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 For the treatment or suppression of cold sores (herpes labialis), herpes zoster (shingles), genital herpes in immunocompetent individuals, and recurrent genital herpes in HIV-infected individuals.
Marketing Status Prescription; Discontinued
ATC Code J05AB11
DrugBank ID DB00577
KEGG ID D08664
MeSH ID D000077483
PubChem ID 135398742
TTD Drug ID D04QJD
NDC Product Code 63304-905; 43063-771; 69117-0010; 31722-704; 68071-4805; 60760-469; 67296-1297; 61919-515; 68071-3332; 0378-4276; 63739-077; 68071-3135; 65841-630; 71335-0630; 50090-2510; 63304-904; 68788-7587; 55700-913; 70934-106; 50090-2575; 31722-705; 65841-629; 72189-051; 71335-1485; 63187-950; 63629-7958; 0378-4275
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)
Abdominal pain07.01.05.002--
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase abnormal13.03.01.001--Not Available
Alopecia23.02.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Angioedema23.04.01.001; 10.01.05.009--Not Available
Aplastic anaemia01.03.03.002--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Auditory disorder04.02.03.002--Not Available
Coma17.02.09.001--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Depressed level of consciousness17.02.04.002--
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dysarthria19.19.03.001; 17.02.08.001--
Dyspnoea22.02.01.004; 02.01.03.002--
Encephalopathy17.13.02.001--
Erythema multiforme23.03.01.003; 10.01.03.015--
Face oedema08.01.07.003; 23.04.01.004; 10.01.05.002--
Fatigue08.01.01.002--
Hallucination, visual19.10.02.004--Not Available
Headache17.14.01.001--
Hepatitis09.01.07.004--Not Available
Hypersensitivity vasculitis24.05.02.012; 23.06.02.005; 10.02.02.017; 01.01.04.008--Not Available
Hypertension24.08.02.001--
Mania19.16.02.002--
Nausea07.01.07.001--
Photosensitivity reaction23.03.09.003--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
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