Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Valaciclovir
Drug ID BADD_D02424
Description Valaciclovir (valacyclovir), also known as _Valtrex_, is an antiviral drug that has been used to manage and treat various herpes infections for more than 2 decades. It was initially approved by the FDA in 1995 [FDA label] and marketed by GlaxoSmithKline [L5671]. Valacyclovir is the L-valine ester of aciclovir. It is a member of the purine (guanine) nucleoside analog drug class [F3949]. This class of drugs forms an important part of hepatitis, HIV, and cytomegalovirus drug regimens [A175900]. One major use of valacyclovir is the treatment of genital herpes episodes or outbreaks. Genital herpes is a frequently diagnosed sexually transmitted disease which currently affects more than 400 million individuals worldwide. It is caused by infection with the herpes simplex virus (HSV). Infection with this virus is lifelong with periodic episodes of reactivation [A175903].
Indications and Usage Valacyclovir is a nucleoside analog DNA polymerase inhibitor indicated for [FDA label]: **Adults** • Cold Sores (Herpes Labialis) • Genital Herpes • Treatment of genital herpes lesions in immunocompetent patients (initial or recurrent episode) • Suppression of genital herpes lesions in immunocompetent or HIV-infected patients • Reduction of viral transmission • Herpes Zoster **Pediatric Patients** • Cold Sores (Herpes Labialis) • Chickenpox **Limitations of use** [FDA label] The efficacy and safety of valacyclovir have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.
Marketing Status Not Available
ATC Code J05AB11
DrugBank ID DB00577
KEGG ID D08664
MeSH ID D000077483
PubChem ID 135398742
TTD Drug ID D04QJD
NDC Product Code Not Available
Synonyms Valacyclovir | Valaciclovir | BW256U87 | Valacyclovir, X-Hydrochloride, (DL)-isomer | Valacyclovir Hydrochloride, (DL)-isomer | Valacyclovir, (D)-isomer | Valacyclovir, D- | D- Valacyclovir | Valacyclovir, (L)-isomer | L-Valylacyclovir | L Valylacyclovir | Acyclovir, L-valyl Ester | Acyclovir, L valyl Ester | L-valyl Ester Acyclovir | 2-((2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy)ethyl L-valinate | Valacyclovir, X-Hydrochloride, (D)-isomer | Valtrex | Valacyclovir Hydrochloride | 256U87 | Valacyclovir, (DL)-isomer
Chemical Information
Molecular Formula C13H20N6O4
CAS Registry Number 124832-26-4
SMILES CC(C)C(C(=O)OCCOCN1C=NC2=C1N=C(NC2=O)N)N
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)
Hepatic function abnormal09.01.02.0010.000483%Not Available
Hepatitis09.01.07.0040.000241%Not Available
Hepatitis toxic12.03.01.016; 09.01.07.0170.000241%Not Available
Hepatocellular injury09.01.07.0080.000241%Not Available
Hepatosplenomegaly09.01.05.002; 01.09.03.0010.000241%Not Available
Herpes simplex23.09.03.001; 11.05.02.0010.000241%Not Available
Congenital herpes simplex infection18.04.05.001; 11.05.02.007; 03.14.01.0010.000315%Not Available
Herpes virus infection11.05.02.0080.000844%Not Available
Herpes zoster23.09.03.002; 11.05.02.0030.001448%
Hyperkalaemia14.05.03.0010.000483%
Hypersensitivity10.01.03.0030.000603%
Hypertension24.08.02.0010.000965%
Hypoaesthesia17.02.06.0230.000965%Not Available
Hyponatraemia14.05.04.0020.000362%
Hypotension24.06.03.002--
Hypotonia17.05.02.002; 15.05.04.0080.000241%Not Available
Incoherent19.10.03.006; 17.02.08.0020.000241%Not Available
Infection11.01.08.002--Not Available
Influenza like illness08.01.03.0100.000241%
Insomnia19.02.01.002; 17.15.03.0020.000965%
Interstitial lung disease22.01.02.003; 10.02.01.0330.000362%Not Available
Intestinal obstruction07.13.01.0020.000241%Not Available
Irritability19.04.02.013; 08.01.03.0110.001448%
Jaundice01.06.04.004; 23.03.03.030; 09.01.01.0040.000362%Not Available
Jaundice neonatal18.04.08.001; 09.01.01.008; 01.06.04.0060.000241%Not Available
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.000603%
Liver function test abnormal13.03.01.0130.000241%Not Available
Logorrhoea19.19.02.001; 17.02.08.0060.000603%Not Available
Loss of consciousness17.02.04.0040.000965%Not Available
Malaise08.01.01.0030.001930%
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