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)
Menorrhagia21.01.03.0020.000603%
Menstruation irregular05.05.01.008; 21.01.01.0050.000241%
Mental impairment19.21.02.003; 17.03.03.0020.000724%Not Available
Metabolic acidosis14.01.01.0030.000603%Not Available
Microcephaly03.11.02.002; 15.11.02.0020.000241%Not Available
Migraine24.03.05.003; 17.14.02.0010.000241%Not Available
Mood altered19.04.02.0070.000241%Not Available
Movement disorder17.01.02.0100.000241%Not Available
Multiple sclerosis17.16.01.001; 10.04.10.0080.000241%Not Available
Muscle spasms15.05.03.0040.000483%
Muscle twitching15.05.03.0050.000241%Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.000603%
Myalgia15.05.02.0010.000483%
Myoclonus17.02.05.0080.000241%Not Available
Nausea07.01.07.0010.003619%
Nephropathy20.05.03.0010.000483%Not Available
Nephropathy toxic20.05.03.002; 12.03.01.0100.000241%Not Available
Nephrotic syndrome20.05.01.0020.000241%
Nervous system disorder17.02.10.0010.002051%Not Available
Neuralgia17.02.07.0050.000362%
Neuropathy peripheral17.09.03.003--Not Available
Neurotoxicity17.02.10.002; 12.03.01.0110.004102%Not Available
Neutropenia01.02.03.004--Not Available
Nightmare19.02.03.0030.000241%Not Available
Ocular hyperaemia06.04.05.0040.000241%Not Available
Oculomucocutaneous syndrome23.03.01.022; 07.05.01.010; 06.04.05.0140.000241%Not Available
Oedema08.01.07.006; 14.05.06.0100.000362%Not Available
Oliguria20.01.03.0040.000241%Not Available
Ophthalmic herpes zoster17.04.08.005; 11.05.02.021; 06.04.05.0230.000362%Not Available
Pain08.01.08.0040.001810%
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