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%Not Available
Dry mouth07.06.01.002--
Dysphagia07.01.06.0030.002004%
Eye irritation06.04.05.0030.000423%Not Available
Fatigue08.01.01.002--
Gastrointestinal disorder07.11.01.0010.001383%Not Available
Gastrointestinal pain07.01.05.005--
Glomerulonephritis20.05.01.001; 10.02.01.006--Not Available
Glomerulonephritis membranous20.05.01.007--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Headache17.14.01.0010.001722%
Hepatic failure09.01.03.0020.000282%
Hepatitis09.01.07.0040.000282%Not Available
Hepatitis B11.05.28.003; 09.01.09.003--
Hepatitis C11.05.28.004; 09.01.09.005--Not Available
Hepatocellular injury09.01.07.0080.000565%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.000423%Not Available
High density lipoprotein decreased13.12.01.003--Not Available
Hypersensitivity10.01.03.0030.000621%
Immune system disorder10.02.01.001--Not Available
Infection11.01.08.002--Not Available
Initial insomnia19.02.01.005; 17.15.03.0050.000423%Not Available
Injection site pain08.02.03.010; 12.07.03.0110.002060%Not Available
Insomnia19.02.01.002; 17.15.03.0020.001242%
Lactic acidosis14.01.01.0020.000282%Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.000960%Not Available
Lipase increased13.05.01.003--
Liver disorder09.01.08.0010.000621%Not Available
Low density lipoprotein increased13.12.01.005--Not Available
Myalgia15.05.02.0010.000762%
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