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)
Nausea07.01.07.001--
Nephrolithiasis20.04.01.002--
Nephrotic syndrome20.05.01.002--
Nervous system disorder17.02.10.001---
Neurotoxicity12.03.01.011; 17.02.10.0020.000706%-
Neutropenia01.02.03.0040.000565%-
Night sweats08.01.03.031; 23.02.03.0060.000960%-
Nightmare19.02.03.0030.000621%-
Opportunistic infection11.01.08.007---
Pancreatitis acute07.18.01.0020.000282%-
Platelet count decreased13.01.04.001--
Polycythaemia01.07.01.0010.000423%-
Rash23.03.13.0010.003444%-
Renal failure20.01.03.0050.000706%-
Seizure17.12.03.0010.000282%
Skin disorder23.03.03.007---
Sleep disorder19.02.04.0010.000423%-
Somnolence17.02.04.006; 19.02.05.003--
Throat irritation07.05.05.037; 22.12.03.0290.000423%-
Urethral disorder20.07.01.002---
Urinary tract disorder20.08.01.001---
Urogenital disorder20.08.01.002; 21.10.05.010---
Vomiting07.01.07.0030.001242%
White blood cell count decreased13.01.06.012--
Lipodystrophy acquired14.08.04.008; 23.07.01.0030.000282%-
Lymphatic disorder01.09.01.003---
Transaminases increased13.03.04.036---
Gastrointestinal toxicity07.08.03.006; 12.03.01.0190.000423%-
Drug resistance08.06.01.0050.000282%-
Adverse event08.06.01.0100.002060%-
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