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valacyclovir

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Brand names: Valtrex

Antiviral Rx

Valacyclovir is an antiviral medicine. It is used to treat infections caused by certain viruses.

Drug Pricing (NADAC)

Brand Price

$20.32/unit

Generic Price

$0.43/unit

Generic Savings

98%

Generic Available

Yes (7 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Valacyclovir treats cold sores, genital herpes, and shingles.

Common side effects

Headache, Nausea, Abdominal pain

Key warnings

Valacyclovir can cause serious problems like TTP/HUS, which is a blood disorder.

How It Works

Valacyclovir stops the virus from growing and spreading. It does this by blocking a key enzyme the virus needs to reproduce. This helps your body fight off the infection.

How to Take It

You can take valacyclovir with or without food. For cold sores, the usual dose is 2 grams every 12 hours for 1 day. For genital herpes, the dose and how long you take it depends on whether it's your first outbreak or a repeat outbreak. Follow your doctor's instructions carefully.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. Studies haven't shown a risk of major birth defects, but there isn't enough data to be sure about miscarriage or other problems. Talk to your doctor about the risks and benefits.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store valacyclovir tablets at room temperature, away from heat and moisture.

Side Effects (from patient reports)

Based on 17,827 FDA adverse event reports.

Using the medicine for something it's not approved for
2,544
Feeling very tired
2,294
Loose, watery stools
2,120
The medicine is not working
1,892
Feeling sick to your stomach
1,838
Fever with low white blood cell count
1,545
Fever
1,490
Lung infection
1,448
Pain in your head
1,355
Discomfort
1,301

FDA Adverse Event Report Analysis

Detailed analysis of 39,048 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

39,048

Death-Related Reports

3,520

Hospitalization Reports

15,607

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 19,606 (56%)
Male 15,435 (44%)

Age Distribution

0–17 737
18–44 3,735
45–64 9,470
65–74 7,506
75+ 5,288

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 OFF LABEL USE 2,544
2 FATIGUE 2,294
3 DIARRHOEA 2,120
4 DRUG INEFFECTIVE 1,892
5 NAUSEA 1,838
6 FEBRILE NEUTROPENIA 1,545
7 PYREXIA 1,490
8 PNEUMONIA 1,448
9 HEADACHE 1,355
10 PAIN 1,301
11 RASH 1,241
12 NEUTROPENIA 1,150
13 ACUTE KIDNEY INJURY 1,101
14 DYSPNOEA 1,063
15 DEATH 1,049

Reactions in Death Reports

DEATH 1,041
OFF LABEL USE 318
PNEUMONIA 217
THROMBOCYTOPENIA 214
NEUTROPENIA 205
PYREXIA 199
SEPTIC SHOCK 195
DISEASE PROGRESSION 187
SEPSIS 183
DIARRHOEA 155

Reactions in Hospitalization Reports

FEBRILE NEUTROPENIA 1,189
PNEUMONIA 1,115
PYREXIA 1,012
OFF LABEL USE 912
ACUTE KIDNEY INJURY 843
DIARRHOEA 799
FATIGUE 630
CYTOKINE RELEASE SYNDROME 627
NAUSEA 607
NEUTROPENIA 507

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Valacyclovir can cause serious problems like TTP/HUS, which is a blood disorder. This is more likely in people with advanced HIV or who have had bone marrow or kidney transplants, especially if they take high doses (8 grams per day). It can also cause kidney failure, especially in older adults or people with kidney problems. Rarely, it can cause confusion, hallucinations, or agitation. Stop taking this medicine and contact your doctor immediately if you experience any of these side effects.

Known Drug Interactions

Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.4) ] .

Mechanism: Both of these drugs are removed from the body through the same pathway in the kidneys, which may cause them to compete for exit.

What to do: Your doctor should monitor your kidney function closely while you are taking both medications.

Some examples include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3) ] .

Mechanism: Both of these drugs are removed from the body through the kidneys, and taking them together can increase the risk of kidney damage.

What to do: Your doctor should monitor your kidney function closely while you are taking both of these medications.

Some examples include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions ( 5.2)].

Mechanism: Both of these drugs are removed from the body by the kidneys, and taking them together can put extra stress on your kidney function.

What to do: Your doctor should check your kidney function regularly while you are using these medications together.

Common Questions

Can I take valacyclovir if I'm allergic to acyclovir?
No, you should not take valacyclovir if you are allergic to acyclovir or any of the ingredients in valacyclovir tablets.
How quickly does valacyclovir work?
Valacyclovir starts working right away, but it may take a few days to notice improvement in your symptoms.
Can valacyclovir cure herpes?
No, valacyclovir cannot cure herpes, but it can help manage the symptoms and prevent outbreaks.
Does valacyclovir interact with other medications?
There are no known major drug interactions with valacyclovir.
Can children take valacyclovir?
Yes, valacyclovir can be used in children to treat cold sores and chickenpox. The dose depends on the child's age and weight.
What should I do if I think I have a side effect?
Tell your doctor about any side effects you experience while taking valacyclovir.
Can I drink alcohol while taking valacyclovir?
There is no known interaction between alcohol and valacyclovir.
How long can I take valacyclovir for suppressive therapy?
The safety and effectiveness of valacyclovir for suppressive therapy has been established for up to 1 year in people with normal immune systems and up to 6 months in people with HIV.
What if I have kidney problems?
If you have kidney problems, your doctor may need to adjust your dose of valacyclovir.
Can valacyclovir prevent the spread of genital herpes?
Valacyclovir can reduce the risk of spreading genital herpes, but it is still important to practice safer sex.
What are the common side effects of valacyclovir?
The most commonly reported side effects of valacyclovir include Headache, Nausea, Abdominal pain. Based on 17,827 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does valacyclovir interact with other medications?
Yes, valacyclovir has 3 known drug interactions. Notable interactions include bictegravir/emtricitabine/tenofovir, emtricitabine/tenofovir, tenofovir disoproxil. Always inform your doctor about all medications you are taking.
What drug class is valacyclovir?
valacyclovir belongs to the Antiviral drug class. It requires a prescription (Rx). Valacyclovir treats cold sores, genital herpes, and shingles.
Is there a generic version of valacyclovir?
Yes, generic valacyclovir is available from 7 manufacturers. The generic costs $0.43 per unit compared to $20.32 for the brand version, saving approximately 98%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is valacyclovir safe during pregnancy?
Tell your doctor if you are pregnant or plan to become pregnant. Studies haven't shown a risk of major birth defects, but there isn't enough data to be sure about miscarriage or other problems. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for valacyclovir

The FDA label for valacyclovir (sold under brand names such as Valtrex) classifies it as a prescription-only medication in the Antiviral class. Valacyclovir treats cold sores, genital herpes, and shingles. Official labeling lists 3 commonly reported side effects, including Headache, Nausea, Abdominal pain.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 17,827 voluntary reports. The database also lists 3 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.43 versus $20.32 for the brand — a 98% generic savings.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: July 11, 2024

All federal data sources used on this page