{
 "query": "valacyclovir",
 "ingredient": "valacyclovir",
 "slug": "valacyclovir",
 "rxcui": "73645",
 "brands": [
  "Valtrex"
 ],
 "names": [
  "valacyclovir",
  "valacyclovir hydrochloride",
  "valacyclovir hydrochloride monohydrate"
 ],
 "classes": [
  {
   "id": "J05AB",
   "name": "Nucleosides and nucleotides excl. reverse transcriptase inhibitors"
  }
 ],
 "alternatives": [
  "acyclovir",
  "brincidofovir",
  "brivudine",
  "cidofovir",
  "famciclovir",
  "ganciclovir",
  "idoxuridine",
  "molnupiravir",
  "penciclovir",
  "remdesivir",
  "valganciclovir",
  "vidarabine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 86
  },
  "boxed_warning": "",
  "indications_and_usage": "Valacyclovir tablets are a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 ) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission Herpes Zoster Pediatric Patients ( 1.2 ) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use ( 1.3 ) The efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients. 1.1 Adult Patients Cold Sores (Herpes Labialis) Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes Initial Episode: Valacyclovir tablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurren...",
  "contraindications": "Valacyclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction [e.g., anaphylaxis, severe cutaneous adverse reactions (SCARs)] to valacyclovir, acyclovir, or any component of the formulation [see Warnings and Precautions (5.4) , Adverse Reactions (6.3) ] . Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or any component of the formulation. ( 4 )",
  "warnings_and_cautions": "Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS): Has occurred in patients with advanced HIV-1 disease and in allogenic bone marrow transplant and renal transplant patients receiving 8 grams per day of valacyclovir tablets in clinical trials. Discontinue treatment if clinical symptoms and laboratory findings consistent with TTP/HUS occur. ( 5.1 ) Acute renal failure: May occur in elderly patients (with or without reduced renal function), patients with underlying renal disease who receive higher-than-recommended doses of valacyclovir tablets for their level of renal function, patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Use with caution in elderly patients and reduce dosage in patients with renal impairment. ( 2.4 , 5.2 ) Central nervous system adverse reactions (e.g., agitation, hallucinations, confusion, and encephalopathy): May occur in both adult and pediatric patients (with or without reduced renal function) and in patients with underlying renal disease who receive higher-than-recommended doses of valacyclovir tablets for their level of renal function. Elderly patients are more likely to have central nervous syste...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome [see Warnings and Precautions (5.1) ]. Acute Renal Failure [see Warnings and Precautions (5.2) ]. Central Nervous System Effects [see Warnings and Precautions (5.3) ]. Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.4) ]. The most common adverse reactions reported in at least 1 indication by greater than 10% of adult subjects treated with valacyclovir tablets and observed more frequently with valacyclovir tablets compared with placebo are headache, nausea, and abdominal pain. The only adverse reaction reported in greater than 10% of pediatric subjects aged less than 18 years was headache. The most common adverse reactions reported in at least one indication by greater than 10% of adult subjects treated with valacyclovir tablets and more commonly than in subjects treated with placebo are headache, nausea, and abdominal pain. ( 6.1 ) The only adverse reaction occurring in greater than 10% of pediatric subjects less than 18 years of age was headache. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, co...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Contraindications ( 4 ) 11/2025 Warnings and Precautions, Severe Cutaneous Adverse Reactions ( 5.4 ) 11/2025",
  "information_for_patients": "Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide , available at www.wprx.com/prescription-catalog). Severe Cutaneous Adverse Reactions Inform patients that severe skin reactions including acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and erythema multiforme (EM) have been reported with valacyclovir. Advise patients to immediately contact their healthcare provider if they develop a rash. Instruct patients to immediately stop taking valacyclovir tablets and seek medical attention if a painful rash with mucosal involvement develops [see Contraindications (4) , Warnings and Precautions (5.4) , Adverse Reactions (6.3) ] . Importance of Adequate Hydration Patients should be advised to maintain adequate hydration. Missed Dose Instruct patients that if they miss a dose of valacyclovir tablets, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose. Cold Sores (Herpes Labialis) Patients should be advised to initiate treatment at the earliest symptom of a cold sore ...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Cold Sores (Herpes Labialis ) Two double-blind, placebo-controlled clinical trials were conducted in 1,856 healthy adults and adolescents (aged greater than or equal to 12 years) with a history of recurrent cold sores. Subjects self-initiated therapy at the earliest symptoms and prior to any signs of a cold sore. The majority of subjects initiated treatment within 2 hours of onset of symptoms. Subjects were randomized to valacyclovir tablets 2 grams twice daily on Day 1 followed by placebo on Day 2, valacyclovir tablets 2 grams twice daily on Day 1 followed by 1 gram twice daily on Day 2, or placebo on Days 1 and 2. The mean duration of cold sore episodes was about 1 day shorter in treated subjects as compared with placebo. The 2-day regimen did not offer additional benefit over the 1-day regimen. No significant difference was observed between subjects receiving valacyclovir tablets or placebo in the prevention of progression of cold sore lesions beyond the papular stage. 14.2 Genital Herpes Infections Initial Episode Six hundred forty-three immunocompetent adults with first-episode genital herpes who presented within 72 hours of symptom onset were randomized in a double-blind...",
  "brand_name": "Valacyclovir",
  "manufacturer": "Westminster Pharmaceuticals, LLC",
  "application_number": "ANDA209553",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260511",
  "set_id": "4bd97421-1e0a-40a6-a66b-f5f14e827eb3",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 71504,
  "serious": 53381,
  "death": 6421,
  "hospitalization": 29184,
  "primary_suspect": 71380,
  "top_reactions": [
   [
    "Off Label Use",
    4392
   ],
   [
    "Fatigue",
    4190
   ],
   [
    "Diarrhoea",
    3718
   ],
   [
    "Nausea",
    3473
   ],
   [
    "Drug Ineffective",
    3001
   ],
   [
    "Pyrexia",
    2969
   ],
   [
    "Headache",
    2568
   ],
   [
    "Pneumonia",
    2545
   ],
   [
    "Acute Kidney Injury",
    2396
   ],
   [
    "Pain",
    2372
   ],
   [
    "Febrile Neutropenia",
    2247
   ],
   [
    "Rash",
    2170
   ],
   [
    "Dyspnoea",
    2015
   ],
   [
    "Asthenia",
    1892
   ],
   [
    "Neutropenia",
    1865
   ]
  ],
  "by_year": {
   "2019": 6875,
   "2020": 7338,
   "2021": 6953,
   "2022": 6890,
   "2023": 6491,
   "2024": 6471,
   "2025": 6117,
   "2026": 2770
  },
  "by_year_primary": {
   "2019": 6874,
   "2020": 7337,
   "2021": 6944,
   "2022": 6868,
   "2023": 6470,
   "2024": 6437,
   "2025": 6092,
   "2026": 2762
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20240425",
   "reason": "Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.",
   "firm": "Viatris Inc",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20180213",
   "reason": "Temperature Abuse: Valganciclovir Tablets USP 450 mg and  Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).",
   "firm": "Hetero Labs Limited Unit V",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 18,
  "nda": 2,
  "anda": 16,
  "first_approval": "19950623",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 15,
  "labeling_recent": 2,
  "sponsors": [
   "AIPING PHARM INC",
   "APOTEX",
   "AUROBINDO PHARMA",
   "CHARTWELL RX",
   "CIPLA",
   "GLAXOSMITHKLINE",
   "HETERO LABS LTD V",
   "HIKMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/23/1995"
 },
 "trials": {
  "total": 147,
  "completed": 100,
  "terminated": 13,
  "with_results": 32,
  "industry": 75,
  "phase3": 22,
  "results_share": 0.32,
  "terminated_share": 0.08843537414965986
 },
 "pubmed": {
  "rct": 106,
  "meta": 8,
  "recent_rct": 8,
  "cochrane": [
   {
    "pmid": "27841441",
    "title": "Valacyclovir versus acyclovir for the treatment of herpes zoster ophthalmicus in immunocompetent patients",
    "year": "2016"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "valacyclovir",
   "Valtrex"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3303226,
  "beneficiaries": 1535607,
  "spend": 111093876.71,
  "by_brand": [
   {
    "brand": "Valacyclovir",
    "claims": 3299119,
    "per_claim": 32.372414942,
    "is_generic": false
   },
   {
    "brand": "Valtrex",
    "claims": 4107,
    "per_claim": 1045.3926224,
    "is_generic": false
   }
  ],
  "per_claim": 33.63193336150781
 },
 "mdl": [],
 "dsc": [],
 "settlements": [
  {
   "year": 2012,
   "company": "GlaxoSmithKline",
   "amount_usd": 3000000000.0,
   "amount_text": "$3 billion ($1B criminal, $2B civil)",
   "violations": "Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to physicians, making false and misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program",
   "products": "Avandia (not providing safety data), Wellbutrin, Paxil (promotion of paediatric use), Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex",
   "laws": "False Claims Act, FDCA",
   "urls": [
    "https://www.justice.gov/opa/pr/2012/July/12-civ-842.html",
    "https://web.archive.org/web/20240714112314/https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report"
   ],
   "matched": "valtrex"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15291,
  "fills": 3303226,
  "per_million": 4629.111056888024,
  "ratio": 1.6717930870905806,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 91,
   "letter": "A",
   "why": [
    "4,629 FDA reports naming it as the suspect drug per million Medicare fills, 1.7x the median drug on this site (-4)",
    "Death share in reports is near or below the FAERS average (1.0x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 45,
   "letter": "F",
   "why": [
    "106 randomized trials and 8 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 32% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 89,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 1 Class III across 16 generic makers (-2)",
    "2 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 65,
   "letter": "C",
   "why": [
    "Maker paid $3 billion ($1B criminal, $2B civil) in 2012 to settle federal allegations naming this drug (Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to) (-35)",
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (16 applications)",
    "12 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "The maker paid $3 billion in 2012 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, nausea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over acyclovir, brincidofovir, brivudine? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}