Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Valacyclovir
Drug ID BADD_D02323
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 approved; investigational
ATC Code J05AB11
DrugBank ID DB00577
KEGG ID D08664
MeSH ID D000077483
PubChem ID 135398742
TTD Drug ID D04QJD
NDC Product Code 0378-4275; 0378-4276; 70518-2402; 82009-040; 65841-630; 82009-041; 55700-913; 69117-0010; 31722-705; 67296-1297; 68788-8482; 43063-771; 63629-7958; 63739-077; 68788-7587; 60760-469; 61919-515; 62135-614; 68071-3332; 69367-262; 69367-263; 70518-3451; 71335-0630; 31722-704; 51407-108; 67296-1473; 51407-107; 62135-613; 63304-904; 65841-629; 68071-2753; 72189-051; 63187-950; 63304-905
UNII MZ1IW7Q79D
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
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)
Swollen tongue07.14.02.003; 10.01.05.015; 23.04.01.014---
Tachycardia02.03.02.007---
Therapeutic response decreased08.06.01.016---
Thrombocytopenia01.08.01.002---
Tremor17.01.06.002--
Urticaria10.01.06.001; 23.04.02.001--
Vertigo04.04.01.003; 17.02.12.002--
Vision blurred06.02.06.007; 17.17.01.010--
Visual impairment06.02.10.013---
Vomiting07.01.07.003--
Balance disorder08.01.03.081; 17.02.02.007---
Musculoskeletal chest pain15.03.04.012; 22.09.01.001--
Skin burning sensation17.02.06.009; 23.03.03.021---
Cognitive disorder17.03.03.003; 19.21.02.001--
Drug resistance08.06.01.005---
Renal injury12.01.05.001; 20.01.03.015---
Ill-defined disorder08.01.03.049---
Renal impairment20.01.03.010---
Hepatic enzyme abnormal13.03.04.026---
Hypophagia07.01.06.010; 14.03.01.006; 19.09.01.004---
Acute kidney injury20.01.03.016--
Tongue discomfort07.14.02.019---
Therapeutic response changed08.06.01.059---
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