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)
Dysarthria19.19.03.001; 17.02.08.0010.003861%
Dysgeusia17.02.07.003; 07.14.03.0010.000241%
Dyskinesia17.01.02.0060.000603%
Dyspepsia07.01.02.0010.000603%
Dysphagia07.01.06.0030.000965%
Dyspnoea22.02.01.004; 02.01.03.002--
Dysuria20.02.02.0020.001206%
Eating disorder19.09.01.008; 14.03.01.0080.000362%Not Available
Encephalitis viral11.05.04.010; 17.06.06.0020.000094%Not Available
Encephalopathy17.13.02.0010.003378%
Erythema23.03.06.001--Not Available
Erythema multiforme23.03.01.003; 10.01.03.0150.000241%
Eye pain06.08.03.0020.000362%
Facial paralysis17.04.03.0080.000362%Not Available
Fatigue08.01.01.002--
Febrile neutropenia08.05.02.004; 01.02.03.0020.000362%
Feeling abnormal08.01.09.0140.000724%Not Available
Flank pain20.02.03.006; 15.03.04.003; 08.01.08.0070.000241%
Flushing23.06.05.003; 08.01.03.025; 24.03.01.0020.000241%
Gait disturbance17.02.05.016; 08.01.02.0020.001930%
Gallbladder disorder09.03.02.0010.000241%Not Available
Genital herpes21.10.03.008; 11.05.02.0120.000362%Not Available
Glomerular filtration rate decreased13.13.01.0090.000483%Not Available
Haematemesis07.12.02.002; 24.07.02.0110.000241%Not Available
Haematuria24.07.01.047; 20.02.01.0060.000362%
Haemorrhage subcutaneous24.07.06.010; 23.06.07.0020.000241%Not Available
Hallucination19.10.02.0020.002533%
Hallucination, auditory19.10.02.0030.000483%Not Available
Hallucination, visual19.10.02.0040.000844%Not Available
Headache17.14.01.0010.002654%
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