Valacyclovir: uses, dosing, side effects & brands
Valacyclovir is a herpes simplex virus nucleoside analog dna polymerase inhibitor sold in the U.S. under one brand, for chickenpox, herpes genitalis and herpes labialis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Herpes Simplex Virus Nucleoside Analog Dna Polymerase Inhibitor
- Treats
- Chickenpox, Herpes Genitalis and Herpes Labialis
- Available as
- Tablet
- Sold as
- Valtrex
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- What the pharmacy pays
- about $7 for a 30-count supply — not your price
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How valacyclovir is dosed
From the FDA label for Valtrex (application NDA020487). Other valacyclovir products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
VALTREX may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500-mg VALTREX tablets for use in pediatric patients for whom a solid dosage form is not appropriate [see Dosage and Administration ( 2.3 )] . Adult Dosage ( 2.1 ) Cold Sores 2 grams every 12 hours for 1 day Genital Herpes Initial episode 1 gram twice daily for 10 days Recurrent episodes 500 mg twice daily for 3 days Suppressive therapy Immunocompetent patients 1 gram once daily Alternate dose in patients with less than or equal to 9 recurrences/year 500 mg once daily HIV-1−infected patients 500 mg twice daily Reduction of transmission 500 mg once daily Herpes Zoster 1 gram 3 times daily for 7 days Pediatric Dosage ( 2.2 ) Cold Sores (aged greater than or equal to 12 years) 2 grams every 12 hours for 1 day Chickenpox (aged 2 to less than 18 years) 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from the 500 mg VALTREX tablets. ( 2.3 ) 2.1 Adult Dosing Recommendations Cold Sores (Herpes Labialis) The recommended dosage of VALTREX for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). Genital Herpes Initial Episode: The…
Valacyclovir side effects
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 VALTREX and observed more frequently with VALTREX 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 VALTREX 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 aged less than 18 years was headache. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience in Adult Subjects Because clinical trials are conducted under widely varying conditions, adverse reaction rates…
Who shouldn’t take valacyclovir
VALTREX is 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 )
Valacyclovir drug interactions
No clinically significant drug-drug or drug-food interactions with VALTREX are known [see Clinical Pharmacology ( 12.3 )].
Every valacyclovir product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Valtrex.
What valacyclovir pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| F;8;3 | — | blue | capsule | — |
| F;82 | 500 mg | blue | capsule | — |
| M122 | 500 mg | white | oval | — |
| VALTREX;500;mg | 500 mg | blue | oval | — |
| VALTREX;1;gram | 1 g | blue | oval | — |
| F;82 | 500 mg | blue | capsule | — |
Valacyclovir recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long valacyclovir keeps
The date on a sealed pack is not the only one: some valacyclovir labels start a second clock once the product is opened or mixed, as short as 28 days.
Does valacyclovir expire? The in-use limits and storage rules from its labelsValacyclovir and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for valacyclovir: levels in milk, effects in breastfed infants, and the drugs it would consider insteadThe dosage of acyclovir in milk after valacyclovir is less than 1% of a typical infant dosage and would not be expected to cause any adverse effects in breastfed infants. Valacyclovir is considered a treatment of choice for Herpes infections during breastfeeding. No special precautions are required when using valacyclovir during breastfeeding. In one study, administration of valacyclovir to mothers with concurrent herpes simplex type 2 and HIV infections reduced breastmilk shedding of the HIV virus in breastmilk at 6 and 14 weeks postpartum, but not later. In another study in HIV-positive mothers, valacyclovir did not reduced breastmilk shedding of cytomegalovirus (CMV) or infant CMV acquisition.
National Institute of Child Health and Human Development, record revised January 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about valacyclovir
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 15,832 reports naming valacyclovir, and the FDA flagged 88% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- pyrexia806 reports
- neutropenia740 reports
- diarrhoea731 reports
- acute kidney injury686 reports
- fatigue664 reports
- nausea656 reports
- febrile neutropenia578 reports
- pneumonia546 reports
Read these as a signal, not a rate. A report does not mean valacyclovir caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is valacyclovir?
VALTREX (valacyclovir hydrochloride) is the hydrochloride salt of the L ‑valyl ester of the antiviral drug acyclovir. VALTREX tablets are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients carnauba wax, colloidal silicon dioxide, crospovidone, FD&C Blue No. 2 Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. The blue, film‑coated tablets are printed with edible white ink.
What kind of drug is valacyclovir?
The FDA classifies valacyclovir as a herpes simplex virus nucleoside analog dna polymerase inhibitor. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take valacyclovir with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run valacyclovir against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does valacyclovir come in?
Across the brands we track, valacyclovir is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic valacyclovir?
We do not currently list a generic-labelled valacyclovir product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has valacyclovir been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions valacyclovir. The most recent: Valacyclovir Tablets USP (Apr 25, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
What are the most common side effects of valacyclovir?
Headache, nausea, and abdominal pain — those are the reactions the FDA label reports in more than 10% of adults in at least one of its indications, and headache was the only one over 10% in patients under 18. Most people taking a short course for a cold sore, genital herpes outbreak, or shingles get through it with nothing worse than a headache. Dizziness and fatigue also appear on the label. These generally do not require stopping the medicine; take doses with a full glass of water and food if your stomach is unsettled.
What valacyclovir side effects mean call a doctor or go to the ER?
Go to the ER for new confusion, agitation, hallucinations, slurred speech, unsteadiness, or a seizure. The FDA label carries a specific warning for central nervous system reactions — including agitation, hallucinations, confusion, delirium, seizures, and encephalopathy — and notes elderly patients are more likely to have them. Also seek urgent care for: passing much less urine, swelling, or flank pain (acute renal failure is a labeled warning); a painful rash with mouth, eye, or genital sores, or a progressive severe rash (the label warns about SJS, TEN, DRESS, and AGEP and says to stop valacyclovir immediately — and it now contraindicates the drug in anyone who has previously had a severe cutaneous reaction to valacyclovir or acyclovir); or unexplained bruising, tiny red skin spots, and severe fatigue (TTP/HUS, which the label reports as sometimes fatal in patients with advanced HIV disease and in bone marrow and kidney transplant recipients taking 8 grams a day).
Does valacyclovir hurt your kidneys?
It can, and the mechanism tells you how to avoid it. Valacyclovir converts to acyclovir, which can crystallize in the kidney tubules when its concentration exceeds its solubility. The FDA label therefore lists inadequate hydration as one of the four situations where acute renal failure has been reported — the other three are elderly patients, people whose dose was too high for their kidney function, and people also taking nephrotoxic drugs. Practical translation: drink fluids steadily through the course, tell the prescriber about any kidney problems so the dose gets reduced, and mention regular NSAID use. The confusion and hallucinations described above usually travel with the same problem, since acyclovir accumulates when the kidneys cannot clear it.
Are side effects worse on daily suppressive valacyclovir than on a short outbreak course?
Not dramatically, but the exposure math changes and so does the monitoring. A cold sore is treated with a one-day regimen and an outbreak with a few days; suppression means taking it every day for months or years. The labeled risks that scale with cumulative dose and duration — kidney effects and CNS effects — are the ones to watch, which is why kidney function should be rechecked periodically on long-term therapy and why the dose must be adjusted if kidney function drops. The TTP/HUS warning is anchored to very high doses (8 grams daily) in immunocompromised patients, not to standard suppressive dosing.
Cite this page
- APA
- pharmaranks. (2026, July 24). Valacyclovir: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/valacyclovir
- MLA
- “Valacyclovir: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/valacyclovir.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for valacyclovir on DailyMed (NIH) ↗.