Frequently Asked Questions

Valacyclovir Hydrochloride

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Purine nucleosides


Valacyclovir is used for:

Treating shingles (herpes zoster), cold sores (fever blisters or herpes labialis), and treating, suppressing, or reducing transmission of genital herpes in patients with healthy immune systems. It is also used to treat chickenpox in children and teenagers. It is also used to suppress genital herpes in patients with HIV infection.

Valacyclovir is an antiviral. It works by stopping viral replication. However, valacyclovir does not eliminate the virus; it is not a cure. When used as a suppressive therapy in patients with healthy immune systems with genital herpes using safer sex practices, the risk of spreading the infections to others is reduced.

Do NOT use valacyclovir if:

  • you are allergic to any ingredient in valacyclovir or to acyclovir

Contact your doctor or health care provider right away if any of these apply to you.

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Before using valacyclovir:

Some medical conditions may interact with valacyclovir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had a bone marrow or kidney transplant
  • if you have HIV or AIDS
  • if you have kidney problems or you are dehydrated

Some MEDICINES MAY INTERACT with valacyclovir. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDS] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney

This may not be a complete list of all interactions that may occur. Ask your health care provider if valacyclovir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use valacyclovir:

Use valacyclovir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take valacyclovir by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Drinking extra fluids while you are taking valacyclovir is recommended. Check with your doctor for instructions.
  • To treat cold sores, chickenpox, shingles, or genital herpes, start treatment as soon as possible after your symptoms start.
  • If treating an acute outbreak, use valacyclovir for the full course of treatment. Keep using it even if you feel better in a few days.
  • For suppressive therapy, valacyclovir works best if it is taken at the same time each day.
  • If you miss a dose of valacyclovir, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use valacyclovir.

Important safety information:

  • Valacyclovir may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use valacyclovir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Valacyclovir is not a cure for herpes. Remain under the care of your doctor.
  • Safer sex practices can lower the chances of passing genital herpes to your partner. Do not have sexual contact with your partner when you have any symptoms or outbreak of genital herpes. Use a condom made of latex or polyurethane whenever you have sexual contact.
  • Valacyclovir has not been shown to decrease the risk of passing other sexually transmitted infections to your partner.
  • Lab tests, including complete blood cell counts, kidney function, and liver function, may be performed while you use valacyclovir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use valacyclovir with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney and nervous system problems.
  • Valacyclovir should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using valacyclovir while you are pregnant. Valacyclovir is found in breast milk. If you are or will be breast-feeding while you use valacyclovir, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of valacyclovir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; aggressive behavior; bloody or dark urine; change in the amount of urine produced; confusion; depression; fatigue; fever; hallucinations; joint pain; lower back pain; painful menstrual periods; pale skin; pinpoint bruises; seizures; severe abdominal pain; severe or persistent headache; shaky movements; speech problems; swelling of the face, hands, feet, or entire body; unsteady movement; unusual bruising or bleeding; weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( ), or emergency room immediately.

Proper storage of valacyclovir:

Store valacyclovir at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep valacyclovir out of the reach of children and away from pets.

General information:

  • If you have any questions about valacyclovir, please talk with your doctor, pharmacist, or other health care provider.
  • Valacyclovir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take valacyclovir or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about valacyclovir. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to valacyclovir. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using valacyclovir.

Issue Date: February 4, 2015
Database Edition
Copyright © 2015 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

It is possible that some side effects of valacyclovir may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to valacyclovir: oral tablet

As well as its needed effects, valacyclovir may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking valacyclovir, check with your doctor immediately:

More common
  • Discouragement
  • feeling sad or empty
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • Black, tarry stools
  • chest pain
  • chills
  • cough
  • decreased frequency or output of urine
  • fever
  • flu-like symptoms
  • headache
  • lower back or side pain
  • reduced mental alertness
  • shortness of breath
  • yellow eyes or skin
Incidence not known
  • Actions that are out of control
  • agitation
  • anxiety
  • back, leg, or stomach pains
  • bleeding gums
  • blood in urine or stools
  • blurred vision
  • change in consciousness
  • change in mental status
  • changes in behavior, especially in interactions with other people
  • changes in patterns and rhythms of speech
  • dark or bloody urine
  • difficult or labored breathing
  • difficulty speaking
  • difficulty swallowing
  • dizziness
  • drowsiness
  • dry mouth
  • fast, pounding, or irregular heartbeat or pulse
  • feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • feeling, seeing, or hearing things that are not there
  • general tiredness and weakness
  • hyperventilation
  • increased thirst
  • itching
  • lightheadedness when getting up from a lying or sitting position
  • light-colored stools
  • loss of consciousness
  • mood or mental changes
  • nausea and vomiting
  • nervousness
  • pale color of skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • seizures
  • severe mood or mental changes
  • shakiness and unsteady walk
  • shakiness in the legs, arms, hands, or feet
  • skin rash
  • slurred speech
  • sores, ulcers, or white spots on the lips or in the mouth
  • stiff neck
  • swelling of the face, fingers, or lower legs
  • swollen or painful glands
  • talking, feeling, and acting with excitement
  • tightness in the chest
  • trembling or shaking of the hands or feet
  • trouble in speaking
  • troubled breathing
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual behavior
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal pain
  • vomiting
  • weight gain
  • wheezing

Some valacyclovir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Body aches or pain
  • cramps
  • difficulty in moving
  • ear congestion
  • heavy bleeding
  • loss of voice
  • muscle aches
  • muscle pain or stiffness
  • nasal congestion
  • pain
  • pain in joints
  • sneezing
  • sore throat
  • stuffy or runny nose
Less common
  • Constipation
  • diarrhea
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • hair loss or thinning of the hair
  • hives or welts
  • increased sensitivity of skin to sunlight
  • red, irritated eyes
  • redness or other discoloration of the skin
  • severe sunburn

For Healthcare Professionals

Applies to valacyclovir: oral tablet


Gastrointestinal side effects have included nausea (up to 15%), abdominal pain (up to 11%), and vomiting (up to 6%). Constipation, anorexia, diarrhea, elevated amylase, and elevated serum lipase have been reported. Diarrhea has been reported during postmarketing experience. In clinical trials of otherwise healthy individuals, frequencies were higher for patients over 50 years of age than for younger patients.[Ref]

Nervous system

Nervous system side effects have included headache (up to 38%) and dizziness (up to 4%). Central nervous system effects including agitation, seizures, and encephalopathy have been reported. Choreiform movements, myoclonus, vasculitic mononeuritis multiplex, somnolence, and Cotard's syndrome have been reported. Agitation, ataxia, coma, decreased consciousness, dysarthria, encephalopathy, seizures, and tremors have been reported during postmarketing experience. Neurotoxicity has been most commonly reported in patients with renal failure, the elderly, and in patients following bone marrow transplant, and is associated with high serum concentrations of acyclovir.[Ref]

Acyclovir neurotoxicity is almost exclusively seen in patients with renal failure. These patients may have longstanding chronic renal failure, or acute failure which may be attributed to acyclovir. One group of six bone marrow transplant patients exhibited abnormal EEGs with diffuse slowing. Although more commonly seen with intravenous administration of higher doses, neurotoxicity has also been reported in patients receiving oral doses of acyclovir. Following discontinuation of therapy, mental status recovered within about a week. Several patients with chronic renal failure exhibiting neurotoxicity improved dramatically following hemodialysis.

Although there have been no similar reports in clinical trials of valacyclovir completed to date, the assumption may be made that neurotoxicity can also occur with valacyclovir based on the fact that plasma acyclovir concentrations from oral valacyclovir administration tend to be much higher than those obtained with oral acyclovir.[Ref]


Psychiatric side effects have included depression (up to 7%) and disorientation. Central nervous system effects including hallucinations, confusion, and delirium have been reported. Aggressive behavior, confusion, mania, and psychosis (including auditory and visual hallucinations) have been reported during postmarketing experience.


Transient renal dysfunction has been reported with both oral and intravenous administration of acyclovir. Crystallization of the drug in the renal tubules is thought to be the mechanism for the development of renal dysfunction based on findings of crystalluria in several case reports and at least one prospective study. Inadequate hydration of the patient and rapid administration of the drug may contribute to the development of crystalluria. Acute tubular necrosis and interstitial nephritis have also been reported in association with acyclovir therapy. Although there have been no similar reports in clinical trials of valacyclovir completed to date, the assumption may be made that renal toxicity can also occur with valacyclovir based on the fact that plasma acyclovir concentrations from oral valacyclovir administration tend to be much higher than those obtained with oral acyclovir.[Ref]

Renal side effects have included acute renal failure, elevated serum creatinine (up to 0.7%), renal toxicity, and renal failure (presenting as an increase in serum creatinine and blood urea nitrogen). Renal failure and renal pain (may be associated with renal failure) have been reported during postmarketing experience. Renal effects are transient and resolve over several days following discontinuation of therapy. Renal damage is most likely due to crystallization of acyclovir in the renal tubules. Patients with preexisting renal insufficiency are at greater risk for developing neurotoxicity and further deterioration in renal function.[Ref]


Hematologic side effects have included thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), and decreased neutrophil counts (18%), platelet counts (up to 3%), hemoglobin (up to 0.8%), and white blood cells (up to 1.3%). Thrombocytopenia, aplastic anemia, leukocytoclastic vasculitis, and TTP/HUS have been reported during postmarketing experience.[Ref]

TTP/HUS, including some fatalities, has been reported during clinical trials in patients with advanced HIV disease and in allogeneic bone marrow transplant and renal transplant recipients, who were receiving 8 g valacyclovir per day.[Ref]


Hepatic side effects have included elevated AST (up to 16%), ALT (up to 14%), and bilirubin. Liver enzyme abnormalities and hepatitis have been reported during postmarketing experience.[Ref]


Hypersensitivity side effects have included acute hypersensitivity reactions (including anaphylaxis, angioedema, dyspnea, pruritus, rash, and urticaria) during postmarketing experience. Stevens-Johnson syndrome has been reported.[Ref]


Dermatologic side effects have included rash (8%). Erythema multiforme, rashes including photosensitivity, and alopecia have been reported during postmarketing experience.[Ref]


Cardiovascular side effects have included hypertension and tachycardia during postmarketing experience.[Ref]


Ocular side effects have included visual abnormalities during postmarketing experience.[Ref]


Respiratory side effects have included nasopharyngitis (16%) and upper respiratory tract infection (9%).[Ref]


Musculoskeletal side effects have included arthralgia (up to 6%).[Ref]


Genitourinary side effects have included dysmenorrhea (up to 8%).[Ref]


Other side effects have included fatigue (8%). Facial edema has been reported during postmarketing experience.[Ref]


Metabolic side effects have included elevated alkaline phosphatase (4%) and hypoglycemia. At least one case of hypercalcemia has been reported.[Ref]


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