Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Valacyclovir hydrochloride
Drug ID BADD_D02324
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 D00398
MeSH ID D000077483
PubChem ID 135398741
TTD Drug ID D04QJD
NDC Product Code 72789-264; 63415-0055; 51079-093; 70518-2266; 71335-1862; 72189-037; 65977-0022; 50268-788; 51655-633; 53002-7830; 63187-627; 63187-832; 68071-2749; 68084-309; 53104-7579; 72761-025; 43063-778; 55111-553; 55154-7985; 57237-042; 68788-6896; 68788-7818; 69097-154; 69117-0011; 0781-5209; 65372-1154; 69875-8014; 16714-697; 49483-690; 50090-2101; 50090-5852; 51655-703; 71335-0708; 62331-034; 65862-462; 43063-730; 0173-0933; 50090-2224; 50268-789; 53002-0061; 63187-538; 68071-2921; 68071-3037; 70518-2346; 70518-3359; 71335-1341; 76420-053; 66651-916; 16714-698; 50090-1735; 55111-552; 68788-8251; 38779-2550; 65015-745; 59746-324; 59746-325; 65862-449; 70518-2928; 70934-628; 0781-5208; 0904-6565; 49452-8087; 82453-6003; 57237-043; 65862-448; 67296-0200; 0173-0565; 49483-691; 53002-0060; 63187-776; 63739-525; 68071-2738; 68084-215; 69097-153; 72789-263; 65015-629
UNII G447S0T1VC
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 C13H21ClN6O4
CAS Registry Number 124832-27-5
SMILES CC(C)C(C(=O)OCCOCN1C=NC2=C1N=C(NC2=O)N)N.Cl
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)
Abdominal discomfort07.01.06.001---
Abdominal pain07.01.05.002--
Acne23.02.01.001---
Aggression19.05.01.001---
Agitation17.02.05.012; 19.06.02.001--
Alanine aminotransferase abnormal13.03.04.003---
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.003---
Anaemia01.03.02.001--
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Anaphylactic shock10.01.07.002; 24.06.02.004---
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Anorectal disorder07.03.01.001---
Aplastic anaemia01.03.03.002---
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001---
Ataxia08.01.02.004; 17.02.02.001--
Auditory disorder04.02.03.002---
Back pain15.03.04.005--
Blood creatinine abnormal13.13.01.002---
Blood creatinine increased13.13.01.004--
Body temperature increased13.15.01.001---
Bronchitis11.01.09.001; 22.07.01.001--
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Chills08.01.09.001; 15.05.03.016--
Coma17.02.09.001---
Confusional state17.02.03.005; 19.13.01.001--
Constipation07.02.02.001--
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