complete treatment regimen with only two drugs for the treatment of adults with HIV-1 named Juluca.[L1031] Rilpivirine in combination with [cabotegravir] was granted FDA approval on 21 January 2021.[L31193]
Indications and Usage Rilpivirine, in combination with other agents, is indicated for the treatment of HIV-1 infections in antiretroviral treatment-naive patients with HIV-1 RNA ≤100,000 copies/mL and CD4+ cell count >200 cells/mm3.[L1030] The FDA combination therapy approval of rilpivirine and dolutegravir is indicated for adults with HIV-1 infections whose virus is currently suppressed (< 50 copies/ml) on a stable regimen for at least six months, without history of treatment failure and no known substitutions associated to resistance to any of the two components of the therapy.[L1031]
Marketing Status Prescription
ATC Code J05AG05
DrugBank ID DB08864
KEGG ID D09958
MeSH ID D000068696
PubChem ID 11711114
TTD Drug ID D0T6WN
NDC Product Code 12502-5500; 65977-0104; 67835-0013; 50370-0052; 53104-7734; 59676-278; 65267-501
Synonyms Rilpivirine | Rilpivirine Hydrochloride | Hydrochloride, Rilpivirine | Rilpivirine HCl | HCl, Rilpivirine | R278474 | TMC 278 | 278, TMC | TMC278 | TMC-278
Chemical Information
Molecular Formula C22H19ClN6
CAS Registry Number 700361-47-3
SMILES CC1=CC(=CC(=C1NC2=NC(=NC=C2)NC3=CC=C(C=C3)C#N)C)C=CC#N.Cl
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Anxiety19.06.02.002--
Cholecystitis09.03.01.001--
Cholelithiasis09.03.01.002--Not Available
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness17.02.05.003; 02.01.02.004; 24.06.02.007--
Fatigue08.01.01.002--
Glomerulonephritis membranous20.05.01.007--Not Available
Headache17.14.01.001--
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Nausea07.01.07.001--
Nephrolithiasis20.04.01.002--
Nephrotic syndrome20.05.01.002--
Rash23.03.13.001--Not Available
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Vomiting07.01.07.003--
Decreased appetite14.03.01.005; 08.01.09.028--
Mesangioproliferative glomerulonephritis20.05.01.010--Not Available
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