Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Rilpivirine
Drug ID BADD_D01940
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 approved
ATC Code J05AG05
DrugBank ID DB08864
KEGG ID D09720
MeSH ID D000068696
PubChem ID 6451164
TTD Drug ID D0T6WN
NDC Product Code 12578-622
UNII FI96A8X663
Synonyms Rilpivirine | Rilpivirine Hydrochloride | Hydrochloride, Rilpivirine | Rilpivirine HCl | HCl, Rilpivirine | R278474 | TMC 278 | 278, TMC | TMC278 | TMC-278
Chemical Information
Molecular Formula C22H18N6
CAS Registry Number 500287-72-9
SMILES CC1=CC(=CC(=C1NC2=NC(=NC=C2)NC3=CC=C(C=C3)C#N)C)C=CC#N
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)
Drug interaction08.06.03.0010.001524%-
Dry mouth07.06.01.002--
Dysphagia07.01.06.0030.002004%
Eye irritation06.04.05.0030.000423%-
Fatigue08.01.01.002--
Gastrointestinal disorder07.11.01.0010.001383%-
Gastrointestinal pain07.01.05.005--
Glomerulonephritis10.02.01.006; 20.05.01.001---
Glomerulonephritis membranous20.05.01.007---
Haemoglobin decreased13.01.05.003---
Headache17.14.01.0010.001722%
Hepatic failure09.01.03.0020.000282%
Hepatitis09.01.07.0040.000282%-
Hepatitis B09.01.09.003; 11.05.28.003--
Hepatitis C09.01.09.005; 11.05.28.004---
Hepatocellular injury09.01.07.0080.000565%-
Hepatotoxicity09.01.07.009; 12.03.01.0080.000423%-
High density lipoprotein decreased13.12.01.003---
Hypersensitivity10.01.03.0030.000621%
Immune system disorder10.02.01.001---
Infection11.01.08.002---
Initial insomnia17.15.03.005; 19.02.01.0050.000423%-
Injection site pain08.02.03.010; 12.07.03.0110.002060%-
Insomnia17.15.03.002; 19.02.01.0020.001242%
Lactic acidosis14.01.01.0020.000282%-
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.0070.000960%-
Lipase increased13.05.01.003--
Liver disorder09.01.08.0010.000621%-
Low density lipoprotein increased13.12.01.005---
Myalgia15.05.02.0010.000762%
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